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Understanding taste dysfunction in cancer
Image by Jonas Töle
Investigators have identified a molecular pathway that aids the renewal of taste buds, and they believe this discovery may have implications for cancer patients who suffer from an altered sense of taste during treatment.
“Taste dysfunction can . . . result from an alteration of the renewal capacities of taste buds and is often associated with psychological distress and malnutrition,” said Dany Gaillard, PhD, of the University of Colorado Anschutz Medical Campus in Aurora.
He and his colleagues decided to investigate this dysfunction using mouse models, and the group reported their findings in PLOS Genetics.
The investigators discovered that a protein in the Wnt pathway, ß-catenin, controls the renewal of taste cells by regulating separate stages of taste-cell turnover.
Previous research showed that Wnt/β-catenin signaling is crucial in developing taste buds in embryos and regulating the renewal of epithelial tissue in adults, including skin, hair follicles, the intestine, and the mouth.
“We show that activating this pathway directs the newly born cells to become, primarily, a specific taste- cell type whose role is to support the other taste cells and help them work efficiently,” said Linda Barlow, PhD, also of the University of Colorado Anschutz Medical Campus.
As chemotherapy destroys dividing precursor cells, including those that produce taste cells, the investigators believe that activating Wnt signaling may be a way to renew taste buds after chemotherapy.
New small-molecule drugs that specifically block the Wnt pathway are under development, and Drs Gaillard and Barlow predict these drugs could also cause taste dysfunction.
Dr Barlow said more research is needed to understand how taste is altered at the cellular level, but this research holds promise for developing new ways to improve cancer patients’ quality of life. 
Image by Jonas Töle
Investigators have identified a molecular pathway that aids the renewal of taste buds, and they believe this discovery may have implications for cancer patients who suffer from an altered sense of taste during treatment.
“Taste dysfunction can . . . result from an alteration of the renewal capacities of taste buds and is often associated with psychological distress and malnutrition,” said Dany Gaillard, PhD, of the University of Colorado Anschutz Medical Campus in Aurora.
He and his colleagues decided to investigate this dysfunction using mouse models, and the group reported their findings in PLOS Genetics.
The investigators discovered that a protein in the Wnt pathway, ß-catenin, controls the renewal of taste cells by regulating separate stages of taste-cell turnover.
Previous research showed that Wnt/β-catenin signaling is crucial in developing taste buds in embryos and regulating the renewal of epithelial tissue in adults, including skin, hair follicles, the intestine, and the mouth.
“We show that activating this pathway directs the newly born cells to become, primarily, a specific taste- cell type whose role is to support the other taste cells and help them work efficiently,” said Linda Barlow, PhD, also of the University of Colorado Anschutz Medical Campus.
As chemotherapy destroys dividing precursor cells, including those that produce taste cells, the investigators believe that activating Wnt signaling may be a way to renew taste buds after chemotherapy.
New small-molecule drugs that specifically block the Wnt pathway are under development, and Drs Gaillard and Barlow predict these drugs could also cause taste dysfunction.
Dr Barlow said more research is needed to understand how taste is altered at the cellular level, but this research holds promise for developing new ways to improve cancer patients’ quality of life.
Image by Jonas Töle
Investigators have identified a molecular pathway that aids the renewal of taste buds, and they believe this discovery may have implications for cancer patients who suffer from an altered sense of taste during treatment.
“Taste dysfunction can . . . result from an alteration of the renewal capacities of taste buds and is often associated with psychological distress and malnutrition,” said Dany Gaillard, PhD, of the University of Colorado Anschutz Medical Campus in Aurora.
He and his colleagues decided to investigate this dysfunction using mouse models, and the group reported their findings in PLOS Genetics.
The investigators discovered that a protein in the Wnt pathway, ß-catenin, controls the renewal of taste cells by regulating separate stages of taste-cell turnover.
Previous research showed that Wnt/β-catenin signaling is crucial in developing taste buds in embryos and regulating the renewal of epithelial tissue in adults, including skin, hair follicles, the intestine, and the mouth.
“We show that activating this pathway directs the newly born cells to become, primarily, a specific taste- cell type whose role is to support the other taste cells and help them work efficiently,” said Linda Barlow, PhD, also of the University of Colorado Anschutz Medical Campus.
As chemotherapy destroys dividing precursor cells, including those that produce taste cells, the investigators believe that activating Wnt signaling may be a way to renew taste buds after chemotherapy.
New small-molecule drugs that specifically block the Wnt pathway are under development, and Drs Gaillard and Barlow predict these drugs could also cause taste dysfunction.
Dr Barlow said more research is needed to understand how taste is altered at the cellular level, but this research holds promise for developing new ways to improve cancer patients’ quality of life.
Verbal Communication at Discharge
Timely and reliable communication of important data between hospital‐based physicians and primary care physicians is critical for prevention of medical adverse events.[1, 2] Extrapolation from high‐performance organizations outside of medicine suggests that verbal communication is an important component of patient handoffs.[3, 4] Though the Joint Commission does not mandate verbal communication during handoffs per se, stipulating instead that handoff participants have an opportunity to ask and respond to questions,[5] there is some evidence that primary care providers prefer verbal handoffs at least for certain patients such as those with medical complexity.[6] Verbal communication offers the receiver the opportunity to ask questions, but in practice, 2‐way verbal communication is often difficult to achieve at hospital discharge.
At our institution, hospital medicine (HM) physicians serve as the primary inpatient providers for nearly 90% of all general pediatric admissions. When the HM service was established, primary care physicians (PCPs) and HM physicians together agreed upon an expectation for verbal, physician‐to‐physician communication at the time of discharge. Discharge communication is provided by either residents or attendings depending on the facility. A telephone operator service called Physician Priority Link (PPL) was made available to facilitate this communication. The PPL service is staffed 24/7 by operators whose only responsibilities are to connect providers inside and outside the institution. By utilizing this service, PCPs could respond in a nonemergent fashion to discharge phone calls.
Over the last several years, PCPs have observed high variation in the reliability of discharge communication phone calls. A review of PPL phone records in 2009 showed that only 52% of HM discharges had a record of a call initiated to the PCP on the day of discharge. The overall goal of this improvement project was to improve the completion of verbal handoffs from HM physicians (residents or attendings) to PCPs. The specific aim of the project was to increase the proportion of completed verbal handoffs from on‐call residents or attendings to PCPs within 24 hours of discharge to more than 90% within 18 months.
METHODS
Human Subjects Protection
Our project was undertaken in accordance with institutional review board (IRB) policy on systems improvement work and did not require formal IRB review.
Setting
This study included all patients admitted to the HM service at an academic children's hospital and its satellite campus.
Planning the Intervention
The project was championed by physicians on the HM service and supported by a chief resident, PPL administrators, and 2 information technology analysts.
At the onset of the project, the team mapped the process for completing a discharge call to the PCPs, conducted a modified failure mode and effects analysis,[7, 8] and examined the key drivers used to prioritize interventions (Figure 1). Through the modified failure modes effect analysis, the team was able to identify system issues that led to unsuccessful communication: failure of call initiation, absence of an identified PCP, long wait times on hold, failure of PCP to call back, and failure of the call to be documented. These failure modes informed the key drivers to achieving the study aim. Figure 2 depicts the final key drivers, which were revised through testing and learning.
Interventions Targeting Key Stakeholder Buy‐in
To improve resident buy‐in and participation, the purpose and goals of the projects were discussed at resident morning report and during monthly team meetings by the pediatric chief resident on our improvement team. Resident physicians were interested in participating to reduce interruptions during daily rounds and to improve interactions with PCPs. The PPL staff was interested in standardizing the discharge call process to reduce confusion in identifying the appropriate contact when PCPs called residents back to discuss discharges. PCPs were interested in ensuring good communication at discharge, and individual PCPs were engaged through person‐to‐person contact by 1 of the HM physician champions.
Interventions to Standardization the Communication Process
To facilitate initiation of calls to PCPs at hospital discharge, the improvement team created a standard process using the PPL service (Figure 3). All patients discharged from the HM service were included in the process. Discharging physicians (who were usually but not always residents, depending on the facility), were instructed to call the PPL operator at the time of discharge. The PPL operator would then page the patient's PCP. It was the responsibility of the discharging physician to identify a PCP prior to discharge. Instances where no PCP was identified were counted as process failures because no phone call could be made. The expectation for the PCPs was that they would return the page within 20 minutes. PPL operators would then page back to the discharging physician to connect the 2 parties with the expectation that the discharging physician respond within 2 to 4 minutes to the PPL operator's page. Standardization of all calls through PPL allowed efficient tracking of incomplete calls and operators to reattempt calls that were not completed. This process also shifted the burden of following up on incomplete calls to PPL. The use of PPL to make the connection also allowed the physician to complete other work while awaiting a call back from the PCP.
Leveraging the Electronic Health Record for Process Initiation
To ensure reliable initiation of the discharge communication pathway, the improvement team introduced changes to the electronic health record (HER) (EpicCare Inpatient; Epic Systems Corp., Verona, WI), which generated a message to PPL operators whenever a discharge order was entered for an HM patient. The message contained the patient's name, medical record number, discharge date, discharging physician, and PCP name and phone number. A checklist was implemented by PPL to ensure that duplicate phone calls were not made. To initiate communication, the operator contacted the resident via text page to ensure they were ready to initiate the call. If the resident was ready to place a call, the operator then generated a phone call to the PCP. When the PCP returned the call, the operator connected the HM resident with the PCP for the handoff.
As the project progressed, several adaptations were made to address newly identified failure modes. To address confusion among PPL operators about which resident physicians should take discharge phone calls after the discharging resident was no longer available (for example, after a shift change), primary responsibility for discharge phone calls was reassigned to the daily on‐call resident rather than the resident who wrote the discharge order. Because the on‐call residents carry a single pager, the pager number listed on the automated discharge notification to PPL would never change and would always reach the appropriate team member. Second, to address the anticipated increase in interruption of resident workflow by calls back from PCPs, particularly during rounds, operators accessed information on pending discharge phone calls in batches at times of increased resident availability to minimize hold times for PCPs and work interruptions for the discharging physicians. Batch times were 1 pm and 4 pm to allow for completion of morning rounds, resident conference at noon, and patient‐care activities during the afternoon. Calls initiated after 4 pm were dispatched at the time of the discharge, and calls initiated after 10 pm were deferred to the following day.
Transparency of Data
Throughout the study, weekly failure data were generated from the EHR and emailed to improvement team members, enabling them to focus on near real‐time feedback of data to create a visible and more reliable system. With the standardization of all discharge calls directed to the PPL operators, the team was able to create a call record linked to the patient's medical record number. Team‐specific and overall results for the 5 HM resident teams were displayed weekly on a run chart in the resident conference room. As improvements in call initiation were demonstrated, completion rate data were also shared every several months with the attending hospitalists during a regularly scheduled divisional conference. This transparency of data gave the improvement team the opportunity to provide individual feedback to residents and attendings about failures. The weekly review of failure data allowed team leaders to learn from failures, identify knowledge gaps, and ensure accountability with the HM physicians.
Planning the Study of the Intervention
Data were collected prospectively from July 2011 to March 2014. A weekly list of patients discharged from the HM service was extracted from the EHR and compared to electronic call logs collected by PPL on the day of discharge. A standard sample size of 30 calls was audited separately by PPL and 1 of the physician leads to verify that the patients were discharged from the HM service and validate the percentage of completed and initiated calls.
The percentage of calls initiated within 24 hours of discharge was tracked as a process measure and served as the initial focus of improvement efforts. Our primary outcome measure was the percentage of calls completed to the PCP by the HM physician within 24 hours of discharge.
Methods of Evaluation and Analysis
We used improvement science methods and run charts to determine the percentage of patients discharged from the HM service with a call initiated to the PCP and completed within 24 hours of discharge. Data on calls initiated within 24 hours of discharge were plotted on a run chart to examine the impact of interventions over time. Once interventions targeted at call initiation had been implemented, we began tracking our primary outcome measure. A new run chart was created documenting the percentage of calls completed. For both metrics, the centerline was adjusted using established rules for special cause variation in run charts.[9, 10, 11, 12, 13]
RESULTS
From July 2011 to March 2014, there were 6313 discharges from the HM service. The process measure (percentage of calls initiated) improved from 50% to 97% after 4 interventions (Figure 4). Data for the outcome measure (percentage of calls completed) were collected starting in August 2012, shortly after linking the EHR discharge order to the discharge call. Over the first 8 weeks, our median was 80%, which increased to a median of 93% (Figure 5). These results were sustained for 18 months.
Several key interventions were identified that were critical to achievement of our goal. Standardization of the communication process through PPL was temporally associated with a shift in the median rate of call initiation from 52% to 72%. Use of the discharge order to initiate discharge communication was associated with an increase from 72% to 97%. Finally, the percentage of completed verbal handoffs increased to more than 93% following batching of phone calls to PCPs at specific times during the day.
DISCUSSION
We used improvement and reliability science methods to implement a successful process for improving verbal handoffs from HM physicians to PCPs within 24 hours of discharge to 93%. This result has been sustained for 18 months.
Utilization of the PPL call center for flexible call facilitation along with support for data analysis and leveraging the EHR to automate the process increased reliability, leading to rapid improvement. Prior to mandating the use of PPL to connect discharging physicians with PCPs, the exact rate of successful handoffs in our institution was not known. We do know, however, that only 52% of calls were initiated, so clearly a large gap was present prior to our improvement work. Data collection from the PPL system was automated so that accurate, timely, and sustainable data could be provided, greatly aiding improvement efforts. Flexibility in call‐back timing was also crucial, because coordinating the availability of PCPs and discharging physicians is often challenging. The EHR‐initiated process for discharge communication was a key intervention, and improvement of our process measure to 97% performance was associated with this implementation. Two final interventions: (1) assignment of responsibility for communication to a team pager held by a designated resident and (2) batching of calls to specific times streamlined the EHR‐initiated process and were associated with achievement of our main outcome goal of >90% completed verbal communication.
There are several reports of successful interventions to improve receipt or content of discharge summaries by PCPs following hospital discharge available in the literature.[14, 15, 16, 17, 18, 19, 20] Recently, Shen et al. reported on the success of a multisite improvement collaborative involving pediatric hospitalist programs at community hospitals whose aim was to improve the timely documentation of communication directed at PCPs.[21] In their report, all 7 hospital sites that participated in the collaborative for more than 4 months were able to demonstrate substantial improvement in documentation of some form of communication directed at PCPs (whether by e‐mail, fax, or telephone call), from a baseline of approximately 50% to more than 90%. A limitation of their study was that they were unable to document whether PCPs had received any information or by what method. A recent survey of PCPs by Sheu et al. indicated that for many discharges, information in addition to that present in the EHR was desirable to ensure a safe transition of care.[6] Two‐way communication, such as with a phone call, allows for senders to verify information receipt and for receivers to ask questions to ensure complete information. To our knowledge, there have been no previous reports describing processes for improving verbal communication between hospitalist services and PCPs at discharge.
It may be that use of the call system allowed PCPs to return phone calls regarding discharges at convenient stopping points in their day while allowing discharging physicians to initiate a call without having to wait on hold. Interestingly, though we anticipated the need for additional PPL resources during the course of this improvement, the final process was efficient enough that PPL did not require additional staffing to accommodate the higher call volume.
A key insight during our implementation was that relying on the EHR to initiate every discharge communication created disruption of resident workflow due to disregard of patient, resident, and PCP factors. This was reflected by the improvement in call initiation (our process measure) following this intervention, whereas at the same time call completion (our outcome measure) remained below goal. To achieve our goal of completing verbal communication required a process that was highly reliable yet flexible enough to allow discharging physicians to complete the call in the unpredictable environment of inpatient care. Ultimately, this was achieved by allowing discharging physicians to initiate the process when convenient, and allowing for the EHR‐initiated process to function as a backup strategy to identify and mitigate failures of initiation.
An important limitation of our study was the lack of PCPs on the improvement team, likely making the success of the project more difficult than it might have been. For example, during the study we did not measure the time PCPs spent on hold or how many reattempts were needed to complete the communication loop. Immediately following the completion of our study, it became apparent that physicians returning calls for our own institution's primary care clinic were experiencing regular workflow interruptions and occasional hold times more than 20 minutes, necessitating ongoing further work to determine the root causes and solutions to these problems. Though this work is ongoing, average PCP hold times measured from a sample of call reviews in 2013 to 2014 was 3 minutes and 15 seconds.
This study has several other limitations. We were unable to account for phone calls to PCPs initiated outside of the new process. It may be that PCPs were called more than 52% of the time at baseline due to noncompliance with the new protocol. Also, we only have data for call completion starting after implementation of the link between the discharge order and the discharge phone call, making the baseline appear artificially high and precluding any analysis of how earlier interventions affected our outcome metric. Communication with PCPs should ideally occur prior to discharge. An important limitation of our process is that calls could occur several hours after discharge between an on‐call resident and an on‐call outpatient physician rather than between the PCP and the discharging resident, limiting appropriate information exchange. Though verbal discharge communication is a desirable goal for many reasons, the current project did not focus on the quality of the call or the information that was transmitted to the PCP. Additionally, direct attending‐to‐attending communication may be valuable with medically or socially complex discharges, but we did not have a process to facilitate this. We also did not measure what effect our new process had on outcomes such as quality of patient and family transition from hospital or physician satisfaction. The existence of programs similar to our PPL subspecialty referral line may be limited to large institutions. However, it should be noted that although some internal resource reallocation was necessary within PPL, no actual staffing increases were required despite a large increase in call volume. It may be that any hospital operator system could be adapted for this purpose with modest additional resources. Finally, although our EHR system is widely utilized, there are many competing systems in the market, and our intervention required utilization of EHR capabilities that may not be present in all systems. However, our EHR intervention utilized existing functionality and did not require modification of the system.
This project focused on discharge phone calls to primary care physicians for patients hospitalized on the hospital medicine service. Because communication with the PCP should ideally occur prior to discharge, future work will include identifying a more proximal trigger than the discharge order to which to link the EHR trigger for discharge communication. Other next steps to improve handoff effectiveness and optimize the efficiency of our process include identifying essential information that should be transmitted to the primary care physician at the time of the phone call, developing processes to ensure communication of this information, measuring PCP satisfaction with this communication, and measuring the impact on patient outcomes. Finally, though expert opinion indicates that verbal handoffs may have safety advantages over nonverbal handoffs, studies comparing the safety and efficacy of verbal versus nonverbal handoffs at patient discharge are lacking. Studies establishing the relative efficacy and safety of verbal versus nonverbal handoffs at hospital discharge are needed. Knowledge gained from these activities could inform future projects centered on the spread of the process to other hospital services and/or other hospitals.
CONCLUSION
We increased the percentage of calls initiated to PCPs at patient discharge from 52% to 97% and the percentage of calls completed between HM physicians and PCPs to 93% through the use of a standardized discharge communication process coupled with a basic EHR messaging functionality. The results of this study may be of interest for further testing and adaptation for any institution with an electronic healthcare system.
Disclosure: Nothing to report.
- , , . Passing the clinical baton: 6 principles to guide the hospitalist. Am J Med. 2001;111(9B):36S–39S.
- , , , , . Evaluating communication between pediatric primary care physicians and hospitalists. Clin Pediatr. 2011;50(10):923–928.
- , , , , , . Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7):433–440.
- , , , , . Handoff strategies in settings with high consequences for failure: lessons for health care operations. Int J Qual Health Care. 2004;16(2):125–132.
- Agency for Healthcare Research and Quality. Patient safety primers: handoffs and signouts. Available at: http://www.psnet.ahrq.gov/primer.aspx?primerID=9. Accessed March 19, 2014.
- , , , , . We need to talk: primary care provider communication at discharge in the era of a shared electronic medical record. J Hosp Med. 2015;10(5):307–310.
- , , . Failure mode and effects analysis: a novel approach to avoiding dangerous medication errors and accidents. Hosp Pharm. 1994;29:319–330.
- , , , . Using health care Failure Mode and Effect Analysis: the VA National Center for Patient Safety's prospective risk analysis system. Jt Comm J Qual Improv. 2002;28:248–267, 209.
- . Statistical quality control methods in infection control and hospital epidemiology, Part II: Chart use, statistical properties, and research issues. Infect Control Hosp Epidemiol. 1998;19(4):265–283.
- . Statistical quality control methods in infection control and hospital epidemiology, part I: Introduction and basic theory. Infect Control Hosp Epidemiol. 1998;19(3):194–214.
- , , . Statistical process control as a tool for research and healthcare improvement. Qual Saf Health Care. 2003;12(6):458–464.
- . The Improvement Guide: A Practical Approach to Enhancing Organizational +Performance. 2nd ed. San Francisco, CA: Jossey‐Bass; 2009.
- , . The Health Care Data Guide: Learning From Data for Improvement. 1st ed. San Francisco, CA: Jossey‐Bass; 2011.
- , . The initial hospital discharge note: send out with the patient or post? Health Trends. 1984;16(2):48.
- , . Which type of hospital discharge report reaches general practitioners most quickly? BMJ. 1989;298(6670):362–363.
- , . The application of a computer data base system to the generation of hospital discharge summaries. Obstet Gynecol. 1989;73(5 pt 1):803–807.
- . Hospital discharge medication: is seven days supply sufficient? Public Health. 1991;105(3):243–247.
- , , , et al. Electronic communication between providers of primary and secondary care. BMJ. 1992;305(6861):1068–1070.
- , , . Communication of discharge information for elderly patients in hospital. Ulster Med J. 1992;61(1):56–58.
- , , , , . A quality use of medicines program for continuity of care in therapeutics from hospital to community. Med J Aust. 2002;177(1):32–34.
- , , , , , . Pediatric hospitalists collaborate to improve timeliness of discharge communication. Hosp Pediatr. 2013;3(3):258–265.
Timely and reliable communication of important data between hospital‐based physicians and primary care physicians is critical for prevention of medical adverse events.[1, 2] Extrapolation from high‐performance organizations outside of medicine suggests that verbal communication is an important component of patient handoffs.[3, 4] Though the Joint Commission does not mandate verbal communication during handoffs per se, stipulating instead that handoff participants have an opportunity to ask and respond to questions,[5] there is some evidence that primary care providers prefer verbal handoffs at least for certain patients such as those with medical complexity.[6] Verbal communication offers the receiver the opportunity to ask questions, but in practice, 2‐way verbal communication is often difficult to achieve at hospital discharge.
At our institution, hospital medicine (HM) physicians serve as the primary inpatient providers for nearly 90% of all general pediatric admissions. When the HM service was established, primary care physicians (PCPs) and HM physicians together agreed upon an expectation for verbal, physician‐to‐physician communication at the time of discharge. Discharge communication is provided by either residents or attendings depending on the facility. A telephone operator service called Physician Priority Link (PPL) was made available to facilitate this communication. The PPL service is staffed 24/7 by operators whose only responsibilities are to connect providers inside and outside the institution. By utilizing this service, PCPs could respond in a nonemergent fashion to discharge phone calls.
Over the last several years, PCPs have observed high variation in the reliability of discharge communication phone calls. A review of PPL phone records in 2009 showed that only 52% of HM discharges had a record of a call initiated to the PCP on the day of discharge. The overall goal of this improvement project was to improve the completion of verbal handoffs from HM physicians (residents or attendings) to PCPs. The specific aim of the project was to increase the proportion of completed verbal handoffs from on‐call residents or attendings to PCPs within 24 hours of discharge to more than 90% within 18 months.
METHODS
Human Subjects Protection
Our project was undertaken in accordance with institutional review board (IRB) policy on systems improvement work and did not require formal IRB review.
Setting
This study included all patients admitted to the HM service at an academic children's hospital and its satellite campus.
Planning the Intervention
The project was championed by physicians on the HM service and supported by a chief resident, PPL administrators, and 2 information technology analysts.
At the onset of the project, the team mapped the process for completing a discharge call to the PCPs, conducted a modified failure mode and effects analysis,[7, 8] and examined the key drivers used to prioritize interventions (Figure 1). Through the modified failure modes effect analysis, the team was able to identify system issues that led to unsuccessful communication: failure of call initiation, absence of an identified PCP, long wait times on hold, failure of PCP to call back, and failure of the call to be documented. These failure modes informed the key drivers to achieving the study aim. Figure 2 depicts the final key drivers, which were revised through testing and learning.
Interventions Targeting Key Stakeholder Buy‐in
To improve resident buy‐in and participation, the purpose and goals of the projects were discussed at resident morning report and during monthly team meetings by the pediatric chief resident on our improvement team. Resident physicians were interested in participating to reduce interruptions during daily rounds and to improve interactions with PCPs. The PPL staff was interested in standardizing the discharge call process to reduce confusion in identifying the appropriate contact when PCPs called residents back to discuss discharges. PCPs were interested in ensuring good communication at discharge, and individual PCPs were engaged through person‐to‐person contact by 1 of the HM physician champions.
Interventions to Standardization the Communication Process
To facilitate initiation of calls to PCPs at hospital discharge, the improvement team created a standard process using the PPL service (Figure 3). All patients discharged from the HM service were included in the process. Discharging physicians (who were usually but not always residents, depending on the facility), were instructed to call the PPL operator at the time of discharge. The PPL operator would then page the patient's PCP. It was the responsibility of the discharging physician to identify a PCP prior to discharge. Instances where no PCP was identified were counted as process failures because no phone call could be made. The expectation for the PCPs was that they would return the page within 20 minutes. PPL operators would then page back to the discharging physician to connect the 2 parties with the expectation that the discharging physician respond within 2 to 4 minutes to the PPL operator's page. Standardization of all calls through PPL allowed efficient tracking of incomplete calls and operators to reattempt calls that were not completed. This process also shifted the burden of following up on incomplete calls to PPL. The use of PPL to make the connection also allowed the physician to complete other work while awaiting a call back from the PCP.
Leveraging the Electronic Health Record for Process Initiation
To ensure reliable initiation of the discharge communication pathway, the improvement team introduced changes to the electronic health record (HER) (EpicCare Inpatient; Epic Systems Corp., Verona, WI), which generated a message to PPL operators whenever a discharge order was entered for an HM patient. The message contained the patient's name, medical record number, discharge date, discharging physician, and PCP name and phone number. A checklist was implemented by PPL to ensure that duplicate phone calls were not made. To initiate communication, the operator contacted the resident via text page to ensure they were ready to initiate the call. If the resident was ready to place a call, the operator then generated a phone call to the PCP. When the PCP returned the call, the operator connected the HM resident with the PCP for the handoff.
As the project progressed, several adaptations were made to address newly identified failure modes. To address confusion among PPL operators about which resident physicians should take discharge phone calls after the discharging resident was no longer available (for example, after a shift change), primary responsibility for discharge phone calls was reassigned to the daily on‐call resident rather than the resident who wrote the discharge order. Because the on‐call residents carry a single pager, the pager number listed on the automated discharge notification to PPL would never change and would always reach the appropriate team member. Second, to address the anticipated increase in interruption of resident workflow by calls back from PCPs, particularly during rounds, operators accessed information on pending discharge phone calls in batches at times of increased resident availability to minimize hold times for PCPs and work interruptions for the discharging physicians. Batch times were 1 pm and 4 pm to allow for completion of morning rounds, resident conference at noon, and patient‐care activities during the afternoon. Calls initiated after 4 pm were dispatched at the time of the discharge, and calls initiated after 10 pm were deferred to the following day.
Transparency of Data
Throughout the study, weekly failure data were generated from the EHR and emailed to improvement team members, enabling them to focus on near real‐time feedback of data to create a visible and more reliable system. With the standardization of all discharge calls directed to the PPL operators, the team was able to create a call record linked to the patient's medical record number. Team‐specific and overall results for the 5 HM resident teams were displayed weekly on a run chart in the resident conference room. As improvements in call initiation were demonstrated, completion rate data were also shared every several months with the attending hospitalists during a regularly scheduled divisional conference. This transparency of data gave the improvement team the opportunity to provide individual feedback to residents and attendings about failures. The weekly review of failure data allowed team leaders to learn from failures, identify knowledge gaps, and ensure accountability with the HM physicians.
Planning the Study of the Intervention
Data were collected prospectively from July 2011 to March 2014. A weekly list of patients discharged from the HM service was extracted from the EHR and compared to electronic call logs collected by PPL on the day of discharge. A standard sample size of 30 calls was audited separately by PPL and 1 of the physician leads to verify that the patients were discharged from the HM service and validate the percentage of completed and initiated calls.
The percentage of calls initiated within 24 hours of discharge was tracked as a process measure and served as the initial focus of improvement efforts. Our primary outcome measure was the percentage of calls completed to the PCP by the HM physician within 24 hours of discharge.
Methods of Evaluation and Analysis
We used improvement science methods and run charts to determine the percentage of patients discharged from the HM service with a call initiated to the PCP and completed within 24 hours of discharge. Data on calls initiated within 24 hours of discharge were plotted on a run chart to examine the impact of interventions over time. Once interventions targeted at call initiation had been implemented, we began tracking our primary outcome measure. A new run chart was created documenting the percentage of calls completed. For both metrics, the centerline was adjusted using established rules for special cause variation in run charts.[9, 10, 11, 12, 13]
RESULTS
From July 2011 to March 2014, there were 6313 discharges from the HM service. The process measure (percentage of calls initiated) improved from 50% to 97% after 4 interventions (Figure 4). Data for the outcome measure (percentage of calls completed) were collected starting in August 2012, shortly after linking the EHR discharge order to the discharge call. Over the first 8 weeks, our median was 80%, which increased to a median of 93% (Figure 5). These results were sustained for 18 months.
Several key interventions were identified that were critical to achievement of our goal. Standardization of the communication process through PPL was temporally associated with a shift in the median rate of call initiation from 52% to 72%. Use of the discharge order to initiate discharge communication was associated with an increase from 72% to 97%. Finally, the percentage of completed verbal handoffs increased to more than 93% following batching of phone calls to PCPs at specific times during the day.
DISCUSSION
We used improvement and reliability science methods to implement a successful process for improving verbal handoffs from HM physicians to PCPs within 24 hours of discharge to 93%. This result has been sustained for 18 months.
Utilization of the PPL call center for flexible call facilitation along with support for data analysis and leveraging the EHR to automate the process increased reliability, leading to rapid improvement. Prior to mandating the use of PPL to connect discharging physicians with PCPs, the exact rate of successful handoffs in our institution was not known. We do know, however, that only 52% of calls were initiated, so clearly a large gap was present prior to our improvement work. Data collection from the PPL system was automated so that accurate, timely, and sustainable data could be provided, greatly aiding improvement efforts. Flexibility in call‐back timing was also crucial, because coordinating the availability of PCPs and discharging physicians is often challenging. The EHR‐initiated process for discharge communication was a key intervention, and improvement of our process measure to 97% performance was associated with this implementation. Two final interventions: (1) assignment of responsibility for communication to a team pager held by a designated resident and (2) batching of calls to specific times streamlined the EHR‐initiated process and were associated with achievement of our main outcome goal of >90% completed verbal communication.
There are several reports of successful interventions to improve receipt or content of discharge summaries by PCPs following hospital discharge available in the literature.[14, 15, 16, 17, 18, 19, 20] Recently, Shen et al. reported on the success of a multisite improvement collaborative involving pediatric hospitalist programs at community hospitals whose aim was to improve the timely documentation of communication directed at PCPs.[21] In their report, all 7 hospital sites that participated in the collaborative for more than 4 months were able to demonstrate substantial improvement in documentation of some form of communication directed at PCPs (whether by e‐mail, fax, or telephone call), from a baseline of approximately 50% to more than 90%. A limitation of their study was that they were unable to document whether PCPs had received any information or by what method. A recent survey of PCPs by Sheu et al. indicated that for many discharges, information in addition to that present in the EHR was desirable to ensure a safe transition of care.[6] Two‐way communication, such as with a phone call, allows for senders to verify information receipt and for receivers to ask questions to ensure complete information. To our knowledge, there have been no previous reports describing processes for improving verbal communication between hospitalist services and PCPs at discharge.
It may be that use of the call system allowed PCPs to return phone calls regarding discharges at convenient stopping points in their day while allowing discharging physicians to initiate a call without having to wait on hold. Interestingly, though we anticipated the need for additional PPL resources during the course of this improvement, the final process was efficient enough that PPL did not require additional staffing to accommodate the higher call volume.
A key insight during our implementation was that relying on the EHR to initiate every discharge communication created disruption of resident workflow due to disregard of patient, resident, and PCP factors. This was reflected by the improvement in call initiation (our process measure) following this intervention, whereas at the same time call completion (our outcome measure) remained below goal. To achieve our goal of completing verbal communication required a process that was highly reliable yet flexible enough to allow discharging physicians to complete the call in the unpredictable environment of inpatient care. Ultimately, this was achieved by allowing discharging physicians to initiate the process when convenient, and allowing for the EHR‐initiated process to function as a backup strategy to identify and mitigate failures of initiation.
An important limitation of our study was the lack of PCPs on the improvement team, likely making the success of the project more difficult than it might have been. For example, during the study we did not measure the time PCPs spent on hold or how many reattempts were needed to complete the communication loop. Immediately following the completion of our study, it became apparent that physicians returning calls for our own institution's primary care clinic were experiencing regular workflow interruptions and occasional hold times more than 20 minutes, necessitating ongoing further work to determine the root causes and solutions to these problems. Though this work is ongoing, average PCP hold times measured from a sample of call reviews in 2013 to 2014 was 3 minutes and 15 seconds.
This study has several other limitations. We were unable to account for phone calls to PCPs initiated outside of the new process. It may be that PCPs were called more than 52% of the time at baseline due to noncompliance with the new protocol. Also, we only have data for call completion starting after implementation of the link between the discharge order and the discharge phone call, making the baseline appear artificially high and precluding any analysis of how earlier interventions affected our outcome metric. Communication with PCPs should ideally occur prior to discharge. An important limitation of our process is that calls could occur several hours after discharge between an on‐call resident and an on‐call outpatient physician rather than between the PCP and the discharging resident, limiting appropriate information exchange. Though verbal discharge communication is a desirable goal for many reasons, the current project did not focus on the quality of the call or the information that was transmitted to the PCP. Additionally, direct attending‐to‐attending communication may be valuable with medically or socially complex discharges, but we did not have a process to facilitate this. We also did not measure what effect our new process had on outcomes such as quality of patient and family transition from hospital or physician satisfaction. The existence of programs similar to our PPL subspecialty referral line may be limited to large institutions. However, it should be noted that although some internal resource reallocation was necessary within PPL, no actual staffing increases were required despite a large increase in call volume. It may be that any hospital operator system could be adapted for this purpose with modest additional resources. Finally, although our EHR system is widely utilized, there are many competing systems in the market, and our intervention required utilization of EHR capabilities that may not be present in all systems. However, our EHR intervention utilized existing functionality and did not require modification of the system.
This project focused on discharge phone calls to primary care physicians for patients hospitalized on the hospital medicine service. Because communication with the PCP should ideally occur prior to discharge, future work will include identifying a more proximal trigger than the discharge order to which to link the EHR trigger for discharge communication. Other next steps to improve handoff effectiveness and optimize the efficiency of our process include identifying essential information that should be transmitted to the primary care physician at the time of the phone call, developing processes to ensure communication of this information, measuring PCP satisfaction with this communication, and measuring the impact on patient outcomes. Finally, though expert opinion indicates that verbal handoffs may have safety advantages over nonverbal handoffs, studies comparing the safety and efficacy of verbal versus nonverbal handoffs at patient discharge are lacking. Studies establishing the relative efficacy and safety of verbal versus nonverbal handoffs at hospital discharge are needed. Knowledge gained from these activities could inform future projects centered on the spread of the process to other hospital services and/or other hospitals.
CONCLUSION
We increased the percentage of calls initiated to PCPs at patient discharge from 52% to 97% and the percentage of calls completed between HM physicians and PCPs to 93% through the use of a standardized discharge communication process coupled with a basic EHR messaging functionality. The results of this study may be of interest for further testing and adaptation for any institution with an electronic healthcare system.
Disclosure: Nothing to report.
Timely and reliable communication of important data between hospital‐based physicians and primary care physicians is critical for prevention of medical adverse events.[1, 2] Extrapolation from high‐performance organizations outside of medicine suggests that verbal communication is an important component of patient handoffs.[3, 4] Though the Joint Commission does not mandate verbal communication during handoffs per se, stipulating instead that handoff participants have an opportunity to ask and respond to questions,[5] there is some evidence that primary care providers prefer verbal handoffs at least for certain patients such as those with medical complexity.[6] Verbal communication offers the receiver the opportunity to ask questions, but in practice, 2‐way verbal communication is often difficult to achieve at hospital discharge.
At our institution, hospital medicine (HM) physicians serve as the primary inpatient providers for nearly 90% of all general pediatric admissions. When the HM service was established, primary care physicians (PCPs) and HM physicians together agreed upon an expectation for verbal, physician‐to‐physician communication at the time of discharge. Discharge communication is provided by either residents or attendings depending on the facility. A telephone operator service called Physician Priority Link (PPL) was made available to facilitate this communication. The PPL service is staffed 24/7 by operators whose only responsibilities are to connect providers inside and outside the institution. By utilizing this service, PCPs could respond in a nonemergent fashion to discharge phone calls.
Over the last several years, PCPs have observed high variation in the reliability of discharge communication phone calls. A review of PPL phone records in 2009 showed that only 52% of HM discharges had a record of a call initiated to the PCP on the day of discharge. The overall goal of this improvement project was to improve the completion of verbal handoffs from HM physicians (residents or attendings) to PCPs. The specific aim of the project was to increase the proportion of completed verbal handoffs from on‐call residents or attendings to PCPs within 24 hours of discharge to more than 90% within 18 months.
METHODS
Human Subjects Protection
Our project was undertaken in accordance with institutional review board (IRB) policy on systems improvement work and did not require formal IRB review.
Setting
This study included all patients admitted to the HM service at an academic children's hospital and its satellite campus.
Planning the Intervention
The project was championed by physicians on the HM service and supported by a chief resident, PPL administrators, and 2 information technology analysts.
At the onset of the project, the team mapped the process for completing a discharge call to the PCPs, conducted a modified failure mode and effects analysis,[7, 8] and examined the key drivers used to prioritize interventions (Figure 1). Through the modified failure modes effect analysis, the team was able to identify system issues that led to unsuccessful communication: failure of call initiation, absence of an identified PCP, long wait times on hold, failure of PCP to call back, and failure of the call to be documented. These failure modes informed the key drivers to achieving the study aim. Figure 2 depicts the final key drivers, which were revised through testing and learning.
Interventions Targeting Key Stakeholder Buy‐in
To improve resident buy‐in and participation, the purpose and goals of the projects were discussed at resident morning report and during monthly team meetings by the pediatric chief resident on our improvement team. Resident physicians were interested in participating to reduce interruptions during daily rounds and to improve interactions with PCPs. The PPL staff was interested in standardizing the discharge call process to reduce confusion in identifying the appropriate contact when PCPs called residents back to discuss discharges. PCPs were interested in ensuring good communication at discharge, and individual PCPs were engaged through person‐to‐person contact by 1 of the HM physician champions.
Interventions to Standardization the Communication Process
To facilitate initiation of calls to PCPs at hospital discharge, the improvement team created a standard process using the PPL service (Figure 3). All patients discharged from the HM service were included in the process. Discharging physicians (who were usually but not always residents, depending on the facility), were instructed to call the PPL operator at the time of discharge. The PPL operator would then page the patient's PCP. It was the responsibility of the discharging physician to identify a PCP prior to discharge. Instances where no PCP was identified were counted as process failures because no phone call could be made. The expectation for the PCPs was that they would return the page within 20 minutes. PPL operators would then page back to the discharging physician to connect the 2 parties with the expectation that the discharging physician respond within 2 to 4 minutes to the PPL operator's page. Standardization of all calls through PPL allowed efficient tracking of incomplete calls and operators to reattempt calls that were not completed. This process also shifted the burden of following up on incomplete calls to PPL. The use of PPL to make the connection also allowed the physician to complete other work while awaiting a call back from the PCP.
Leveraging the Electronic Health Record for Process Initiation
To ensure reliable initiation of the discharge communication pathway, the improvement team introduced changes to the electronic health record (HER) (EpicCare Inpatient; Epic Systems Corp., Verona, WI), which generated a message to PPL operators whenever a discharge order was entered for an HM patient. The message contained the patient's name, medical record number, discharge date, discharging physician, and PCP name and phone number. A checklist was implemented by PPL to ensure that duplicate phone calls were not made. To initiate communication, the operator contacted the resident via text page to ensure they were ready to initiate the call. If the resident was ready to place a call, the operator then generated a phone call to the PCP. When the PCP returned the call, the operator connected the HM resident with the PCP for the handoff.
As the project progressed, several adaptations were made to address newly identified failure modes. To address confusion among PPL operators about which resident physicians should take discharge phone calls after the discharging resident was no longer available (for example, after a shift change), primary responsibility for discharge phone calls was reassigned to the daily on‐call resident rather than the resident who wrote the discharge order. Because the on‐call residents carry a single pager, the pager number listed on the automated discharge notification to PPL would never change and would always reach the appropriate team member. Second, to address the anticipated increase in interruption of resident workflow by calls back from PCPs, particularly during rounds, operators accessed information on pending discharge phone calls in batches at times of increased resident availability to minimize hold times for PCPs and work interruptions for the discharging physicians. Batch times were 1 pm and 4 pm to allow for completion of morning rounds, resident conference at noon, and patient‐care activities during the afternoon. Calls initiated after 4 pm were dispatched at the time of the discharge, and calls initiated after 10 pm were deferred to the following day.
Transparency of Data
Throughout the study, weekly failure data were generated from the EHR and emailed to improvement team members, enabling them to focus on near real‐time feedback of data to create a visible and more reliable system. With the standardization of all discharge calls directed to the PPL operators, the team was able to create a call record linked to the patient's medical record number. Team‐specific and overall results for the 5 HM resident teams were displayed weekly on a run chart in the resident conference room. As improvements in call initiation were demonstrated, completion rate data were also shared every several months with the attending hospitalists during a regularly scheduled divisional conference. This transparency of data gave the improvement team the opportunity to provide individual feedback to residents and attendings about failures. The weekly review of failure data allowed team leaders to learn from failures, identify knowledge gaps, and ensure accountability with the HM physicians.
Planning the Study of the Intervention
Data were collected prospectively from July 2011 to March 2014. A weekly list of patients discharged from the HM service was extracted from the EHR and compared to electronic call logs collected by PPL on the day of discharge. A standard sample size of 30 calls was audited separately by PPL and 1 of the physician leads to verify that the patients were discharged from the HM service and validate the percentage of completed and initiated calls.
The percentage of calls initiated within 24 hours of discharge was tracked as a process measure and served as the initial focus of improvement efforts. Our primary outcome measure was the percentage of calls completed to the PCP by the HM physician within 24 hours of discharge.
Methods of Evaluation and Analysis
We used improvement science methods and run charts to determine the percentage of patients discharged from the HM service with a call initiated to the PCP and completed within 24 hours of discharge. Data on calls initiated within 24 hours of discharge were plotted on a run chart to examine the impact of interventions over time. Once interventions targeted at call initiation had been implemented, we began tracking our primary outcome measure. A new run chart was created documenting the percentage of calls completed. For both metrics, the centerline was adjusted using established rules for special cause variation in run charts.[9, 10, 11, 12, 13]
RESULTS
From July 2011 to March 2014, there were 6313 discharges from the HM service. The process measure (percentage of calls initiated) improved from 50% to 97% after 4 interventions (Figure 4). Data for the outcome measure (percentage of calls completed) were collected starting in August 2012, shortly after linking the EHR discharge order to the discharge call. Over the first 8 weeks, our median was 80%, which increased to a median of 93% (Figure 5). These results were sustained for 18 months.
Several key interventions were identified that were critical to achievement of our goal. Standardization of the communication process through PPL was temporally associated with a shift in the median rate of call initiation from 52% to 72%. Use of the discharge order to initiate discharge communication was associated with an increase from 72% to 97%. Finally, the percentage of completed verbal handoffs increased to more than 93% following batching of phone calls to PCPs at specific times during the day.
DISCUSSION
We used improvement and reliability science methods to implement a successful process for improving verbal handoffs from HM physicians to PCPs within 24 hours of discharge to 93%. This result has been sustained for 18 months.
Utilization of the PPL call center for flexible call facilitation along with support for data analysis and leveraging the EHR to automate the process increased reliability, leading to rapid improvement. Prior to mandating the use of PPL to connect discharging physicians with PCPs, the exact rate of successful handoffs in our institution was not known. We do know, however, that only 52% of calls were initiated, so clearly a large gap was present prior to our improvement work. Data collection from the PPL system was automated so that accurate, timely, and sustainable data could be provided, greatly aiding improvement efforts. Flexibility in call‐back timing was also crucial, because coordinating the availability of PCPs and discharging physicians is often challenging. The EHR‐initiated process for discharge communication was a key intervention, and improvement of our process measure to 97% performance was associated with this implementation. Two final interventions: (1) assignment of responsibility for communication to a team pager held by a designated resident and (2) batching of calls to specific times streamlined the EHR‐initiated process and were associated with achievement of our main outcome goal of >90% completed verbal communication.
There are several reports of successful interventions to improve receipt or content of discharge summaries by PCPs following hospital discharge available in the literature.[14, 15, 16, 17, 18, 19, 20] Recently, Shen et al. reported on the success of a multisite improvement collaborative involving pediatric hospitalist programs at community hospitals whose aim was to improve the timely documentation of communication directed at PCPs.[21] In their report, all 7 hospital sites that participated in the collaborative for more than 4 months were able to demonstrate substantial improvement in documentation of some form of communication directed at PCPs (whether by e‐mail, fax, or telephone call), from a baseline of approximately 50% to more than 90%. A limitation of their study was that they were unable to document whether PCPs had received any information or by what method. A recent survey of PCPs by Sheu et al. indicated that for many discharges, information in addition to that present in the EHR was desirable to ensure a safe transition of care.[6] Two‐way communication, such as with a phone call, allows for senders to verify information receipt and for receivers to ask questions to ensure complete information. To our knowledge, there have been no previous reports describing processes for improving verbal communication between hospitalist services and PCPs at discharge.
It may be that use of the call system allowed PCPs to return phone calls regarding discharges at convenient stopping points in their day while allowing discharging physicians to initiate a call without having to wait on hold. Interestingly, though we anticipated the need for additional PPL resources during the course of this improvement, the final process was efficient enough that PPL did not require additional staffing to accommodate the higher call volume.
A key insight during our implementation was that relying on the EHR to initiate every discharge communication created disruption of resident workflow due to disregard of patient, resident, and PCP factors. This was reflected by the improvement in call initiation (our process measure) following this intervention, whereas at the same time call completion (our outcome measure) remained below goal. To achieve our goal of completing verbal communication required a process that was highly reliable yet flexible enough to allow discharging physicians to complete the call in the unpredictable environment of inpatient care. Ultimately, this was achieved by allowing discharging physicians to initiate the process when convenient, and allowing for the EHR‐initiated process to function as a backup strategy to identify and mitigate failures of initiation.
An important limitation of our study was the lack of PCPs on the improvement team, likely making the success of the project more difficult than it might have been. For example, during the study we did not measure the time PCPs spent on hold or how many reattempts were needed to complete the communication loop. Immediately following the completion of our study, it became apparent that physicians returning calls for our own institution's primary care clinic were experiencing regular workflow interruptions and occasional hold times more than 20 minutes, necessitating ongoing further work to determine the root causes and solutions to these problems. Though this work is ongoing, average PCP hold times measured from a sample of call reviews in 2013 to 2014 was 3 minutes and 15 seconds.
This study has several other limitations. We were unable to account for phone calls to PCPs initiated outside of the new process. It may be that PCPs were called more than 52% of the time at baseline due to noncompliance with the new protocol. Also, we only have data for call completion starting after implementation of the link between the discharge order and the discharge phone call, making the baseline appear artificially high and precluding any analysis of how earlier interventions affected our outcome metric. Communication with PCPs should ideally occur prior to discharge. An important limitation of our process is that calls could occur several hours after discharge between an on‐call resident and an on‐call outpatient physician rather than between the PCP and the discharging resident, limiting appropriate information exchange. Though verbal discharge communication is a desirable goal for many reasons, the current project did not focus on the quality of the call or the information that was transmitted to the PCP. Additionally, direct attending‐to‐attending communication may be valuable with medically or socially complex discharges, but we did not have a process to facilitate this. We also did not measure what effect our new process had on outcomes such as quality of patient and family transition from hospital or physician satisfaction. The existence of programs similar to our PPL subspecialty referral line may be limited to large institutions. However, it should be noted that although some internal resource reallocation was necessary within PPL, no actual staffing increases were required despite a large increase in call volume. It may be that any hospital operator system could be adapted for this purpose with modest additional resources. Finally, although our EHR system is widely utilized, there are many competing systems in the market, and our intervention required utilization of EHR capabilities that may not be present in all systems. However, our EHR intervention utilized existing functionality and did not require modification of the system.
This project focused on discharge phone calls to primary care physicians for patients hospitalized on the hospital medicine service. Because communication with the PCP should ideally occur prior to discharge, future work will include identifying a more proximal trigger than the discharge order to which to link the EHR trigger for discharge communication. Other next steps to improve handoff effectiveness and optimize the efficiency of our process include identifying essential information that should be transmitted to the primary care physician at the time of the phone call, developing processes to ensure communication of this information, measuring PCP satisfaction with this communication, and measuring the impact on patient outcomes. Finally, though expert opinion indicates that verbal handoffs may have safety advantages over nonverbal handoffs, studies comparing the safety and efficacy of verbal versus nonverbal handoffs at patient discharge are lacking. Studies establishing the relative efficacy and safety of verbal versus nonverbal handoffs at hospital discharge are needed. Knowledge gained from these activities could inform future projects centered on the spread of the process to other hospital services and/or other hospitals.
CONCLUSION
We increased the percentage of calls initiated to PCPs at patient discharge from 52% to 97% and the percentage of calls completed between HM physicians and PCPs to 93% through the use of a standardized discharge communication process coupled with a basic EHR messaging functionality. The results of this study may be of interest for further testing and adaptation for any institution with an electronic healthcare system.
Disclosure: Nothing to report.
- , , . Passing the clinical baton: 6 principles to guide the hospitalist. Am J Med. 2001;111(9B):36S–39S.
- , , , , . Evaluating communication between pediatric primary care physicians and hospitalists. Clin Pediatr. 2011;50(10):923–928.
- , , , , , . Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7):433–440.
- , , , , . Handoff strategies in settings with high consequences for failure: lessons for health care operations. Int J Qual Health Care. 2004;16(2):125–132.
- Agency for Healthcare Research and Quality. Patient safety primers: handoffs and signouts. Available at: http://www.psnet.ahrq.gov/primer.aspx?primerID=9. Accessed March 19, 2014.
- , , , , . We need to talk: primary care provider communication at discharge in the era of a shared electronic medical record. J Hosp Med. 2015;10(5):307–310.
- , , . Failure mode and effects analysis: a novel approach to avoiding dangerous medication errors and accidents. Hosp Pharm. 1994;29:319–330.
- , , , . Using health care Failure Mode and Effect Analysis: the VA National Center for Patient Safety's prospective risk analysis system. Jt Comm J Qual Improv. 2002;28:248–267, 209.
- . Statistical quality control methods in infection control and hospital epidemiology, Part II: Chart use, statistical properties, and research issues. Infect Control Hosp Epidemiol. 1998;19(4):265–283.
- . Statistical quality control methods in infection control and hospital epidemiology, part I: Introduction and basic theory. Infect Control Hosp Epidemiol. 1998;19(3):194–214.
- , , . Statistical process control as a tool for research and healthcare improvement. Qual Saf Health Care. 2003;12(6):458–464.
- . The Improvement Guide: A Practical Approach to Enhancing Organizational +Performance. 2nd ed. San Francisco, CA: Jossey‐Bass; 2009.
- , . The Health Care Data Guide: Learning From Data for Improvement. 1st ed. San Francisco, CA: Jossey‐Bass; 2011.
- , . The initial hospital discharge note: send out with the patient or post? Health Trends. 1984;16(2):48.
- , . Which type of hospital discharge report reaches general practitioners most quickly? BMJ. 1989;298(6670):362–363.
- , . The application of a computer data base system to the generation of hospital discharge summaries. Obstet Gynecol. 1989;73(5 pt 1):803–807.
- . Hospital discharge medication: is seven days supply sufficient? Public Health. 1991;105(3):243–247.
- , , , et al. Electronic communication between providers of primary and secondary care. BMJ. 1992;305(6861):1068–1070.
- , , . Communication of discharge information for elderly patients in hospital. Ulster Med J. 1992;61(1):56–58.
- , , , , . A quality use of medicines program for continuity of care in therapeutics from hospital to community. Med J Aust. 2002;177(1):32–34.
- , , , , , . Pediatric hospitalists collaborate to improve timeliness of discharge communication. Hosp Pediatr. 2013;3(3):258–265.
- , , . Passing the clinical baton: 6 principles to guide the hospitalist. Am J Med. 2001;111(9B):36S–39S.
- , , , , . Evaluating communication between pediatric primary care physicians and hospitalists. Clin Pediatr. 2011;50(10):923–928.
- , , , , , . Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7):433–440.
- , , , , . Handoff strategies in settings with high consequences for failure: lessons for health care operations. Int J Qual Health Care. 2004;16(2):125–132.
- Agency for Healthcare Research and Quality. Patient safety primers: handoffs and signouts. Available at: http://www.psnet.ahrq.gov/primer.aspx?primerID=9. Accessed March 19, 2014.
- , , , , . We need to talk: primary care provider communication at discharge in the era of a shared electronic medical record. J Hosp Med. 2015;10(5):307–310.
- , , . Failure mode and effects analysis: a novel approach to avoiding dangerous medication errors and accidents. Hosp Pharm. 1994;29:319–330.
- , , , . Using health care Failure Mode and Effect Analysis: the VA National Center for Patient Safety's prospective risk analysis system. Jt Comm J Qual Improv. 2002;28:248–267, 209.
- . Statistical quality control methods in infection control and hospital epidemiology, Part II: Chart use, statistical properties, and research issues. Infect Control Hosp Epidemiol. 1998;19(4):265–283.
- . Statistical quality control methods in infection control and hospital epidemiology, part I: Introduction and basic theory. Infect Control Hosp Epidemiol. 1998;19(3):194–214.
- , , . Statistical process control as a tool for research and healthcare improvement. Qual Saf Health Care. 2003;12(6):458–464.
- . The Improvement Guide: A Practical Approach to Enhancing Organizational +Performance. 2nd ed. San Francisco, CA: Jossey‐Bass; 2009.
- , . The Health Care Data Guide: Learning From Data for Improvement. 1st ed. San Francisco, CA: Jossey‐Bass; 2011.
- , . The initial hospital discharge note: send out with the patient or post? Health Trends. 1984;16(2):48.
- , . Which type of hospital discharge report reaches general practitioners most quickly? BMJ. 1989;298(6670):362–363.
- , . The application of a computer data base system to the generation of hospital discharge summaries. Obstet Gynecol. 1989;73(5 pt 1):803–807.
- . Hospital discharge medication: is seven days supply sufficient? Public Health. 1991;105(3):243–247.
- , , , et al. Electronic communication between providers of primary and secondary care. BMJ. 1992;305(6861):1068–1070.
- , , . Communication of discharge information for elderly patients in hospital. Ulster Med J. 1992;61(1):56–58.
- , , , , . A quality use of medicines program for continuity of care in therapeutics from hospital to community. Med J Aust. 2002;177(1):32–34.
- , , , , , . Pediatric hospitalists collaborate to improve timeliness of discharge communication. Hosp Pediatr. 2013;3(3):258–265.
© 2015 Society of Hospital Medicine
Baby Boomer HCV Screening and Care
INTRODUCTION
The baby boomer generation, born from 1945 to 1965, accounts for 75% of the estimated 2.7 to 3.9 million persons with chronic hepatitis C virus (HCV) infection in the US.[1, 2, 3] Most HCV‐infected baby boomers do not know that they are infected.[4] With the advent of better‐tolerated, more‐effective therapies to treat chronic HCV infection,[5] and to reduce rates of complications such as cirrhosis, liver failure, and hepatocellular carcinoma,[6] universal 1‐time screening of baby boomers has been endorsed by the Centers for Disease Control and Prevention (CDC) and the United States Preventive Services Task Force.[1, 7] Hospitalized baby boomers may offer an important target for HCV screening. Our group conducted an anonymous HCV seroprevalence study of nearly 800 patients on general medicine and trauma services of 2 Philadelphia hospitals, and found that 8% had undiagnosed HCV infection, and 8% had diagnosed HCV. [8]
Little is known about barriers and facilitators to implementation of universal HCV screening of baby boomers. Lessons from implementing HIV screening offer a useful guide.[9] First, limited clinician knowledge and confusion about screening guidelines necessitated convenient, well‐designed educational programs.[10] Second, burdensome consent procedures were reduced by opt‐out consent for screening supplemented by patient education.[9] Third, electronic medical record (EMR) algorithms minimized burdens on staff by efficiently identifying and flagging eligible persons for screening.[11] Fourth, ancillary staff support for patient education and linkage to follow‐up care increased screening rates compared with usual care by physicians/staff.[11] Finally, routine human immunodeficiency virus (HIV) testing of inpatients increased rates of diagnosis, especially compared with physician referral systems.[12]
This article describes how HIV screening strategies informed the development in a baby boomer HCV screening and linkage to a care program in a safety‐net hospital serving a majority Hispanic population. We report results of the first 14 months of the screening program and linkage to care for chronically HCV‐infected persons after a minimum 10 months follow‐up. We also estimate costs for program implementation and maintenance to inform hospital administrators, healthcare policymakers, and clinicians about resources that may be required to effectively screen hospitalized baby boomers for HCV.
METHODS
Study Setting
The HCV baby boomer screening program was pilot tested in November 2012 and launched December 1, 2012 in a 498‐bed academic‐affiliated hospital of a healthcare system serving the indigent population of South Texas.
Project Development Phase
From October 1, 2012 to November 30, 2012, project infrastructure development and provider/staff education were conducted. A half‐hour PowerPoint lecture (in person or online) was developed about HCV epidemiology, birth‐cohort HCV screening guidelines, newer treatment modalities, and screening program components. Lectures were delivered to departmental chairs at the affiliated medical school, departmental grand rounds, and the hospital's nursing supervisors. One‐on‐one informational meetings were also held with hospital administrators and staff.
With the hospital's information technology team, screens were developed to identify eligible baby boomers from up to 7 years of previous inpatient and outpatient encounters in the EMR from: birth year (19451965) and no prior diagnosis of HCV infection (070.41, 070.44, 070.51, 070.54, 070.7x, V02.62) or any type of completed test for HCV. The algorithm also excluded patients admitted to psychiatry due to lack of decision‐making capacity or patients with a poor prognosis such as metastatic cancer. An audit of 100 consecutive excluded patients identified all as legitimate.
A new laboratory order for HCV screening was developed by laboratory administrators and pathology faculty for an anti‐HCV antibody test followed by reflex HCV RNA testing for positive results per CDC recommendations.[13] The anti‐HCV test was performed on serum or ethylenediaminetetraacetic acid plasma using the Advia Centaur HCV Assay (Bayer HealthCare LLC, Tarrytown, NY). This assay has excellent sensitivity (99.9%) and specificity (97.5%).[14, 15] The HCV RNA assay was performed using quantitative real‐time polymerase chain reaction (PCR) using the COBAS AmpliPrep/COBAS TaqMan HCV test (Roche Molecular Systems, Pleasanton, CA). Use of plasma preparation tubes (PPTs) (BD Vacutainer PPT tubes; Becton, Dickinson and Co., Franklin Lakes, NJ) permitted both anti‐HCV antibody and HCV PCR testing to be performed on the same specimen when anti‐HCV antibody was detected, eliminating a second blood draw for the PCR test. For patients eligible for screening, an EMR algorithm was created to add an HCV screening order to over 50 different admission order sets.
To educate patients newly diagnosed with HCV infection, we developed an interactive, low‐literacy, educational program in Spanish and English for an electronic tablet device that addressed: HCV epidemiology, transmission prevention, factors that can accelerate chronic HCV infection, and management/treatment strategies. At several points in the program, the patient needed to answer questions correctly to continue. The tablet retained responses linked to a study identification about alcohol consumption, history of past and current illicit drug use, sexual risk behavior, and offered risk reduction messages. The tablet content and presentation reflected suggestions by Hispanic patient‐reviewers about cultural appropriateness and comprehension.
Project Implementation and Maintenance Phase
We report implementation of the program from December 1, 2012 to January 31, 2014. An automated EMR report classified all baby boomers admitted in the previous 24 hours as: (1) eligible with pending screening test order, (2) eligible without an order, (3) ineligible due to prior HCV test or diagnosis, or (4) ineligible due to comorbidity (eg, metastatic cancer). For approximately one‐third of eligible patients, a study team member placed an order after review of the daily admission report because the order had not been automatically placed.
Admitting nurses initially asked for consent from eligible patients for HCV screening, but this was ultimately deemed too onerous a task along with all of their other duties. We then instituted opt‐out consent with patient education about testing and opportunities to refuse via posters placed throughout the hospital and flyers in admission packets. A bilingual HCV counselor provided HCV screening test results to all patients. She counseled patients who screened positive for HCV with the educational program on an electronic tablet and developed a follow‐up care plan.
A bilingual promotora (community health worker) contacted patients newly diagnosed with chronic HCV infection after hospital discharge to address the following: obtaining insurance, access to primary care and HCV specialty care, scheduling appointments, and treatment for alcohol problems or drug abuse. After obtaining signed consent, the promotora sent test results and recommendations for follow‐up care (eg, hepatitis A and B immunization) to a designated outpatient physician and reminded patients about appointments and pending tests. The promotora received training in motivational interviewing skills to engage patients with needed care including alcohol treatment.
Study Data
A summary report was developed from the EMR with demographic, insurance, clinical, and HCV screening data for all admitted baby boomers. For patients diagnosed with chronic HCV infection, the promotora obtained data about follow‐up HCV care through December 10, 2014 from the EMR, outside provider records, and patient reports.
Study Variables
The 2 outcome measures were a positive anti‐HCV antibody test and positive HCV RNA test. Insurance status was categorized as insured (private, public, Veterans Administration, Department of Defense) or uninsured (self‐pay or county‐based financial assistance program). Problem drinking was identified from International Classification of Diseases, Ninth Revision, Clinical Modification codes for the admission, notes by clinicians describing alcohol abuse/dependence, or quantity/frequency meeting National Institute on Alcohol Abuse and Alcoholism criteria for alcohol problems of >14 drinks/week or >4 drinks/day for men and >7 drinks per week or >3 drinks per day for women.[16]
Implementation costs included informatics support, mobile app development, other patient educational materials, costs of screening tests for uninsured, and 0.3 full‐time equivalent (FTE) of a clinician for half a year. Maintenance costs included salaries for the study team, HCV testing costs, and postage.
Analysis
Demographics by HCV antibody test results are compared using [2] tests or Student t tests as appropriate. Among persons with a positive HCV antibody test, HCV RNA results are similarly compared. This implementation project was approved by the University of Texas Health Science Center at San Antonio Institutional Review Board (HSC20130033N).
RESULTS
Within 14 months, 6410 unique baby boomers were admitted with a mean age 56.4 years (standard deviation [SD] 5.7), 55.9% men, 59.1% Hispanic, 8.2% nonwhite, and 46.7% uninsured (Table 1). Among admitted patients, 729 (11.4%) had a previous HCV diagnosis and 1904 (29.7%) had been tested for HCV (Figure 1). Anti‐HCV antibody testing was completed for 3168 (49.4% of all admitted patients and 83.9% of never‐tested patients). After exclusions such as significant comorbidity or psychiatric admission, 95% of eligible persons were tested. Of screened patients, 240 (7.6%) were positive; these patients were significantly younger (P<0.0001) and more likely to be men (P<0.0001) and uninsured (P=0.002) (Table 1). Notably, 10% of men were anti‐HCV positive versus 4% of women. In this predominantly Hispanic cohort, no significant difference appeared by race‐ethnicity, but African Americans had a higher prevalence (10.4%) than other groups.
| Characteristic | All Screened Patients, No. | Anti‐HCV Antibody‐Positive Patients, No. (Row %) | P Value* |
|---|---|---|---|
| |||
| Overall | 3,168 | Total=240 (7.6) | |
| Age, mean (SD) | 57.0 (5.7) | 54.8 (5.0) | <0.0001 |
| Sex | |||
| Men | 1,771 | 185 (10.4) | <0.0001 |
| Women | 1,397 | 55 (3.9) | |
| Race | |||
| Non‐Hispanic white | 1,036 | 86 (8.3) | 0.12 |
| Hispanic | 1,872 | 134 (7.2) | |
| African American | 163 | 17 (10.4) | |
| Other | 97 | 3 (3.1) | |
| Insurance | |||
| Insured | 1,740 | 109 (6.3) | 0.002 |
| Uninsured | 1,428 | 131 (9.2) | |
HCV RNA testing was completed for 214 (89.2%) anti‐HCVpositive patients, of whom 134 (62.6%) had detectable RNA, indicating chronic HCV infection (Figure 1). Overall, 4.2% of all eligible patients tested for HCV were chronically infected. No characteristics were significantly associated with chronic HCV, but persons with chronic infection tended to be younger, uninsured, and African American (Table 2).
| Characteristics | All HCV RNA‐Tested Patients, No. | HCV RNA‐Positive Patients, No. (Row %) | P Value* |
|---|---|---|---|
| |||
| Overall | 214 | 134 (62.6) | |
| Age, y, mean (SD) | 54.6 (5.0) | 54.2 (5.1) | 0.09 |
| Sex | |||
| Men | 165 | 106 (64.2) | 0.37 |
| Women | 49 | 28 (57.1) | |
| Race | |||
| Non‐Hispanic white | 78 | 49 (62.8) | 0.65 |
| Hispanic | 118 | 73 (61.8) | |
| African American | 15 | 11 (73.3) | |
| Other | 3 | 1 (33.3) | |
| Insurance | |||
| Insured | 92 | 52 (56.5) | 0.11 |
| Uninsured | 122 | 82 (67.2) | |
Among patients with chronic HCV infection, 129 (96.3%) were counseled and follow‐up plans developed (Figure 2). By December 10, 2014, 108 (80.6%) patients had received follow‐up primary care, and 52 (38.8%) had care from a hepatologist. Five had initiated HCV‐specific treatment, but many others were awaiting approval for compassionate drug programs offering direct‐acting antivirals. Barriers to care included 82 (61.2%) uninsured, 45 (34%) problem drinkers, 22 (16%) homeless, and 25 (18.6%) incarcerated (not shown). The promotora addressed these issues by visiting homes or homeless shelters, assistance with obtaining county‐based or other types of insurance, offering alcohol risk‐reduction counseling, linking patients to alcohol‐treatment programs, and communicating with the county jail about follow‐up care.
Most of the developmental costs for the program were dedicated to developing EMR programs (Table 3). An optional cost was for the development of the tablet educational program about HCV. In regard to maintenance costs for the first 14 months, the majority was to support the program faculty, counseling/case management, and a nurse practitioner who helped with ordering tests. We also estimated costs for testing uninsured patients (45% of HCV antibody tested, 57% of HCV PCR tested, per Tables 1 and 2, respectively), as they must be borne by the hospital.
| Program Component | Monthly ($) | Total ($) |
|---|---|---|
| ||
| Development phase (2 months prior to start) | ||
| Personnel | ||
| Faculty physicians (0.3 FTE salary+benefits) | 6,641 | 13,282 |
| Role: Development educational materials, provider education, and pilot testing | ||
| Technology | ||
| Development of eligibility screen and order sets for electronic medical record | 41,171 | |
| HCV counseling educational program for tabletdevelopment and pilot testing (optional) | 15,000 | |
| Patient educational materials (posters, flyers) | 400 | |
| Total for development phase | 69,853 | |
| Maintenance phase (14 months) | ||
| Personnel | ||
| Faculty physicians (0.3 FTE, salary+benefits) | 6,641 | 92,974 |
| Role: Coordinate with hospital staff and faculty, liaison with laboratory, supervise study team, review all identified cases for eligibility and management plans | ||
| Inpatient counselor and outpatient case management (2 FTE, salary+benefits) | 6,343 | 88,802 |
| Role: Inpatient and outpatient counseling of HCV Ab+patients and facilitation of follow‐up care for patients with chronic HCV infection | ||
| Nurse practitioner ($35/hour @ 10 hours/month) | 350 | 4,900 |
| Role: Review daily list of admitted baby boomers and manually order HCV screening test for those missed by the automated order | ||
| Postage | 10 | 140 |
| Laboratory costs for uninsured (based on % in cohort) | ||
| HCV antibody in plasma preparation tubes ($13.41/test 1,423) | 19,082 | |
| HCV RNA PCR ($87.96/test 122) | 10,731 | |
| Total for maintenance phase | 216,629 | |
| Total program costs | 286,482 | |
DISCUSSION
Implementation of universal HCV screening and linkage to care for hospitalized baby boomers utilizes a multicomponent infrastructure that reflects lessons learned from similar HIV programs. Use of an EMR algorithm to identify eligible patients and programs to automatically order HCV screening was a linchpin of our high testing rate and averted testing those who did not require screening. Of all 6410 baby boomers admitted to our safety‐net hospital, the EMR screen identified over 40% as ineligible due to prior diagnosis of HCV infection or prior HCV tests. Most of the additional 609 patients who were not tested were excluded due to comorbidities or admission to psychiatry. Overall, the EMR programs, tests ordered by the team, and opt‐out screening with education resulted in screening 95% of eligible patients. However, this program carries substantial costs, nearly $300,000 for the first 2 years, for unreimbursed services in this safety‐net hospital. The new guidelines for HCV screening[1, 2] are not accompanied by financial support either for program implementation or for screening and linkage to care for the uninsured, creating significant financial hurdles to achieve guideline compliance within already overtaxed public healthcare systems.
The infrastructure implemented in this hospital succeeded in achieving a higher rate of HCV screening of baby boomers than reported by other programs. In an emergency department in Birmingham, Alabama, a screening program for baby boomers tested 66% of 2325 persons who were HCV‐unaware.[17] In an outpatient clinic for men who have sex with men, only 54% of 1329 patients were screened for HCV.[18]
Among 3168 screened patients in our cohort, 7.6% were anti‐HCV antibody positive, which is over twice the prevalence of 3.5% (95% confidence interval: 2.2%‐4.8%) for anti‐HCVpositive tests in baby boomers based on National Health and Nutrition Examination Survey (NHANES) data from 2001 to 2010.[19] However, the Alabama emergency department study found that 11% of tested patients were anti‐HCV positive.[17] Although that study lacked race‐ethnicity data for half of the subjects, among those with this information, 13% of black and 7% of white subjects tested anti‐HCV positive. Compared with the Alabama study, the anti‐HCV prevalence in our cohort was somewhat lower for blacks (10.4%) but higher for non‐Hispanic whites (8.3%). Hispanics in our cohort had the lowest anti‐HCV prevalence (7.2%), whereas the Alabama study did not report this figure. National studies also find that the prevalence of anti‐HCVpositive results is twice as high for blacks compared with non‐Hispanic whites and Hispanics, and nearly twice as high for men compared with women.[19] In our cohort, the proportion of men with anti‐HCVpositive results was nearly 3 times that for women.
Diagnosis of chronic HCV infection requires 2 tests, similar to performing a Western blot test after a positive enzyme‐linked immunoassay for HIV. In a Veterans Affairs study, only 64% of patients with a positive anti‐HCV antibody test had a HCV RNA performed when reflex testing was not performed, and patients had to come in for a second test versus >90% of patients in sites that offer reflex testing.[20] At a somewhat increased price due to using more expensive PPTs ($96/100 PPT tubes vs $6.50/100 for serum red top tubes), both tests were performed on the same blood sample, resulting in 89% of anti‐HCV antibody‐positive patients being tested for HCV RNA.
Overall, 62% of patients in our cohort with a positive anti‐HCV antibody test had HCV RNA detected (viremic) compared with 71% of persons aged 20 years in an NHANES study from 2003 to 2010.[21] Several factors may contribute to this lower rate of chronic infection. In a study of HCV seropositive blood donors, Hispanics and non‐Hispanic whites were significantly more likely to have spontaneously cleared HCV infection than Asians and non‐Hispanic blacks.[22] Spontaneous clearance of HCV has also been associated with younger age at infection and HCV genotype 1.[23] Poorly understood genetic factors may also play a role.[24] The high rate of HCV clearance in our cohort reinforces the need to perform HCV RNA testing.
Overall, 4.2% of our cohort had chronic HCV infection. According to CDC estimates from 1999 to 2008 NHANES data, 2.74 million (3.25%) of 84.2 million US baby boomers have been infected with HCV, and 2.04 million (2.4%) have chronic infection.[1] Therefore, our safety‐net cohort of never‐tested baby boomers had over twice the prevalence of chronic HCV infection than the national estimate for this age group. This high proportion of chronic HCV may reflect our predominantly low‐income patient population. An analysis conducted by Milliman, Inc. using 2010 data estimated that half of all persons with undiagnosed HCV infection are uninsured.[25] This finding reinforces the need to conduct HCV screening in acute‐care settings such as hospitals, because the uninsured have poor access to ambulatory care.
Our chronic HCV‐infected cohort had many barriers to follow‐up care because most were uninsured and 15% were homeless. Our counselors addressed socioeconomic barriers to care[26] and concerns about the disease.[27] Many patients also had problem drinking based on either self‐report or documented in the medical record. Even moderate alcohol use may increase the risk of overall and liver‐related mortality from chronic HCV infection,[28] so our team offered brief alcohol counseling and partnered with healthcare providers and local Alcoholics Anonymous programs to offer support.
We linked 80% of newly diagnosed patients to primary care or hepatology providers, aided by a county‐level financial assistance program for healthcare services for uninsured residents, but it still required patients to pay out of pocket for care. Access to newer, highly effective, all‐oral therapy treatment[5] was slowed while awaiting US Food and Drug Administration approval in the first year of this project, then treatment provided only after lengthy applications to drug company assistance programs with priority given to persons with compensated cirrhosis.
Our project raises serious concerns for policymakers and payers. Should universal baby boomer HCV testing be undertaken without taking into account the financial and personnel resources required to implement this screening program or the substantial expenditures necessary to treat chronically infected persons? Although the Centers for Medicaid and Medicare Services pay for HCV screening costs,[29] our hospital had to cover costs for uninsured persons. Admittedly, Texas has the highest proportion of residents who are uninsured in the nation, but even in other states, Medicaid and other insurance programs are wrestling with how to deal with the high cost of HCV therapy.[30]
We acknowledge several limitations of this project. First, it was undertaken in only 1 hospital. Yet, our challenges and solutions are likely to be applicable to other hospitals nationally, especially those serving vulnerable populations. Second, patients in our cohort were usually admitted for comorbidities that needed to be managed before HCV infection could be addressed. However, persons with a poor prognosis, such as metastatic cancer, were excluded. We did not attempt to exclude other persons with serious comorbidities such as congestive heart failure, because the guidelines do not currently recommend this, and there may be benefits for patients, their families, and providers from knowing that an individual is chronically HCV infected even if they are not eligible to be treated. Third, the cost of the program was supported in part by a grant and would otherwise have to be borne by the hospital. Fourth, the EMR used by our hospital allows hundreds of admission order sets to be created and made automated order entry hard to implement. This is unlikely to be the situation in other hospitals using different types of EMRs.
It remains to be seen whether safety‐net hospitals with populations at greater risk of HCV infection can afford to support HCV testing and linkage to care. In view of several cost‐effectiveness studies that find screening and treating chronic HCV‐infected baby boomers cost‐effective within standard thresholds,[31, 32, 33] it may be important for policymakers and payers to consider lessons from HIV programs. Because HIV‐infected persons could not afford life‐saving medication, vigorous advocacy efforts led to legislation approving the Ryan White program in 1990 to fill gaps in HIV care that were not covered by other sources of support.[34] HCV infection is the most common blood‐borne infection in the nation, with potentially devastating consequences if ignored, but the underlying premise that universal HCV testing will save lives is in question if most of the individuals who are diagnosed with chronic HCV are low income, uninsured, or underinsured with limited access to curative medications. A rigorous public policy debate regarding both the merits of screening and the availability of treatment to those who are diagnosed is essential to the success of these programs.
Disclosure
Funding for this study was received from the Centers for Disease Control and Prevention CDC PS12‐1209PPHF12. The authors report no conflicts of interest.
- , , , , , Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945–1965. MMWR Recomm Rep. 2012;61:1–32.
- 2. Centers for Disease Control and Prevention. Vital signs: evaluation of hepatitis C virus infection testing and reporting–eight U.S. sites, 2005‐2011. MMWR Morb Mortal Wkly Rep. 2013;62:357–361.
- , , , , Hepatitis C virus infection in USA: an estimate of true prevalence. Liver Int. 2011;31:1090–1101.
- Institute of Medicine. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Washington, DC: The National Academies Press; 2010.
- , Current and future therapies for hepatitis C virus infection. N Engl J Med. 2013;368:1907–1917.
- , , , et al. Increasing prevalence of HCC and cirrhosis in patients with chronic hepatitis C virus infection. Gastroenterology. 2011;140:1182–1188.
- U.S. Preventive Services Task Force. Screening for hepatitis C virus infection in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2013;159:349–357.
- , , Undiagnosed hepatitis C on the general medicine and trauma services of two urban hospitals. J Infect. 2009;59:62–69.
- U.S. Preventive Services Task Force. Screening for HIV: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2013;159:51–60.
- , , , et al. Factors affecting clinician educator encouragement of routine HIV testing among trainees. J Gen Intern Med. 2012;27:839–844.
- , , , et al. Counselor‐versus provider‐based HIV screening in the emergency department: Results from the universal screening for HIV infection in the emergency room (USHER) randomized controlled trial. Ann Emerg Med. 2011;58:S126–S132.e1–4.
- , , Approaching the CDC's guidelines on the HIV testing of inpatients: physician‐referral versus nonreferral‐based testing. AIDS Patient Care STDS. 2006;20:311–317.
- Centers for Disease Control and Prevention (CDC). Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. 2013;62:362–365.
- Advia Centaur Assay Manual. Malvern, PA: Siemens Medical Solutions Diagnostics; Pub# 07063235, Rev. C, 2005‐01.
- , , , Comparison of the ADVIA Centaur and Abbott AxSYM immunoassay systems for a routine diagnostic virology laboratory. J Clin Virol. 2004;30:S11–S15.
- National Institute on Alcohol Abuse and Alcoholism. Drinking levels defined. Available at: http://www.niaaa.nih.gov/alcohol‐health/overview‐alcohol‐consumption/moderate‐binge‐drinking. Accessed June 12, 2014.
- , , , et al. Unrecognized chronic hepatitis C virus infection among baby boomers in the emergency department. Hepatology. 2015;61:776–782.
- , , , et al. Low rates of hepatitis screening and vaccination of HIV‐infected MSM in HIV clinics. Sex Transm Dis. 2012;39:349–353.
- , , , , , The changing epidemiology of hepatitis C virus infection in the United States: National Health and Nutrition Examination Survey 2001 through 2010. J Hepatol. 2014;60:691–698.
- , , , , Viral RNA testing in hepatitis C antibody‐positive veterans. Am J Prev Med. 2009;36:235–238.
- , , , et al. Chronic hepatitis C virus infection in the United States: National Health and Nutrition Examination Survey 2003 to 2010. Ann Intern Med. 2014;160:293–300.
- , , , et al. NHLBI Retrovirus Epidemiology Donor Study (REDS) Group. Correlates of hepatitis C virus (HCV) RNA negativity among HCV‐seropositive blood donors. Transfusion. 2006;46:469–475.
- , , , , , Spontaneous loss of hepatitis C virus RNA from serum is associated with genotype 1 and younger age at exposure. J Med Virol. 2011;83:1338–1344.
- , , , et al. Genetics of spontaneous clearance of hepatitis C virus infection: a complex topic with much to learn. Hepatology. 2014;60:2127–2128.
- , , , Health care reform and hepatitis C: a convergence of risk and opportunity. Available at: http://us.milliman.com/uploadedFiles/insight/2013/convergence‐of‐risk‐and‐opportunity.pdf. Accessed February 5, 2015.
- , , , Hepatitis C testing, infection, and linkage to care among racial and ethnic minorities in the United States, 2009‐2010. Am J Public Health. 2013;103:112–119.
- , Barriers to hepatitis C treatment. Liver Int. 2012;32:151–156.
- , , , , Moderate, excessive or heavy alcohol consumption: Each is significantly associated with increased mortality in patients with chronic hepatitis C. Aliment Pharmacol Ther. 2013;37:703–709.
- Centers for Medicare and Medicaid Services. Proposed decision memo for screening for hepatitis c virus (HCV) in adults (CAG‐00436N). Available at: http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=272. Accessed June 2, 2014.
- , Therapy for hepatitis C—the costs of success. N Engl J Med. 2014;370:1552–1553.
- , , , et al. Economic model of a birth cohort screening program for hepatitis C. Hepatology. 2012;55:1344–1355.
- , , , Cost‐effectiveness analysis of risk‐factor guided and birth‐cohort screening for chronic hepatitis C infection in the United States. PLoS One. 2013;8:e58975.
- , , , et al. The cost‐effectiveness of birth‐cohort screening for hepatitis C antibody in U.S. primary care settings. Ann Intern Med. 2012;156:263–270.
- U.S. Department of Health and Human Services. Health Resources and Services Administration: HIV/AIDS programs. Available at: http://hab.hrsa.gov/abouthab/legislation.html. Accessed April 8, 2015.
INTRODUCTION
The baby boomer generation, born from 1945 to 1965, accounts for 75% of the estimated 2.7 to 3.9 million persons with chronic hepatitis C virus (HCV) infection in the US.[1, 2, 3] Most HCV‐infected baby boomers do not know that they are infected.[4] With the advent of better‐tolerated, more‐effective therapies to treat chronic HCV infection,[5] and to reduce rates of complications such as cirrhosis, liver failure, and hepatocellular carcinoma,[6] universal 1‐time screening of baby boomers has been endorsed by the Centers for Disease Control and Prevention (CDC) and the United States Preventive Services Task Force.[1, 7] Hospitalized baby boomers may offer an important target for HCV screening. Our group conducted an anonymous HCV seroprevalence study of nearly 800 patients on general medicine and trauma services of 2 Philadelphia hospitals, and found that 8% had undiagnosed HCV infection, and 8% had diagnosed HCV. [8]
Little is known about barriers and facilitators to implementation of universal HCV screening of baby boomers. Lessons from implementing HIV screening offer a useful guide.[9] First, limited clinician knowledge and confusion about screening guidelines necessitated convenient, well‐designed educational programs.[10] Second, burdensome consent procedures were reduced by opt‐out consent for screening supplemented by patient education.[9] Third, electronic medical record (EMR) algorithms minimized burdens on staff by efficiently identifying and flagging eligible persons for screening.[11] Fourth, ancillary staff support for patient education and linkage to follow‐up care increased screening rates compared with usual care by physicians/staff.[11] Finally, routine human immunodeficiency virus (HIV) testing of inpatients increased rates of diagnosis, especially compared with physician referral systems.[12]
This article describes how HIV screening strategies informed the development in a baby boomer HCV screening and linkage to a care program in a safety‐net hospital serving a majority Hispanic population. We report results of the first 14 months of the screening program and linkage to care for chronically HCV‐infected persons after a minimum 10 months follow‐up. We also estimate costs for program implementation and maintenance to inform hospital administrators, healthcare policymakers, and clinicians about resources that may be required to effectively screen hospitalized baby boomers for HCV.
METHODS
Study Setting
The HCV baby boomer screening program was pilot tested in November 2012 and launched December 1, 2012 in a 498‐bed academic‐affiliated hospital of a healthcare system serving the indigent population of South Texas.
Project Development Phase
From October 1, 2012 to November 30, 2012, project infrastructure development and provider/staff education were conducted. A half‐hour PowerPoint lecture (in person or online) was developed about HCV epidemiology, birth‐cohort HCV screening guidelines, newer treatment modalities, and screening program components. Lectures were delivered to departmental chairs at the affiliated medical school, departmental grand rounds, and the hospital's nursing supervisors. One‐on‐one informational meetings were also held with hospital administrators and staff.
With the hospital's information technology team, screens were developed to identify eligible baby boomers from up to 7 years of previous inpatient and outpatient encounters in the EMR from: birth year (19451965) and no prior diagnosis of HCV infection (070.41, 070.44, 070.51, 070.54, 070.7x, V02.62) or any type of completed test for HCV. The algorithm also excluded patients admitted to psychiatry due to lack of decision‐making capacity or patients with a poor prognosis such as metastatic cancer. An audit of 100 consecutive excluded patients identified all as legitimate.
A new laboratory order for HCV screening was developed by laboratory administrators and pathology faculty for an anti‐HCV antibody test followed by reflex HCV RNA testing for positive results per CDC recommendations.[13] The anti‐HCV test was performed on serum or ethylenediaminetetraacetic acid plasma using the Advia Centaur HCV Assay (Bayer HealthCare LLC, Tarrytown, NY). This assay has excellent sensitivity (99.9%) and specificity (97.5%).[14, 15] The HCV RNA assay was performed using quantitative real‐time polymerase chain reaction (PCR) using the COBAS AmpliPrep/COBAS TaqMan HCV test (Roche Molecular Systems, Pleasanton, CA). Use of plasma preparation tubes (PPTs) (BD Vacutainer PPT tubes; Becton, Dickinson and Co., Franklin Lakes, NJ) permitted both anti‐HCV antibody and HCV PCR testing to be performed on the same specimen when anti‐HCV antibody was detected, eliminating a second blood draw for the PCR test. For patients eligible for screening, an EMR algorithm was created to add an HCV screening order to over 50 different admission order sets.
To educate patients newly diagnosed with HCV infection, we developed an interactive, low‐literacy, educational program in Spanish and English for an electronic tablet device that addressed: HCV epidemiology, transmission prevention, factors that can accelerate chronic HCV infection, and management/treatment strategies. At several points in the program, the patient needed to answer questions correctly to continue. The tablet retained responses linked to a study identification about alcohol consumption, history of past and current illicit drug use, sexual risk behavior, and offered risk reduction messages. The tablet content and presentation reflected suggestions by Hispanic patient‐reviewers about cultural appropriateness and comprehension.
Project Implementation and Maintenance Phase
We report implementation of the program from December 1, 2012 to January 31, 2014. An automated EMR report classified all baby boomers admitted in the previous 24 hours as: (1) eligible with pending screening test order, (2) eligible without an order, (3) ineligible due to prior HCV test or diagnosis, or (4) ineligible due to comorbidity (eg, metastatic cancer). For approximately one‐third of eligible patients, a study team member placed an order after review of the daily admission report because the order had not been automatically placed.
Admitting nurses initially asked for consent from eligible patients for HCV screening, but this was ultimately deemed too onerous a task along with all of their other duties. We then instituted opt‐out consent with patient education about testing and opportunities to refuse via posters placed throughout the hospital and flyers in admission packets. A bilingual HCV counselor provided HCV screening test results to all patients. She counseled patients who screened positive for HCV with the educational program on an electronic tablet and developed a follow‐up care plan.
A bilingual promotora (community health worker) contacted patients newly diagnosed with chronic HCV infection after hospital discharge to address the following: obtaining insurance, access to primary care and HCV specialty care, scheduling appointments, and treatment for alcohol problems or drug abuse. After obtaining signed consent, the promotora sent test results and recommendations for follow‐up care (eg, hepatitis A and B immunization) to a designated outpatient physician and reminded patients about appointments and pending tests. The promotora received training in motivational interviewing skills to engage patients with needed care including alcohol treatment.
Study Data
A summary report was developed from the EMR with demographic, insurance, clinical, and HCV screening data for all admitted baby boomers. For patients diagnosed with chronic HCV infection, the promotora obtained data about follow‐up HCV care through December 10, 2014 from the EMR, outside provider records, and patient reports.
Study Variables
The 2 outcome measures were a positive anti‐HCV antibody test and positive HCV RNA test. Insurance status was categorized as insured (private, public, Veterans Administration, Department of Defense) or uninsured (self‐pay or county‐based financial assistance program). Problem drinking was identified from International Classification of Diseases, Ninth Revision, Clinical Modification codes for the admission, notes by clinicians describing alcohol abuse/dependence, or quantity/frequency meeting National Institute on Alcohol Abuse and Alcoholism criteria for alcohol problems of >14 drinks/week or >4 drinks/day for men and >7 drinks per week or >3 drinks per day for women.[16]
Implementation costs included informatics support, mobile app development, other patient educational materials, costs of screening tests for uninsured, and 0.3 full‐time equivalent (FTE) of a clinician for half a year. Maintenance costs included salaries for the study team, HCV testing costs, and postage.
Analysis
Demographics by HCV antibody test results are compared using [2] tests or Student t tests as appropriate. Among persons with a positive HCV antibody test, HCV RNA results are similarly compared. This implementation project was approved by the University of Texas Health Science Center at San Antonio Institutional Review Board (HSC20130033N).
RESULTS
Within 14 months, 6410 unique baby boomers were admitted with a mean age 56.4 years (standard deviation [SD] 5.7), 55.9% men, 59.1% Hispanic, 8.2% nonwhite, and 46.7% uninsured (Table 1). Among admitted patients, 729 (11.4%) had a previous HCV diagnosis and 1904 (29.7%) had been tested for HCV (Figure 1). Anti‐HCV antibody testing was completed for 3168 (49.4% of all admitted patients and 83.9% of never‐tested patients). After exclusions such as significant comorbidity or psychiatric admission, 95% of eligible persons were tested. Of screened patients, 240 (7.6%) were positive; these patients were significantly younger (P<0.0001) and more likely to be men (P<0.0001) and uninsured (P=0.002) (Table 1). Notably, 10% of men were anti‐HCV positive versus 4% of women. In this predominantly Hispanic cohort, no significant difference appeared by race‐ethnicity, but African Americans had a higher prevalence (10.4%) than other groups.
| Characteristic | All Screened Patients, No. | Anti‐HCV Antibody‐Positive Patients, No. (Row %) | P Value* |
|---|---|---|---|
| |||
| Overall | 3,168 | Total=240 (7.6) | |
| Age, mean (SD) | 57.0 (5.7) | 54.8 (5.0) | <0.0001 |
| Sex | |||
| Men | 1,771 | 185 (10.4) | <0.0001 |
| Women | 1,397 | 55 (3.9) | |
| Race | |||
| Non‐Hispanic white | 1,036 | 86 (8.3) | 0.12 |
| Hispanic | 1,872 | 134 (7.2) | |
| African American | 163 | 17 (10.4) | |
| Other | 97 | 3 (3.1) | |
| Insurance | |||
| Insured | 1,740 | 109 (6.3) | 0.002 |
| Uninsured | 1,428 | 131 (9.2) | |
HCV RNA testing was completed for 214 (89.2%) anti‐HCVpositive patients, of whom 134 (62.6%) had detectable RNA, indicating chronic HCV infection (Figure 1). Overall, 4.2% of all eligible patients tested for HCV were chronically infected. No characteristics were significantly associated with chronic HCV, but persons with chronic infection tended to be younger, uninsured, and African American (Table 2).
| Characteristics | All HCV RNA‐Tested Patients, No. | HCV RNA‐Positive Patients, No. (Row %) | P Value* |
|---|---|---|---|
| |||
| Overall | 214 | 134 (62.6) | |
| Age, y, mean (SD) | 54.6 (5.0) | 54.2 (5.1) | 0.09 |
| Sex | |||
| Men | 165 | 106 (64.2) | 0.37 |
| Women | 49 | 28 (57.1) | |
| Race | |||
| Non‐Hispanic white | 78 | 49 (62.8) | 0.65 |
| Hispanic | 118 | 73 (61.8) | |
| African American | 15 | 11 (73.3) | |
| Other | 3 | 1 (33.3) | |
| Insurance | |||
| Insured | 92 | 52 (56.5) | 0.11 |
| Uninsured | 122 | 82 (67.2) | |
Among patients with chronic HCV infection, 129 (96.3%) were counseled and follow‐up plans developed (Figure 2). By December 10, 2014, 108 (80.6%) patients had received follow‐up primary care, and 52 (38.8%) had care from a hepatologist. Five had initiated HCV‐specific treatment, but many others were awaiting approval for compassionate drug programs offering direct‐acting antivirals. Barriers to care included 82 (61.2%) uninsured, 45 (34%) problem drinkers, 22 (16%) homeless, and 25 (18.6%) incarcerated (not shown). The promotora addressed these issues by visiting homes or homeless shelters, assistance with obtaining county‐based or other types of insurance, offering alcohol risk‐reduction counseling, linking patients to alcohol‐treatment programs, and communicating with the county jail about follow‐up care.
Most of the developmental costs for the program were dedicated to developing EMR programs (Table 3). An optional cost was for the development of the tablet educational program about HCV. In regard to maintenance costs for the first 14 months, the majority was to support the program faculty, counseling/case management, and a nurse practitioner who helped with ordering tests. We also estimated costs for testing uninsured patients (45% of HCV antibody tested, 57% of HCV PCR tested, per Tables 1 and 2, respectively), as they must be borne by the hospital.
| Program Component | Monthly ($) | Total ($) |
|---|---|---|
| ||
| Development phase (2 months prior to start) | ||
| Personnel | ||
| Faculty physicians (0.3 FTE salary+benefits) | 6,641 | 13,282 |
| Role: Development educational materials, provider education, and pilot testing | ||
| Technology | ||
| Development of eligibility screen and order sets for electronic medical record | 41,171 | |
| HCV counseling educational program for tabletdevelopment and pilot testing (optional) | 15,000 | |
| Patient educational materials (posters, flyers) | 400 | |
| Total for development phase | 69,853 | |
| Maintenance phase (14 months) | ||
| Personnel | ||
| Faculty physicians (0.3 FTE, salary+benefits) | 6,641 | 92,974 |
| Role: Coordinate with hospital staff and faculty, liaison with laboratory, supervise study team, review all identified cases for eligibility and management plans | ||
| Inpatient counselor and outpatient case management (2 FTE, salary+benefits) | 6,343 | 88,802 |
| Role: Inpatient and outpatient counseling of HCV Ab+patients and facilitation of follow‐up care for patients with chronic HCV infection | ||
| Nurse practitioner ($35/hour @ 10 hours/month) | 350 | 4,900 |
| Role: Review daily list of admitted baby boomers and manually order HCV screening test for those missed by the automated order | ||
| Postage | 10 | 140 |
| Laboratory costs for uninsured (based on % in cohort) | ||
| HCV antibody in plasma preparation tubes ($13.41/test 1,423) | 19,082 | |
| HCV RNA PCR ($87.96/test 122) | 10,731 | |
| Total for maintenance phase | 216,629 | |
| Total program costs | 286,482 | |
DISCUSSION
Implementation of universal HCV screening and linkage to care for hospitalized baby boomers utilizes a multicomponent infrastructure that reflects lessons learned from similar HIV programs. Use of an EMR algorithm to identify eligible patients and programs to automatically order HCV screening was a linchpin of our high testing rate and averted testing those who did not require screening. Of all 6410 baby boomers admitted to our safety‐net hospital, the EMR screen identified over 40% as ineligible due to prior diagnosis of HCV infection or prior HCV tests. Most of the additional 609 patients who were not tested were excluded due to comorbidities or admission to psychiatry. Overall, the EMR programs, tests ordered by the team, and opt‐out screening with education resulted in screening 95% of eligible patients. However, this program carries substantial costs, nearly $300,000 for the first 2 years, for unreimbursed services in this safety‐net hospital. The new guidelines for HCV screening[1, 2] are not accompanied by financial support either for program implementation or for screening and linkage to care for the uninsured, creating significant financial hurdles to achieve guideline compliance within already overtaxed public healthcare systems.
The infrastructure implemented in this hospital succeeded in achieving a higher rate of HCV screening of baby boomers than reported by other programs. In an emergency department in Birmingham, Alabama, a screening program for baby boomers tested 66% of 2325 persons who were HCV‐unaware.[17] In an outpatient clinic for men who have sex with men, only 54% of 1329 patients were screened for HCV.[18]
Among 3168 screened patients in our cohort, 7.6% were anti‐HCV antibody positive, which is over twice the prevalence of 3.5% (95% confidence interval: 2.2%‐4.8%) for anti‐HCVpositive tests in baby boomers based on National Health and Nutrition Examination Survey (NHANES) data from 2001 to 2010.[19] However, the Alabama emergency department study found that 11% of tested patients were anti‐HCV positive.[17] Although that study lacked race‐ethnicity data for half of the subjects, among those with this information, 13% of black and 7% of white subjects tested anti‐HCV positive. Compared with the Alabama study, the anti‐HCV prevalence in our cohort was somewhat lower for blacks (10.4%) but higher for non‐Hispanic whites (8.3%). Hispanics in our cohort had the lowest anti‐HCV prevalence (7.2%), whereas the Alabama study did not report this figure. National studies also find that the prevalence of anti‐HCVpositive results is twice as high for blacks compared with non‐Hispanic whites and Hispanics, and nearly twice as high for men compared with women.[19] In our cohort, the proportion of men with anti‐HCVpositive results was nearly 3 times that for women.
Diagnosis of chronic HCV infection requires 2 tests, similar to performing a Western blot test after a positive enzyme‐linked immunoassay for HIV. In a Veterans Affairs study, only 64% of patients with a positive anti‐HCV antibody test had a HCV RNA performed when reflex testing was not performed, and patients had to come in for a second test versus >90% of patients in sites that offer reflex testing.[20] At a somewhat increased price due to using more expensive PPTs ($96/100 PPT tubes vs $6.50/100 for serum red top tubes), both tests were performed on the same blood sample, resulting in 89% of anti‐HCV antibody‐positive patients being tested for HCV RNA.
Overall, 62% of patients in our cohort with a positive anti‐HCV antibody test had HCV RNA detected (viremic) compared with 71% of persons aged 20 years in an NHANES study from 2003 to 2010.[21] Several factors may contribute to this lower rate of chronic infection. In a study of HCV seropositive blood donors, Hispanics and non‐Hispanic whites were significantly more likely to have spontaneously cleared HCV infection than Asians and non‐Hispanic blacks.[22] Spontaneous clearance of HCV has also been associated with younger age at infection and HCV genotype 1.[23] Poorly understood genetic factors may also play a role.[24] The high rate of HCV clearance in our cohort reinforces the need to perform HCV RNA testing.
Overall, 4.2% of our cohort had chronic HCV infection. According to CDC estimates from 1999 to 2008 NHANES data, 2.74 million (3.25%) of 84.2 million US baby boomers have been infected with HCV, and 2.04 million (2.4%) have chronic infection.[1] Therefore, our safety‐net cohort of never‐tested baby boomers had over twice the prevalence of chronic HCV infection than the national estimate for this age group. This high proportion of chronic HCV may reflect our predominantly low‐income patient population. An analysis conducted by Milliman, Inc. using 2010 data estimated that half of all persons with undiagnosed HCV infection are uninsured.[25] This finding reinforces the need to conduct HCV screening in acute‐care settings such as hospitals, because the uninsured have poor access to ambulatory care.
Our chronic HCV‐infected cohort had many barriers to follow‐up care because most were uninsured and 15% were homeless. Our counselors addressed socioeconomic barriers to care[26] and concerns about the disease.[27] Many patients also had problem drinking based on either self‐report or documented in the medical record. Even moderate alcohol use may increase the risk of overall and liver‐related mortality from chronic HCV infection,[28] so our team offered brief alcohol counseling and partnered with healthcare providers and local Alcoholics Anonymous programs to offer support.
We linked 80% of newly diagnosed patients to primary care or hepatology providers, aided by a county‐level financial assistance program for healthcare services for uninsured residents, but it still required patients to pay out of pocket for care. Access to newer, highly effective, all‐oral therapy treatment[5] was slowed while awaiting US Food and Drug Administration approval in the first year of this project, then treatment provided only after lengthy applications to drug company assistance programs with priority given to persons with compensated cirrhosis.
Our project raises serious concerns for policymakers and payers. Should universal baby boomer HCV testing be undertaken without taking into account the financial and personnel resources required to implement this screening program or the substantial expenditures necessary to treat chronically infected persons? Although the Centers for Medicaid and Medicare Services pay for HCV screening costs,[29] our hospital had to cover costs for uninsured persons. Admittedly, Texas has the highest proportion of residents who are uninsured in the nation, but even in other states, Medicaid and other insurance programs are wrestling with how to deal with the high cost of HCV therapy.[30]
We acknowledge several limitations of this project. First, it was undertaken in only 1 hospital. Yet, our challenges and solutions are likely to be applicable to other hospitals nationally, especially those serving vulnerable populations. Second, patients in our cohort were usually admitted for comorbidities that needed to be managed before HCV infection could be addressed. However, persons with a poor prognosis, such as metastatic cancer, were excluded. We did not attempt to exclude other persons with serious comorbidities such as congestive heart failure, because the guidelines do not currently recommend this, and there may be benefits for patients, their families, and providers from knowing that an individual is chronically HCV infected even if they are not eligible to be treated. Third, the cost of the program was supported in part by a grant and would otherwise have to be borne by the hospital. Fourth, the EMR used by our hospital allows hundreds of admission order sets to be created and made automated order entry hard to implement. This is unlikely to be the situation in other hospitals using different types of EMRs.
It remains to be seen whether safety‐net hospitals with populations at greater risk of HCV infection can afford to support HCV testing and linkage to care. In view of several cost‐effectiveness studies that find screening and treating chronic HCV‐infected baby boomers cost‐effective within standard thresholds,[31, 32, 33] it may be important for policymakers and payers to consider lessons from HIV programs. Because HIV‐infected persons could not afford life‐saving medication, vigorous advocacy efforts led to legislation approving the Ryan White program in 1990 to fill gaps in HIV care that were not covered by other sources of support.[34] HCV infection is the most common blood‐borne infection in the nation, with potentially devastating consequences if ignored, but the underlying premise that universal HCV testing will save lives is in question if most of the individuals who are diagnosed with chronic HCV are low income, uninsured, or underinsured with limited access to curative medications. A rigorous public policy debate regarding both the merits of screening and the availability of treatment to those who are diagnosed is essential to the success of these programs.
Disclosure
Funding for this study was received from the Centers for Disease Control and Prevention CDC PS12‐1209PPHF12. The authors report no conflicts of interest.
INTRODUCTION
The baby boomer generation, born from 1945 to 1965, accounts for 75% of the estimated 2.7 to 3.9 million persons with chronic hepatitis C virus (HCV) infection in the US.[1, 2, 3] Most HCV‐infected baby boomers do not know that they are infected.[4] With the advent of better‐tolerated, more‐effective therapies to treat chronic HCV infection,[5] and to reduce rates of complications such as cirrhosis, liver failure, and hepatocellular carcinoma,[6] universal 1‐time screening of baby boomers has been endorsed by the Centers for Disease Control and Prevention (CDC) and the United States Preventive Services Task Force.[1, 7] Hospitalized baby boomers may offer an important target for HCV screening. Our group conducted an anonymous HCV seroprevalence study of nearly 800 patients on general medicine and trauma services of 2 Philadelphia hospitals, and found that 8% had undiagnosed HCV infection, and 8% had diagnosed HCV. [8]
Little is known about barriers and facilitators to implementation of universal HCV screening of baby boomers. Lessons from implementing HIV screening offer a useful guide.[9] First, limited clinician knowledge and confusion about screening guidelines necessitated convenient, well‐designed educational programs.[10] Second, burdensome consent procedures were reduced by opt‐out consent for screening supplemented by patient education.[9] Third, electronic medical record (EMR) algorithms minimized burdens on staff by efficiently identifying and flagging eligible persons for screening.[11] Fourth, ancillary staff support for patient education and linkage to follow‐up care increased screening rates compared with usual care by physicians/staff.[11] Finally, routine human immunodeficiency virus (HIV) testing of inpatients increased rates of diagnosis, especially compared with physician referral systems.[12]
This article describes how HIV screening strategies informed the development in a baby boomer HCV screening and linkage to a care program in a safety‐net hospital serving a majority Hispanic population. We report results of the first 14 months of the screening program and linkage to care for chronically HCV‐infected persons after a minimum 10 months follow‐up. We also estimate costs for program implementation and maintenance to inform hospital administrators, healthcare policymakers, and clinicians about resources that may be required to effectively screen hospitalized baby boomers for HCV.
METHODS
Study Setting
The HCV baby boomer screening program was pilot tested in November 2012 and launched December 1, 2012 in a 498‐bed academic‐affiliated hospital of a healthcare system serving the indigent population of South Texas.
Project Development Phase
From October 1, 2012 to November 30, 2012, project infrastructure development and provider/staff education were conducted. A half‐hour PowerPoint lecture (in person or online) was developed about HCV epidemiology, birth‐cohort HCV screening guidelines, newer treatment modalities, and screening program components. Lectures were delivered to departmental chairs at the affiliated medical school, departmental grand rounds, and the hospital's nursing supervisors. One‐on‐one informational meetings were also held with hospital administrators and staff.
With the hospital's information technology team, screens were developed to identify eligible baby boomers from up to 7 years of previous inpatient and outpatient encounters in the EMR from: birth year (19451965) and no prior diagnosis of HCV infection (070.41, 070.44, 070.51, 070.54, 070.7x, V02.62) or any type of completed test for HCV. The algorithm also excluded patients admitted to psychiatry due to lack of decision‐making capacity or patients with a poor prognosis such as metastatic cancer. An audit of 100 consecutive excluded patients identified all as legitimate.
A new laboratory order for HCV screening was developed by laboratory administrators and pathology faculty for an anti‐HCV antibody test followed by reflex HCV RNA testing for positive results per CDC recommendations.[13] The anti‐HCV test was performed on serum or ethylenediaminetetraacetic acid plasma using the Advia Centaur HCV Assay (Bayer HealthCare LLC, Tarrytown, NY). This assay has excellent sensitivity (99.9%) and specificity (97.5%).[14, 15] The HCV RNA assay was performed using quantitative real‐time polymerase chain reaction (PCR) using the COBAS AmpliPrep/COBAS TaqMan HCV test (Roche Molecular Systems, Pleasanton, CA). Use of plasma preparation tubes (PPTs) (BD Vacutainer PPT tubes; Becton, Dickinson and Co., Franklin Lakes, NJ) permitted both anti‐HCV antibody and HCV PCR testing to be performed on the same specimen when anti‐HCV antibody was detected, eliminating a second blood draw for the PCR test. For patients eligible for screening, an EMR algorithm was created to add an HCV screening order to over 50 different admission order sets.
To educate patients newly diagnosed with HCV infection, we developed an interactive, low‐literacy, educational program in Spanish and English for an electronic tablet device that addressed: HCV epidemiology, transmission prevention, factors that can accelerate chronic HCV infection, and management/treatment strategies. At several points in the program, the patient needed to answer questions correctly to continue. The tablet retained responses linked to a study identification about alcohol consumption, history of past and current illicit drug use, sexual risk behavior, and offered risk reduction messages. The tablet content and presentation reflected suggestions by Hispanic patient‐reviewers about cultural appropriateness and comprehension.
Project Implementation and Maintenance Phase
We report implementation of the program from December 1, 2012 to January 31, 2014. An automated EMR report classified all baby boomers admitted in the previous 24 hours as: (1) eligible with pending screening test order, (2) eligible without an order, (3) ineligible due to prior HCV test or diagnosis, or (4) ineligible due to comorbidity (eg, metastatic cancer). For approximately one‐third of eligible patients, a study team member placed an order after review of the daily admission report because the order had not been automatically placed.
Admitting nurses initially asked for consent from eligible patients for HCV screening, but this was ultimately deemed too onerous a task along with all of their other duties. We then instituted opt‐out consent with patient education about testing and opportunities to refuse via posters placed throughout the hospital and flyers in admission packets. A bilingual HCV counselor provided HCV screening test results to all patients. She counseled patients who screened positive for HCV with the educational program on an electronic tablet and developed a follow‐up care plan.
A bilingual promotora (community health worker) contacted patients newly diagnosed with chronic HCV infection after hospital discharge to address the following: obtaining insurance, access to primary care and HCV specialty care, scheduling appointments, and treatment for alcohol problems or drug abuse. After obtaining signed consent, the promotora sent test results and recommendations for follow‐up care (eg, hepatitis A and B immunization) to a designated outpatient physician and reminded patients about appointments and pending tests. The promotora received training in motivational interviewing skills to engage patients with needed care including alcohol treatment.
Study Data
A summary report was developed from the EMR with demographic, insurance, clinical, and HCV screening data for all admitted baby boomers. For patients diagnosed with chronic HCV infection, the promotora obtained data about follow‐up HCV care through December 10, 2014 from the EMR, outside provider records, and patient reports.
Study Variables
The 2 outcome measures were a positive anti‐HCV antibody test and positive HCV RNA test. Insurance status was categorized as insured (private, public, Veterans Administration, Department of Defense) or uninsured (self‐pay or county‐based financial assistance program). Problem drinking was identified from International Classification of Diseases, Ninth Revision, Clinical Modification codes for the admission, notes by clinicians describing alcohol abuse/dependence, or quantity/frequency meeting National Institute on Alcohol Abuse and Alcoholism criteria for alcohol problems of >14 drinks/week or >4 drinks/day for men and >7 drinks per week or >3 drinks per day for women.[16]
Implementation costs included informatics support, mobile app development, other patient educational materials, costs of screening tests for uninsured, and 0.3 full‐time equivalent (FTE) of a clinician for half a year. Maintenance costs included salaries for the study team, HCV testing costs, and postage.
Analysis
Demographics by HCV antibody test results are compared using [2] tests or Student t tests as appropriate. Among persons with a positive HCV antibody test, HCV RNA results are similarly compared. This implementation project was approved by the University of Texas Health Science Center at San Antonio Institutional Review Board (HSC20130033N).
RESULTS
Within 14 months, 6410 unique baby boomers were admitted with a mean age 56.4 years (standard deviation [SD] 5.7), 55.9% men, 59.1% Hispanic, 8.2% nonwhite, and 46.7% uninsured (Table 1). Among admitted patients, 729 (11.4%) had a previous HCV diagnosis and 1904 (29.7%) had been tested for HCV (Figure 1). Anti‐HCV antibody testing was completed for 3168 (49.4% of all admitted patients and 83.9% of never‐tested patients). After exclusions such as significant comorbidity or psychiatric admission, 95% of eligible persons were tested. Of screened patients, 240 (7.6%) were positive; these patients were significantly younger (P<0.0001) and more likely to be men (P<0.0001) and uninsured (P=0.002) (Table 1). Notably, 10% of men were anti‐HCV positive versus 4% of women. In this predominantly Hispanic cohort, no significant difference appeared by race‐ethnicity, but African Americans had a higher prevalence (10.4%) than other groups.
| Characteristic | All Screened Patients, No. | Anti‐HCV Antibody‐Positive Patients, No. (Row %) | P Value* |
|---|---|---|---|
| |||
| Overall | 3,168 | Total=240 (7.6) | |
| Age, mean (SD) | 57.0 (5.7) | 54.8 (5.0) | <0.0001 |
| Sex | |||
| Men | 1,771 | 185 (10.4) | <0.0001 |
| Women | 1,397 | 55 (3.9) | |
| Race | |||
| Non‐Hispanic white | 1,036 | 86 (8.3) | 0.12 |
| Hispanic | 1,872 | 134 (7.2) | |
| African American | 163 | 17 (10.4) | |
| Other | 97 | 3 (3.1) | |
| Insurance | |||
| Insured | 1,740 | 109 (6.3) | 0.002 |
| Uninsured | 1,428 | 131 (9.2) | |
HCV RNA testing was completed for 214 (89.2%) anti‐HCVpositive patients, of whom 134 (62.6%) had detectable RNA, indicating chronic HCV infection (Figure 1). Overall, 4.2% of all eligible patients tested for HCV were chronically infected. No characteristics were significantly associated with chronic HCV, but persons with chronic infection tended to be younger, uninsured, and African American (Table 2).
| Characteristics | All HCV RNA‐Tested Patients, No. | HCV RNA‐Positive Patients, No. (Row %) | P Value* |
|---|---|---|---|
| |||
| Overall | 214 | 134 (62.6) | |
| Age, y, mean (SD) | 54.6 (5.0) | 54.2 (5.1) | 0.09 |
| Sex | |||
| Men | 165 | 106 (64.2) | 0.37 |
| Women | 49 | 28 (57.1) | |
| Race | |||
| Non‐Hispanic white | 78 | 49 (62.8) | 0.65 |
| Hispanic | 118 | 73 (61.8) | |
| African American | 15 | 11 (73.3) | |
| Other | 3 | 1 (33.3) | |
| Insurance | |||
| Insured | 92 | 52 (56.5) | 0.11 |
| Uninsured | 122 | 82 (67.2) | |
Among patients with chronic HCV infection, 129 (96.3%) were counseled and follow‐up plans developed (Figure 2). By December 10, 2014, 108 (80.6%) patients had received follow‐up primary care, and 52 (38.8%) had care from a hepatologist. Five had initiated HCV‐specific treatment, but many others were awaiting approval for compassionate drug programs offering direct‐acting antivirals. Barriers to care included 82 (61.2%) uninsured, 45 (34%) problem drinkers, 22 (16%) homeless, and 25 (18.6%) incarcerated (not shown). The promotora addressed these issues by visiting homes or homeless shelters, assistance with obtaining county‐based or other types of insurance, offering alcohol risk‐reduction counseling, linking patients to alcohol‐treatment programs, and communicating with the county jail about follow‐up care.
Most of the developmental costs for the program were dedicated to developing EMR programs (Table 3). An optional cost was for the development of the tablet educational program about HCV. In regard to maintenance costs for the first 14 months, the majority was to support the program faculty, counseling/case management, and a nurse practitioner who helped with ordering tests. We also estimated costs for testing uninsured patients (45% of HCV antibody tested, 57% of HCV PCR tested, per Tables 1 and 2, respectively), as they must be borne by the hospital.
| Program Component | Monthly ($) | Total ($) |
|---|---|---|
| ||
| Development phase (2 months prior to start) | ||
| Personnel | ||
| Faculty physicians (0.3 FTE salary+benefits) | 6,641 | 13,282 |
| Role: Development educational materials, provider education, and pilot testing | ||
| Technology | ||
| Development of eligibility screen and order sets for electronic medical record | 41,171 | |
| HCV counseling educational program for tabletdevelopment and pilot testing (optional) | 15,000 | |
| Patient educational materials (posters, flyers) | 400 | |
| Total for development phase | 69,853 | |
| Maintenance phase (14 months) | ||
| Personnel | ||
| Faculty physicians (0.3 FTE, salary+benefits) | 6,641 | 92,974 |
| Role: Coordinate with hospital staff and faculty, liaison with laboratory, supervise study team, review all identified cases for eligibility and management plans | ||
| Inpatient counselor and outpatient case management (2 FTE, salary+benefits) | 6,343 | 88,802 |
| Role: Inpatient and outpatient counseling of HCV Ab+patients and facilitation of follow‐up care for patients with chronic HCV infection | ||
| Nurse practitioner ($35/hour @ 10 hours/month) | 350 | 4,900 |
| Role: Review daily list of admitted baby boomers and manually order HCV screening test for those missed by the automated order | ||
| Postage | 10 | 140 |
| Laboratory costs for uninsured (based on % in cohort) | ||
| HCV antibody in plasma preparation tubes ($13.41/test 1,423) | 19,082 | |
| HCV RNA PCR ($87.96/test 122) | 10,731 | |
| Total for maintenance phase | 216,629 | |
| Total program costs | 286,482 | |
DISCUSSION
Implementation of universal HCV screening and linkage to care for hospitalized baby boomers utilizes a multicomponent infrastructure that reflects lessons learned from similar HIV programs. Use of an EMR algorithm to identify eligible patients and programs to automatically order HCV screening was a linchpin of our high testing rate and averted testing those who did not require screening. Of all 6410 baby boomers admitted to our safety‐net hospital, the EMR screen identified over 40% as ineligible due to prior diagnosis of HCV infection or prior HCV tests. Most of the additional 609 patients who were not tested were excluded due to comorbidities or admission to psychiatry. Overall, the EMR programs, tests ordered by the team, and opt‐out screening with education resulted in screening 95% of eligible patients. However, this program carries substantial costs, nearly $300,000 for the first 2 years, for unreimbursed services in this safety‐net hospital. The new guidelines for HCV screening[1, 2] are not accompanied by financial support either for program implementation or for screening and linkage to care for the uninsured, creating significant financial hurdles to achieve guideline compliance within already overtaxed public healthcare systems.
The infrastructure implemented in this hospital succeeded in achieving a higher rate of HCV screening of baby boomers than reported by other programs. In an emergency department in Birmingham, Alabama, a screening program for baby boomers tested 66% of 2325 persons who were HCV‐unaware.[17] In an outpatient clinic for men who have sex with men, only 54% of 1329 patients were screened for HCV.[18]
Among 3168 screened patients in our cohort, 7.6% were anti‐HCV antibody positive, which is over twice the prevalence of 3.5% (95% confidence interval: 2.2%‐4.8%) for anti‐HCVpositive tests in baby boomers based on National Health and Nutrition Examination Survey (NHANES) data from 2001 to 2010.[19] However, the Alabama emergency department study found that 11% of tested patients were anti‐HCV positive.[17] Although that study lacked race‐ethnicity data for half of the subjects, among those with this information, 13% of black and 7% of white subjects tested anti‐HCV positive. Compared with the Alabama study, the anti‐HCV prevalence in our cohort was somewhat lower for blacks (10.4%) but higher for non‐Hispanic whites (8.3%). Hispanics in our cohort had the lowest anti‐HCV prevalence (7.2%), whereas the Alabama study did not report this figure. National studies also find that the prevalence of anti‐HCVpositive results is twice as high for blacks compared with non‐Hispanic whites and Hispanics, and nearly twice as high for men compared with women.[19] In our cohort, the proportion of men with anti‐HCVpositive results was nearly 3 times that for women.
Diagnosis of chronic HCV infection requires 2 tests, similar to performing a Western blot test after a positive enzyme‐linked immunoassay for HIV. In a Veterans Affairs study, only 64% of patients with a positive anti‐HCV antibody test had a HCV RNA performed when reflex testing was not performed, and patients had to come in for a second test versus >90% of patients in sites that offer reflex testing.[20] At a somewhat increased price due to using more expensive PPTs ($96/100 PPT tubes vs $6.50/100 for serum red top tubes), both tests were performed on the same blood sample, resulting in 89% of anti‐HCV antibody‐positive patients being tested for HCV RNA.
Overall, 62% of patients in our cohort with a positive anti‐HCV antibody test had HCV RNA detected (viremic) compared with 71% of persons aged 20 years in an NHANES study from 2003 to 2010.[21] Several factors may contribute to this lower rate of chronic infection. In a study of HCV seropositive blood donors, Hispanics and non‐Hispanic whites were significantly more likely to have spontaneously cleared HCV infection than Asians and non‐Hispanic blacks.[22] Spontaneous clearance of HCV has also been associated with younger age at infection and HCV genotype 1.[23] Poorly understood genetic factors may also play a role.[24] The high rate of HCV clearance in our cohort reinforces the need to perform HCV RNA testing.
Overall, 4.2% of our cohort had chronic HCV infection. According to CDC estimates from 1999 to 2008 NHANES data, 2.74 million (3.25%) of 84.2 million US baby boomers have been infected with HCV, and 2.04 million (2.4%) have chronic infection.[1] Therefore, our safety‐net cohort of never‐tested baby boomers had over twice the prevalence of chronic HCV infection than the national estimate for this age group. This high proportion of chronic HCV may reflect our predominantly low‐income patient population. An analysis conducted by Milliman, Inc. using 2010 data estimated that half of all persons with undiagnosed HCV infection are uninsured.[25] This finding reinforces the need to conduct HCV screening in acute‐care settings such as hospitals, because the uninsured have poor access to ambulatory care.
Our chronic HCV‐infected cohort had many barriers to follow‐up care because most were uninsured and 15% were homeless. Our counselors addressed socioeconomic barriers to care[26] and concerns about the disease.[27] Many patients also had problem drinking based on either self‐report or documented in the medical record. Even moderate alcohol use may increase the risk of overall and liver‐related mortality from chronic HCV infection,[28] so our team offered brief alcohol counseling and partnered with healthcare providers and local Alcoholics Anonymous programs to offer support.
We linked 80% of newly diagnosed patients to primary care or hepatology providers, aided by a county‐level financial assistance program for healthcare services for uninsured residents, but it still required patients to pay out of pocket for care. Access to newer, highly effective, all‐oral therapy treatment[5] was slowed while awaiting US Food and Drug Administration approval in the first year of this project, then treatment provided only after lengthy applications to drug company assistance programs with priority given to persons with compensated cirrhosis.
Our project raises serious concerns for policymakers and payers. Should universal baby boomer HCV testing be undertaken without taking into account the financial and personnel resources required to implement this screening program or the substantial expenditures necessary to treat chronically infected persons? Although the Centers for Medicaid and Medicare Services pay for HCV screening costs,[29] our hospital had to cover costs for uninsured persons. Admittedly, Texas has the highest proportion of residents who are uninsured in the nation, but even in other states, Medicaid and other insurance programs are wrestling with how to deal with the high cost of HCV therapy.[30]
We acknowledge several limitations of this project. First, it was undertaken in only 1 hospital. Yet, our challenges and solutions are likely to be applicable to other hospitals nationally, especially those serving vulnerable populations. Second, patients in our cohort were usually admitted for comorbidities that needed to be managed before HCV infection could be addressed. However, persons with a poor prognosis, such as metastatic cancer, were excluded. We did not attempt to exclude other persons with serious comorbidities such as congestive heart failure, because the guidelines do not currently recommend this, and there may be benefits for patients, their families, and providers from knowing that an individual is chronically HCV infected even if they are not eligible to be treated. Third, the cost of the program was supported in part by a grant and would otherwise have to be borne by the hospital. Fourth, the EMR used by our hospital allows hundreds of admission order sets to be created and made automated order entry hard to implement. This is unlikely to be the situation in other hospitals using different types of EMRs.
It remains to be seen whether safety‐net hospitals with populations at greater risk of HCV infection can afford to support HCV testing and linkage to care. In view of several cost‐effectiveness studies that find screening and treating chronic HCV‐infected baby boomers cost‐effective within standard thresholds,[31, 32, 33] it may be important for policymakers and payers to consider lessons from HIV programs. Because HIV‐infected persons could not afford life‐saving medication, vigorous advocacy efforts led to legislation approving the Ryan White program in 1990 to fill gaps in HIV care that were not covered by other sources of support.[34] HCV infection is the most common blood‐borne infection in the nation, with potentially devastating consequences if ignored, but the underlying premise that universal HCV testing will save lives is in question if most of the individuals who are diagnosed with chronic HCV are low income, uninsured, or underinsured with limited access to curative medications. A rigorous public policy debate regarding both the merits of screening and the availability of treatment to those who are diagnosed is essential to the success of these programs.
Disclosure
Funding for this study was received from the Centers for Disease Control and Prevention CDC PS12‐1209PPHF12. The authors report no conflicts of interest.
- , , , , , Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945–1965. MMWR Recomm Rep. 2012;61:1–32.
- 2. Centers for Disease Control and Prevention. Vital signs: evaluation of hepatitis C virus infection testing and reporting–eight U.S. sites, 2005‐2011. MMWR Morb Mortal Wkly Rep. 2013;62:357–361.
- , , , , Hepatitis C virus infection in USA: an estimate of true prevalence. Liver Int. 2011;31:1090–1101.
- Institute of Medicine. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Washington, DC: The National Academies Press; 2010.
- , Current and future therapies for hepatitis C virus infection. N Engl J Med. 2013;368:1907–1917.
- , , , et al. Increasing prevalence of HCC and cirrhosis in patients with chronic hepatitis C virus infection. Gastroenterology. 2011;140:1182–1188.
- U.S. Preventive Services Task Force. Screening for hepatitis C virus infection in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2013;159:349–357.
- , , Undiagnosed hepatitis C on the general medicine and trauma services of two urban hospitals. J Infect. 2009;59:62–69.
- U.S. Preventive Services Task Force. Screening for HIV: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2013;159:51–60.
- , , , et al. Factors affecting clinician educator encouragement of routine HIV testing among trainees. J Gen Intern Med. 2012;27:839–844.
- , , , et al. Counselor‐versus provider‐based HIV screening in the emergency department: Results from the universal screening for HIV infection in the emergency room (USHER) randomized controlled trial. Ann Emerg Med. 2011;58:S126–S132.e1–4.
- , , Approaching the CDC's guidelines on the HIV testing of inpatients: physician‐referral versus nonreferral‐based testing. AIDS Patient Care STDS. 2006;20:311–317.
- Centers for Disease Control and Prevention (CDC). Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. 2013;62:362–365.
- Advia Centaur Assay Manual. Malvern, PA: Siemens Medical Solutions Diagnostics; Pub# 07063235, Rev. C, 2005‐01.
- , , , Comparison of the ADVIA Centaur and Abbott AxSYM immunoassay systems for a routine diagnostic virology laboratory. J Clin Virol. 2004;30:S11–S15.
- National Institute on Alcohol Abuse and Alcoholism. Drinking levels defined. Available at: http://www.niaaa.nih.gov/alcohol‐health/overview‐alcohol‐consumption/moderate‐binge‐drinking. Accessed June 12, 2014.
- , , , et al. Unrecognized chronic hepatitis C virus infection among baby boomers in the emergency department. Hepatology. 2015;61:776–782.
- , , , et al. Low rates of hepatitis screening and vaccination of HIV‐infected MSM in HIV clinics. Sex Transm Dis. 2012;39:349–353.
- , , , , , The changing epidemiology of hepatitis C virus infection in the United States: National Health and Nutrition Examination Survey 2001 through 2010. J Hepatol. 2014;60:691–698.
- , , , , Viral RNA testing in hepatitis C antibody‐positive veterans. Am J Prev Med. 2009;36:235–238.
- , , , et al. Chronic hepatitis C virus infection in the United States: National Health and Nutrition Examination Survey 2003 to 2010. Ann Intern Med. 2014;160:293–300.
- , , , et al. NHLBI Retrovirus Epidemiology Donor Study (REDS) Group. Correlates of hepatitis C virus (HCV) RNA negativity among HCV‐seropositive blood donors. Transfusion. 2006;46:469–475.
- , , , , , Spontaneous loss of hepatitis C virus RNA from serum is associated with genotype 1 and younger age at exposure. J Med Virol. 2011;83:1338–1344.
- , , , et al. Genetics of spontaneous clearance of hepatitis C virus infection: a complex topic with much to learn. Hepatology. 2014;60:2127–2128.
- , , , Health care reform and hepatitis C: a convergence of risk and opportunity. Available at: http://us.milliman.com/uploadedFiles/insight/2013/convergence‐of‐risk‐and‐opportunity.pdf. Accessed February 5, 2015.
- , , , Hepatitis C testing, infection, and linkage to care among racial and ethnic minorities in the United States, 2009‐2010. Am J Public Health. 2013;103:112–119.
- , Barriers to hepatitis C treatment. Liver Int. 2012;32:151–156.
- , , , , Moderate, excessive or heavy alcohol consumption: Each is significantly associated with increased mortality in patients with chronic hepatitis C. Aliment Pharmacol Ther. 2013;37:703–709.
- Centers for Medicare and Medicaid Services. Proposed decision memo for screening for hepatitis c virus (HCV) in adults (CAG‐00436N). Available at: http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=272. Accessed June 2, 2014.
- , Therapy for hepatitis C—the costs of success. N Engl J Med. 2014;370:1552–1553.
- , , , et al. Economic model of a birth cohort screening program for hepatitis C. Hepatology. 2012;55:1344–1355.
- , , , Cost‐effectiveness analysis of risk‐factor guided and birth‐cohort screening for chronic hepatitis C infection in the United States. PLoS One. 2013;8:e58975.
- , , , et al. The cost‐effectiveness of birth‐cohort screening for hepatitis C antibody in U.S. primary care settings. Ann Intern Med. 2012;156:263–270.
- U.S. Department of Health and Human Services. Health Resources and Services Administration: HIV/AIDS programs. Available at: http://hab.hrsa.gov/abouthab/legislation.html. Accessed April 8, 2015.
- , , , , , Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945–1965. MMWR Recomm Rep. 2012;61:1–32.
- 2. Centers for Disease Control and Prevention. Vital signs: evaluation of hepatitis C virus infection testing and reporting–eight U.S. sites, 2005‐2011. MMWR Morb Mortal Wkly Rep. 2013;62:357–361.
- , , , , Hepatitis C virus infection in USA: an estimate of true prevalence. Liver Int. 2011;31:1090–1101.
- Institute of Medicine. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Washington, DC: The National Academies Press; 2010.
- , Current and future therapies for hepatitis C virus infection. N Engl J Med. 2013;368:1907–1917.
- , , , et al. Increasing prevalence of HCC and cirrhosis in patients with chronic hepatitis C virus infection. Gastroenterology. 2011;140:1182–1188.
- U.S. Preventive Services Task Force. Screening for hepatitis C virus infection in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2013;159:349–357.
- , , Undiagnosed hepatitis C on the general medicine and trauma services of two urban hospitals. J Infect. 2009;59:62–69.
- U.S. Preventive Services Task Force. Screening for HIV: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2013;159:51–60.
- , , , et al. Factors affecting clinician educator encouragement of routine HIV testing among trainees. J Gen Intern Med. 2012;27:839–844.
- , , , et al. Counselor‐versus provider‐based HIV screening in the emergency department: Results from the universal screening for HIV infection in the emergency room (USHER) randomized controlled trial. Ann Emerg Med. 2011;58:S126–S132.e1–4.
- , , Approaching the CDC's guidelines on the HIV testing of inpatients: physician‐referral versus nonreferral‐based testing. AIDS Patient Care STDS. 2006;20:311–317.
- Centers for Disease Control and Prevention (CDC). Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. 2013;62:362–365.
- Advia Centaur Assay Manual. Malvern, PA: Siemens Medical Solutions Diagnostics; Pub# 07063235, Rev. C, 2005‐01.
- , , , Comparison of the ADVIA Centaur and Abbott AxSYM immunoassay systems for a routine diagnostic virology laboratory. J Clin Virol. 2004;30:S11–S15.
- National Institute on Alcohol Abuse and Alcoholism. Drinking levels defined. Available at: http://www.niaaa.nih.gov/alcohol‐health/overview‐alcohol‐consumption/moderate‐binge‐drinking. Accessed June 12, 2014.
- , , , et al. Unrecognized chronic hepatitis C virus infection among baby boomers in the emergency department. Hepatology. 2015;61:776–782.
- , , , et al. Low rates of hepatitis screening and vaccination of HIV‐infected MSM in HIV clinics. Sex Transm Dis. 2012;39:349–353.
- , , , , , The changing epidemiology of hepatitis C virus infection in the United States: National Health and Nutrition Examination Survey 2001 through 2010. J Hepatol. 2014;60:691–698.
- , , , , Viral RNA testing in hepatitis C antibody‐positive veterans. Am J Prev Med. 2009;36:235–238.
- , , , et al. Chronic hepatitis C virus infection in the United States: National Health and Nutrition Examination Survey 2003 to 2010. Ann Intern Med. 2014;160:293–300.
- , , , et al. NHLBI Retrovirus Epidemiology Donor Study (REDS) Group. Correlates of hepatitis C virus (HCV) RNA negativity among HCV‐seropositive blood donors. Transfusion. 2006;46:469–475.
- , , , , , Spontaneous loss of hepatitis C virus RNA from serum is associated with genotype 1 and younger age at exposure. J Med Virol. 2011;83:1338–1344.
- , , , et al. Genetics of spontaneous clearance of hepatitis C virus infection: a complex topic with much to learn. Hepatology. 2014;60:2127–2128.
- , , , Health care reform and hepatitis C: a convergence of risk and opportunity. Available at: http://us.milliman.com/uploadedFiles/insight/2013/convergence‐of‐risk‐and‐opportunity.pdf. Accessed February 5, 2015.
- , , , Hepatitis C testing, infection, and linkage to care among racial and ethnic minorities in the United States, 2009‐2010. Am J Public Health. 2013;103:112–119.
- , Barriers to hepatitis C treatment. Liver Int. 2012;32:151–156.
- , , , , Moderate, excessive or heavy alcohol consumption: Each is significantly associated with increased mortality in patients with chronic hepatitis C. Aliment Pharmacol Ther. 2013;37:703–709.
- Centers for Medicare and Medicaid Services. Proposed decision memo for screening for hepatitis c virus (HCV) in adults (CAG‐00436N). Available at: http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=272. Accessed June 2, 2014.
- , Therapy for hepatitis C—the costs of success. N Engl J Med. 2014;370:1552–1553.
- , , , et al. Economic model of a birth cohort screening program for hepatitis C. Hepatology. 2012;55:1344–1355.
- , , , Cost‐effectiveness analysis of risk‐factor guided and birth‐cohort screening for chronic hepatitis C infection in the United States. PLoS One. 2013;8:e58975.
- , , , et al. The cost‐effectiveness of birth‐cohort screening for hepatitis C antibody in U.S. primary care settings. Ann Intern Med. 2012;156:263–270.
- U.S. Department of Health and Human Services. Health Resources and Services Administration: HIV/AIDS programs. Available at: http://hab.hrsa.gov/abouthab/legislation.html. Accessed April 8, 2015.
© 2015 Society of Hospital Medicine
Insomnia in the ICU—and after
Two recent studies—one conducted by researchers from Yale University in New Haven and one conducted by researchers from VA Puget Sound Health Care System in Seattle—suggest it is possible to help patients get better sleep, both in the intensive care unit (ICU) and after ICU discharge. However, protocol and policy changes—as well as education—are needed.
To read the full article, go to Federal Practitioner: http://www.fedprac.com/articles/the-latest/article/insomnia-in-the-icu-and-after/7823e1c993201366966884fa1863b588/ocregister.html.
Two recent studies—one conducted by researchers from Yale University in New Haven and one conducted by researchers from VA Puget Sound Health Care System in Seattle—suggest it is possible to help patients get better sleep, both in the intensive care unit (ICU) and after ICU discharge. However, protocol and policy changes—as well as education—are needed.
To read the full article, go to Federal Practitioner: http://www.fedprac.com/articles/the-latest/article/insomnia-in-the-icu-and-after/7823e1c993201366966884fa1863b588/ocregister.html.
Two recent studies—one conducted by researchers from Yale University in New Haven and one conducted by researchers from VA Puget Sound Health Care System in Seattle—suggest it is possible to help patients get better sleep, both in the intensive care unit (ICU) and after ICU discharge. However, protocol and policy changes—as well as education—are needed.
To read the full article, go to Federal Practitioner: http://www.fedprac.com/articles/the-latest/article/insomnia-in-the-icu-and-after/7823e1c993201366966884fa1863b588/ocregister.html.
Helping patients afford the new hepatitis C medications
New antiviral medications for hepatitis C are effective, but the cost of a full course of treatment can reach $100,000. In “How to pay for costly hepatitis C drugs,” which is available at http://www.everydayhealth.com/news/how-pay-costly-hepatitis-c-drugs/, Madeline Vann, MPH, details strategies that patients can use to obtain these medications, including negotiating directly with an insurance company, checking if the manufacturer offers a patient assistance program, and contacting the Patient Access Network Foundation.
New antiviral medications for hepatitis C are effective, but the cost of a full course of treatment can reach $100,000. In “How to pay for costly hepatitis C drugs,” which is available at http://www.everydayhealth.com/news/how-pay-costly-hepatitis-c-drugs/, Madeline Vann, MPH, details strategies that patients can use to obtain these medications, including negotiating directly with an insurance company, checking if the manufacturer offers a patient assistance program, and contacting the Patient Access Network Foundation.
New antiviral medications for hepatitis C are effective, but the cost of a full course of treatment can reach $100,000. In “How to pay for costly hepatitis C drugs,” which is available at http://www.everydayhealth.com/news/how-pay-costly-hepatitis-c-drugs/, Madeline Vann, MPH, details strategies that patients can use to obtain these medications, including negotiating directly with an insurance company, checking if the manufacturer offers a patient assistance program, and contacting the Patient Access Network Foundation.
AACE: Bisphosphonates do not prevent fractures in adults with osteogenesis imperfecta
NASHVILLE, TENN. – Bisphosphonates help prevent fractures in some children with osteogenesis imperfecta, but they don't do the same for adults with the condition, according to a review from Johns Hopkins University and the Kennedy Krieger Institute.
Even so, bisphosphonates are used widely for adult osteogenesis imperfecta (OI) “because people have nothing else to hang their hat on, and the average physician doesn’t understand that osteogenesis imperfecta is not the same as age-related osteoporosis,” said senior investigator Dr. Jay R. Shapiro, director of Kennedy Krieger’s osteogenesis imperfecta program in Baltimore.
“We see adults with OI all the time who have been on bisphosphonates for 10 years, 12 years. It’s not doing anything for them, and sooner or later they come to realize that.” Meanwhile, “I think people are getting a little bit of a queasy feeling about not fully understanding the effectiveness and side effects of long-term treatment with bisphosphonates,” said Dr. Shapiro, also professor in the department of physical medicine and rehabilitation at Johns Hopkins University, Baltimore.
Adults with OI “also don’t respond to Forteo [teriparatide]. I do not recommend treatment with bisphosphonates or Forteo in” adults, he said at the annual meeting of the American Association of Clinical Endocrinologists.
Dr. Shapiro shared his thoughts during an interview regarding his latest study, an analysis of five children with OI under 18 years of age who responded to pamidronate (Aredia) and 11 who did not, meaning that they had two or more fractures per year while on the drug.
His team also compared fracture outcomes in 34 adults with OI treated with oral or intravenous bisphosphonates with 12 untreated adults. The adults were, on average, 52 years old.
The goal was to see if common bone markers predicted who would respond to bisphosphonates, but they did not. Vitamin D, phosphorus, alkaline phosphatase, C-telopeptide, and other measures were the same in children regardless of their response to pamidronate, and the same in adults with OI whether or not they were on bisphosphonates.
“We have not yet defined what the difference is between responders and nonresponders. If you take a crack at the simple things, they don’t help,” Dr. Shapiro said.
Children who responded had a mean of 4.8 fractures over an average of 42.6 months of treatment. Nonresponders had a mean of 15.6 fractures over an average of 72.7 months of treatment.
“For a period of time, you can expect about two-thirds of kids to respond. I would look to see a decrease in fracture rates within 2 years of treatment. If they haven’t decreased their fracture rate [by then], I would be very cautious about continuing,” he said, adding that the optimal duration of treatment in children is unknown.
In adults, the team found no difference in fracture rates at 5 and 10 years. Treated adults had an average of 1.71 fractures over 10 years, versus 1.23 in untreated adults (P = 0.109).
The numbers in the study were too small for meaningful subgroup analysis by OI type.
The findings parallel recent meta-analyses; some have found that bisphosphonates help OI children, but none has found benefits for adults (J. Bone. Miner. Res. 2015;30:929-33). “To date, there is no evidence indicating that bisphosphonates have a positive effect on fracture rates in adults,” Dr. Shapiro said.
Bone turnover declines after puberty, which may explain why the drugs lose their effectiveness after age 18 or so. “What happens in OI anyway is that, after puberty, the fracture rates normally go way down,” Dr. Shapiro said.
Dr. Shapiro said that he had no relevant disclosures, and that there was no outside funding for the work.
NASHVILLE, TENN. – Bisphosphonates help prevent fractures in some children with osteogenesis imperfecta, but they don't do the same for adults with the condition, according to a review from Johns Hopkins University and the Kennedy Krieger Institute.
Even so, bisphosphonates are used widely for adult osteogenesis imperfecta (OI) “because people have nothing else to hang their hat on, and the average physician doesn’t understand that osteogenesis imperfecta is not the same as age-related osteoporosis,” said senior investigator Dr. Jay R. Shapiro, director of Kennedy Krieger’s osteogenesis imperfecta program in Baltimore.
“We see adults with OI all the time who have been on bisphosphonates for 10 years, 12 years. It’s not doing anything for them, and sooner or later they come to realize that.” Meanwhile, “I think people are getting a little bit of a queasy feeling about not fully understanding the effectiveness and side effects of long-term treatment with bisphosphonates,” said Dr. Shapiro, also professor in the department of physical medicine and rehabilitation at Johns Hopkins University, Baltimore.
Adults with OI “also don’t respond to Forteo [teriparatide]. I do not recommend treatment with bisphosphonates or Forteo in” adults, he said at the annual meeting of the American Association of Clinical Endocrinologists.
Dr. Shapiro shared his thoughts during an interview regarding his latest study, an analysis of five children with OI under 18 years of age who responded to pamidronate (Aredia) and 11 who did not, meaning that they had two or more fractures per year while on the drug.
His team also compared fracture outcomes in 34 adults with OI treated with oral or intravenous bisphosphonates with 12 untreated adults. The adults were, on average, 52 years old.
The goal was to see if common bone markers predicted who would respond to bisphosphonates, but they did not. Vitamin D, phosphorus, alkaline phosphatase, C-telopeptide, and other measures were the same in children regardless of their response to pamidronate, and the same in adults with OI whether or not they were on bisphosphonates.
“We have not yet defined what the difference is between responders and nonresponders. If you take a crack at the simple things, they don’t help,” Dr. Shapiro said.
Children who responded had a mean of 4.8 fractures over an average of 42.6 months of treatment. Nonresponders had a mean of 15.6 fractures over an average of 72.7 months of treatment.
“For a period of time, you can expect about two-thirds of kids to respond. I would look to see a decrease in fracture rates within 2 years of treatment. If they haven’t decreased their fracture rate [by then], I would be very cautious about continuing,” he said, adding that the optimal duration of treatment in children is unknown.
In adults, the team found no difference in fracture rates at 5 and 10 years. Treated adults had an average of 1.71 fractures over 10 years, versus 1.23 in untreated adults (P = 0.109).
The numbers in the study were too small for meaningful subgroup analysis by OI type.
The findings parallel recent meta-analyses; some have found that bisphosphonates help OI children, but none has found benefits for adults (J. Bone. Miner. Res. 2015;30:929-33). “To date, there is no evidence indicating that bisphosphonates have a positive effect on fracture rates in adults,” Dr. Shapiro said.
Bone turnover declines after puberty, which may explain why the drugs lose their effectiveness after age 18 or so. “What happens in OI anyway is that, after puberty, the fracture rates normally go way down,” Dr. Shapiro said.
Dr. Shapiro said that he had no relevant disclosures, and that there was no outside funding for the work.
NASHVILLE, TENN. – Bisphosphonates help prevent fractures in some children with osteogenesis imperfecta, but they don't do the same for adults with the condition, according to a review from Johns Hopkins University and the Kennedy Krieger Institute.
Even so, bisphosphonates are used widely for adult osteogenesis imperfecta (OI) “because people have nothing else to hang their hat on, and the average physician doesn’t understand that osteogenesis imperfecta is not the same as age-related osteoporosis,” said senior investigator Dr. Jay R. Shapiro, director of Kennedy Krieger’s osteogenesis imperfecta program in Baltimore.
“We see adults with OI all the time who have been on bisphosphonates for 10 years, 12 years. It’s not doing anything for them, and sooner or later they come to realize that.” Meanwhile, “I think people are getting a little bit of a queasy feeling about not fully understanding the effectiveness and side effects of long-term treatment with bisphosphonates,” said Dr. Shapiro, also professor in the department of physical medicine and rehabilitation at Johns Hopkins University, Baltimore.
Adults with OI “also don’t respond to Forteo [teriparatide]. I do not recommend treatment with bisphosphonates or Forteo in” adults, he said at the annual meeting of the American Association of Clinical Endocrinologists.
Dr. Shapiro shared his thoughts during an interview regarding his latest study, an analysis of five children with OI under 18 years of age who responded to pamidronate (Aredia) and 11 who did not, meaning that they had two or more fractures per year while on the drug.
His team also compared fracture outcomes in 34 adults with OI treated with oral or intravenous bisphosphonates with 12 untreated adults. The adults were, on average, 52 years old.
The goal was to see if common bone markers predicted who would respond to bisphosphonates, but they did not. Vitamin D, phosphorus, alkaline phosphatase, C-telopeptide, and other measures were the same in children regardless of their response to pamidronate, and the same in adults with OI whether or not they were on bisphosphonates.
“We have not yet defined what the difference is between responders and nonresponders. If you take a crack at the simple things, they don’t help,” Dr. Shapiro said.
Children who responded had a mean of 4.8 fractures over an average of 42.6 months of treatment. Nonresponders had a mean of 15.6 fractures over an average of 72.7 months of treatment.
“For a period of time, you can expect about two-thirds of kids to respond. I would look to see a decrease in fracture rates within 2 years of treatment. If they haven’t decreased their fracture rate [by then], I would be very cautious about continuing,” he said, adding that the optimal duration of treatment in children is unknown.
In adults, the team found no difference in fracture rates at 5 and 10 years. Treated adults had an average of 1.71 fractures over 10 years, versus 1.23 in untreated adults (P = 0.109).
The numbers in the study were too small for meaningful subgroup analysis by OI type.
The findings parallel recent meta-analyses; some have found that bisphosphonates help OI children, but none has found benefits for adults (J. Bone. Miner. Res. 2015;30:929-33). “To date, there is no evidence indicating that bisphosphonates have a positive effect on fracture rates in adults,” Dr. Shapiro said.
Bone turnover declines after puberty, which may explain why the drugs lose their effectiveness after age 18 or so. “What happens in OI anyway is that, after puberty, the fracture rates normally go way down,” Dr. Shapiro said.
Dr. Shapiro said that he had no relevant disclosures, and that there was no outside funding for the work.
AT AACE 2015
Key clinical point: Adult osteogenesis imperfecta patients don’t need bisphosphonates.
Major finding: Treated adults had an average of 1.71 fractures over 10 years; untreated adults had an average of 1.23 (P = 0.109).
Data source: Retrospective study of 16 pediatric and 46 adult OI patients.
Disclosures: There was no outside funding for the work, and the senior investigator had no relevant disclosures.
How do you dismiss a patient from your practice’s care?
Case: Patient becomes a liability when nonadherant to prescribed tests
MC, a 42-year-old woman (G1P1001), presents for an office visit. As the medical assistant hands you the chart, she says, “Good luck with this one. She yelled at me because you were 20 minutes behind schedule. She didn’t like sitting in the waiting room.” You greet the patient, obtain her medical history, proceed with a physical examination, and outline a management plan. You recall from the chart that you operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the operating room (OR) for a laparotomy to control bleeding. The patient has not brought this up since being discharged from the hospital.
During the current office visit, the esprit de corps in the consultation room is a bit uncomfortable, and you sense the patient is not happy. You leave the examination room and discuss the management plan with the nurse, who then returns to the patient to review the plan. The patient is unhappy with the battery of tests you have ordered but tells the nurse that she will comply.
One week later the nurse follows up with the patient by phone because she has not obtained the requested lab tests. The nurse reports to you, “She read me the riot act: ‘Why do I need all these tests? They are expensive.’ The patient indicated that she has no understanding as to why the tests were ordered in the first place.” After a discussion with you, the nurse calls the patient back in an effort to clarify her understanding of the need for the tests. The patient hangs up on her in the middle of the conversation.
The office manager tracks you down to discuss this patient. “Enough is enough,” she exclaims. “This patient is harassing the staff. She told the nurse what tests she herself believes are best and that those are the only ones she will comply with.” Your office manager states that this patient is “a liability.”
What are your choices at this point? You have thought about picking up the phone and calling her. You have considered ending her relationship with your practice. You ask yourself again, what is the best approach?
Patients have the legal right to “dismiss” or change health care providers at any time and for almost any reason without notice. But that right is not reciprocal—clinicians have a legal duty not to abandon a patient and an ethical duty to promote continuity of patient care. A clinician may dismiss a patient from his or her practice (other than for a discriminatory reason that violates ethical or legal limitations), but it must be done in the proper way.
We examine the legal, practical, and ethical issues in dismissing a patient, and how to do it without unnecessary risk. In addition, we will look at a new issue that sometimes arises in these circumstances—managed care limitations.
Physicians’ ethical obligations
The American Medical Association suggests the following ethical consideration:
Reference
- American Medical Association Council on Ethical and Judicial Affairs. Opinion 10.015. The Patient-Physician Relationship. Code of Medical Ethics. American Medical Association. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion10015.page. Issued December 2001. Accessed May 8, 2015.
Legal and medical issues
Why would you end a clinician−patient relationship?
There are a number of reasons for dismissing a patient, including1,2:
- the patient’s failure to comply with a treatment plan (probably the most frequent reason)
- persistent, inappropriate, rude, or disruptive behavior
- falsifying medical history
- seductive behavior toward health care professionals or staff
- Sentinel incident (verbal threat, violence, or criminal activity—as when a patient threatens or inappropriately touches or hits your staff)
- failure to pay billed charges (this can raise special legal issues).
The legal details vary from state to state, but fortunately there is sufficient similarity that best practices can be determined. The law starts with the proposition that ordinarily professionals may choose their patients or clients. There are limits, however, in state and federal law. A clinician may not discriminate based, for example, on ethnicity, religion, gender, or sexual orientation. In addition, the Americans with Disabilities Act limits the basis for not providing care to a patient.3
Limiting factors when dismissing a patient
Once a patient has been accepted and a professional relationship has begun, the clinician has a duty of continued care and must act reasonably to end the relationship in a way that protects the patient’s well-being.
Other recognized limitations to the ending of a treatment relationship exist. These are:
- In an emergency situation or during ongoing care in which it proves unfeasible to find another physician. At the extreme, a surgeon may not leave in the middle of surgery. Less clear, but still problematic, is the obstetrician who wants to dismiss a patient 1 or 2 weeks before an expected delivery. In any event, a clinician should not leave a patient at a critical stage without giving reasonable notice or making suitable arrangements for the attendance of another equally competent substitute.
- When there is no other health care provider available who could provide the continuity of care the clinician has begun. This limitation probably arises from the frontier days (when it was much more common for no other health care professional to be available who could provide the continuity of care the clinician began). A modern version of this might be a patient in an HMO who does not have other physicians of the same subspecialty available who are taking patients. This, of course, requires consultation with the managed care organization.
Abandonment
The legal and ethical issues are essentially related to “abandonment”—dismissing a patient improperly. Technically, abandonment is a form of negligence (the clinician does not act reasonably to protect the patient’s interests). The Oklahoma Supreme Court put it clearly: “When further medical and/or surgical attention is needed, a physician may terminate the doctor−patient relationship only after giving reasonable notice and affording an ample opportunity for the patient to secure other medical attention from other physicians” (emphasis added).4–6
How to end a patient relationship
Always send a letter
Two elements must be taken into account when dismissing a patient:
- reasonable notice
- reasonable opportunity to find another clinician.
Together, these elements mean that the intention of ending the clinician−patient relationship and the importance of finding an alternative care provider must be clearly communicated to the patient. That communication needs to be in writing—both to get the patient’s attention and as clear proof of what was said.
Some experts suggest that the best process is to have a face-to-face meeting with the patient followed by a letter. A goal of such a meeting is to make the parting as amicable as possible. It may seem more professional for a clinician to communicate such an important matter in person. The risk is that it may become a confrontation that exacerbates the situation because one or both parties may have some built-up emotion. It, therefore, depends on the circumstances as to whether such a meeting is desirable. Even if there is an oral conversation, it must be followed up with a letter to the patient.
A reasonable time frame to give the patient to find another clinician is commonly a maximum of 30 days of follow-up and emergency care. A set period of time may be a legitimate starting point but it needs to be adjusted in lieu of special circumstances, such as the availability of other similar specialists in the vicinity who are taking new patients or managed care complications. A specific time period should be indicated, along with an agreement to provide care during that time period in “emergency” or “urgent” circumstances. Of course, ongoing care also should be continued for a reasonable time (30 days is often reasonable, as mentioned). It may be best to also discuss any specific ongoing issues that should be attended to (such as the recommended tests in our opening case).
There is disagreement among experts as to whether a general statement of the reasons for ending the care relationship should be included in the letter. The argument for doing so is that, without a stated reason, the patient may call to ask why. The other side of the argument is that it adds an element of accusation; the patient undoubtedly knows what the problem is. Not writing down the reasons seems the better part of valor, especially if there has been an oral conversation.7,8
The box above provides an example of a letter to a patient (but not a model). Experts agree that the letter should be sent by certified mail with return receipt. Should the patient reject the letter, a regular delivery letter should be sent with full documentation kept in the file of the time and place it was mailed.
Managed care considerations
A consideration of increasing importance is managed care. Before taking any action, ensure that the managed care contract(s) (including federal or state government programs) have provisions concerning patient dismissals. These may be as simple as notifying the organization as to any time limits for care or of the process of dismissal.
Make sure your staff knows
Your scheduling staff needs to know with clarity the rules for scheduling (or not scheduling) this patient in the future. As a general matter, the better course of action is to allow an appointment if the patient reports that it is an emergency, whether the staff believes it is or not. In such cases it may be good to document to the patient that the emergency care does not constitute reestablishing a regular clinician−patient relationship.
Document everything
The patient’s record, at a minimum, should contain a copy of the letter sent to the patient and a log of any conversations with her about ending the relationship. Keep your own notes concerning the disruption or problems with the patient over time.
Are there risks of a malpractice lawsuit?
The abandonment claim is, of course, one possibility for a malpractice lawsuit. That is why documentation and careful communication are so important. This is one area in which having legal advice when developing a letter template should be part of the ongoing relationship with a health law attorney.
There is another malpractice risk illustrated in our hypothetical case. The physician “operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the OR and laparotomy to control bleeding.” Malpractice claims (as opposed to actual malpractice occurrences) most often arise because of bad communication with patients or when patients feel ignored. The clinician is thus between a rock and a hard place. On one hand, by ending this relationship, the clinician could well precipitate a claim based primarily on the earlier “maloccurrence.” On the other hand, continuing to treat a patient who is resisting care and creating problems with the staff has its own difficulties. It may be time for the health care professional to discuss the matter with an attorney.
Although not present in this hypothetical case, ending a patient relationship because of nonpayment of professional fees is also a touchy situation. It can be one of the other precipitating events for malpractice claims, and calls for special care.
Tread with care
Having to dismiss a patient is almost always a difficult process. The decision neither can be made lightly nor implemented sloppily. Because it is difficult, it calls on professionals to be particularly careful to not cut essential corners.9
Case: Resolved
You ask the nurse to note the details of her follow-up phone conversation with the patient in the chart. You then call MC to explain the importance of the tests. She says she is unavailable to talk right now, so you ask her to come in for an appointment, free of charge. The patient makes an appointment but does not show.
You send a letter by certified mail describing the medical necessity for the tests and that her lack of adherence and refusal to come to the office have compelled you to end your clinician−patient relationship. You write that she should immediately identify another health care professional and suggest that she contact her managed care organization for assistance. You note that, should there be a medical emergency or urgent care needed in the next 30 days, you will provide that care. You enclose a release of medical records form in the letter.
In the patient’s record you note the details of the phone conversation and ask the office manager to add that the patient was a no show for her appointment. You include a copy of the certified letter and proof of mailing in the chart.
Two weeks later, the office manager reports that she is sending the patient’s records to another physician upon receipt of the release of medical records form from the patient.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
1. Kodner C. Challenging physician-patient interactions. FP Essentials. ed 354. AAFP home study. Leawood, KS: American Academy of Family Physicians; November 2008.
2. Harris SM. Take care when firing a patient. Am Med News. http://www.ama-assn.org/amed- news/2008/02/04/bica0204 .htm. Published February 4, 2008. Accessed May 8, 2015.
3. Lynch HF. Discrimination at the doctor’s office. N Engl J Med. 2013;386(18):1668–1670.
4. Jackson v Oklahoma Memorial Hospital, 909 P.2d 765 (OK 1995). http://law.justia.com/cases/oklahoma/supreme-court/1995/4226-1.html. Accessed May 8, 2015.
5. Randolph DS, Burkett TM. When physicians fire patients: avoiding patient “abandonment” lawsuits. J Okla State Med Assoc. 2009;102(11):356–358.
6. Crauman R, Baruch J. Abandonment in the physician-patient relationship. Med Health R I. 2004;87(5):154–156.
7. Cepelewicz BB. Firing a patient: when its needed and how to handle it correctly. Med Econ. 2014;91(2):42–43.
8. Santalucia C, Michota F. When and how is it appropriate to terminate the physician-patient relationship? Cleve Clin J Med. 2004;71(3):179–183.
9. Lippman H, Davenport J. Patient dismissal: the right way to do it. J Fam Pract. 2011;60(3):135–140. http://www.jfponline.com/specialty-focus/practice-management/article/patient-dismissal-the-right-way-to-do-it/30f9501e8b3eb6ddaf6dd67ce88e0d16.html. Accessed May 8, 2015.
Joseph S. Sanfilippo, MD, MBA, and Steven R. Smith, JD
 | Joseph S. Sanfilippo, MD, MBA is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Director, Reproductive Endocrinology & Infertility, at Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors. |
|
Steven R. Smith, JD, is Professor of Law and Dean Emeritus at California Western School of Law, San Diego, California. |
|
Shirley M. Pruitt, BSN, JD, is a Partner in the firm of Yates, McLamb & Weyher, LLP, in Raleigh, North Carolina. She is an OBG Management Contributing Editor. |
The authors report no financial relationships relevant to this article.
*The “facts” of this case are based on actual cases but are a composite of several events and do not reflect a specific case.
Joseph S. Sanfilippo, MD, MBA, and Steven R. Smith, JD
| Joseph S. Sanfilippo, MD, MBA is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Director, Reproductive Endocrinology & Infertility, at Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors. |
|
Steven R. Smith, JD, is Professor of Law and Dean Emeritus at California Western School of Law, San Diego, California. |
|
Shirley M. Pruitt, BSN, JD, is a Partner in the firm of Yates, McLamb & Weyher, LLP, in Raleigh, North Carolina. She is an OBG Management Contributing Editor. |
The authors report no financial relationships relevant to this article.
*The “facts” of this case are based on actual cases but are a composite of several events and do not reflect a specific case.
Joseph S. Sanfilippo, MD, MBA, and Steven R. Smith, JD
| Joseph S. Sanfilippo, MD, MBA is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Director, Reproductive Endocrinology & Infertility, at Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors. |
|
Steven R. Smith, JD, is Professor of Law and Dean Emeritus at California Western School of Law, San Diego, California. |
|
Shirley M. Pruitt, BSN, JD, is a Partner in the firm of Yates, McLamb & Weyher, LLP, in Raleigh, North Carolina. She is an OBG Management Contributing Editor. |
The authors report no financial relationships relevant to this article.
*The “facts” of this case are based on actual cases but are a composite of several events and do not reflect a specific case.
Case: Patient becomes a liability when nonadherant to prescribed tests
MC, a 42-year-old woman (G1P1001), presents for an office visit. As the medical assistant hands you the chart, she says, “Good luck with this one. She yelled at me because you were 20 minutes behind schedule. She didn’t like sitting in the waiting room.” You greet the patient, obtain her medical history, proceed with a physical examination, and outline a management plan. You recall from the chart that you operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the operating room (OR) for a laparotomy to control bleeding. The patient has not brought this up since being discharged from the hospital.
During the current office visit, the esprit de corps in the consultation room is a bit uncomfortable, and you sense the patient is not happy. You leave the examination room and discuss the management plan with the nurse, who then returns to the patient to review the plan. The patient is unhappy with the battery of tests you have ordered but tells the nurse that she will comply.
One week later the nurse follows up with the patient by phone because she has not obtained the requested lab tests. The nurse reports to you, “She read me the riot act: ‘Why do I need all these tests? They are expensive.’ The patient indicated that she has no understanding as to why the tests were ordered in the first place.” After a discussion with you, the nurse calls the patient back in an effort to clarify her understanding of the need for the tests. The patient hangs up on her in the middle of the conversation.
The office manager tracks you down to discuss this patient. “Enough is enough,” she exclaims. “This patient is harassing the staff. She told the nurse what tests she herself believes are best and that those are the only ones she will comply with.” Your office manager states that this patient is “a liability.”
What are your choices at this point? You have thought about picking up the phone and calling her. You have considered ending her relationship with your practice. You ask yourself again, what is the best approach?
Patients have the legal right to “dismiss” or change health care providers at any time and for almost any reason without notice. But that right is not reciprocal—clinicians have a legal duty not to abandon a patient and an ethical duty to promote continuity of patient care. A clinician may dismiss a patient from his or her practice (other than for a discriminatory reason that violates ethical or legal limitations), but it must be done in the proper way.
We examine the legal, practical, and ethical issues in dismissing a patient, and how to do it without unnecessary risk. In addition, we will look at a new issue that sometimes arises in these circumstances—managed care limitations.
Physicians’ ethical obligations
The American Medical Association suggests the following ethical consideration:
Reference
- American Medical Association Council on Ethical and Judicial Affairs. Opinion 10.015. The Patient-Physician Relationship. Code of Medical Ethics. American Medical Association. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion10015.page. Issued December 2001. Accessed May 8, 2015.
Legal and medical issues
Why would you end a clinician−patient relationship?
There are a number of reasons for dismissing a patient, including1,2:
- the patient’s failure to comply with a treatment plan (probably the most frequent reason)
- persistent, inappropriate, rude, or disruptive behavior
- falsifying medical history
- seductive behavior toward health care professionals or staff
- Sentinel incident (verbal threat, violence, or criminal activity—as when a patient threatens or inappropriately touches or hits your staff)
- failure to pay billed charges (this can raise special legal issues).
The legal details vary from state to state, but fortunately there is sufficient similarity that best practices can be determined. The law starts with the proposition that ordinarily professionals may choose their patients or clients. There are limits, however, in state and federal law. A clinician may not discriminate based, for example, on ethnicity, religion, gender, or sexual orientation. In addition, the Americans with Disabilities Act limits the basis for not providing care to a patient.3
Limiting factors when dismissing a patient
Once a patient has been accepted and a professional relationship has begun, the clinician has a duty of continued care and must act reasonably to end the relationship in a way that protects the patient’s well-being.
Other recognized limitations to the ending of a treatment relationship exist. These are:
- In an emergency situation or during ongoing care in which it proves unfeasible to find another physician. At the extreme, a surgeon may not leave in the middle of surgery. Less clear, but still problematic, is the obstetrician who wants to dismiss a patient 1 or 2 weeks before an expected delivery. In any event, a clinician should not leave a patient at a critical stage without giving reasonable notice or making suitable arrangements for the attendance of another equally competent substitute.
- When there is no other health care provider available who could provide the continuity of care the clinician has begun. This limitation probably arises from the frontier days (when it was much more common for no other health care professional to be available who could provide the continuity of care the clinician began). A modern version of this might be a patient in an HMO who does not have other physicians of the same subspecialty available who are taking patients. This, of course, requires consultation with the managed care organization.
Abandonment
The legal and ethical issues are essentially related to “abandonment”—dismissing a patient improperly. Technically, abandonment is a form of negligence (the clinician does not act reasonably to protect the patient’s interests). The Oklahoma Supreme Court put it clearly: “When further medical and/or surgical attention is needed, a physician may terminate the doctor−patient relationship only after giving reasonable notice and affording an ample opportunity for the patient to secure other medical attention from other physicians” (emphasis added).4–6
How to end a patient relationship
Always send a letter
Two elements must be taken into account when dismissing a patient:
- reasonable notice
- reasonable opportunity to find another clinician.
Together, these elements mean that the intention of ending the clinician−patient relationship and the importance of finding an alternative care provider must be clearly communicated to the patient. That communication needs to be in writing—both to get the patient’s attention and as clear proof of what was said.
Some experts suggest that the best process is to have a face-to-face meeting with the patient followed by a letter. A goal of such a meeting is to make the parting as amicable as possible. It may seem more professional for a clinician to communicate such an important matter in person. The risk is that it may become a confrontation that exacerbates the situation because one or both parties may have some built-up emotion. It, therefore, depends on the circumstances as to whether such a meeting is desirable. Even if there is an oral conversation, it must be followed up with a letter to the patient.
A reasonable time frame to give the patient to find another clinician is commonly a maximum of 30 days of follow-up and emergency care. A set period of time may be a legitimate starting point but it needs to be adjusted in lieu of special circumstances, such as the availability of other similar specialists in the vicinity who are taking new patients or managed care complications. A specific time period should be indicated, along with an agreement to provide care during that time period in “emergency” or “urgent” circumstances. Of course, ongoing care also should be continued for a reasonable time (30 days is often reasonable, as mentioned). It may be best to also discuss any specific ongoing issues that should be attended to (such as the recommended tests in our opening case).
There is disagreement among experts as to whether a general statement of the reasons for ending the care relationship should be included in the letter. The argument for doing so is that, without a stated reason, the patient may call to ask why. The other side of the argument is that it adds an element of accusation; the patient undoubtedly knows what the problem is. Not writing down the reasons seems the better part of valor, especially if there has been an oral conversation.7,8
The box above provides an example of a letter to a patient (but not a model). Experts agree that the letter should be sent by certified mail with return receipt. Should the patient reject the letter, a regular delivery letter should be sent with full documentation kept in the file of the time and place it was mailed.
Managed care considerations
A consideration of increasing importance is managed care. Before taking any action, ensure that the managed care contract(s) (including federal or state government programs) have provisions concerning patient dismissals. These may be as simple as notifying the organization as to any time limits for care or of the process of dismissal.
Make sure your staff knows
Your scheduling staff needs to know with clarity the rules for scheduling (or not scheduling) this patient in the future. As a general matter, the better course of action is to allow an appointment if the patient reports that it is an emergency, whether the staff believes it is or not. In such cases it may be good to document to the patient that the emergency care does not constitute reestablishing a regular clinician−patient relationship.
Document everything
The patient’s record, at a minimum, should contain a copy of the letter sent to the patient and a log of any conversations with her about ending the relationship. Keep your own notes concerning the disruption or problems with the patient over time.
Are there risks of a malpractice lawsuit?
The abandonment claim is, of course, one possibility for a malpractice lawsuit. That is why documentation and careful communication are so important. This is one area in which having legal advice when developing a letter template should be part of the ongoing relationship with a health law attorney.
There is another malpractice risk illustrated in our hypothetical case. The physician “operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the OR and laparotomy to control bleeding.” Malpractice claims (as opposed to actual malpractice occurrences) most often arise because of bad communication with patients or when patients feel ignored. The clinician is thus between a rock and a hard place. On one hand, by ending this relationship, the clinician could well precipitate a claim based primarily on the earlier “maloccurrence.” On the other hand, continuing to treat a patient who is resisting care and creating problems with the staff has its own difficulties. It may be time for the health care professional to discuss the matter with an attorney.
Although not present in this hypothetical case, ending a patient relationship because of nonpayment of professional fees is also a touchy situation. It can be one of the other precipitating events for malpractice claims, and calls for special care.
Tread with care
Having to dismiss a patient is almost always a difficult process. The decision neither can be made lightly nor implemented sloppily. Because it is difficult, it calls on professionals to be particularly careful to not cut essential corners.9
Case: Resolved
You ask the nurse to note the details of her follow-up phone conversation with the patient in the chart. You then call MC to explain the importance of the tests. She says she is unavailable to talk right now, so you ask her to come in for an appointment, free of charge. The patient makes an appointment but does not show.
You send a letter by certified mail describing the medical necessity for the tests and that her lack of adherence and refusal to come to the office have compelled you to end your clinician−patient relationship. You write that she should immediately identify another health care professional and suggest that she contact her managed care organization for assistance. You note that, should there be a medical emergency or urgent care needed in the next 30 days, you will provide that care. You enclose a release of medical records form in the letter.
In the patient’s record you note the details of the phone conversation and ask the office manager to add that the patient was a no show for her appointment. You include a copy of the certified letter and proof of mailing in the chart.
Two weeks later, the office manager reports that she is sending the patient’s records to another physician upon receipt of the release of medical records form from the patient.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Case: Patient becomes a liability when nonadherant to prescribed tests
MC, a 42-year-old woman (G1P1001), presents for an office visit. As the medical assistant hands you the chart, she says, “Good luck with this one. She yelled at me because you were 20 minutes behind schedule. She didn’t like sitting in the waiting room.” You greet the patient, obtain her medical history, proceed with a physical examination, and outline a management plan. You recall from the chart that you operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the operating room (OR) for a laparotomy to control bleeding. The patient has not brought this up since being discharged from the hospital.
During the current office visit, the esprit de corps in the consultation room is a bit uncomfortable, and you sense the patient is not happy. You leave the examination room and discuss the management plan with the nurse, who then returns to the patient to review the plan. The patient is unhappy with the battery of tests you have ordered but tells the nurse that she will comply.
One week later the nurse follows up with the patient by phone because she has not obtained the requested lab tests. The nurse reports to you, “She read me the riot act: ‘Why do I need all these tests? They are expensive.’ The patient indicated that she has no understanding as to why the tests were ordered in the first place.” After a discussion with you, the nurse calls the patient back in an effort to clarify her understanding of the need for the tests. The patient hangs up on her in the middle of the conversation.
The office manager tracks you down to discuss this patient. “Enough is enough,” she exclaims. “This patient is harassing the staff. She told the nurse what tests she herself believes are best and that those are the only ones she will comply with.” Your office manager states that this patient is “a liability.”
What are your choices at this point? You have thought about picking up the phone and calling her. You have considered ending her relationship with your practice. You ask yourself again, what is the best approach?
Patients have the legal right to “dismiss” or change health care providers at any time and for almost any reason without notice. But that right is not reciprocal—clinicians have a legal duty not to abandon a patient and an ethical duty to promote continuity of patient care. A clinician may dismiss a patient from his or her practice (other than for a discriminatory reason that violates ethical or legal limitations), but it must be done in the proper way.
We examine the legal, practical, and ethical issues in dismissing a patient, and how to do it without unnecessary risk. In addition, we will look at a new issue that sometimes arises in these circumstances—managed care limitations.
Physicians’ ethical obligations
The American Medical Association suggests the following ethical consideration:
Reference
- American Medical Association Council on Ethical and Judicial Affairs. Opinion 10.015. The Patient-Physician Relationship. Code of Medical Ethics. American Medical Association. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion10015.page. Issued December 2001. Accessed May 8, 2015.
Legal and medical issues
Why would you end a clinician−patient relationship?
There are a number of reasons for dismissing a patient, including1,2:
- the patient’s failure to comply with a treatment plan (probably the most frequent reason)
- persistent, inappropriate, rude, or disruptive behavior
- falsifying medical history
- seductive behavior toward health care professionals or staff
- Sentinel incident (verbal threat, violence, or criminal activity—as when a patient threatens or inappropriately touches or hits your staff)
- failure to pay billed charges (this can raise special legal issues).
The legal details vary from state to state, but fortunately there is sufficient similarity that best practices can be determined. The law starts with the proposition that ordinarily professionals may choose their patients or clients. There are limits, however, in state and federal law. A clinician may not discriminate based, for example, on ethnicity, religion, gender, or sexual orientation. In addition, the Americans with Disabilities Act limits the basis for not providing care to a patient.3
Limiting factors when dismissing a patient
Once a patient has been accepted and a professional relationship has begun, the clinician has a duty of continued care and must act reasonably to end the relationship in a way that protects the patient’s well-being.
Other recognized limitations to the ending of a treatment relationship exist. These are:
- In an emergency situation or during ongoing care in which it proves unfeasible to find another physician. At the extreme, a surgeon may not leave in the middle of surgery. Less clear, but still problematic, is the obstetrician who wants to dismiss a patient 1 or 2 weeks before an expected delivery. In any event, a clinician should not leave a patient at a critical stage without giving reasonable notice or making suitable arrangements for the attendance of another equally competent substitute.
- When there is no other health care provider available who could provide the continuity of care the clinician has begun. This limitation probably arises from the frontier days (when it was much more common for no other health care professional to be available who could provide the continuity of care the clinician began). A modern version of this might be a patient in an HMO who does not have other physicians of the same subspecialty available who are taking patients. This, of course, requires consultation with the managed care organization.
Abandonment
The legal and ethical issues are essentially related to “abandonment”—dismissing a patient improperly. Technically, abandonment is a form of negligence (the clinician does not act reasonably to protect the patient’s interests). The Oklahoma Supreme Court put it clearly: “When further medical and/or surgical attention is needed, a physician may terminate the doctor−patient relationship only after giving reasonable notice and affording an ample opportunity for the patient to secure other medical attention from other physicians” (emphasis added).4–6
How to end a patient relationship
Always send a letter
Two elements must be taken into account when dismissing a patient:
- reasonable notice
- reasonable opportunity to find another clinician.
Together, these elements mean that the intention of ending the clinician−patient relationship and the importance of finding an alternative care provider must be clearly communicated to the patient. That communication needs to be in writing—both to get the patient’s attention and as clear proof of what was said.
Some experts suggest that the best process is to have a face-to-face meeting with the patient followed by a letter. A goal of such a meeting is to make the parting as amicable as possible. It may seem more professional for a clinician to communicate such an important matter in person. The risk is that it may become a confrontation that exacerbates the situation because one or both parties may have some built-up emotion. It, therefore, depends on the circumstances as to whether such a meeting is desirable. Even if there is an oral conversation, it must be followed up with a letter to the patient.
A reasonable time frame to give the patient to find another clinician is commonly a maximum of 30 days of follow-up and emergency care. A set period of time may be a legitimate starting point but it needs to be adjusted in lieu of special circumstances, such as the availability of other similar specialists in the vicinity who are taking new patients or managed care complications. A specific time period should be indicated, along with an agreement to provide care during that time period in “emergency” or “urgent” circumstances. Of course, ongoing care also should be continued for a reasonable time (30 days is often reasonable, as mentioned). It may be best to also discuss any specific ongoing issues that should be attended to (such as the recommended tests in our opening case).
There is disagreement among experts as to whether a general statement of the reasons for ending the care relationship should be included in the letter. The argument for doing so is that, without a stated reason, the patient may call to ask why. The other side of the argument is that it adds an element of accusation; the patient undoubtedly knows what the problem is. Not writing down the reasons seems the better part of valor, especially if there has been an oral conversation.7,8
The box above provides an example of a letter to a patient (but not a model). Experts agree that the letter should be sent by certified mail with return receipt. Should the patient reject the letter, a regular delivery letter should be sent with full documentation kept in the file of the time and place it was mailed.
Managed care considerations
A consideration of increasing importance is managed care. Before taking any action, ensure that the managed care contract(s) (including federal or state government programs) have provisions concerning patient dismissals. These may be as simple as notifying the organization as to any time limits for care or of the process of dismissal.
Make sure your staff knows
Your scheduling staff needs to know with clarity the rules for scheduling (or not scheduling) this patient in the future. As a general matter, the better course of action is to allow an appointment if the patient reports that it is an emergency, whether the staff believes it is or not. In such cases it may be good to document to the patient that the emergency care does not constitute reestablishing a regular clinician−patient relationship.
Document everything
The patient’s record, at a minimum, should contain a copy of the letter sent to the patient and a log of any conversations with her about ending the relationship. Keep your own notes concerning the disruption or problems with the patient over time.
Are there risks of a malpractice lawsuit?
The abandonment claim is, of course, one possibility for a malpractice lawsuit. That is why documentation and careful communication are so important. This is one area in which having legal advice when developing a letter template should be part of the ongoing relationship with a health law attorney.
There is another malpractice risk illustrated in our hypothetical case. The physician “operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the OR and laparotomy to control bleeding.” Malpractice claims (as opposed to actual malpractice occurrences) most often arise because of bad communication with patients or when patients feel ignored. The clinician is thus between a rock and a hard place. On one hand, by ending this relationship, the clinician could well precipitate a claim based primarily on the earlier “maloccurrence.” On the other hand, continuing to treat a patient who is resisting care and creating problems with the staff has its own difficulties. It may be time for the health care professional to discuss the matter with an attorney.
Although not present in this hypothetical case, ending a patient relationship because of nonpayment of professional fees is also a touchy situation. It can be one of the other precipitating events for malpractice claims, and calls for special care.
Tread with care
Having to dismiss a patient is almost always a difficult process. The decision neither can be made lightly nor implemented sloppily. Because it is difficult, it calls on professionals to be particularly careful to not cut essential corners.9
Case: Resolved
You ask the nurse to note the details of her follow-up phone conversation with the patient in the chart. You then call MC to explain the importance of the tests. She says she is unavailable to talk right now, so you ask her to come in for an appointment, free of charge. The patient makes an appointment but does not show.
You send a letter by certified mail describing the medical necessity for the tests and that her lack of adherence and refusal to come to the office have compelled you to end your clinician−patient relationship. You write that she should immediately identify another health care professional and suggest that she contact her managed care organization for assistance. You note that, should there be a medical emergency or urgent care needed in the next 30 days, you will provide that care. You enclose a release of medical records form in the letter.
In the patient’s record you note the details of the phone conversation and ask the office manager to add that the patient was a no show for her appointment. You include a copy of the certified letter and proof of mailing in the chart.
Two weeks later, the office manager reports that she is sending the patient’s records to another physician upon receipt of the release of medical records form from the patient.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
1. Kodner C. Challenging physician-patient interactions. FP Essentials. ed 354. AAFP home study. Leawood, KS: American Academy of Family Physicians; November 2008.
2. Harris SM. Take care when firing a patient. Am Med News. http://www.ama-assn.org/amed- news/2008/02/04/bica0204 .htm. Published February 4, 2008. Accessed May 8, 2015.
3. Lynch HF. Discrimination at the doctor’s office. N Engl J Med. 2013;386(18):1668–1670.
4. Jackson v Oklahoma Memorial Hospital, 909 P.2d 765 (OK 1995). http://law.justia.com/cases/oklahoma/supreme-court/1995/4226-1.html. Accessed May 8, 2015.
5. Randolph DS, Burkett TM. When physicians fire patients: avoiding patient “abandonment” lawsuits. J Okla State Med Assoc. 2009;102(11):356–358.
6. Crauman R, Baruch J. Abandonment in the physician-patient relationship. Med Health R I. 2004;87(5):154–156.
7. Cepelewicz BB. Firing a patient: when its needed and how to handle it correctly. Med Econ. 2014;91(2):42–43.
8. Santalucia C, Michota F. When and how is it appropriate to terminate the physician-patient relationship? Cleve Clin J Med. 2004;71(3):179–183.
9. Lippman H, Davenport J. Patient dismissal: the right way to do it. J Fam Pract. 2011;60(3):135–140. http://www.jfponline.com/specialty-focus/practice-management/article/patient-dismissal-the-right-way-to-do-it/30f9501e8b3eb6ddaf6dd67ce88e0d16.html. Accessed May 8, 2015.
1. Kodner C. Challenging physician-patient interactions. FP Essentials. ed 354. AAFP home study. Leawood, KS: American Academy of Family Physicians; November 2008.
2. Harris SM. Take care when firing a patient. Am Med News. http://www.ama-assn.org/amed- news/2008/02/04/bica0204 .htm. Published February 4, 2008. Accessed May 8, 2015.
3. Lynch HF. Discrimination at the doctor’s office. N Engl J Med. 2013;386(18):1668–1670.
4. Jackson v Oklahoma Memorial Hospital, 909 P.2d 765 (OK 1995). http://law.justia.com/cases/oklahoma/supreme-court/1995/4226-1.html. Accessed May 8, 2015.
5. Randolph DS, Burkett TM. When physicians fire patients: avoiding patient “abandonment” lawsuits. J Okla State Med Assoc. 2009;102(11):356–358.
6. Crauman R, Baruch J. Abandonment in the physician-patient relationship. Med Health R I. 2004;87(5):154–156.
7. Cepelewicz BB. Firing a patient: when its needed and how to handle it correctly. Med Econ. 2014;91(2):42–43.
8. Santalucia C, Michota F. When and how is it appropriate to terminate the physician-patient relationship? Cleve Clin J Med. 2004;71(3):179–183.
9. Lippman H, Davenport J. Patient dismissal: the right way to do it. J Fam Pract. 2011;60(3):135–140. http://www.jfponline.com/specialty-focus/practice-management/article/patient-dismissal-the-right-way-to-do-it/30f9501e8b3eb6ddaf6dd67ce88e0d16.html. Accessed May 8, 2015.
In this article
- Physicians’ ethical obligations
- Sample letter ending a clinician–patient relationship
The SGR is abolished! What comes next?
Congratulations, OBG Management readers! After years of hard work and collective advocacy on your part, the US Congress finally passed, and President Barack Obama quickly signed into law, a permanent repeal of the Medicare Sustainable Growth Rate (SGR) physician payment system. Yes, celebrations are in order.
The US House of Representatives passed the bill, HR 2, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), sponsored by American College of Obstetricians and Gynecologists (ACOG) Fellow and US Rep. Michael Burgess (R-TX), on March 26, with 382 Republicans and Democrats voting “Yes.” The Senate followed, on April 14, and agreed with the House to repeal, forever, the Medicare SGR, passing the Burgess bill without amendment, on a bipartisan vote of 92–8. With only hours to go before the scheduled 21.2% cut took effect, the President signed the bill, now Public Law (PL) 114-10, on April 16. The President noted that he was “proud to sign the bill into law.” ACOG is proud to have been such an important part of this landmark moment.
SGR: the perennial nemesis of physicians
The SGR has wreaked havoc on medicine and patient care for 15 years or more. Approximately 30,000 ObGyns participate in Medicare, and many private health insurers use Medicare payment policies, as does TriCare, the nation’s health care coverage for military members and their families. The SGR’s effect was felt widely across medicine, making it nearly impossible for physician practices to invest in health information technology and other patient safety advances, or even to plan for the next year or continue accepting Medicare patients.
When it was introduced last year, HR 2 was supported by more than 600 national and state medical societies and specialty organizations, plus patient and provider organizations, policy think tanks, and advocacy groups across the political spectrum.
ACOG Fellows petitioned their members of Congress with incredible passion, perseverance, and commitment to put an end to the SGR wrecking ball. Hundreds flew into Washington, DC, sent thousands of emails, made phone calls, wrote letters, and personally lobbied at home and in the halls of Congress.
Special kudos, too, to our champions in Congress, and there are many, led by ACOG Fellows and US Reps. Dr. Burgess and Phil Roe, MD (R-TN). Burgess wrote the House bill and, together with Roe, pushed nonstop to get this bill over the finish line. It wouldn’t have happened without them.
ACOG worked tirelessly on its own and in coalition with the American Medical Association, surgical groups, and many other partners. We were able to win important provisions in the statute that we anticipate will greatly help ObGyns successfully transition to this new payment system.
PL114-10 replaces the SGR with a new payment system intended to promote care coordination and quality improvement and lead to better health for our nation’s seniors. Congress developed this new payment plan with the physician community, rather than imposing it on us. That’s why throughout the statute, we see repeated requirements that the Secretary of Health and Human Services must develop quality measures, alternative payment models, and a host of key aspects with input from and in consultation with physicians and the relevant medical specialties, ensuring that physicians retain their preeminent roles in these areas. Funding is provided for quality measure development at $15 million per year from 2015 to 2019.
This law will likely change physician practices more than the ACA ever will, and Congress agreed that physicians should be integral to its development to ensure that they can continue to thrive and provide high-quality care and access for their patients.
Let’s take a closer look at the new Medicare payment system—especially what it will mean for your practice.
What the new law does
Important provisions
- MACRA retains the fee-for-service payment model, now called the Merit-based Incentive Payment System, or MIPS. Physician participation in the Advanced Payment Models (APMs) is entirely voluntary. But physicians who participate in APMs and who score better each year will earn more.
- All physician types are treated equally. Congress didn’t pick specialty winners and losers.
- The new payment system rewards physicians for continuous improvement. You can determine how financially well you do.
- Beginning in 2019, Medicare physician payments will reflect each individual physician’s performance, based on a range of measures developed by the relevant medical specialty that will give individuals options that best reflect their practices.
- Individual physicians will receive confidential quarterly feedback on their performance.
- Technical support is provided for smaller practices, funded at $20 million per year from 2016 to 2020, to help them transition to MIPS and APMs. And physicians in small practices can opt to join a “virtual MIPS group,” associating with other practices or hospitals in the same geographic region or by specialty types.
- The law protects physicians from liability from federal or state standards of care. No health care guideline or other standard developed under federal or state requirements associated with this law may be used as a standard of care or duty of care owed by a health care professional to a patient in a medical liability lawsuit.
MACRA stabilizes the Medicare payment system by permanently repealing the SGR and scheduling payments into the future:
- through June 2015: Stable payments with no cuts
- July 2015–2019: 0.5% annual payment increases to all Medicare physicians
- 2020–2025: No automatic annual payment changes but opportunities for payment increases based on individual performance
- 2026 and beyond: 0.75% annual payment increases for qualifying APMs, 0.25% for MIPS providers, with opportunities in both systems for higher payments based on individual performance.
Top ACOG wins
Among the most meaningful accomplishments achieved by ACOG in its work to repeal the sustainable growth rate are:
- Reliable payment increases for the first 5 years. The law ensures a period of stability with modest Medicare payment in-
creases for 5 years and no cuts, with opportunity for payment increases for the next 5 years. This 5-year period gives physicians time to get ready for the new payment systems. - Protection for low-Medicare–volume physician practices. ObGyns and other physicians with a small Medicare patient population are exempt from many program requirements and penalties.
- Stops the Centers for Medicare and Medicaid Services (CMS) policy on global surgical codes, reinstating 10-day and 90-day global payment bundles for surgical services. This directly helps ObGyn subspecialists, including urogynecologists and gynecologic oncologists.
- Physician liability protections. The law ensures that federal quality measurements cannot be used to imply medical negligence and generate lawsuits.
- Protection for ultrasound. There are no cuts to ultrasound reimbursement.
- An end, in 2018, to penalties related to electronic health record (EHR) meaningful use, Physician Quality Reporting Systems, and the use of the value-based modifier.
- APM bonus payments. Bonus eligibility for Alternative Payment Model (APM) participation is based on patient volume, not just revenue, to make it easier for ObGyns to qualify.
- 2-year extension of the Children’s Health Insurance Program (CHIP), which provides comprehensive coverage to 8 million children, adolescents, and pregnant women across the country.
- Quality-measure development. The law helps professional organizations, such as ACOG, develop quality measures for the Merit-Based Incentive Payment System (MIPS) rather than allow these measures to be developed by a federal agency, ensuring that this new program works for physicians and our patients.
Two payment system options reward continuous quality improvement
Option 1: MIPS. MACRA consolidates and expands pay-for-performance incentives within the old SGR fee-for-service system, creating the new MIPS. Under MIPS, the Physician Quality Reporting System (PQRS), electronic health record (EHR) meaningful use incentive program, and physician value-based modifiers (VBMs) become a single program. In 2019, a physician’s individual score on these measures will be used to adjust his or her Medicare payments, and the penalties previously associated with these programs come to an end.
MACRA creates 4 categories of measures that are weighted to calculate an individual physician’s MIPS score:
- Quality (50% of total adjustment in 2019, shrinking to 30% of total adjustment in 2021). Quality measures currently in use in the PQRS, VBM, and EHR meaningful use programs will continue to be used. The Secretary of Health and Human Services must fund and work with specialty societies to develop any additional measures, and measures utilized in clinical data registries can be used for this category as well. Measures will be updated annually, and ACOG and other specialties can submit measures directly for approval, rather than rely on an outside entity.
- Resource use (10% of total adjustment in 2019, growing to 30% of total adjustment by 2021). Resource use measures are risk-adjusted and include those already used in the VBM program; others must be developed with physicians, reflecting both the physician’s role in treating the patient (eg, primary or specialty care) and the type of treatment (eg, chronic or acute).
- EHR use (25% of total adjustment). Current meaningful use systems will qualify for this category. The law also requires EHR interoperability by 2018 and prohibits the blocking of information sharing between EHR vendors.
- Clinical improvement (15% of total adjustment). This is a new component of physician measurement, intended to give physicians credit for working to improve their practices and help them participate in APMs, which have higher reimbursement potential. This menu of qualifying activities—including 24-hour availability, safety, and patient satisfaction—must be developed with physicians and must be attainable by all specialties and practice types, including small practices and those in rural and underserved areas. Maintenance of certification can be used to qual-ify for a high score.
Physicians will only be assessed on the categories, measures, and activities that apply to them. A physician’s composite score (0–100) will be compared with a performance threshold that reflects all physicians. Those who score above the threshold will receive increased payments; those who score below the threshold will receive reduced payments. Physicians will know these thresholds in advance and will know the score they must reach to avoid penalties and win higher reimbursements in each performance period.
As physicians as a whole improve their performance, the threshold will move with them. So each year, physicians will have the incentive to keep improving their quality, resource use, clinical improvement, and EHR use. A physician’s payment adjustment in one year will not affect his or her payment adjustment in the next year.
The range of potential payment adjustments based on MIPS performance measures increases each year through 2022. Providers who have high scores are rewarded with a 4% increase in 2019. By 2022, the reward is 9%. The program is budget-neutral, so total positive adjustments across all providers will equal total negative adjustments across all providers to poor performers. Separate funds are set aside to reward the highest performers, who will earn bonuses of up to 10% of their fee-for-service payment rate from 2019 through 2024, as well as to help low performers improve and qualify for increased payments from 2016 through 2020.
Help for physicians includes:
- flexibility to participate in a way that best reflects their practice, using risk-adjusted clinical outcome measures
- option to participate in a virtual MIPS group rather than go it alone
- technical assistance to practices with 15 or fewer professionals, $20 million annually from 2016 through 2020, with preference to practices with low MIPS scores and those in rural and underserved areas
- quarterly confidential feedback on performance in the quality and resource use categories
- advance notification to each physician of the score needed to reach higher payment levels
- exclusion from MIPS of physicians who treat few Medicare patients, as well as those who receive a significant portion of their revenues from APMs.
Option 2: APMs. Physicians can earn higher fees by opting out of MIPS fee for service and participating in APMs. The law defines qualifying APMs as those that require participating providers to take on “more than nominal” financial risk, report quality measures, and use certified EHR technology.
APMs will cover multiple services, show that they can limit the growth of spending, and use performance-based methods of compensation. These and other provisions will likely continue the trend away from physicians practicing in solo or small-group fee-for-service practices into risk-based multispecialty settings that are subject to increased management and oversight.
From 2019 to 2024, qualified APM physicians will receive a 5% annual lump sum bonus based on their prior year’s physician fee-schedule payments plus shared savings from participation. This bonus is based on patient volume, not just revenue, to make it easier for ObGyns to qualify. To make the bonus widely available, the Secretary of Health and Human Services must test APMs designed for specific specialties and physicians in small practices. As in MIPS, top APM performers will also receive an additional bonus.
To qualify, physicians must meet increasing thresholds for the percentage of their revenue that they receive through APMs. Those who are below but near the required level of APM revenue can be exempted from MIPS adjustments.
- 2019–2020: 25% of Medicare revenue must be received through APMs.
- 2021–2022: 50% of Medicare revenue or 50% of all-payer revenue along with 25% of Medicare revenue must be received through APMs.
- 2023 and beyond: 75% of Medicare revenue or 75% of all-payer revenue along with 25% of Medicare revenue must be received through APMs.
Who pays the bill?
Medicare beneficiaries pay more
The new law increases the percentage of Medicare Parts B and D premiums that high-income beneficiaries must pay beginning in 2018:
- Single seniors reporting income of more than $133,500 and married couples with income of more than $267,000 will see their share of premiums rise from 50% to 65%.
- Single seniors reporting income above $160,000 and married couples with income above $320,000 will see their premium share rise from 65% to 80%.
This change will affect about 2% of Medicare beneficiaries; half of all Medicare beneficiaries currently have annual incomes below $26,000.1
Medigap “first-dollar coverage” will end
Many Medigap plans on the market today provide “first-dollar coverage” for beneficiaries, which means that the plans pay the deductibles and copayments so that the beneficiaries have no out-of-pocket costs. Beginning in 2020, Medigap plans will only be available to cover costs above the Medicare Part B deductible, currently $147 per year, for new Medigap enrollees. Many lawmakers thought it was important for Medicare beneficiaries to have “skin in the game.”
The law cuts payments for some providers
To partially offset the cost of repealing the SGR, MACRA cuts Medicare payments to hospitals and postacute providers. It:
- delays Disproportionate Share Hospital (DSH) cuts scheduled to begin in 2017 by a year and extends them through 2025
- requires an increase in payments to hospitals scheduled for 2018 to instead be phased in over 6 years
- limits the 2018 payment update for post-acute providers to 1%.
The law extends many programs
These programs are vital to support the future ObGyn workforce and access to health care. Among these programs are:
- a halt to the Centers for Medicare and Medicaid Services (CMS) policy on global surgical codes. The law reinstates 10-day and 90-day global payment bundles for surgical services. This directly helps ObGyn subspecialists, such as urogynecologists and gynecologic oncologists.
- renewal of the Children’s Health Insurance Program (CHIP), which provides comprehensive coverage to 8 million children, adolescents, and pregnant women across the country
- establishment of a Medicaid/CHIP Pediatric Quality Measures Program, supporting the development and physician adoption of quality measures, including for prenatal and preconception care
- funding for the Maternal, Infant, and Early Childhood Home Visiting Program, helping at-risk pregnant women and their families to promote healthy births and early childhood development
- funding for community health centers, an important source of care for 13 million women and girls in all 50 states and the District of Columbia
- funding for the National Health Service Corps, bringing ObGyns and other primary care providers to underserved rural and urban areas through scholarships and loan repayment programs
- funding for the Teaching Health Center Graduate Medical Education Payment Program, enhancing training for ObGyns and other primary care providers in community-based settings
- extending the Medicare Geographic Practice Cost Index floor, helping ensure access to care for women in rural areas
- extending the Personal Responsibility Education Program to help prevent teen pregnancies and sexually transmitted infections.
Next steps
It’s very important that ObGyns and other physicians use these early years to understand and get ready for the new payment systems. ACOG is developing educational material for our members, and will work closely with our colleague medical organizations and the Department of Health and Human Services to develop key aspects of the law and ensure that it is properly implemented to work for physicians and patients.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Reference
1. Aaron HJ. Three cheers for log-rolling: The demise of the SGR. Brookings Health360. http://www.brookings.edu/blogs/health360/posts/2015/04/22-medicare-sgr-repeal-doc-fix-aaron. Published April 22, 2015. Accessed May 12, 2015.
Lucia DiVenere, MA
Ms. DiVenere is Officer, Government and Political Affairs, at the American Congress of Obstetricians and Gynecologists in Washington, DC.
The author reports no financial relationships relevant to this article.
Lucia DiVenere, MA
Ms. DiVenere is Officer, Government and Political Affairs, at the American Congress of Obstetricians and Gynecologists in Washington, DC.
The author reports no financial relationships relevant to this article.
Lucia DiVenere, MA
Ms. DiVenere is Officer, Government and Political Affairs, at the American Congress of Obstetricians and Gynecologists in Washington, DC.
The author reports no financial relationships relevant to this article.
Congratulations, OBG Management readers! After years of hard work and collective advocacy on your part, the US Congress finally passed, and President Barack Obama quickly signed into law, a permanent repeal of the Medicare Sustainable Growth Rate (SGR) physician payment system. Yes, celebrations are in order.
The US House of Representatives passed the bill, HR 2, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), sponsored by American College of Obstetricians and Gynecologists (ACOG) Fellow and US Rep. Michael Burgess (R-TX), on March 26, with 382 Republicans and Democrats voting “Yes.” The Senate followed, on April 14, and agreed with the House to repeal, forever, the Medicare SGR, passing the Burgess bill without amendment, on a bipartisan vote of 92–8. With only hours to go before the scheduled 21.2% cut took effect, the President signed the bill, now Public Law (PL) 114-10, on April 16. The President noted that he was “proud to sign the bill into law.” ACOG is proud to have been such an important part of this landmark moment.
SGR: the perennial nemesis of physicians
The SGR has wreaked havoc on medicine and patient care for 15 years or more. Approximately 30,000 ObGyns participate in Medicare, and many private health insurers use Medicare payment policies, as does TriCare, the nation’s health care coverage for military members and their families. The SGR’s effect was felt widely across medicine, making it nearly impossible for physician practices to invest in health information technology and other patient safety advances, or even to plan for the next year or continue accepting Medicare patients.
When it was introduced last year, HR 2 was supported by more than 600 national and state medical societies and specialty organizations, plus patient and provider organizations, policy think tanks, and advocacy groups across the political spectrum.
ACOG Fellows petitioned their members of Congress with incredible passion, perseverance, and commitment to put an end to the SGR wrecking ball. Hundreds flew into Washington, DC, sent thousands of emails, made phone calls, wrote letters, and personally lobbied at home and in the halls of Congress.
Special kudos, too, to our champions in Congress, and there are many, led by ACOG Fellows and US Reps. Dr. Burgess and Phil Roe, MD (R-TN). Burgess wrote the House bill and, together with Roe, pushed nonstop to get this bill over the finish line. It wouldn’t have happened without them.
ACOG worked tirelessly on its own and in coalition with the American Medical Association, surgical groups, and many other partners. We were able to win important provisions in the statute that we anticipate will greatly help ObGyns successfully transition to this new payment system.
PL114-10 replaces the SGR with a new payment system intended to promote care coordination and quality improvement and lead to better health for our nation’s seniors. Congress developed this new payment plan with the physician community, rather than imposing it on us. That’s why throughout the statute, we see repeated requirements that the Secretary of Health and Human Services must develop quality measures, alternative payment models, and a host of key aspects with input from and in consultation with physicians and the relevant medical specialties, ensuring that physicians retain their preeminent roles in these areas. Funding is provided for quality measure development at $15 million per year from 2015 to 2019.
This law will likely change physician practices more than the ACA ever will, and Congress agreed that physicians should be integral to its development to ensure that they can continue to thrive and provide high-quality care and access for their patients.
Let’s take a closer look at the new Medicare payment system—especially what it will mean for your practice.
What the new law does
Important provisions
- MACRA retains the fee-for-service payment model, now called the Merit-based Incentive Payment System, or MIPS. Physician participation in the Advanced Payment Models (APMs) is entirely voluntary. But physicians who participate in APMs and who score better each year will earn more.
- All physician types are treated equally. Congress didn’t pick specialty winners and losers.
- The new payment system rewards physicians for continuous improvement. You can determine how financially well you do.
- Beginning in 2019, Medicare physician payments will reflect each individual physician’s performance, based on a range of measures developed by the relevant medical specialty that will give individuals options that best reflect their practices.
- Individual physicians will receive confidential quarterly feedback on their performance.
- Technical support is provided for smaller practices, funded at $20 million per year from 2016 to 2020, to help them transition to MIPS and APMs. And physicians in small practices can opt to join a “virtual MIPS group,” associating with other practices or hospitals in the same geographic region or by specialty types.
- The law protects physicians from liability from federal or state standards of care. No health care guideline or other standard developed under federal or state requirements associated with this law may be used as a standard of care or duty of care owed by a health care professional to a patient in a medical liability lawsuit.
MACRA stabilizes the Medicare payment system by permanently repealing the SGR and scheduling payments into the future:
- through June 2015: Stable payments with no cuts
- July 2015–2019: 0.5% annual payment increases to all Medicare physicians
- 2020–2025: No automatic annual payment changes but opportunities for payment increases based on individual performance
- 2026 and beyond: 0.75% annual payment increases for qualifying APMs, 0.25% for MIPS providers, with opportunities in both systems for higher payments based on individual performance.
Top ACOG wins
Among the most meaningful accomplishments achieved by ACOG in its work to repeal the sustainable growth rate are:
- Reliable payment increases for the first 5 years. The law ensures a period of stability with modest Medicare payment in-
creases for 5 years and no cuts, with opportunity for payment increases for the next 5 years. This 5-year period gives physicians time to get ready for the new payment systems. - Protection for low-Medicare–volume physician practices. ObGyns and other physicians with a small Medicare patient population are exempt from many program requirements and penalties.
- Stops the Centers for Medicare and Medicaid Services (CMS) policy on global surgical codes, reinstating 10-day and 90-day global payment bundles for surgical services. This directly helps ObGyn subspecialists, including urogynecologists and gynecologic oncologists.
- Physician liability protections. The law ensures that federal quality measurements cannot be used to imply medical negligence and generate lawsuits.
- Protection for ultrasound. There are no cuts to ultrasound reimbursement.
- An end, in 2018, to penalties related to electronic health record (EHR) meaningful use, Physician Quality Reporting Systems, and the use of the value-based modifier.
- APM bonus payments. Bonus eligibility for Alternative Payment Model (APM) participation is based on patient volume, not just revenue, to make it easier for ObGyns to qualify.
- 2-year extension of the Children’s Health Insurance Program (CHIP), which provides comprehensive coverage to 8 million children, adolescents, and pregnant women across the country.
- Quality-measure development. The law helps professional organizations, such as ACOG, develop quality measures for the Merit-Based Incentive Payment System (MIPS) rather than allow these measures to be developed by a federal agency, ensuring that this new program works for physicians and our patients.
Two payment system options reward continuous quality improvement
Option 1: MIPS. MACRA consolidates and expands pay-for-performance incentives within the old SGR fee-for-service system, creating the new MIPS. Under MIPS, the Physician Quality Reporting System (PQRS), electronic health record (EHR) meaningful use incentive program, and physician value-based modifiers (VBMs) become a single program. In 2019, a physician’s individual score on these measures will be used to adjust his or her Medicare payments, and the penalties previously associated with these programs come to an end.
MACRA creates 4 categories of measures that are weighted to calculate an individual physician’s MIPS score:
- Quality (50% of total adjustment in 2019, shrinking to 30% of total adjustment in 2021). Quality measures currently in use in the PQRS, VBM, and EHR meaningful use programs will continue to be used. The Secretary of Health and Human Services must fund and work with specialty societies to develop any additional measures, and measures utilized in clinical data registries can be used for this category as well. Measures will be updated annually, and ACOG and other specialties can submit measures directly for approval, rather than rely on an outside entity.
- Resource use (10% of total adjustment in 2019, growing to 30% of total adjustment by 2021). Resource use measures are risk-adjusted and include those already used in the VBM program; others must be developed with physicians, reflecting both the physician’s role in treating the patient (eg, primary or specialty care) and the type of treatment (eg, chronic or acute).
- EHR use (25% of total adjustment). Current meaningful use systems will qualify for this category. The law also requires EHR interoperability by 2018 and prohibits the blocking of information sharing between EHR vendors.
- Clinical improvement (15% of total adjustment). This is a new component of physician measurement, intended to give physicians credit for working to improve their practices and help them participate in APMs, which have higher reimbursement potential. This menu of qualifying activities—including 24-hour availability, safety, and patient satisfaction—must be developed with physicians and must be attainable by all specialties and practice types, including small practices and those in rural and underserved areas. Maintenance of certification can be used to qual-ify for a high score.
Physicians will only be assessed on the categories, measures, and activities that apply to them. A physician’s composite score (0–100) will be compared with a performance threshold that reflects all physicians. Those who score above the threshold will receive increased payments; those who score below the threshold will receive reduced payments. Physicians will know these thresholds in advance and will know the score they must reach to avoid penalties and win higher reimbursements in each performance period.
As physicians as a whole improve their performance, the threshold will move with them. So each year, physicians will have the incentive to keep improving their quality, resource use, clinical improvement, and EHR use. A physician’s payment adjustment in one year will not affect his or her payment adjustment in the next year.
The range of potential payment adjustments based on MIPS performance measures increases each year through 2022. Providers who have high scores are rewarded with a 4% increase in 2019. By 2022, the reward is 9%. The program is budget-neutral, so total positive adjustments across all providers will equal total negative adjustments across all providers to poor performers. Separate funds are set aside to reward the highest performers, who will earn bonuses of up to 10% of their fee-for-service payment rate from 2019 through 2024, as well as to help low performers improve and qualify for increased payments from 2016 through 2020.
Help for physicians includes:
- flexibility to participate in a way that best reflects their practice, using risk-adjusted clinical outcome measures
- option to participate in a virtual MIPS group rather than go it alone
- technical assistance to practices with 15 or fewer professionals, $20 million annually from 2016 through 2020, with preference to practices with low MIPS scores and those in rural and underserved areas
- quarterly confidential feedback on performance in the quality and resource use categories
- advance notification to each physician of the score needed to reach higher payment levels
- exclusion from MIPS of physicians who treat few Medicare patients, as well as those who receive a significant portion of their revenues from APMs.
Option 2: APMs. Physicians can earn higher fees by opting out of MIPS fee for service and participating in APMs. The law defines qualifying APMs as those that require participating providers to take on “more than nominal” financial risk, report quality measures, and use certified EHR technology.
APMs will cover multiple services, show that they can limit the growth of spending, and use performance-based methods of compensation. These and other provisions will likely continue the trend away from physicians practicing in solo or small-group fee-for-service practices into risk-based multispecialty settings that are subject to increased management and oversight.
From 2019 to 2024, qualified APM physicians will receive a 5% annual lump sum bonus based on their prior year’s physician fee-schedule payments plus shared savings from participation. This bonus is based on patient volume, not just revenue, to make it easier for ObGyns to qualify. To make the bonus widely available, the Secretary of Health and Human Services must test APMs designed for specific specialties and physicians in small practices. As in MIPS, top APM performers will also receive an additional bonus.
To qualify, physicians must meet increasing thresholds for the percentage of their revenue that they receive through APMs. Those who are below but near the required level of APM revenue can be exempted from MIPS adjustments.
- 2019–2020: 25% of Medicare revenue must be received through APMs.
- 2021–2022: 50% of Medicare revenue or 50% of all-payer revenue along with 25% of Medicare revenue must be received through APMs.
- 2023 and beyond: 75% of Medicare revenue or 75% of all-payer revenue along with 25% of Medicare revenue must be received through APMs.
Who pays the bill?
Medicare beneficiaries pay more
The new law increases the percentage of Medicare Parts B and D premiums that high-income beneficiaries must pay beginning in 2018:
- Single seniors reporting income of more than $133,500 and married couples with income of more than $267,000 will see their share of premiums rise from 50% to 65%.
- Single seniors reporting income above $160,000 and married couples with income above $320,000 will see their premium share rise from 65% to 80%.
This change will affect about 2% of Medicare beneficiaries; half of all Medicare beneficiaries currently have annual incomes below $26,000.1
Medigap “first-dollar coverage” will end
Many Medigap plans on the market today provide “first-dollar coverage” for beneficiaries, which means that the plans pay the deductibles and copayments so that the beneficiaries have no out-of-pocket costs. Beginning in 2020, Medigap plans will only be available to cover costs above the Medicare Part B deductible, currently $147 per year, for new Medigap enrollees. Many lawmakers thought it was important for Medicare beneficiaries to have “skin in the game.”
The law cuts payments for some providers
To partially offset the cost of repealing the SGR, MACRA cuts Medicare payments to hospitals and postacute providers. It:
- delays Disproportionate Share Hospital (DSH) cuts scheduled to begin in 2017 by a year and extends them through 2025
- requires an increase in payments to hospitals scheduled for 2018 to instead be phased in over 6 years
- limits the 2018 payment update for post-acute providers to 1%.
The law extends many programs
These programs are vital to support the future ObGyn workforce and access to health care. Among these programs are:
- a halt to the Centers for Medicare and Medicaid Services (CMS) policy on global surgical codes. The law reinstates 10-day and 90-day global payment bundles for surgical services. This directly helps ObGyn subspecialists, such as urogynecologists and gynecologic oncologists.
- renewal of the Children’s Health Insurance Program (CHIP), which provides comprehensive coverage to 8 million children, adolescents, and pregnant women across the country
- establishment of a Medicaid/CHIP Pediatric Quality Measures Program, supporting the development and physician adoption of quality measures, including for prenatal and preconception care
- funding for the Maternal, Infant, and Early Childhood Home Visiting Program, helping at-risk pregnant women and their families to promote healthy births and early childhood development
- funding for community health centers, an important source of care for 13 million women and girls in all 50 states and the District of Columbia
- funding for the National Health Service Corps, bringing ObGyns and other primary care providers to underserved rural and urban areas through scholarships and loan repayment programs
- funding for the Teaching Health Center Graduate Medical Education Payment Program, enhancing training for ObGyns and other primary care providers in community-based settings
- extending the Medicare Geographic Practice Cost Index floor, helping ensure access to care for women in rural areas
- extending the Personal Responsibility Education Program to help prevent teen pregnancies and sexually transmitted infections.
Next steps
It’s very important that ObGyns and other physicians use these early years to understand and get ready for the new payment systems. ACOG is developing educational material for our members, and will work closely with our colleague medical organizations and the Department of Health and Human Services to develop key aspects of the law and ensure that it is properly implemented to work for physicians and patients.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Congratulations, OBG Management readers! After years of hard work and collective advocacy on your part, the US Congress finally passed, and President Barack Obama quickly signed into law, a permanent repeal of the Medicare Sustainable Growth Rate (SGR) physician payment system. Yes, celebrations are in order.
The US House of Representatives passed the bill, HR 2, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), sponsored by American College of Obstetricians and Gynecologists (ACOG) Fellow and US Rep. Michael Burgess (R-TX), on March 26, with 382 Republicans and Democrats voting “Yes.” The Senate followed, on April 14, and agreed with the House to repeal, forever, the Medicare SGR, passing the Burgess bill without amendment, on a bipartisan vote of 92–8. With only hours to go before the scheduled 21.2% cut took effect, the President signed the bill, now Public Law (PL) 114-10, on April 16. The President noted that he was “proud to sign the bill into law.” ACOG is proud to have been such an important part of this landmark moment.
SGR: the perennial nemesis of physicians
The SGR has wreaked havoc on medicine and patient care for 15 years or more. Approximately 30,000 ObGyns participate in Medicare, and many private health insurers use Medicare payment policies, as does TriCare, the nation’s health care coverage for military members and their families. The SGR’s effect was felt widely across medicine, making it nearly impossible for physician practices to invest in health information technology and other patient safety advances, or even to plan for the next year or continue accepting Medicare patients.
When it was introduced last year, HR 2 was supported by more than 600 national and state medical societies and specialty organizations, plus patient and provider organizations, policy think tanks, and advocacy groups across the political spectrum.
ACOG Fellows petitioned their members of Congress with incredible passion, perseverance, and commitment to put an end to the SGR wrecking ball. Hundreds flew into Washington, DC, sent thousands of emails, made phone calls, wrote letters, and personally lobbied at home and in the halls of Congress.
Special kudos, too, to our champions in Congress, and there are many, led by ACOG Fellows and US Reps. Dr. Burgess and Phil Roe, MD (R-TN). Burgess wrote the House bill and, together with Roe, pushed nonstop to get this bill over the finish line. It wouldn’t have happened without them.
ACOG worked tirelessly on its own and in coalition with the American Medical Association, surgical groups, and many other partners. We were able to win important provisions in the statute that we anticipate will greatly help ObGyns successfully transition to this new payment system.
PL114-10 replaces the SGR with a new payment system intended to promote care coordination and quality improvement and lead to better health for our nation’s seniors. Congress developed this new payment plan with the physician community, rather than imposing it on us. That’s why throughout the statute, we see repeated requirements that the Secretary of Health and Human Services must develop quality measures, alternative payment models, and a host of key aspects with input from and in consultation with physicians and the relevant medical specialties, ensuring that physicians retain their preeminent roles in these areas. Funding is provided for quality measure development at $15 million per year from 2015 to 2019.
This law will likely change physician practices more than the ACA ever will, and Congress agreed that physicians should be integral to its development to ensure that they can continue to thrive and provide high-quality care and access for their patients.
Let’s take a closer look at the new Medicare payment system—especially what it will mean for your practice.
What the new law does
Important provisions
- MACRA retains the fee-for-service payment model, now called the Merit-based Incentive Payment System, or MIPS. Physician participation in the Advanced Payment Models (APMs) is entirely voluntary. But physicians who participate in APMs and who score better each year will earn more.
- All physician types are treated equally. Congress didn’t pick specialty winners and losers.
- The new payment system rewards physicians for continuous improvement. You can determine how financially well you do.
- Beginning in 2019, Medicare physician payments will reflect each individual physician’s performance, based on a range of measures developed by the relevant medical specialty that will give individuals options that best reflect their practices.
- Individual physicians will receive confidential quarterly feedback on their performance.
- Technical support is provided for smaller practices, funded at $20 million per year from 2016 to 2020, to help them transition to MIPS and APMs. And physicians in small practices can opt to join a “virtual MIPS group,” associating with other practices or hospitals in the same geographic region or by specialty types.
- The law protects physicians from liability from federal or state standards of care. No health care guideline or other standard developed under federal or state requirements associated with this law may be used as a standard of care or duty of care owed by a health care professional to a patient in a medical liability lawsuit.
MACRA stabilizes the Medicare payment system by permanently repealing the SGR and scheduling payments into the future:
- through June 2015: Stable payments with no cuts
- July 2015–2019: 0.5% annual payment increases to all Medicare physicians
- 2020–2025: No automatic annual payment changes but opportunities for payment increases based on individual performance
- 2026 and beyond: 0.75% annual payment increases for qualifying APMs, 0.25% for MIPS providers, with opportunities in both systems for higher payments based on individual performance.
Top ACOG wins
Among the most meaningful accomplishments achieved by ACOG in its work to repeal the sustainable growth rate are:
- Reliable payment increases for the first 5 years. The law ensures a period of stability with modest Medicare payment in-
creases for 5 years and no cuts, with opportunity for payment increases for the next 5 years. This 5-year period gives physicians time to get ready for the new payment systems. - Protection for low-Medicare–volume physician practices. ObGyns and other physicians with a small Medicare patient population are exempt from many program requirements and penalties.
- Stops the Centers for Medicare and Medicaid Services (CMS) policy on global surgical codes, reinstating 10-day and 90-day global payment bundles for surgical services. This directly helps ObGyn subspecialists, including urogynecologists and gynecologic oncologists.
- Physician liability protections. The law ensures that federal quality measurements cannot be used to imply medical negligence and generate lawsuits.
- Protection for ultrasound. There are no cuts to ultrasound reimbursement.
- An end, in 2018, to penalties related to electronic health record (EHR) meaningful use, Physician Quality Reporting Systems, and the use of the value-based modifier.
- APM bonus payments. Bonus eligibility for Alternative Payment Model (APM) participation is based on patient volume, not just revenue, to make it easier for ObGyns to qualify.
- 2-year extension of the Children’s Health Insurance Program (CHIP), which provides comprehensive coverage to 8 million children, adolescents, and pregnant women across the country.
- Quality-measure development. The law helps professional organizations, such as ACOG, develop quality measures for the Merit-Based Incentive Payment System (MIPS) rather than allow these measures to be developed by a federal agency, ensuring that this new program works for physicians and our patients.
Two payment system options reward continuous quality improvement
Option 1: MIPS. MACRA consolidates and expands pay-for-performance incentives within the old SGR fee-for-service system, creating the new MIPS. Under MIPS, the Physician Quality Reporting System (PQRS), electronic health record (EHR) meaningful use incentive program, and physician value-based modifiers (VBMs) become a single program. In 2019, a physician’s individual score on these measures will be used to adjust his or her Medicare payments, and the penalties previously associated with these programs come to an end.
MACRA creates 4 categories of measures that are weighted to calculate an individual physician’s MIPS score:
- Quality (50% of total adjustment in 2019, shrinking to 30% of total adjustment in 2021). Quality measures currently in use in the PQRS, VBM, and EHR meaningful use programs will continue to be used. The Secretary of Health and Human Services must fund and work with specialty societies to develop any additional measures, and measures utilized in clinical data registries can be used for this category as well. Measures will be updated annually, and ACOG and other specialties can submit measures directly for approval, rather than rely on an outside entity.
- Resource use (10% of total adjustment in 2019, growing to 30% of total adjustment by 2021). Resource use measures are risk-adjusted and include those already used in the VBM program; others must be developed with physicians, reflecting both the physician’s role in treating the patient (eg, primary or specialty care) and the type of treatment (eg, chronic or acute).
- EHR use (25% of total adjustment). Current meaningful use systems will qualify for this category. The law also requires EHR interoperability by 2018 and prohibits the blocking of information sharing between EHR vendors.
- Clinical improvement (15% of total adjustment). This is a new component of physician measurement, intended to give physicians credit for working to improve their practices and help them participate in APMs, which have higher reimbursement potential. This menu of qualifying activities—including 24-hour availability, safety, and patient satisfaction—must be developed with physicians and must be attainable by all specialties and practice types, including small practices and those in rural and underserved areas. Maintenance of certification can be used to qual-ify for a high score.
Physicians will only be assessed on the categories, measures, and activities that apply to them. A physician’s composite score (0–100) will be compared with a performance threshold that reflects all physicians. Those who score above the threshold will receive increased payments; those who score below the threshold will receive reduced payments. Physicians will know these thresholds in advance and will know the score they must reach to avoid penalties and win higher reimbursements in each performance period.
As physicians as a whole improve their performance, the threshold will move with them. So each year, physicians will have the incentive to keep improving their quality, resource use, clinical improvement, and EHR use. A physician’s payment adjustment in one year will not affect his or her payment adjustment in the next year.
The range of potential payment adjustments based on MIPS performance measures increases each year through 2022. Providers who have high scores are rewarded with a 4% increase in 2019. By 2022, the reward is 9%. The program is budget-neutral, so total positive adjustments across all providers will equal total negative adjustments across all providers to poor performers. Separate funds are set aside to reward the highest performers, who will earn bonuses of up to 10% of their fee-for-service payment rate from 2019 through 2024, as well as to help low performers improve and qualify for increased payments from 2016 through 2020.
Help for physicians includes:
- flexibility to participate in a way that best reflects their practice, using risk-adjusted clinical outcome measures
- option to participate in a virtual MIPS group rather than go it alone
- technical assistance to practices with 15 or fewer professionals, $20 million annually from 2016 through 2020, with preference to practices with low MIPS scores and those in rural and underserved areas
- quarterly confidential feedback on performance in the quality and resource use categories
- advance notification to each physician of the score needed to reach higher payment levels
- exclusion from MIPS of physicians who treat few Medicare patients, as well as those who receive a significant portion of their revenues from APMs.
Option 2: APMs. Physicians can earn higher fees by opting out of MIPS fee for service and participating in APMs. The law defines qualifying APMs as those that require participating providers to take on “more than nominal” financial risk, report quality measures, and use certified EHR technology.
APMs will cover multiple services, show that they can limit the growth of spending, and use performance-based methods of compensation. These and other provisions will likely continue the trend away from physicians practicing in solo or small-group fee-for-service practices into risk-based multispecialty settings that are subject to increased management and oversight.
From 2019 to 2024, qualified APM physicians will receive a 5% annual lump sum bonus based on their prior year’s physician fee-schedule payments plus shared savings from participation. This bonus is based on patient volume, not just revenue, to make it easier for ObGyns to qualify. To make the bonus widely available, the Secretary of Health and Human Services must test APMs designed for specific specialties and physicians in small practices. As in MIPS, top APM performers will also receive an additional bonus.
To qualify, physicians must meet increasing thresholds for the percentage of their revenue that they receive through APMs. Those who are below but near the required level of APM revenue can be exempted from MIPS adjustments.
- 2019–2020: 25% of Medicare revenue must be received through APMs.
- 2021–2022: 50% of Medicare revenue or 50% of all-payer revenue along with 25% of Medicare revenue must be received through APMs.
- 2023 and beyond: 75% of Medicare revenue or 75% of all-payer revenue along with 25% of Medicare revenue must be received through APMs.
Who pays the bill?
Medicare beneficiaries pay more
The new law increases the percentage of Medicare Parts B and D premiums that high-income beneficiaries must pay beginning in 2018:
- Single seniors reporting income of more than $133,500 and married couples with income of more than $267,000 will see their share of premiums rise from 50% to 65%.
- Single seniors reporting income above $160,000 and married couples with income above $320,000 will see their premium share rise from 65% to 80%.
This change will affect about 2% of Medicare beneficiaries; half of all Medicare beneficiaries currently have annual incomes below $26,000.1
Medigap “first-dollar coverage” will end
Many Medigap plans on the market today provide “first-dollar coverage” for beneficiaries, which means that the plans pay the deductibles and copayments so that the beneficiaries have no out-of-pocket costs. Beginning in 2020, Medigap plans will only be available to cover costs above the Medicare Part B deductible, currently $147 per year, for new Medigap enrollees. Many lawmakers thought it was important for Medicare beneficiaries to have “skin in the game.”
The law cuts payments for some providers
To partially offset the cost of repealing the SGR, MACRA cuts Medicare payments to hospitals and postacute providers. It:
- delays Disproportionate Share Hospital (DSH) cuts scheduled to begin in 2017 by a year and extends them through 2025
- requires an increase in payments to hospitals scheduled for 2018 to instead be phased in over 6 years
- limits the 2018 payment update for post-acute providers to 1%.
The law extends many programs
These programs are vital to support the future ObGyn workforce and access to health care. Among these programs are:
- a halt to the Centers for Medicare and Medicaid Services (CMS) policy on global surgical codes. The law reinstates 10-day and 90-day global payment bundles for surgical services. This directly helps ObGyn subspecialists, such as urogynecologists and gynecologic oncologists.
- renewal of the Children’s Health Insurance Program (CHIP), which provides comprehensive coverage to 8 million children, adolescents, and pregnant women across the country
- establishment of a Medicaid/CHIP Pediatric Quality Measures Program, supporting the development and physician adoption of quality measures, including for prenatal and preconception care
- funding for the Maternal, Infant, and Early Childhood Home Visiting Program, helping at-risk pregnant women and their families to promote healthy births and early childhood development
- funding for community health centers, an important source of care for 13 million women and girls in all 50 states and the District of Columbia
- funding for the National Health Service Corps, bringing ObGyns and other primary care providers to underserved rural and urban areas through scholarships and loan repayment programs
- funding for the Teaching Health Center Graduate Medical Education Payment Program, enhancing training for ObGyns and other primary care providers in community-based settings
- extending the Medicare Geographic Practice Cost Index floor, helping ensure access to care for women in rural areas
- extending the Personal Responsibility Education Program to help prevent teen pregnancies and sexually transmitted infections.
Next steps
It’s very important that ObGyns and other physicians use these early years to understand and get ready for the new payment systems. ACOG is developing educational material for our members, and will work closely with our colleague medical organizations and the Department of Health and Human Services to develop key aspects of the law and ensure that it is properly implemented to work for physicians and patients.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Reference
1. Aaron HJ. Three cheers for log-rolling: The demise of the SGR. Brookings Health360. http://www.brookings.edu/blogs/health360/posts/2015/04/22-medicare-sgr-repeal-doc-fix-aaron. Published April 22, 2015. Accessed May 12, 2015.
Reference
1. Aaron HJ. Three cheers for log-rolling: The demise of the SGR. Brookings Health360. http://www.brookings.edu/blogs/health360/posts/2015/04/22-medicare-sgr-repeal-doc-fix-aaron. Published April 22, 2015. Accessed May 12, 2015.
Bridge therapy may be detrimental for some VTE patients
Anticoagulant bridge therapy may be harmful for patients with a low to moderate risk of venous thromboembolism (VTE), according to research published in JAMA Internal Medicine.
The study included more than 1000 patients with VTE who had to stop receiving warfarin prior to a procedure.
Investigators compared outcomes in patients who received bridge therapy—a short-acting anticoagulant during the periprocedural period—and patients who did not.
Nathan Clark, PharmD, of Kaiser Permanente Colorado in Aurora, and his colleagues conducted this research.
They examined the electronic medical records of 1178 patients with VTE who underwent 1812 invasive diagnostic or surgical procedures between January 2006 and March 2012 that required the interruption of warfarin.
The investigators divided patients into 3 groups based on their annual risk of VTE recurrence without anticoagulant therapy. Seventy-nine percent of patients were categorized as low-risk, 17.9% as moderate-risk, and 3.1% as high-risk.
The team then divided patients according to the use of bridge therapy. Of the 1812 procedures, 555 included bridge therapy, and 1257 did not.
Patients in the bridged group had a significantly higher incidence of clinically relevant bleeding at 30 days than patients in the non-bridged group—2.7% and 0.2%, respectively (P=0.01).
When the investigators assessed patients according to VTE risk, they found the increased incidence of bleeding in the bridged group was significant among low-risk patients (2.0% vs 0.1%, P<0.001) and moderate-risk patients (4.6% vs 0%, P=0.004) but not high-risk patients (5.6% vs 4.8%, P=0.90).
On the other hand, there was no significant difference in VTE recurrence between the bridged and non-bridged groups—for all risk categories (0 vs 3 cases, P=0.56), low-risk patients (0 vs 2, P=0.37), moderate-risk patients (0 vs 1, P=0.48), or high-risk patients (0 vs 0, P>0.99)
The investigators said further research is needed to identify patient and procedure-related characteristics associated with the highest risk for perioperative VTE recurrence where targeted bridge therapy may be beneficial.
Anticoagulant bridge therapy may be harmful for patients with a low to moderate risk of venous thromboembolism (VTE), according to research published in JAMA Internal Medicine.
The study included more than 1000 patients with VTE who had to stop receiving warfarin prior to a procedure.
Investigators compared outcomes in patients who received bridge therapy—a short-acting anticoagulant during the periprocedural period—and patients who did not.
Nathan Clark, PharmD, of Kaiser Permanente Colorado in Aurora, and his colleagues conducted this research.
They examined the electronic medical records of 1178 patients with VTE who underwent 1812 invasive diagnostic or surgical procedures between January 2006 and March 2012 that required the interruption of warfarin.
The investigators divided patients into 3 groups based on their annual risk of VTE recurrence without anticoagulant therapy. Seventy-nine percent of patients were categorized as low-risk, 17.9% as moderate-risk, and 3.1% as high-risk.
The team then divided patients according to the use of bridge therapy. Of the 1812 procedures, 555 included bridge therapy, and 1257 did not.
Patients in the bridged group had a significantly higher incidence of clinically relevant bleeding at 30 days than patients in the non-bridged group—2.7% and 0.2%, respectively (P=0.01).
When the investigators assessed patients according to VTE risk, they found the increased incidence of bleeding in the bridged group was significant among low-risk patients (2.0% vs 0.1%, P<0.001) and moderate-risk patients (4.6% vs 0%, P=0.004) but not high-risk patients (5.6% vs 4.8%, P=0.90).
On the other hand, there was no significant difference in VTE recurrence between the bridged and non-bridged groups—for all risk categories (0 vs 3 cases, P=0.56), low-risk patients (0 vs 2, P=0.37), moderate-risk patients (0 vs 1, P=0.48), or high-risk patients (0 vs 0, P>0.99)
The investigators said further research is needed to identify patient and procedure-related characteristics associated with the highest risk for perioperative VTE recurrence where targeted bridge therapy may be beneficial.
Anticoagulant bridge therapy may be harmful for patients with a low to moderate risk of venous thromboembolism (VTE), according to research published in JAMA Internal Medicine.
The study included more than 1000 patients with VTE who had to stop receiving warfarin prior to a procedure.
Investigators compared outcomes in patients who received bridge therapy—a short-acting anticoagulant during the periprocedural period—and patients who did not.
Nathan Clark, PharmD, of Kaiser Permanente Colorado in Aurora, and his colleagues conducted this research.
They examined the electronic medical records of 1178 patients with VTE who underwent 1812 invasive diagnostic or surgical procedures between January 2006 and March 2012 that required the interruption of warfarin.
The investigators divided patients into 3 groups based on their annual risk of VTE recurrence without anticoagulant therapy. Seventy-nine percent of patients were categorized as low-risk, 17.9% as moderate-risk, and 3.1% as high-risk.
The team then divided patients according to the use of bridge therapy. Of the 1812 procedures, 555 included bridge therapy, and 1257 did not.
Patients in the bridged group had a significantly higher incidence of clinically relevant bleeding at 30 days than patients in the non-bridged group—2.7% and 0.2%, respectively (P=0.01).
When the investigators assessed patients according to VTE risk, they found the increased incidence of bleeding in the bridged group was significant among low-risk patients (2.0% vs 0.1%, P<0.001) and moderate-risk patients (4.6% vs 0%, P=0.004) but not high-risk patients (5.6% vs 4.8%, P=0.90).
On the other hand, there was no significant difference in VTE recurrence between the bridged and non-bridged groups—for all risk categories (0 vs 3 cases, P=0.56), low-risk patients (0 vs 2, P=0.37), moderate-risk patients (0 vs 1, P=0.48), or high-risk patients (0 vs 0, P>0.99)
The investigators said further research is needed to identify patient and procedure-related characteristics associated with the highest risk for perioperative VTE recurrence where targeted bridge therapy may be beneficial.
Reducing distress in caregivers of HSCT recipients
Photo by Chad McNeeley
Research has shown that caring for cancer patients after hematopoietic stem cell transplant (HSCT) can have negative psychological effects on the caregiver, but results of a new study suggest a psychosocial intervention could change that.
The trial showed that counseling sessions focused on stress management could significantly reduce stress, anxiety, depression, and mood disturbance among these caregivers.
“The first 100 days after a stem cell transplant is a critical period for patients, in which caregivers are called upon to deliver around-the-clock care, providing support for patients’ everyday needs and also patients’ emotional health, but who takes care of the caregivers?” asked Mark Laudenslager, PhD, of the University of Colorado Denver.
To address this problem, Dr Laudenslager and his colleagues studied 148 caregivers of patients who underwent allogeneic HSCT. The team described this research in Bone Marrow Transplantation.
The caregivers were randomized to a group that was offered a psychosocial intervention (n=74) and a group that received standard treatment, in which mental health support services were available but not required (n=74).
In the experimental group, caregivers attended 8 sessions on stress management. These one-on-one sessions focused on understanding stress and its physical consequences, changing roles as caregivers, cognitive behavioral stress management, pacing respiration, and identifying social support. The researchers call this intervention PsychoEducation, Paced Respiration and Relaxation (PEPRR).
After a patient underwent HSCT, Dr Laudenslager and his colleagues used several questionnaires to follow the trajectory of caregiver distress over time. The questionnaires were used to measure stress, depression, anxiety, mood disturbance, sleep quality, and other mental health outcomes.
There was no significant difference in stress or other mental health measures between the 2 treatment groups at baseline.
However, at 3 months after transplant, caregivers in the PEPRR group saw some significant improvements over caregivers in the standard treatment group.
The PEPRR group had less stress according to the Perceived Stress Scale (P=0.039), less depression according to the Center for Epidemiologic Studies Depression test (P=0.016), less anxiety according to the State-Trait Anxiety Inventory-State questionnaire (P=0.0009), and less mood disturbance according to the Profile of Mood States-Total Mood Disturbance test (P=0.039).
Overall caregiver distress (composite scores from the questionnaires) was significantly lower in the PEPRR group than the standard treatment group (P=0.019).
However, there was no significant difference in caregiver well-being (composite scores) or scores on the Caregiver Reaction Assessment, Pittsburgh Sleep Quality Index, Short Form 36 Health Survey, or Impact of Events scale.
Still, the other improvements caregivers experienced suggest PEPRR is a promising intervention, Dr Laudenslager said.
He and his colleagues are now recruiting subjects for a follow-up study (NCT02037568) focused on evaluating quality of life in allogeneic HSCT recipients whose caregivers participate in programs similar to the PEPRR intervention.
Photo by Chad McNeeley
Research has shown that caring for cancer patients after hematopoietic stem cell transplant (HSCT) can have negative psychological effects on the caregiver, but results of a new study suggest a psychosocial intervention could change that.
The trial showed that counseling sessions focused on stress management could significantly reduce stress, anxiety, depression, and mood disturbance among these caregivers.
“The first 100 days after a stem cell transplant is a critical period for patients, in which caregivers are called upon to deliver around-the-clock care, providing support for patients’ everyday needs and also patients’ emotional health, but who takes care of the caregivers?” asked Mark Laudenslager, PhD, of the University of Colorado Denver.
To address this problem, Dr Laudenslager and his colleagues studied 148 caregivers of patients who underwent allogeneic HSCT. The team described this research in Bone Marrow Transplantation.
The caregivers were randomized to a group that was offered a psychosocial intervention (n=74) and a group that received standard treatment, in which mental health support services were available but not required (n=74).
In the experimental group, caregivers attended 8 sessions on stress management. These one-on-one sessions focused on understanding stress and its physical consequences, changing roles as caregivers, cognitive behavioral stress management, pacing respiration, and identifying social support. The researchers call this intervention PsychoEducation, Paced Respiration and Relaxation (PEPRR).
After a patient underwent HSCT, Dr Laudenslager and his colleagues used several questionnaires to follow the trajectory of caregiver distress over time. The questionnaires were used to measure stress, depression, anxiety, mood disturbance, sleep quality, and other mental health outcomes.
There was no significant difference in stress or other mental health measures between the 2 treatment groups at baseline.
However, at 3 months after transplant, caregivers in the PEPRR group saw some significant improvements over caregivers in the standard treatment group.
The PEPRR group had less stress according to the Perceived Stress Scale (P=0.039), less depression according to the Center for Epidemiologic Studies Depression test (P=0.016), less anxiety according to the State-Trait Anxiety Inventory-State questionnaire (P=0.0009), and less mood disturbance according to the Profile of Mood States-Total Mood Disturbance test (P=0.039).
Overall caregiver distress (composite scores from the questionnaires) was significantly lower in the PEPRR group than the standard treatment group (P=0.019).
However, there was no significant difference in caregiver well-being (composite scores) or scores on the Caregiver Reaction Assessment, Pittsburgh Sleep Quality Index, Short Form 36 Health Survey, or Impact of Events scale.
Still, the other improvements caregivers experienced suggest PEPRR is a promising intervention, Dr Laudenslager said.
He and his colleagues are now recruiting subjects for a follow-up study (NCT02037568) focused on evaluating quality of life in allogeneic HSCT recipients whose caregivers participate in programs similar to the PEPRR intervention.
Photo by Chad McNeeley
Research has shown that caring for cancer patients after hematopoietic stem cell transplant (HSCT) can have negative psychological effects on the caregiver, but results of a new study suggest a psychosocial intervention could change that.
The trial showed that counseling sessions focused on stress management could significantly reduce stress, anxiety, depression, and mood disturbance among these caregivers.
“The first 100 days after a stem cell transplant is a critical period for patients, in which caregivers are called upon to deliver around-the-clock care, providing support for patients’ everyday needs and also patients’ emotional health, but who takes care of the caregivers?” asked Mark Laudenslager, PhD, of the University of Colorado Denver.
To address this problem, Dr Laudenslager and his colleagues studied 148 caregivers of patients who underwent allogeneic HSCT. The team described this research in Bone Marrow Transplantation.
The caregivers were randomized to a group that was offered a psychosocial intervention (n=74) and a group that received standard treatment, in which mental health support services were available but not required (n=74).
In the experimental group, caregivers attended 8 sessions on stress management. These one-on-one sessions focused on understanding stress and its physical consequences, changing roles as caregivers, cognitive behavioral stress management, pacing respiration, and identifying social support. The researchers call this intervention PsychoEducation, Paced Respiration and Relaxation (PEPRR).
After a patient underwent HSCT, Dr Laudenslager and his colleagues used several questionnaires to follow the trajectory of caregiver distress over time. The questionnaires were used to measure stress, depression, anxiety, mood disturbance, sleep quality, and other mental health outcomes.
There was no significant difference in stress or other mental health measures between the 2 treatment groups at baseline.
However, at 3 months after transplant, caregivers in the PEPRR group saw some significant improvements over caregivers in the standard treatment group.
The PEPRR group had less stress according to the Perceived Stress Scale (P=0.039), less depression according to the Center for Epidemiologic Studies Depression test (P=0.016), less anxiety according to the State-Trait Anxiety Inventory-State questionnaire (P=0.0009), and less mood disturbance according to the Profile of Mood States-Total Mood Disturbance test (P=0.039).
Overall caregiver distress (composite scores from the questionnaires) was significantly lower in the PEPRR group than the standard treatment group (P=0.019).
However, there was no significant difference in caregiver well-being (composite scores) or scores on the Caregiver Reaction Assessment, Pittsburgh Sleep Quality Index, Short Form 36 Health Survey, or Impact of Events scale.
Still, the other improvements caregivers experienced suggest PEPRR is a promising intervention, Dr Laudenslager said.
He and his colleagues are now recruiting subjects for a follow-up study (NCT02037568) focused on evaluating quality of life in allogeneic HSCT recipients whose caregivers participate in programs similar to the PEPRR intervention.