Practice Management

Study Overview

Objective. To examine differences in care, specifically hospitalization towards the end of life, among nursing home residents with dementia who were Black compared with those who were White.

Design. Population based cohort study in the US. The study included all decedents with Alzheimer’s disease or related dementia (ADRD) who resided in a nursing home from 2014 to 2017. Decedents from nursing homes were identified by death within 1 day of an identified nursing home stay or within 8 days of a hospital transfer from nursing home. Data were obtained from Minimum Data Set 3.0 (MDS) which contains clinical data from all Medicaid or Medicare certified nursing homes, and from the Medicare Beneficiary Summary File (MBSF) and Medicare Provider and Analysis and Review (MedPAR) which contains hospitalization events for all Medicare Beneficiaries. These files were linked to identify nursing home residents with ADRD who were hospitalized at the end of life. ADRD diagnosis was identified from the chronic condition list from the MBSF and from MDS diagnosis list.

Setting and participants. The study included 665 033 residents from 14 595 nursing homes who died during the study period. Resident race was categorized as White or Black based on the MBSF. Severe cognitive impairment was identified using the MDS that categorized residents as severe or not using the Brief Interview for Mental Status and the Cognitive Performance Scale. The mean (SD) age of the study population was 86.7 (9.2) years for White residents and 82.6 (11.1) years for Black residents. Of the participants, 68.8% and 61.2% were female for Black and White residents, respectively. Approximately 23.4% of White and 32.5% of Black residents had severe cognitive impairment. For nursing home characteristics, 71.5% of the 14 595 nursing homes represented were for profit; average bedside was 109.5 (57.0) and occupancy rate was on average 81.2% (14.3%).

Main outcome measures. The study outcome measure was any hospitalization within 30 days prior to death. The outcome was selected as an indicator of quality of care because as older adults living with ADRD experience progressive worsening of cognitive symptoms, at the end of life when dementia is severe, advance care planning and communication with health care proxies and surrogates often result in coordinated care that avoids acute hospitalizations, which are often burdensome to both patient and family and may yield poorer quality of life.

Main results. The study found that approximately 29.5% of White decedents and 40.7% of Black decedents were hospitalized towards the end of life. Nursing homes with a higher proportion of Black residents were more likely to have residents hospitalized towards the end of life with 35% of residents hospitalized in the highest quartile (27% Black) compared with 17% hospitalized for nursing homes in the lowest quartile (0% Black).After adjusting for covariates, Black residents were 7.9% more likely to be hospitalized in the last 30 days of life compared with White residents. Blacks with severe cognitive impairment has elevated risk of hospitalization by 4.9% when compared with White residents. After accounting for nursing home facility–level characteristics, nursing homes with a low proportion of Black residents had a 5.2% higher risk of hospitalizations compared with nursing homes with no Black residents, and nursing homes with a higher percentage of Black residents had a 13.3% higher risk of hospitalization compared with nursing homes with no Black residents.

Conclusion. Race is associated with care disparities in older nursing home residents with dementia. This study suggests that hospitalization towards the end of life as a quality of care marker differs across nursing homes, and nursing homes with a higher proportion of Black residents were more likely to be hospitalized. This suggests that these nursing homes may have fewer resources and delivered poorer quality of care, and that disparities in health systems or institutions contribute to differences in quality of care for this vulnerable group.

Commentary

Disparities of health status, health care, and affordability across race and ethnicity have persisted throughout the past 20 years.¹ There is further evidence to support systemic differences that can contribute to differences in health outcomes.² Although changes in health care policy such as the Affordable Care Act have expanded health care coverage, and instituted changes that aims to improve health care quality and reduce disparities, it is clear that factors contributing to disparities in care are structural and perhaps systemic. The latest evidence comes in this study that examines racial disparities in health care quality in one of the most vulnerable populations—older adults with Alzheimer’s disease and dementia. The finding that Black nursing home residents, when compared with White residents, often has higher risk of hospitalization at the end of life, even among those with severe dementia where better coordinated care, clear goals of care and perhaps instituting palliative care would result in lower rate of hospitalization. The disparities were observed across nursing homes as well, where nursing homes with higher proportion of Black residents appear to have lower quality of care.

These findings are consistent with prior work that has examined differences in Black and White population on uptake of palliative care, discussion, and the documentation of advance care planning.³ Factors that may contribute to these differences include mistrust of the health care system among minorities, and not being connected to adequate health care resources. Family members and surrogate health care decision makers may consider receiving more aggressive care as advocating for better health care for their family members.⁴ These differences may contribute to the differences in hospitalization rates among residents within the same nursing home; however, the differences between nursing homes even after accounting for individual differences may indicate more widespread systemic differences that is associated with race. Policy changes that will address these differences are needed to level these differences so that quality care can be delivered regardless of race.⁵ For this vulnerable population with a terminal illness, approaches to enhance uptake of palliative approaches and care delivery for dementia patients at terminal stage are needed and understanding and targeting factors that contribute to low uptake of these approaches will enhance end of life care. Understanding the differences in resources and systems of care in nursing homes and perhaps how palliative care is integrated in these settings will be important to address care disparities that occurs across nursing homes.

Applications for Clinical Practice

Clinicians who take care of this population of older adults with advanced dementia should be aware of the potential for racial disparities that may lead to differences in the quality of care. The underlying reasons for these differences could be targeted so that older adults in all racial groups may have equal access to quality care including palliative approaches that avoid aggressive care for terminal illnesses across settings that may yield better care and quality of life. Policy makers and health systems leaders need to consider the current realities with racial disparities that policies need to address these differences so that they may not continue to persist in our systems of care.

Financial disclosures: None.

Study Overview

Objective. To examine differences in care, specifically hospitalization towards the end of life, among nursing home residents with dementia who were Black compared with those who were White.

Design. Population based cohort study in the US. The study included all decedents with Alzheimer’s disease or related dementia (ADRD) who resided in a nursing home from 2014 to 2017. Decedents from nursing homes were identified by death within 1 day of an identified nursing home stay or within 8 days of a hospital transfer from nursing home. Data were obtained from Minimum Data Set 3.0 (MDS) which contains clinical data from all Medicaid or Medicare certified nursing homes, and from the Medicare Beneficiary Summary File (MBSF) and Medicare Provider and Analysis and Review (MedPAR) which contains hospitalization events for all Medicare Beneficiaries. These files were linked to identify nursing home residents with ADRD who were hospitalized at the end of life. ADRD diagnosis was identified from the chronic condition list from the MBSF and from MDS diagnosis list.

Setting and participants. The study included 665 033 residents from 14 595 nursing homes who died during the study period. Resident race was categorized as White or Black based on the MBSF. Severe cognitive impairment was identified using the MDS that categorized residents as severe or not using the Brief Interview for Mental Status and the Cognitive Performance Scale. The mean (SD) age of the study population was 86.7 (9.2) years for White residents and 82.6 (11.1) years for Black residents. Of the participants, 68.8% and 61.2% were female for Black and White residents, respectively. Approximately 23.4% of White and 32.5% of Black residents had severe cognitive impairment. For nursing home characteristics, 71.5% of the 14 595 nursing homes represented were for profit; average bedside was 109.5 (57.0) and occupancy rate was on average 81.2% (14.3%).

Main outcome measures. The study outcome measure was any hospitalization within 30 days prior to death. The outcome was selected as an indicator of quality of care because as older adults living with ADRD experience progressive worsening of cognitive symptoms, at the end of life when dementia is severe, advance care planning and communication with health care proxies and surrogates often result in coordinated care that avoids acute hospitalizations, which are often burdensome to both patient and family and may yield poorer quality of life.

Main results. The study found that approximately 29.5% of White decedents and 40.7% of Black decedents were hospitalized towards the end of life. Nursing homes with a higher proportion of Black residents were more likely to have residents hospitalized towards the end of life with 35% of residents hospitalized in the highest quartile (27% Black) compared with 17% hospitalized for nursing homes in the lowest quartile (0% Black).After adjusting for covariates, Black residents were 7.9% more likely to be hospitalized in the last 30 days of life compared with White residents. Blacks with severe cognitive impairment has elevated risk of hospitalization by 4.9% when compared with White residents. After accounting for nursing home facility–level characteristics, nursing homes with a low proportion of Black residents had a 5.2% higher risk of hospitalizations compared with nursing homes with no Black residents, and nursing homes with a higher percentage of Black residents had a 13.3% higher risk of hospitalization compared with nursing homes with no Black residents.

Conclusion. Race is associated with care disparities in older nursing home residents with dementia. This study suggests that hospitalization towards the end of life as a quality of care marker differs across nursing homes, and nursing homes with a higher proportion of Black residents were more likely to be hospitalized. This suggests that these nursing homes may have fewer resources and delivered poorer quality of care, and that disparities in health systems or institutions contribute to differences in quality of care for this vulnerable group.

Commentary

Disparities of health status, health care, and affordability across race and ethnicity have persisted throughout the past 20 years.¹ There is further evidence to support systemic differences that can contribute to differences in health outcomes.² Although changes in health care policy such as the Affordable Care Act have expanded health care coverage, and instituted changes that aims to improve health care quality and reduce disparities, it is clear that factors contributing to disparities in care are structural and perhaps systemic. The latest evidence comes in this study that examines racial disparities in health care quality in one of the most vulnerable populations—older adults with Alzheimer’s disease and dementia. The finding that Black nursing home residents, when compared with White residents, often has higher risk of hospitalization at the end of life, even among those with severe dementia where better coordinated care, clear goals of care and perhaps instituting palliative care would result in lower rate of hospitalization. The disparities were observed across nursing homes as well, where nursing homes with higher proportion of Black residents appear to have lower quality of care.

These findings are consistent with prior work that has examined differences in Black and White population on uptake of palliative care, discussion, and the documentation of advance care planning.³ Factors that may contribute to these differences include mistrust of the health care system among minorities, and not being connected to adequate health care resources. Family members and surrogate health care decision makers may consider receiving more aggressive care as advocating for better health care for their family members.⁴ These differences may contribute to the differences in hospitalization rates among residents within the same nursing home; however, the differences between nursing homes even after accounting for individual differences may indicate more widespread systemic differences that is associated with race. Policy changes that will address these differences are needed to level these differences so that quality care can be delivered regardless of race.⁵ For this vulnerable population with a terminal illness, approaches to enhance uptake of palliative approaches and care delivery for dementia patients at terminal stage are needed and understanding and targeting factors that contribute to low uptake of these approaches will enhance end of life care. Understanding the differences in resources and systems of care in nursing homes and perhaps how palliative care is integrated in these settings will be important to address care disparities that occurs across nursing homes.

Applications for Clinical Practice

Clinicians who take care of this population of older adults with advanced dementia should be aware of the potential for racial disparities that may lead to differences in the quality of care. The underlying reasons for these differences could be targeted so that older adults in all racial groups may have equal access to quality care including palliative approaches that avoid aggressive care for terminal illnesses across settings that may yield better care and quality of life. Policy makers and health systems leaders need to consider the current realities with racial disparities that policies need to address these differences so that they may not continue to persist in our systems of care.

Financial disclosures: None.

Study Overview

Objective. To examine differences in care, specifically hospitalization towards the end of life, among nursing home residents with dementia who were Black compared with those who were White.

Design. Population based cohort study in the US. The study included all decedents with Alzheimer’s disease or related dementia (ADRD) who resided in a nursing home from 2014 to 2017. Decedents from nursing homes were identified by death within 1 day of an identified nursing home stay or within 8 days of a hospital transfer from nursing home. Data were obtained from Minimum Data Set 3.0 (MDS) which contains clinical data from all Medicaid or Medicare certified nursing homes, and from the Medicare Beneficiary Summary File (MBSF) and Medicare Provider and Analysis and Review (MedPAR) which contains hospitalization events for all Medicare Beneficiaries. These files were linked to identify nursing home residents with ADRD who were hospitalized at the end of life. ADRD diagnosis was identified from the chronic condition list from the MBSF and from MDS diagnosis list.

Setting and participants. The study included 665 033 residents from 14 595 nursing homes who died during the study period. Resident race was categorized as White or Black based on the MBSF. Severe cognitive impairment was identified using the MDS that categorized residents as severe or not using the Brief Interview for Mental Status and the Cognitive Performance Scale. The mean (SD) age of the study population was 86.7 (9.2) years for White residents and 82.6 (11.1) years for Black residents. Of the participants, 68.8% and 61.2% were female for Black and White residents, respectively. Approximately 23.4% of White and 32.5% of Black residents had severe cognitive impairment. For nursing home characteristics, 71.5% of the 14 595 nursing homes represented were for profit; average bedside was 109.5 (57.0) and occupancy rate was on average 81.2% (14.3%).

Main outcome measures. The study outcome measure was any hospitalization within 30 days prior to death. The outcome was selected as an indicator of quality of care because as older adults living with ADRD experience progressive worsening of cognitive symptoms, at the end of life when dementia is severe, advance care planning and communication with health care proxies and surrogates often result in coordinated care that avoids acute hospitalizations, which are often burdensome to both patient and family and may yield poorer quality of life.

Main results. The study found that approximately 29.5% of White decedents and 40.7% of Black decedents were hospitalized towards the end of life. Nursing homes with a higher proportion of Black residents were more likely to have residents hospitalized towards the end of life with 35% of residents hospitalized in the highest quartile (27% Black) compared with 17% hospitalized for nursing homes in the lowest quartile (0% Black).After adjusting for covariates, Black residents were 7.9% more likely to be hospitalized in the last 30 days of life compared with White residents. Blacks with severe cognitive impairment has elevated risk of hospitalization by 4.9% when compared with White residents. After accounting for nursing home facility–level characteristics, nursing homes with a low proportion of Black residents had a 5.2% higher risk of hospitalizations compared with nursing homes with no Black residents, and nursing homes with a higher percentage of Black residents had a 13.3% higher risk of hospitalization compared with nursing homes with no Black residents.

Conclusion. Race is associated with care disparities in older nursing home residents with dementia. This study suggests that hospitalization towards the end of life as a quality of care marker differs across nursing homes, and nursing homes with a higher proportion of Black residents were more likely to be hospitalized. This suggests that these nursing homes may have fewer resources and delivered poorer quality of care, and that disparities in health systems or institutions contribute to differences in quality of care for this vulnerable group.

Commentary

Disparities of health status, health care, and affordability across race and ethnicity have persisted throughout the past 20 years.¹ There is further evidence to support systemic differences that can contribute to differences in health outcomes.² Although changes in health care policy such as the Affordable Care Act have expanded health care coverage, and instituted changes that aims to improve health care quality and reduce disparities, it is clear that factors contributing to disparities in care are structural and perhaps systemic. The latest evidence comes in this study that examines racial disparities in health care quality in one of the most vulnerable populations—older adults with Alzheimer’s disease and dementia. The finding that Black nursing home residents, when compared with White residents, often has higher risk of hospitalization at the end of life, even among those with severe dementia where better coordinated care, clear goals of care and perhaps instituting palliative care would result in lower rate of hospitalization. The disparities were observed across nursing homes as well, where nursing homes with higher proportion of Black residents appear to have lower quality of care.

These findings are consistent with prior work that has examined differences in Black and White population on uptake of palliative care, discussion, and the documentation of advance care planning.³ Factors that may contribute to these differences include mistrust of the health care system among minorities, and not being connected to adequate health care resources. Family members and surrogate health care decision makers may consider receiving more aggressive care as advocating for better health care for their family members.⁴ These differences may contribute to the differences in hospitalization rates among residents within the same nursing home; however, the differences between nursing homes even after accounting for individual differences may indicate more widespread systemic differences that is associated with race. Policy changes that will address these differences are needed to level these differences so that quality care can be delivered regardless of race.⁵ For this vulnerable population with a terminal illness, approaches to enhance uptake of palliative approaches and care delivery for dementia patients at terminal stage are needed and understanding and targeting factors that contribute to low uptake of these approaches will enhance end of life care. Understanding the differences in resources and systems of care in nursing homes and perhaps how palliative care is integrated in these settings will be important to address care disparities that occurs across nursing homes.

Applications for Clinical Practice

Clinicians who take care of this population of older adults with advanced dementia should be aware of the potential for racial disparities that may lead to differences in the quality of care. The underlying reasons for these differences could be targeted so that older adults in all racial groups may have equal access to quality care including palliative approaches that avoid aggressive care for terminal illnesses across settings that may yield better care and quality of life. Policy makers and health systems leaders need to consider the current realities with racial disparities that policies need to address these differences so that they may not continue to persist in our systems of care.

Financial disclosures: None.

Study Overview

Objective. The objectives of this study were to (1) quantify the frequency of preoperative advance care planning (ACP) discussion and documentation for older adults undergoing major surgery in a national sample, and (2) characterize how surgical patients and their family members considered ACP after postoperative complications.

Design. A secondary analysis of data from a multisite randomized clinical trial testing the effects of a question prompt list intervention (a Question Problem List [QPL] brochure with 11 questions) given to patients aged 60 years or older undergoing high-risk surgery on preoperative communication with their surgeons.

Setting and participants. This multisite randomized controlled trial involved 5 study sites that encompassed distinct US geographic areas, including University of Wisconsin Hospital and Clinics (UWHC), Madison; the University of California, San Francisco, Medical Center (UCSF); Oregon Health & Science University (OHSU), Portland; the University Hospital of Rutgers New Jersey Medical School (Rutgers), Newark; and the Brigham and Women’s Hospital (BWH), Boston, Massachusetts. The study enrolled 40 surgeons who routinely performed high-risk oncological or vascular surgery via purposeful sampling; patients aged 60 years or older with at least 1 comorbidity and an oncological or vascular problem that were treatable with high-risk surgery; and 1 invited family member per enrolled patient to participate in open-ended interviews postsurgery. High-risk surgery was defined as an operation that has a 30-day in-hospital mortality rate greater than or equal to 1%. Data were collected from June 1, 2016, to November 30, 2018.

Main outcome measures. The frequency of preoperative discussions and documentation of ACP was determined. For patients who had major surgery, any mention of ACP (ie, mention of advance directive [AD], health care power of attorney, or preference for limitations of life-sustaining treatments) by the surgeon, patient or family member during the audio recorded, transcribed, and coded preoperative consultation was counted. The presence of a written AD in the medical record at the time of the initial consultation, filed between the consultation and the date of surgery, or added postoperatively, was recorded using a standardized abstraction form. Postoperative treatments administered and complications experienced within 6 weeks after surgery were recorded. Open-ended interviews with patients who experienced significant postoperative complications (eg, prolonged hospitalization > 8 days, intensive care unit stay > 3 days) and their family members were conducted 6 weeks after surgery. Information ascertained during interviews focused on treatment decisions, postoperative experiences, and interpersonal relationships among patients, families, and clinicians. Transcripts of these interviews were then subjected to qualitative content analysis.

Main results. A total of 446 patients were enrolled in the primary study. Of these patients, 213 (122 men [57%]; 91 women [43%]; mean [SD] age, 72 [7] years) underwent major surgery. Only 13 (6.1%) of those who had major surgery had any discussion related to ACP in the preoperative consultation. In this cohort, 141 (66%) patients did not have an AD on file before undergoing major surgery. The presence of AD was not associated with age (60-69 years, 26 [31%]; 70-79 years, 31 [33%]; ≥ 80 years, 15 [42%]; P = .55), number of comorbidities (1, 35 [32%]; 2, 18 [33%]; ≥ 3, 19 [40%]; P = .62), or type of procedure (oncological, 53 [32%]; vascular, 19 [42%]; P = .22). Moreover, there was no difference in preoperative communication about ACP or documentation of an AD for patients who were mailed a QPL brochure compared to those who received usual care (intervention, 38 [35%]; usual care, 34 [33%]; P = .77). Rates of AD documentation were associated with individual study sites with BWH and UWHC having higher rates of documentation (20 [50%] and 27 [44%], respectively) compared to OHSU, UCSF, or Rutgers (7 [17%], 17 [35%], and 1 [5%], respectively). Analysis from the interviews indicated that patients and families felt unprepared for serious surgical complications and had varied interpretations of ACP. Patients with complications were enthusiastic about ACP but did not think it was important to discuss their preferences for life-sustaining treatments with their surgeon preoperatively.

Conclusion. Although surgeons and patients report that they believe ACP is important, preoperative discussion of patient preferences rarely occurs. This study found that the frequency of ACP discussions or AD documentations among older patients undergoing high-risk oncologic or vascular surgery was low. Interventions that are aimed to increase rates of preoperative ACP discussions should be implemented to help prepare patients and their families for difficult decisions in the setting of serious surgical complications and could help decrease postoperative conflicts that result from unclear patient care goals.

Commentary

Surgeons and patients approach surgical interventions with optimistic outlooks while simultaneously preparing for unintended adverse outcomes. For patients, preoperative ACP discussions ease the burden on their families and ensure their wishes and care goals are communicated. For surgeons, these discussions inform them how best to support the values of the patient. Therefore, it is unsurprising that preoperative ACP is viewed favorably by both groups. Given the consensus that ACP is important in the care of older adults undergoing high-risk surgery, one would assume that preoperative ACP discussion is a standard of practice among surgeons and their aging patients. However, in a secondary analysis of a randomized control trial testing a patient-mediated intervention to improve preoperative communication, Kalbfell et al¹ showed that ACP discussions rarely take place prior to major surgery in older adults. This finding highlights the significant discrepancy between the belief that ACP is important, and the actual rate that it is practiced, in older patients undergoing high-risk surgery. This discordance is highly concerning because it suggests that surgeons who provide care to a very vulnerable subset of older patients may overlook an essential aspect of preoperative care and therefore lack a thorough and thoughtful understanding of the patient’s care goals. In practice, this omission can pose significant challenges associated with the surgeon and family’s decisions to use postoperative life-sustaining interventions or to manage unforeseen complications should a patient become unable to make medical decisions.

The barriers to conducting successful ACP discussions between surgeons and patients are multifactorial. Kalbfell et al¹ highlighted several of these barriers, including lack of patient efficacy, physician attitudes, and institutional values in older adults who require major surgeries. The inadequacy of patient efficacy in preoperative ACP is illustrated by findings from the primary, multisite trial of QPL intervention conducted by Schwarze et al. Interestingly, the authors found that patients who did not receive QPL brochure had no ACP discussions, and that QPL implementation did not significantly improve discussion rates despite its intent to encourage these discussions.² Possible explanations for this lack of engagement might be a lack of health literacy or patient efficacy in the study population. Qualitative data from the current study provided further evidence to support these explanations. For instance, some patients provided limited or incomplete information about their wishes for health care management while others felt it was unnecessary to have ACP discussions unless complications arose.¹ However, the latter example counters the purpose of ACP which is to enable patients to make plans about future health care and not reactive to a medical complication or emergency.

Surgeons bear a large responsibility in providing treatments that are consistent with the care goals of the patient. Thus, surgeons play a crucial role in engaging, guiding, and facilitating ACP discussions with patients. This role is even more critical when patients are unable or unwilling to initiate care goal discussions. Physician attitudes towards ACP, therefore, greatly influence the effectiveness of these discussions. In a study of self-administered surveys by vascular, neurologic, and cardiothoracic surgeons, greater than 90% of respondents viewed postoperative life-supporting therapy as necessary, and 54% would decline to operate on patients with an AD limiting life-supporting therapy.³ Moreover, the same study showed that 52% of respondents reported discussing AD before surgery, a figure that exceeded the actual rates at which ACP discussions occur in many other studies. In the current study, Kalbfell et al¹ also found that surgeons viewed ACP discussions largely in the context of AD creation and declined to investigate the full scope of patient preferences. These findings, when combined with other studies that indicate an incomplete understanding of ACP in some surgeons, suggest that not all physicians are able or willing to navigate these sometimes lengthy and difficult conversations with patients. This gap in practice provides opportunities for training in surgical specialties that center on optimizing preoperative ACP discussions to meet the care needs of older patients.

Institutional value and culture are important factors that impact physician behavior and the practice of ACP discussion. In the current study, the authors reported that the majority of ACP discussions were held by a minority of surgeons and that different institutions and study sites had vastly different rates of ACP documentation.¹ These results are further supported by findings of large variations between physicians and hospitals in ACP reporting in hospitalized frail older adults.⁴ These variations in practices at different institutions suggest that it is possible to improve rates of preoperative ACP discussion. Reasons for these differences need to be further investigated in order to identify strategies, resources, or trainings required by medical institutions to support surgeons to carry out ACP discussions with patients undergoing high-risk surgeries.

The study conducted by Kalbfell et al¹ has several strengths. For example, it included Spanish-speaking patients and the use of a Spanish version of the QPL intervention to account for cultural differences. The study also included multiple surgical specialties and institutions and captured a large and national sample, thus making its findings more generalizable. However, the lack of data on the duration of preoperative consultation visits in patients who completed ACP discussions poses a limitation to this study. This is relevant because surgeon availability to engage in lengthy ACP discussions may be limited due to busy clinical schedules. Additional data on the duration of preoperative visits inclusive of a thoughtfully conducted ACP discussion could help to modify clinical workflow to facilitate its uptake in surgical practices.

Applications for Clinical Practice

The findings from the current study indicate that patients and surgeons agree that preoperative ACP discussions are beneficial to the clinical care of older adults before high-risk surgeries. However, these important conversations do not occur frequently. Surgeons and health care institutions need to identify strategies to initiate, facilitate, and optimize productive preoperative ACP discussions to provide patient-centered care in vulnerable older surgical patients.

Financial disclosures: None.

Study Overview

Objective. The objectives of this study were to (1) quantify the frequency of preoperative advance care planning (ACP) discussion and documentation for older adults undergoing major surgery in a national sample, and (2) characterize how surgical patients and their family members considered ACP after postoperative complications.

Design. A secondary analysis of data from a multisite randomized clinical trial testing the effects of a question prompt list intervention (a Question Problem List [QPL] brochure with 11 questions) given to patients aged 60 years or older undergoing high-risk surgery on preoperative communication with their surgeons.

Setting and participants. This multisite randomized controlled trial involved 5 study sites that encompassed distinct US geographic areas, including University of Wisconsin Hospital and Clinics (UWHC), Madison; the University of California, San Francisco, Medical Center (UCSF); Oregon Health & Science University (OHSU), Portland; the University Hospital of Rutgers New Jersey Medical School (Rutgers), Newark; and the Brigham and Women’s Hospital (BWH), Boston, Massachusetts. The study enrolled 40 surgeons who routinely performed high-risk oncological or vascular surgery via purposeful sampling; patients aged 60 years or older with at least 1 comorbidity and an oncological or vascular problem that were treatable with high-risk surgery; and 1 invited family member per enrolled patient to participate in open-ended interviews postsurgery. High-risk surgery was defined as an operation that has a 30-day in-hospital mortality rate greater than or equal to 1%. Data were collected from June 1, 2016, to November 30, 2018.

Main outcome measures. The frequency of preoperative discussions and documentation of ACP was determined. For patients who had major surgery, any mention of ACP (ie, mention of advance directive [AD], health care power of attorney, or preference for limitations of life-sustaining treatments) by the surgeon, patient or family member during the audio recorded, transcribed, and coded preoperative consultation was counted. The presence of a written AD in the medical record at the time of the initial consultation, filed between the consultation and the date of surgery, or added postoperatively, was recorded using a standardized abstraction form. Postoperative treatments administered and complications experienced within 6 weeks after surgery were recorded. Open-ended interviews with patients who experienced significant postoperative complications (eg, prolonged hospitalization > 8 days, intensive care unit stay > 3 days) and their family members were conducted 6 weeks after surgery. Information ascertained during interviews focused on treatment decisions, postoperative experiences, and interpersonal relationships among patients, families, and clinicians. Transcripts of these interviews were then subjected to qualitative content analysis.

Main results. A total of 446 patients were enrolled in the primary study. Of these patients, 213 (122 men [57%]; 91 women [43%]; mean [SD] age, 72 [7] years) underwent major surgery. Only 13 (6.1%) of those who had major surgery had any discussion related to ACP in the preoperative consultation. In this cohort, 141 (66%) patients did not have an AD on file before undergoing major surgery. The presence of AD was not associated with age (60-69 years, 26 [31%]; 70-79 years, 31 [33%]; ≥ 80 years, 15 [42%]; P = .55), number of comorbidities (1, 35 [32%]; 2, 18 [33%]; ≥ 3, 19 [40%]; P = .62), or type of procedure (oncological, 53 [32%]; vascular, 19 [42%]; P = .22). Moreover, there was no difference in preoperative communication about ACP or documentation of an AD for patients who were mailed a QPL brochure compared to those who received usual care (intervention, 38 [35%]; usual care, 34 [33%]; P = .77). Rates of AD documentation were associated with individual study sites with BWH and UWHC having higher rates of documentation (20 [50%] and 27 [44%], respectively) compared to OHSU, UCSF, or Rutgers (7 [17%], 17 [35%], and 1 [5%], respectively). Analysis from the interviews indicated that patients and families felt unprepared for serious surgical complications and had varied interpretations of ACP. Patients with complications were enthusiastic about ACP but did not think it was important to discuss their preferences for life-sustaining treatments with their surgeon preoperatively.

Conclusion. Although surgeons and patients report that they believe ACP is important, preoperative discussion of patient preferences rarely occurs. This study found that the frequency of ACP discussions or AD documentations among older patients undergoing high-risk oncologic or vascular surgery was low. Interventions that are aimed to increase rates of preoperative ACP discussions should be implemented to help prepare patients and their families for difficult decisions in the setting of serious surgical complications and could help decrease postoperative conflicts that result from unclear patient care goals.

Commentary

Surgeons and patients approach surgical interventions with optimistic outlooks while simultaneously preparing for unintended adverse outcomes. For patients, preoperative ACP discussions ease the burden on their families and ensure their wishes and care goals are communicated. For surgeons, these discussions inform them how best to support the values of the patient. Therefore, it is unsurprising that preoperative ACP is viewed favorably by both groups. Given the consensus that ACP is important in the care of older adults undergoing high-risk surgery, one would assume that preoperative ACP discussion is a standard of practice among surgeons and their aging patients. However, in a secondary analysis of a randomized control trial testing a patient-mediated intervention to improve preoperative communication, Kalbfell et al¹ showed that ACP discussions rarely take place prior to major surgery in older adults. This finding highlights the significant discrepancy between the belief that ACP is important, and the actual rate that it is practiced, in older patients undergoing high-risk surgery. This discordance is highly concerning because it suggests that surgeons who provide care to a very vulnerable subset of older patients may overlook an essential aspect of preoperative care and therefore lack a thorough and thoughtful understanding of the patient’s care goals. In practice, this omission can pose significant challenges associated with the surgeon and family’s decisions to use postoperative life-sustaining interventions or to manage unforeseen complications should a patient become unable to make medical decisions.

The barriers to conducting successful ACP discussions between surgeons and patients are multifactorial. Kalbfell et al¹ highlighted several of these barriers, including lack of patient efficacy, physician attitudes, and institutional values in older adults who require major surgeries. The inadequacy of patient efficacy in preoperative ACP is illustrated by findings from the primary, multisite trial of QPL intervention conducted by Schwarze et al. Interestingly, the authors found that patients who did not receive QPL brochure had no ACP discussions, and that QPL implementation did not significantly improve discussion rates despite its intent to encourage these discussions.² Possible explanations for this lack of engagement might be a lack of health literacy or patient efficacy in the study population. Qualitative data from the current study provided further evidence to support these explanations. For instance, some patients provided limited or incomplete information about their wishes for health care management while others felt it was unnecessary to have ACP discussions unless complications arose.¹ However, the latter example counters the purpose of ACP which is to enable patients to make plans about future health care and not reactive to a medical complication or emergency.

Surgeons bear a large responsibility in providing treatments that are consistent with the care goals of the patient. Thus, surgeons play a crucial role in engaging, guiding, and facilitating ACP discussions with patients. This role is even more critical when patients are unable or unwilling to initiate care goal discussions. Physician attitudes towards ACP, therefore, greatly influence the effectiveness of these discussions. In a study of self-administered surveys by vascular, neurologic, and cardiothoracic surgeons, greater than 90% of respondents viewed postoperative life-supporting therapy as necessary, and 54% would decline to operate on patients with an AD limiting life-supporting therapy.³ Moreover, the same study showed that 52% of respondents reported discussing AD before surgery, a figure that exceeded the actual rates at which ACP discussions occur in many other studies. In the current study, Kalbfell et al¹ also found that surgeons viewed ACP discussions largely in the context of AD creation and declined to investigate the full scope of patient preferences. These findings, when combined with other studies that indicate an incomplete understanding of ACP in some surgeons, suggest that not all physicians are able or willing to navigate these sometimes lengthy and difficult conversations with patients. This gap in practice provides opportunities for training in surgical specialties that center on optimizing preoperative ACP discussions to meet the care needs of older patients.

Institutional value and culture are important factors that impact physician behavior and the practice of ACP discussion. In the current study, the authors reported that the majority of ACP discussions were held by a minority of surgeons and that different institutions and study sites had vastly different rates of ACP documentation.¹ These results are further supported by findings of large variations between physicians and hospitals in ACP reporting in hospitalized frail older adults.⁴ These variations in practices at different institutions suggest that it is possible to improve rates of preoperative ACP discussion. Reasons for these differences need to be further investigated in order to identify strategies, resources, or trainings required by medical institutions to support surgeons to carry out ACP discussions with patients undergoing high-risk surgeries.

The study conducted by Kalbfell et al¹ has several strengths. For example, it included Spanish-speaking patients and the use of a Spanish version of the QPL intervention to account for cultural differences. The study also included multiple surgical specialties and institutions and captured a large and national sample, thus making its findings more generalizable. However, the lack of data on the duration of preoperative consultation visits in patients who completed ACP discussions poses a limitation to this study. This is relevant because surgeon availability to engage in lengthy ACP discussions may be limited due to busy clinical schedules. Additional data on the duration of preoperative visits inclusive of a thoughtfully conducted ACP discussion could help to modify clinical workflow to facilitate its uptake in surgical practices.

Applications for Clinical Practice

The findings from the current study indicate that patients and surgeons agree that preoperative ACP discussions are beneficial to the clinical care of older adults before high-risk surgeries. However, these important conversations do not occur frequently. Surgeons and health care institutions need to identify strategies to initiate, facilitate, and optimize productive preoperative ACP discussions to provide patient-centered care in vulnerable older surgical patients.

Financial disclosures: None.

Study Overview

Objective. The objectives of this study were to (1) quantify the frequency of preoperative advance care planning (ACP) discussion and documentation for older adults undergoing major surgery in a national sample, and (2) characterize how surgical patients and their family members considered ACP after postoperative complications.

Design. A secondary analysis of data from a multisite randomized clinical trial testing the effects of a question prompt list intervention (a Question Problem List [QPL] brochure with 11 questions) given to patients aged 60 years or older undergoing high-risk surgery on preoperative communication with their surgeons.

Setting and participants. This multisite randomized controlled trial involved 5 study sites that encompassed distinct US geographic areas, including University of Wisconsin Hospital and Clinics (UWHC), Madison; the University of California, San Francisco, Medical Center (UCSF); Oregon Health & Science University (OHSU), Portland; the University Hospital of Rutgers New Jersey Medical School (Rutgers), Newark; and the Brigham and Women’s Hospital (BWH), Boston, Massachusetts. The study enrolled 40 surgeons who routinely performed high-risk oncological or vascular surgery via purposeful sampling; patients aged 60 years or older with at least 1 comorbidity and an oncological or vascular problem that were treatable with high-risk surgery; and 1 invited family member per enrolled patient to participate in open-ended interviews postsurgery. High-risk surgery was defined as an operation that has a 30-day in-hospital mortality rate greater than or equal to 1%. Data were collected from June 1, 2016, to November 30, 2018.

Main outcome measures. The frequency of preoperative discussions and documentation of ACP was determined. For patients who had major surgery, any mention of ACP (ie, mention of advance directive [AD], health care power of attorney, or preference for limitations of life-sustaining treatments) by the surgeon, patient or family member during the audio recorded, transcribed, and coded preoperative consultation was counted. The presence of a written AD in the medical record at the time of the initial consultation, filed between the consultation and the date of surgery, or added postoperatively, was recorded using a standardized abstraction form. Postoperative treatments administered and complications experienced within 6 weeks after surgery were recorded. Open-ended interviews with patients who experienced significant postoperative complications (eg, prolonged hospitalization > 8 days, intensive care unit stay > 3 days) and their family members were conducted 6 weeks after surgery. Information ascertained during interviews focused on treatment decisions, postoperative experiences, and interpersonal relationships among patients, families, and clinicians. Transcripts of these interviews were then subjected to qualitative content analysis.

Main results. A total of 446 patients were enrolled in the primary study. Of these patients, 213 (122 men [57%]; 91 women [43%]; mean [SD] age, 72 [7] years) underwent major surgery. Only 13 (6.1%) of those who had major surgery had any discussion related to ACP in the preoperative consultation. In this cohort, 141 (66%) patients did not have an AD on file before undergoing major surgery. The presence of AD was not associated with age (60-69 years, 26 [31%]; 70-79 years, 31 [33%]; ≥ 80 years, 15 [42%]; P = .55), number of comorbidities (1, 35 [32%]; 2, 18 [33%]; ≥ 3, 19 [40%]; P = .62), or type of procedure (oncological, 53 [32%]; vascular, 19 [42%]; P = .22). Moreover, there was no difference in preoperative communication about ACP or documentation of an AD for patients who were mailed a QPL brochure compared to those who received usual care (intervention, 38 [35%]; usual care, 34 [33%]; P = .77). Rates of AD documentation were associated with individual study sites with BWH and UWHC having higher rates of documentation (20 [50%] and 27 [44%], respectively) compared to OHSU, UCSF, or Rutgers (7 [17%], 17 [35%], and 1 [5%], respectively). Analysis from the interviews indicated that patients and families felt unprepared for serious surgical complications and had varied interpretations of ACP. Patients with complications were enthusiastic about ACP but did not think it was important to discuss their preferences for life-sustaining treatments with their surgeon preoperatively.

Conclusion. Although surgeons and patients report that they believe ACP is important, preoperative discussion of patient preferences rarely occurs. This study found that the frequency of ACP discussions or AD documentations among older patients undergoing high-risk oncologic or vascular surgery was low. Interventions that are aimed to increase rates of preoperative ACP discussions should be implemented to help prepare patients and their families for difficult decisions in the setting of serious surgical complications and could help decrease postoperative conflicts that result from unclear patient care goals.

Commentary

Surgeons and patients approach surgical interventions with optimistic outlooks while simultaneously preparing for unintended adverse outcomes. For patients, preoperative ACP discussions ease the burden on their families and ensure their wishes and care goals are communicated. For surgeons, these discussions inform them how best to support the values of the patient. Therefore, it is unsurprising that preoperative ACP is viewed favorably by both groups. Given the consensus that ACP is important in the care of older adults undergoing high-risk surgery, one would assume that preoperative ACP discussion is a standard of practice among surgeons and their aging patients. However, in a secondary analysis of a randomized control trial testing a patient-mediated intervention to improve preoperative communication, Kalbfell et al¹ showed that ACP discussions rarely take place prior to major surgery in older adults. This finding highlights the significant discrepancy between the belief that ACP is important, and the actual rate that it is practiced, in older patients undergoing high-risk surgery. This discordance is highly concerning because it suggests that surgeons who provide care to a very vulnerable subset of older patients may overlook an essential aspect of preoperative care and therefore lack a thorough and thoughtful understanding of the patient’s care goals. In practice, this omission can pose significant challenges associated with the surgeon and family’s decisions to use postoperative life-sustaining interventions or to manage unforeseen complications should a patient become unable to make medical decisions.

The barriers to conducting successful ACP discussions between surgeons and patients are multifactorial. Kalbfell et al¹ highlighted several of these barriers, including lack of patient efficacy, physician attitudes, and institutional values in older adults who require major surgeries. The inadequacy of patient efficacy in preoperative ACP is illustrated by findings from the primary, multisite trial of QPL intervention conducted by Schwarze et al. Interestingly, the authors found that patients who did not receive QPL brochure had no ACP discussions, and that QPL implementation did not significantly improve discussion rates despite its intent to encourage these discussions.² Possible explanations for this lack of engagement might be a lack of health literacy or patient efficacy in the study population. Qualitative data from the current study provided further evidence to support these explanations. For instance, some patients provided limited or incomplete information about their wishes for health care management while others felt it was unnecessary to have ACP discussions unless complications arose.¹ However, the latter example counters the purpose of ACP which is to enable patients to make plans about future health care and not reactive to a medical complication or emergency.

Surgeons bear a large responsibility in providing treatments that are consistent with the care goals of the patient. Thus, surgeons play a crucial role in engaging, guiding, and facilitating ACP discussions with patients. This role is even more critical when patients are unable or unwilling to initiate care goal discussions. Physician attitudes towards ACP, therefore, greatly influence the effectiveness of these discussions. In a study of self-administered surveys by vascular, neurologic, and cardiothoracic surgeons, greater than 90% of respondents viewed postoperative life-supporting therapy as necessary, and 54% would decline to operate on patients with an AD limiting life-supporting therapy.³ Moreover, the same study showed that 52% of respondents reported discussing AD before surgery, a figure that exceeded the actual rates at which ACP discussions occur in many other studies. In the current study, Kalbfell et al¹ also found that surgeons viewed ACP discussions largely in the context of AD creation and declined to investigate the full scope of patient preferences. These findings, when combined with other studies that indicate an incomplete understanding of ACP in some surgeons, suggest that not all physicians are able or willing to navigate these sometimes lengthy and difficult conversations with patients. This gap in practice provides opportunities for training in surgical specialties that center on optimizing preoperative ACP discussions to meet the care needs of older patients.

Institutional value and culture are important factors that impact physician behavior and the practice of ACP discussion. In the current study, the authors reported that the majority of ACP discussions were held by a minority of surgeons and that different institutions and study sites had vastly different rates of ACP documentation.¹ These results are further supported by findings of large variations between physicians and hospitals in ACP reporting in hospitalized frail older adults.⁴ These variations in practices at different institutions suggest that it is possible to improve rates of preoperative ACP discussion. Reasons for these differences need to be further investigated in order to identify strategies, resources, or trainings required by medical institutions to support surgeons to carry out ACP discussions with patients undergoing high-risk surgeries.

The study conducted by Kalbfell et al¹ has several strengths. For example, it included Spanish-speaking patients and the use of a Spanish version of the QPL intervention to account for cultural differences. The study also included multiple surgical specialties and institutions and captured a large and national sample, thus making its findings more generalizable. However, the lack of data on the duration of preoperative consultation visits in patients who completed ACP discussions poses a limitation to this study. This is relevant because surgeon availability to engage in lengthy ACP discussions may be limited due to busy clinical schedules. Additional data on the duration of preoperative visits inclusive of a thoughtfully conducted ACP discussion could help to modify clinical workflow to facilitate its uptake in surgical practices.

Applications for Clinical Practice

The findings from the current study indicate that patients and surgeons agree that preoperative ACP discussions are beneficial to the clinical care of older adults before high-risk surgeries. However, these important conversations do not occur frequently. Surgeons and health care institutions need to identify strategies to initiate, facilitate, and optimize productive preoperative ACP discussions to provide patient-centered care in vulnerable older surgical patients.

Financial disclosures: None.

Even a decade ago, the idea of providers sharing clinical notes with patients was almost unfathomable to most in medicine. We have since seen a sea change regarding the need for transparency in health care, leading to dramatic legislative and policy shifts in recent years.

On April 5, 2021, the federal program rule on Interoperability, Information Blocking, and ONC Health IT Certification took effect, which implemented a part of the bipartisan 21st Century Cures Act of 2016 requiring most of a patient’s electronic health information (EHI) be made easily accessible free of charge and “without delay.”¹

Included in this defined set of EHI, known as the United States Core Data for Interoperability, are eight types of clinical notes that must be shared with patients, including: progress notes, history and physical notes, consultation notes, discharge summary notes, procedure notes, laboratory report narratives, imaging narratives, and pathology report narratives. Many clinicians viewed this federally mandated transition to note sharing with patients with concern, fearing increased documentation burdens, needless patient anxiety, and inevitable deluge of follow-up questions and requests for chart corrections.

In reality, the Health Insurance Portability and Accountability Act (HIPAA) granted virtually all patients the right to review a paper copy of their medical records, including all clinical notes, way back in 1996. Practically speaking, though, the multiple steps required to formally make these requests kept most patients from regularly accessing their health information.

The 21st Century Cures Act streamlines and modernizes this process by requiring electronic access. Certain note types, including psychotherapy notes, are exempt from this requirement. As has always been true since HIPAA was enacted, exceptions may be used for circumstances in which a clinician holds a reasonable belief that blocking information is necessary to prevent harm to a patient or another person or to protect an individual’s privacy. By continuing to allow for these exceptions, clinicians maintain the autonomy to block sharing of notes in the rare, complex situations in which doing so may truly be harmful.

And while the legal requirement to share most clinical notes is new, there is already a wealth of evidence from the earliest adopters (part of the OpenNotes movement) affirming the significant benefits from this practice – for patients and providers – with few negative effects on workflows or documentation patterns.² Findings published as early as 2012, and regularly since then, among OpenNotes adopters from a diverse set of health care institutions have shown access to notes improves patient engagement, activation, and communication, as well as patient and clinician satisfaction.³

Still, providers may argue, shouldn’t clinical notes be a space where providers are free to articulate uncertainties, work through clinical reasoning, and share subtle observations about a patient’s presentation and findings with colleagues without having to worry about alarming patients who may lack the background to understand medical nuances?

It’s a fine balance in certain situations since we want to document our objective clinical assessments and prognoses without needlessly upsetting our patients, especially when considering a potentially life-changing diagnosis. How do we continue offering hope to our patients while still respecting their autonomy and sharing their health information with them? There is no uniform approach or standard playbook to follow since each patient and clinical circumstance is unique.

Fundamentally, sharing clinical notes is about granting access to one’s own health information, promoting patient activation and engagement, and making health care more patient centered. As a clinician, it’s important to frame the conversations we have with our patients so they are not surprised or caught off guard by what we have written in our notes. If you had a difficult or contentious conversation, document it objectively and without bias. If you are discussing obesity, substance abuse, or mental health, do so respectfully, supportively, and without judgment. If one of the reasons you are doing a CT scan is to rule out pancreatic cancer, it’s hard to argue that the patient does not deserve to know that beforehand.

The OpenNotes experience to date has consistently shown that patients benefit from direct discussions and transparency, which can even motivate difficult behavior changes.⁴ As clinicians, we may have to make minor changes in how we document, such as using less medical jargon and fewer abbreviations, but based on data from the longest tenured participants in OpenNotes, these adjustments do not add to documentation burdens.⁵ An activated patient who is reading their notes is an engaged patient, one who will often collaborate more in their own care, offer additional insights, and feel more empowered to take responsibility for their own health.⁶

When surveyed, patients report that access to their clinical notes helps them feel more in control of their health by understanding their medical conditions better, which makes them feel more prepared for their visits.4 Studies have shown that patients forget between 40%-80% of the information communicated during a visit, making clinical notes a valuable reminder and reference. Over 75% of patients in one study reported that reading notes helped them better understand the meaning of results and the rationale for referrals and tests, which led to greater follow-through with their treatment plans and follow-up appointments.³ A remarkable 99% of patients in the same study reported feeling the same or better about their physician after reading their notes.

Sharing notes with patients also makes care safer and more equitable. A written record of a visit serves as an important source of information about why a medicine is prescribed, a reminder about additions or changes to a regimen, and potential adverse effects of medications. In the first OpenNotes study, which had more than 100 primary care physicians and 20,000 patients, 60%-78% of patients with access to their notes reported improved medication adherence.² A later study reported similar benefits, particularly among patients who identify as racial or ethnic minorities, non-native English speakers, and those with a high school education or less. These findings may reflect increased trust that comes with a more collaborative relationship between providers and patients. Patients who can read their notes also show a willingness to review their medication lists and report discrepancies and errors, making their care safer still.⁷

Conclusion

The move to widespread shared notes, though prompted by a federal mandate, is a critical step forward in patient activation, engagement, and satisfaction. Importantly, there is a large body of evidence showing multiple benefits, including better communication and safer and more equitable care at sites that have already been sharing notes for over a decade. When surveyed, both patients and providers who have been participating in shared notes believe the practice should continue.

In April 2021, we began a massive natural experiment in the U.S. with ubiquitous sharing of clinical notes, one that will help us learn more about how best to make our patients’ health information accessible, meaningful, and most meaningful in improving their overall health and well-being. Sharing notes with our patients is at once relatively easy to implement but complex in its implications and represents a significant paradigm shift in medicine toward a safer, more patient-centered approach. The evidence to date has shown that embracing shared notes promotes greater patient activation and engagement, and with it a more transparent and collaborative relationship between providers and patients that could lead to transformative benefits to the quality of the care we can achieve together.

Dr. Shah is an associate professor of medicine and pediatrics and associate chief medical information officer at University of Chicago Medicine. He has no disclosures

References

1. 21st Century Cures Act, HR 34, 114th Congress (2015). Accessed 2021 Sep 23. https://www.congress.gov/bill/114th-congress/house-bill/34.

2. Delbanco T et al. Ann Intern Med. 2012 Oct;157(7):461-70.

3. Bell S et al. BMJ Qual Saf. 2017 Apr;26(4):262-70.

4. Walker J et al. J Med Internet Res. 2019 May. doi: 10.2196/13876.

5. DesRoches C et al. JAMA Netw Open. 2020 Mar. doi: 10.1001/jamanetworkopen.2020.1753.

6. Blease C et al. J Med Ethics. 2021 May. doi: 10.1136/medethics-2021-107275.

7. DesRoches C et al. Ann Intern Med. 2019 Jul 2;171(1):69-71.


 

Even a decade ago, the idea of providers sharing clinical notes with patients was almost unfathomable to most in medicine. We have since seen a sea change regarding the need for transparency in health care, leading to dramatic legislative and policy shifts in recent years.

On April 5, 2021, the federal program rule on Interoperability, Information Blocking, and ONC Health IT Certification took effect, which implemented a part of the bipartisan 21st Century Cures Act of 2016 requiring most of a patient’s electronic health information (EHI) be made easily accessible free of charge and “without delay.”¹

Included in this defined set of EHI, known as the United States Core Data for Interoperability, are eight types of clinical notes that must be shared with patients, including: progress notes, history and physical notes, consultation notes, discharge summary notes, procedure notes, laboratory report narratives, imaging narratives, and pathology report narratives. Many clinicians viewed this federally mandated transition to note sharing with patients with concern, fearing increased documentation burdens, needless patient anxiety, and inevitable deluge of follow-up questions and requests for chart corrections.

In reality, the Health Insurance Portability and Accountability Act (HIPAA) granted virtually all patients the right to review a paper copy of their medical records, including all clinical notes, way back in 1996. Practically speaking, though, the multiple steps required to formally make these requests kept most patients from regularly accessing their health information.

The 21st Century Cures Act streamlines and modernizes this process by requiring electronic access. Certain note types, including psychotherapy notes, are exempt from this requirement. As has always been true since HIPAA was enacted, exceptions may be used for circumstances in which a clinician holds a reasonable belief that blocking information is necessary to prevent harm to a patient or another person or to protect an individual’s privacy. By continuing to allow for these exceptions, clinicians maintain the autonomy to block sharing of notes in the rare, complex situations in which doing so may truly be harmful.

And while the legal requirement to share most clinical notes is new, there is already a wealth of evidence from the earliest adopters (part of the OpenNotes movement) affirming the significant benefits from this practice – for patients and providers – with few negative effects on workflows or documentation patterns.² Findings published as early as 2012, and regularly since then, among OpenNotes adopters from a diverse set of health care institutions have shown access to notes improves patient engagement, activation, and communication, as well as patient and clinician satisfaction.³

Still, providers may argue, shouldn’t clinical notes be a space where providers are free to articulate uncertainties, work through clinical reasoning, and share subtle observations about a patient’s presentation and findings with colleagues without having to worry about alarming patients who may lack the background to understand medical nuances?

It’s a fine balance in certain situations since we want to document our objective clinical assessments and prognoses without needlessly upsetting our patients, especially when considering a potentially life-changing diagnosis. How do we continue offering hope to our patients while still respecting their autonomy and sharing their health information with them? There is no uniform approach or standard playbook to follow since each patient and clinical circumstance is unique.

Fundamentally, sharing clinical notes is about granting access to one’s own health information, promoting patient activation and engagement, and making health care more patient centered. As a clinician, it’s important to frame the conversations we have with our patients so they are not surprised or caught off guard by what we have written in our notes. If you had a difficult or contentious conversation, document it objectively and without bias. If you are discussing obesity, substance abuse, or mental health, do so respectfully, supportively, and without judgment. If one of the reasons you are doing a CT scan is to rule out pancreatic cancer, it’s hard to argue that the patient does not deserve to know that beforehand.

The OpenNotes experience to date has consistently shown that patients benefit from direct discussions and transparency, which can even motivate difficult behavior changes.⁴ As clinicians, we may have to make minor changes in how we document, such as using less medical jargon and fewer abbreviations, but based on data from the longest tenured participants in OpenNotes, these adjustments do not add to documentation burdens.⁵ An activated patient who is reading their notes is an engaged patient, one who will often collaborate more in their own care, offer additional insights, and feel more empowered to take responsibility for their own health.⁶

When surveyed, patients report that access to their clinical notes helps them feel more in control of their health by understanding their medical conditions better, which makes them feel more prepared for their visits.4 Studies have shown that patients forget between 40%-80% of the information communicated during a visit, making clinical notes a valuable reminder and reference. Over 75% of patients in one study reported that reading notes helped them better understand the meaning of results and the rationale for referrals and tests, which led to greater follow-through with their treatment plans and follow-up appointments.³ A remarkable 99% of patients in the same study reported feeling the same or better about their physician after reading their notes.

Sharing notes with patients also makes care safer and more equitable. A written record of a visit serves as an important source of information about why a medicine is prescribed, a reminder about additions or changes to a regimen, and potential adverse effects of medications. In the first OpenNotes study, which had more than 100 primary care physicians and 20,000 patients, 60%-78% of patients with access to their notes reported improved medication adherence.² A later study reported similar benefits, particularly among patients who identify as racial or ethnic minorities, non-native English speakers, and those with a high school education or less. These findings may reflect increased trust that comes with a more collaborative relationship between providers and patients. Patients who can read their notes also show a willingness to review their medication lists and report discrepancies and errors, making their care safer still.⁷

Conclusion

The move to widespread shared notes, though prompted by a federal mandate, is a critical step forward in patient activation, engagement, and satisfaction. Importantly, there is a large body of evidence showing multiple benefits, including better communication and safer and more equitable care at sites that have already been sharing notes for over a decade. When surveyed, both patients and providers who have been participating in shared notes believe the practice should continue.

In April 2021, we began a massive natural experiment in the U.S. with ubiquitous sharing of clinical notes, one that will help us learn more about how best to make our patients’ health information accessible, meaningful, and most meaningful in improving their overall health and well-being. Sharing notes with our patients is at once relatively easy to implement but complex in its implications and represents a significant paradigm shift in medicine toward a safer, more patient-centered approach. The evidence to date has shown that embracing shared notes promotes greater patient activation and engagement, and with it a more transparent and collaborative relationship between providers and patients that could lead to transformative benefits to the quality of the care we can achieve together.

Dr. Shah is an associate professor of medicine and pediatrics and associate chief medical information officer at University of Chicago Medicine. He has no disclosures

References

1. 21st Century Cures Act, HR 34, 114th Congress (2015). Accessed 2021 Sep 23. https://www.congress.gov/bill/114th-congress/house-bill/34.

2. Delbanco T et al. Ann Intern Med. 2012 Oct;157(7):461-70.

3. Bell S et al. BMJ Qual Saf. 2017 Apr;26(4):262-70.

4. Walker J et al. J Med Internet Res. 2019 May. doi: 10.2196/13876.

5. DesRoches C et al. JAMA Netw Open. 2020 Mar. doi: 10.1001/jamanetworkopen.2020.1753.

6. Blease C et al. J Med Ethics. 2021 May. doi: 10.1136/medethics-2021-107275.

7. DesRoches C et al. Ann Intern Med. 2019 Jul 2;171(1):69-71.


 

Even a decade ago, the idea of providers sharing clinical notes with patients was almost unfathomable to most in medicine. We have since seen a sea change regarding the need for transparency in health care, leading to dramatic legislative and policy shifts in recent years.

On April 5, 2021, the federal program rule on Interoperability, Information Blocking, and ONC Health IT Certification took effect, which implemented a part of the bipartisan 21st Century Cures Act of 2016 requiring most of a patient’s electronic health information (EHI) be made easily accessible free of charge and “without delay.”¹

Included in this defined set of EHI, known as the United States Core Data for Interoperability, are eight types of clinical notes that must be shared with patients, including: progress notes, history and physical notes, consultation notes, discharge summary notes, procedure notes, laboratory report narratives, imaging narratives, and pathology report narratives. Many clinicians viewed this federally mandated transition to note sharing with patients with concern, fearing increased documentation burdens, needless patient anxiety, and inevitable deluge of follow-up questions and requests for chart corrections.

In reality, the Health Insurance Portability and Accountability Act (HIPAA) granted virtually all patients the right to review a paper copy of their medical records, including all clinical notes, way back in 1996. Practically speaking, though, the multiple steps required to formally make these requests kept most patients from regularly accessing their health information.

The 21st Century Cures Act streamlines and modernizes this process by requiring electronic access. Certain note types, including psychotherapy notes, are exempt from this requirement. As has always been true since HIPAA was enacted, exceptions may be used for circumstances in which a clinician holds a reasonable belief that blocking information is necessary to prevent harm to a patient or another person or to protect an individual’s privacy. By continuing to allow for these exceptions, clinicians maintain the autonomy to block sharing of notes in the rare, complex situations in which doing so may truly be harmful.

And while the legal requirement to share most clinical notes is new, there is already a wealth of evidence from the earliest adopters (part of the OpenNotes movement) affirming the significant benefits from this practice – for patients and providers – with few negative effects on workflows or documentation patterns.² Findings published as early as 2012, and regularly since then, among OpenNotes adopters from a diverse set of health care institutions have shown access to notes improves patient engagement, activation, and communication, as well as patient and clinician satisfaction.³

Still, providers may argue, shouldn’t clinical notes be a space where providers are free to articulate uncertainties, work through clinical reasoning, and share subtle observations about a patient’s presentation and findings with colleagues without having to worry about alarming patients who may lack the background to understand medical nuances?

It’s a fine balance in certain situations since we want to document our objective clinical assessments and prognoses without needlessly upsetting our patients, especially when considering a potentially life-changing diagnosis. How do we continue offering hope to our patients while still respecting their autonomy and sharing their health information with them? There is no uniform approach or standard playbook to follow since each patient and clinical circumstance is unique.

Fundamentally, sharing clinical notes is about granting access to one’s own health information, promoting patient activation and engagement, and making health care more patient centered. As a clinician, it’s important to frame the conversations we have with our patients so they are not surprised or caught off guard by what we have written in our notes. If you had a difficult or contentious conversation, document it objectively and without bias. If you are discussing obesity, substance abuse, or mental health, do so respectfully, supportively, and without judgment. If one of the reasons you are doing a CT scan is to rule out pancreatic cancer, it’s hard to argue that the patient does not deserve to know that beforehand.

The OpenNotes experience to date has consistently shown that patients benefit from direct discussions and transparency, which can even motivate difficult behavior changes.⁴ As clinicians, we may have to make minor changes in how we document, such as using less medical jargon and fewer abbreviations, but based on data from the longest tenured participants in OpenNotes, these adjustments do not add to documentation burdens.⁵ An activated patient who is reading their notes is an engaged patient, one who will often collaborate more in their own care, offer additional insights, and feel more empowered to take responsibility for their own health.⁶

When surveyed, patients report that access to their clinical notes helps them feel more in control of their health by understanding their medical conditions better, which makes them feel more prepared for their visits.4 Studies have shown that patients forget between 40%-80% of the information communicated during a visit, making clinical notes a valuable reminder and reference. Over 75% of patients in one study reported that reading notes helped them better understand the meaning of results and the rationale for referrals and tests, which led to greater follow-through with their treatment plans and follow-up appointments.³ A remarkable 99% of patients in the same study reported feeling the same or better about their physician after reading their notes.

Sharing notes with patients also makes care safer and more equitable. A written record of a visit serves as an important source of information about why a medicine is prescribed, a reminder about additions or changes to a regimen, and potential adverse effects of medications. In the first OpenNotes study, which had more than 100 primary care physicians and 20,000 patients, 60%-78% of patients with access to their notes reported improved medication adherence.² A later study reported similar benefits, particularly among patients who identify as racial or ethnic minorities, non-native English speakers, and those with a high school education or less. These findings may reflect increased trust that comes with a more collaborative relationship between providers and patients. Patients who can read their notes also show a willingness to review their medication lists and report discrepancies and errors, making their care safer still.⁷

Conclusion

The move to widespread shared notes, though prompted by a federal mandate, is a critical step forward in patient activation, engagement, and satisfaction. Importantly, there is a large body of evidence showing multiple benefits, including better communication and safer and more equitable care at sites that have already been sharing notes for over a decade. When surveyed, both patients and providers who have been participating in shared notes believe the practice should continue.

In April 2021, we began a massive natural experiment in the U.S. with ubiquitous sharing of clinical notes, one that will help us learn more about how best to make our patients’ health information accessible, meaningful, and most meaningful in improving their overall health and well-being. Sharing notes with our patients is at once relatively easy to implement but complex in its implications and represents a significant paradigm shift in medicine toward a safer, more patient-centered approach. The evidence to date has shown that embracing shared notes promotes greater patient activation and engagement, and with it a more transparent and collaborative relationship between providers and patients that could lead to transformative benefits to the quality of the care we can achieve together.

Dr. Shah is an associate professor of medicine and pediatrics and associate chief medical information officer at University of Chicago Medicine. He has no disclosures

References

1. 21st Century Cures Act, HR 34, 114th Congress (2015). Accessed 2021 Sep 23. https://www.congress.gov/bill/114th-congress/house-bill/34.

2. Delbanco T et al. Ann Intern Med. 2012 Oct;157(7):461-70.

3. Bell S et al. BMJ Qual Saf. 2017 Apr;26(4):262-70.

4. Walker J et al. J Med Internet Res. 2019 May. doi: 10.2196/13876.

5. DesRoches C et al. JAMA Netw Open. 2020 Mar. doi: 10.1001/jamanetworkopen.2020.1753.

6. Blease C et al. J Med Ethics. 2021 May. doi: 10.1136/medethics-2021-107275.

7. DesRoches C et al. Ann Intern Med. 2019 Jul 2;171(1):69-71.


 

Physicians are bracing for upcoming changes in reimbursement that may start within a few months. As doctors gear up for another wave of COVID, payment trends may not be the top priority, but some “uh oh” announcements in the fall of 2021 could have far-reaching implications that could affect your future.

The Centers for Medicare & Medicaid Services issued a proposed rule in the summer covering key aspects of physician payment. Although the rule contained some small bright lights, the most important changes proposed were far from welcome.

Here’s what could be in store:

1. The highly anticipated Medicare Physician Fee Schedule ruling confirmed a sweeping payment cut. The drive to maintain budget neutrality forced the federal agency to reduce Medicare payments, on average, by nearly 4%. Many physicians are outraged at the proposed cut.

2. More bad news for 2022: Sequestration will be back. Sequestration is the mandatory, pesky, negative 2% adjustment on all Medicare payments. It had been put on hold and is set to return at the beginning of 2022.

Essentially, sequestration reduces what Medicare pays its providers for health services, but Medicare beneficiaries bear no responsibility for the cost difference. To prevent further debt, CMS imposes financially on hospitals, physicians, and other health care providers.

The Health Resources and Services Administration has funds remaining to reimburse for all COVID-related testing, treatment, and vaccines provided to uninsured individuals. You can apply and be reimbursed at Medicare rates for these services when COVID is the primary diagnosis (or secondary in the case of pregnancy). Patients need not be American citizens for you to get paid.

3. Down to a nail-biter: The final ruling is expected in early November. The situation smacks of earlier days when physicians clung to a precipice, waiting in anticipation for a legislative body to save them from the dreaded income plunge. Indeed, we are slipping back to the decade-long period when Congress kept coming to the rescue simply to maintain the status quo.

Many anticipate a last-minute Congressional intervention to save the day, particularly in the midst of another COVID spike. The promises of a stable reimbursement system made possible by the Medicare Access and CHIP Reauthorization Act have been far from realized, and there are signs that the payment landscape is in the midst of a fundamental transformation.

Other changes proposed in the 1,747-page ruling include:
 

Positive:

• More telehealth services will be covered by Medicare, including home visits.
• Tele–mental health services got a big boost; many restrictions were removed so that now the patient’s home is considered a permissible originating site. It also allows for audio-only (no visual required) encounters; the audio-only allowance will extend to opioid use disorder treatment services. Phone treatment is covered.
• Permanent adoption of G2252: The 11- to 20-minute virtual check-in code wasn’t just a one-time payment but will be reimbursed in perpetuity.
• Boosts in reimbursement for chronic care and principal care management codes, which range on the basis of service but indicate a commitment to pay for care coordination.
• Clarification of roles and billing opportunities for split/shared visits, which occur if a physician and advanced practice provider see the same patient on a particular day. Prepare for new coding rules to include a modifier. Previously, the rules for billing were muddled, so transparency helps guide payment opportunities.
• Delay of the appropriate use criteria for advanced imaging for 1 (more) year, a welcome postponement of the ruling that carries a significant administrative burden.
• Physician assistants will be able to bill Medicare directly, and referrals to be made to medical nutrition therapy by a nontreating physician.
• A new approach to patient cost-sharing for colorectal cancer screenings will be phased in. This area has caused problems in the past when the physician identifies a need for additional services (for example, polyp removal by a gastroenterologist during routine colonoscopy).
•  

Not positive:

• Which specialties benefit and which get zapped? The anticipated impact by specialty ranges from hits to interventional radiologists (–9%) and vascular surgeons (–8%), to increases for family practitioners, hand surgeons, endocrinologists, and geriatricians, each estimated to gain a modest 2%. (The exception is portable x-ray supplier, with an estimated increase of 10%.) All other specialties fall in between.
• The proposed conversion factor for 2022 is $33.58, a 3.75% drop from the 2021 conversion factor of $34.89.

The proposed ruling also covered the Quality Payment Program, the overarching program of which the Merit-based Incentive Payment System (MIPS) is the main track for participation. The proposal incorporates additional episode-based cost measures as well as updates to quality indicators and improvement activities.

MIPS penalties. The stakes are higher now, with 9% penalties on the table for nonparticipants. The government offers physicians the ability to officially get out of the program in 2021 because of the COVID-19 pandemic, thereby staving off the steep penalty. The option, which is available through the end of the year, requires a simple application that can be completed on behalf of the entire practice. If you want out, now is the time to find and fill out that application.

Exempt from technology requirements. If the proposal is accepted, small practices – defined by CMS as 15 eligible clinicians or fewer – won’t have to file an annual application to reweight the “promoting interoperability” portion of the program. If acknowledged, small practices will automatically be exempt from the program’s technology section. That’s a big plus, as one of the many chief complaints from small practices is the onus of meeting the technology requirements, which include a security risk analysis, bi-directional health information exchange, public health reporting, and patient access to health information. Meeting the requirements is no small feat. That will only affect future years, so be sure to apply in 2021 if applicable for your practice.

Changes in MIPS. MIPS Value Pathways (MVPs) are anticipated for 2023, with the government releasing details about proposed models for heart disease, rheumatology, joint repair, and more. The MVPs are slated to take over the traditional MIPS by 2027.

The program will shift to 30% of your score coming from the “cost” category, which is based on the government’s analysis of a physician’s claims – and, if attributed, the claims of the patients for whom you care. This area is tricky to manage, but recognize that the costs under scrutiny are the expenses paid by Medicare on behalf of its patients.

In essence, Medicare is measuring the cost of your patients as compared with your colleagues’ costs (in the form of specialty-based benchmarks). Therefore, if you’re referring, or ordering, a more costly set of diagnostic tests, assessments, or interventions than your peers, you’ll be dinged.

However, physicians are more likely this year to flat out reject participation in the federal payment program. Payouts have been paltry and dismal to date, and the buzz is that physicians just don’t consider it worth the effort. Of course, clearing the threshold (which is proposed at 70 points next year) is a must to avoid the penalty, but don’t go crazy to get a perfect score as it won’t count for much. 2022 is the final year that there are any monies for exceptional performance.

Considering that the payouts for exceptional performance have been less than 2% for several years now, it’s hard to justify dedicating resources to achieve perfection. Experts believe that even exceptional performance will only be worth pennies in bonus payments.

The fear of the stick, therefore, may be the only motivation. And that is subjective, as physicians weigh the effort required versus just taking the hit on the penalty. But the penalty is substantial, and so even without the incentive, it’s important to participate at least at the threshold.

Fewer cost-sharing waivers. While the federal government’s payment policies have a major impact on reimbursement, other forces may have broader implications. Commercial payers have rolled back cost-sharing waivers, bringing to light the significant financial responsibility that patients have for their health care in the form of deductibles, coinsurance, and so forth.

More than a third of Americans had trouble paying their health care bills before the pandemic; as patients catch up with services that were postponed or delayed because of the pandemic, this may expose challenges for you. Patients with unpaid bills translate into your financial burden.

Virtual-first health plans. Patients may be seeking alternatives to avoid the frustrating cycle of unpaid medical bills. This may be a factor propelling another trend: Lower-cost virtual-first health plans such as Alignment Health have taken hold in the market. As the name implies, insurance coverage features telehealth that extends to in-person services if necessary.

These disruptors may have their hands at least somewhat tied, however. The market may not be able to fully embrace telemedicine until state licensure is addressed. Despite the federal regulatory relaxations, states still control the distribution of medical care through licensure requirements. Many are rolling back their pandemic-based emergency orders and only allowing licensed physicians to see patients in their state, even over telemedicine.

While seemingly frustrating for physicians who want to see patients over state lines, the delays imposed by states may actually have a welcome effect. If licensure migrates to the federal level, there are many implications. For the purposes of this article, the competitive landscape will become incredibly aggressive. You will need to compete with Amazon Care, Walmart, Cigna, and many other well-funded national players that would love nothing more than to launch a campaign to target the entire nation. Investors are eager to capture part of the nearly quarter-trillion-dollar market, with telemedicine at 38 times prepandemic levels and no signs of abating.

Increased competition for insurers. While the proposed drop in Medicare reimbursement is frustrating, keep a pulse on the fact that your patients may soon be lured by vendors like Amazon and others eager to gain access to physician payments. Instead of analyzing Federal Registers in the future, we may be assessing stock prices.

Consider, therefore, how to ensure that your digital front door is at least available, if not wide open, in the meantime. The nature of physician payments is surely changing.

Ms. Woodcock is president of Woodcock & Associates, Atlanta. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

Physicians are bracing for upcoming changes in reimbursement that may start within a few months. As doctors gear up for another wave of COVID, payment trends may not be the top priority, but some “uh oh” announcements in the fall of 2021 could have far-reaching implications that could affect your future.

The Centers for Medicare & Medicaid Services issued a proposed rule in the summer covering key aspects of physician payment. Although the rule contained some small bright lights, the most important changes proposed were far from welcome.

Here’s what could be in store:

1. The highly anticipated Medicare Physician Fee Schedule ruling confirmed a sweeping payment cut. The drive to maintain budget neutrality forced the federal agency to reduce Medicare payments, on average, by nearly 4%. Many physicians are outraged at the proposed cut.

2. More bad news for 2022: Sequestration will be back. Sequestration is the mandatory, pesky, negative 2% adjustment on all Medicare payments. It had been put on hold and is set to return at the beginning of 2022.

Essentially, sequestration reduces what Medicare pays its providers for health services, but Medicare beneficiaries bear no responsibility for the cost difference. To prevent further debt, CMS imposes financially on hospitals, physicians, and other health care providers.

The Health Resources and Services Administration has funds remaining to reimburse for all COVID-related testing, treatment, and vaccines provided to uninsured individuals. You can apply and be reimbursed at Medicare rates for these services when COVID is the primary diagnosis (or secondary in the case of pregnancy). Patients need not be American citizens for you to get paid.

3. Down to a nail-biter: The final ruling is expected in early November. The situation smacks of earlier days when physicians clung to a precipice, waiting in anticipation for a legislative body to save them from the dreaded income plunge. Indeed, we are slipping back to the decade-long period when Congress kept coming to the rescue simply to maintain the status quo.

Many anticipate a last-minute Congressional intervention to save the day, particularly in the midst of another COVID spike. The promises of a stable reimbursement system made possible by the Medicare Access and CHIP Reauthorization Act have been far from realized, and there are signs that the payment landscape is in the midst of a fundamental transformation.

Other changes proposed in the 1,747-page ruling include:
 

Positive:

• More telehealth services will be covered by Medicare, including home visits.
• Tele–mental health services got a big boost; many restrictions were removed so that now the patient’s home is considered a permissible originating site. It also allows for audio-only (no visual required) encounters; the audio-only allowance will extend to opioid use disorder treatment services. Phone treatment is covered.
• Permanent adoption of G2252: The 11- to 20-minute virtual check-in code wasn’t just a one-time payment but will be reimbursed in perpetuity.
• Boosts in reimbursement for chronic care and principal care management codes, which range on the basis of service but indicate a commitment to pay for care coordination.
• Clarification of roles and billing opportunities for split/shared visits, which occur if a physician and advanced practice provider see the same patient on a particular day. Prepare for new coding rules to include a modifier. Previously, the rules for billing were muddled, so transparency helps guide payment opportunities.
• Delay of the appropriate use criteria for advanced imaging for 1 (more) year, a welcome postponement of the ruling that carries a significant administrative burden.
• Physician assistants will be able to bill Medicare directly, and referrals to be made to medical nutrition therapy by a nontreating physician.
• A new approach to patient cost-sharing for colorectal cancer screenings will be phased in. This area has caused problems in the past when the physician identifies a need for additional services (for example, polyp removal by a gastroenterologist during routine colonoscopy).
•  

Not positive:

• Which specialties benefit and which get zapped? The anticipated impact by specialty ranges from hits to interventional radiologists (–9%) and vascular surgeons (–8%), to increases for family practitioners, hand surgeons, endocrinologists, and geriatricians, each estimated to gain a modest 2%. (The exception is portable x-ray supplier, with an estimated increase of 10%.) All other specialties fall in between.
• The proposed conversion factor for 2022 is $33.58, a 3.75% drop from the 2021 conversion factor of $34.89.

The proposed ruling also covered the Quality Payment Program, the overarching program of which the Merit-based Incentive Payment System (MIPS) is the main track for participation. The proposal incorporates additional episode-based cost measures as well as updates to quality indicators and improvement activities.

MIPS penalties. The stakes are higher now, with 9% penalties on the table for nonparticipants. The government offers physicians the ability to officially get out of the program in 2021 because of the COVID-19 pandemic, thereby staving off the steep penalty. The option, which is available through the end of the year, requires a simple application that can be completed on behalf of the entire practice. If you want out, now is the time to find and fill out that application.

Exempt from technology requirements. If the proposal is accepted, small practices – defined by CMS as 15 eligible clinicians or fewer – won’t have to file an annual application to reweight the “promoting interoperability” portion of the program. If acknowledged, small practices will automatically be exempt from the program’s technology section. That’s a big plus, as one of the many chief complaints from small practices is the onus of meeting the technology requirements, which include a security risk analysis, bi-directional health information exchange, public health reporting, and patient access to health information. Meeting the requirements is no small feat. That will only affect future years, so be sure to apply in 2021 if applicable for your practice.

Changes in MIPS. MIPS Value Pathways (MVPs) are anticipated for 2023, with the government releasing details about proposed models for heart disease, rheumatology, joint repair, and more. The MVPs are slated to take over the traditional MIPS by 2027.

The program will shift to 30% of your score coming from the “cost” category, which is based on the government’s analysis of a physician’s claims – and, if attributed, the claims of the patients for whom you care. This area is tricky to manage, but recognize that the costs under scrutiny are the expenses paid by Medicare on behalf of its patients.

In essence, Medicare is measuring the cost of your patients as compared with your colleagues’ costs (in the form of specialty-based benchmarks). Therefore, if you’re referring, or ordering, a more costly set of diagnostic tests, assessments, or interventions than your peers, you’ll be dinged.

However, physicians are more likely this year to flat out reject participation in the federal payment program. Payouts have been paltry and dismal to date, and the buzz is that physicians just don’t consider it worth the effort. Of course, clearing the threshold (which is proposed at 70 points next year) is a must to avoid the penalty, but don’t go crazy to get a perfect score as it won’t count for much. 2022 is the final year that there are any monies for exceptional performance.

Considering that the payouts for exceptional performance have been less than 2% for several years now, it’s hard to justify dedicating resources to achieve perfection. Experts believe that even exceptional performance will only be worth pennies in bonus payments.

The fear of the stick, therefore, may be the only motivation. And that is subjective, as physicians weigh the effort required versus just taking the hit on the penalty. But the penalty is substantial, and so even without the incentive, it’s important to participate at least at the threshold.

Fewer cost-sharing waivers. While the federal government’s payment policies have a major impact on reimbursement, other forces may have broader implications. Commercial payers have rolled back cost-sharing waivers, bringing to light the significant financial responsibility that patients have for their health care in the form of deductibles, coinsurance, and so forth.

More than a third of Americans had trouble paying their health care bills before the pandemic; as patients catch up with services that were postponed or delayed because of the pandemic, this may expose challenges for you. Patients with unpaid bills translate into your financial burden.

Virtual-first health plans. Patients may be seeking alternatives to avoid the frustrating cycle of unpaid medical bills. This may be a factor propelling another trend: Lower-cost virtual-first health plans such as Alignment Health have taken hold in the market. As the name implies, insurance coverage features telehealth that extends to in-person services if necessary.

These disruptors may have their hands at least somewhat tied, however. The market may not be able to fully embrace telemedicine until state licensure is addressed. Despite the federal regulatory relaxations, states still control the distribution of medical care through licensure requirements. Many are rolling back their pandemic-based emergency orders and only allowing licensed physicians to see patients in their state, even over telemedicine.

While seemingly frustrating for physicians who want to see patients over state lines, the delays imposed by states may actually have a welcome effect. If licensure migrates to the federal level, there are many implications. For the purposes of this article, the competitive landscape will become incredibly aggressive. You will need to compete with Amazon Care, Walmart, Cigna, and many other well-funded national players that would love nothing more than to launch a campaign to target the entire nation. Investors are eager to capture part of the nearly quarter-trillion-dollar market, with telemedicine at 38 times prepandemic levels and no signs of abating.

Increased competition for insurers. While the proposed drop in Medicare reimbursement is frustrating, keep a pulse on the fact that your patients may soon be lured by vendors like Amazon and others eager to gain access to physician payments. Instead of analyzing Federal Registers in the future, we may be assessing stock prices.

Consider, therefore, how to ensure that your digital front door is at least available, if not wide open, in the meantime. The nature of physician payments is surely changing.

Ms. Woodcock is president of Woodcock & Associates, Atlanta. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

Physicians are bracing for upcoming changes in reimbursement that may start within a few months. As doctors gear up for another wave of COVID, payment trends may not be the top priority, but some “uh oh” announcements in the fall of 2021 could have far-reaching implications that could affect your future.

The Centers for Medicare & Medicaid Services issued a proposed rule in the summer covering key aspects of physician payment. Although the rule contained some small bright lights, the most important changes proposed were far from welcome.

Here’s what could be in store:

1. The highly anticipated Medicare Physician Fee Schedule ruling confirmed a sweeping payment cut. The drive to maintain budget neutrality forced the federal agency to reduce Medicare payments, on average, by nearly 4%. Many physicians are outraged at the proposed cut.

2. More bad news for 2022: Sequestration will be back. Sequestration is the mandatory, pesky, negative 2% adjustment on all Medicare payments. It had been put on hold and is set to return at the beginning of 2022.

Essentially, sequestration reduces what Medicare pays its providers for health services, but Medicare beneficiaries bear no responsibility for the cost difference. To prevent further debt, CMS imposes financially on hospitals, physicians, and other health care providers.

The Health Resources and Services Administration has funds remaining to reimburse for all COVID-related testing, treatment, and vaccines provided to uninsured individuals. You can apply and be reimbursed at Medicare rates for these services when COVID is the primary diagnosis (or secondary in the case of pregnancy). Patients need not be American citizens for you to get paid.

3. Down to a nail-biter: The final ruling is expected in early November. The situation smacks of earlier days when physicians clung to a precipice, waiting in anticipation for a legislative body to save them from the dreaded income plunge. Indeed, we are slipping back to the decade-long period when Congress kept coming to the rescue simply to maintain the status quo.

Many anticipate a last-minute Congressional intervention to save the day, particularly in the midst of another COVID spike. The promises of a stable reimbursement system made possible by the Medicare Access and CHIP Reauthorization Act have been far from realized, and there are signs that the payment landscape is in the midst of a fundamental transformation.

Other changes proposed in the 1,747-page ruling include:
 

Positive:

• More telehealth services will be covered by Medicare, including home visits.
• Tele–mental health services got a big boost; many restrictions were removed so that now the patient’s home is considered a permissible originating site. It also allows for audio-only (no visual required) encounters; the audio-only allowance will extend to opioid use disorder treatment services. Phone treatment is covered.
• Permanent adoption of G2252: The 11- to 20-minute virtual check-in code wasn’t just a one-time payment but will be reimbursed in perpetuity.
• Boosts in reimbursement for chronic care and principal care management codes, which range on the basis of service but indicate a commitment to pay for care coordination.
• Clarification of roles and billing opportunities for split/shared visits, which occur if a physician and advanced practice provider see the same patient on a particular day. Prepare for new coding rules to include a modifier. Previously, the rules for billing were muddled, so transparency helps guide payment opportunities.
• Delay of the appropriate use criteria for advanced imaging for 1 (more) year, a welcome postponement of the ruling that carries a significant administrative burden.
• Physician assistants will be able to bill Medicare directly, and referrals to be made to medical nutrition therapy by a nontreating physician.
• A new approach to patient cost-sharing for colorectal cancer screenings will be phased in. This area has caused problems in the past when the physician identifies a need for additional services (for example, polyp removal by a gastroenterologist during routine colonoscopy).
•  

Not positive:

• Which specialties benefit and which get zapped? The anticipated impact by specialty ranges from hits to interventional radiologists (–9%) and vascular surgeons (–8%), to increases for family practitioners, hand surgeons, endocrinologists, and geriatricians, each estimated to gain a modest 2%. (The exception is portable x-ray supplier, with an estimated increase of 10%.) All other specialties fall in between.
• The proposed conversion factor for 2022 is $33.58, a 3.75% drop from the 2021 conversion factor of $34.89.

The proposed ruling also covered the Quality Payment Program, the overarching program of which the Merit-based Incentive Payment System (MIPS) is the main track for participation. The proposal incorporates additional episode-based cost measures as well as updates to quality indicators and improvement activities.

MIPS penalties. The stakes are higher now, with 9% penalties on the table for nonparticipants. The government offers physicians the ability to officially get out of the program in 2021 because of the COVID-19 pandemic, thereby staving off the steep penalty. The option, which is available through the end of the year, requires a simple application that can be completed on behalf of the entire practice. If you want out, now is the time to find and fill out that application.

Exempt from technology requirements. If the proposal is accepted, small practices – defined by CMS as 15 eligible clinicians or fewer – won’t have to file an annual application to reweight the “promoting interoperability” portion of the program. If acknowledged, small practices will automatically be exempt from the program’s technology section. That’s a big plus, as one of the many chief complaints from small practices is the onus of meeting the technology requirements, which include a security risk analysis, bi-directional health information exchange, public health reporting, and patient access to health information. Meeting the requirements is no small feat. That will only affect future years, so be sure to apply in 2021 if applicable for your practice.

Changes in MIPS. MIPS Value Pathways (MVPs) are anticipated for 2023, with the government releasing details about proposed models for heart disease, rheumatology, joint repair, and more. The MVPs are slated to take over the traditional MIPS by 2027.

The program will shift to 30% of your score coming from the “cost” category, which is based on the government’s analysis of a physician’s claims – and, if attributed, the claims of the patients for whom you care. This area is tricky to manage, but recognize that the costs under scrutiny are the expenses paid by Medicare on behalf of its patients.

In essence, Medicare is measuring the cost of your patients as compared with your colleagues’ costs (in the form of specialty-based benchmarks). Therefore, if you’re referring, or ordering, a more costly set of diagnostic tests, assessments, or interventions than your peers, you’ll be dinged.

However, physicians are more likely this year to flat out reject participation in the federal payment program. Payouts have been paltry and dismal to date, and the buzz is that physicians just don’t consider it worth the effort. Of course, clearing the threshold (which is proposed at 70 points next year) is a must to avoid the penalty, but don’t go crazy to get a perfect score as it won’t count for much. 2022 is the final year that there are any monies for exceptional performance.

Considering that the payouts for exceptional performance have been less than 2% for several years now, it’s hard to justify dedicating resources to achieve perfection. Experts believe that even exceptional performance will only be worth pennies in bonus payments.

The fear of the stick, therefore, may be the only motivation. And that is subjective, as physicians weigh the effort required versus just taking the hit on the penalty. But the penalty is substantial, and so even without the incentive, it’s important to participate at least at the threshold.

Fewer cost-sharing waivers. While the federal government’s payment policies have a major impact on reimbursement, other forces may have broader implications. Commercial payers have rolled back cost-sharing waivers, bringing to light the significant financial responsibility that patients have for their health care in the form of deductibles, coinsurance, and so forth.

More than a third of Americans had trouble paying their health care bills before the pandemic; as patients catch up with services that were postponed or delayed because of the pandemic, this may expose challenges for you. Patients with unpaid bills translate into your financial burden.

Virtual-first health plans. Patients may be seeking alternatives to avoid the frustrating cycle of unpaid medical bills. This may be a factor propelling another trend: Lower-cost virtual-first health plans such as Alignment Health have taken hold in the market. As the name implies, insurance coverage features telehealth that extends to in-person services if necessary.

These disruptors may have their hands at least somewhat tied, however. The market may not be able to fully embrace telemedicine until state licensure is addressed. Despite the federal regulatory relaxations, states still control the distribution of medical care through licensure requirements. Many are rolling back their pandemic-based emergency orders and only allowing licensed physicians to see patients in their state, even over telemedicine.

While seemingly frustrating for physicians who want to see patients over state lines, the delays imposed by states may actually have a welcome effect. If licensure migrates to the federal level, there are many implications. For the purposes of this article, the competitive landscape will become incredibly aggressive. You will need to compete with Amazon Care, Walmart, Cigna, and many other well-funded national players that would love nothing more than to launch a campaign to target the entire nation. Investors are eager to capture part of the nearly quarter-trillion-dollar market, with telemedicine at 38 times prepandemic levels and no signs of abating.

Increased competition for insurers. While the proposed drop in Medicare reimbursement is frustrating, keep a pulse on the fact that your patients may soon be lured by vendors like Amazon and others eager to gain access to physician payments. Instead of analyzing Federal Registers in the future, we may be assessing stock prices.

Consider, therefore, how to ensure that your digital front door is at least available, if not wide open, in the meantime. The nature of physician payments is surely changing.

Ms. Woodcock is president of Woodcock & Associates, Atlanta. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

Insurers Target Modifier -25

Modifier -25 allows reporting of both a minor procedure (ie, one with a 0- or 10-day global period) and a separate and distinct evaluation and management (E/M) service on the same date of service.¹ Because of the multicomplaint nature of dermatology, the ability to report a same-day procedure and an E/M service is critical for efficient, cost-effective, and patient-centered dermatologic care. However, it is well known that the use of modifier -25 has been under notable insurer scrutiny and is a common reason for medical record audits.^2,3 Some insurers have responded to increased utilization of modifier -25 by cutting reimbursement for claims that include both a procedure and an E/M service or by denying one of the services altogether.^4-6 The Centers for Medicare and Medicaid Services also have expressed concern about this coding combination with proposed cuts to reimbursement.⁷ Moreover, the Office of Inspector General has announced a work plan to investigate the frequent utilization of E/M codes and minor procedures by dermatologists.⁸ Clearly, modifier -25 is a continued target by insurers and regulators; therefore, dermatologists will want to make sure their coding and documentation meet all requirements and are updated for the new E/M codes for 2021.

The American Medical Association’s Current Procedural Terminology indicates that modifier -25 allows reporting of a “significant, separately identifiable evaluation and management service by the same physician or other qualified health care professional on the same day of a procedure or other service.”¹ Given that dermatology patients typically present with multiple concerns, dermatologists commonly evaluate and treat numerous conditions during one visit. Understanding what constitutes a separately identifiable E/M service is critical to bill accurately and to pass insurer audits.

Global Surgical Package

To appropriately bill both a procedure and an E/M service, the physician must indicate that the patient’s condition required an E/M service above and beyond the usual work of the procedure. The compilation of evaluation and work included in the payment for a procedure is called the global surgical package.⁹ In general, the global surgical package includes local or topical anesthesia; the surgical service/procedure itself; immediate postoperative care, including dictating the operative note; meeting/discussing the patient’s procedure with family and other physicians; and writing orders for the patient. For minor procedures (ie, those with either 0- or 10-day global periods), the surgical package also includes same-day E/M services associated with the decision to perform surgery. An appropriate history and physical examination as well as a discussion of the differential diagnosis, treatment options, and risk and benefits of treatment are all included in the payment of a minor procedure itself. Therefore, an evaluation to discuss a patient’s condition or change in condition, alternatives to treatment, or next steps after a diagnosis related to a treatment or diagnostic procedure should not be separately reported. Moreover, the fact that the patient is new to the physician is not in itself sufficient to allow reporting of an E/M service with these minor procedures. For major procedures (ie, those with 90-day postoperative periods), the decision for surgery is excluded from the global surgical package.

2021 E/M Codes Simplify Documentation

The biggest coding change of 2021 was the new E/M codes.¹⁰ Prior to this year, the descriptors of E/M services recognized 7 components to define the levels of E/M services¹¹: history and nature of the presenting problem; physical examination; medical decision-making (MDM); counseling; coordination of care; and time. Furthermore, history, physical examination, and MDM were all broken down into more granular elements that were summed to determine the level for each component; for example, the history of the presenting problem was defined as a chronological description of the development of the patient’s present illness, including the following elements: location, quality, severity, duration, timing, context, modifying factors, and associated signs and symptoms. Each of these categories would constitute bullet points to be summed to determine the level of history. Physical examination and MDM bullet points also would be summed to determine a proper coding level.¹¹ Understandably, this coding scheme was complicated and burdensome to medical providers.

The redefinition of the E/M codes for 2021 substantially simplified the determination of coding level and documentation.¹⁰ The revisions to the E/M office visit code descriptors and documentation standards are now centered around how physicians think and take care of patients and not on mandatory standards and checking boxes. The main changes involve MDM as the prime determinant of the coding level. Elements of MDM affecting coding for an outpatient or office visit now include only 3 components: the number and complexity of problems addressed in the encounter, the amount or complexity of data to be reviewed and analyzed, and the risk of complications or morbidity of patient management. Gone are the requirements from the earlier criteria requiring so many bullet points for the history, physical examination, and MDM.

Dermatologists may ask, “How does the new E/M coding structure affect reporting and documenting an E/M and a procedure on the same day?” The answer is that the determination of separate and distinct is basically unchanged with the new E/M codes; however, the documentation requirements for modifier -25 using the new E/M codes are simplified.

As always, the key to determining whether a separate and distinct E/M service was provided and subsequently documented is to deconstruct the medical note. All evaluation services associated with the procedure—making a clinical diagnosis or differential diagnosis, decision to perform surgery, and discussion of alternative treatments—should be removed from one’s documentation as shown in the example below. If a complete E/M service still exists, then an E/M may be billed in addition to the procedure. Physical examination of the treatment area is included in the surgical package. With the prior E/M criteria, physical examination of the procedural area could not be used again as a bullet point to count for the E/M level. However, with the new 2021 coding requirements, the documentation of a separate MDM will be sufficient to meet criteria because documentation of physical examination is not a requirement.

Modifier -25 Examples

Let’s examine a typical dermatologist medical note. An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. The patient also complains of a growing tender lesion on the left elbow of 2 months’ duration. Physical examination reveals a linear vesicular eruption on the left wrist and a tender hyperkeratotic papule on the left elbow. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed. The decision is made to perform a tangential biopsy of the lesion on the left elbow because of the suspicion for malignancy. The biopsy is performed the same day.

This case clearly illustrates performance of an E/M service in the treatment of rhus dermatitis, which is separate and distinct from the biopsy procedure; however, in evaluating whether the case meets the documentation requirements for modifier -25, the information in the medical note inclusive to the procedure’s global surgical package, including history associated with establishing the diagnosis, physical examination of the procedure area(s), and discussion of treatment options, is eliminated, leaving the following notes: An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed.

Because the physical examination of the body part (left arm) is included in the procedure’s global surgical package, the examination of the left wrist cannot be used as coding support for the E/M service. This makes a difference for coding level in the prior E/M coding requirements, which required examination bullet points. However, with the 2021 E/M codes, documentation of physical examination bullet points is irrelevant to the coding level. Therefore, qualifying for a modifier -25 claim is more straightforward in this case with the new code set. Because bullet points are not integral to the 2021 E/M codes, qualifying and properly documenting for a higher level of service will likely be more common in dermatology.

Final Thoughts

Frequent use of modifier -25 is a critical part of a high-quality and cost-effective dermatology practice. Same-day performance of minor procedures and E/M services allows for more rapid and efficient diagnosis and treatment of various conditions as well as minimizing unnecessary office visits. The new E/M codes for 2021 actually make the documentation of a separate and distinct E/M service less complicated because the bullet point requirements associated with the old E/M codes have been eliminated. Understanding how the new E/M code descriptors affect modifier -25 reporting and clear documentation of separate, distinct, and medically necessary E/M services will be needed due to increased insurer scrutiny and audits.

Insurers Target Modifier -25

Modifier -25 allows reporting of both a minor procedure (ie, one with a 0- or 10-day global period) and a separate and distinct evaluation and management (E/M) service on the same date of service.¹ Because of the multicomplaint nature of dermatology, the ability to report a same-day procedure and an E/M service is critical for efficient, cost-effective, and patient-centered dermatologic care. However, it is well known that the use of modifier -25 has been under notable insurer scrutiny and is a common reason for medical record audits.^2,3 Some insurers have responded to increased utilization of modifier -25 by cutting reimbursement for claims that include both a procedure and an E/M service or by denying one of the services altogether.^4-6 The Centers for Medicare and Medicaid Services also have expressed concern about this coding combination with proposed cuts to reimbursement.⁷ Moreover, the Office of Inspector General has announced a work plan to investigate the frequent utilization of E/M codes and minor procedures by dermatologists.⁸ Clearly, modifier -25 is a continued target by insurers and regulators; therefore, dermatologists will want to make sure their coding and documentation meet all requirements and are updated for the new E/M codes for 2021.

The American Medical Association’s Current Procedural Terminology indicates that modifier -25 allows reporting of a “significant, separately identifiable evaluation and management service by the same physician or other qualified health care professional on the same day of a procedure or other service.”¹ Given that dermatology patients typically present with multiple concerns, dermatologists commonly evaluate and treat numerous conditions during one visit. Understanding what constitutes a separately identifiable E/M service is critical to bill accurately and to pass insurer audits.

Global Surgical Package

To appropriately bill both a procedure and an E/M service, the physician must indicate that the patient’s condition required an E/M service above and beyond the usual work of the procedure. The compilation of evaluation and work included in the payment for a procedure is called the global surgical package.⁹ In general, the global surgical package includes local or topical anesthesia; the surgical service/procedure itself; immediate postoperative care, including dictating the operative note; meeting/discussing the patient’s procedure with family and other physicians; and writing orders for the patient. For minor procedures (ie, those with either 0- or 10-day global periods), the surgical package also includes same-day E/M services associated with the decision to perform surgery. An appropriate history and physical examination as well as a discussion of the differential diagnosis, treatment options, and risk and benefits of treatment are all included in the payment of a minor procedure itself. Therefore, an evaluation to discuss a patient’s condition or change in condition, alternatives to treatment, or next steps after a diagnosis related to a treatment or diagnostic procedure should not be separately reported. Moreover, the fact that the patient is new to the physician is not in itself sufficient to allow reporting of an E/M service with these minor procedures. For major procedures (ie, those with 90-day postoperative periods), the decision for surgery is excluded from the global surgical package.

2021 E/M Codes Simplify Documentation

The biggest coding change of 2021 was the new E/M codes.¹⁰ Prior to this year, the descriptors of E/M services recognized 7 components to define the levels of E/M services¹¹: history and nature of the presenting problem; physical examination; medical decision-making (MDM); counseling; coordination of care; and time. Furthermore, history, physical examination, and MDM were all broken down into more granular elements that were summed to determine the level for each component; for example, the history of the presenting problem was defined as a chronological description of the development of the patient’s present illness, including the following elements: location, quality, severity, duration, timing, context, modifying factors, and associated signs and symptoms. Each of these categories would constitute bullet points to be summed to determine the level of history. Physical examination and MDM bullet points also would be summed to determine a proper coding level.¹¹ Understandably, this coding scheme was complicated and burdensome to medical providers.

The redefinition of the E/M codes for 2021 substantially simplified the determination of coding level and documentation.¹⁰ The revisions to the E/M office visit code descriptors and documentation standards are now centered around how physicians think and take care of patients and not on mandatory standards and checking boxes. The main changes involve MDM as the prime determinant of the coding level. Elements of MDM affecting coding for an outpatient or office visit now include only 3 components: the number and complexity of problems addressed in the encounter, the amount or complexity of data to be reviewed and analyzed, and the risk of complications or morbidity of patient management. Gone are the requirements from the earlier criteria requiring so many bullet points for the history, physical examination, and MDM.

Dermatologists may ask, “How does the new E/M coding structure affect reporting and documenting an E/M and a procedure on the same day?” The answer is that the determination of separate and distinct is basically unchanged with the new E/M codes; however, the documentation requirements for modifier -25 using the new E/M codes are simplified.

As always, the key to determining whether a separate and distinct E/M service was provided and subsequently documented is to deconstruct the medical note. All evaluation services associated with the procedure—making a clinical diagnosis or differential diagnosis, decision to perform surgery, and discussion of alternative treatments—should be removed from one’s documentation as shown in the example below. If a complete E/M service still exists, then an E/M may be billed in addition to the procedure. Physical examination of the treatment area is included in the surgical package. With the prior E/M criteria, physical examination of the procedural area could not be used again as a bullet point to count for the E/M level. However, with the new 2021 coding requirements, the documentation of a separate MDM will be sufficient to meet criteria because documentation of physical examination is not a requirement.

Modifier -25 Examples

Let’s examine a typical dermatologist medical note. An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. The patient also complains of a growing tender lesion on the left elbow of 2 months’ duration. Physical examination reveals a linear vesicular eruption on the left wrist and a tender hyperkeratotic papule on the left elbow. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed. The decision is made to perform a tangential biopsy of the lesion on the left elbow because of the suspicion for malignancy. The biopsy is performed the same day.

This case clearly illustrates performance of an E/M service in the treatment of rhus dermatitis, which is separate and distinct from the biopsy procedure; however, in evaluating whether the case meets the documentation requirements for modifier -25, the information in the medical note inclusive to the procedure’s global surgical package, including history associated with establishing the diagnosis, physical examination of the procedure area(s), and discussion of treatment options, is eliminated, leaving the following notes: An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed.

Because the physical examination of the body part (left arm) is included in the procedure’s global surgical package, the examination of the left wrist cannot be used as coding support for the E/M service. This makes a difference for coding level in the prior E/M coding requirements, which required examination bullet points. However, with the 2021 E/M codes, documentation of physical examination bullet points is irrelevant to the coding level. Therefore, qualifying for a modifier -25 claim is more straightforward in this case with the new code set. Because bullet points are not integral to the 2021 E/M codes, qualifying and properly documenting for a higher level of service will likely be more common in dermatology.

Final Thoughts

Frequent use of modifier -25 is a critical part of a high-quality and cost-effective dermatology practice. Same-day performance of minor procedures and E/M services allows for more rapid and efficient diagnosis and treatment of various conditions as well as minimizing unnecessary office visits. The new E/M codes for 2021 actually make the documentation of a separate and distinct E/M service less complicated because the bullet point requirements associated with the old E/M codes have been eliminated. Understanding how the new E/M code descriptors affect modifier -25 reporting and clear documentation of separate, distinct, and medically necessary E/M services will be needed due to increased insurer scrutiny and audits.

Insurers Target Modifier -25

Modifier -25 allows reporting of both a minor procedure (ie, one with a 0- or 10-day global period) and a separate and distinct evaluation and management (E/M) service on the same date of service.¹ Because of the multicomplaint nature of dermatology, the ability to report a same-day procedure and an E/M service is critical for efficient, cost-effective, and patient-centered dermatologic care. However, it is well known that the use of modifier -25 has been under notable insurer scrutiny and is a common reason for medical record audits.^2,3 Some insurers have responded to increased utilization of modifier -25 by cutting reimbursement for claims that include both a procedure and an E/M service or by denying one of the services altogether.^4-6 The Centers for Medicare and Medicaid Services also have expressed concern about this coding combination with proposed cuts to reimbursement.⁷ Moreover, the Office of Inspector General has announced a work plan to investigate the frequent utilization of E/M codes and minor procedures by dermatologists.⁸ Clearly, modifier -25 is a continued target by insurers and regulators; therefore, dermatologists will want to make sure their coding and documentation meet all requirements and are updated for the new E/M codes for 2021.

The American Medical Association’s Current Procedural Terminology indicates that modifier -25 allows reporting of a “significant, separately identifiable evaluation and management service by the same physician or other qualified health care professional on the same day of a procedure or other service.”¹ Given that dermatology patients typically present with multiple concerns, dermatologists commonly evaluate and treat numerous conditions during one visit. Understanding what constitutes a separately identifiable E/M service is critical to bill accurately and to pass insurer audits.

Global Surgical Package

To appropriately bill both a procedure and an E/M service, the physician must indicate that the patient’s condition required an E/M service above and beyond the usual work of the procedure. The compilation of evaluation and work included in the payment for a procedure is called the global surgical package.⁹ In general, the global surgical package includes local or topical anesthesia; the surgical service/procedure itself; immediate postoperative care, including dictating the operative note; meeting/discussing the patient’s procedure with family and other physicians; and writing orders for the patient. For minor procedures (ie, those with either 0- or 10-day global periods), the surgical package also includes same-day E/M services associated with the decision to perform surgery. An appropriate history and physical examination as well as a discussion of the differential diagnosis, treatment options, and risk and benefits of treatment are all included in the payment of a minor procedure itself. Therefore, an evaluation to discuss a patient’s condition or change in condition, alternatives to treatment, or next steps after a diagnosis related to a treatment or diagnostic procedure should not be separately reported. Moreover, the fact that the patient is new to the physician is not in itself sufficient to allow reporting of an E/M service with these minor procedures. For major procedures (ie, those with 90-day postoperative periods), the decision for surgery is excluded from the global surgical package.

2021 E/M Codes Simplify Documentation

The biggest coding change of 2021 was the new E/M codes.¹⁰ Prior to this year, the descriptors of E/M services recognized 7 components to define the levels of E/M services¹¹: history and nature of the presenting problem; physical examination; medical decision-making (MDM); counseling; coordination of care; and time. Furthermore, history, physical examination, and MDM were all broken down into more granular elements that were summed to determine the level for each component; for example, the history of the presenting problem was defined as a chronological description of the development of the patient’s present illness, including the following elements: location, quality, severity, duration, timing, context, modifying factors, and associated signs and symptoms. Each of these categories would constitute bullet points to be summed to determine the level of history. Physical examination and MDM bullet points also would be summed to determine a proper coding level.¹¹ Understandably, this coding scheme was complicated and burdensome to medical providers.

The redefinition of the E/M codes for 2021 substantially simplified the determination of coding level and documentation.¹⁰ The revisions to the E/M office visit code descriptors and documentation standards are now centered around how physicians think and take care of patients and not on mandatory standards and checking boxes. The main changes involve MDM as the prime determinant of the coding level. Elements of MDM affecting coding for an outpatient or office visit now include only 3 components: the number and complexity of problems addressed in the encounter, the amount or complexity of data to be reviewed and analyzed, and the risk of complications or morbidity of patient management. Gone are the requirements from the earlier criteria requiring so many bullet points for the history, physical examination, and MDM.

Dermatologists may ask, “How does the new E/M coding structure affect reporting and documenting an E/M and a procedure on the same day?” The answer is that the determination of separate and distinct is basically unchanged with the new E/M codes; however, the documentation requirements for modifier -25 using the new E/M codes are simplified.

As always, the key to determining whether a separate and distinct E/M service was provided and subsequently documented is to deconstruct the medical note. All evaluation services associated with the procedure—making a clinical diagnosis or differential diagnosis, decision to perform surgery, and discussion of alternative treatments—should be removed from one’s documentation as shown in the example below. If a complete E/M service still exists, then an E/M may be billed in addition to the procedure. Physical examination of the treatment area is included in the surgical package. With the prior E/M criteria, physical examination of the procedural area could not be used again as a bullet point to count for the E/M level. However, with the new 2021 coding requirements, the documentation of a separate MDM will be sufficient to meet criteria because documentation of physical examination is not a requirement.

Modifier -25 Examples

Let’s examine a typical dermatologist medical note. An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. The patient also complains of a growing tender lesion on the left elbow of 2 months’ duration. Physical examination reveals a linear vesicular eruption on the left wrist and a tender hyperkeratotic papule on the left elbow. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed. The decision is made to perform a tangential biopsy of the lesion on the left elbow because of the suspicion for malignancy. The biopsy is performed the same day.

This case clearly illustrates performance of an E/M service in the treatment of rhus dermatitis, which is separate and distinct from the biopsy procedure; however, in evaluating whether the case meets the documentation requirements for modifier -25, the information in the medical note inclusive to the procedure’s global surgical package, including history associated with establishing the diagnosis, physical examination of the procedure area(s), and discussion of treatment options, is eliminated, leaving the following notes: An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed.

Because the physical examination of the body part (left arm) is included in the procedure’s global surgical package, the examination of the left wrist cannot be used as coding support for the E/M service. This makes a difference for coding level in the prior E/M coding requirements, which required examination bullet points. However, with the 2021 E/M codes, documentation of physical examination bullet points is irrelevant to the coding level. Therefore, qualifying for a modifier -25 claim is more straightforward in this case with the new code set. Because bullet points are not integral to the 2021 E/M codes, qualifying and properly documenting for a higher level of service will likely be more common in dermatology.

Final Thoughts

Frequent use of modifier -25 is a critical part of a high-quality and cost-effective dermatology practice. Same-day performance of minor procedures and E/M services allows for more rapid and efficient diagnosis and treatment of various conditions as well as minimizing unnecessary office visits. The new E/M codes for 2021 actually make the documentation of a separate and distinct E/M service less complicated because the bullet point requirements associated with the old E/M codes have been eliminated. Understanding how the new E/M code descriptors affect modifier -25 reporting and clear documentation of separate, distinct, and medically necessary E/M services will be needed due to increased insurer scrutiny and audits.

This fall, the Supreme Court of the United States (SCOTUS) will announce when they will hear oral arguments for Dobbs v Jackson Women’s Health Organization. The court will examine a Mississippi law, known as the “Gestational Age Act,” originally passed in 2018, that sought to “limit abortions to fifteen weeks’ gestation except in a medical emergency or in cases of severe fetal abnormality.”¹ This sets the stage for SCOTUS to make a major ruling on abortion, one which could affirm or upend landmark decisions and nearly 50 years of abortion legislative precedent. Additionally, SCOTUS’ recent decision to not intervene on Texas’ Senate Bill 8 (SB8), which essentially bans all abortions after 6 weeks’ gestational age, may foreshadow how this case will be decided. The current abortion restrictions in Texas and the implications of SB8 will be discussed in a forthcoming column.

SCOTUS and abortion rights

The decision to hear this case comes on the heels of another recent decision regarding a Louisiana law in June Medical Services v Russo. This case examined Louisiana Act 620, which would have required physicians to have hospital admitting privileges within 30 miles of where they provide abortion services.² The law was deemed constitutionally invalid, with the majority noting the law would have drastically burdened a woman’s right to access abortion services. The Court ruled similarly in 2016 in Whole Women’s Health (WWH) v Hellerstedt, in which WWH challenged Texas House Bill 2, a nearly identical law requiring admitting privileges for abortion care providers. In both of these cases, SCOTUS pointed to precedent set by Southeastern Pennsylvania v Casey, which established that it is unconstitutional for a state to create an “undue burden” on a woman’s right to abortion prior to fetal viability.³ The precedent to this, Roe v Wade, and 5 decades of abortion legislation set may be upended by a SCOTUS decision this next term.

Dobbs v Jackson

On March 19, 2018, Mississippi enacted the “Gestational Age Act” into law. The newly enacted law would limit abortions to 15 weeks’ gestation except in a medical emergency or in cases of severe fetal anomalies. Jackson Women’s Health Organization, the only licensed abortion provider in the state, challenged the constitutionality of the law with legal support from Center for Reproductive Rights (CRR). The US District Court for the Southern District of Mississippi granted summary judgement in favor of the clinic and placed an injunction on the law’s enforcement. The state appealed to the Fifth Circuit Court of Appeals, which upheld the district court decision in a 3-0 decision in November 2019. Mississippi appealed to the Supreme Court, with their petition focusing on multiple questions from the appeals process. After repeatedly rescheduling the case, and multiple reviews in conference, SCOTUS agreed to hear the case. Most recently, the state has narrowed its argument, changing course, and attacking Roe v Wade directly. In a brief submitted in July 2021, the state argues the court should hold that all pre-viability prohibitions on elective abortions are constitutional.

Interestingly, during this time the Mississippi legislature also passed a law, House Bill 2116, also known as the “fetal heartbeat bill,” banning abortion with gestational ages after detection of a fetal heartbeat. This was also challenged, deemed unconstitutional, and affirmed on appeal by the Fifth US Circuit Court.

While recent challenges have focused on the “undue burden” state laws placed on those trying to access abortion care, this case will bring the issue of “viability” and gestational age limits to the forefront.^4,5 In addition to Roe v Wade, the Court will have the opportunity to reexamine other relevant precedent, such as Southeastern Pennsylvania v Casey, in considering the most recent arguments of the state. In this most recent brief, the state argues that the Court should, “reject viability as a barrier to prohibiting elective abortions” and that a “viability rule has no constitutional basis.” The state goes on to argue the “Constitution does not protect a right to abortion or limit States’ authority to restrict it.”⁶ The language and tone in this brief are more direct and aggressive than the states’ petition submitted last June.

However, the composition of the Court is different than in the past. This case will be argued with Justice Amy Coney Barrett seated in place of Justice Ruth Bader Ginsburg, who was a strong advocate for women’s rights.⁷ She joins Justices Neil Gorsuch and Brett Kavanaugh, also appointed by President Donald Trump and widely viewed as conservative judges, tipping the scales to a more conservative Supreme Court. This case will also be argued in a polarized political environment.^8,9 Given the conservative Supreme Court in the setting of an increasingly politically charged environment, reproductive right advocates are understandably worried that members of the anti-abortion movement view this as an opportunity to weaken or remove federal constitutional protections for abortion.

Continue to: Potential outcome of Dobbs v Jackson...

 

 

Potential outcome of Dobbs v Jackson

Should SCOTUS choose to rule in favor of Mississippi, it could severely weaken, or even overturn Roe v Wade. This would leave a legal path for states with pre-Roe abortion bans and currently unenforced post-Roe bans to take effect. These “trigger” laws are bans or severe restrictions on abortion providers and patients intended to take effect if Roe were to be overturned. Alternatively, the Court may overturn Southeastern Pennsylvania v Casey, but maintain Roe v Wade, essentially leaving the regulation of pre-viability abortion care to individual states. Currently 21 states have laws that would restrict the legal status of abortion.¹⁰ In addition, state legislatures are aggressively introducing abortion restrictions. As of June 2021, there have been 561 abortion restrictions, including 165 abortion bans, introduced across 47 states, putting 2021 on course to be the most devastating anti-abortion state legislative session in decades.¹¹

The damage caused by such restriction on abortion care would be significant. It would block or push access out of reach for many. The negative effects of such legislative action would most heavily burden those already marginalized by systemic, structural inequalities including those of low socioeconomic status, people of color, young people, those in rural communities, and members of the LGBTQ community. The medical community has long recognized the harm caused by restricting access to abortion care. Restriction of access to safe abortion care paradoxically has been shown not to decrease the incidence of abortion, but rather increases the number of unsafe abortions.¹² The American College of Obstetricians and Gynecologists (ACOG) acknowledge “individuals require access to safe, legal abortion” and that this represents “a necessary component for comprehensive health care.”^13,14 They joined the American Medical Association and other professional groups in a 2019 amicus brief to SCOTUS opposing restrictions on abortion access.¹⁵ In addition, government laws restricting access to abortion care undermine the fundamental relationship between a person and their physician, limiting a physician’s obligation to honor patient autonomy and provide appropriate medical care.

By taking up the question whether all pre-viability bans on elective abortions violate the Constitution, SCOTUS is indicating a possible willingness to revisit the central holding of abortion jurisprudence. Their decision regarding this case will likely be the most significant ruling regarding the legal status of abortion care in decades, and will significantly affect the delivery of abortion care in the future.

Action items

• Reach out to your representatives to support the Women’s Health Protection Act, an initiative introduced to Congress to protect access to abortion care. If you reside in a state where your federal representatives support the Women’s Health Protection Act, reach out to friends and colleagues in states without supportive elected officials and ask them to call their representatives and ask them to support the bill.
• Get involved with local grassroots groups fighting to protect abortion access.
• Continue to speak out against laws and policies designed to limit access to safe abortion care.
• Connect with your local ACOG chapter for more ways to become involved.
• As always, make sure you are registered to vote, and exercise your right whenever you can.

This fall, the Supreme Court of the United States (SCOTUS) will announce when they will hear oral arguments for Dobbs v Jackson Women’s Health Organization. The court will examine a Mississippi law, known as the “Gestational Age Act,” originally passed in 2018, that sought to “limit abortions to fifteen weeks’ gestation except in a medical emergency or in cases of severe fetal abnormality.”¹ This sets the stage for SCOTUS to make a major ruling on abortion, one which could affirm or upend landmark decisions and nearly 50 years of abortion legislative precedent. Additionally, SCOTUS’ recent decision to not intervene on Texas’ Senate Bill 8 (SB8), which essentially bans all abortions after 6 weeks’ gestational age, may foreshadow how this case will be decided. The current abortion restrictions in Texas and the implications of SB8 will be discussed in a forthcoming column.

SCOTUS and abortion rights

The decision to hear this case comes on the heels of another recent decision regarding a Louisiana law in June Medical Services v Russo. This case examined Louisiana Act 620, which would have required physicians to have hospital admitting privileges within 30 miles of where they provide abortion services.² The law was deemed constitutionally invalid, with the majority noting the law would have drastically burdened a woman’s right to access abortion services. The Court ruled similarly in 2016 in Whole Women’s Health (WWH) v Hellerstedt, in which WWH challenged Texas House Bill 2, a nearly identical law requiring admitting privileges for abortion care providers. In both of these cases, SCOTUS pointed to precedent set by Southeastern Pennsylvania v Casey, which established that it is unconstitutional for a state to create an “undue burden” on a woman’s right to abortion prior to fetal viability.³ The precedent to this, Roe v Wade, and 5 decades of abortion legislation set may be upended by a SCOTUS decision this next term.

Dobbs v Jackson

On March 19, 2018, Mississippi enacted the “Gestational Age Act” into law. The newly enacted law would limit abortions to 15 weeks’ gestation except in a medical emergency or in cases of severe fetal anomalies. Jackson Women’s Health Organization, the only licensed abortion provider in the state, challenged the constitutionality of the law with legal support from Center for Reproductive Rights (CRR). The US District Court for the Southern District of Mississippi granted summary judgement in favor of the clinic and placed an injunction on the law’s enforcement. The state appealed to the Fifth Circuit Court of Appeals, which upheld the district court decision in a 3-0 decision in November 2019. Mississippi appealed to the Supreme Court, with their petition focusing on multiple questions from the appeals process. After repeatedly rescheduling the case, and multiple reviews in conference, SCOTUS agreed to hear the case. Most recently, the state has narrowed its argument, changing course, and attacking Roe v Wade directly. In a brief submitted in July 2021, the state argues the court should hold that all pre-viability prohibitions on elective abortions are constitutional.

Interestingly, during this time the Mississippi legislature also passed a law, House Bill 2116, also known as the “fetal heartbeat bill,” banning abortion with gestational ages after detection of a fetal heartbeat. This was also challenged, deemed unconstitutional, and affirmed on appeal by the Fifth US Circuit Court.

While recent challenges have focused on the “undue burden” state laws placed on those trying to access abortion care, this case will bring the issue of “viability” and gestational age limits to the forefront.^4,5 In addition to Roe v Wade, the Court will have the opportunity to reexamine other relevant precedent, such as Southeastern Pennsylvania v Casey, in considering the most recent arguments of the state. In this most recent brief, the state argues that the Court should, “reject viability as a barrier to prohibiting elective abortions” and that a “viability rule has no constitutional basis.” The state goes on to argue the “Constitution does not protect a right to abortion or limit States’ authority to restrict it.”⁶ The language and tone in this brief are more direct and aggressive than the states’ petition submitted last June.

However, the composition of the Court is different than in the past. This case will be argued with Justice Amy Coney Barrett seated in place of Justice Ruth Bader Ginsburg, who was a strong advocate for women’s rights.⁷ She joins Justices Neil Gorsuch and Brett Kavanaugh, also appointed by President Donald Trump and widely viewed as conservative judges, tipping the scales to a more conservative Supreme Court. This case will also be argued in a polarized political environment.^8,9 Given the conservative Supreme Court in the setting of an increasingly politically charged environment, reproductive right advocates are understandably worried that members of the anti-abortion movement view this as an opportunity to weaken or remove federal constitutional protections for abortion.

Continue to: Potential outcome of Dobbs v Jackson...

 

 

Potential outcome of Dobbs v Jackson

Should SCOTUS choose to rule in favor of Mississippi, it could severely weaken, or even overturn Roe v Wade. This would leave a legal path for states with pre-Roe abortion bans and currently unenforced post-Roe bans to take effect. These “trigger” laws are bans or severe restrictions on abortion providers and patients intended to take effect if Roe were to be overturned. Alternatively, the Court may overturn Southeastern Pennsylvania v Casey, but maintain Roe v Wade, essentially leaving the regulation of pre-viability abortion care to individual states. Currently 21 states have laws that would restrict the legal status of abortion.¹⁰ In addition, state legislatures are aggressively introducing abortion restrictions. As of June 2021, there have been 561 abortion restrictions, including 165 abortion bans, introduced across 47 states, putting 2021 on course to be the most devastating anti-abortion state legislative session in decades.¹¹

The damage caused by such restriction on abortion care would be significant. It would block or push access out of reach for many. The negative effects of such legislative action would most heavily burden those already marginalized by systemic, structural inequalities including those of low socioeconomic status, people of color, young people, those in rural communities, and members of the LGBTQ community. The medical community has long recognized the harm caused by restricting access to abortion care. Restriction of access to safe abortion care paradoxically has been shown not to decrease the incidence of abortion, but rather increases the number of unsafe abortions.¹² The American College of Obstetricians and Gynecologists (ACOG) acknowledge “individuals require access to safe, legal abortion” and that this represents “a necessary component for comprehensive health care.”^13,14 They joined the American Medical Association and other professional groups in a 2019 amicus brief to SCOTUS opposing restrictions on abortion access.¹⁵ In addition, government laws restricting access to abortion care undermine the fundamental relationship between a person and their physician, limiting a physician’s obligation to honor patient autonomy and provide appropriate medical care.

By taking up the question whether all pre-viability bans on elective abortions violate the Constitution, SCOTUS is indicating a possible willingness to revisit the central holding of abortion jurisprudence. Their decision regarding this case will likely be the most significant ruling regarding the legal status of abortion care in decades, and will significantly affect the delivery of abortion care in the future.

Action items

• Reach out to your representatives to support the Women’s Health Protection Act, an initiative introduced to Congress to protect access to abortion care. If you reside in a state where your federal representatives support the Women’s Health Protection Act, reach out to friends and colleagues in states without supportive elected officials and ask them to call their representatives and ask them to support the bill.
• Get involved with local grassroots groups fighting to protect abortion access.
• Continue to speak out against laws and policies designed to limit access to safe abortion care.
• Connect with your local ACOG chapter for more ways to become involved.
• As always, make sure you are registered to vote, and exercise your right whenever you can.

This fall, the Supreme Court of the United States (SCOTUS) will announce when they will hear oral arguments for Dobbs v Jackson Women’s Health Organization. The court will examine a Mississippi law, known as the “Gestational Age Act,” originally passed in 2018, that sought to “limit abortions to fifteen weeks’ gestation except in a medical emergency or in cases of severe fetal abnormality.”¹ This sets the stage for SCOTUS to make a major ruling on abortion, one which could affirm or upend landmark decisions and nearly 50 years of abortion legislative precedent. Additionally, SCOTUS’ recent decision to not intervene on Texas’ Senate Bill 8 (SB8), which essentially bans all abortions after 6 weeks’ gestational age, may foreshadow how this case will be decided. The current abortion restrictions in Texas and the implications of SB8 will be discussed in a forthcoming column.

SCOTUS and abortion rights

The decision to hear this case comes on the heels of another recent decision regarding a Louisiana law in June Medical Services v Russo. This case examined Louisiana Act 620, which would have required physicians to have hospital admitting privileges within 30 miles of where they provide abortion services.² The law was deemed constitutionally invalid, with the majority noting the law would have drastically burdened a woman’s right to access abortion services. The Court ruled similarly in 2016 in Whole Women’s Health (WWH) v Hellerstedt, in which WWH challenged Texas House Bill 2, a nearly identical law requiring admitting privileges for abortion care providers. In both of these cases, SCOTUS pointed to precedent set by Southeastern Pennsylvania v Casey, which established that it is unconstitutional for a state to create an “undue burden” on a woman’s right to abortion prior to fetal viability.³ The precedent to this, Roe v Wade, and 5 decades of abortion legislation set may be upended by a SCOTUS decision this next term.

Dobbs v Jackson

On March 19, 2018, Mississippi enacted the “Gestational Age Act” into law. The newly enacted law would limit abortions to 15 weeks’ gestation except in a medical emergency or in cases of severe fetal anomalies. Jackson Women’s Health Organization, the only licensed abortion provider in the state, challenged the constitutionality of the law with legal support from Center for Reproductive Rights (CRR). The US District Court for the Southern District of Mississippi granted summary judgement in favor of the clinic and placed an injunction on the law’s enforcement. The state appealed to the Fifth Circuit Court of Appeals, which upheld the district court decision in a 3-0 decision in November 2019. Mississippi appealed to the Supreme Court, with their petition focusing on multiple questions from the appeals process. After repeatedly rescheduling the case, and multiple reviews in conference, SCOTUS agreed to hear the case. Most recently, the state has narrowed its argument, changing course, and attacking Roe v Wade directly. In a brief submitted in July 2021, the state argues the court should hold that all pre-viability prohibitions on elective abortions are constitutional.

Interestingly, during this time the Mississippi legislature also passed a law, House Bill 2116, also known as the “fetal heartbeat bill,” banning abortion with gestational ages after detection of a fetal heartbeat. This was also challenged, deemed unconstitutional, and affirmed on appeal by the Fifth US Circuit Court.

While recent challenges have focused on the “undue burden” state laws placed on those trying to access abortion care, this case will bring the issue of “viability” and gestational age limits to the forefront.^4,5 In addition to Roe v Wade, the Court will have the opportunity to reexamine other relevant precedent, such as Southeastern Pennsylvania v Casey, in considering the most recent arguments of the state. In this most recent brief, the state argues that the Court should, “reject viability as a barrier to prohibiting elective abortions” and that a “viability rule has no constitutional basis.” The state goes on to argue the “Constitution does not protect a right to abortion or limit States’ authority to restrict it.”⁶ The language and tone in this brief are more direct and aggressive than the states’ petition submitted last June.

However, the composition of the Court is different than in the past. This case will be argued with Justice Amy Coney Barrett seated in place of Justice Ruth Bader Ginsburg, who was a strong advocate for women’s rights.⁷ She joins Justices Neil Gorsuch and Brett Kavanaugh, also appointed by President Donald Trump and widely viewed as conservative judges, tipping the scales to a more conservative Supreme Court. This case will also be argued in a polarized political environment.^8,9 Given the conservative Supreme Court in the setting of an increasingly politically charged environment, reproductive right advocates are understandably worried that members of the anti-abortion movement view this as an opportunity to weaken or remove federal constitutional protections for abortion.

Continue to: Potential outcome of Dobbs v Jackson...

 

 

Potential outcome of Dobbs v Jackson

Should SCOTUS choose to rule in favor of Mississippi, it could severely weaken, or even overturn Roe v Wade. This would leave a legal path for states with pre-Roe abortion bans and currently unenforced post-Roe bans to take effect. These “trigger” laws are bans or severe restrictions on abortion providers and patients intended to take effect if Roe were to be overturned. Alternatively, the Court may overturn Southeastern Pennsylvania v Casey, but maintain Roe v Wade, essentially leaving the regulation of pre-viability abortion care to individual states. Currently 21 states have laws that would restrict the legal status of abortion.¹⁰ In addition, state legislatures are aggressively introducing abortion restrictions. As of June 2021, there have been 561 abortion restrictions, including 165 abortion bans, introduced across 47 states, putting 2021 on course to be the most devastating anti-abortion state legislative session in decades.¹¹

The damage caused by such restriction on abortion care would be significant. It would block or push access out of reach for many. The negative effects of such legislative action would most heavily burden those already marginalized by systemic, structural inequalities including those of low socioeconomic status, people of color, young people, those in rural communities, and members of the LGBTQ community. The medical community has long recognized the harm caused by restricting access to abortion care. Restriction of access to safe abortion care paradoxically has been shown not to decrease the incidence of abortion, but rather increases the number of unsafe abortions.¹² The American College of Obstetricians and Gynecologists (ACOG) acknowledge “individuals require access to safe, legal abortion” and that this represents “a necessary component for comprehensive health care.”^13,14 They joined the American Medical Association and other professional groups in a 2019 amicus brief to SCOTUS opposing restrictions on abortion access.¹⁵ In addition, government laws restricting access to abortion care undermine the fundamental relationship between a person and their physician, limiting a physician’s obligation to honor patient autonomy and provide appropriate medical care.

By taking up the question whether all pre-viability bans on elective abortions violate the Constitution, SCOTUS is indicating a possible willingness to revisit the central holding of abortion jurisprudence. Their decision regarding this case will likely be the most significant ruling regarding the legal status of abortion care in decades, and will significantly affect the delivery of abortion care in the future.

Action items

• Reach out to your representatives to support the Women’s Health Protection Act, an initiative introduced to Congress to protect access to abortion care. If you reside in a state where your federal representatives support the Women’s Health Protection Act, reach out to friends and colleagues in states without supportive elected officials and ask them to call their representatives and ask them to support the bill.
• Get involved with local grassroots groups fighting to protect abortion access.
• Continue to speak out against laws and policies designed to limit access to safe abortion care.
• Connect with your local ACOG chapter for more ways to become involved.
• As always, make sure you are registered to vote, and exercise your right whenever you can.

After making an insulting comment to a surgery scheduler, a surgeon become the subject of a peer review investigation.

The surgeon had been called in on a Saturday morning for surgery, but when he arrived at the hospital, staff informed him that the operating room had been incorrectly booked and asked him to come back that afternoon. When the surgeon returned, the room still wasn’t ready, recounted David Beran, DO, a peer reviewer and medical director for the emergency department at University Medical Center New Orleans, in Louisiana. After more waiting and staff uncertainty about which operating room was going to open, the surgeon became frustrated and said to the scheduler: “Any idiot could figure this out!”

During his peer review, the surgeon acknowledged that he shouldn’t have made the rude remark to the scheduler, Dr. Beran said. His exasperation stemmed from an ongoing problem – operating rooms at the hospital were being inefficiently managed.

“The surgeon acknowledged that even though there was a systems issue at the root, that’s not justification to speak to people unprofessionally,” Dr. Beran said. “So, there was education for the surgeon, but the surgeon was also able to explain the frustration that led to that point.”

System problems are commonly encountered by peer reviewers, said Dr. Beran.

“There’s a huge gap between administration and clinical professionals when it comes to peer review,” he said. “So many times, bad situations, whether they’re clinical or behavioral, often boil down to systems issues or some inadequacy, whether it’s an EMR [electronic medical record] problem, an inefficacy, or how complicated a process is for an end user. But having a peer review situation that then leads to a system-level change that prevents that problem from happening again is really unlikely. There’s a huge disconnect between those two.”

Peer review is generally a process that goes on behind closed doors. Although structures may differ, peer review is generally described as the process by which physicians assess the quality of their peers’ work to ensure that standards of care are being met. The process is often used to evaluate issues regarding clinical care as well as behavioral complaints against physicians.

Doctors who undergo peer review frequently share their experiences, but reviewers themselves rarely speak out. For this story, this news organization spoke with several current and former peer reviewers about what really goes on during peer reviews, what frustrates them, and what they’ve learned along the way.

“Peer review processes are in place to build stronger institutions and stronger practices, and they’re supposed to be helpful,” Dr. Beran said. “But because of how opaque they are, it immediately puts physicians on the defensive, and it doesn’t always succeed in what it’s trying to do. I think that’s one of the biggest challenges.”
 

Biased reviewers taint evaluations

A peer reviewer on and off throughout her career, Indiana family physician Lana Patch, MD, said she always strived to be fair when evaluating fellow physicians. But not every reviewer she encountered operated the same way, she said. Some were biased.

In one case, Dr. Patch peer reviewed a general surgeon who had performed a hysterectomy on a 16-year-old girl. The surgeon believed the teenager likely had an acute appendicitis, but it turned out she had a uterine pathology, Dr. Patch said. The surgeon saved the girl’s life, but the case came under review because of the patient’s age and the fact that her uterus was removed. A local obstetrician-gynecologist weighed in on the case.

“The local ob.gyn. saw it as a turf battle,” recalled Dr. Patch, who is now retired after 30 years of practice in eastern Indiana. “The doctor had nothing but bad to say about the surgeon. He was a competitor.”

Because it was a small hospital, the committee sometimes had trouble finding a specialist who was qualified to give an opinion and who wasn’t in competition with the physician in question, said Dr. Patch. Eventually they found an outside pediatric gynecologist who reviewed the case and concluded that the surgeon had followed the standard of care.

Personal agendas in can come from different directions, said Robert Marder, MD, the author of several books on peer review. Dr. Marder is a consultant who assists with peer review redesign. He has worked with hundreds of medical staff leaders and is a former vice president at the Greeley Company, a consulting firm in Danvers, Mass., that performs peer review redesign. Dr. Marder is president of Robert J. Marder Consulting.

“It goes both ways,” Dr. Marder said. “I’ve seen where somebody with a personal view decides to bring things to the peer review committee specifically because they want the peer review committee to have an adverse view of this person and get them off the medical staff. And I’ve seen hospitals that are uncomfortable with a certain person for whatever reason and want the peer review committee to address it, as opposed to addressing it from a human resource standpoint.”

Dr. Patch recalled a case in which reviewers and hospital leaders were at odds over the credentialing of a physician. Fifteen years earlier, while driving in California, the psychiatrist had been pulled over and was found with an ounce of marijuana, she said.

“We wanted to privilege him,” Dr. Patch said. “As staff physicians, we felt that was 15 years ago, people change over time. Doctors are human beings, too. He seemed to have good credentials and good training. The hospital said, ‘Oh no, we can’t have somebody like this.’ “

The psychiatrist was placed on probation and had to undergo a review every 90 days for about 3 years. Eventually, he was privileged, Dr. Patch said.

Bias among reviewers, including unintentional bias, is also a challenge, Dr. Marder noted. Some initial reviewers score a physician too harshly, he said, whereas others underscore.

“Underscoring is more insidious and more difficult to deal with,” Dr. Marder said. “Underscoring is where the reviewer is too nice. They tend to dismiss things from their colleagues rather than recognize them as an opportunity to help them improve. With underscoring, a lot of committees, if the initial reviewer says the care was appropriate, they don’t even look at the case. They just take that one person’s word for it.”
 

Reviewers: Looks can be deceiving

When first examining the documented details of a case, it can be easy for peer reviewers to make a quick judgment about what happened, Dr. Beran said.

“You get these complaints, and you read through it, and you think, ‘Oh man, this person really messed up,’ “ he said. “Then you hear the doctor’s side of it, and you realize, ‘No, there’s a much bigger picture at play.’ You realize both sides have valid perspectives on it.”

In one case, for example, Dr. Beran recalled a complaint against a physician who made a snarky remark to a nurse. The doctor had asked the nurse for a piece of equipment, and the nurse said she was busy preparing the room for a patient. The doctor made a comment along the lines of, “Well, would you like me to do that for you and also intubate the patient while you do some charting?!”

At first glance, it appeared that the physician lashed out inappropriately at the nurse. But when reviewers heard from the doctor, they learned that the nurses knew that a trauma patient was coming by ambulance and that he would likely require a ventilator, Dr. Beran said. As the minutes ticked by, however, the nurses were seen in the break room chatting. Nothing had been prepared in the room, including any airway supply.

“The patient had a prolonged course and a very difficult intubation and could have very easily wound up with a much worse outcome for something the nurses had been warned about prior to the patient’s arrival,” he said. “I can see anybody getting upset in that situation if I warned them 5 or 10 minutes beforehand, ‘Get this stuff ready,’ and then nothing was done.”

There was no direct penalty for the physician.

Just as some complaints can be misleading, the clinical record in some peer review cases can also lead reviewers astray.

Physicians frequently include too much irrelevant information in the record, which can cloud a peer review, said Hans Duvefelt, MD, a family physician at Pines Health Services, in Van Buren, Maine. Dr. Duvefelt is a former medical director at Bucksport Regional Health Center, in Ellsworth, Maine. Both facilities are federally qualified health centers where continuous, random peer reviews are required.

In one case, Dr. Duvefelt was peer reviewing a physician’s office note regarding an elderly patient with a low-grade fever. The final diagnosis was urinary tract infection. Dr. Duvefelt said he had trouble following the doctor’s line of thinking because of a plethora of unnecessary data in the 10-page document. The office note included past medical history, prior lab and imaging test results, and an extensive narrative section that included a mixture of active medical problems and ongoing relationships with specialists, he said.

After reading through the printout three times, Dr. Duvefelt said he finally found mention of increased urinary dribbling and details about an enlarged prostate. He also spotted a same-day urinalysis among nearly a dozen other previous lab tests that had no connection to body temperature. Dr. Duvefelt gave the physician a passing grade but also left a scathing note about all the irrelevant information.

“It’s very common,” Dr. Duvefelt said. “It’s a disaster. Other doctors can’t follow your thinking. A reviewer has a hard time determining whether the doctor acted reasonably.”
 

Slackers make bad reviewers

Although dedicated reviewers work hard to get to the bottom of cases, it’s not uncommon for some committee members to hardly work at all, according to experts.

Dr. Marder said he’s seen many instances in which reviewers were assigned a review but did not complete it for months. Most committees have set time frames in which reviewers must complete their review.

“That delays that review, and by that time, the review is older and it’s harder to remember things,” he said. “It’s not fair to the physician. If there was a problem the physician could fix and you don’t tell him for 3 or 4 months what it is, he may do the same thing again. The case might come before the committee again and it looks like he’s repeated something, but you never gave him the opportunity to improve.”

Other reviewers fail to attend meetings regularly. Peer review committee members are generally volunteers, and meetings are usually held in the early mornings or late evenings.

“There are reasons for not attending occasionally, but some people put on a committee just don’t take it seriously,” Dr. Marder said. “They don’t fulfill their responsibilities as well as they should. If you accept the job, do the job.”

For physicians considering becoming a peer reviewer, Dr. Beran offers these tips: Be transparent, help physicians understand next steps, and make yourself as available as allowed to answer questions.

Know your committee’s policies and procedures, and follow them, added Dr. Marder. It’s also a good idea to work with your hospital’s quality staff, he said.

Reviewers should keep in mind that they may not always be the one assessing someone else, Dr. Beran said.

“Realize very easily you could be on the other side of that table for things that are outside your control,” he said. “How would you want to be treated?”

A version of this article first appeared on Medscape.com.

After making an insulting comment to a surgery scheduler, a surgeon become the subject of a peer review investigation.

The surgeon had been called in on a Saturday morning for surgery, but when he arrived at the hospital, staff informed him that the operating room had been incorrectly booked and asked him to come back that afternoon. When the surgeon returned, the room still wasn’t ready, recounted David Beran, DO, a peer reviewer and medical director for the emergency department at University Medical Center New Orleans, in Louisiana. After more waiting and staff uncertainty about which operating room was going to open, the surgeon became frustrated and said to the scheduler: “Any idiot could figure this out!”

During his peer review, the surgeon acknowledged that he shouldn’t have made the rude remark to the scheduler, Dr. Beran said. His exasperation stemmed from an ongoing problem – operating rooms at the hospital were being inefficiently managed.

“The surgeon acknowledged that even though there was a systems issue at the root, that’s not justification to speak to people unprofessionally,” Dr. Beran said. “So, there was education for the surgeon, but the surgeon was also able to explain the frustration that led to that point.”

System problems are commonly encountered by peer reviewers, said Dr. Beran.

“There’s a huge gap between administration and clinical professionals when it comes to peer review,” he said. “So many times, bad situations, whether they’re clinical or behavioral, often boil down to systems issues or some inadequacy, whether it’s an EMR [electronic medical record] problem, an inefficacy, or how complicated a process is for an end user. But having a peer review situation that then leads to a system-level change that prevents that problem from happening again is really unlikely. There’s a huge disconnect between those two.”

Peer review is generally a process that goes on behind closed doors. Although structures may differ, peer review is generally described as the process by which physicians assess the quality of their peers’ work to ensure that standards of care are being met. The process is often used to evaluate issues regarding clinical care as well as behavioral complaints against physicians.

Doctors who undergo peer review frequently share their experiences, but reviewers themselves rarely speak out. For this story, this news organization spoke with several current and former peer reviewers about what really goes on during peer reviews, what frustrates them, and what they’ve learned along the way.

“Peer review processes are in place to build stronger institutions and stronger practices, and they’re supposed to be helpful,” Dr. Beran said. “But because of how opaque they are, it immediately puts physicians on the defensive, and it doesn’t always succeed in what it’s trying to do. I think that’s one of the biggest challenges.”
 

Biased reviewers taint evaluations

A peer reviewer on and off throughout her career, Indiana family physician Lana Patch, MD, said she always strived to be fair when evaluating fellow physicians. But not every reviewer she encountered operated the same way, she said. Some were biased.

In one case, Dr. Patch peer reviewed a general surgeon who had performed a hysterectomy on a 16-year-old girl. The surgeon believed the teenager likely had an acute appendicitis, but it turned out she had a uterine pathology, Dr. Patch said. The surgeon saved the girl’s life, but the case came under review because of the patient’s age and the fact that her uterus was removed. A local obstetrician-gynecologist weighed in on the case.

“The local ob.gyn. saw it as a turf battle,” recalled Dr. Patch, who is now retired after 30 years of practice in eastern Indiana. “The doctor had nothing but bad to say about the surgeon. He was a competitor.”

Because it was a small hospital, the committee sometimes had trouble finding a specialist who was qualified to give an opinion and who wasn’t in competition with the physician in question, said Dr. Patch. Eventually they found an outside pediatric gynecologist who reviewed the case and concluded that the surgeon had followed the standard of care.

Personal agendas in can come from different directions, said Robert Marder, MD, the author of several books on peer review. Dr. Marder is a consultant who assists with peer review redesign. He has worked with hundreds of medical staff leaders and is a former vice president at the Greeley Company, a consulting firm in Danvers, Mass., that performs peer review redesign. Dr. Marder is president of Robert J. Marder Consulting.

“It goes both ways,” Dr. Marder said. “I’ve seen where somebody with a personal view decides to bring things to the peer review committee specifically because they want the peer review committee to have an adverse view of this person and get them off the medical staff. And I’ve seen hospitals that are uncomfortable with a certain person for whatever reason and want the peer review committee to address it, as opposed to addressing it from a human resource standpoint.”

Dr. Patch recalled a case in which reviewers and hospital leaders were at odds over the credentialing of a physician. Fifteen years earlier, while driving in California, the psychiatrist had been pulled over and was found with an ounce of marijuana, she said.

“We wanted to privilege him,” Dr. Patch said. “As staff physicians, we felt that was 15 years ago, people change over time. Doctors are human beings, too. He seemed to have good credentials and good training. The hospital said, ‘Oh no, we can’t have somebody like this.’ “

The psychiatrist was placed on probation and had to undergo a review every 90 days for about 3 years. Eventually, he was privileged, Dr. Patch said.

Bias among reviewers, including unintentional bias, is also a challenge, Dr. Marder noted. Some initial reviewers score a physician too harshly, he said, whereas others underscore.

“Underscoring is more insidious and more difficult to deal with,” Dr. Marder said. “Underscoring is where the reviewer is too nice. They tend to dismiss things from their colleagues rather than recognize them as an opportunity to help them improve. With underscoring, a lot of committees, if the initial reviewer says the care was appropriate, they don’t even look at the case. They just take that one person’s word for it.”
 

Reviewers: Looks can be deceiving

When first examining the documented details of a case, it can be easy for peer reviewers to make a quick judgment about what happened, Dr. Beran said.

“You get these complaints, and you read through it, and you think, ‘Oh man, this person really messed up,’ “ he said. “Then you hear the doctor’s side of it, and you realize, ‘No, there’s a much bigger picture at play.’ You realize both sides have valid perspectives on it.”

In one case, for example, Dr. Beran recalled a complaint against a physician who made a snarky remark to a nurse. The doctor had asked the nurse for a piece of equipment, and the nurse said she was busy preparing the room for a patient. The doctor made a comment along the lines of, “Well, would you like me to do that for you and also intubate the patient while you do some charting?!”

At first glance, it appeared that the physician lashed out inappropriately at the nurse. But when reviewers heard from the doctor, they learned that the nurses knew that a trauma patient was coming by ambulance and that he would likely require a ventilator, Dr. Beran said. As the minutes ticked by, however, the nurses were seen in the break room chatting. Nothing had been prepared in the room, including any airway supply.

“The patient had a prolonged course and a very difficult intubation and could have very easily wound up with a much worse outcome for something the nurses had been warned about prior to the patient’s arrival,” he said. “I can see anybody getting upset in that situation if I warned them 5 or 10 minutes beforehand, ‘Get this stuff ready,’ and then nothing was done.”

There was no direct penalty for the physician.

Just as some complaints can be misleading, the clinical record in some peer review cases can also lead reviewers astray.

Physicians frequently include too much irrelevant information in the record, which can cloud a peer review, said Hans Duvefelt, MD, a family physician at Pines Health Services, in Van Buren, Maine. Dr. Duvefelt is a former medical director at Bucksport Regional Health Center, in Ellsworth, Maine. Both facilities are federally qualified health centers where continuous, random peer reviews are required.

In one case, Dr. Duvefelt was peer reviewing a physician’s office note regarding an elderly patient with a low-grade fever. The final diagnosis was urinary tract infection. Dr. Duvefelt said he had trouble following the doctor’s line of thinking because of a plethora of unnecessary data in the 10-page document. The office note included past medical history, prior lab and imaging test results, and an extensive narrative section that included a mixture of active medical problems and ongoing relationships with specialists, he said.

After reading through the printout three times, Dr. Duvefelt said he finally found mention of increased urinary dribbling and details about an enlarged prostate. He also spotted a same-day urinalysis among nearly a dozen other previous lab tests that had no connection to body temperature. Dr. Duvefelt gave the physician a passing grade but also left a scathing note about all the irrelevant information.

“It’s very common,” Dr. Duvefelt said. “It’s a disaster. Other doctors can’t follow your thinking. A reviewer has a hard time determining whether the doctor acted reasonably.”
 

Slackers make bad reviewers

Although dedicated reviewers work hard to get to the bottom of cases, it’s not uncommon for some committee members to hardly work at all, according to experts.

Dr. Marder said he’s seen many instances in which reviewers were assigned a review but did not complete it for months. Most committees have set time frames in which reviewers must complete their review.

“That delays that review, and by that time, the review is older and it’s harder to remember things,” he said. “It’s not fair to the physician. If there was a problem the physician could fix and you don’t tell him for 3 or 4 months what it is, he may do the same thing again. The case might come before the committee again and it looks like he’s repeated something, but you never gave him the opportunity to improve.”

Other reviewers fail to attend meetings regularly. Peer review committee members are generally volunteers, and meetings are usually held in the early mornings or late evenings.

“There are reasons for not attending occasionally, but some people put on a committee just don’t take it seriously,” Dr. Marder said. “They don’t fulfill their responsibilities as well as they should. If you accept the job, do the job.”

For physicians considering becoming a peer reviewer, Dr. Beran offers these tips: Be transparent, help physicians understand next steps, and make yourself as available as allowed to answer questions.

Know your committee’s policies and procedures, and follow them, added Dr. Marder. It’s also a good idea to work with your hospital’s quality staff, he said.

Reviewers should keep in mind that they may not always be the one assessing someone else, Dr. Beran said.

“Realize very easily you could be on the other side of that table for things that are outside your control,” he said. “How would you want to be treated?”

A version of this article first appeared on Medscape.com.

After making an insulting comment to a surgery scheduler, a surgeon become the subject of a peer review investigation.

The surgeon had been called in on a Saturday morning for surgery, but when he arrived at the hospital, staff informed him that the operating room had been incorrectly booked and asked him to come back that afternoon. When the surgeon returned, the room still wasn’t ready, recounted David Beran, DO, a peer reviewer and medical director for the emergency department at University Medical Center New Orleans, in Louisiana. After more waiting and staff uncertainty about which operating room was going to open, the surgeon became frustrated and said to the scheduler: “Any idiot could figure this out!”

During his peer review, the surgeon acknowledged that he shouldn’t have made the rude remark to the scheduler, Dr. Beran said. His exasperation stemmed from an ongoing problem – operating rooms at the hospital were being inefficiently managed.

“The surgeon acknowledged that even though there was a systems issue at the root, that’s not justification to speak to people unprofessionally,” Dr. Beran said. “So, there was education for the surgeon, but the surgeon was also able to explain the frustration that led to that point.”

System problems are commonly encountered by peer reviewers, said Dr. Beran.

“There’s a huge gap between administration and clinical professionals when it comes to peer review,” he said. “So many times, bad situations, whether they’re clinical or behavioral, often boil down to systems issues or some inadequacy, whether it’s an EMR [electronic medical record] problem, an inefficacy, or how complicated a process is for an end user. But having a peer review situation that then leads to a system-level change that prevents that problem from happening again is really unlikely. There’s a huge disconnect between those two.”

Peer review is generally a process that goes on behind closed doors. Although structures may differ, peer review is generally described as the process by which physicians assess the quality of their peers’ work to ensure that standards of care are being met. The process is often used to evaluate issues regarding clinical care as well as behavioral complaints against physicians.

Doctors who undergo peer review frequently share their experiences, but reviewers themselves rarely speak out. For this story, this news organization spoke with several current and former peer reviewers about what really goes on during peer reviews, what frustrates them, and what they’ve learned along the way.

“Peer review processes are in place to build stronger institutions and stronger practices, and they’re supposed to be helpful,” Dr. Beran said. “But because of how opaque they are, it immediately puts physicians on the defensive, and it doesn’t always succeed in what it’s trying to do. I think that’s one of the biggest challenges.”
 

Biased reviewers taint evaluations

A peer reviewer on and off throughout her career, Indiana family physician Lana Patch, MD, said she always strived to be fair when evaluating fellow physicians. But not every reviewer she encountered operated the same way, she said. Some were biased.

In one case, Dr. Patch peer reviewed a general surgeon who had performed a hysterectomy on a 16-year-old girl. The surgeon believed the teenager likely had an acute appendicitis, but it turned out she had a uterine pathology, Dr. Patch said. The surgeon saved the girl’s life, but the case came under review because of the patient’s age and the fact that her uterus was removed. A local obstetrician-gynecologist weighed in on the case.

“The local ob.gyn. saw it as a turf battle,” recalled Dr. Patch, who is now retired after 30 years of practice in eastern Indiana. “The doctor had nothing but bad to say about the surgeon. He was a competitor.”

Because it was a small hospital, the committee sometimes had trouble finding a specialist who was qualified to give an opinion and who wasn’t in competition with the physician in question, said Dr. Patch. Eventually they found an outside pediatric gynecologist who reviewed the case and concluded that the surgeon had followed the standard of care.

Personal agendas in can come from different directions, said Robert Marder, MD, the author of several books on peer review. Dr. Marder is a consultant who assists with peer review redesign. He has worked with hundreds of medical staff leaders and is a former vice president at the Greeley Company, a consulting firm in Danvers, Mass., that performs peer review redesign. Dr. Marder is president of Robert J. Marder Consulting.

“It goes both ways,” Dr. Marder said. “I’ve seen where somebody with a personal view decides to bring things to the peer review committee specifically because they want the peer review committee to have an adverse view of this person and get them off the medical staff. And I’ve seen hospitals that are uncomfortable with a certain person for whatever reason and want the peer review committee to address it, as opposed to addressing it from a human resource standpoint.”

Dr. Patch recalled a case in which reviewers and hospital leaders were at odds over the credentialing of a physician. Fifteen years earlier, while driving in California, the psychiatrist had been pulled over and was found with an ounce of marijuana, she said.

“We wanted to privilege him,” Dr. Patch said. “As staff physicians, we felt that was 15 years ago, people change over time. Doctors are human beings, too. He seemed to have good credentials and good training. The hospital said, ‘Oh no, we can’t have somebody like this.’ “

The psychiatrist was placed on probation and had to undergo a review every 90 days for about 3 years. Eventually, he was privileged, Dr. Patch said.

Bias among reviewers, including unintentional bias, is also a challenge, Dr. Marder noted. Some initial reviewers score a physician too harshly, he said, whereas others underscore.

“Underscoring is more insidious and more difficult to deal with,” Dr. Marder said. “Underscoring is where the reviewer is too nice. They tend to dismiss things from their colleagues rather than recognize them as an opportunity to help them improve. With underscoring, a lot of committees, if the initial reviewer says the care was appropriate, they don’t even look at the case. They just take that one person’s word for it.”
 

Reviewers: Looks can be deceiving

When first examining the documented details of a case, it can be easy for peer reviewers to make a quick judgment about what happened, Dr. Beran said.

“You get these complaints, and you read through it, and you think, ‘Oh man, this person really messed up,’ “ he said. “Then you hear the doctor’s side of it, and you realize, ‘No, there’s a much bigger picture at play.’ You realize both sides have valid perspectives on it.”

In one case, for example, Dr. Beran recalled a complaint against a physician who made a snarky remark to a nurse. The doctor had asked the nurse for a piece of equipment, and the nurse said she was busy preparing the room for a patient. The doctor made a comment along the lines of, “Well, would you like me to do that for you and also intubate the patient while you do some charting?!”

At first glance, it appeared that the physician lashed out inappropriately at the nurse. But when reviewers heard from the doctor, they learned that the nurses knew that a trauma patient was coming by ambulance and that he would likely require a ventilator, Dr. Beran said. As the minutes ticked by, however, the nurses were seen in the break room chatting. Nothing had been prepared in the room, including any airway supply.

“The patient had a prolonged course and a very difficult intubation and could have very easily wound up with a much worse outcome for something the nurses had been warned about prior to the patient’s arrival,” he said. “I can see anybody getting upset in that situation if I warned them 5 or 10 minutes beforehand, ‘Get this stuff ready,’ and then nothing was done.”

There was no direct penalty for the physician.

Just as some complaints can be misleading, the clinical record in some peer review cases can also lead reviewers astray.

Physicians frequently include too much irrelevant information in the record, which can cloud a peer review, said Hans Duvefelt, MD, a family physician at Pines Health Services, in Van Buren, Maine. Dr. Duvefelt is a former medical director at Bucksport Regional Health Center, in Ellsworth, Maine. Both facilities are federally qualified health centers where continuous, random peer reviews are required.

In one case, Dr. Duvefelt was peer reviewing a physician’s office note regarding an elderly patient with a low-grade fever. The final diagnosis was urinary tract infection. Dr. Duvefelt said he had trouble following the doctor’s line of thinking because of a plethora of unnecessary data in the 10-page document. The office note included past medical history, prior lab and imaging test results, and an extensive narrative section that included a mixture of active medical problems and ongoing relationships with specialists, he said.

After reading through the printout three times, Dr. Duvefelt said he finally found mention of increased urinary dribbling and details about an enlarged prostate. He also spotted a same-day urinalysis among nearly a dozen other previous lab tests that had no connection to body temperature. Dr. Duvefelt gave the physician a passing grade but also left a scathing note about all the irrelevant information.

“It’s very common,” Dr. Duvefelt said. “It’s a disaster. Other doctors can’t follow your thinking. A reviewer has a hard time determining whether the doctor acted reasonably.”
 

Slackers make bad reviewers

Although dedicated reviewers work hard to get to the bottom of cases, it’s not uncommon for some committee members to hardly work at all, according to experts.

Dr. Marder said he’s seen many instances in which reviewers were assigned a review but did not complete it for months. Most committees have set time frames in which reviewers must complete their review.

“That delays that review, and by that time, the review is older and it’s harder to remember things,” he said. “It’s not fair to the physician. If there was a problem the physician could fix and you don’t tell him for 3 or 4 months what it is, he may do the same thing again. The case might come before the committee again and it looks like he’s repeated something, but you never gave him the opportunity to improve.”

Other reviewers fail to attend meetings regularly. Peer review committee members are generally volunteers, and meetings are usually held in the early mornings or late evenings.

“There are reasons for not attending occasionally, but some people put on a committee just don’t take it seriously,” Dr. Marder said. “They don’t fulfill their responsibilities as well as they should. If you accept the job, do the job.”

For physicians considering becoming a peer reviewer, Dr. Beran offers these tips: Be transparent, help physicians understand next steps, and make yourself as available as allowed to answer questions.

Know your committee’s policies and procedures, and follow them, added Dr. Marder. It’s also a good idea to work with your hospital’s quality staff, he said.

Reviewers should keep in mind that they may not always be the one assessing someone else, Dr. Beran said.

“Realize very easily you could be on the other side of that table for things that are outside your control,” he said. “How would you want to be treated?”

A version of this article first appeared on Medscape.com.

In July 2021, the Centers for Medicare & Medicaid Services released the Medicare Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS)/Ambulatory Surgery Center (ASC) proposed rules for calendar year (CY) 2022. While the OPPS/ASC proposed rule was largely positive for gastroenterology, the PFS proposed rule was more of a mixed bag for practices.

No more colonoscopy coinsurance “loophole”: After nearly a decade of advocacy, the Removing Barriers to Colorectal Cancer Screening Act was finally signed into law this year and will take effect Jan. 1, 2023. The legislation phases out Medicare beneficiary cost-sharing obligations when a polyp or lesion is found and biopsied or removed as part of a screening colonoscopy or flexible sigmoidoscopy. The American Gastroenterological Association is pleased this will finally eliminate a surprise bill for patients and remove a barrier to colorectal cancer screening.

The phase out timeline is as follows:

• 80% payment for services furnished during CY 2022 (coinsurance, 20%).
• 85% payment for services furnished during CY 2023 through CY 2026 (coinsurance, 15%).
• 90% payment for services furnished during CY 2027 through CY 2029 (coinsurance, 10%).
• 100% payment for services furnished from CY 2030 onward (coinsurance, 0%).

Providers must continue to report HCPCS modifier “PT” in the hospital outpatient and ASC during the transition period to indicate that a planned colorectal cancer screening service converted to a diagnostic service.

Proposed 2022 PFS conversion factor could fall 3.75% unless Congress acts: The proposed 2022 PFS conversion factor is $33.58. The decrease reflects the expiration of the 3.75% payment increase provided by the Consolidated Appropriations Act. This congressional intervention averted a significant cut in Medicare physician payment that would have resulted in an almost 10% cut to GI services. The GI societies are working with Congress to avert cuts to physician payments next year as practices continue to recover from the pandemic.

GI procedure payments to increase 3% for hospital outpatient and ASCs: A 2.3% increase has been proposed for the conversion factors, resulting in $84.46 for hospitals and $50.04 for ASCs meeting quality reporting requirements. However, GI endoscopy procedure payments are expected to increase on average 3% in CY 2022.

Colon capsule endoscopy and POEM get new codes and payments: CMS accepted new CPT codes for colon capsule endoscopy (CCE) and peroral endoscopic myotomy (POEM) beginning Jan. 1, 2022.

CMS’s proposed CCE value of 2.41 physician work relative value units (wRVUs) reflects the recommendation of the American Medical Association RVS Update Committee (RUC), which is based on data from physicians who perform the procedure. The proposed national-level physician payments are $116.52 for the professional component and $664.21 for the technical component.

However, CMS did not accept the RUC’s recommendation of 15.50 wRVUs for POEM and, instead, proposed that POEM is similar in work to hemodialysis access CPT code 36819, which has a wRVU of 13.29 and a payment of $792.82. The RUC’s valuation of 15.50 wRVUs was based on data from nearly 120 physicians who perform POEM, and we are disappointed CMS chose to reject the robust survey data. The GI societies will defend the 15.50 wRVU in our comments.

The proposed facility fee for POEM is $3,160.76 in the hospital outpatient setting and $1,848.32 in the ASC. CMS’s proposed facility fee for colon capsule endoscopy is $814.44 in the hospital outpatient setting.

CMS moves physicians to MVPs and plans to phase out MIPS: CMS proposes to revise and phase out the Merit-Based Incentive Payment System (MIPS) and move physicians towards the MIPS Value Pathways (MVPs) system beginning in the 2023 performance year (PY). No GI MVPs were proposed for PY 2023. The GI societies are working with CMS as they develop MVPs to ensure any gastroenterology-related MVPs do not harm gastroenterologists.

CMS is statutorily required to weigh the MIPS Cost and Quality performance categories equally beginning with PY 2022. The proposed PY 2022 MIPS performance categories are:

• Quality: 30%.
• Cost: 30%.
• Promoting Interoperability: 25% (no change from 2021).
• Improvement Activities: 15% (no change from 2021).

CMS is also required by law beginning in 2022 to set the MIPS performance threshold to either the mean or median of the final scores for all MIPS eligible clinicians for a prior period. CMS proposes to use the mean final score from MIPS 2017 performance year/MIPS 2019 payment year, which would result in a performance threshold of 75 points and an additional performance threshold set at 89 points for exceptional performance.

CMS keeps all AGA-stewarded measures in MIPS 2022 program year: CMS has proposed to keep all AGA-stewarded measures in the MIPS program for the 2022 program year and accepted the substantive changes for the one-time screening for hepatitis C virus measure we received last year from the Physician Consortium for Performance Improvement. CMS proposed removal of the claims reporting option of American Society for Gastrointestinal Endoscopy–stewarded measure for photodocumentation of cecal intubation because it is topped-out; however, the registry version is still available in MIPS.

OQR Program includes colonoscopy measure for disparities reporting: CMS has identified six priority measures included in the Hospital Outpatient Quality Reporting (OQR) Program as candidate measures for disparities reporting stratified by dual eligibility, one of which is the Facility 7-Day Risk-Standardized Hospital Visit Rate After Outpatient Colonoscopy (OP-32).

The GI societies will jointly comment on issues in the 2022 PFS and OPPS/ASC proposed rules impacting gastroenterologists. We may also organize members to take action by submitting letters during the comment period, so watch your inbox for invitations to participate. We need your help to influence change.

Shivan Mehta, MD, MBA, is with the division of gastroenterology and hepatology at the University of Pennsylvania, Philadelphia, and is an AGA adviser to the American Medical Association RVS Update Committee. David A. Leiman, MD, MSHP, is with the division of gastroenterology at Duke University, Durham, N.C., and is the chair of the AGA Quality Committee. Neither have conflicts to declare.

In July 2021, the Centers for Medicare & Medicaid Services released the Medicare Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS)/Ambulatory Surgery Center (ASC) proposed rules for calendar year (CY) 2022. While the OPPS/ASC proposed rule was largely positive for gastroenterology, the PFS proposed rule was more of a mixed bag for practices.

No more colonoscopy coinsurance “loophole”: After nearly a decade of advocacy, the Removing Barriers to Colorectal Cancer Screening Act was finally signed into law this year and will take effect Jan. 1, 2023. The legislation phases out Medicare beneficiary cost-sharing obligations when a polyp or lesion is found and biopsied or removed as part of a screening colonoscopy or flexible sigmoidoscopy. The American Gastroenterological Association is pleased this will finally eliminate a surprise bill for patients and remove a barrier to colorectal cancer screening.

The phase out timeline is as follows:

• 80% payment for services furnished during CY 2022 (coinsurance, 20%).
• 85% payment for services furnished during CY 2023 through CY 2026 (coinsurance, 15%).
• 90% payment for services furnished during CY 2027 through CY 2029 (coinsurance, 10%).
• 100% payment for services furnished from CY 2030 onward (coinsurance, 0%).

Providers must continue to report HCPCS modifier “PT” in the hospital outpatient and ASC during the transition period to indicate that a planned colorectal cancer screening service converted to a diagnostic service.

Proposed 2022 PFS conversion factor could fall 3.75% unless Congress acts: The proposed 2022 PFS conversion factor is $33.58. The decrease reflects the expiration of the 3.75% payment increase provided by the Consolidated Appropriations Act. This congressional intervention averted a significant cut in Medicare physician payment that would have resulted in an almost 10% cut to GI services. The GI societies are working with Congress to avert cuts to physician payments next year as practices continue to recover from the pandemic.

GI procedure payments to increase 3% for hospital outpatient and ASCs: A 2.3% increase has been proposed for the conversion factors, resulting in $84.46 for hospitals and $50.04 for ASCs meeting quality reporting requirements. However, GI endoscopy procedure payments are expected to increase on average 3% in CY 2022.

Colon capsule endoscopy and POEM get new codes and payments: CMS accepted new CPT codes for colon capsule endoscopy (CCE) and peroral endoscopic myotomy (POEM) beginning Jan. 1, 2022.

CMS’s proposed CCE value of 2.41 physician work relative value units (wRVUs) reflects the recommendation of the American Medical Association RVS Update Committee (RUC), which is based on data from physicians who perform the procedure. The proposed national-level physician payments are $116.52 for the professional component and $664.21 for the technical component.

However, CMS did not accept the RUC’s recommendation of 15.50 wRVUs for POEM and, instead, proposed that POEM is similar in work to hemodialysis access CPT code 36819, which has a wRVU of 13.29 and a payment of $792.82. The RUC’s valuation of 15.50 wRVUs was based on data from nearly 120 physicians who perform POEM, and we are disappointed CMS chose to reject the robust survey data. The GI societies will defend the 15.50 wRVU in our comments.

The proposed facility fee for POEM is $3,160.76 in the hospital outpatient setting and $1,848.32 in the ASC. CMS’s proposed facility fee for colon capsule endoscopy is $814.44 in the hospital outpatient setting.

CMS moves physicians to MVPs and plans to phase out MIPS: CMS proposes to revise and phase out the Merit-Based Incentive Payment System (MIPS) and move physicians towards the MIPS Value Pathways (MVPs) system beginning in the 2023 performance year (PY). No GI MVPs were proposed for PY 2023. The GI societies are working with CMS as they develop MVPs to ensure any gastroenterology-related MVPs do not harm gastroenterologists.

CMS is statutorily required to weigh the MIPS Cost and Quality performance categories equally beginning with PY 2022. The proposed PY 2022 MIPS performance categories are:

• Quality: 30%.
• Cost: 30%.
• Promoting Interoperability: 25% (no change from 2021).
• Improvement Activities: 15% (no change from 2021).

CMS is also required by law beginning in 2022 to set the MIPS performance threshold to either the mean or median of the final scores for all MIPS eligible clinicians for a prior period. CMS proposes to use the mean final score from MIPS 2017 performance year/MIPS 2019 payment year, which would result in a performance threshold of 75 points and an additional performance threshold set at 89 points for exceptional performance.

CMS keeps all AGA-stewarded measures in MIPS 2022 program year: CMS has proposed to keep all AGA-stewarded measures in the MIPS program for the 2022 program year and accepted the substantive changes for the one-time screening for hepatitis C virus measure we received last year from the Physician Consortium for Performance Improvement. CMS proposed removal of the claims reporting option of American Society for Gastrointestinal Endoscopy–stewarded measure for photodocumentation of cecal intubation because it is topped-out; however, the registry version is still available in MIPS.

OQR Program includes colonoscopy measure for disparities reporting: CMS has identified six priority measures included in the Hospital Outpatient Quality Reporting (OQR) Program as candidate measures for disparities reporting stratified by dual eligibility, one of which is the Facility 7-Day Risk-Standardized Hospital Visit Rate After Outpatient Colonoscopy (OP-32).

The GI societies will jointly comment on issues in the 2022 PFS and OPPS/ASC proposed rules impacting gastroenterologists. We may also organize members to take action by submitting letters during the comment period, so watch your inbox for invitations to participate. We need your help to influence change.

Shivan Mehta, MD, MBA, is with the division of gastroenterology and hepatology at the University of Pennsylvania, Philadelphia, and is an AGA adviser to the American Medical Association RVS Update Committee. David A. Leiman, MD, MSHP, is with the division of gastroenterology at Duke University, Durham, N.C., and is the chair of the AGA Quality Committee. Neither have conflicts to declare.

In July 2021, the Centers for Medicare & Medicaid Services released the Medicare Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS)/Ambulatory Surgery Center (ASC) proposed rules for calendar year (CY) 2022. While the OPPS/ASC proposed rule was largely positive for gastroenterology, the PFS proposed rule was more of a mixed bag for practices.

No more colonoscopy coinsurance “loophole”: After nearly a decade of advocacy, the Removing Barriers to Colorectal Cancer Screening Act was finally signed into law this year and will take effect Jan. 1, 2023. The legislation phases out Medicare beneficiary cost-sharing obligations when a polyp or lesion is found and biopsied or removed as part of a screening colonoscopy or flexible sigmoidoscopy. The American Gastroenterological Association is pleased this will finally eliminate a surprise bill for patients and remove a barrier to colorectal cancer screening.

The phase out timeline is as follows:

• 80% payment for services furnished during CY 2022 (coinsurance, 20%).
• 85% payment for services furnished during CY 2023 through CY 2026 (coinsurance, 15%).
• 90% payment for services furnished during CY 2027 through CY 2029 (coinsurance, 10%).
• 100% payment for services furnished from CY 2030 onward (coinsurance, 0%).

Providers must continue to report HCPCS modifier “PT” in the hospital outpatient and ASC during the transition period to indicate that a planned colorectal cancer screening service converted to a diagnostic service.

Proposed 2022 PFS conversion factor could fall 3.75% unless Congress acts: The proposed 2022 PFS conversion factor is $33.58. The decrease reflects the expiration of the 3.75% payment increase provided by the Consolidated Appropriations Act. This congressional intervention averted a significant cut in Medicare physician payment that would have resulted in an almost 10% cut to GI services. The GI societies are working with Congress to avert cuts to physician payments next year as practices continue to recover from the pandemic.

GI procedure payments to increase 3% for hospital outpatient and ASCs: A 2.3% increase has been proposed for the conversion factors, resulting in $84.46 for hospitals and $50.04 for ASCs meeting quality reporting requirements. However, GI endoscopy procedure payments are expected to increase on average 3% in CY 2022.

Colon capsule endoscopy and POEM get new codes and payments: CMS accepted new CPT codes for colon capsule endoscopy (CCE) and peroral endoscopic myotomy (POEM) beginning Jan. 1, 2022.

CMS’s proposed CCE value of 2.41 physician work relative value units (wRVUs) reflects the recommendation of the American Medical Association RVS Update Committee (RUC), which is based on data from physicians who perform the procedure. The proposed national-level physician payments are $116.52 for the professional component and $664.21 for the technical component.

However, CMS did not accept the RUC’s recommendation of 15.50 wRVUs for POEM and, instead, proposed that POEM is similar in work to hemodialysis access CPT code 36819, which has a wRVU of 13.29 and a payment of $792.82. The RUC’s valuation of 15.50 wRVUs was based on data from nearly 120 physicians who perform POEM, and we are disappointed CMS chose to reject the robust survey data. The GI societies will defend the 15.50 wRVU in our comments.

The proposed facility fee for POEM is $3,160.76 in the hospital outpatient setting and $1,848.32 in the ASC. CMS’s proposed facility fee for colon capsule endoscopy is $814.44 in the hospital outpatient setting.

CMS moves physicians to MVPs and plans to phase out MIPS: CMS proposes to revise and phase out the Merit-Based Incentive Payment System (MIPS) and move physicians towards the MIPS Value Pathways (MVPs) system beginning in the 2023 performance year (PY). No GI MVPs were proposed for PY 2023. The GI societies are working with CMS as they develop MVPs to ensure any gastroenterology-related MVPs do not harm gastroenterologists.

CMS is statutorily required to weigh the MIPS Cost and Quality performance categories equally beginning with PY 2022. The proposed PY 2022 MIPS performance categories are:

• Quality: 30%.
• Cost: 30%.
• Promoting Interoperability: 25% (no change from 2021).
• Improvement Activities: 15% (no change from 2021).

CMS is also required by law beginning in 2022 to set the MIPS performance threshold to either the mean or median of the final scores for all MIPS eligible clinicians for a prior period. CMS proposes to use the mean final score from MIPS 2017 performance year/MIPS 2019 payment year, which would result in a performance threshold of 75 points and an additional performance threshold set at 89 points for exceptional performance.

CMS keeps all AGA-stewarded measures in MIPS 2022 program year: CMS has proposed to keep all AGA-stewarded measures in the MIPS program for the 2022 program year and accepted the substantive changes for the one-time screening for hepatitis C virus measure we received last year from the Physician Consortium for Performance Improvement. CMS proposed removal of the claims reporting option of American Society for Gastrointestinal Endoscopy–stewarded measure for photodocumentation of cecal intubation because it is topped-out; however, the registry version is still available in MIPS.

OQR Program includes colonoscopy measure for disparities reporting: CMS has identified six priority measures included in the Hospital Outpatient Quality Reporting (OQR) Program as candidate measures for disparities reporting stratified by dual eligibility, one of which is the Facility 7-Day Risk-Standardized Hospital Visit Rate After Outpatient Colonoscopy (OP-32).

The GI societies will jointly comment on issues in the 2022 PFS and OPPS/ASC proposed rules impacting gastroenterologists. We may also organize members to take action by submitting letters during the comment period, so watch your inbox for invitations to participate. We need your help to influence change.

Shivan Mehta, MD, MBA, is with the division of gastroenterology and hepatology at the University of Pennsylvania, Philadelphia, and is an AGA adviser to the American Medical Association RVS Update Committee. David A. Leiman, MD, MSHP, is with the division of gastroenterology at Duke University, Durham, N.C., and is the chair of the AGA Quality Committee. Neither have conflicts to declare.

Due to broad social changes and efforts from leaders in GI, there is renewed interest in family planning and parental leave policies for GI trainees. The American Board of Medical Specialties now permits trainees a minimum of 6 weeks away during training, without automatically requiring an extension of training time or completely depleting vacation time, for boards eligibility.^1,2 However, national and institutional guidance for family planning and pregnancy during GI fellowship is lacking. How can gastroenterology fellowship programs support fellows taking parental leave and enact fair policies? We review the scope of the problem, describe our experience in developing resources within our GI fellowship program, and highlight areas that require further development.

The scope of the issue

There is no national data yet on the number of GI fellows that are parents prior to starting fellowship or who become parents during fellowship. We estimate that approximately 25% of fellows enter training as parents or become parents during fellowship, although 40%-50% may have an intention to have children.^3,4 Fellows may be worried that they will “fall behind” or be perceived as less committed if they devote time to childrearing or take parental leave.^5-7 Indeed, worries about discrimination based on pregnancy and parental leave are borne out by the experiences of older physicians (in particular, female physicians).^8,9

State- and institution-specific benefits vary from program to program. Nationally, the Family and Medical Leave Act provides only unpaid leave and applies only to trainees who have been employed for greater than 12 months.¹⁰ Benefits may not always be well advertised, and even when they are, trainees (and attendings) may feel uncomfortable taking full advantage. One survey of GIs revealed that, although two-thirds believed that 6-8 weeks of maternity leave was inadequate, half took less than that amount due to fears about financial and professional consequences.⁸

Pregnancy during GI fellowship is a special concern. GI fellowship consists of long work hours, includes night call, and can be physically demanding. All three of these factors have been associated with preterm delivery, infertility, and miscarriage.^11,12 In addition, there are no guidelines for ergonomic adjustments or infection precautions for pregnant endoscopists. We have compiled information about infection prevention guidance in pregnancy (available from the authors on request) derived from guidance from the National Institute for Occupational Safety and Health, which recommends the same precautions for pregnant health care workers as for nonpregnant health care workers.¹³ In regards to SARS-CoV-2, we believe that the decision to perform procedures on patients with COVID-19 infection should be individualized, although vaccinated endoscopists should be reassured by the exceedingly low rates of infection after vaccination and with appropriate personal protective equipment. Radiation is yet another concern. There are limited data on radiation dosages incurred by workers in the endoscopy suite and no pregnancy-specific data, which may lead trainees to avoid fluoroscopic procedures and unnecessarily double up on lead gowns.^8,11,14-17

Breastfeeding accommodations, and access to lactation rooms for trainees, are required by federal law for a minimum of 12 months.¹⁸ Should a trainee choose to breastfeed, education of staff and attendings is critical because many may be unaware of the specific needs pertaining to lactation. Staff should be aware that 30-45 minutes are needed to prepare, pump, and store milk. Trainees should not be solely responsible for educating their attendings and staff.
 

Our Experience in Creating a Policy

We developed a formal fellowship program policy on parental leave and pregnancy in the setting of a broader discussion about fellow workload and wellness. We agreed that trainees should be allowed to make changes to their schedule with co-fellows as needed for medical appointments or procedures and that our backup policy should be flexible enough to provide spot coverage for unexpected complications and family emergencies. We also incorporated a GI psychologist to provide wellness resources and suggestions for reducing burnout for our fellows.

We strove to follow certain principles in creating this policy. Trainees who are parents should have a comparable clinical experience to their nonparenting colleagues and should take the lead in rearranging their own schedule. Nonbirthing parents, adopting parents, and parents using surrogacy should be included in any parental leave policy. Fellowship leaders have an important responsibility in helping fellows proactively plan to meet requirements for graduation and maximize learning and exposure (Figure). We also recognized the importance of equitable coverage. For example, there is sometimes a perception that fellows with children “burden” fellows who are not parents.^3,19 On the other hand, fellows without children may feel that they are called on more than their colleagues with children to cover those with childcare issues. In addition, as a recent study of general surgery residency program directors indicates, there are complex interpersonal issues that play into a colleague’s willingness to provide coverage.²⁰ It behooves program leadership to be cognizant of group dynamics that might cause conflict over what should be a straightforward coverage situation.

We first researched national and societal guidelines if available, as well as our institution’s graduate medical education (GME) website. We categorized benefits by whether they were federal, state-mandated, or institutional. It is important to note that any concerns about trainee salaries should be discussed with one’s GME office to ensure the leave policy is in accordance with federal funding policies.²¹ We solicited experiences and advice from former and current fellows who had gone through, or were planning, pregnancy and parental leave. A few faculty members volunteered to serve as a resource for fellows; these “ambassadors” discussed their experiences during a lunchtime panel, as well as offered to provide one-on-one advice and participate in future panels. We also reached out to our infection control experts to review the literature and federal policies on infections of special consideration during pregnancy and endoscopy. As for radiation safety, given the importance of education and active monitoring, we offer the option of reaching out to our radiation safety officer for individualized counseling.²²

Based on these efforts, we drafted a written policy designed for pregnant fellows and fellows planning parental leave on expectations for the program and fellows, benefits, and advice, including childcare options, lactation room locations, and financial planning tips. We shared this document with fellows and incorporated feedback. As a “living document” it is subject to change and will be updated as needed (at least annually).
 

Additional planning considerations for fellows

Research childcare options (ideally 6 months or more before leave).

• Start to explore your institution’s resources for leave and childcare options (daycare waitlists may be greater than 1 year in some cities).

Inform your program director (4-5 months before leave).

• Consider informing your program director about pregnancy at the beginning of the second trimester.
• Discuss Accreditation Council for Graduate Medical Education requirements and scheduling responsibilities.
• Explicitly discuss whether you plan to graduate on time or extend fellowship.

Inform your colleagues and patients (at least 3-4 months before leave).

• If comfortable, consider getting advice from a co-fellow and/or faculty mentor parent to facilitate transition to parenthood.
• When you feel ready, begin trading rotations and calls with co-fellows. If you have a results inbox or pager, discuss who can help cover those during your leave.
• Inform research collaborators about your leave and make preparations to keep projects progressing during your leave.
• If you have “active” clinic patients, when appropriate, begin to inform them that you will be away and provide reassurance that a colleague will be covering you. Leave clear plans with contingencies for these patients in your last progress notes.

Complete institutional paperwork and map out facilities (at least 2-3 months before leave).

• Review your options for using time toward leave, including vacation, research, or Family and Medical Leave Act–provided leave (unpaid), and what paperwork you need to fill out.
• Contact your payroll and/or human resources office to inform them of birth/adoption.
• Research potential program parental benefits, such as dependent daycare and/or health care flexible spending accounts.
• If choosing to breastfeed, explore the lactation rooms that are closest to your workroom and endoscopy suite and determine how much time you will need to set aside for pumping.

Be prepared to make adjustments as needed.

• Endoscopy-heavy rotations may be more difficult in the third trimester of pregnancy.
• Make contingency plans for early or late delivery dates, as well as if you undergo a cesarean that requires additional recovery time.
• Consider scheduling elective rotations (research, clinic) toward the end of leave and for the first month of “return to work.”
• If you plan to join limited clinic or outpatient endoscopy blocks later in your leave, make early arrangements to work regularly with these attendings.

Conclusion

Trainee needs assessments in gastroenterology fellowship similar to those in other specialties should be performed, and are in fact underway.^19,23,24 There is a lack of data regarding the availability of fellowship program guidance and, specifically, adherence to required policies, and more data from program directors at a national level need to be collected.²⁰ We recommend that programs engage in identifying specific needs at their institutions with the goal of eventually sharing this knowledge with other programs. Gastroenterology society recommendations for performing endoscopy while pregnant, with regard to ergonomics, infection control, and radiation exposure, would be instrumental. GI fellowships should consolidate institutional knowledge and engage key stakeholders – including trainees, prior trainees, occupational safety experts, radiation safety offices, wellness experts, and GME – to create program-specific policies that are flexible but rigorous and generous but equitable.

Dr. Liu and Dr. Summa are gastroenterology fellows at Northwestern University, Chicago. Dr. Patel is an assistant professor of medicine and a gastroenterology fellowship assistant program director at Northwestern University, Chicago. Dr. Donnan and Dr. Guentner are assistant professors of medicine at Northwestern University. Dr. Kia is an assistant professor of medicine and the gastroenterology fellowship program director at Northwestern University. They have no conflicts of interest to disclose. The authors would like to thank Michelle Clermont, MD, and Maureen K. Bolon, MD, for their discussion and assistance during the drafting of this article.

References

1. Section on Medical Students, Residents, and Fellowship Trainees; Committee on Early Childhood. Pediatrics. 2013;131(2):387-90.

2. American Board of Medical Specialties. ABMS Announces Progressive Leave Policy for Residents and Fellows. July 13, 2020. Accessed May 1, 2021. https://www.abms.org/news-events/abms-announces-progressive-leave-policy-for-residents-and-fellows/.

3. Magudia K et al. J Grad Med Educ. 2020;12(2):162-7.

4. Blair JE et al. Acad Med. 2016;91(7):972-8.

5. Feld LD. Am J Gastroenterol. 2021;116(3):505-8.

6. Roubaud MS. Plast Reconstr Surg Glob Open. 2019. doi: 10.1097/GOX.0000000000002104.

7. Price J, Dunbar K. Gastrointest Endosc. 2009;69(1):121-3.

8. David YN et al. Gastrointest Endosc. 2020;91(6):AB75-AB76.

9. Webb AMB et al. Acad Med J Assoc Am Med Coll. 2019;94(11):1631-4.

10. Weinstein DF et al. N Engl J Med. 2019 Sep 12;381(11):995-7.

11. Anderson M, Goldman RH. JAMA Surg. 2020;155(3):243-9.

12. Palmer KT et al. Occup Environ Med. 2013;70(4):213-22.

13. Siegel JD et al; Healthcare Infection, Control Practices Advisory Committee. Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007). 2007. Last reviewed July 22, 2019. Accessed April 28, 2021. https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html

14. David YN et al. Am J Gastroenterol. 2021;116(3):539-50.

15. Sethi S et al. Dig Dis Sci. 2019;64(9):2455-66.

16. Alzimami K et al. Gastroenterol Res Pract. 2013;2013:587574.

17. Hayashi S et al. World J Clin Cases. 2018;6(16):1087-93.

18. U.S. Department of Labor, Wage and Hour Division. “Frequently Asked Questions – Break Time for Nursing Mothers.” Accessed May 1, 2021. https://www.dol.gov/agencies/whd/nursing-mothers/faq.

19. Mwakyanjala EJ et al. J Am Heart Assoc. 2019. doi: 10.1161/JAHA.119.012137.

20. Castillo-Angeles M et al. JAMA Surg. 2021 Jul 1;156(7):647-53.

21. Prasad S et al. J Grad Med Educ. 2021 Jun;13(3):349-54.

22. Ho IKH et al. Am J Gastroenterol. 2014;109(8):1180-94.

23. Sherbaf FG et al. AJNR Am J Neuroradiol. 2020;41(8):1348-54.

24. Altieri MS et al. JAMA Surg. 2019;154(10):952-58.

Due to broad social changes and efforts from leaders in GI, there is renewed interest in family planning and parental leave policies for GI trainees. The American Board of Medical Specialties now permits trainees a minimum of 6 weeks away during training, without automatically requiring an extension of training time or completely depleting vacation time, for boards eligibility.^1,2 However, national and institutional guidance for family planning and pregnancy during GI fellowship is lacking. How can gastroenterology fellowship programs support fellows taking parental leave and enact fair policies? We review the scope of the problem, describe our experience in developing resources within our GI fellowship program, and highlight areas that require further development.

The scope of the issue

There is no national data yet on the number of GI fellows that are parents prior to starting fellowship or who become parents during fellowship. We estimate that approximately 25% of fellows enter training as parents or become parents during fellowship, although 40%-50% may have an intention to have children.^3,4 Fellows may be worried that they will “fall behind” or be perceived as less committed if they devote time to childrearing or take parental leave.^5-7 Indeed, worries about discrimination based on pregnancy and parental leave are borne out by the experiences of older physicians (in particular, female physicians).^8,9

State- and institution-specific benefits vary from program to program. Nationally, the Family and Medical Leave Act provides only unpaid leave and applies only to trainees who have been employed for greater than 12 months.¹⁰ Benefits may not always be well advertised, and even when they are, trainees (and attendings) may feel uncomfortable taking full advantage. One survey of GIs revealed that, although two-thirds believed that 6-8 weeks of maternity leave was inadequate, half took less than that amount due to fears about financial and professional consequences.⁸

Pregnancy during GI fellowship is a special concern. GI fellowship consists of long work hours, includes night call, and can be physically demanding. All three of these factors have been associated with preterm delivery, infertility, and miscarriage.^11,12 In addition, there are no guidelines for ergonomic adjustments or infection precautions for pregnant endoscopists. We have compiled information about infection prevention guidance in pregnancy (available from the authors on request) derived from guidance from the National Institute for Occupational Safety and Health, which recommends the same precautions for pregnant health care workers as for nonpregnant health care workers.¹³ In regards to SARS-CoV-2, we believe that the decision to perform procedures on patients with COVID-19 infection should be individualized, although vaccinated endoscopists should be reassured by the exceedingly low rates of infection after vaccination and with appropriate personal protective equipment. Radiation is yet another concern. There are limited data on radiation dosages incurred by workers in the endoscopy suite and no pregnancy-specific data, which may lead trainees to avoid fluoroscopic procedures and unnecessarily double up on lead gowns.^8,11,14-17

Breastfeeding accommodations, and access to lactation rooms for trainees, are required by federal law for a minimum of 12 months.¹⁸ Should a trainee choose to breastfeed, education of staff and attendings is critical because many may be unaware of the specific needs pertaining to lactation. Staff should be aware that 30-45 minutes are needed to prepare, pump, and store milk. Trainees should not be solely responsible for educating their attendings and staff.
 

Our Experience in Creating a Policy

We developed a formal fellowship program policy on parental leave and pregnancy in the setting of a broader discussion about fellow workload and wellness. We agreed that trainees should be allowed to make changes to their schedule with co-fellows as needed for medical appointments or procedures and that our backup policy should be flexible enough to provide spot coverage for unexpected complications and family emergencies. We also incorporated a GI psychologist to provide wellness resources and suggestions for reducing burnout for our fellows.

We strove to follow certain principles in creating this policy. Trainees who are parents should have a comparable clinical experience to their nonparenting colleagues and should take the lead in rearranging their own schedule. Nonbirthing parents, adopting parents, and parents using surrogacy should be included in any parental leave policy. Fellowship leaders have an important responsibility in helping fellows proactively plan to meet requirements for graduation and maximize learning and exposure (Figure). We also recognized the importance of equitable coverage. For example, there is sometimes a perception that fellows with children “burden” fellows who are not parents.^3,19 On the other hand, fellows without children may feel that they are called on more than their colleagues with children to cover those with childcare issues. In addition, as a recent study of general surgery residency program directors indicates, there are complex interpersonal issues that play into a colleague’s willingness to provide coverage.²⁰ It behooves program leadership to be cognizant of group dynamics that might cause conflict over what should be a straightforward coverage situation.

We first researched national and societal guidelines if available, as well as our institution’s graduate medical education (GME) website. We categorized benefits by whether they were federal, state-mandated, or institutional. It is important to note that any concerns about trainee salaries should be discussed with one’s GME office to ensure the leave policy is in accordance with federal funding policies.²¹ We solicited experiences and advice from former and current fellows who had gone through, or were planning, pregnancy and parental leave. A few faculty members volunteered to serve as a resource for fellows; these “ambassadors” discussed their experiences during a lunchtime panel, as well as offered to provide one-on-one advice and participate in future panels. We also reached out to our infection control experts to review the literature and federal policies on infections of special consideration during pregnancy and endoscopy. As for radiation safety, given the importance of education and active monitoring, we offer the option of reaching out to our radiation safety officer for individualized counseling.²²

Based on these efforts, we drafted a written policy designed for pregnant fellows and fellows planning parental leave on expectations for the program and fellows, benefits, and advice, including childcare options, lactation room locations, and financial planning tips. We shared this document with fellows and incorporated feedback. As a “living document” it is subject to change and will be updated as needed (at least annually).
 

Additional planning considerations for fellows

Research childcare options (ideally 6 months or more before leave).

• Start to explore your institution’s resources for leave and childcare options (daycare waitlists may be greater than 1 year in some cities).

Inform your program director (4-5 months before leave).

• Consider informing your program director about pregnancy at the beginning of the second trimester.
• Discuss Accreditation Council for Graduate Medical Education requirements and scheduling responsibilities.
• Explicitly discuss whether you plan to graduate on time or extend fellowship.

Inform your colleagues and patients (at least 3-4 months before leave).

• If comfortable, consider getting advice from a co-fellow and/or faculty mentor parent to facilitate transition to parenthood.
• When you feel ready, begin trading rotations and calls with co-fellows. If you have a results inbox or pager, discuss who can help cover those during your leave.
• Inform research collaborators about your leave and make preparations to keep projects progressing during your leave.
• If you have “active” clinic patients, when appropriate, begin to inform them that you will be away and provide reassurance that a colleague will be covering you. Leave clear plans with contingencies for these patients in your last progress notes.

Complete institutional paperwork and map out facilities (at least 2-3 months before leave).

• Review your options for using time toward leave, including vacation, research, or Family and Medical Leave Act–provided leave (unpaid), and what paperwork you need to fill out.
• Contact your payroll and/or human resources office to inform them of birth/adoption.
• Research potential program parental benefits, such as dependent daycare and/or health care flexible spending accounts.
• If choosing to breastfeed, explore the lactation rooms that are closest to your workroom and endoscopy suite and determine how much time you will need to set aside for pumping.

Be prepared to make adjustments as needed.

• Endoscopy-heavy rotations may be more difficult in the third trimester of pregnancy.
• Make contingency plans for early or late delivery dates, as well as if you undergo a cesarean that requires additional recovery time.
• Consider scheduling elective rotations (research, clinic) toward the end of leave and for the first month of “return to work.”
• If you plan to join limited clinic or outpatient endoscopy blocks later in your leave, make early arrangements to work regularly with these attendings.

Conclusion

Trainee needs assessments in gastroenterology fellowship similar to those in other specialties should be performed, and are in fact underway.^19,23,24 There is a lack of data regarding the availability of fellowship program guidance and, specifically, adherence to required policies, and more data from program directors at a national level need to be collected.²⁰ We recommend that programs engage in identifying specific needs at their institutions with the goal of eventually sharing this knowledge with other programs. Gastroenterology society recommendations for performing endoscopy while pregnant, with regard to ergonomics, infection control, and radiation exposure, would be instrumental. GI fellowships should consolidate institutional knowledge and engage key stakeholders – including trainees, prior trainees, occupational safety experts, radiation safety offices, wellness experts, and GME – to create program-specific policies that are flexible but rigorous and generous but equitable.

Dr. Liu and Dr. Summa are gastroenterology fellows at Northwestern University, Chicago. Dr. Patel is an assistant professor of medicine and a gastroenterology fellowship assistant program director at Northwestern University, Chicago. Dr. Donnan and Dr. Guentner are assistant professors of medicine at Northwestern University. Dr. Kia is an assistant professor of medicine and the gastroenterology fellowship program director at Northwestern University. They have no conflicts of interest to disclose. The authors would like to thank Michelle Clermont, MD, and Maureen K. Bolon, MD, for their discussion and assistance during the drafting of this article.

References

1. Section on Medical Students, Residents, and Fellowship Trainees; Committee on Early Childhood. Pediatrics. 2013;131(2):387-90.

2. American Board of Medical Specialties. ABMS Announces Progressive Leave Policy for Residents and Fellows. July 13, 2020. Accessed May 1, 2021. https://www.abms.org/news-events/abms-announces-progressive-leave-policy-for-residents-and-fellows/.

3. Magudia K et al. J Grad Med Educ. 2020;12(2):162-7.

4. Blair JE et al. Acad Med. 2016;91(7):972-8.

5. Feld LD. Am J Gastroenterol. 2021;116(3):505-8.

6. Roubaud MS. Plast Reconstr Surg Glob Open. 2019. doi: 10.1097/GOX.0000000000002104.

7. Price J, Dunbar K. Gastrointest Endosc. 2009;69(1):121-3.

8. David YN et al. Gastrointest Endosc. 2020;91(6):AB75-AB76.

9. Webb AMB et al. Acad Med J Assoc Am Med Coll. 2019;94(11):1631-4.

10. Weinstein DF et al. N Engl J Med. 2019 Sep 12;381(11):995-7.

11. Anderson M, Goldman RH. JAMA Surg. 2020;155(3):243-9.

12. Palmer KT et al. Occup Environ Med. 2013;70(4):213-22.

13. Siegel JD et al; Healthcare Infection, Control Practices Advisory Committee. Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007). 2007. Last reviewed July 22, 2019. Accessed April 28, 2021. https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html

14. David YN et al. Am J Gastroenterol. 2021;116(3):539-50.

15. Sethi S et al. Dig Dis Sci. 2019;64(9):2455-66.

16. Alzimami K et al. Gastroenterol Res Pract. 2013;2013:587574.

17. Hayashi S et al. World J Clin Cases. 2018;6(16):1087-93.

18. U.S. Department of Labor, Wage and Hour Division. “Frequently Asked Questions – Break Time for Nursing Mothers.” Accessed May 1, 2021. https://www.dol.gov/agencies/whd/nursing-mothers/faq.

19. Mwakyanjala EJ et al. J Am Heart Assoc. 2019. doi: 10.1161/JAHA.119.012137.

20. Castillo-Angeles M et al. JAMA Surg. 2021 Jul 1;156(7):647-53.

21. Prasad S et al. J Grad Med Educ. 2021 Jun;13(3):349-54.

22. Ho IKH et al. Am J Gastroenterol. 2014;109(8):1180-94.

23. Sherbaf FG et al. AJNR Am J Neuroradiol. 2020;41(8):1348-54.

24. Altieri MS et al. JAMA Surg. 2019;154(10):952-58.

Due to broad social changes and efforts from leaders in GI, there is renewed interest in family planning and parental leave policies for GI trainees. The American Board of Medical Specialties now permits trainees a minimum of 6 weeks away during training, without automatically requiring an extension of training time or completely depleting vacation time, for boards eligibility.^1,2 However, national and institutional guidance for family planning and pregnancy during GI fellowship is lacking. How can gastroenterology fellowship programs support fellows taking parental leave and enact fair policies? We review the scope of the problem, describe our experience in developing resources within our GI fellowship program, and highlight areas that require further development.

The scope of the issue

There is no national data yet on the number of GI fellows that are parents prior to starting fellowship or who become parents during fellowship. We estimate that approximately 25% of fellows enter training as parents or become parents during fellowship, although 40%-50% may have an intention to have children.^3,4 Fellows may be worried that they will “fall behind” or be perceived as less committed if they devote time to childrearing or take parental leave.^5-7 Indeed, worries about discrimination based on pregnancy and parental leave are borne out by the experiences of older physicians (in particular, female physicians).^8,9

State- and institution-specific benefits vary from program to program. Nationally, the Family and Medical Leave Act provides only unpaid leave and applies only to trainees who have been employed for greater than 12 months.¹⁰ Benefits may not always be well advertised, and even when they are, trainees (and attendings) may feel uncomfortable taking full advantage. One survey of GIs revealed that, although two-thirds believed that 6-8 weeks of maternity leave was inadequate, half took less than that amount due to fears about financial and professional consequences.⁸

Pregnancy during GI fellowship is a special concern. GI fellowship consists of long work hours, includes night call, and can be physically demanding. All three of these factors have been associated with preterm delivery, infertility, and miscarriage.^11,12 In addition, there are no guidelines for ergonomic adjustments or infection precautions for pregnant endoscopists. We have compiled information about infection prevention guidance in pregnancy (available from the authors on request) derived from guidance from the National Institute for Occupational Safety and Health, which recommends the same precautions for pregnant health care workers as for nonpregnant health care workers.¹³ In regards to SARS-CoV-2, we believe that the decision to perform procedures on patients with COVID-19 infection should be individualized, although vaccinated endoscopists should be reassured by the exceedingly low rates of infection after vaccination and with appropriate personal protective equipment. Radiation is yet another concern. There are limited data on radiation dosages incurred by workers in the endoscopy suite and no pregnancy-specific data, which may lead trainees to avoid fluoroscopic procedures and unnecessarily double up on lead gowns.^8,11,14-17

Breastfeeding accommodations, and access to lactation rooms for trainees, are required by federal law for a minimum of 12 months.¹⁸ Should a trainee choose to breastfeed, education of staff and attendings is critical because many may be unaware of the specific needs pertaining to lactation. Staff should be aware that 30-45 minutes are needed to prepare, pump, and store milk. Trainees should not be solely responsible for educating their attendings and staff.
 

Our Experience in Creating a Policy

We developed a formal fellowship program policy on parental leave and pregnancy in the setting of a broader discussion about fellow workload and wellness. We agreed that trainees should be allowed to make changes to their schedule with co-fellows as needed for medical appointments or procedures and that our backup policy should be flexible enough to provide spot coverage for unexpected complications and family emergencies. We also incorporated a GI psychologist to provide wellness resources and suggestions for reducing burnout for our fellows.

We strove to follow certain principles in creating this policy. Trainees who are parents should have a comparable clinical experience to their nonparenting colleagues and should take the lead in rearranging their own schedule. Nonbirthing parents, adopting parents, and parents using surrogacy should be included in any parental leave policy. Fellowship leaders have an important responsibility in helping fellows proactively plan to meet requirements for graduation and maximize learning and exposure (Figure). We also recognized the importance of equitable coverage. For example, there is sometimes a perception that fellows with children “burden” fellows who are not parents.^3,19 On the other hand, fellows without children may feel that they are called on more than their colleagues with children to cover those with childcare issues. In addition, as a recent study of general surgery residency program directors indicates, there are complex interpersonal issues that play into a colleague’s willingness to provide coverage.²⁰ It behooves program leadership to be cognizant of group dynamics that might cause conflict over what should be a straightforward coverage situation.

We first researched national and societal guidelines if available, as well as our institution’s graduate medical education (GME) website. We categorized benefits by whether they were federal, state-mandated, or institutional. It is important to note that any concerns about trainee salaries should be discussed with one’s GME office to ensure the leave policy is in accordance with federal funding policies.²¹ We solicited experiences and advice from former and current fellows who had gone through, or were planning, pregnancy and parental leave. A few faculty members volunteered to serve as a resource for fellows; these “ambassadors” discussed their experiences during a lunchtime panel, as well as offered to provide one-on-one advice and participate in future panels. We also reached out to our infection control experts to review the literature and federal policies on infections of special consideration during pregnancy and endoscopy. As for radiation safety, given the importance of education and active monitoring, we offer the option of reaching out to our radiation safety officer for individualized counseling.²²

Based on these efforts, we drafted a written policy designed for pregnant fellows and fellows planning parental leave on expectations for the program and fellows, benefits, and advice, including childcare options, lactation room locations, and financial planning tips. We shared this document with fellows and incorporated feedback. As a “living document” it is subject to change and will be updated as needed (at least annually).
 

Additional planning considerations for fellows

Research childcare options (ideally 6 months or more before leave).

• Start to explore your institution’s resources for leave and childcare options (daycare waitlists may be greater than 1 year in some cities).

Inform your program director (4-5 months before leave).

• Consider informing your program director about pregnancy at the beginning of the second trimester.
• Discuss Accreditation Council for Graduate Medical Education requirements and scheduling responsibilities.
• Explicitly discuss whether you plan to graduate on time or extend fellowship.

Inform your colleagues and patients (at least 3-4 months before leave).

• If comfortable, consider getting advice from a co-fellow and/or faculty mentor parent to facilitate transition to parenthood.
• When you feel ready, begin trading rotations and calls with co-fellows. If you have a results inbox or pager, discuss who can help cover those during your leave.
• Inform research collaborators about your leave and make preparations to keep projects progressing during your leave.
• If you have “active” clinic patients, when appropriate, begin to inform them that you will be away and provide reassurance that a colleague will be covering you. Leave clear plans with contingencies for these patients in your last progress notes.

Complete institutional paperwork and map out facilities (at least 2-3 months before leave).

• Review your options for using time toward leave, including vacation, research, or Family and Medical Leave Act–provided leave (unpaid), and what paperwork you need to fill out.
• Contact your payroll and/or human resources office to inform them of birth/adoption.
• Research potential program parental benefits, such as dependent daycare and/or health care flexible spending accounts.
• If choosing to breastfeed, explore the lactation rooms that are closest to your workroom and endoscopy suite and determine how much time you will need to set aside for pumping.

Be prepared to make adjustments as needed.

• Endoscopy-heavy rotations may be more difficult in the third trimester of pregnancy.
• Make contingency plans for early or late delivery dates, as well as if you undergo a cesarean that requires additional recovery time.
• Consider scheduling elective rotations (research, clinic) toward the end of leave and for the first month of “return to work.”
• If you plan to join limited clinic or outpatient endoscopy blocks later in your leave, make early arrangements to work regularly with these attendings.

Conclusion

Trainee needs assessments in gastroenterology fellowship similar to those in other specialties should be performed, and are in fact underway.^19,23,24 There is a lack of data regarding the availability of fellowship program guidance and, specifically, adherence to required policies, and more data from program directors at a national level need to be collected.²⁰ We recommend that programs engage in identifying specific needs at their institutions with the goal of eventually sharing this knowledge with other programs. Gastroenterology society recommendations for performing endoscopy while pregnant, with regard to ergonomics, infection control, and radiation exposure, would be instrumental. GI fellowships should consolidate institutional knowledge and engage key stakeholders – including trainees, prior trainees, occupational safety experts, radiation safety offices, wellness experts, and GME – to create program-specific policies that are flexible but rigorous and generous but equitable.

Dr. Liu and Dr. Summa are gastroenterology fellows at Northwestern University, Chicago. Dr. Patel is an assistant professor of medicine and a gastroenterology fellowship assistant program director at Northwestern University, Chicago. Dr. Donnan and Dr. Guentner are assistant professors of medicine at Northwestern University. Dr. Kia is an assistant professor of medicine and the gastroenterology fellowship program director at Northwestern University. They have no conflicts of interest to disclose. The authors would like to thank Michelle Clermont, MD, and Maureen K. Bolon, MD, for their discussion and assistance during the drafting of this article.

References

1. Section on Medical Students, Residents, and Fellowship Trainees; Committee on Early Childhood. Pediatrics. 2013;131(2):387-90.

2. American Board of Medical Specialties. ABMS Announces Progressive Leave Policy for Residents and Fellows. July 13, 2020. Accessed May 1, 2021. https://www.abms.org/news-events/abms-announces-progressive-leave-policy-for-residents-and-fellows/.

3. Magudia K et al. J Grad Med Educ. 2020;12(2):162-7.

4. Blair JE et al. Acad Med. 2016;91(7):972-8.

5. Feld LD. Am J Gastroenterol. 2021;116(3):505-8.

6. Roubaud MS. Plast Reconstr Surg Glob Open. 2019. doi: 10.1097/GOX.0000000000002104.

7. Price J, Dunbar K. Gastrointest Endosc. 2009;69(1):121-3.

8. David YN et al. Gastrointest Endosc. 2020;91(6):AB75-AB76.

9. Webb AMB et al. Acad Med J Assoc Am Med Coll. 2019;94(11):1631-4.

10. Weinstein DF et al. N Engl J Med. 2019 Sep 12;381(11):995-7.

11. Anderson M, Goldman RH. JAMA Surg. 2020;155(3):243-9.

12. Palmer KT et al. Occup Environ Med. 2013;70(4):213-22.

13. Siegel JD et al; Healthcare Infection, Control Practices Advisory Committee. Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007). 2007. Last reviewed July 22, 2019. Accessed April 28, 2021. https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html

14. David YN et al. Am J Gastroenterol. 2021;116(3):539-50.

15. Sethi S et al. Dig Dis Sci. 2019;64(9):2455-66.

16. Alzimami K et al. Gastroenterol Res Pract. 2013;2013:587574.

17. Hayashi S et al. World J Clin Cases. 2018;6(16):1087-93.

18. U.S. Department of Labor, Wage and Hour Division. “Frequently Asked Questions – Break Time for Nursing Mothers.” Accessed May 1, 2021. https://www.dol.gov/agencies/whd/nursing-mothers/faq.

19. Mwakyanjala EJ et al. J Am Heart Assoc. 2019. doi: 10.1161/JAHA.119.012137.

20. Castillo-Angeles M et al. JAMA Surg. 2021 Jul 1;156(7):647-53.

21. Prasad S et al. J Grad Med Educ. 2021 Jun;13(3):349-54.

22. Ho IKH et al. Am J Gastroenterol. 2014;109(8):1180-94.

23. Sherbaf FG et al. AJNR Am J Neuroradiol. 2020;41(8):1348-54.

24. Altieri MS et al. JAMA Surg. 2019;154(10):952-58.

Proposals for a new mandatory payment model for radiation oncology have been met with strong pushback from the medical community. The new model would cut payments for some high-value radiation treatment by 22% in order to save an estimated $160 million.

The changes, proposed by the Centers for Medicare & Medicaid Services to their Radiation Oncology (RO) Model, have been challenged primarily by the American Society for Radiation Oncology (ASTRO), but by other groups as well.

These excessive reductions will jeopardize access to lifesaving radiation therapy services for Medicare beneficiaries at a time when the U.S. health care system needs “all doors open” to treat patients with cancer, says ASTRO.  

The proposed cuts are scheduled to take effect Jan. 1 and will be mandatory for the 30% of providers that will be randomly selected to participate.

The timing could not be worse, says the Community Oncology Alliance. “How can payment be ratcheted down on a vital aspect of cancer in the middle of a pandemic?” said Ted Okon, MBA, executive director of COA. “What was CMS thinking? These are extreme circumstances, and this is so ill-timed and so tone deaf that it just takes my breath away.”

He pointed out that with hospitals being overrun with COVID-19 patients, community practices have to keep their doors open to treat patients. “This is an extended public health emergency, and a variant can reignite the surge,” said Mr. Okon. “CMS should be asking practices what they can do to help them – and not trying to make drastic cuts.”

Mr. Okon is also concerned that as a result of the pandemic, “we are going to be seeing more advanced cancers, which are more difficult and expensive to treat, and radiation therapy is going to come into play,” he said. “These are serious and unintended consequences, and CMS needs to come out of their [Washington] D.C. bubble and see what’s really going on.”

The timing of the rollout is particularly precarious, given the financial upheaval caused by the COVID-19 pandemic, agrees Constantine Mantz, MD, ASTRO’s Health Policy Council vice-chair.

“Medicare’s proposed cuts, unfortunately, compound the enormous financial challenges imposed by the COVID-19 pandemic on physicians and their practices,” said Dr. Mantz. “Radiation oncology is particularly at risk given its dependence on expensive treatment equipment to deliver cancer care.”

The high costs of maintaining this equipment remain the same whether the equipment is used or not. “This means that fewer patients being seen during the pandemic combined with these steep reimbursement cuts in the near future risk the continued viability of many centers and their ability to provide lifesaving cancer treatment,” he said.
 

ASTRO calls on Congress to intervene

ASTRO has asked President Biden and Congress to intervene immediately on not only the Radiation Oncology model but the severe cuts that were proposed for the 2022 Medicare Physician Fee Schedule.

“The RO Model, which was last updated in the 2022 Medicare Hospital Outpatient Prospective Payment System Proposed Rule, would cut payments for radiation therapy services by 3.75% for physicians and 4.75% for facilities,” said Dr. Mantz. “This cut would be in addition to an 8.75% cut to radiation oncology in the 2022 Medicare Physician Fee Schedule Proposed Rule.”

As a result, the physicians and facilities that are required to participate in the RO Model are facing steep declines in Medicare reimbursement. “This amounts to well over 10% for their patients covered by Medicare next year,” Dr. Mantz told this news organization.
 

The radiation oncology model

The goal of the RO Model is to test a change in the way radiation therapy services are paid – from the current “fee-for-service” payments” to prospective, site-neutral, modality-agnostic, episode-based payments that incentivize physicians to deliver higher-value care. It requires mandatory participation of practices.

The Center for Medicare and Medicaid Innovation published a final rule in September 2020 that established the RO Model, which was to begin on Jan. 1, 2021. However, because of the ongoing COVID-19 pandemic, the start of the RO Model was delayed until July 1, 2021, and subsequently, the Consolidated Appropriations Act, 2021, included a provision that prohibits implementation of the RO Model before Jan. 1, 2022.

Further changes to the RO model were proposed last month, which included some slight revisions to the discount factor. But ASTRO points out that these revisions did not address numerous concerns raised by both the radiation oncology community and a broad coalition of medical provider groups, patients, hospitals, health systems, and bipartisan members of Congress.

The new model would provide an alternative to the traditional fee-for-service payments. Instead, the payments are prospective and episode-based, and based on the cancer diagnosis. It would cover radiation therapy that is administered during a 90-day episode, and would meet the included cancer type criteria described in the final rule.

The RO model would use “site-neutral payment” by establishing a common, adjusted national base payment amount for the episode, regardless of the setting where it is administered.

The episode payments would be divided into professional and technical components to allow the current claims systems for the Physician Fee Schedule (PFS) and the Outpatient Prospective Payment System (OPPS) to be used to adjudicate claims as well as to maintain consistency with existing business relationships.

Another aspect is that the model links “payment” to “quality” using reporting and performance on quality measures, clinical data reporting, and patient experience as factors when determining payment to RO participants. Finally, providers will be randomly selected and participation is mandatory.

Mr. Okon feels that the idea of a mandatory model is wrong. “They are going to be taking 30% of practices to participate in an experiment,” he said. “Mandatory means that you can’t get enough people to participate so it is mandated to force them into it.”

Dr. Mantz also noted that the model is going to have a widespread impact on a wide range of issues. “Sharply reduced reimbursement for radiation therapy services under the RO Model is expected to delay, if not prevent, the equipment upgrades and other improvements that are necessary for practices to continue to provide high-quality, high-value cancer care.

“These problematic barriers to access advanced treatment technology also come at a critical time for radiation oncology, in that we already are seeing more difficult-to-treat cancers and caring for patients with more advanced-stage diseases due to delayed diagnoses during the peak of the pandemic last year.”

In addition, the RO model, in its current inception, is expected to further widen existing gaps in access to cancer care, disproportionately harming patients from marginalized groups, such as poor patients and medically underserved patients.

“For example, ASTRO analyses have demonstrated that patients in rural areas currently face significantly reduced access to stereotactic radiotherapy and lifesaving brachytherapy treatments, compared to patients in urban areas,” said Dr. Mantz. “It’s difficult to imagine that these serious health inequities could even begin to be addressed with the aggregate payment cuts imposed by the RO model.”

A version of this article first appeared on Medscape.com.

Proposals for a new mandatory payment model for radiation oncology have been met with strong pushback from the medical community. The new model would cut payments for some high-value radiation treatment by 22% in order to save an estimated $160 million.

The changes, proposed by the Centers for Medicare & Medicaid Services to their Radiation Oncology (RO) Model, have been challenged primarily by the American Society for Radiation Oncology (ASTRO), but by other groups as well.

These excessive reductions will jeopardize access to lifesaving radiation therapy services for Medicare beneficiaries at a time when the U.S. health care system needs “all doors open” to treat patients with cancer, says ASTRO.  

The proposed cuts are scheduled to take effect Jan. 1 and will be mandatory for the 30% of providers that will be randomly selected to participate.

The timing could not be worse, says the Community Oncology Alliance. “How can payment be ratcheted down on a vital aspect of cancer in the middle of a pandemic?” said Ted Okon, MBA, executive director of COA. “What was CMS thinking? These are extreme circumstances, and this is so ill-timed and so tone deaf that it just takes my breath away.”

He pointed out that with hospitals being overrun with COVID-19 patients, community practices have to keep their doors open to treat patients. “This is an extended public health emergency, and a variant can reignite the surge,” said Mr. Okon. “CMS should be asking practices what they can do to help them – and not trying to make drastic cuts.”

Mr. Okon is also concerned that as a result of the pandemic, “we are going to be seeing more advanced cancers, which are more difficult and expensive to treat, and radiation therapy is going to come into play,” he said. “These are serious and unintended consequences, and CMS needs to come out of their [Washington] D.C. bubble and see what’s really going on.”

The timing of the rollout is particularly precarious, given the financial upheaval caused by the COVID-19 pandemic, agrees Constantine Mantz, MD, ASTRO’s Health Policy Council vice-chair.

“Medicare’s proposed cuts, unfortunately, compound the enormous financial challenges imposed by the COVID-19 pandemic on physicians and their practices,” said Dr. Mantz. “Radiation oncology is particularly at risk given its dependence on expensive treatment equipment to deliver cancer care.”

The high costs of maintaining this equipment remain the same whether the equipment is used or not. “This means that fewer patients being seen during the pandemic combined with these steep reimbursement cuts in the near future risk the continued viability of many centers and their ability to provide lifesaving cancer treatment,” he said.
 

ASTRO calls on Congress to intervene

ASTRO has asked President Biden and Congress to intervene immediately on not only the Radiation Oncology model but the severe cuts that were proposed for the 2022 Medicare Physician Fee Schedule.

“The RO Model, which was last updated in the 2022 Medicare Hospital Outpatient Prospective Payment System Proposed Rule, would cut payments for radiation therapy services by 3.75% for physicians and 4.75% for facilities,” said Dr. Mantz. “This cut would be in addition to an 8.75% cut to radiation oncology in the 2022 Medicare Physician Fee Schedule Proposed Rule.”

As a result, the physicians and facilities that are required to participate in the RO Model are facing steep declines in Medicare reimbursement. “This amounts to well over 10% for their patients covered by Medicare next year,” Dr. Mantz told this news organization.
 

The radiation oncology model

The goal of the RO Model is to test a change in the way radiation therapy services are paid – from the current “fee-for-service” payments” to prospective, site-neutral, modality-agnostic, episode-based payments that incentivize physicians to deliver higher-value care. It requires mandatory participation of practices.

The Center for Medicare and Medicaid Innovation published a final rule in September 2020 that established the RO Model, which was to begin on Jan. 1, 2021. However, because of the ongoing COVID-19 pandemic, the start of the RO Model was delayed until July 1, 2021, and subsequently, the Consolidated Appropriations Act, 2021, included a provision that prohibits implementation of the RO Model before Jan. 1, 2022.

Further changes to the RO model were proposed last month, which included some slight revisions to the discount factor. But ASTRO points out that these revisions did not address numerous concerns raised by both the radiation oncology community and a broad coalition of medical provider groups, patients, hospitals, health systems, and bipartisan members of Congress.

The new model would provide an alternative to the traditional fee-for-service payments. Instead, the payments are prospective and episode-based, and based on the cancer diagnosis. It would cover radiation therapy that is administered during a 90-day episode, and would meet the included cancer type criteria described in the final rule.

The RO model would use “site-neutral payment” by establishing a common, adjusted national base payment amount for the episode, regardless of the setting where it is administered.

The episode payments would be divided into professional and technical components to allow the current claims systems for the Physician Fee Schedule (PFS) and the Outpatient Prospective Payment System (OPPS) to be used to adjudicate claims as well as to maintain consistency with existing business relationships.

Another aspect is that the model links “payment” to “quality” using reporting and performance on quality measures, clinical data reporting, and patient experience as factors when determining payment to RO participants. Finally, providers will be randomly selected and participation is mandatory.

Mr. Okon feels that the idea of a mandatory model is wrong. “They are going to be taking 30% of practices to participate in an experiment,” he said. “Mandatory means that you can’t get enough people to participate so it is mandated to force them into it.”

Dr. Mantz also noted that the model is going to have a widespread impact on a wide range of issues. “Sharply reduced reimbursement for radiation therapy services under the RO Model is expected to delay, if not prevent, the equipment upgrades and other improvements that are necessary for practices to continue to provide high-quality, high-value cancer care.

“These problematic barriers to access advanced treatment technology also come at a critical time for radiation oncology, in that we already are seeing more difficult-to-treat cancers and caring for patients with more advanced-stage diseases due to delayed diagnoses during the peak of the pandemic last year.”

In addition, the RO model, in its current inception, is expected to further widen existing gaps in access to cancer care, disproportionately harming patients from marginalized groups, such as poor patients and medically underserved patients.

“For example, ASTRO analyses have demonstrated that patients in rural areas currently face significantly reduced access to stereotactic radiotherapy and lifesaving brachytherapy treatments, compared to patients in urban areas,” said Dr. Mantz. “It’s difficult to imagine that these serious health inequities could even begin to be addressed with the aggregate payment cuts imposed by the RO model.”

A version of this article first appeared on Medscape.com.

Proposals for a new mandatory payment model for radiation oncology have been met with strong pushback from the medical community. The new model would cut payments for some high-value radiation treatment by 22% in order to save an estimated $160 million.

The changes, proposed by the Centers for Medicare & Medicaid Services to their Radiation Oncology (RO) Model, have been challenged primarily by the American Society for Radiation Oncology (ASTRO), but by other groups as well.

These excessive reductions will jeopardize access to lifesaving radiation therapy services for Medicare beneficiaries at a time when the U.S. health care system needs “all doors open” to treat patients with cancer, says ASTRO.  

The proposed cuts are scheduled to take effect Jan. 1 and will be mandatory for the 30% of providers that will be randomly selected to participate.

The timing could not be worse, says the Community Oncology Alliance. “How can payment be ratcheted down on a vital aspect of cancer in the middle of a pandemic?” said Ted Okon, MBA, executive director of COA. “What was CMS thinking? These are extreme circumstances, and this is so ill-timed and so tone deaf that it just takes my breath away.”

He pointed out that with hospitals being overrun with COVID-19 patients, community practices have to keep their doors open to treat patients. “This is an extended public health emergency, and a variant can reignite the surge,” said Mr. Okon. “CMS should be asking practices what they can do to help them – and not trying to make drastic cuts.”

Mr. Okon is also concerned that as a result of the pandemic, “we are going to be seeing more advanced cancers, which are more difficult and expensive to treat, and radiation therapy is going to come into play,” he said. “These are serious and unintended consequences, and CMS needs to come out of their [Washington] D.C. bubble and see what’s really going on.”

The timing of the rollout is particularly precarious, given the financial upheaval caused by the COVID-19 pandemic, agrees Constantine Mantz, MD, ASTRO’s Health Policy Council vice-chair.

“Medicare’s proposed cuts, unfortunately, compound the enormous financial challenges imposed by the COVID-19 pandemic on physicians and their practices,” said Dr. Mantz. “Radiation oncology is particularly at risk given its dependence on expensive treatment equipment to deliver cancer care.”

The high costs of maintaining this equipment remain the same whether the equipment is used or not. “This means that fewer patients being seen during the pandemic combined with these steep reimbursement cuts in the near future risk the continued viability of many centers and their ability to provide lifesaving cancer treatment,” he said.
 

ASTRO calls on Congress to intervene

ASTRO has asked President Biden and Congress to intervene immediately on not only the Radiation Oncology model but the severe cuts that were proposed for the 2022 Medicare Physician Fee Schedule.

“The RO Model, which was last updated in the 2022 Medicare Hospital Outpatient Prospective Payment System Proposed Rule, would cut payments for radiation therapy services by 3.75% for physicians and 4.75% for facilities,” said Dr. Mantz. “This cut would be in addition to an 8.75% cut to radiation oncology in the 2022 Medicare Physician Fee Schedule Proposed Rule.”

As a result, the physicians and facilities that are required to participate in the RO Model are facing steep declines in Medicare reimbursement. “This amounts to well over 10% for their patients covered by Medicare next year,” Dr. Mantz told this news organization.
 

The radiation oncology model

The goal of the RO Model is to test a change in the way radiation therapy services are paid – from the current “fee-for-service” payments” to prospective, site-neutral, modality-agnostic, episode-based payments that incentivize physicians to deliver higher-value care. It requires mandatory participation of practices.

The Center for Medicare and Medicaid Innovation published a final rule in September 2020 that established the RO Model, which was to begin on Jan. 1, 2021. However, because of the ongoing COVID-19 pandemic, the start of the RO Model was delayed until July 1, 2021, and subsequently, the Consolidated Appropriations Act, 2021, included a provision that prohibits implementation of the RO Model before Jan. 1, 2022.

Further changes to the RO model were proposed last month, which included some slight revisions to the discount factor. But ASTRO points out that these revisions did not address numerous concerns raised by both the radiation oncology community and a broad coalition of medical provider groups, patients, hospitals, health systems, and bipartisan members of Congress.

The new model would provide an alternative to the traditional fee-for-service payments. Instead, the payments are prospective and episode-based, and based on the cancer diagnosis. It would cover radiation therapy that is administered during a 90-day episode, and would meet the included cancer type criteria described in the final rule.

The RO model would use “site-neutral payment” by establishing a common, adjusted national base payment amount for the episode, regardless of the setting where it is administered.

The episode payments would be divided into professional and technical components to allow the current claims systems for the Physician Fee Schedule (PFS) and the Outpatient Prospective Payment System (OPPS) to be used to adjudicate claims as well as to maintain consistency with existing business relationships.

Another aspect is that the model links “payment” to “quality” using reporting and performance on quality measures, clinical data reporting, and patient experience as factors when determining payment to RO participants. Finally, providers will be randomly selected and participation is mandatory.

Mr. Okon feels that the idea of a mandatory model is wrong. “They are going to be taking 30% of practices to participate in an experiment,” he said. “Mandatory means that you can’t get enough people to participate so it is mandated to force them into it.”

Dr. Mantz also noted that the model is going to have a widespread impact on a wide range of issues. “Sharply reduced reimbursement for radiation therapy services under the RO Model is expected to delay, if not prevent, the equipment upgrades and other improvements that are necessary for practices to continue to provide high-quality, high-value cancer care.

“These problematic barriers to access advanced treatment technology also come at a critical time for radiation oncology, in that we already are seeing more difficult-to-treat cancers and caring for patients with more advanced-stage diseases due to delayed diagnoses during the peak of the pandemic last year.”

In addition, the RO model, in its current inception, is expected to further widen existing gaps in access to cancer care, disproportionately harming patients from marginalized groups, such as poor patients and medically underserved patients.

“For example, ASTRO analyses have demonstrated that patients in rural areas currently face significantly reduced access to stereotactic radiotherapy and lifesaving brachytherapy treatments, compared to patients in urban areas,” said Dr. Mantz. “It’s difficult to imagine that these serious health inequities could even begin to be addressed with the aggregate payment cuts imposed by the RO model.”

A version of this article first appeared on Medscape.com.