A three-pronged treatment approach can produce responses in indolent non-Hodgkin lymphoma (iNHL), according to research published in Nature Medicine.

The approach – “in situ vaccination (ISV)” – involves intratumoral injections of Fms-like tyrosine kinase 3 ligand (Flt3L), local radiotherapy, and intratumoral injections of a TLR3 agonist (poly-ICLC).

ISV produced responses in patients with iNHL, prompting regression of tumors that were directly targeted with ISV, as well as untreated tumors.

In preclinical experiments, ISV induced tumor regression in mice but also overcame resistance to PD1 inhibition. This result led researchers to initiate a trial testing ISV in combination with pembrolizumab in patients with lymphoma and solid tumors.

“We discovered why some tumors do not respond to PD1 blockade: insufficient dendritic cells (DCs) and cross-presentation,” lead study author Joshua Brody, MD, of the Icahn School of Medicine at Mount Sinai, New York, said in an interview. “We developed a treatment, in situ vaccination (ISV), which brings DCs to the tumor, loads them with tumor antigens, and activates the DCs.”

Specifically, the researchers found that injecting Flt3L into a tumor recruits intratumoral DCs, local radiotherapy loads the DCs with tumor-associated antigens, and poly-ICLC activates DCs. This approach produced responses in mouse models of lymphoma and patients with iNHL.
 

Preclinical results

Dr. Brody and his colleagues tested ISV in A20 tumor-bearing mice. The mice received intratumoral injections of Flt3L, followed by local radiotherapy and poly-ICLC.

Tumor regression occurred within days of radiotherapy. About 40% of mice experienced tumor-free survival of at least 3 months, although most tumors recurred within 4 weeks of ISV administration.

However, the researchers observed increased PD1 and PD-L1 expression in ISV-treated mice, so the team theorized that an anti-PD1 monoclonal antibody (RMP1-14) could improve the efficacy of ISV.

The researchers found that ISV plus RMP1-14 delayed tumor growth when compared with ISV alone, and the rate of durable remissions increased from about 40% to about 80%.
 

Clinical results

Dr. Brody and his colleagues also tested ISV in a clinical trial. That trial included 11 iNHL patients – 9 with follicular lymphoma, 1 with marginal zone lymphoma, and 1 with small lymphocytic lymphoma.

The patients received nine daily injections of Flt3L (25 mcg/kg) into a target lesion, then two doses of radiation (2 Gy) to the same lesion, and eight intratumoral injections of poly-ICLC (2 mg).

“We ... have observed dramatic clinical responses; i.e., we administer ISV at one tumor site, and tumors throughout the body regress,” Dr. Brody said.

At the target lesion, there were two complete responses, six partial responses, and three cases of stable disease. At nontarget lesions, there was one complete response, two partial responses, six cases of stable disease, and two cases of progression.

ISV was considered well tolerated. One patient had grade 2 fever, three had grade 1 fever, and nine had grade 1 flu-like symptoms. Two patients did not have any adverse events.

This research was supported by Merck, Celldex Therapeutics, Oncovir, and Genentech. The authors reported relationships with Acerta Pharma, Bristol Myers Squibb, Genentech, Gilead Sciences, Seattle Genetics, Pharmacyclics, Celgene, Celldex Therapeutics, and Oncovir.

[email protected]

SOURCE: Hammerich L et al. Nat Med. 2019 Apr 8. doi: 10.1038/s41591-019-0410-x.

A three-pronged treatment approach can produce responses in indolent non-Hodgkin lymphoma (iNHL), according to research published in Nature Medicine.

The approach – “in situ vaccination (ISV)” – involves intratumoral injections of Fms-like tyrosine kinase 3 ligand (Flt3L), local radiotherapy, and intratumoral injections of a TLR3 agonist (poly-ICLC).

ISV produced responses in patients with iNHL, prompting regression of tumors that were directly targeted with ISV, as well as untreated tumors.

In preclinical experiments, ISV induced tumor regression in mice but also overcame resistance to PD1 inhibition. This result led researchers to initiate a trial testing ISV in combination with pembrolizumab in patients with lymphoma and solid tumors.

“We discovered why some tumors do not respond to PD1 blockade: insufficient dendritic cells (DCs) and cross-presentation,” lead study author Joshua Brody, MD, of the Icahn School of Medicine at Mount Sinai, New York, said in an interview. “We developed a treatment, in situ vaccination (ISV), which brings DCs to the tumor, loads them with tumor antigens, and activates the DCs.”

Specifically, the researchers found that injecting Flt3L into a tumor recruits intratumoral DCs, local radiotherapy loads the DCs with tumor-associated antigens, and poly-ICLC activates DCs. This approach produced responses in mouse models of lymphoma and patients with iNHL.
 

Preclinical results

Dr. Brody and his colleagues tested ISV in A20 tumor-bearing mice. The mice received intratumoral injections of Flt3L, followed by local radiotherapy and poly-ICLC.

Tumor regression occurred within days of radiotherapy. About 40% of mice experienced tumor-free survival of at least 3 months, although most tumors recurred within 4 weeks of ISV administration.

However, the researchers observed increased PD1 and PD-L1 expression in ISV-treated mice, so the team theorized that an anti-PD1 monoclonal antibody (RMP1-14) could improve the efficacy of ISV.

The researchers found that ISV plus RMP1-14 delayed tumor growth when compared with ISV alone, and the rate of durable remissions increased from about 40% to about 80%.
 

Clinical results

Dr. Brody and his colleagues also tested ISV in a clinical trial. That trial included 11 iNHL patients – 9 with follicular lymphoma, 1 with marginal zone lymphoma, and 1 with small lymphocytic lymphoma.

The patients received nine daily injections of Flt3L (25 mcg/kg) into a target lesion, then two doses of radiation (2 Gy) to the same lesion, and eight intratumoral injections of poly-ICLC (2 mg).

“We ... have observed dramatic clinical responses; i.e., we administer ISV at one tumor site, and tumors throughout the body regress,” Dr. Brody said.

At the target lesion, there were two complete responses, six partial responses, and three cases of stable disease. At nontarget lesions, there was one complete response, two partial responses, six cases of stable disease, and two cases of progression.

ISV was considered well tolerated. One patient had grade 2 fever, three had grade 1 fever, and nine had grade 1 flu-like symptoms. Two patients did not have any adverse events.

This research was supported by Merck, Celldex Therapeutics, Oncovir, and Genentech. The authors reported relationships with Acerta Pharma, Bristol Myers Squibb, Genentech, Gilead Sciences, Seattle Genetics, Pharmacyclics, Celgene, Celldex Therapeutics, and Oncovir.

[email protected]

SOURCE: Hammerich L et al. Nat Med. 2019 Apr 8. doi: 10.1038/s41591-019-0410-x.

A three-pronged treatment approach can produce responses in indolent non-Hodgkin lymphoma (iNHL), according to research published in Nature Medicine.

The approach – “in situ vaccination (ISV)” – involves intratumoral injections of Fms-like tyrosine kinase 3 ligand (Flt3L), local radiotherapy, and intratumoral injections of a TLR3 agonist (poly-ICLC).

ISV produced responses in patients with iNHL, prompting regression of tumors that were directly targeted with ISV, as well as untreated tumors.

In preclinical experiments, ISV induced tumor regression in mice but also overcame resistance to PD1 inhibition. This result led researchers to initiate a trial testing ISV in combination with pembrolizumab in patients with lymphoma and solid tumors.

“We discovered why some tumors do not respond to PD1 blockade: insufficient dendritic cells (DCs) and cross-presentation,” lead study author Joshua Brody, MD, of the Icahn School of Medicine at Mount Sinai, New York, said in an interview. “We developed a treatment, in situ vaccination (ISV), which brings DCs to the tumor, loads them with tumor antigens, and activates the DCs.”

Specifically, the researchers found that injecting Flt3L into a tumor recruits intratumoral DCs, local radiotherapy loads the DCs with tumor-associated antigens, and poly-ICLC activates DCs. This approach produced responses in mouse models of lymphoma and patients with iNHL.
 

Preclinical results

Dr. Brody and his colleagues tested ISV in A20 tumor-bearing mice. The mice received intratumoral injections of Flt3L, followed by local radiotherapy and poly-ICLC.

Tumor regression occurred within days of radiotherapy. About 40% of mice experienced tumor-free survival of at least 3 months, although most tumors recurred within 4 weeks of ISV administration.

However, the researchers observed increased PD1 and PD-L1 expression in ISV-treated mice, so the team theorized that an anti-PD1 monoclonal antibody (RMP1-14) could improve the efficacy of ISV.

The researchers found that ISV plus RMP1-14 delayed tumor growth when compared with ISV alone, and the rate of durable remissions increased from about 40% to about 80%.
 

Clinical results

Dr. Brody and his colleagues also tested ISV in a clinical trial. That trial included 11 iNHL patients – 9 with follicular lymphoma, 1 with marginal zone lymphoma, and 1 with small lymphocytic lymphoma.

The patients received nine daily injections of Flt3L (25 mcg/kg) into a target lesion, then two doses of radiation (2 Gy) to the same lesion, and eight intratumoral injections of poly-ICLC (2 mg).

“We ... have observed dramatic clinical responses; i.e., we administer ISV at one tumor site, and tumors throughout the body regress,” Dr. Brody said.

At the target lesion, there were two complete responses, six partial responses, and three cases of stable disease. At nontarget lesions, there was one complete response, two partial responses, six cases of stable disease, and two cases of progression.

ISV was considered well tolerated. One patient had grade 2 fever, three had grade 1 fever, and nine had grade 1 flu-like symptoms. Two patients did not have any adverse events.

This research was supported by Merck, Celldex Therapeutics, Oncovir, and Genentech. The authors reported relationships with Acerta Pharma, Bristol Myers Squibb, Genentech, Gilead Sciences, Seattle Genetics, Pharmacyclics, Celgene, Celldex Therapeutics, and Oncovir.

[email protected]

SOURCE: Hammerich L et al. Nat Med. 2019 Apr 8. doi: 10.1038/s41591-019-0410-x.

Chronic pain is common among veterans treated in Veterans Health Administration (VHA) facilities, and optimal management remains challenging in the context of the national opioid misuse epidemic. The Eastern Oklahoma VA Health Care System (EOVAHCS) Pain Program offers a range of services that allow clinicians to tailor multimodal treatment strategies to a veteran’s needs. In 2014, a Modality Clinic was established to assess the utility of adding noninvasive treatment devices to the pain program’s armamentarium. This article addresses the context for introducing these devices and describes the EOVAHCS Pain Program and Modality Clinic. Also discussed are procedures and findings from an initial quality improvement evaluation designed to inform decision making regarding retention, expansion, or elimination of the EOVAHCS noninvasive, pain treatment device program.

Opioid prescriptions increased from 76 million in 1991 to 219 million in 2011. In 2011, the annual cost of chronic pain in the US was estimated at $635 billion.^1-6 The confluence of an increasing concern about undertreatment of pain and overconfidence for the safety of opioids led to what former US Surgeon General Vivek H. Murthy, MD, called the opioid crisis.⁷ As awareness of its unintended consequences of opioid prescribing increased, the VHA began looking for nonopioid treatments that would decrease pain intensity. The 1993 article by Kehlet and Dahl was one of the first discussions of a multimodal nonpharmacologic strategy for addressing acute postoperative pain.⁸ Their pivotal literature review concluded that nonpharmacologic modalities, such as acupuncture, cranial manipulation, cranial electrostimulation treatment (CES), and low-level light technologies (LLLT), carried less risk and produced equal or greater clinical effects than those of drug therapies.⁸

Electrical and Cold Laser Modalities

Multimodal treatment approaches increasingly are encouraged, and nonopioid pain control has become more common across medical disciplines from physical therapy to anesthesiology.^8-10 Innovative, noninvasive devices designed for self-use have appeared on the market. Many of these devices incorporate microcurrent electrical therapy (MET), CES, and/or LLLT (also known as cold laser).^11-16 LLLT is a light modality that seems to lead to increased ATP production, resulting in improved healing and decreased inflammation.^13-16 Although CES has been studied in a variety of patient populations, its effectiveness is not well understood.¹⁶ Research on the effects of CES on neurotransmitter levels as well as activation of parts of the brain involved in pain reception and transmission should clarify these mechanisms. Research has shown improvements in sleep and mood as well as overall pain reduction.^11,16 Research has focused primarily on individual modalities rather than on combination devices and has been conducted on populations unlike the veteran population (eg, women with fibromyalgia).

Most of the devices that use electrical or LLLT cannot be used safely by patients who have implantable electrical devices or have medical conditions such as unstable seizures, pregnancy, and active malignancies.

The most common adverse effects (AEs) of CES—dizziness and headaches—are minimal compared with the AEs of pain medications. MET and LLLT AEs generally are limited to skin irritation and muscle soreness.¹¹ Most devices require a prescription, and manufacturers provide training for purchase.

The Pain Program

EOVAHCS initially established its consultative pain program in 2013 to provide support, recommendations, and education about managing pain in veterans to primary care providers (PCPs). Veterans are referred to the pain program for a face-to-face assessment and set of recommendations to assist in developing a comprehensive pain treatment plan. Consistent with its multimodal, biopsychosocial rehabilitation model approach, the program also offers several chronic pain treatment services, including patient education courses, cognitive behavioral therapy (CBT) for chronic pain, chiropractic care, biofeedback, relaxation training, steroid injections, pain coaching, and a pain modality (noninvasive device) clinic. During their assessment, veterans are evaluated for the appropriateness of these programs, including treatment through the Pain Modality Clinic.

Pain Modality Clinic

The EOVAHCS Pain Modality Clinic was created in 2014 as a treatment and device-trial program to provide veterans access to newer noninvasive, patient-driven treatment devices as part of an active chronic pain self-management plan. A crucial innovation is that these devices are designed to be used by patients in their homes. These devices can be expensive, and not every patient will benefit from their use; therefore, clinic leaders recommended a trial before a device is issued to a veteran for home use.

The Pain Modality Clinic coordinator trains clinic facilitators on the device according to manufacturer’s guidelines. Each participating veteran takes part in a device trial to confirm that he or she is able to use the recommended device independently and is likely to benefit from its use. When appropriate, veterans who do not respond to the initial device trial could test the potential benefit of another device. Although data from these device trials are collected primarily to inform clinical decision making, this information also is useful in guiding local policy regarding continued support for each of the modalities.

Veterans who have chronic or persistent pain (≥ 3 months) that interferes with function or quality of life are considered good candidates for a device trial if they are actively involved in pain self-care, logistically able to participate, able to use a device long-term, and have no contraindications. “Active involvement” could be met by participation in any pain management effort, whether a specific exercise program, CBT, or other treatment.

The Modality Clinic currently offers device trials for persistent pain with Alpha-Stim-M (AS-M; Electromedical Products International, Mineral Wells, TX), Laser Touch One (LTO; Renewal Technologies, LLC, Phoenix, AZ), and Neurolumen (Oklahoma City, OK). Neurolumen devices were not available in the clinic initially and will not be discussed further in this article.

The first Alpha-Stim machine using MET and CES technology was created in 1981 for in-office pain management. In 2012, the currently used AS-M became available.¹¹ AS-M is FDA approved for treating pain, anxiety, depression, and sleep problems and is the device used in the EOVAHCS Modality Clinic. AS-M uses probes or electrodes to send a MET waveform through the body area in pain. The device uses ear clips to provide CES, which is thought to increase alpha waves in the brain.¹¹ The LTO is a device that combines LLLT and MET technologies in a home-use design.¹⁴ LTO is FDA approved for treating painand is a portable personal pain-relief device applied to the area of pain using electroconductive gel.

Both devices are designed for long-term, self-use, making them viable parts of a multimodal, chronic pain treatment plan. Contraindications for AS-M and LTO include having a pacemaker or an implantable defibrillator, pregnancy, current malignancy, or seizures. Eligible veterans with persistent pain and high levels of depression, anxiety, and/or sleep problems generally are triaged to AS-M, whereas those who have only pain intensity issues usually are assigned to LTO. Referral to the Modality Clinic is not limited to a specific type of pain; common pain conditions seen in the clinic are spine and joint pain, arthritis pain, myofascial pain, headaches, and neuropathy.

Training and Device Trials

Eligible veterans are educated about the device and complete clinical informed consent, which is documented in the electronic health record. The veterans’ primary care and/or specialist providers are contacted for concurrence regarding veterans’ participation in the treatment.

Protocols for the device trials are based on the manufacturers’ recommendations, adjusted to what is feasible in the clinic (manufacturers approved the changes). The number of treatments per trial varies by device. For AS-M, veterans come to the clinic 5 days a week for 2 weeks. For LTO, veterans attend the clinic 5 days a week for 1 week.

At the beginning of a device trial, a trained facilitator teaches each veteran and caregiver to use the device, sets functional goals for the trial, and provides education on the trial questionnaires and daily pain logs. The veteran then follows the device protocol in the clinic where the facilitator can respond to questions and address any issues. With support from their caregivers, veterans are expected to become independent on their device use by the end of the trial. Clinic staff or the veteran can stop the device trial at any point, without affecting the veteran’s participation in or eligibility for other EOVAHCS pain programs.

This project was submitted to the University of Oklahoma Health Sciences Center Institutional Review Board and was exempted from institutional review board oversight as a retrospective, quality improvement effort. Before data analysis, the EOVAHCS Coordinator for Research and Development reviewed the procedures to ensure that all policies were being followed.

Methods

Data for veterans who completed valid treatments of AS-M or LTO from May 9, 2014 to August 20, 2016, were included in the analyses. For an AS-M treatment to be considered valid, the veteran must have attended at least 8 sessions and completed assessment instruments at baseline (preintervention) and following completion (postintervention). For an LTO treatment to be considered valid, the veteran must have attended at least 4 sessions and completed assessment measures at baseline and after completion.

Measures

Veterans completed the following measures at baseline and after trial completion:

The Beck Depression Inventory (BDI-II) is a 21-item measure designed to assess depressive symptoms. Each item assesses intensity on a 0-to-3 scale. Scores from 0 to 13 indicate minimum depression; 14 to 19, mild depression; 20 to 28, moderate depression, and 29 to 63, severe depression.¹⁷

The Beck Anxiety Inventory (BAI) is a 21-item measure of anxiety symptoms that uses a 0-to-3 scale to assess severity of subjective, somatic, or panic-related symptoms of anxiety. Scores ranging from 0 to 9 indicate minimal anxiety; 10 to 16, mild anxiety; 17 to 29, moderate anxiety, and 30 to 63, severe anxiety.¹⁸

The Pain Catastrophizing Scale (PCS) is a 13-item measure of pain catastrophizing, a crucial marker of how individuals experience pain. Items are scored on a 0-to-4 scale; scores of ≥ 30 indicate a clinically relevant level of catastrophizing.¹⁹

The Subjective Units of Distress Scale (SUD) is a single-item measure of the subjective intensity of disturbance or distress currently being experienced. It is scored from 0 to 10; 1 to 4 is mild, 5 to 6 is moderate, and 7 to 10 is severe.²⁰

The Brief Pain Inventory (BPI) measures pain intensity and the impact of pain on functioning. Four items assess pain intensity at its worst, least, and average over the previous 24 hours and at the time of assessment; responses are on a 0-to-10 scale with 10 being most severe. The pain intensity measure is the average of scores on these 4 items. Pain interference is measured with respect to 7 daily activities; general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each of these items is scored on a 0-to-10 scale with 10 being the most severe. The pain interference measure is the average of scores on these 7 items.²¹

Participants completed a daily pain log and recorded self-ratings (0-to-10 scale) of pain and relaxation levels before and after using the device. These scores were primarily used to assist in determining whether goals, set collaboratively by the clinician and the veteran at the first session, had been met.

Analysis

Descriptive statistics were used to characterize the sample overall and by modality. Paired t tests were used to assess changes on each assessment measure over time and for each device separately. The significance of change was assessed for 8 outcomes for each device. In this context, using a conservative Bonferroni correction, significance was set at P < .006. Because AS-M is designed to address depression, anxiety, and sleep as well as pain, whereas LTO is not, device assignments were based on clinical considerations rather than randomization. Therefore, no comparisons were made between devices, and outcomes were assessed independently for the 2 devices. Analyses were performed using SAS 9.4 (Cary, NC).

Results

Device trials were initiated for 161 veterans (LTO, 70; AS-M, 91). Distribution of devices was unequal because veterans are assigned to 1 device or the other based on clinical presentation. Failure to complete a trial (n = 46; 28.6%) typically was because of travel barriers, lack of interest in continuing, and for 3 veterans, reports of headaches that they attributed to the AS-M treatment. Of the 115 participants who completed valid trials, 88 (76.5%) also completed assessment measures at pre- and postintervention (LTO = 38; AS-M = 50). None of the participants in this study completed trials with both the AS-M and LTO devices.

Most participants were male (84.1%) and rural residents (85.5%) (Table 1). 

Pain Reduction

Treatment with AS-M or LTO was associated with statistically significant reductions in pain severity (BPI), pain interference (BPI), daily pain intensity scores (daily pain log), and pain catastrophizing (PCS) (Tables 2 and 3).

Impact on Mood

Use of AS-M was associated with statistically significant improvements in depression (BDI-II), anxiety (BAI), and distress (SUD) scores. In addition, veterans completing AS-M treatment showed a statistically significant improvement in self-reported relaxation scores. Interestingly, use of LTO also resulted in a statistically significant decrease in anxiety (BAI) and a nonstatistically significant decrease in depression (BDI-II).

Figure 1 and 2 illustrates the clinical impact of each device in shifting participants from 1 level of symptom severity to another. 

Discussion

Use of both AS-M and LTO at EOVAHC was associated with reduced pain intensity. The devices also had positive effects beyond pain in areas such as depression, anxiety, and distress. Remission of depression and anxiety symptoms has been associated with significant decline in pain symptoms, suggesting that pain is best treated through multimodal approaches.²²

In the context of the opioid crisis, the availability of effective nonopioid, nonpharmacologic, noninvasive treatments for chronic pain is needed. The Joint Commission recently expanded its pain management guidelines to support hospitals offering nonpharmacologic pain treatments.²³ Integrating AS-M, LTO, or similar products into standard pain management practices allows for other treatment pathways with positive outcomes for providers and patients. The Joint Commission also recommends an interdisciplinary approach, defined as a process whereby health care professionals from different disciplines collaborate to diagnose and treat patients experiencing difficult pain conditions. This approach facilitates multimodal management because these disciplines contribute knowledge about a variety of treatment options. Devices such AS-M and LTO are well suited to interdisciplinary pain management because they are not seen as being under the purview of a specific health care specialty.

Limitations

Our findings are limited because they are derived from a retrospective, quality improvement evaluation of outcomes from a single clinic. Findings must be considered in the context of the relatively small samples of veterans. Because analyses were conducted as part of a quality improvement effort, veterans were offered a specific device based on clinical indications, there were no comparisons between devices, and there was no comparison group. Although most participants were using medication and other treatments as part of their pain treatment plan, all reported continued pain intensity before use of a device. Analyses did not control for variation in treatments received concurrently. Last, the logs used to collect self-report data on daily pain and relaxation levels were not validated.

The data highlight a clear need for research to better understand the long-term effects of these devices as well as the characteristics of patients who respond best to each device. Noninvasive treatments for pain often are dismissed as placebos. Rigorously designed, controlled studies will help demonstrate that these devices offer a statistically significant benefit beyond any placebo effect.

Conclusion

Understanding of chronic pain and its treatment will continue to evolve. It is clear that each person dealing with chronic pain requires a tailored combination of treatments and multimodal approaches, which is more effective than any single treatment. Nonpharmacologic, noninvasive devices pose fewer risks and seem to be more effective in reducing pain intensity than traditional treatments, including medications or surgical intervention. In light of the current emphasis on evidence-based health care and as the evidence for the effectiveness of noninvasive pain devices modalities grows, it is likely that treatments incorporating modalities such as MET, CES, and LLLT will become common options for managing chronic pain.

Chronic pain is common among veterans treated in Veterans Health Administration (VHA) facilities, and optimal management remains challenging in the context of the national opioid misuse epidemic. The Eastern Oklahoma VA Health Care System (EOVAHCS) Pain Program offers a range of services that allow clinicians to tailor multimodal treatment strategies to a veteran’s needs. In 2014, a Modality Clinic was established to assess the utility of adding noninvasive treatment devices to the pain program’s armamentarium. This article addresses the context for introducing these devices and describes the EOVAHCS Pain Program and Modality Clinic. Also discussed are procedures and findings from an initial quality improvement evaluation designed to inform decision making regarding retention, expansion, or elimination of the EOVAHCS noninvasive, pain treatment device program.

Opioid prescriptions increased from 76 million in 1991 to 219 million in 2011. In 2011, the annual cost of chronic pain in the US was estimated at $635 billion.^1-6 The confluence of an increasing concern about undertreatment of pain and overconfidence for the safety of opioids led to what former US Surgeon General Vivek H. Murthy, MD, called the opioid crisis.⁷ As awareness of its unintended consequences of opioid prescribing increased, the VHA began looking for nonopioid treatments that would decrease pain intensity. The 1993 article by Kehlet and Dahl was one of the first discussions of a multimodal nonpharmacologic strategy for addressing acute postoperative pain.⁸ Their pivotal literature review concluded that nonpharmacologic modalities, such as acupuncture, cranial manipulation, cranial electrostimulation treatment (CES), and low-level light technologies (LLLT), carried less risk and produced equal or greater clinical effects than those of drug therapies.⁸

Electrical and Cold Laser Modalities

Multimodal treatment approaches increasingly are encouraged, and nonopioid pain control has become more common across medical disciplines from physical therapy to anesthesiology.^8-10 Innovative, noninvasive devices designed for self-use have appeared on the market. Many of these devices incorporate microcurrent electrical therapy (MET), CES, and/or LLLT (also known as cold laser).^11-16 LLLT is a light modality that seems to lead to increased ATP production, resulting in improved healing and decreased inflammation.^13-16 Although CES has been studied in a variety of patient populations, its effectiveness is not well understood.¹⁶ Research on the effects of CES on neurotransmitter levels as well as activation of parts of the brain involved in pain reception and transmission should clarify these mechanisms. Research has shown improvements in sleep and mood as well as overall pain reduction.^11,16 Research has focused primarily on individual modalities rather than on combination devices and has been conducted on populations unlike the veteran population (eg, women with fibromyalgia).

Most of the devices that use electrical or LLLT cannot be used safely by patients who have implantable electrical devices or have medical conditions such as unstable seizures, pregnancy, and active malignancies.

The most common adverse effects (AEs) of CES—dizziness and headaches—are minimal compared with the AEs of pain medications. MET and LLLT AEs generally are limited to skin irritation and muscle soreness.¹¹ Most devices require a prescription, and manufacturers provide training for purchase.

The Pain Program

EOVAHCS initially established its consultative pain program in 2013 to provide support, recommendations, and education about managing pain in veterans to primary care providers (PCPs). Veterans are referred to the pain program for a face-to-face assessment and set of recommendations to assist in developing a comprehensive pain treatment plan. Consistent with its multimodal, biopsychosocial rehabilitation model approach, the program also offers several chronic pain treatment services, including patient education courses, cognitive behavioral therapy (CBT) for chronic pain, chiropractic care, biofeedback, relaxation training, steroid injections, pain coaching, and a pain modality (noninvasive device) clinic. During their assessment, veterans are evaluated for the appropriateness of these programs, including treatment through the Pain Modality Clinic.

Pain Modality Clinic

The EOVAHCS Pain Modality Clinic was created in 2014 as a treatment and device-trial program to provide veterans access to newer noninvasive, patient-driven treatment devices as part of an active chronic pain self-management plan. A crucial innovation is that these devices are designed to be used by patients in their homes. These devices can be expensive, and not every patient will benefit from their use; therefore, clinic leaders recommended a trial before a device is issued to a veteran for home use.

The Pain Modality Clinic coordinator trains clinic facilitators on the device according to manufacturer’s guidelines. Each participating veteran takes part in a device trial to confirm that he or she is able to use the recommended device independently and is likely to benefit from its use. When appropriate, veterans who do not respond to the initial device trial could test the potential benefit of another device. Although data from these device trials are collected primarily to inform clinical decision making, this information also is useful in guiding local policy regarding continued support for each of the modalities.

Veterans who have chronic or persistent pain (≥ 3 months) that interferes with function or quality of life are considered good candidates for a device trial if they are actively involved in pain self-care, logistically able to participate, able to use a device long-term, and have no contraindications. “Active involvement” could be met by participation in any pain management effort, whether a specific exercise program, CBT, or other treatment.

The Modality Clinic currently offers device trials for persistent pain with Alpha-Stim-M (AS-M; Electromedical Products International, Mineral Wells, TX), Laser Touch One (LTO; Renewal Technologies, LLC, Phoenix, AZ), and Neurolumen (Oklahoma City, OK). Neurolumen devices were not available in the clinic initially and will not be discussed further in this article.

The first Alpha-Stim machine using MET and CES technology was created in 1981 for in-office pain management. In 2012, the currently used AS-M became available.¹¹ AS-M is FDA approved for treating pain, anxiety, depression, and sleep problems and is the device used in the EOVAHCS Modality Clinic. AS-M uses probes or electrodes to send a MET waveform through the body area in pain. The device uses ear clips to provide CES, which is thought to increase alpha waves in the brain.¹¹ The LTO is a device that combines LLLT and MET technologies in a home-use design.¹⁴ LTO is FDA approved for treating painand is a portable personal pain-relief device applied to the area of pain using electroconductive gel.

Both devices are designed for long-term, self-use, making them viable parts of a multimodal, chronic pain treatment plan. Contraindications for AS-M and LTO include having a pacemaker or an implantable defibrillator, pregnancy, current malignancy, or seizures. Eligible veterans with persistent pain and high levels of depression, anxiety, and/or sleep problems generally are triaged to AS-M, whereas those who have only pain intensity issues usually are assigned to LTO. Referral to the Modality Clinic is not limited to a specific type of pain; common pain conditions seen in the clinic are spine and joint pain, arthritis pain, myofascial pain, headaches, and neuropathy.

Training and Device Trials

Eligible veterans are educated about the device and complete clinical informed consent, which is documented in the electronic health record. The veterans’ primary care and/or specialist providers are contacted for concurrence regarding veterans’ participation in the treatment.

Protocols for the device trials are based on the manufacturers’ recommendations, adjusted to what is feasible in the clinic (manufacturers approved the changes). The number of treatments per trial varies by device. For AS-M, veterans come to the clinic 5 days a week for 2 weeks. For LTO, veterans attend the clinic 5 days a week for 1 week.

At the beginning of a device trial, a trained facilitator teaches each veteran and caregiver to use the device, sets functional goals for the trial, and provides education on the trial questionnaires and daily pain logs. The veteran then follows the device protocol in the clinic where the facilitator can respond to questions and address any issues. With support from their caregivers, veterans are expected to become independent on their device use by the end of the trial. Clinic staff or the veteran can stop the device trial at any point, without affecting the veteran’s participation in or eligibility for other EOVAHCS pain programs.

This project was submitted to the University of Oklahoma Health Sciences Center Institutional Review Board and was exempted from institutional review board oversight as a retrospective, quality improvement effort. Before data analysis, the EOVAHCS Coordinator for Research and Development reviewed the procedures to ensure that all policies were being followed.

Methods

Data for veterans who completed valid treatments of AS-M or LTO from May 9, 2014 to August 20, 2016, were included in the analyses. For an AS-M treatment to be considered valid, the veteran must have attended at least 8 sessions and completed assessment instruments at baseline (preintervention) and following completion (postintervention). For an LTO treatment to be considered valid, the veteran must have attended at least 4 sessions and completed assessment measures at baseline and after completion.

Measures

Veterans completed the following measures at baseline and after trial completion:

The Beck Depression Inventory (BDI-II) is a 21-item measure designed to assess depressive symptoms. Each item assesses intensity on a 0-to-3 scale. Scores from 0 to 13 indicate minimum depression; 14 to 19, mild depression; 20 to 28, moderate depression, and 29 to 63, severe depression.¹⁷

The Beck Anxiety Inventory (BAI) is a 21-item measure of anxiety symptoms that uses a 0-to-3 scale to assess severity of subjective, somatic, or panic-related symptoms of anxiety. Scores ranging from 0 to 9 indicate minimal anxiety; 10 to 16, mild anxiety; 17 to 29, moderate anxiety, and 30 to 63, severe anxiety.¹⁸

The Pain Catastrophizing Scale (PCS) is a 13-item measure of pain catastrophizing, a crucial marker of how individuals experience pain. Items are scored on a 0-to-4 scale; scores of ≥ 30 indicate a clinically relevant level of catastrophizing.¹⁹

The Subjective Units of Distress Scale (SUD) is a single-item measure of the subjective intensity of disturbance or distress currently being experienced. It is scored from 0 to 10; 1 to 4 is mild, 5 to 6 is moderate, and 7 to 10 is severe.²⁰

The Brief Pain Inventory (BPI) measures pain intensity and the impact of pain on functioning. Four items assess pain intensity at its worst, least, and average over the previous 24 hours and at the time of assessment; responses are on a 0-to-10 scale with 10 being most severe. The pain intensity measure is the average of scores on these 4 items. Pain interference is measured with respect to 7 daily activities; general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each of these items is scored on a 0-to-10 scale with 10 being the most severe. The pain interference measure is the average of scores on these 7 items.²¹

Participants completed a daily pain log and recorded self-ratings (0-to-10 scale) of pain and relaxation levels before and after using the device. These scores were primarily used to assist in determining whether goals, set collaboratively by the clinician and the veteran at the first session, had been met.

Analysis

Descriptive statistics were used to characterize the sample overall and by modality. Paired t tests were used to assess changes on each assessment measure over time and for each device separately. The significance of change was assessed for 8 outcomes for each device. In this context, using a conservative Bonferroni correction, significance was set at P < .006. Because AS-M is designed to address depression, anxiety, and sleep as well as pain, whereas LTO is not, device assignments were based on clinical considerations rather than randomization. Therefore, no comparisons were made between devices, and outcomes were assessed independently for the 2 devices. Analyses were performed using SAS 9.4 (Cary, NC).

Results

Device trials were initiated for 161 veterans (LTO, 70; AS-M, 91). Distribution of devices was unequal because veterans are assigned to 1 device or the other based on clinical presentation. Failure to complete a trial (n = 46; 28.6%) typically was because of travel barriers, lack of interest in continuing, and for 3 veterans, reports of headaches that they attributed to the AS-M treatment. Of the 115 participants who completed valid trials, 88 (76.5%) also completed assessment measures at pre- and postintervention (LTO = 38; AS-M = 50). None of the participants in this study completed trials with both the AS-M and LTO devices.

Most participants were male (84.1%) and rural residents (85.5%) (Table 1). 

Pain Reduction

Treatment with AS-M or LTO was associated with statistically significant reductions in pain severity (BPI), pain interference (BPI), daily pain intensity scores (daily pain log), and pain catastrophizing (PCS) (Tables 2 and 3).

Impact on Mood

Use of AS-M was associated with statistically significant improvements in depression (BDI-II), anxiety (BAI), and distress (SUD) scores. In addition, veterans completing AS-M treatment showed a statistically significant improvement in self-reported relaxation scores. Interestingly, use of LTO also resulted in a statistically significant decrease in anxiety (BAI) and a nonstatistically significant decrease in depression (BDI-II).

Figure 1 and 2 illustrates the clinical impact of each device in shifting participants from 1 level of symptom severity to another. 

Discussion

Use of both AS-M and LTO at EOVAHC was associated with reduced pain intensity. The devices also had positive effects beyond pain in areas such as depression, anxiety, and distress. Remission of depression and anxiety symptoms has been associated with significant decline in pain symptoms, suggesting that pain is best treated through multimodal approaches.²²

In the context of the opioid crisis, the availability of effective nonopioid, nonpharmacologic, noninvasive treatments for chronic pain is needed. The Joint Commission recently expanded its pain management guidelines to support hospitals offering nonpharmacologic pain treatments.²³ Integrating AS-M, LTO, or similar products into standard pain management practices allows for other treatment pathways with positive outcomes for providers and patients. The Joint Commission also recommends an interdisciplinary approach, defined as a process whereby health care professionals from different disciplines collaborate to diagnose and treat patients experiencing difficult pain conditions. This approach facilitates multimodal management because these disciplines contribute knowledge about a variety of treatment options. Devices such AS-M and LTO are well suited to interdisciplinary pain management because they are not seen as being under the purview of a specific health care specialty.

Limitations

Our findings are limited because they are derived from a retrospective, quality improvement evaluation of outcomes from a single clinic. Findings must be considered in the context of the relatively small samples of veterans. Because analyses were conducted as part of a quality improvement effort, veterans were offered a specific device based on clinical indications, there were no comparisons between devices, and there was no comparison group. Although most participants were using medication and other treatments as part of their pain treatment plan, all reported continued pain intensity before use of a device. Analyses did not control for variation in treatments received concurrently. Last, the logs used to collect self-report data on daily pain and relaxation levels were not validated.

The data highlight a clear need for research to better understand the long-term effects of these devices as well as the characteristics of patients who respond best to each device. Noninvasive treatments for pain often are dismissed as placebos. Rigorously designed, controlled studies will help demonstrate that these devices offer a statistically significant benefit beyond any placebo effect.

Conclusion

Understanding of chronic pain and its treatment will continue to evolve. It is clear that each person dealing with chronic pain requires a tailored combination of treatments and multimodal approaches, which is more effective than any single treatment. Nonpharmacologic, noninvasive devices pose fewer risks and seem to be more effective in reducing pain intensity than traditional treatments, including medications or surgical intervention. In light of the current emphasis on evidence-based health care and as the evidence for the effectiveness of noninvasive pain devices modalities grows, it is likely that treatments incorporating modalities such as MET, CES, and LLLT will become common options for managing chronic pain.

Chronic pain is common among veterans treated in Veterans Health Administration (VHA) facilities, and optimal management remains challenging in the context of the national opioid misuse epidemic. The Eastern Oklahoma VA Health Care System (EOVAHCS) Pain Program offers a range of services that allow clinicians to tailor multimodal treatment strategies to a veteran’s needs. In 2014, a Modality Clinic was established to assess the utility of adding noninvasive treatment devices to the pain program’s armamentarium. This article addresses the context for introducing these devices and describes the EOVAHCS Pain Program and Modality Clinic. Also discussed are procedures and findings from an initial quality improvement evaluation designed to inform decision making regarding retention, expansion, or elimination of the EOVAHCS noninvasive, pain treatment device program.

Opioid prescriptions increased from 76 million in 1991 to 219 million in 2011. In 2011, the annual cost of chronic pain in the US was estimated at $635 billion.^1-6 The confluence of an increasing concern about undertreatment of pain and overconfidence for the safety of opioids led to what former US Surgeon General Vivek H. Murthy, MD, called the opioid crisis.⁷ As awareness of its unintended consequences of opioid prescribing increased, the VHA began looking for nonopioid treatments that would decrease pain intensity. The 1993 article by Kehlet and Dahl was one of the first discussions of a multimodal nonpharmacologic strategy for addressing acute postoperative pain.⁸ Their pivotal literature review concluded that nonpharmacologic modalities, such as acupuncture, cranial manipulation, cranial electrostimulation treatment (CES), and low-level light technologies (LLLT), carried less risk and produced equal or greater clinical effects than those of drug therapies.⁸

Electrical and Cold Laser Modalities

Multimodal treatment approaches increasingly are encouraged, and nonopioid pain control has become more common across medical disciplines from physical therapy to anesthesiology.^8-10 Innovative, noninvasive devices designed for self-use have appeared on the market. Many of these devices incorporate microcurrent electrical therapy (MET), CES, and/or LLLT (also known as cold laser).^11-16 LLLT is a light modality that seems to lead to increased ATP production, resulting in improved healing and decreased inflammation.^13-16 Although CES has been studied in a variety of patient populations, its effectiveness is not well understood.¹⁶ Research on the effects of CES on neurotransmitter levels as well as activation of parts of the brain involved in pain reception and transmission should clarify these mechanisms. Research has shown improvements in sleep and mood as well as overall pain reduction.^11,16 Research has focused primarily on individual modalities rather than on combination devices and has been conducted on populations unlike the veteran population (eg, women with fibromyalgia).

Most of the devices that use electrical or LLLT cannot be used safely by patients who have implantable electrical devices or have medical conditions such as unstable seizures, pregnancy, and active malignancies.

The most common adverse effects (AEs) of CES—dizziness and headaches—are minimal compared with the AEs of pain medications. MET and LLLT AEs generally are limited to skin irritation and muscle soreness.¹¹ Most devices require a prescription, and manufacturers provide training for purchase.

The Pain Program

EOVAHCS initially established its consultative pain program in 2013 to provide support, recommendations, and education about managing pain in veterans to primary care providers (PCPs). Veterans are referred to the pain program for a face-to-face assessment and set of recommendations to assist in developing a comprehensive pain treatment plan. Consistent with its multimodal, biopsychosocial rehabilitation model approach, the program also offers several chronic pain treatment services, including patient education courses, cognitive behavioral therapy (CBT) for chronic pain, chiropractic care, biofeedback, relaxation training, steroid injections, pain coaching, and a pain modality (noninvasive device) clinic. During their assessment, veterans are evaluated for the appropriateness of these programs, including treatment through the Pain Modality Clinic.

Pain Modality Clinic

The EOVAHCS Pain Modality Clinic was created in 2014 as a treatment and device-trial program to provide veterans access to newer noninvasive, patient-driven treatment devices as part of an active chronic pain self-management plan. A crucial innovation is that these devices are designed to be used by patients in their homes. These devices can be expensive, and not every patient will benefit from their use; therefore, clinic leaders recommended a trial before a device is issued to a veteran for home use.

The Pain Modality Clinic coordinator trains clinic facilitators on the device according to manufacturer’s guidelines. Each participating veteran takes part in a device trial to confirm that he or she is able to use the recommended device independently and is likely to benefit from its use. When appropriate, veterans who do not respond to the initial device trial could test the potential benefit of another device. Although data from these device trials are collected primarily to inform clinical decision making, this information also is useful in guiding local policy regarding continued support for each of the modalities.

Veterans who have chronic or persistent pain (≥ 3 months) that interferes with function or quality of life are considered good candidates for a device trial if they are actively involved in pain self-care, logistically able to participate, able to use a device long-term, and have no contraindications. “Active involvement” could be met by participation in any pain management effort, whether a specific exercise program, CBT, or other treatment.

The Modality Clinic currently offers device trials for persistent pain with Alpha-Stim-M (AS-M; Electromedical Products International, Mineral Wells, TX), Laser Touch One (LTO; Renewal Technologies, LLC, Phoenix, AZ), and Neurolumen (Oklahoma City, OK). Neurolumen devices were not available in the clinic initially and will not be discussed further in this article.

The first Alpha-Stim machine using MET and CES technology was created in 1981 for in-office pain management. In 2012, the currently used AS-M became available.¹¹ AS-M is FDA approved for treating pain, anxiety, depression, and sleep problems and is the device used in the EOVAHCS Modality Clinic. AS-M uses probes or electrodes to send a MET waveform through the body area in pain. The device uses ear clips to provide CES, which is thought to increase alpha waves in the brain.¹¹ The LTO is a device that combines LLLT and MET technologies in a home-use design.¹⁴ LTO is FDA approved for treating painand is a portable personal pain-relief device applied to the area of pain using electroconductive gel.

Both devices are designed for long-term, self-use, making them viable parts of a multimodal, chronic pain treatment plan. Contraindications for AS-M and LTO include having a pacemaker or an implantable defibrillator, pregnancy, current malignancy, or seizures. Eligible veterans with persistent pain and high levels of depression, anxiety, and/or sleep problems generally are triaged to AS-M, whereas those who have only pain intensity issues usually are assigned to LTO. Referral to the Modality Clinic is not limited to a specific type of pain; common pain conditions seen in the clinic are spine and joint pain, arthritis pain, myofascial pain, headaches, and neuropathy.

Training and Device Trials

Eligible veterans are educated about the device and complete clinical informed consent, which is documented in the electronic health record. The veterans’ primary care and/or specialist providers are contacted for concurrence regarding veterans’ participation in the treatment.

Protocols for the device trials are based on the manufacturers’ recommendations, adjusted to what is feasible in the clinic (manufacturers approved the changes). The number of treatments per trial varies by device. For AS-M, veterans come to the clinic 5 days a week for 2 weeks. For LTO, veterans attend the clinic 5 days a week for 1 week.

At the beginning of a device trial, a trained facilitator teaches each veteran and caregiver to use the device, sets functional goals for the trial, and provides education on the trial questionnaires and daily pain logs. The veteran then follows the device protocol in the clinic where the facilitator can respond to questions and address any issues. With support from their caregivers, veterans are expected to become independent on their device use by the end of the trial. Clinic staff or the veteran can stop the device trial at any point, without affecting the veteran’s participation in or eligibility for other EOVAHCS pain programs.

This project was submitted to the University of Oklahoma Health Sciences Center Institutional Review Board and was exempted from institutional review board oversight as a retrospective, quality improvement effort. Before data analysis, the EOVAHCS Coordinator for Research and Development reviewed the procedures to ensure that all policies were being followed.

Methods

Data for veterans who completed valid treatments of AS-M or LTO from May 9, 2014 to August 20, 2016, were included in the analyses. For an AS-M treatment to be considered valid, the veteran must have attended at least 8 sessions and completed assessment instruments at baseline (preintervention) and following completion (postintervention). For an LTO treatment to be considered valid, the veteran must have attended at least 4 sessions and completed assessment measures at baseline and after completion.

Measures

Veterans completed the following measures at baseline and after trial completion:

The Beck Depression Inventory (BDI-II) is a 21-item measure designed to assess depressive symptoms. Each item assesses intensity on a 0-to-3 scale. Scores from 0 to 13 indicate minimum depression; 14 to 19, mild depression; 20 to 28, moderate depression, and 29 to 63, severe depression.¹⁷

The Beck Anxiety Inventory (BAI) is a 21-item measure of anxiety symptoms that uses a 0-to-3 scale to assess severity of subjective, somatic, or panic-related symptoms of anxiety. Scores ranging from 0 to 9 indicate minimal anxiety; 10 to 16, mild anxiety; 17 to 29, moderate anxiety, and 30 to 63, severe anxiety.¹⁸

The Pain Catastrophizing Scale (PCS) is a 13-item measure of pain catastrophizing, a crucial marker of how individuals experience pain. Items are scored on a 0-to-4 scale; scores of ≥ 30 indicate a clinically relevant level of catastrophizing.¹⁹

The Subjective Units of Distress Scale (SUD) is a single-item measure of the subjective intensity of disturbance or distress currently being experienced. It is scored from 0 to 10; 1 to 4 is mild, 5 to 6 is moderate, and 7 to 10 is severe.²⁰

The Brief Pain Inventory (BPI) measures pain intensity and the impact of pain on functioning. Four items assess pain intensity at its worst, least, and average over the previous 24 hours and at the time of assessment; responses are on a 0-to-10 scale with 10 being most severe. The pain intensity measure is the average of scores on these 4 items. Pain interference is measured with respect to 7 daily activities; general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each of these items is scored on a 0-to-10 scale with 10 being the most severe. The pain interference measure is the average of scores on these 7 items.²¹

Participants completed a daily pain log and recorded self-ratings (0-to-10 scale) of pain and relaxation levels before and after using the device. These scores were primarily used to assist in determining whether goals, set collaboratively by the clinician and the veteran at the first session, had been met.

Analysis

Descriptive statistics were used to characterize the sample overall and by modality. Paired t tests were used to assess changes on each assessment measure over time and for each device separately. The significance of change was assessed for 8 outcomes for each device. In this context, using a conservative Bonferroni correction, significance was set at P < .006. Because AS-M is designed to address depression, anxiety, and sleep as well as pain, whereas LTO is not, device assignments were based on clinical considerations rather than randomization. Therefore, no comparisons were made between devices, and outcomes were assessed independently for the 2 devices. Analyses were performed using SAS 9.4 (Cary, NC).

Results

Device trials were initiated for 161 veterans (LTO, 70; AS-M, 91). Distribution of devices was unequal because veterans are assigned to 1 device or the other based on clinical presentation. Failure to complete a trial (n = 46; 28.6%) typically was because of travel barriers, lack of interest in continuing, and for 3 veterans, reports of headaches that they attributed to the AS-M treatment. Of the 115 participants who completed valid trials, 88 (76.5%) also completed assessment measures at pre- and postintervention (LTO = 38; AS-M = 50). None of the participants in this study completed trials with both the AS-M and LTO devices.

Most participants were male (84.1%) and rural residents (85.5%) (Table 1). 

Pain Reduction

Treatment with AS-M or LTO was associated with statistically significant reductions in pain severity (BPI), pain interference (BPI), daily pain intensity scores (daily pain log), and pain catastrophizing (PCS) (Tables 2 and 3).

Impact on Mood

Use of AS-M was associated with statistically significant improvements in depression (BDI-II), anxiety (BAI), and distress (SUD) scores. In addition, veterans completing AS-M treatment showed a statistically significant improvement in self-reported relaxation scores. Interestingly, use of LTO also resulted in a statistically significant decrease in anxiety (BAI) and a nonstatistically significant decrease in depression (BDI-II).

Figure 1 and 2 illustrates the clinical impact of each device in shifting participants from 1 level of symptom severity to another. 

Discussion

Use of both AS-M and LTO at EOVAHC was associated with reduced pain intensity. The devices also had positive effects beyond pain in areas such as depression, anxiety, and distress. Remission of depression and anxiety symptoms has been associated with significant decline in pain symptoms, suggesting that pain is best treated through multimodal approaches.²²

In the context of the opioid crisis, the availability of effective nonopioid, nonpharmacologic, noninvasive treatments for chronic pain is needed. The Joint Commission recently expanded its pain management guidelines to support hospitals offering nonpharmacologic pain treatments.²³ Integrating AS-M, LTO, or similar products into standard pain management practices allows for other treatment pathways with positive outcomes for providers and patients. The Joint Commission also recommends an interdisciplinary approach, defined as a process whereby health care professionals from different disciplines collaborate to diagnose and treat patients experiencing difficult pain conditions. This approach facilitates multimodal management because these disciplines contribute knowledge about a variety of treatment options. Devices such AS-M and LTO are well suited to interdisciplinary pain management because they are not seen as being under the purview of a specific health care specialty.

Limitations

Our findings are limited because they are derived from a retrospective, quality improvement evaluation of outcomes from a single clinic. Findings must be considered in the context of the relatively small samples of veterans. Because analyses were conducted as part of a quality improvement effort, veterans were offered a specific device based on clinical indications, there were no comparisons between devices, and there was no comparison group. Although most participants were using medication and other treatments as part of their pain treatment plan, all reported continued pain intensity before use of a device. Analyses did not control for variation in treatments received concurrently. Last, the logs used to collect self-report data on daily pain and relaxation levels were not validated.

The data highlight a clear need for research to better understand the long-term effects of these devices as well as the characteristics of patients who respond best to each device. Noninvasive treatments for pain often are dismissed as placebos. Rigorously designed, controlled studies will help demonstrate that these devices offer a statistically significant benefit beyond any placebo effect.

Conclusion

Understanding of chronic pain and its treatment will continue to evolve. It is clear that each person dealing with chronic pain requires a tailored combination of treatments and multimodal approaches, which is more effective than any single treatment. Nonpharmacologic, noninvasive devices pose fewer risks and seem to be more effective in reducing pain intensity than traditional treatments, including medications or surgical intervention. In light of the current emphasis on evidence-based health care and as the evidence for the effectiveness of noninvasive pain devices modalities grows, it is likely that treatments incorporating modalities such as MET, CES, and LLLT will become common options for managing chronic pain.

Cataract surgery is the most commonly performed surgical procedure in the US, including within the Veterans Health Administration (VHA).^1,2 As the risk of surgical complications has decreased with improved techniques and instrumentation, the threshold for performing surgery has lowered.³ A substantial number of patients do not develop clinically significant cataracts until they are “very elderly,” defined as aged ≥ 85 years by the World Health Organization and National Institute of Aging.⁴

Should the general approach to cataract evaluation and surgery differ in this subset of patients? Advanced age is associated with a variety of systemic and ocular comorbidities that theoretically increase the risk of cataract surgery and reduce the potential visual benefit it might yield. However, the impact of age on the outcomes of cataract surgery differs even among the very elderly. There are no universally acknowledged guidelines that address the perioperative evaluation and management of cataracts in the very elderly, whose systemic and ocular health have greater variability than those of their younger counterparts. For very elderly patients who are found to have visually significant cataracts by their ophthalmologists, input from the primary care provider (PCP), who has insight into a patient’s health and well-being, is vital for formulating a management plan. Herein, we provide a framework for PCPs to assist very elderly patients and their ophthalmologists in making an informed decision regarding cataract surgery and in planning for perioperative care.

Cataract Surgery

Cataract surgeons recommend surgical extraction when there is a clinically significant lens opacity that imposes functional impairment, such as inability to read, perform near work, watch television, or drive.⁴ The standard of care for a clinically significant cataract is surgical removal of the crystalline lens and replacement with an artificial intraocular lens (IOL). At times, the onset of vision loss from a cataract is insidious such that patients may not be aware of their declining vision or the deterioration in quality of life (QOL) that it causes.

Despite the higher burden of ocular comorbidity (eg, age-related macular degeneration, glaucoma) relative to their younger counterparts, most very elderly patients obtain functionally important improvement in their vision, QOL, and cognitive function after surgery.^5-16 Cataract surgery can also reduce the risk of dementia and the risk of falls and hip fractures.^{6,9,12-14,16-18} Ophthalmic complications of cataract surgery in the very elderly include posterior capsule tear (< 1%-9%), vitreous loss (< 1%-8%), zonular rupture (2%-5%), and retained lens fragments (≤ 1%).^{5,8-11,17,19-21} There is no evidence from well-controlled studies that suggests that very elderly cataract surgery patients are at higher risk of ocular complications relative to that of their younger counterparts.²²

Surgery Alternatives

In some very elderly patients, cataract surgery may not be the best option, and PCPs can aid in establishing an alternative plan. Such patients include those with a limited life expectancy, incapacitating anxiety over surgery, or those in whom the potential for visual improvement is marginal because of ocular or systemic comorbidities—eg, vision-limiting glaucoma or age-related macular degeneration, history of stroke to the visual pathway, or restriction to bed. Alternatives to cataract surgery in these instances include changing environmental conditions to improve visual function, such as enhanced lighting and contrast, and/or use of low-vision aids (referring patients to low-vision professionals often improves QOL).²³ Low-vision specialists also have a variety of nonvisual aids that can expand functional capabilities: large-print and talking versions of reading materials, telephones, remote controls, clocks, scales, calculators, and glucose monitors; glare-free lights for stairs, floors, and counters; and specialty glasses that use light-emitting diode screens and live video streams to magnify sight.^23-25

Medical Evaluation

For patients who decide to proceed with surgery, it can be helpful to have a medical evaluation by their PCPs to minimize potential complications during surgery. The very elderly may be at increased risk of intraoperative transient hypertension, restlessness, and electrocardiogram abnormalities.^5,7,17 Systemic comorbidities that become more prevalent with age, such as diabetes mellitus (DM), hypertension, heart disease, chronic obstructive pulmonary disease, and dementia, may adversely impact the risk of sedation and/or general anesthesia. In the VHA, providers also must be aware of combat-related disorders that can confound cataract surgery, such as posttraumatic stress disorder (PTSD), anxiety, and claustrophobia.^26,27

Anesthesia in cataract surgery ranges from topical to general, and the selection largely rests on patient physical and psychological comfort and cooperation. Often, intracameral (inside the anterior eye) anesthetic is used with topical anesthesia to provide additional comfort.²⁷ Patients who have high levels of anxiety about surgery may not tolerate topical anesthesia alone.²⁸ In these cases, retrobulbar anesthesia may be performed to block all sensation and motility of the eye. IV sedation is performed prior to the retrobulbar injection to calm patients. Although cataract surgery is typically performed with topical or retrobulbar anesthesia (reducing the potential for systemic complications), there are cases in which general anesthesia may be considered.²⁷ Very elderly patients may become confused or disoriented in the operating room (OR), leading to surgical complications and less than optimal outcomes.⁵ A higher rate of intraoperative “restlessness,” which occurred in patients who had comorbid dementia, and transient hypertension were found in a study on cataract surgery in the very elderly, but well-controlled studies are lacking.⁵ Dementia can impose problems with intraoperative cooperation, which is vital for successful surgery in patients who undergo topical or local anesthesia. If these potential problems are thought likely preoperatively, light sedation or general anesthesia—in conjunction with input from the patient’s PCP—are options to minimize disruptive behavior in the OR.

Additional features of the VHA population may influence the selection of anesthesia. The VHA has an important educational mission, and retrobulbar anesthesia may be preferred to minimize unpredictable intraoperative behavior in cases where resident surgeons are performing surgery under attending supervision.^27,29,30 The prevalence of PTSD among veterans also may impact the selection of anesthesia. Patients with PTSD have displayed greater levels of anxiety and more discomfort, requiring more sedation and longer surgical times compared with that of a control group.²⁸ Ophthalmic comorbidities prevalent among the predominantly older male population in the VHA include the use of α-1 antagonist prostate medications, such as tamsulosin and terazosin. These medications are associated with intraoperative floppy iris syndrome, which can increase case difficulty and prolong operative time.²⁹

Surgery Preparation

Cataract surgery induces minimal physiologic stress since most surgeries are performed under local or topical anesthesia. Unless the preoperative medical history or physical examination detects an active or unattended medical condition that needs to be addressed, preoperative laboratory testing is generally not required.^31-33 Current general guidelines for preoperative testing for cataract surgery exist but do not address specific issues facing very elderly patients. The American Academy of Ophthalmology advises against preoperative medical tests for eye surgery unless there are medical indications: an electrocardiogram for patients with a history of heart disease, a blood glucose test for those with DM, and a potassium test for patients who are on diuretics.³¹ The direct correlation of age with these comorbidities may translate into higher rates of preoperative testing among very elderly patients. In the VHA, 45% of ophthalmology services studied routinely performed preoperative electrocardiography, chemical analysis, and complete blood counts prior to performing cataract surgery.²⁷ Patients who live with chronic bacterial colonization from indwelling catheters, ostomies, or bed sores need to be given instructions for proper hygienic practices to minimize risks of postoperative infection.³⁴

Some patients undergoing cataract surgery may not be candidates for topical or local anesthesia alone. Sedation is often used to reduce anxiety and discomfort of surgery, but very elderly patients have narrower margins of therapeutic safety because of advanced aged or medical comorbidities. Since patients need to follow basic commands in the OR for ideal surgical execution, general anesthesia may need to be considered for those with dementia, deafness, anxiety attacks, or language barriers. Although there are no published investigations on the risks of general anesthesia in patients undergoing cataract surgery, a procedure with minimal blood loss and relatively short surgical time, age alone is not a contraindication for general anesthesia.³⁵ Communication among eye surgeons, PCPs, and anesthesiologists is needed to weigh the risk of surgery with the level of sedation (or anesthesia) required to guarantee a controlled OR environment.³¹

Postsurgical Care

Although cataract surgery is a less invasive procedure than it was in the past, full postoperative recovery regularly spans a month. During this time, proper healing relies on the regular administration of eye drops and a refrain from heavy lifting, straining, and eye rubbing. Very elderly patients may need varying degrees of assistance with postsurgical care. For example, adherence to the regimen of eye drops can be complicated by decreased dexterity from arthritis and difficulty remembering the administration schedule in some patients. Reliable transportation also is an important factor as patients are routinely scheduled for postoperative visits at the 1- day, 1-week, and 1-month mark. PCPs can assist in ensuring patients have prearranged assistance for eye care and transportation to and from appointments. Additionally, very elderly patients with a history of constipation may benefit from stool softeners and/or laxatives to help prevent straining.

Conclusion

The limited literature on clinical outcomes of cataract surgery in the very elderly indicates that most have successful surgery and improved postoperative QOL.²² Much of the benefits derived from cataract surgery in the very elderly can be ascribed to thoughtful preoperative evaluation and planning with the PCP. 

Cataract surgery is the most commonly performed surgical procedure in the US, including within the Veterans Health Administration (VHA).^1,2 As the risk of surgical complications has decreased with improved techniques and instrumentation, the threshold for performing surgery has lowered.³ A substantial number of patients do not develop clinically significant cataracts until they are “very elderly,” defined as aged ≥ 85 years by the World Health Organization and National Institute of Aging.⁴

Should the general approach to cataract evaluation and surgery differ in this subset of patients? Advanced age is associated with a variety of systemic and ocular comorbidities that theoretically increase the risk of cataract surgery and reduce the potential visual benefit it might yield. However, the impact of age on the outcomes of cataract surgery differs even among the very elderly. There are no universally acknowledged guidelines that address the perioperative evaluation and management of cataracts in the very elderly, whose systemic and ocular health have greater variability than those of their younger counterparts. For very elderly patients who are found to have visually significant cataracts by their ophthalmologists, input from the primary care provider (PCP), who has insight into a patient’s health and well-being, is vital for formulating a management plan. Herein, we provide a framework for PCPs to assist very elderly patients and their ophthalmologists in making an informed decision regarding cataract surgery and in planning for perioperative care.

Cataract Surgery

Cataract surgeons recommend surgical extraction when there is a clinically significant lens opacity that imposes functional impairment, such as inability to read, perform near work, watch television, or drive.⁴ The standard of care for a clinically significant cataract is surgical removal of the crystalline lens and replacement with an artificial intraocular lens (IOL). At times, the onset of vision loss from a cataract is insidious such that patients may not be aware of their declining vision or the deterioration in quality of life (QOL) that it causes.

Despite the higher burden of ocular comorbidity (eg, age-related macular degeneration, glaucoma) relative to their younger counterparts, most very elderly patients obtain functionally important improvement in their vision, QOL, and cognitive function after surgery.^5-16 Cataract surgery can also reduce the risk of dementia and the risk of falls and hip fractures.^{6,9,12-14,16-18} Ophthalmic complications of cataract surgery in the very elderly include posterior capsule tear (< 1%-9%), vitreous loss (< 1%-8%), zonular rupture (2%-5%), and retained lens fragments (≤ 1%).^{5,8-11,17,19-21} There is no evidence from well-controlled studies that suggests that very elderly cataract surgery patients are at higher risk of ocular complications relative to that of their younger counterparts.²²

Surgery Alternatives

In some very elderly patients, cataract surgery may not be the best option, and PCPs can aid in establishing an alternative plan. Such patients include those with a limited life expectancy, incapacitating anxiety over surgery, or those in whom the potential for visual improvement is marginal because of ocular or systemic comorbidities—eg, vision-limiting glaucoma or age-related macular degeneration, history of stroke to the visual pathway, or restriction to bed. Alternatives to cataract surgery in these instances include changing environmental conditions to improve visual function, such as enhanced lighting and contrast, and/or use of low-vision aids (referring patients to low-vision professionals often improves QOL).²³ Low-vision specialists also have a variety of nonvisual aids that can expand functional capabilities: large-print and talking versions of reading materials, telephones, remote controls, clocks, scales, calculators, and glucose monitors; glare-free lights for stairs, floors, and counters; and specialty glasses that use light-emitting diode screens and live video streams to magnify sight.^23-25

Medical Evaluation

For patients who decide to proceed with surgery, it can be helpful to have a medical evaluation by their PCPs to minimize potential complications during surgery. The very elderly may be at increased risk of intraoperative transient hypertension, restlessness, and electrocardiogram abnormalities.^5,7,17 Systemic comorbidities that become more prevalent with age, such as diabetes mellitus (DM), hypertension, heart disease, chronic obstructive pulmonary disease, and dementia, may adversely impact the risk of sedation and/or general anesthesia. In the VHA, providers also must be aware of combat-related disorders that can confound cataract surgery, such as posttraumatic stress disorder (PTSD), anxiety, and claustrophobia.^26,27

Anesthesia in cataract surgery ranges from topical to general, and the selection largely rests on patient physical and psychological comfort and cooperation. Often, intracameral (inside the anterior eye) anesthetic is used with topical anesthesia to provide additional comfort.²⁷ Patients who have high levels of anxiety about surgery may not tolerate topical anesthesia alone.²⁸ In these cases, retrobulbar anesthesia may be performed to block all sensation and motility of the eye. IV sedation is performed prior to the retrobulbar injection to calm patients. Although cataract surgery is typically performed with topical or retrobulbar anesthesia (reducing the potential for systemic complications), there are cases in which general anesthesia may be considered.²⁷ Very elderly patients may become confused or disoriented in the operating room (OR), leading to surgical complications and less than optimal outcomes.⁵ A higher rate of intraoperative “restlessness,” which occurred in patients who had comorbid dementia, and transient hypertension were found in a study on cataract surgery in the very elderly, but well-controlled studies are lacking.⁵ Dementia can impose problems with intraoperative cooperation, which is vital for successful surgery in patients who undergo topical or local anesthesia. If these potential problems are thought likely preoperatively, light sedation or general anesthesia—in conjunction with input from the patient’s PCP—are options to minimize disruptive behavior in the OR.

Additional features of the VHA population may influence the selection of anesthesia. The VHA has an important educational mission, and retrobulbar anesthesia may be preferred to minimize unpredictable intraoperative behavior in cases where resident surgeons are performing surgery under attending supervision.^27,29,30 The prevalence of PTSD among veterans also may impact the selection of anesthesia. Patients with PTSD have displayed greater levels of anxiety and more discomfort, requiring more sedation and longer surgical times compared with that of a control group.²⁸ Ophthalmic comorbidities prevalent among the predominantly older male population in the VHA include the use of α-1 antagonist prostate medications, such as tamsulosin and terazosin. These medications are associated with intraoperative floppy iris syndrome, which can increase case difficulty and prolong operative time.²⁹

Surgery Preparation

Cataract surgery induces minimal physiologic stress since most surgeries are performed under local or topical anesthesia. Unless the preoperative medical history or physical examination detects an active or unattended medical condition that needs to be addressed, preoperative laboratory testing is generally not required.^31-33 Current general guidelines for preoperative testing for cataract surgery exist but do not address specific issues facing very elderly patients. The American Academy of Ophthalmology advises against preoperative medical tests for eye surgery unless there are medical indications: an electrocardiogram for patients with a history of heart disease, a blood glucose test for those with DM, and a potassium test for patients who are on diuretics.³¹ The direct correlation of age with these comorbidities may translate into higher rates of preoperative testing among very elderly patients. In the VHA, 45% of ophthalmology services studied routinely performed preoperative electrocardiography, chemical analysis, and complete blood counts prior to performing cataract surgery.²⁷ Patients who live with chronic bacterial colonization from indwelling catheters, ostomies, or bed sores need to be given instructions for proper hygienic practices to minimize risks of postoperative infection.³⁴

Some patients undergoing cataract surgery may not be candidates for topical or local anesthesia alone. Sedation is often used to reduce anxiety and discomfort of surgery, but very elderly patients have narrower margins of therapeutic safety because of advanced aged or medical comorbidities. Since patients need to follow basic commands in the OR for ideal surgical execution, general anesthesia may need to be considered for those with dementia, deafness, anxiety attacks, or language barriers. Although there are no published investigations on the risks of general anesthesia in patients undergoing cataract surgery, a procedure with minimal blood loss and relatively short surgical time, age alone is not a contraindication for general anesthesia.³⁵ Communication among eye surgeons, PCPs, and anesthesiologists is needed to weigh the risk of surgery with the level of sedation (or anesthesia) required to guarantee a controlled OR environment.³¹

Postsurgical Care

Although cataract surgery is a less invasive procedure than it was in the past, full postoperative recovery regularly spans a month. During this time, proper healing relies on the regular administration of eye drops and a refrain from heavy lifting, straining, and eye rubbing. Very elderly patients may need varying degrees of assistance with postsurgical care. For example, adherence to the regimen of eye drops can be complicated by decreased dexterity from arthritis and difficulty remembering the administration schedule in some patients. Reliable transportation also is an important factor as patients are routinely scheduled for postoperative visits at the 1- day, 1-week, and 1-month mark. PCPs can assist in ensuring patients have prearranged assistance for eye care and transportation to and from appointments. Additionally, very elderly patients with a history of constipation may benefit from stool softeners and/or laxatives to help prevent straining.

Conclusion

The limited literature on clinical outcomes of cataract surgery in the very elderly indicates that most have successful surgery and improved postoperative QOL.²² Much of the benefits derived from cataract surgery in the very elderly can be ascribed to thoughtful preoperative evaluation and planning with the PCP. 

Cataract surgery is the most commonly performed surgical procedure in the US, including within the Veterans Health Administration (VHA).^1,2 As the risk of surgical complications has decreased with improved techniques and instrumentation, the threshold for performing surgery has lowered.³ A substantial number of patients do not develop clinically significant cataracts until they are “very elderly,” defined as aged ≥ 85 years by the World Health Organization and National Institute of Aging.⁴

Should the general approach to cataract evaluation and surgery differ in this subset of patients? Advanced age is associated with a variety of systemic and ocular comorbidities that theoretically increase the risk of cataract surgery and reduce the potential visual benefit it might yield. However, the impact of age on the outcomes of cataract surgery differs even among the very elderly. There are no universally acknowledged guidelines that address the perioperative evaluation and management of cataracts in the very elderly, whose systemic and ocular health have greater variability than those of their younger counterparts. For very elderly patients who are found to have visually significant cataracts by their ophthalmologists, input from the primary care provider (PCP), who has insight into a patient’s health and well-being, is vital for formulating a management plan. Herein, we provide a framework for PCPs to assist very elderly patients and their ophthalmologists in making an informed decision regarding cataract surgery and in planning for perioperative care.

Cataract Surgery

Cataract surgeons recommend surgical extraction when there is a clinically significant lens opacity that imposes functional impairment, such as inability to read, perform near work, watch television, or drive.⁴ The standard of care for a clinically significant cataract is surgical removal of the crystalline lens and replacement with an artificial intraocular lens (IOL). At times, the onset of vision loss from a cataract is insidious such that patients may not be aware of their declining vision or the deterioration in quality of life (QOL) that it causes.

Despite the higher burden of ocular comorbidity (eg, age-related macular degeneration, glaucoma) relative to their younger counterparts, most very elderly patients obtain functionally important improvement in their vision, QOL, and cognitive function after surgery.^5-16 Cataract surgery can also reduce the risk of dementia and the risk of falls and hip fractures.^{6,9,12-14,16-18} Ophthalmic complications of cataract surgery in the very elderly include posterior capsule tear (< 1%-9%), vitreous loss (< 1%-8%), zonular rupture (2%-5%), and retained lens fragments (≤ 1%).^{5,8-11,17,19-21} There is no evidence from well-controlled studies that suggests that very elderly cataract surgery patients are at higher risk of ocular complications relative to that of their younger counterparts.²²

Surgery Alternatives

In some very elderly patients, cataract surgery may not be the best option, and PCPs can aid in establishing an alternative plan. Such patients include those with a limited life expectancy, incapacitating anxiety over surgery, or those in whom the potential for visual improvement is marginal because of ocular or systemic comorbidities—eg, vision-limiting glaucoma or age-related macular degeneration, history of stroke to the visual pathway, or restriction to bed. Alternatives to cataract surgery in these instances include changing environmental conditions to improve visual function, such as enhanced lighting and contrast, and/or use of low-vision aids (referring patients to low-vision professionals often improves QOL).²³ Low-vision specialists also have a variety of nonvisual aids that can expand functional capabilities: large-print and talking versions of reading materials, telephones, remote controls, clocks, scales, calculators, and glucose monitors; glare-free lights for stairs, floors, and counters; and specialty glasses that use light-emitting diode screens and live video streams to magnify sight.^23-25

Medical Evaluation

For patients who decide to proceed with surgery, it can be helpful to have a medical evaluation by their PCPs to minimize potential complications during surgery. The very elderly may be at increased risk of intraoperative transient hypertension, restlessness, and electrocardiogram abnormalities.^5,7,17 Systemic comorbidities that become more prevalent with age, such as diabetes mellitus (DM), hypertension, heart disease, chronic obstructive pulmonary disease, and dementia, may adversely impact the risk of sedation and/or general anesthesia. In the VHA, providers also must be aware of combat-related disorders that can confound cataract surgery, such as posttraumatic stress disorder (PTSD), anxiety, and claustrophobia.^26,27

Anesthesia in cataract surgery ranges from topical to general, and the selection largely rests on patient physical and psychological comfort and cooperation. Often, intracameral (inside the anterior eye) anesthetic is used with topical anesthesia to provide additional comfort.²⁷ Patients who have high levels of anxiety about surgery may not tolerate topical anesthesia alone.²⁸ In these cases, retrobulbar anesthesia may be performed to block all sensation and motility of the eye. IV sedation is performed prior to the retrobulbar injection to calm patients. Although cataract surgery is typically performed with topical or retrobulbar anesthesia (reducing the potential for systemic complications), there are cases in which general anesthesia may be considered.²⁷ Very elderly patients may become confused or disoriented in the operating room (OR), leading to surgical complications and less than optimal outcomes.⁵ A higher rate of intraoperative “restlessness,” which occurred in patients who had comorbid dementia, and transient hypertension were found in a study on cataract surgery in the very elderly, but well-controlled studies are lacking.⁵ Dementia can impose problems with intraoperative cooperation, which is vital for successful surgery in patients who undergo topical or local anesthesia. If these potential problems are thought likely preoperatively, light sedation or general anesthesia—in conjunction with input from the patient’s PCP—are options to minimize disruptive behavior in the OR.

Additional features of the VHA population may influence the selection of anesthesia. The VHA has an important educational mission, and retrobulbar anesthesia may be preferred to minimize unpredictable intraoperative behavior in cases where resident surgeons are performing surgery under attending supervision.^27,29,30 The prevalence of PTSD among veterans also may impact the selection of anesthesia. Patients with PTSD have displayed greater levels of anxiety and more discomfort, requiring more sedation and longer surgical times compared with that of a control group.²⁸ Ophthalmic comorbidities prevalent among the predominantly older male population in the VHA include the use of α-1 antagonist prostate medications, such as tamsulosin and terazosin. These medications are associated with intraoperative floppy iris syndrome, which can increase case difficulty and prolong operative time.²⁹

Surgery Preparation

Cataract surgery induces minimal physiologic stress since most surgeries are performed under local or topical anesthesia. Unless the preoperative medical history or physical examination detects an active or unattended medical condition that needs to be addressed, preoperative laboratory testing is generally not required.^31-33 Current general guidelines for preoperative testing for cataract surgery exist but do not address specific issues facing very elderly patients. The American Academy of Ophthalmology advises against preoperative medical tests for eye surgery unless there are medical indications: an electrocardiogram for patients with a history of heart disease, a blood glucose test for those with DM, and a potassium test for patients who are on diuretics.³¹ The direct correlation of age with these comorbidities may translate into higher rates of preoperative testing among very elderly patients. In the VHA, 45% of ophthalmology services studied routinely performed preoperative electrocardiography, chemical analysis, and complete blood counts prior to performing cataract surgery.²⁷ Patients who live with chronic bacterial colonization from indwelling catheters, ostomies, or bed sores need to be given instructions for proper hygienic practices to minimize risks of postoperative infection.³⁴

Some patients undergoing cataract surgery may not be candidates for topical or local anesthesia alone. Sedation is often used to reduce anxiety and discomfort of surgery, but very elderly patients have narrower margins of therapeutic safety because of advanced aged or medical comorbidities. Since patients need to follow basic commands in the OR for ideal surgical execution, general anesthesia may need to be considered for those with dementia, deafness, anxiety attacks, or language barriers. Although there are no published investigations on the risks of general anesthesia in patients undergoing cataract surgery, a procedure with minimal blood loss and relatively short surgical time, age alone is not a contraindication for general anesthesia.³⁵ Communication among eye surgeons, PCPs, and anesthesiologists is needed to weigh the risk of surgery with the level of sedation (or anesthesia) required to guarantee a controlled OR environment.³¹

Postsurgical Care

Although cataract surgery is a less invasive procedure than it was in the past, full postoperative recovery regularly spans a month. During this time, proper healing relies on the regular administration of eye drops and a refrain from heavy lifting, straining, and eye rubbing. Very elderly patients may need varying degrees of assistance with postsurgical care. For example, adherence to the regimen of eye drops can be complicated by decreased dexterity from arthritis and difficulty remembering the administration schedule in some patients. Reliable transportation also is an important factor as patients are routinely scheduled for postoperative visits at the 1- day, 1-week, and 1-month mark. PCPs can assist in ensuring patients have prearranged assistance for eye care and transportation to and from appointments. Additionally, very elderly patients with a history of constipation may benefit from stool softeners and/or laxatives to help prevent straining.

Conclusion

The limited literature on clinical outcomes of cataract surgery in the very elderly indicates that most have successful surgery and improved postoperative QOL.²² Much of the benefits derived from cataract surgery in the very elderly can be ascribed to thoughtful preoperative evaluation and planning with the PCP. 

In recent years, driven by accelerating health care costs and desire for improved health care value, major specialty group guidelines have incorporated resource utilization and value calculations into their recommendations. High-value care has the characteristics of enhancing outcomes, safety, and patient satisfaction at a reasonable cost. As one example, the American College of Cardiology (ACC) recently published a consensus statement on its clinical practice guidelines with a specific focus on cost and value.¹ This guideline acknowledges the difficulty in incorporating value into clinical decision making but stresses a need for increased transparency and consistency to boost value in everyday practice.

Chest pain and related symptoms were listed as the second leading principle reasons for emergency department visits in the US in 2011 with 14% of patients undergoing cardiac enzyme testing.² The ACC guidelines advocate use of troponin as the preferred laboratory test for the initial evaluation of acute coronary syndrome (ACS). Fractionated creatine kinase (CK-MB) is an acceptable alternative only when a cardiac troponin test is not available.³ Furthermore, troponins should be obtained no more than 3 times for the initial evaluation of a single event, and further trending provides no additional benefit or prognostic information.

A recent study from an academic hospital showed that process improvement interventions focused on eliminating unnecessary cardiac enzyme testing led to a 1-year cost savings of $1.25 million while increasing the rate of ACS diagnosis.⁴ Common clinical practice at Naval Medical Center Portsmouth (NMCP) in Virginia still routinely includes both troponin as well as a CK panel comprised of CK, CK-MB, and a calculated CK-MB/CK index. Our study focuses on the implementation of quality improvement efforts described by Larochelle and colleagues at NMCP.⁴ The study aimed to determine the impact of implementing interventions designed to improve the ordering practices and reduce the cost of cardiac enzyme testing.

Methods

The primary focus of the intervention was on ordering practices of the emergency medicine department (EMD), internal medicine (IM) inpatient services, and cardiology inpatient services. Specific interventions were: (1) removal of the CK panel from the chest pain order set in the EMD electronic health record (EHR); (2) removal of the CK panel from the inpatient cardiology order set; (3) education of staff on the changes in CK panel utility via direct communication during IM academic seminars; (4) education of nursing staff ordering laboratory results on behalf of physicians on the cardiology service at the morning and evening huddles; and (5) addition of “max of 3 tests indicated” comment to the inpatient EHR ordering page of the troponin test. Acknowledging that the CK-MB has some utility to interventional cardiologists in the setting of confirmed ACS, the laboratory instituted an automated, reflexive order of the CK-MB panel only if the troponin tests were positive. This test was automatically run on the same vial originally sent to the lab to mitigate any additional delay in determining results.

Data Source

The process improvement interventions were considered exempt from institutional review board (IRB) approval; however, we obtained expedited IRB approval with waiver of consent for the research aspect of the project. We obtained clinical administrative data from the Military Health System Data Repository (MDR). We identified all adult patients aged ≥ 18 years who had a troponin test, CK-MB, or both drawn at NMCP on the following services: the EMD, IM, and cardiology. A troponin or CK-MB test was defined using Current Procedural Terminology (CPT) codes and unique Logical Observation Identifiers Names and Codes (LOINC).

Measures

The study was divided into 3 periods: the preintervention period from August 1, 2013 to July 31, 2014; the intervention period from August 1, 2014 to January 31, 2015; and the postintervention period February 1, 2015 to January 31, 2016.

The primary outcomes measured were the frequency of guideline concordance and total costs for tests ordered per month using the Centers for Medicare and Medicaid Services (CMS) clinical laboratory fee schedule of $13.40 for troponin and $16.17 for CK-MB.⁵Concordance was defined as ≤ 3 troponin tests and no CK-MB tests ordered during 1 encounter for a patient without an ACS diagnosis in the preceding 7 days. Due to faster cellular release kinetics of CK-MB compared with that of troponin, this test has utility in evaluating new or worsening chest pain in the setting of a recent myocardial infarction (MI). Therefore, we excluded any patient who had a MI within the preceding 7 days of an order for either CK-MB or troponin tests. Additionally, the number of tests, both CK-MB and troponin, ordered per patient encounter (hereafter referred to as an episode) were measured. Finally, we measured the monthly prevalence of ACS diagnosis and percentage of visits having that diagnosis.

Data Analysis

Descriptive statistics were used to calculate population demographics of age group, sex, beneficiary category, sponsor service, and clinical setting. Monthly data were grouped into the preintervention and postintervention periods. The analysis was performed using t tests to compare mean values and CIs before and after the intervention. Simple linear regression with attention to correlation was used to create best fit lines with confidence bands before and after the intervention. Interrupted time series (ITS) regression was used to describe all data points throughout the study. Consistency between these various methods was verified. Mean values and CIs were reported from the t tests. Statistical significance was reported when appropriate. Equations and confidence predictions on the simple linear regressions were produced and reported. These were used to identify values at the start, midpoint, and end of the pre- and postintervention periods.

Results

There were a total of 6,281 patients in the study population. More patients were seen during the postintervention period than in the preintervention period. The mean age of patients was slightly higher during the preintervention period (Table 1).

Guideline Concordance

To determine whether ordering practices for cardiac enzyme testing improved, we assessed the changes in the frequency of guideline concordance during the pre- and postintervention period. On average during the preintervention year, the percentage of tests ordered that met guideline concordance was 10.1% (95% CI, 7.4%-12.9%), increasing by 0.80% (95% CI, 0.17%-1.42%) each month. 

Costs

We assessed changes in total dollars spent on cardiac enzyme testing during the pre- and postintervention periods. During the preintervention year, $9,400 (95% CI, $8,700-$10,100) was spent on average each month, which did not change significantly throughout the period. During the postintervention year, the cost was stable at $5,000 (95% CI, $4,600-$5,300) on average each month, a reduction of $4,400 (95% CI, $3,700-$5,100) (Figure 2).

CK-MB and Troponin Tests per Patient

To further assess ordering practices for cardiac enzyme testing, we compared the changes in the monthly number of tests and the average number of CK-MB and troponin tests ordered per episode pre- and postintervention. On average during the preintervention year, 297 tests (95% CI, 278-315) were run per month, with an average of 1.21 CK tests (95% CI, 1.15-1.27) per episode (Table 2, Figure 3). 

The changes in troponin testing were not as dramatic. The counts of tests each month remained similar, with a preintervention year average of 341 (95% CI, 306-377) and postintervention year average of 310 (95% CI, 287-332), which were not statistically different. However, there was a statistically significant decrease in the number of tests per episode. During the preintervention year, 1.38 troponin tests (95% CI, 1.31-1.45) were ordered per patient on average. This dropped by 0.17 (95% CI, 0.09-0.24) to the postintervention average of 1.21 (95% CI, 1.17-1.25) (Table 2, Figure 4). 

ACS Prevalence

To determine whether there was an impact on ACS diagnoses, we looked at the numbers of ACS diagnoses and their prevalence among visits before and after the intervention. During the preintervention year, the average monthly number of diagnoses was 29.7 (95% CI, 26.1-33.2), and prevalence of ACS was 0.56% (95% CI, 0.48%-0.63%) of all episodes. Although the monthly rate was statistically decreasing by 0.022% (95% CI, 0.003-0.41), this has little meaning since the level of correlation (r² = 0.2522, not displayed) was poor due to the essentially nonexistent correlation in number of visits each month (r² = 0.0112, not displayed). During the postintervention year, the average number of diagnoses was 32.2 (95% CI, 27.9-36.6), and the prevalence of ACS was 0.62% (95% CI, 0.54-0.65). Neither of these values changed significantly between the pre- and postintervention period. All ICD-9 and ICD-10 diagnosis codes used for the analysis are available upon request from the authors.

Discussion

Our data demonstrate the ability of simple process improvement interventions to decrease unnecessary testing in the workup of ACS, increasing the rate of guideline concordant testing by > 70% at a single military treatment facility (MTF). In particular, with the now widespread use of EHR, the order set presents a high-yield target for process improvement in an easily implemented, durable fashion. We had expected to see some decrease in the efficacy of the intervention at a time of staff turnover in the summer of 2015 because ongoing dedicated teaching sessions were not performed. Despite that, the intervention remained effective without further dedicated teaching sessions. This outcome was certainly attributable to the hardwired interventions made (mainly via order sets), but possibly indicates an institutional memory that can take hold after an initial concerted effort is made.

We reduced the estimated preintervention annual cost of $113,000 by $53,000 (95% CI, $42,000-$64,000). Although on a much smaller scale than the study by Larochelle, our study represents a nearly 50% reduction in the total cost of initial testing for possible ACS and a > 80% reduction in unnecessary CK-MB testing.⁴ This result was achieved with no statistical change in the prevalence of ACS. The cost reduction does not account for the labor costs to clinically follow-up and address additional unnecessary lab results. The estimated cost of intervention was limited to the time required to educate residents, interns, and nursing staff as well as the implementation of the automated, reflexive laboratory results ordering process.

Unique to our study, we also demonstrated an intervention that satisfied all the major stakeholders in the ordering of these laboratory results. By instituting the reflexive ordering of CK-MB tests for positive troponins, we obtained the support of the facility’s interventional cardiology department, which finds value in that data. Appreciating the time-sensitive nature of an ACS diagnosis, the reflexive ordering minimized the delay in receiving these data while still greatly reducing the number of tests performed. That being said, if the current trend away from CK-MB in favor of exclusively testing troponin continues, removing the reflexive ordering for positive laboratory results protocol would be an easy follow-on intervention.

Limitations

Our study presented several limitations. First, reporting errors due to improper or insufficient medical coding as well as data entry errors may exist within the MDR; therefore, the results of this analysis may be over- or underestimated. Specifically, CPT codes for troponin and CK-MB were available only in 1 of the 2 data sets used for this study, which primarily contains outpatient patient encounters. For this reason, most of the laboratory testing comes from the EMD rather than from inpatient services. However, because we excluded all patients who eventually had an ACS diagnosis (patients who likely had more inpatient time and better indication for repeat troponin), we feel that our intervention was still thoroughly investigated. Second, the number of tests drawn per patient was significantly < 2, the expected minimum number of tests to rule out ACS in patients with appropriate symptoms.

This study was not designed to answer the source of variation from guidelines. Many patients had only 1 test, which we feel represents an opportunity for future study to identify other ways cardiac enzyme testing is being used clinically. These tests might be used for patients without convincing symptoms and signs of coronary syndromes or for patients with other primary problems. Third, by using the ITS analysis, we assumed that the outcome during each intervention period follows a linear pattern. However, changes may follow a nonlinear pattern over a long period. Finally, our intervention was limited to only a single MTF, which may limit generalizability to other facilities across military medicine. However, we feel this study should serve as a guide for other MTFs as well as US Department of Veterans Affairs facilities that could institute similar process improvements.

Conclusion

We made easily implemented and durable process improvement interventions that changed institution-wide ordering practices. These changes dramatically increased the rate of guideline-concordant testing, decreasing cost and furthering the goal of high-value medical care.

In recent years, driven by accelerating health care costs and desire for improved health care value, major specialty group guidelines have incorporated resource utilization and value calculations into their recommendations. High-value care has the characteristics of enhancing outcomes, safety, and patient satisfaction at a reasonable cost. As one example, the American College of Cardiology (ACC) recently published a consensus statement on its clinical practice guidelines with a specific focus on cost and value.¹ This guideline acknowledges the difficulty in incorporating value into clinical decision making but stresses a need for increased transparency and consistency to boost value in everyday practice.

Chest pain and related symptoms were listed as the second leading principle reasons for emergency department visits in the US in 2011 with 14% of patients undergoing cardiac enzyme testing.² The ACC guidelines advocate use of troponin as the preferred laboratory test for the initial evaluation of acute coronary syndrome (ACS). Fractionated creatine kinase (CK-MB) is an acceptable alternative only when a cardiac troponin test is not available.³ Furthermore, troponins should be obtained no more than 3 times for the initial evaluation of a single event, and further trending provides no additional benefit or prognostic information.

A recent study from an academic hospital showed that process improvement interventions focused on eliminating unnecessary cardiac enzyme testing led to a 1-year cost savings of $1.25 million while increasing the rate of ACS diagnosis.⁴ Common clinical practice at Naval Medical Center Portsmouth (NMCP) in Virginia still routinely includes both troponin as well as a CK panel comprised of CK, CK-MB, and a calculated CK-MB/CK index. Our study focuses on the implementation of quality improvement efforts described by Larochelle and colleagues at NMCP.⁴ The study aimed to determine the impact of implementing interventions designed to improve the ordering practices and reduce the cost of cardiac enzyme testing.

Methods

The primary focus of the intervention was on ordering practices of the emergency medicine department (EMD), internal medicine (IM) inpatient services, and cardiology inpatient services. Specific interventions were: (1) removal of the CK panel from the chest pain order set in the EMD electronic health record (EHR); (2) removal of the CK panel from the inpatient cardiology order set; (3) education of staff on the changes in CK panel utility via direct communication during IM academic seminars; (4) education of nursing staff ordering laboratory results on behalf of physicians on the cardiology service at the morning and evening huddles; and (5) addition of “max of 3 tests indicated” comment to the inpatient EHR ordering page of the troponin test. Acknowledging that the CK-MB has some utility to interventional cardiologists in the setting of confirmed ACS, the laboratory instituted an automated, reflexive order of the CK-MB panel only if the troponin tests were positive. This test was automatically run on the same vial originally sent to the lab to mitigate any additional delay in determining results.

Data Source

The process improvement interventions were considered exempt from institutional review board (IRB) approval; however, we obtained expedited IRB approval with waiver of consent for the research aspect of the project. We obtained clinical administrative data from the Military Health System Data Repository (MDR). We identified all adult patients aged ≥ 18 years who had a troponin test, CK-MB, or both drawn at NMCP on the following services: the EMD, IM, and cardiology. A troponin or CK-MB test was defined using Current Procedural Terminology (CPT) codes and unique Logical Observation Identifiers Names and Codes (LOINC).

Measures

The study was divided into 3 periods: the preintervention period from August 1, 2013 to July 31, 2014; the intervention period from August 1, 2014 to January 31, 2015; and the postintervention period February 1, 2015 to January 31, 2016.

The primary outcomes measured were the frequency of guideline concordance and total costs for tests ordered per month using the Centers for Medicare and Medicaid Services (CMS) clinical laboratory fee schedule of $13.40 for troponin and $16.17 for CK-MB.⁵Concordance was defined as ≤ 3 troponin tests and no CK-MB tests ordered during 1 encounter for a patient without an ACS diagnosis in the preceding 7 days. Due to faster cellular release kinetics of CK-MB compared with that of troponin, this test has utility in evaluating new or worsening chest pain in the setting of a recent myocardial infarction (MI). Therefore, we excluded any patient who had a MI within the preceding 7 days of an order for either CK-MB or troponin tests. Additionally, the number of tests, both CK-MB and troponin, ordered per patient encounter (hereafter referred to as an episode) were measured. Finally, we measured the monthly prevalence of ACS diagnosis and percentage of visits having that diagnosis.

Data Analysis

Descriptive statistics were used to calculate population demographics of age group, sex, beneficiary category, sponsor service, and clinical setting. Monthly data were grouped into the preintervention and postintervention periods. The analysis was performed using t tests to compare mean values and CIs before and after the intervention. Simple linear regression with attention to correlation was used to create best fit lines with confidence bands before and after the intervention. Interrupted time series (ITS) regression was used to describe all data points throughout the study. Consistency between these various methods was verified. Mean values and CIs were reported from the t tests. Statistical significance was reported when appropriate. Equations and confidence predictions on the simple linear regressions were produced and reported. These were used to identify values at the start, midpoint, and end of the pre- and postintervention periods.

Results

There were a total of 6,281 patients in the study population. More patients were seen during the postintervention period than in the preintervention period. The mean age of patients was slightly higher during the preintervention period (Table 1).

Guideline Concordance

To determine whether ordering practices for cardiac enzyme testing improved, we assessed the changes in the frequency of guideline concordance during the pre- and postintervention period. On average during the preintervention year, the percentage of tests ordered that met guideline concordance was 10.1% (95% CI, 7.4%-12.9%), increasing by 0.80% (95% CI, 0.17%-1.42%) each month. 

Costs

We assessed changes in total dollars spent on cardiac enzyme testing during the pre- and postintervention periods. During the preintervention year, $9,400 (95% CI, $8,700-$10,100) was spent on average each month, which did not change significantly throughout the period. During the postintervention year, the cost was stable at $5,000 (95% CI, $4,600-$5,300) on average each month, a reduction of $4,400 (95% CI, $3,700-$5,100) (Figure 2).

CK-MB and Troponin Tests per Patient

To further assess ordering practices for cardiac enzyme testing, we compared the changes in the monthly number of tests and the average number of CK-MB and troponin tests ordered per episode pre- and postintervention. On average during the preintervention year, 297 tests (95% CI, 278-315) were run per month, with an average of 1.21 CK tests (95% CI, 1.15-1.27) per episode (Table 2, Figure 3). 

The changes in troponin testing were not as dramatic. The counts of tests each month remained similar, with a preintervention year average of 341 (95% CI, 306-377) and postintervention year average of 310 (95% CI, 287-332), which were not statistically different. However, there was a statistically significant decrease in the number of tests per episode. During the preintervention year, 1.38 troponin tests (95% CI, 1.31-1.45) were ordered per patient on average. This dropped by 0.17 (95% CI, 0.09-0.24) to the postintervention average of 1.21 (95% CI, 1.17-1.25) (Table 2, Figure 4). 

ACS Prevalence

To determine whether there was an impact on ACS diagnoses, we looked at the numbers of ACS diagnoses and their prevalence among visits before and after the intervention. During the preintervention year, the average monthly number of diagnoses was 29.7 (95% CI, 26.1-33.2), and prevalence of ACS was 0.56% (95% CI, 0.48%-0.63%) of all episodes. Although the monthly rate was statistically decreasing by 0.022% (95% CI, 0.003-0.41), this has little meaning since the level of correlation (r² = 0.2522, not displayed) was poor due to the essentially nonexistent correlation in number of visits each month (r² = 0.0112, not displayed). During the postintervention year, the average number of diagnoses was 32.2 (95% CI, 27.9-36.6), and the prevalence of ACS was 0.62% (95% CI, 0.54-0.65). Neither of these values changed significantly between the pre- and postintervention period. All ICD-9 and ICD-10 diagnosis codes used for the analysis are available upon request from the authors.

Discussion

Our data demonstrate the ability of simple process improvement interventions to decrease unnecessary testing in the workup of ACS, increasing the rate of guideline concordant testing by > 70% at a single military treatment facility (MTF). In particular, with the now widespread use of EHR, the order set presents a high-yield target for process improvement in an easily implemented, durable fashion. We had expected to see some decrease in the efficacy of the intervention at a time of staff turnover in the summer of 2015 because ongoing dedicated teaching sessions were not performed. Despite that, the intervention remained effective without further dedicated teaching sessions. This outcome was certainly attributable to the hardwired interventions made (mainly via order sets), but possibly indicates an institutional memory that can take hold after an initial concerted effort is made.

We reduced the estimated preintervention annual cost of $113,000 by $53,000 (95% CI, $42,000-$64,000). Although on a much smaller scale than the study by Larochelle, our study represents a nearly 50% reduction in the total cost of initial testing for possible ACS and a > 80% reduction in unnecessary CK-MB testing.⁴ This result was achieved with no statistical change in the prevalence of ACS. The cost reduction does not account for the labor costs to clinically follow-up and address additional unnecessary lab results. The estimated cost of intervention was limited to the time required to educate residents, interns, and nursing staff as well as the implementation of the automated, reflexive laboratory results ordering process.

Unique to our study, we also demonstrated an intervention that satisfied all the major stakeholders in the ordering of these laboratory results. By instituting the reflexive ordering of CK-MB tests for positive troponins, we obtained the support of the facility’s interventional cardiology department, which finds value in that data. Appreciating the time-sensitive nature of an ACS diagnosis, the reflexive ordering minimized the delay in receiving these data while still greatly reducing the number of tests performed. That being said, if the current trend away from CK-MB in favor of exclusively testing troponin continues, removing the reflexive ordering for positive laboratory results protocol would be an easy follow-on intervention.

Limitations

Our study presented several limitations. First, reporting errors due to improper or insufficient medical coding as well as data entry errors may exist within the MDR; therefore, the results of this analysis may be over- or underestimated. Specifically, CPT codes for troponin and CK-MB were available only in 1 of the 2 data sets used for this study, which primarily contains outpatient patient encounters. For this reason, most of the laboratory testing comes from the EMD rather than from inpatient services. However, because we excluded all patients who eventually had an ACS diagnosis (patients who likely had more inpatient time and better indication for repeat troponin), we feel that our intervention was still thoroughly investigated. Second, the number of tests drawn per patient was significantly < 2, the expected minimum number of tests to rule out ACS in patients with appropriate symptoms.

This study was not designed to answer the source of variation from guidelines. Many patients had only 1 test, which we feel represents an opportunity for future study to identify other ways cardiac enzyme testing is being used clinically. These tests might be used for patients without convincing symptoms and signs of coronary syndromes or for patients with other primary problems. Third, by using the ITS analysis, we assumed that the outcome during each intervention period follows a linear pattern. However, changes may follow a nonlinear pattern over a long period. Finally, our intervention was limited to only a single MTF, which may limit generalizability to other facilities across military medicine. However, we feel this study should serve as a guide for other MTFs as well as US Department of Veterans Affairs facilities that could institute similar process improvements.

Conclusion

We made easily implemented and durable process improvement interventions that changed institution-wide ordering practices. These changes dramatically increased the rate of guideline-concordant testing, decreasing cost and furthering the goal of high-value medical care.

In recent years, driven by accelerating health care costs and desire for improved health care value, major specialty group guidelines have incorporated resource utilization and value calculations into their recommendations. High-value care has the characteristics of enhancing outcomes, safety, and patient satisfaction at a reasonable cost. As one example, the American College of Cardiology (ACC) recently published a consensus statement on its clinical practice guidelines with a specific focus on cost and value.¹ This guideline acknowledges the difficulty in incorporating value into clinical decision making but stresses a need for increased transparency and consistency to boost value in everyday practice.

Chest pain and related symptoms were listed as the second leading principle reasons for emergency department visits in the US in 2011 with 14% of patients undergoing cardiac enzyme testing.² The ACC guidelines advocate use of troponin as the preferred laboratory test for the initial evaluation of acute coronary syndrome (ACS). Fractionated creatine kinase (CK-MB) is an acceptable alternative only when a cardiac troponin test is not available.³ Furthermore, troponins should be obtained no more than 3 times for the initial evaluation of a single event, and further trending provides no additional benefit or prognostic information.

A recent study from an academic hospital showed that process improvement interventions focused on eliminating unnecessary cardiac enzyme testing led to a 1-year cost savings of $1.25 million while increasing the rate of ACS diagnosis.⁴ Common clinical practice at Naval Medical Center Portsmouth (NMCP) in Virginia still routinely includes both troponin as well as a CK panel comprised of CK, CK-MB, and a calculated CK-MB/CK index. Our study focuses on the implementation of quality improvement efforts described by Larochelle and colleagues at NMCP.⁴ The study aimed to determine the impact of implementing interventions designed to improve the ordering practices and reduce the cost of cardiac enzyme testing.

Methods

The primary focus of the intervention was on ordering practices of the emergency medicine department (EMD), internal medicine (IM) inpatient services, and cardiology inpatient services. Specific interventions were: (1) removal of the CK panel from the chest pain order set in the EMD electronic health record (EHR); (2) removal of the CK panel from the inpatient cardiology order set; (3) education of staff on the changes in CK panel utility via direct communication during IM academic seminars; (4) education of nursing staff ordering laboratory results on behalf of physicians on the cardiology service at the morning and evening huddles; and (5) addition of “max of 3 tests indicated” comment to the inpatient EHR ordering page of the troponin test. Acknowledging that the CK-MB has some utility to interventional cardiologists in the setting of confirmed ACS, the laboratory instituted an automated, reflexive order of the CK-MB panel only if the troponin tests were positive. This test was automatically run on the same vial originally sent to the lab to mitigate any additional delay in determining results.

Data Source

The process improvement interventions were considered exempt from institutional review board (IRB) approval; however, we obtained expedited IRB approval with waiver of consent for the research aspect of the project. We obtained clinical administrative data from the Military Health System Data Repository (MDR). We identified all adult patients aged ≥ 18 years who had a troponin test, CK-MB, or both drawn at NMCP on the following services: the EMD, IM, and cardiology. A troponin or CK-MB test was defined using Current Procedural Terminology (CPT) codes and unique Logical Observation Identifiers Names and Codes (LOINC).

Measures

The study was divided into 3 periods: the preintervention period from August 1, 2013 to July 31, 2014; the intervention period from August 1, 2014 to January 31, 2015; and the postintervention period February 1, 2015 to January 31, 2016.

The primary outcomes measured were the frequency of guideline concordance and total costs for tests ordered per month using the Centers for Medicare and Medicaid Services (CMS) clinical laboratory fee schedule of $13.40 for troponin and $16.17 for CK-MB.⁵Concordance was defined as ≤ 3 troponin tests and no CK-MB tests ordered during 1 encounter for a patient without an ACS diagnosis in the preceding 7 days. Due to faster cellular release kinetics of CK-MB compared with that of troponin, this test has utility in evaluating new or worsening chest pain in the setting of a recent myocardial infarction (MI). Therefore, we excluded any patient who had a MI within the preceding 7 days of an order for either CK-MB or troponin tests. Additionally, the number of tests, both CK-MB and troponin, ordered per patient encounter (hereafter referred to as an episode) were measured. Finally, we measured the monthly prevalence of ACS diagnosis and percentage of visits having that diagnosis.

Data Analysis

Descriptive statistics were used to calculate population demographics of age group, sex, beneficiary category, sponsor service, and clinical setting. Monthly data were grouped into the preintervention and postintervention periods. The analysis was performed using t tests to compare mean values and CIs before and after the intervention. Simple linear regression with attention to correlation was used to create best fit lines with confidence bands before and after the intervention. Interrupted time series (ITS) regression was used to describe all data points throughout the study. Consistency between these various methods was verified. Mean values and CIs were reported from the t tests. Statistical significance was reported when appropriate. Equations and confidence predictions on the simple linear regressions were produced and reported. These were used to identify values at the start, midpoint, and end of the pre- and postintervention periods.

Results

There were a total of 6,281 patients in the study population. More patients were seen during the postintervention period than in the preintervention period. The mean age of patients was slightly higher during the preintervention period (Table 1).

Guideline Concordance

To determine whether ordering practices for cardiac enzyme testing improved, we assessed the changes in the frequency of guideline concordance during the pre- and postintervention period. On average during the preintervention year, the percentage of tests ordered that met guideline concordance was 10.1% (95% CI, 7.4%-12.9%), increasing by 0.80% (95% CI, 0.17%-1.42%) each month. 

Costs

We assessed changes in total dollars spent on cardiac enzyme testing during the pre- and postintervention periods. During the preintervention year, $9,400 (95% CI, $8,700-$10,100) was spent on average each month, which did not change significantly throughout the period. During the postintervention year, the cost was stable at $5,000 (95% CI, $4,600-$5,300) on average each month, a reduction of $4,400 (95% CI, $3,700-$5,100) (Figure 2).

CK-MB and Troponin Tests per Patient

To further assess ordering practices for cardiac enzyme testing, we compared the changes in the monthly number of tests and the average number of CK-MB and troponin tests ordered per episode pre- and postintervention. On average during the preintervention year, 297 tests (95% CI, 278-315) were run per month, with an average of 1.21 CK tests (95% CI, 1.15-1.27) per episode (Table 2, Figure 3). 

The changes in troponin testing were not as dramatic. The counts of tests each month remained similar, with a preintervention year average of 341 (95% CI, 306-377) and postintervention year average of 310 (95% CI, 287-332), which were not statistically different. However, there was a statistically significant decrease in the number of tests per episode. During the preintervention year, 1.38 troponin tests (95% CI, 1.31-1.45) were ordered per patient on average. This dropped by 0.17 (95% CI, 0.09-0.24) to the postintervention average of 1.21 (95% CI, 1.17-1.25) (Table 2, Figure 4). 

ACS Prevalence

To determine whether there was an impact on ACS diagnoses, we looked at the numbers of ACS diagnoses and their prevalence among visits before and after the intervention. During the preintervention year, the average monthly number of diagnoses was 29.7 (95% CI, 26.1-33.2), and prevalence of ACS was 0.56% (95% CI, 0.48%-0.63%) of all episodes. Although the monthly rate was statistically decreasing by 0.022% (95% CI, 0.003-0.41), this has little meaning since the level of correlation (r² = 0.2522, not displayed) was poor due to the essentially nonexistent correlation in number of visits each month (r² = 0.0112, not displayed). During the postintervention year, the average number of diagnoses was 32.2 (95% CI, 27.9-36.6), and the prevalence of ACS was 0.62% (95% CI, 0.54-0.65). Neither of these values changed significantly between the pre- and postintervention period. All ICD-9 and ICD-10 diagnosis codes used for the analysis are available upon request from the authors.

Discussion

Our data demonstrate the ability of simple process improvement interventions to decrease unnecessary testing in the workup of ACS, increasing the rate of guideline concordant testing by > 70% at a single military treatment facility (MTF). In particular, with the now widespread use of EHR, the order set presents a high-yield target for process improvement in an easily implemented, durable fashion. We had expected to see some decrease in the efficacy of the intervention at a time of staff turnover in the summer of 2015 because ongoing dedicated teaching sessions were not performed. Despite that, the intervention remained effective without further dedicated teaching sessions. This outcome was certainly attributable to the hardwired interventions made (mainly via order sets), but possibly indicates an institutional memory that can take hold after an initial concerted effort is made.

We reduced the estimated preintervention annual cost of $113,000 by $53,000 (95% CI, $42,000-$64,000). Although on a much smaller scale than the study by Larochelle, our study represents a nearly 50% reduction in the total cost of initial testing for possible ACS and a > 80% reduction in unnecessary CK-MB testing.⁴ This result was achieved with no statistical change in the prevalence of ACS. The cost reduction does not account for the labor costs to clinically follow-up and address additional unnecessary lab results. The estimated cost of intervention was limited to the time required to educate residents, interns, and nursing staff as well as the implementation of the automated, reflexive laboratory results ordering process.

Unique to our study, we also demonstrated an intervention that satisfied all the major stakeholders in the ordering of these laboratory results. By instituting the reflexive ordering of CK-MB tests for positive troponins, we obtained the support of the facility’s interventional cardiology department, which finds value in that data. Appreciating the time-sensitive nature of an ACS diagnosis, the reflexive ordering minimized the delay in receiving these data while still greatly reducing the number of tests performed. That being said, if the current trend away from CK-MB in favor of exclusively testing troponin continues, removing the reflexive ordering for positive laboratory results protocol would be an easy follow-on intervention.

Limitations

Our study presented several limitations. First, reporting errors due to improper or insufficient medical coding as well as data entry errors may exist within the MDR; therefore, the results of this analysis may be over- or underestimated. Specifically, CPT codes for troponin and CK-MB were available only in 1 of the 2 data sets used for this study, which primarily contains outpatient patient encounters. For this reason, most of the laboratory testing comes from the EMD rather than from inpatient services. However, because we excluded all patients who eventually had an ACS diagnosis (patients who likely had more inpatient time and better indication for repeat troponin), we feel that our intervention was still thoroughly investigated. Second, the number of tests drawn per patient was significantly < 2, the expected minimum number of tests to rule out ACS in patients with appropriate symptoms.

This study was not designed to answer the source of variation from guidelines. Many patients had only 1 test, which we feel represents an opportunity for future study to identify other ways cardiac enzyme testing is being used clinically. These tests might be used for patients without convincing symptoms and signs of coronary syndromes or for patients with other primary problems. Third, by using the ITS analysis, we assumed that the outcome during each intervention period follows a linear pattern. However, changes may follow a nonlinear pattern over a long period. Finally, our intervention was limited to only a single MTF, which may limit generalizability to other facilities across military medicine. However, we feel this study should serve as a guide for other MTFs as well as US Department of Veterans Affairs facilities that could institute similar process improvements.

Conclusion

We made easily implemented and durable process improvement interventions that changed institution-wide ordering practices. These changes dramatically increased the rate of guideline-concordant testing, decreasing cost and furthering the goal of high-value medical care.

A new measles outbreak in Michigan has already resulted in 39 cases, and four more states reported their first cases of 2019 during the week ending April 4, according to the Centers for Disease Control and Prevention

The measles virus has now infected individuals in Florida, Indiana, Massachusetts, and Nevada, which means that 19 states have now reported a total of 465 cases this year, and that is the second-highest total “reported in the U.S. since measles was eliminated in 2000,” the CDC said April 8.

The Michigan outbreak is mostly concentrated in Oakland County, where 38 cases have occurred. The county has posted an up-to-date list of exposure locations.


Not to be outdone, New York reported 45 new cases last week: 44 in Brooklyn and 1 in Queens. There have been 259 confirmed cases in the two boroughs since the outbreak began in October of last year.

Besides Michigan and New York City, there are five other outbreaks ongoing in the United States: Rockland County, N.Y.; Washington State (no new cases since March 22); Butte County, Calif.; Santa Cruz County, Calif.; and New Jersey, the CDC reported.


A judge in New York State temporarily blocked an order banning unimmunized children from public spaces in Rockland County and has set a hearing date of April 19, CNN reported. The ban, ordered by Rockland County Executive Ed Day, went into effect on March 27.

On April 2, the Maine Center for Disease Control & Prevention announced that an out-of-state resident with a confirmed case of measles had visited two health care offices – one in Falmouth and one in Westbrook – on March 27. No cases in Maine residents have been reported yet.

On a vaccine-related note, the Washington State Senate’s Health and Long Term Care Committee approved a proposal on April 1 that would “end the personal exemption for parents who don’t want their children vaccinated against measles,” the Spokane Spokesman-Review said. The bill, which would still allow medical and religious exemptions, has already passed the state’s House of Representatives and goes next to the full senate.

[email protected]

A new measles outbreak in Michigan has already resulted in 39 cases, and four more states reported their first cases of 2019 during the week ending April 4, according to the Centers for Disease Control and Prevention

The measles virus has now infected individuals in Florida, Indiana, Massachusetts, and Nevada, which means that 19 states have now reported a total of 465 cases this year, and that is the second-highest total “reported in the U.S. since measles was eliminated in 2000,” the CDC said April 8.

The Michigan outbreak is mostly concentrated in Oakland County, where 38 cases have occurred. The county has posted an up-to-date list of exposure locations.


Not to be outdone, New York reported 45 new cases last week: 44 in Brooklyn and 1 in Queens. There have been 259 confirmed cases in the two boroughs since the outbreak began in October of last year.

Besides Michigan and New York City, there are five other outbreaks ongoing in the United States: Rockland County, N.Y.; Washington State (no new cases since March 22); Butte County, Calif.; Santa Cruz County, Calif.; and New Jersey, the CDC reported.


A judge in New York State temporarily blocked an order banning unimmunized children from public spaces in Rockland County and has set a hearing date of April 19, CNN reported. The ban, ordered by Rockland County Executive Ed Day, went into effect on March 27.

On April 2, the Maine Center for Disease Control & Prevention announced that an out-of-state resident with a confirmed case of measles had visited two health care offices – one in Falmouth and one in Westbrook – on March 27. No cases in Maine residents have been reported yet.

On a vaccine-related note, the Washington State Senate’s Health and Long Term Care Committee approved a proposal on April 1 that would “end the personal exemption for parents who don’t want their children vaccinated against measles,” the Spokane Spokesman-Review said. The bill, which would still allow medical and religious exemptions, has already passed the state’s House of Representatives and goes next to the full senate.

[email protected]

A new measles outbreak in Michigan has already resulted in 39 cases, and four more states reported their first cases of 2019 during the week ending April 4, according to the Centers for Disease Control and Prevention

The measles virus has now infected individuals in Florida, Indiana, Massachusetts, and Nevada, which means that 19 states have now reported a total of 465 cases this year, and that is the second-highest total “reported in the U.S. since measles was eliminated in 2000,” the CDC said April 8.

The Michigan outbreak is mostly concentrated in Oakland County, where 38 cases have occurred. The county has posted an up-to-date list of exposure locations.


Not to be outdone, New York reported 45 new cases last week: 44 in Brooklyn and 1 in Queens. There have been 259 confirmed cases in the two boroughs since the outbreak began in October of last year.

Besides Michigan and New York City, there are five other outbreaks ongoing in the United States: Rockland County, N.Y.; Washington State (no new cases since March 22); Butte County, Calif.; Santa Cruz County, Calif.; and New Jersey, the CDC reported.


A judge in New York State temporarily blocked an order banning unimmunized children from public spaces in Rockland County and has set a hearing date of April 19, CNN reported. The ban, ordered by Rockland County Executive Ed Day, went into effect on March 27.

On April 2, the Maine Center for Disease Control & Prevention announced that an out-of-state resident with a confirmed case of measles had visited two health care offices – one in Falmouth and one in Westbrook – on March 27. No cases in Maine residents have been reported yet.

On a vaccine-related note, the Washington State Senate’s Health and Long Term Care Committee approved a proposal on April 1 that would “end the personal exemption for parents who don’t want their children vaccinated against measles,” the Spokane Spokesman-Review said. The bill, which would still allow medical and religious exemptions, has already passed the state’s House of Representatives and goes next to the full senate.

[email protected]

A 45-year-old African American woman presented with painless fingernail detachment and cracks on her fingernails that had developed over the previous month. Her medical history was notable for an episode of Stevens-Johnson syndrome 2 months prior that required treatment with prednisone, IV immunoglobulin, etanercept, acetaminophen, and diphenhydramine.

A physical examination revealed multiple fingernails on both hands that exhibited 4 mm of proximal painless nail detachment with cream-colored discoloration, friability, and horizontal splitting (Figure). New, healthy nail was visible beneath the affected areas. Toenails were not affected.

• What is your diagnosis?
• How would you treat this patient?

Diagnosis

Based on the timing and characteristics of her nail detachment, the patient was diagnosed with onychomadesis, which is defined as painless detachment of the proximal nail plate from the nail matrix and nail bed after at least 40 days from an initial insult. Air beneath the detached nail plate causes a characteristic creamy-white discoloration. The severity of onychomadesis ranges from transverse furrows that affect a single nail without shedding, known as Beau lines, to multiple nails that are completely shed.^1,2 Nail plate shedding is typical because the nail matrix, the site of stem cells and the most proximal portion of the nail apparatus, is damaged and transiently arrested.

Various etiologies can halt nail plate production abruptly within the matrix. These typically manifest ≥ 40 days after the initial insult (the length of time for a fingernail to emerge from the proximal nail fold).² The annual incidence of these etiologies ranges from approximately 1 per 1 million people for Stevens-Johnson syndrome, a rare cause of onychomadesis, to 1 per 10 people for onychomycosis, one of the more common causes of onychomadesis.³ The Table compares the characteristics of the diagnoses that are most commonly associated with nail detachment and discoloration.

When a single nail is affected, the etiology of onychomadesis usually is primary and local, including mechanical nail trauma and fungal nail infections (onychomycosis).^1,2 Candida onychia is onychomycosis caused by Candida species typically Candida albicans, which result in localized nail darkening, chronic inflammation of the paronychial skin, and cuticle loss. The infection favors immunocompromised people; coinfections are common, and onychomadesis or onycholysis can occur. Unlike onychomadesis, onycholysis is defined by painless detachment of the distal nail plate from the nail bed, but nail shedding typically does not occur because the nail matrix is spared. The preferred treatment for Candida onychia is oral itraconazole, and guided screenings for immunodeficiencies and endocrinopathies, especially diabetes mellitus, should be completed.^3,4

Tinea unguium is another form of onychomycosis, but it is caused by dermatophytes, typically Trichophyton rubrum or Trichophyton mentagrophytes, which produce white and yellow nail discoloration followed by distal to proximal nail thickening and softening. Infection usually begins in toenails and demonstrates variable involvement in each nail as well as asymmetric distribution among digits.³ This condition also may eventuate in onychomadesis or onycholysis. Debridement followed by oral terbinafine is the treatment of choice.⁴

Two other causes of localized nail discoloration with or without nail detachment include melanonychia and nail bed infection by Pseudomonas aeruginosa (P aeruginosa). Melanonychia can be linear or diffuse brown discoloration of 1 or more nails caused by melanin deposition. Either pattern is a common finding in dark-skinned people, especially by age 50 years, but melanocyte hyperplasia should be excluded in all individuals along with drug adverse effects, exogenous pigments, infections, and systemic diseases.^3,5 P aeruginosa produces pyocyanin, the green pigment responsible for the discoloration seen in this opportunistic infection often localized to a single nail. Prior maceration of the nail apparatus by repeated water submersion is common among affected individuals. Avoidance of submerging fingernails in liquids followed by nail debridement and oral antipseudomonal antibiotics is the preferred treatment course.³

The etiology is usually secondary and systemic when multiple nails demonstrate onychomadesis, but the exact pathophysiology is poorly understood. One of the most studied infectious etiologies of onychomadesis is hand-foot-and-mouth disease (HFMD), which typically affects children aged < 10 years. Parents often will recall their child being ill 1 to 2 months prior to the nail findings. Scarlet fever and varicella also can result in onychomadesis. Although not common systemic causes, Stevens-Johnson syndrome and toxic epidermal necrolysis can trigger onychomadesis of multiple nails that usually resolves in several months, but other nail deformities often persist.^2,6 Onycholysis also can accompany this finding.⁷ Autoimmune etiologies of onychomadesis include alopecia areata and pemphigus vulgaris. Inciting medications that are toxic to the nail matrix include chemotherapy agents, valproic acid, carbamazepine, lithium, and azithromycin. Rare congenital disorders and birth trauma also can present with onychomadesis of multiple nails during infancy.²

Systemic etiologies typically affect fingernails more than toenails because of the faster growth rate of fingernails. Once the source of onychomadesis is controlled or eradicated, complete regrowth of fingernails can take from 4 to 6 months. Toenails can take twice as long and older age increases all regrowth periods.⁵

Our patient was treated with analgesics until her mucosal surfaces fully healed, and topical emollients and keratolytics were used to soften eschars from previous blisters and prevent further scar formation. Her affected fingernails shed and regrew after 6 months without additional interventions.

Conclusion

Although Stevens-Johnson syndrome is a rare cause of onychomadesis, and the pathophysiology of this sequela is poorly understood, this case illustrates a common nail abnormality with multiple potential etiologies that are discerned by an accurate history and thorough exam. In the absence of decorative nail polish, nails can be easily examined to provide helpful clues for past injuries or underlying diseases. An understanding of nail growth mechanics and associated terminology reveals the diagnostic and therapeutic implications of proximal vs distal nail detachment, the hue of nail discoloration, as well as single vs multiple affected nails.

Onychomadesis in single nails should prompt questions about nail trauma or risk factors for fungal infections. Depending on the etiology, manual activities need to be adjusted, or antifungals need to be initiated while investigating for an immunocompromised state. Onychomadesis in multiple nails in children should raise suspicion for HFMD or even birth trauma and congenital disorders. Multiple affected nails in adults should prompt guided questions for autoimmune diseases and inciting medications. For onycholysis, trauma, psoriasis, or certain infections should be the target. Green nails are easily recognized and treated with a defined regiment, whereas dark nails should be examined closely to differentiate Candida onychia from melanonychia. Whether from a rare cause in an adult to a common illness in a child, primary care providers have sufficient expertise to diagnose and treat various nail disorders and reassure worried patients and parents with an understanding of nail regrowth.

A 45-year-old African American woman presented with painless fingernail detachment and cracks on her fingernails that had developed over the previous month. Her medical history was notable for an episode of Stevens-Johnson syndrome 2 months prior that required treatment with prednisone, IV immunoglobulin, etanercept, acetaminophen, and diphenhydramine.

A physical examination revealed multiple fingernails on both hands that exhibited 4 mm of proximal painless nail detachment with cream-colored discoloration, friability, and horizontal splitting (Figure). New, healthy nail was visible beneath the affected areas. Toenails were not affected.

• What is your diagnosis?
• How would you treat this patient?

Diagnosis

Based on the timing and characteristics of her nail detachment, the patient was diagnosed with onychomadesis, which is defined as painless detachment of the proximal nail plate from the nail matrix and nail bed after at least 40 days from an initial insult. Air beneath the detached nail plate causes a characteristic creamy-white discoloration. The severity of onychomadesis ranges from transverse furrows that affect a single nail without shedding, known as Beau lines, to multiple nails that are completely shed.^1,2 Nail plate shedding is typical because the nail matrix, the site of stem cells and the most proximal portion of the nail apparatus, is damaged and transiently arrested.

Various etiologies can halt nail plate production abruptly within the matrix. These typically manifest ≥ 40 days after the initial insult (the length of time for a fingernail to emerge from the proximal nail fold).² The annual incidence of these etiologies ranges from approximately 1 per 1 million people for Stevens-Johnson syndrome, a rare cause of onychomadesis, to 1 per 10 people for onychomycosis, one of the more common causes of onychomadesis.³ The Table compares the characteristics of the diagnoses that are most commonly associated with nail detachment and discoloration.

When a single nail is affected, the etiology of onychomadesis usually is primary and local, including mechanical nail trauma and fungal nail infections (onychomycosis).^1,2 Candida onychia is onychomycosis caused by Candida species typically Candida albicans, which result in localized nail darkening, chronic inflammation of the paronychial skin, and cuticle loss. The infection favors immunocompromised people; coinfections are common, and onychomadesis or onycholysis can occur. Unlike onychomadesis, onycholysis is defined by painless detachment of the distal nail plate from the nail bed, but nail shedding typically does not occur because the nail matrix is spared. The preferred treatment for Candida onychia is oral itraconazole, and guided screenings for immunodeficiencies and endocrinopathies, especially diabetes mellitus, should be completed.^3,4

Tinea unguium is another form of onychomycosis, but it is caused by dermatophytes, typically Trichophyton rubrum or Trichophyton mentagrophytes, which produce white and yellow nail discoloration followed by distal to proximal nail thickening and softening. Infection usually begins in toenails and demonstrates variable involvement in each nail as well as asymmetric distribution among digits.³ This condition also may eventuate in onychomadesis or onycholysis. Debridement followed by oral terbinafine is the treatment of choice.⁴

Two other causes of localized nail discoloration with or without nail detachment include melanonychia and nail bed infection by Pseudomonas aeruginosa (P aeruginosa). Melanonychia can be linear or diffuse brown discoloration of 1 or more nails caused by melanin deposition. Either pattern is a common finding in dark-skinned people, especially by age 50 years, but melanocyte hyperplasia should be excluded in all individuals along with drug adverse effects, exogenous pigments, infections, and systemic diseases.^3,5 P aeruginosa produces pyocyanin, the green pigment responsible for the discoloration seen in this opportunistic infection often localized to a single nail. Prior maceration of the nail apparatus by repeated water submersion is common among affected individuals. Avoidance of submerging fingernails in liquids followed by nail debridement and oral antipseudomonal antibiotics is the preferred treatment course.³

The etiology is usually secondary and systemic when multiple nails demonstrate onychomadesis, but the exact pathophysiology is poorly understood. One of the most studied infectious etiologies of onychomadesis is hand-foot-and-mouth disease (HFMD), which typically affects children aged < 10 years. Parents often will recall their child being ill 1 to 2 months prior to the nail findings. Scarlet fever and varicella also can result in onychomadesis. Although not common systemic causes, Stevens-Johnson syndrome and toxic epidermal necrolysis can trigger onychomadesis of multiple nails that usually resolves in several months, but other nail deformities often persist.^2,6 Onycholysis also can accompany this finding.⁷ Autoimmune etiologies of onychomadesis include alopecia areata and pemphigus vulgaris. Inciting medications that are toxic to the nail matrix include chemotherapy agents, valproic acid, carbamazepine, lithium, and azithromycin. Rare congenital disorders and birth trauma also can present with onychomadesis of multiple nails during infancy.²

Systemic etiologies typically affect fingernails more than toenails because of the faster growth rate of fingernails. Once the source of onychomadesis is controlled or eradicated, complete regrowth of fingernails can take from 4 to 6 months. Toenails can take twice as long and older age increases all regrowth periods.⁵

Our patient was treated with analgesics until her mucosal surfaces fully healed, and topical emollients and keratolytics were used to soften eschars from previous blisters and prevent further scar formation. Her affected fingernails shed and regrew after 6 months without additional interventions.

Conclusion

Although Stevens-Johnson syndrome is a rare cause of onychomadesis, and the pathophysiology of this sequela is poorly understood, this case illustrates a common nail abnormality with multiple potential etiologies that are discerned by an accurate history and thorough exam. In the absence of decorative nail polish, nails can be easily examined to provide helpful clues for past injuries or underlying diseases. An understanding of nail growth mechanics and associated terminology reveals the diagnostic and therapeutic implications of proximal vs distal nail detachment, the hue of nail discoloration, as well as single vs multiple affected nails.

Onychomadesis in single nails should prompt questions about nail trauma or risk factors for fungal infections. Depending on the etiology, manual activities need to be adjusted, or antifungals need to be initiated while investigating for an immunocompromised state. Onychomadesis in multiple nails in children should raise suspicion for HFMD or even birth trauma and congenital disorders. Multiple affected nails in adults should prompt guided questions for autoimmune diseases and inciting medications. For onycholysis, trauma, psoriasis, or certain infections should be the target. Green nails are easily recognized and treated with a defined regiment, whereas dark nails should be examined closely to differentiate Candida onychia from melanonychia. Whether from a rare cause in an adult to a common illness in a child, primary care providers have sufficient expertise to diagnose and treat various nail disorders and reassure worried patients and parents with an understanding of nail regrowth.

A 45-year-old African American woman presented with painless fingernail detachment and cracks on her fingernails that had developed over the previous month. Her medical history was notable for an episode of Stevens-Johnson syndrome 2 months prior that required treatment with prednisone, IV immunoglobulin, etanercept, acetaminophen, and diphenhydramine.

A physical examination revealed multiple fingernails on both hands that exhibited 4 mm of proximal painless nail detachment with cream-colored discoloration, friability, and horizontal splitting (Figure). New, healthy nail was visible beneath the affected areas. Toenails were not affected.

• What is your diagnosis?
• How would you treat this patient?

Diagnosis

Based on the timing and characteristics of her nail detachment, the patient was diagnosed with onychomadesis, which is defined as painless detachment of the proximal nail plate from the nail matrix and nail bed after at least 40 days from an initial insult. Air beneath the detached nail plate causes a characteristic creamy-white discoloration. The severity of onychomadesis ranges from transverse furrows that affect a single nail without shedding, known as Beau lines, to multiple nails that are completely shed.^1,2 Nail plate shedding is typical because the nail matrix, the site of stem cells and the most proximal portion of the nail apparatus, is damaged and transiently arrested.

Various etiologies can halt nail plate production abruptly within the matrix. These typically manifest ≥ 40 days after the initial insult (the length of time for a fingernail to emerge from the proximal nail fold).² The annual incidence of these etiologies ranges from approximately 1 per 1 million people for Stevens-Johnson syndrome, a rare cause of onychomadesis, to 1 per 10 people for onychomycosis, one of the more common causes of onychomadesis.³ The Table compares the characteristics of the diagnoses that are most commonly associated with nail detachment and discoloration.

When a single nail is affected, the etiology of onychomadesis usually is primary and local, including mechanical nail trauma and fungal nail infections (onychomycosis).^1,2 Candida onychia is onychomycosis caused by Candida species typically Candida albicans, which result in localized nail darkening, chronic inflammation of the paronychial skin, and cuticle loss. The infection favors immunocompromised people; coinfections are common, and onychomadesis or onycholysis can occur. Unlike onychomadesis, onycholysis is defined by painless detachment of the distal nail plate from the nail bed, but nail shedding typically does not occur because the nail matrix is spared. The preferred treatment for Candida onychia is oral itraconazole, and guided screenings for immunodeficiencies and endocrinopathies, especially diabetes mellitus, should be completed.^3,4

Tinea unguium is another form of onychomycosis, but it is caused by dermatophytes, typically Trichophyton rubrum or Trichophyton mentagrophytes, which produce white and yellow nail discoloration followed by distal to proximal nail thickening and softening. Infection usually begins in toenails and demonstrates variable involvement in each nail as well as asymmetric distribution among digits.³ This condition also may eventuate in onychomadesis or onycholysis. Debridement followed by oral terbinafine is the treatment of choice.⁴

Two other causes of localized nail discoloration with or without nail detachment include melanonychia and nail bed infection by Pseudomonas aeruginosa (P aeruginosa). Melanonychia can be linear or diffuse brown discoloration of 1 or more nails caused by melanin deposition. Either pattern is a common finding in dark-skinned people, especially by age 50 years, but melanocyte hyperplasia should be excluded in all individuals along with drug adverse effects, exogenous pigments, infections, and systemic diseases.^3,5 P aeruginosa produces pyocyanin, the green pigment responsible for the discoloration seen in this opportunistic infection often localized to a single nail. Prior maceration of the nail apparatus by repeated water submersion is common among affected individuals. Avoidance of submerging fingernails in liquids followed by nail debridement and oral antipseudomonal antibiotics is the preferred treatment course.³

The etiology is usually secondary and systemic when multiple nails demonstrate onychomadesis, but the exact pathophysiology is poorly understood. One of the most studied infectious etiologies of onychomadesis is hand-foot-and-mouth disease (HFMD), which typically affects children aged < 10 years. Parents often will recall their child being ill 1 to 2 months prior to the nail findings. Scarlet fever and varicella also can result in onychomadesis. Although not common systemic causes, Stevens-Johnson syndrome and toxic epidermal necrolysis can trigger onychomadesis of multiple nails that usually resolves in several months, but other nail deformities often persist.^2,6 Onycholysis also can accompany this finding.⁷ Autoimmune etiologies of onychomadesis include alopecia areata and pemphigus vulgaris. Inciting medications that are toxic to the nail matrix include chemotherapy agents, valproic acid, carbamazepine, lithium, and azithromycin. Rare congenital disorders and birth trauma also can present with onychomadesis of multiple nails during infancy.²

Systemic etiologies typically affect fingernails more than toenails because of the faster growth rate of fingernails. Once the source of onychomadesis is controlled or eradicated, complete regrowth of fingernails can take from 4 to 6 months. Toenails can take twice as long and older age increases all regrowth periods.⁵

Our patient was treated with analgesics until her mucosal surfaces fully healed, and topical emollients and keratolytics were used to soften eschars from previous blisters and prevent further scar formation. Her affected fingernails shed and regrew after 6 months without additional interventions.

Conclusion

Although Stevens-Johnson syndrome is a rare cause of onychomadesis, and the pathophysiology of this sequela is poorly understood, this case illustrates a common nail abnormality with multiple potential etiologies that are discerned by an accurate history and thorough exam. In the absence of decorative nail polish, nails can be easily examined to provide helpful clues for past injuries or underlying diseases. An understanding of nail growth mechanics and associated terminology reveals the diagnostic and therapeutic implications of proximal vs distal nail detachment, the hue of nail discoloration, as well as single vs multiple affected nails.

Onychomadesis in single nails should prompt questions about nail trauma or risk factors for fungal infections. Depending on the etiology, manual activities need to be adjusted, or antifungals need to be initiated while investigating for an immunocompromised state. Onychomadesis in multiple nails in children should raise suspicion for HFMD or even birth trauma and congenital disorders. Multiple affected nails in adults should prompt guided questions for autoimmune diseases and inciting medications. For onycholysis, trauma, psoriasis, or certain infections should be the target. Green nails are easily recognized and treated with a defined regiment, whereas dark nails should be examined closely to differentiate Candida onychia from melanonychia. Whether from a rare cause in an adult to a common illness in a child, primary care providers have sufficient expertise to diagnose and treat various nail disorders and reassure worried patients and parents with an understanding of nail regrowth.

The Red Lake Indian Health Service (IHS) health care facility is in north-central Minnesota within the Red Lake Nation. The facility supports primary care, emergency, urgent care, pharmacy, inpatient, optometry, dental, radiology, laboratory, physical therapy, and behavioral health services to about 10,000 Red Lake Band of Chippewa Indian patients. The Red Lake pharmacy provides inpatient and outpatient medication services and pharmacist-managed clinical patient care.

In 2013, the Red Lake IHS medical staff endorsed the implementation of comprehensive clinical pharmacy services to increase health care access and optimize clinical outcomes for patients. During the evolution of pharmacy-based patient-centric care, the clinical programs offered by Red Lake IHS pharmacy expanded from 1 anticoagulation clinic to multiple advanced-practice clinical pharmacy services. This included pharmacy primary care, medication-assisted therapy, naloxone, hepatitis C, and behavioral health medication management clinics.

The immense clinical growth of the pharmacy department demonstrated a need to assess and monitor pharmacist competency to ensure the delivery of quality patient care. Essential quality improvement processes were lacking. To fill these quality improvement gaps, a robust pharmacist credentialing and privileging program was implemented in 2015.

Patient Care

As efforts within health care establishments across the US focus on the delivery of efficient, high-quality, affordable health care, pharmacists have become increasingly instrumental in providing patient care within expanded clinical roles.^1-8 Many clinical pharmacy models have evolved into interdisciplinary approaches to care.⁹ Within these models, abiding by state and federal laws, pharmacists practice under the indirect supervision of licensed independent practitioners (LIPs), such as physicians, nurse practitioners, and physician assistants.⁸ Under collaborative practice agreements (CPAs), patients are initially diagnosed by LIPs, then referred to clinical pharmacists for therapeutic management.^5,7

Clinical pharmacist functions encompass comprehensive medication management (ie, prescribing, monitoring, and adjustment of medications), nonpharmacologic guidance, and coordination of care. Interdisciplinary collaboration allows pharmacists opportunities to provide direct patient care or consultations by telecommunication in many different clinical environments, including disease management, primary care, or specialty care. Pharmacists may manage chronic or acute illnesses associated with endocrine, cardiovascular, respiratory, gastrointestinal, or other systems.

Pharmacist Credentialing

With the advancement of modern clinical pharmacy practice, many pharmacists have undertaken responsibilities to fulfill the complex duties of clinical care and diverse patient situations, but with few or no requirements to prove initial or ongoing clinical competency.² Traditionally, pharmacist credentialing is limited to a onetime or periodic review of education and licensure, with little to no involvement in privileging and ongoing monitoring of clinical proficiency.¹⁰ These quality assurance disparities can be met and satisfied through credentialing and privileging processes. Credentialing and privileging are systematic, evidence-based processes that provide validation to HCPs, employers, and patients that pharmacists are qualified to practice clinically. ^2,9 According to the Council on Credentialing in Pharmacy, clinical pharmacists should be held accountable for demonstrating competency and providing quality care through credentialing and privileging, as required for other HCPs.^2,12

Credentialing and recredentialing is a primary source verification process. These processes ensure that there are no license restrictions or revocations; certifications are current; mandatory courses, certificates, and continuing education are complete; training and orientation are satisfactory; and any disciplinary action, malpractice claims, or history of impairment is reported. Privileging is the review of credentials and evaluation of clinical training and competence by the Clinical Director and Medical Executive Committee to determine whether a clinical pharmacist is competent to practice within requested privileges.¹¹

Credentialing and privileging processes are designed not only to initially confirm that a pharmacist is competent to practice clinically, but also monitor ongoing performance.^2,13 Participation in professional practice evaluations, which includes peer reviews, ongoing professional practice evaluations, and focused professional practice evaluations, is required for all credentialed and privileged practitioners. These evaluations are used to identify, assess, and correct unsatisfactory trends. Individual practices, documentation, and processes are evaluated against existing department standards (eg, CPAs, policies, processes)^11,13 The results of individual professional practice evaluations are reviewed with practitioners on a regular basis and performance improvement plans implemented as needed.

Since 2015, 17 pharmacists at the Red Lake IHS health care facility have been granted membership to the medical staff as credentialed and privileged practitioners. In a retrospective review of professional practice evaluations by the Red Lake IHS pharmacy clinical coordinator, 971 outpatient clinical peer reviews, including the evaluation of 21,526 peer-review elements were completed by pharmacists from fiscal year 2015 through 2018. Peer-review elements assessed visit documentation, patient care, and other clinic processes defined by department standards. Beginning in 2016, peer-review feedback was implemented and completed on a quarterly basis with each pharmacist. In fiscal years 2015, 2016, 2017, and 2018, the percentage of peer-review elements found as noncompliant with department standards were 18.0%, 11.6%, 3.7%, and 3.4%, respectively. Compared with the 2015 year baseline, these data correlate with a decrease of peer-review concerns by 35.5% in 2016, 79.4% in 2017, and 81.1% in 2018.

Conclusion

Pharmacists have become increasingly instrumental in providing effective, cost-efficient, and accessible clinical services by continuing to move toward expanding and evolving roles within comprehensive, patient-centered clinical pharmacy practice settings.^5,6 Multifaceted clinical responsibilities associated with health care delivery necessitate assessment and monitoring of pharmacist performance. Credentialing and privileging is an established and trusted systematic process that assures HCPs, employers, and patients that pharmacists are qualified and competent to practice clinically.^2,4,12 Implementation of professional practice evaluations suggest improved staff compliance with visit documentation, patient care standards, and clinic processes required by CPAs, policies, and department standards to ensure the delivery of safe, high-quality patient care.

The Red Lake Indian Health Service (IHS) health care facility is in north-central Minnesota within the Red Lake Nation. The facility supports primary care, emergency, urgent care, pharmacy, inpatient, optometry, dental, radiology, laboratory, physical therapy, and behavioral health services to about 10,000 Red Lake Band of Chippewa Indian patients. The Red Lake pharmacy provides inpatient and outpatient medication services and pharmacist-managed clinical patient care.

In 2013, the Red Lake IHS medical staff endorsed the implementation of comprehensive clinical pharmacy services to increase health care access and optimize clinical outcomes for patients. During the evolution of pharmacy-based patient-centric care, the clinical programs offered by Red Lake IHS pharmacy expanded from 1 anticoagulation clinic to multiple advanced-practice clinical pharmacy services. This included pharmacy primary care, medication-assisted therapy, naloxone, hepatitis C, and behavioral health medication management clinics.

The immense clinical growth of the pharmacy department demonstrated a need to assess and monitor pharmacist competency to ensure the delivery of quality patient care. Essential quality improvement processes were lacking. To fill these quality improvement gaps, a robust pharmacist credentialing and privileging program was implemented in 2015.

Patient Care

As efforts within health care establishments across the US focus on the delivery of efficient, high-quality, affordable health care, pharmacists have become increasingly instrumental in providing patient care within expanded clinical roles.^1-8 Many clinical pharmacy models have evolved into interdisciplinary approaches to care.⁹ Within these models, abiding by state and federal laws, pharmacists practice under the indirect supervision of licensed independent practitioners (LIPs), such as physicians, nurse practitioners, and physician assistants.⁸ Under collaborative practice agreements (CPAs), patients are initially diagnosed by LIPs, then referred to clinical pharmacists for therapeutic management.^5,7

Clinical pharmacist functions encompass comprehensive medication management (ie, prescribing, monitoring, and adjustment of medications), nonpharmacologic guidance, and coordination of care. Interdisciplinary collaboration allows pharmacists opportunities to provide direct patient care or consultations by telecommunication in many different clinical environments, including disease management, primary care, or specialty care. Pharmacists may manage chronic or acute illnesses associated with endocrine, cardiovascular, respiratory, gastrointestinal, or other systems.

Pharmacist Credentialing

With the advancement of modern clinical pharmacy practice, many pharmacists have undertaken responsibilities to fulfill the complex duties of clinical care and diverse patient situations, but with few or no requirements to prove initial or ongoing clinical competency.² Traditionally, pharmacist credentialing is limited to a onetime or periodic review of education and licensure, with little to no involvement in privileging and ongoing monitoring of clinical proficiency.¹⁰ These quality assurance disparities can be met and satisfied through credentialing and privileging processes. Credentialing and privileging are systematic, evidence-based processes that provide validation to HCPs, employers, and patients that pharmacists are qualified to practice clinically. ^2,9 According to the Council on Credentialing in Pharmacy, clinical pharmacists should be held accountable for demonstrating competency and providing quality care through credentialing and privileging, as required for other HCPs.^2,12

Credentialing and recredentialing is a primary source verification process. These processes ensure that there are no license restrictions or revocations; certifications are current; mandatory courses, certificates, and continuing education are complete; training and orientation are satisfactory; and any disciplinary action, malpractice claims, or history of impairment is reported. Privileging is the review of credentials and evaluation of clinical training and competence by the Clinical Director and Medical Executive Committee to determine whether a clinical pharmacist is competent to practice within requested privileges.¹¹

Credentialing and privileging processes are designed not only to initially confirm that a pharmacist is competent to practice clinically, but also monitor ongoing performance.^2,13 Participation in professional practice evaluations, which includes peer reviews, ongoing professional practice evaluations, and focused professional practice evaluations, is required for all credentialed and privileged practitioners. These evaluations are used to identify, assess, and correct unsatisfactory trends. Individual practices, documentation, and processes are evaluated against existing department standards (eg, CPAs, policies, processes)^11,13 The results of individual professional practice evaluations are reviewed with practitioners on a regular basis and performance improvement plans implemented as needed.

Since 2015, 17 pharmacists at the Red Lake IHS health care facility have been granted membership to the medical staff as credentialed and privileged practitioners. In a retrospective review of professional practice evaluations by the Red Lake IHS pharmacy clinical coordinator, 971 outpatient clinical peer reviews, including the evaluation of 21,526 peer-review elements were completed by pharmacists from fiscal year 2015 through 2018. Peer-review elements assessed visit documentation, patient care, and other clinic processes defined by department standards. Beginning in 2016, peer-review feedback was implemented and completed on a quarterly basis with each pharmacist. In fiscal years 2015, 2016, 2017, and 2018, the percentage of peer-review elements found as noncompliant with department standards were 18.0%, 11.6%, 3.7%, and 3.4%, respectively. Compared with the 2015 year baseline, these data correlate with a decrease of peer-review concerns by 35.5% in 2016, 79.4% in 2017, and 81.1% in 2018.

Conclusion

Pharmacists have become increasingly instrumental in providing effective, cost-efficient, and accessible clinical services by continuing to move toward expanding and evolving roles within comprehensive, patient-centered clinical pharmacy practice settings.^5,6 Multifaceted clinical responsibilities associated with health care delivery necessitate assessment and monitoring of pharmacist performance. Credentialing and privileging is an established and trusted systematic process that assures HCPs, employers, and patients that pharmacists are qualified and competent to practice clinically.^2,4,12 Implementation of professional practice evaluations suggest improved staff compliance with visit documentation, patient care standards, and clinic processes required by CPAs, policies, and department standards to ensure the delivery of safe, high-quality patient care.

The Red Lake Indian Health Service (IHS) health care facility is in north-central Minnesota within the Red Lake Nation. The facility supports primary care, emergency, urgent care, pharmacy, inpatient, optometry, dental, radiology, laboratory, physical therapy, and behavioral health services to about 10,000 Red Lake Band of Chippewa Indian patients. The Red Lake pharmacy provides inpatient and outpatient medication services and pharmacist-managed clinical patient care.

In 2013, the Red Lake IHS medical staff endorsed the implementation of comprehensive clinical pharmacy services to increase health care access and optimize clinical outcomes for patients. During the evolution of pharmacy-based patient-centric care, the clinical programs offered by Red Lake IHS pharmacy expanded from 1 anticoagulation clinic to multiple advanced-practice clinical pharmacy services. This included pharmacy primary care, medication-assisted therapy, naloxone, hepatitis C, and behavioral health medication management clinics.

The immense clinical growth of the pharmacy department demonstrated a need to assess and monitor pharmacist competency to ensure the delivery of quality patient care. Essential quality improvement processes were lacking. To fill these quality improvement gaps, a robust pharmacist credentialing and privileging program was implemented in 2015.

Patient Care

As efforts within health care establishments across the US focus on the delivery of efficient, high-quality, affordable health care, pharmacists have become increasingly instrumental in providing patient care within expanded clinical roles.^1-8 Many clinical pharmacy models have evolved into interdisciplinary approaches to care.⁹ Within these models, abiding by state and federal laws, pharmacists practice under the indirect supervision of licensed independent practitioners (LIPs), such as physicians, nurse practitioners, and physician assistants.⁸ Under collaborative practice agreements (CPAs), patients are initially diagnosed by LIPs, then referred to clinical pharmacists for therapeutic management.^5,7

Clinical pharmacist functions encompass comprehensive medication management (ie, prescribing, monitoring, and adjustment of medications), nonpharmacologic guidance, and coordination of care. Interdisciplinary collaboration allows pharmacists opportunities to provide direct patient care or consultations by telecommunication in many different clinical environments, including disease management, primary care, or specialty care. Pharmacists may manage chronic or acute illnesses associated with endocrine, cardiovascular, respiratory, gastrointestinal, or other systems.

Pharmacist Credentialing

With the advancement of modern clinical pharmacy practice, many pharmacists have undertaken responsibilities to fulfill the complex duties of clinical care and diverse patient situations, but with few or no requirements to prove initial or ongoing clinical competency.² Traditionally, pharmacist credentialing is limited to a onetime or periodic review of education and licensure, with little to no involvement in privileging and ongoing monitoring of clinical proficiency.¹⁰ These quality assurance disparities can be met and satisfied through credentialing and privileging processes. Credentialing and privileging are systematic, evidence-based processes that provide validation to HCPs, employers, and patients that pharmacists are qualified to practice clinically. ^2,9 According to the Council on Credentialing in Pharmacy, clinical pharmacists should be held accountable for demonstrating competency and providing quality care through credentialing and privileging, as required for other HCPs.^2,12

Credentialing and recredentialing is a primary source verification process. These processes ensure that there are no license restrictions or revocations; certifications are current; mandatory courses, certificates, and continuing education are complete; training and orientation are satisfactory; and any disciplinary action, malpractice claims, or history of impairment is reported. Privileging is the review of credentials and evaluation of clinical training and competence by the Clinical Director and Medical Executive Committee to determine whether a clinical pharmacist is competent to practice within requested privileges.¹¹

Credentialing and privileging processes are designed not only to initially confirm that a pharmacist is competent to practice clinically, but also monitor ongoing performance.^2,13 Participation in professional practice evaluations, which includes peer reviews, ongoing professional practice evaluations, and focused professional practice evaluations, is required for all credentialed and privileged practitioners. These evaluations are used to identify, assess, and correct unsatisfactory trends. Individual practices, documentation, and processes are evaluated against existing department standards (eg, CPAs, policies, processes)^11,13 The results of individual professional practice evaluations are reviewed with practitioners on a regular basis and performance improvement plans implemented as needed.

Since 2015, 17 pharmacists at the Red Lake IHS health care facility have been granted membership to the medical staff as credentialed and privileged practitioners. In a retrospective review of professional practice evaluations by the Red Lake IHS pharmacy clinical coordinator, 971 outpatient clinical peer reviews, including the evaluation of 21,526 peer-review elements were completed by pharmacists from fiscal year 2015 through 2018. Peer-review elements assessed visit documentation, patient care, and other clinic processes defined by department standards. Beginning in 2016, peer-review feedback was implemented and completed on a quarterly basis with each pharmacist. In fiscal years 2015, 2016, 2017, and 2018, the percentage of peer-review elements found as noncompliant with department standards were 18.0%, 11.6%, 3.7%, and 3.4%, respectively. Compared with the 2015 year baseline, these data correlate with a decrease of peer-review concerns by 35.5% in 2016, 79.4% in 2017, and 81.1% in 2018.

Conclusion

Pharmacists have become increasingly instrumental in providing effective, cost-efficient, and accessible clinical services by continuing to move toward expanding and evolving roles within comprehensive, patient-centered clinical pharmacy practice settings.^5,6 Multifaceted clinical responsibilities associated with health care delivery necessitate assessment and monitoring of pharmacist performance. Credentialing and privileging is an established and trusted systematic process that assures HCPs, employers, and patients that pharmacists are qualified and competent to practice clinically.^2,4,12 Implementation of professional practice evaluations suggest improved staff compliance with visit documentation, patient care standards, and clinic processes required by CPAs, policies, and department standards to ensure the delivery of safe, high-quality patient care.

Rapid deterioration of life quality of patients with idiopathic pulmonary fibrosis (IPF) begins years before death and indicates that early, integrated palliative care should be a priority, according to the finding of a survey study.

IPFeditor/Wikimedia Commons

“Patients with IPF suffer from exceptionally low [health-related quality of life] together with severe breathlessness and fatigue already two years before death. In addition, physical and emotional well-being further deteriorates near death concurrently with escalating overall symptom burden,” wrote Kaisa Rajala, MD, and her colleagues at Helsinki University Hospital.

They conducted a substudy of patients in the larger FinnishIPF study to assess health-related quality of life (HRQOL) and symptom burden in the period before death. Among 300 patients invited to participate, 247 agreed. Patient disease and sociodemographic data were collected from the FinnishIPF records and the study group completed questionnaires five times at 6 month intervals. The study began in April 2015 and continued until August 2017, by which time 92 (37%) of the patients had died (BMC Pulmonary Medicine 2018;18:172; doi: 0.1186/s12890-018-0738-x).

The investigators used self-reporting tools to look at HRQOL and symptom burden: RAND 36-item Health Survey (RAND-36), the Modified Medical Research and Council Dyspnea Scale (MMRC), the Modified Edmonton Symptom Assessment Scale (ESAS), and the Numeric Rating Scale (NRS).

[email protected]

SOURCE: Rajala K et al. BMC Pulm Med. 2018;18:172. doi: 0.1186/s12890-018-0738-x.

Rapid deterioration of life quality of patients with idiopathic pulmonary fibrosis (IPF) begins years before death and indicates that early, integrated palliative care should be a priority, according to the finding of a survey study.

IPFeditor/Wikimedia Commons

“Patients with IPF suffer from exceptionally low [health-related quality of life] together with severe breathlessness and fatigue already two years before death. In addition, physical and emotional well-being further deteriorates near death concurrently with escalating overall symptom burden,” wrote Kaisa Rajala, MD, and her colleagues at Helsinki University Hospital.

They conducted a substudy of patients in the larger FinnishIPF study to assess health-related quality of life (HRQOL) and symptom burden in the period before death. Among 300 patients invited to participate, 247 agreed. Patient disease and sociodemographic data were collected from the FinnishIPF records and the study group completed questionnaires five times at 6 month intervals. The study began in April 2015 and continued until August 2017, by which time 92 (37%) of the patients had died (BMC Pulmonary Medicine 2018;18:172; doi: 0.1186/s12890-018-0738-x).

The investigators used self-reporting tools to look at HRQOL and symptom burden: RAND 36-item Health Survey (RAND-36), the Modified Medical Research and Council Dyspnea Scale (MMRC), the Modified Edmonton Symptom Assessment Scale (ESAS), and the Numeric Rating Scale (NRS).

[email protected]

SOURCE: Rajala K et al. BMC Pulm Med. 2018;18:172. doi: 0.1186/s12890-018-0738-x.

Rapid deterioration of life quality of patients with idiopathic pulmonary fibrosis (IPF) begins years before death and indicates that early, integrated palliative care should be a priority, according to the finding of a survey study.

IPFeditor/Wikimedia Commons

“Patients with IPF suffer from exceptionally low [health-related quality of life] together with severe breathlessness and fatigue already two years before death. In addition, physical and emotional well-being further deteriorates near death concurrently with escalating overall symptom burden,” wrote Kaisa Rajala, MD, and her colleagues at Helsinki University Hospital.

They conducted a substudy of patients in the larger FinnishIPF study to assess health-related quality of life (HRQOL) and symptom burden in the period before death. Among 300 patients invited to participate, 247 agreed. Patient disease and sociodemographic data were collected from the FinnishIPF records and the study group completed questionnaires five times at 6 month intervals. The study began in April 2015 and continued until August 2017, by which time 92 (37%) of the patients had died (BMC Pulmonary Medicine 2018;18:172; doi: 0.1186/s12890-018-0738-x).

The investigators used self-reporting tools to look at HRQOL and symptom burden: RAND 36-item Health Survey (RAND-36), the Modified Medical Research and Council Dyspnea Scale (MMRC), the Modified Edmonton Symptom Assessment Scale (ESAS), and the Numeric Rating Scale (NRS).

[email protected]

SOURCE: Rajala K et al. BMC Pulm Med. 2018;18:172. doi: 0.1186/s12890-018-0738-x.

As the US population continues to grow and patients become more aware of their health needs, payers are beginning to recognize the benefits of more efficient and cost-effective health care. With the implementation of the new Medicare Physician Fee Schedule on January 1, 2019, some old billing codes were revalued while others were replaced entirely with new codes.¹ The restructuring of the standard biopsy codes now takes the complexity of different sampling techniques into consideration. Furthermore, Current Procedural Terminology (CPT) Category III tracking codes for some imaging devices (eg, optical coherence tomography) added in 2017 require more data before obtaining a Category I reimbursable code, while codes for other imaging devices such as reflectance confocal microscopy (RCM) remain relatively the same.^2-4 Notably, the majority of the new 2019 telemedicine codes are applicable to dermatology.^2,3 In this article, we discuss the new CPT codes for reporting diagnostic procedures, including biopsy, noninvasive imaging, and telemedicine services. We also provide a summary of the national average reimbursement rates for these procedures. 

Background on Reimbursement 

To better understand how reimbursement works, it is important to know that all billing codes are provided a relative value unit (RVU), a number representing the value of the work involved and cost of providing a service relative to other services.⁵ The total RVU consists of the work RVU (wRVU), practice expense RVU (peRVU), and malpractice expense RVU (mRVU). The wRVU represents the time, effort, and complexity involved in performing the service. The peRVU reflects the direct cost of supplies, personnel, and durable equipment involved in providing the service, excluding typical office overhead costs such as rent, utilities, and administrative staff. The mRVU is to cover the cost of malpractice insurance.⁵ The peRVU can be further specified as facility versus nonfacility services depending on where the service is performed.⁶ A facility peRVU is for services completed in a facility such as a hospital, outpatient hospital setting, or nursing home. The facility provides some of the involved supplies, personnel, and equipment for which they can recapture costs by separate reporting, resulting in a lower total RVU for the provider charges compared with nonfacility locations where the physician must provide these items.⁶ Many physicians may not be aware of how critical their role is in determining their own reimbursement rates by understanding RVUs and properly filling out Relative Value Scale Update Committee (RUC) surveys. If surveys sent to practitioners are accurately completed, RVUs have the potential to be fairly valued; however, if respondents are unaware of all of the components that are inherent to a procedure, they may end up minimizing the effort or time involved, which would skew the results and hurt those who perform the procedure. Rather than inputting appropriate preoperative and postoperative service times, many respondents often put 0s and 1s throughout the survey, which misrepresents the amount of time involved for a procedure. For example, inputting a preoperative time as 0 or 1 minute may severely underestimate the work involved for a procedure if the true preoperative time is 5 minutes. Such survey responses affect whether or not RVUs are valued appropriately. 

The billing codes and their RVUs as well as Medicare payment values in your area can be found on the Centers for Medicare & Medicaid Services website.^2,3 Table 1 provides a comparison of the old and new biopsy codes, and Table 2 shows the new RCM codes. 

Biopsy Codes 

Prior to 2019, biopsies were reimbursed using CPT code 11100 for the initial biopsy and 11101 for each additional biopsy.² Called up for refinement in the RUC process, initial data from the Physician Practice Expense Information Survey pointed to the likelihood of different sampling techniques having different amounts of work being supplied by different techniques.¹ Imaging modalities such as dermoscopy or RCM could help minimize the need for surgical biopsies. Dermoscopy, which has been proven to allow for more efficient and accurate diagnoses in dermatology, is reimbursed in Europe but not in the United States.^7-9 In 2016, CPT codes 96931 through 96936 were created for RCM and are covered by most insurances.¹⁰ Optical coherence tomography, another noninvasive imaging technology, currently is not reimbursed but did receive Category III codes (0470T-0471T), also known as a tracking codes, in 2017.⁴ Category III codes are used for emerging technologies that have future potential but do not have enough US-based evidence to support receiving Category I CPT codes. The use of Category III codes allows for data collection on emerging technologies and services, with the potential to convert the Category III codes to Category I codes once certain criteria are met.¹¹ 

Beginning in 2019, the standard biopsy codes 11100 and 11101 were replaced with 6 new codes to represent primary (11102, 11104, 11106) and add-on biopsies (11103, 11105, 11107) based on the sampling technique utilized and the thickness of the sample (Table 1). Previously, the biopsy codes did not reflect the complexity of the different biopsy techniques, whereas the new codes provide differentiation of the method of removal (ie, tangential, punch, incisional).^2,3 The base code is dependent on whichever biopsy performed has the highest complexity, with incisional biopsy--a partial excision--being considered the most complex.³ Punch biopsy is considered the next level of complexity, followed by tangential biopsy. Each of the 6 new biopsy codes also received a new wRVU, which determines reimbursement under Medicare and most other insurers when combined with direct peRVU and mRVU. Additional biopsies, reported using the add-on codes, are reimbursed at a lower level than the base codes because of removal of duplicate inputs for preservice and postservice care.³  

Telehealth Codes 

Telemedicine services offer another form of imaging that providers can use to communicate remotely with patients through a live interactive video stream (with audio), a store-and-forward system with photographs or videos shared asynchronously, or remote patient monitoring.¹² Although live video streaming uses a webcam, store-and-forward services involve sending photographs or videos electronically for later evaluation.^12,13 Remote patient monitoring allows the collection of health-related data and transmission to a physician without the need for an office visit.¹³ Most states require physicians to have a license in the state in which the patient is located at the time of the encounter. Given the difficulty of applying for licensure in multiple states, several states started creating their own special licenses to allow out-of-state providers to offer services through telemedicine.¹⁴ The Federation of State Medical Boards then created the Interstate Medical Licensure Compact (IMLC) for an expedited process to apply for medical licensure in other states. The IMLC was formed to increase access to health care in underserved or rural areas including but not limited to the use of telemedicine.¹⁵ To qualify for IMLC, a physician must have a medical license in a state registered with the IMLC (ie, state of principal license) and have at least one of the following in their state of principal license: primary residence, 25% of their medical practice, a current employer, or US federal income taxes filed.¹⁵ The remaining states that do not have a licensing process for telemedicine allow practice in contiguous states or may provide temporary licenses dependent on the situation.¹⁴ 

Since 2017, billing codes for telemedicine have been the same as those used for in-person evaluation and management services with modifiers -95 or GQ added to the end of the code. Modifier -95 has been used for real-time telemedicine services, while modifier GQ has been used for store-and-forward services.¹⁶ For example, the code 99201, which is used to bill for new patients at outpatient visits, would become 99201-95 if performed using a live audio and video feed or 99201-GQ if information was sent electronically for later analysis. To receive reimbursement from Medicare, modifier -95 requires real-time communication using both audio and video; however, modifier GQ is only reimbursable in federal telemedicine demonstration programs in Alaska or Hawaii.¹² Note that reimbursement is up to the discretion of private providers, and even Medicare reimbursement can vary from state to state. 

In 2019, new Healthcare Common Procedure Coding System telemedicine codes were introduced to include virtual check-ins (G2012) and evaluation of patient-transmitted images and videos (G2010). G2010 is the first store-and-forward code that has the potential to be reimbursed outside of Alaska or Hawaii.^3,12 G2012 allows providers to monitor the patients' well-being outside of the office setting, a cost-effective alternative if patients do not require a full visit. More detailed descriptions of the new codes can be found in Table 3.¹ 

Final Thoughts 

As insurance providers continue to better monitor health care costs, it is of utmost importance that physicians become more involved in accurately assessing their services and procedures, given that the changes in RVUs mirror the Centers for Medicare & Medicaid Services' utilization of the RUC's interpretation of our survey responses.¹ The current billing codes attempt to better represent the work involved for each service, one example being the modification to more specific biopsy codes in 2019.  

With the growth of technology, CPT and Healthcare Common Procedure Coding System codes also reflect a push toward more efficient health care delivery and broader coverage for provider services, as demonstrated by the introduction of new telemedicine codes as well as recent additions of noninvasive imaging codes. Although technology makes health care more cost-effective for patients, clinicians can still maintain their overall reimbursements by efficiently seeing an increasing number of patients; for example, a patient diagnosed noninvasively using RCM can then receive same-day care, which impacts patients' quality of life by minimizing travel time, number of office visits, and time taken off from work, while allowing providers to manage a higher patient volume more productively. The new CPT codes discussed here reflect the growth of medical technology potential, which increases our diagnostic capability, making it even more critical for physicians to engage with these developments. 
 

As the US population continues to grow and patients become more aware of their health needs, payers are beginning to recognize the benefits of more efficient and cost-effective health care. With the implementation of the new Medicare Physician Fee Schedule on January 1, 2019, some old billing codes were revalued while others were replaced entirely with new codes.¹ The restructuring of the standard biopsy codes now takes the complexity of different sampling techniques into consideration. Furthermore, Current Procedural Terminology (CPT) Category III tracking codes for some imaging devices (eg, optical coherence tomography) added in 2017 require more data before obtaining a Category I reimbursable code, while codes for other imaging devices such as reflectance confocal microscopy (RCM) remain relatively the same.^2-4 Notably, the majority of the new 2019 telemedicine codes are applicable to dermatology.^2,3 In this article, we discuss the new CPT codes for reporting diagnostic procedures, including biopsy, noninvasive imaging, and telemedicine services. We also provide a summary of the national average reimbursement rates for these procedures. 

Background on Reimbursement 

To better understand how reimbursement works, it is important to know that all billing codes are provided a relative value unit (RVU), a number representing the value of the work involved and cost of providing a service relative to other services.⁵ The total RVU consists of the work RVU (wRVU), practice expense RVU (peRVU), and malpractice expense RVU (mRVU). The wRVU represents the time, effort, and complexity involved in performing the service. The peRVU reflects the direct cost of supplies, personnel, and durable equipment involved in providing the service, excluding typical office overhead costs such as rent, utilities, and administrative staff. The mRVU is to cover the cost of malpractice insurance.⁵ The peRVU can be further specified as facility versus nonfacility services depending on where the service is performed.⁶ A facility peRVU is for services completed in a facility such as a hospital, outpatient hospital setting, or nursing home. The facility provides some of the involved supplies, personnel, and equipment for which they can recapture costs by separate reporting, resulting in a lower total RVU for the provider charges compared with nonfacility locations where the physician must provide these items.⁶ Many physicians may not be aware of how critical their role is in determining their own reimbursement rates by understanding RVUs and properly filling out Relative Value Scale Update Committee (RUC) surveys. If surveys sent to practitioners are accurately completed, RVUs have the potential to be fairly valued; however, if respondents are unaware of all of the components that are inherent to a procedure, they may end up minimizing the effort or time involved, which would skew the results and hurt those who perform the procedure. Rather than inputting appropriate preoperative and postoperative service times, many respondents often put 0s and 1s throughout the survey, which misrepresents the amount of time involved for a procedure. For example, inputting a preoperative time as 0 or 1 minute may severely underestimate the work involved for a procedure if the true preoperative time is 5 minutes. Such survey responses affect whether or not RVUs are valued appropriately. 

The billing codes and their RVUs as well as Medicare payment values in your area can be found on the Centers for Medicare & Medicaid Services website.^2,3 Table 1 provides a comparison of the old and new biopsy codes, and Table 2 shows the new RCM codes. 

Biopsy Codes 

Prior to 2019, biopsies were reimbursed using CPT code 11100 for the initial biopsy and 11101 for each additional biopsy.² Called up for refinement in the RUC process, initial data from the Physician Practice Expense Information Survey pointed to the likelihood of different sampling techniques having different amounts of work being supplied by different techniques.¹ Imaging modalities such as dermoscopy or RCM could help minimize the need for surgical biopsies. Dermoscopy, which has been proven to allow for more efficient and accurate diagnoses in dermatology, is reimbursed in Europe but not in the United States.^7-9 In 2016, CPT codes 96931 through 96936 were created for RCM and are covered by most insurances.¹⁰ Optical coherence tomography, another noninvasive imaging technology, currently is not reimbursed but did receive Category III codes (0470T-0471T), also known as a tracking codes, in 2017.⁴ Category III codes are used for emerging technologies that have future potential but do not have enough US-based evidence to support receiving Category I CPT codes. The use of Category III codes allows for data collection on emerging technologies and services, with the potential to convert the Category III codes to Category I codes once certain criteria are met.¹¹ 

Beginning in 2019, the standard biopsy codes 11100 and 11101 were replaced with 6 new codes to represent primary (11102, 11104, 11106) and add-on biopsies (11103, 11105, 11107) based on the sampling technique utilized and the thickness of the sample (Table 1). Previously, the biopsy codes did not reflect the complexity of the different biopsy techniques, whereas the new codes provide differentiation of the method of removal (ie, tangential, punch, incisional).^2,3 The base code is dependent on whichever biopsy performed has the highest complexity, with incisional biopsy--a partial excision--being considered the most complex.³ Punch biopsy is considered the next level of complexity, followed by tangential biopsy. Each of the 6 new biopsy codes also received a new wRVU, which determines reimbursement under Medicare and most other insurers when combined with direct peRVU and mRVU. Additional biopsies, reported using the add-on codes, are reimbursed at a lower level than the base codes because of removal of duplicate inputs for preservice and postservice care.³  

Telehealth Codes 

Telemedicine services offer another form of imaging that providers can use to communicate remotely with patients through a live interactive video stream (with audio), a store-and-forward system with photographs or videos shared asynchronously, or remote patient monitoring.¹² Although live video streaming uses a webcam, store-and-forward services involve sending photographs or videos electronically for later evaluation.^12,13 Remote patient monitoring allows the collection of health-related data and transmission to a physician without the need for an office visit.¹³ Most states require physicians to have a license in the state in which the patient is located at the time of the encounter. Given the difficulty of applying for licensure in multiple states, several states started creating their own special licenses to allow out-of-state providers to offer services through telemedicine.¹⁴ The Federation of State Medical Boards then created the Interstate Medical Licensure Compact (IMLC) for an expedited process to apply for medical licensure in other states. The IMLC was formed to increase access to health care in underserved or rural areas including but not limited to the use of telemedicine.¹⁵ To qualify for IMLC, a physician must have a medical license in a state registered with the IMLC (ie, state of principal license) and have at least one of the following in their state of principal license: primary residence, 25% of their medical practice, a current employer, or US federal income taxes filed.¹⁵ The remaining states that do not have a licensing process for telemedicine allow practice in contiguous states or may provide temporary licenses dependent on the situation.¹⁴ 

Since 2017, billing codes for telemedicine have been the same as those used for in-person evaluation and management services with modifiers -95 or GQ added to the end of the code. Modifier -95 has been used for real-time telemedicine services, while modifier GQ has been used for store-and-forward services.¹⁶ For example, the code 99201, which is used to bill for new patients at outpatient visits, would become 99201-95 if performed using a live audio and video feed or 99201-GQ if information was sent electronically for later analysis. To receive reimbursement from Medicare, modifier -95 requires real-time communication using both audio and video; however, modifier GQ is only reimbursable in federal telemedicine demonstration programs in Alaska or Hawaii.¹² Note that reimbursement is up to the discretion of private providers, and even Medicare reimbursement can vary from state to state. 

In 2019, new Healthcare Common Procedure Coding System telemedicine codes were introduced to include virtual check-ins (G2012) and evaluation of patient-transmitted images and videos (G2010). G2010 is the first store-and-forward code that has the potential to be reimbursed outside of Alaska or Hawaii.^3,12 G2012 allows providers to monitor the patients' well-being outside of the office setting, a cost-effective alternative if patients do not require a full visit. More detailed descriptions of the new codes can be found in Table 3.¹ 

Final Thoughts 

As insurance providers continue to better monitor health care costs, it is of utmost importance that physicians become more involved in accurately assessing their services and procedures, given that the changes in RVUs mirror the Centers for Medicare & Medicaid Services' utilization of the RUC's interpretation of our survey responses.¹ The current billing codes attempt to better represent the work involved for each service, one example being the modification to more specific biopsy codes in 2019.  

With the growth of technology, CPT and Healthcare Common Procedure Coding System codes also reflect a push toward more efficient health care delivery and broader coverage for provider services, as demonstrated by the introduction of new telemedicine codes as well as recent additions of noninvasive imaging codes. Although technology makes health care more cost-effective for patients, clinicians can still maintain their overall reimbursements by efficiently seeing an increasing number of patients; for example, a patient diagnosed noninvasively using RCM can then receive same-day care, which impacts patients' quality of life by minimizing travel time, number of office visits, and time taken off from work, while allowing providers to manage a higher patient volume more productively. The new CPT codes discussed here reflect the growth of medical technology potential, which increases our diagnostic capability, making it even more critical for physicians to engage with these developments. 
 

As the US population continues to grow and patients become more aware of their health needs, payers are beginning to recognize the benefits of more efficient and cost-effective health care. With the implementation of the new Medicare Physician Fee Schedule on January 1, 2019, some old billing codes were revalued while others were replaced entirely with new codes.¹ The restructuring of the standard biopsy codes now takes the complexity of different sampling techniques into consideration. Furthermore, Current Procedural Terminology (CPT) Category III tracking codes for some imaging devices (eg, optical coherence tomography) added in 2017 require more data before obtaining a Category I reimbursable code, while codes for other imaging devices such as reflectance confocal microscopy (RCM) remain relatively the same.^2-4 Notably, the majority of the new 2019 telemedicine codes are applicable to dermatology.^2,3 In this article, we discuss the new CPT codes for reporting diagnostic procedures, including biopsy, noninvasive imaging, and telemedicine services. We also provide a summary of the national average reimbursement rates for these procedures. 

Background on Reimbursement 

To better understand how reimbursement works, it is important to know that all billing codes are provided a relative value unit (RVU), a number representing the value of the work involved and cost of providing a service relative to other services.⁵ The total RVU consists of the work RVU (wRVU), practice expense RVU (peRVU), and malpractice expense RVU (mRVU). The wRVU represents the time, effort, and complexity involved in performing the service. The peRVU reflects the direct cost of supplies, personnel, and durable equipment involved in providing the service, excluding typical office overhead costs such as rent, utilities, and administrative staff. The mRVU is to cover the cost of malpractice insurance.⁵ The peRVU can be further specified as facility versus nonfacility services depending on where the service is performed.⁶ A facility peRVU is for services completed in a facility such as a hospital, outpatient hospital setting, or nursing home. The facility provides some of the involved supplies, personnel, and equipment for which they can recapture costs by separate reporting, resulting in a lower total RVU for the provider charges compared with nonfacility locations where the physician must provide these items.⁶ Many physicians may not be aware of how critical their role is in determining their own reimbursement rates by understanding RVUs and properly filling out Relative Value Scale Update Committee (RUC) surveys. If surveys sent to practitioners are accurately completed, RVUs have the potential to be fairly valued; however, if respondents are unaware of all of the components that are inherent to a procedure, they may end up minimizing the effort or time involved, which would skew the results and hurt those who perform the procedure. Rather than inputting appropriate preoperative and postoperative service times, many respondents often put 0s and 1s throughout the survey, which misrepresents the amount of time involved for a procedure. For example, inputting a preoperative time as 0 or 1 minute may severely underestimate the work involved for a procedure if the true preoperative time is 5 minutes. Such survey responses affect whether or not RVUs are valued appropriately. 

The billing codes and their RVUs as well as Medicare payment values in your area can be found on the Centers for Medicare & Medicaid Services website.^2,3 Table 1 provides a comparison of the old and new biopsy codes, and Table 2 shows the new RCM codes. 

Biopsy Codes 

Prior to 2019, biopsies were reimbursed using CPT code 11100 for the initial biopsy and 11101 for each additional biopsy.² Called up for refinement in the RUC process, initial data from the Physician Practice Expense Information Survey pointed to the likelihood of different sampling techniques having different amounts of work being supplied by different techniques.¹ Imaging modalities such as dermoscopy or RCM could help minimize the need for surgical biopsies. Dermoscopy, which has been proven to allow for more efficient and accurate diagnoses in dermatology, is reimbursed in Europe but not in the United States.^7-9 In 2016, CPT codes 96931 through 96936 were created for RCM and are covered by most insurances.¹⁰ Optical coherence tomography, another noninvasive imaging technology, currently is not reimbursed but did receive Category III codes (0470T-0471T), also known as a tracking codes, in 2017.⁴ Category III codes are used for emerging technologies that have future potential but do not have enough US-based evidence to support receiving Category I CPT codes. The use of Category III codes allows for data collection on emerging technologies and services, with the potential to convert the Category III codes to Category I codes once certain criteria are met.¹¹ 

Beginning in 2019, the standard biopsy codes 11100 and 11101 were replaced with 6 new codes to represent primary (11102, 11104, 11106) and add-on biopsies (11103, 11105, 11107) based on the sampling technique utilized and the thickness of the sample (Table 1). Previously, the biopsy codes did not reflect the complexity of the different biopsy techniques, whereas the new codes provide differentiation of the method of removal (ie, tangential, punch, incisional).^2,3 The base code is dependent on whichever biopsy performed has the highest complexity, with incisional biopsy--a partial excision--being considered the most complex.³ Punch biopsy is considered the next level of complexity, followed by tangential biopsy. Each of the 6 new biopsy codes also received a new wRVU, which determines reimbursement under Medicare and most other insurers when combined with direct peRVU and mRVU. Additional biopsies, reported using the add-on codes, are reimbursed at a lower level than the base codes because of removal of duplicate inputs for preservice and postservice care.³  

Telehealth Codes 

Telemedicine services offer another form of imaging that providers can use to communicate remotely with patients through a live interactive video stream (with audio), a store-and-forward system with photographs or videos shared asynchronously, or remote patient monitoring.¹² Although live video streaming uses a webcam, store-and-forward services involve sending photographs or videos electronically for later evaluation.^12,13 Remote patient monitoring allows the collection of health-related data and transmission to a physician without the need for an office visit.¹³ Most states require physicians to have a license in the state in which the patient is located at the time of the encounter. Given the difficulty of applying for licensure in multiple states, several states started creating their own special licenses to allow out-of-state providers to offer services through telemedicine.¹⁴ The Federation of State Medical Boards then created the Interstate Medical Licensure Compact (IMLC) for an expedited process to apply for medical licensure in other states. The IMLC was formed to increase access to health care in underserved or rural areas including but not limited to the use of telemedicine.¹⁵ To qualify for IMLC, a physician must have a medical license in a state registered with the IMLC (ie, state of principal license) and have at least one of the following in their state of principal license: primary residence, 25% of their medical practice, a current employer, or US federal income taxes filed.¹⁵ The remaining states that do not have a licensing process for telemedicine allow practice in contiguous states or may provide temporary licenses dependent on the situation.¹⁴ 

Since 2017, billing codes for telemedicine have been the same as those used for in-person evaluation and management services with modifiers -95 or GQ added to the end of the code. Modifier -95 has been used for real-time telemedicine services, while modifier GQ has been used for store-and-forward services.¹⁶ For example, the code 99201, which is used to bill for new patients at outpatient visits, would become 99201-95 if performed using a live audio and video feed or 99201-GQ if information was sent electronically for later analysis. To receive reimbursement from Medicare, modifier -95 requires real-time communication using both audio and video; however, modifier GQ is only reimbursable in federal telemedicine demonstration programs in Alaska or Hawaii.¹² Note that reimbursement is up to the discretion of private providers, and even Medicare reimbursement can vary from state to state. 

In 2019, new Healthcare Common Procedure Coding System telemedicine codes were introduced to include virtual check-ins (G2012) and evaluation of patient-transmitted images and videos (G2010). G2010 is the first store-and-forward code that has the potential to be reimbursed outside of Alaska or Hawaii.^3,12 G2012 allows providers to monitor the patients' well-being outside of the office setting, a cost-effective alternative if patients do not require a full visit. More detailed descriptions of the new codes can be found in Table 3.¹ 

Final Thoughts 

As insurance providers continue to better monitor health care costs, it is of utmost importance that physicians become more involved in accurately assessing their services and procedures, given that the changes in RVUs mirror the Centers for Medicare & Medicaid Services' utilization of the RUC's interpretation of our survey responses.¹ The current billing codes attempt to better represent the work involved for each service, one example being the modification to more specific biopsy codes in 2019.  

With the growth of technology, CPT and Healthcare Common Procedure Coding System codes also reflect a push toward more efficient health care delivery and broader coverage for provider services, as demonstrated by the introduction of new telemedicine codes as well as recent additions of noninvasive imaging codes. Although technology makes health care more cost-effective for patients, clinicians can still maintain their overall reimbursements by efficiently seeing an increasing number of patients; for example, a patient diagnosed noninvasively using RCM can then receive same-day care, which impacts patients' quality of life by minimizing travel time, number of office visits, and time taken off from work, while allowing providers to manage a higher patient volume more productively. The new CPT codes discussed here reflect the growth of medical technology potential, which increases our diagnostic capability, making it even more critical for physicians to engage with these developments. 
 

As nurses who are often the first face that a veteran sees, members of NOVA (Nurses Organization of Veterans Affairs) are committed to enhancing access, coordinating care, and improving health care at the US Department of Veterans Affairs (VA). NOVA also is the voice of VA nurses on Capitol Hill. Every year, the leadership and legislative committee members provide a list of critical issues identified in their Legislative Priority Goals. For 2019, the goals are divided into 3 areas of concern that either require legislation, funding, or implementation at the regulatory level within the VA.

At the top of the list is implementation of the VA Mission Act and its community care network. The 2018 VA Mission Act (Section 101 of Public Law 115-182) mandated the VA to consolidate existing community care programs and rewrite eligibility rules. Currently, the VA has at least 7 separate community care programs, including the Veterans Choice Program, which gives veterans who live ≥ 40 miles from a VA facility or have a wait time of ≥ 30 days an option to receive care in the local community with VA picking up the bill. Proposed access standards for the new program—Veterans Community Care Program (VCCP)—were made public in January 2019 and would allow veterans with ≥ 30-minute drive time and/or a wait time of ≥ 20 days for primary care or mental health appointments at a VA facility to use outside care. For specialty care eligibility, the drive time would increase to ≥ 60 minutes and ≥ 28 days for an appointment at a VA facility.

NOVA understands the need for community care partners: They are a crucial part of an integrated network designed to provide care for services that are not readily available within the Veterans Health Administration (VHA), but care that veterans receive in the community must be equal to VHA care. Equal care will require training and strict quality measures and standards verified for the VCCP providers. The VA also must remain the primary provider of care and the coordinator of care for all enrolled veterans.

NOVA identified 6 goals for VA Mission Act implementation. These include the following:

• Require that training, competency, and quality standards for VCCP providers are equal to those of VHA providers;
• Request third-party administrator to verify that providers meet those standards before assigning to VCCP panel;
• Simplify eligibility/access rules for community care without depleting VA funds;
• Ensure that VHA continues to be the first point of access and coordinator of all health care for enrolled veterans;
• Implement a care coordination system allowing veterans to return with ease to the VA when resources are available; and
• Employ mandatory training for VHA personnel and all community providers to improve the coordination of care, understanding of military culture, and health care needs across networks.

Other priorities include staffing/recruitment and retention—a longstanding issue within many VA facilities. Currently, the VHA has > 40,000 unfilled positions. It is no secret that the VA has had difficulty hiring essential staff at many levels. Complexities of job site databases and excessive time required to complete on-boarding, shortages in human resources personnel, and less than competitive salaries all add to the growing backlog. The inability for the VA to hire and train providers negatively impacts the access to VHA care and spurs increases in veterans using private sector care.

The VA modernization must include an electronic health record designed to support VHA’s model of health care delivery. It is crucial that Congress ensure proper IT funding to improve patient safety, software usability, and standardization of patient health care records across VHA.

VA nurses are the largest sector of employees within VHA with > 90,000 currently taking care of veterans. As VA continues its modernization, NOVA asks that nursing leadership be at the forefront of all strategic decision making.

In March, NOVA nurses shared their thoughts and views with members of Congress. They also continued discussions with the administration and VA leadership about how we can work together toward common goals—whether that be educating the next generation of nurses, providing innovative health care solutions, or engaging veterans in how they envision their health care in the future. Visit www.vanurse.org for more information about NOVA, the Legislative Priority Goals, or to become a member.

As nurses who are often the first face that a veteran sees, members of NOVA (Nurses Organization of Veterans Affairs) are committed to enhancing access, coordinating care, and improving health care at the US Department of Veterans Affairs (VA). NOVA also is the voice of VA nurses on Capitol Hill. Every year, the leadership and legislative committee members provide a list of critical issues identified in their Legislative Priority Goals. For 2019, the goals are divided into 3 areas of concern that either require legislation, funding, or implementation at the regulatory level within the VA.

At the top of the list is implementation of the VA Mission Act and its community care network. The 2018 VA Mission Act (Section 101 of Public Law 115-182) mandated the VA to consolidate existing community care programs and rewrite eligibility rules. Currently, the VA has at least 7 separate community care programs, including the Veterans Choice Program, which gives veterans who live ≥ 40 miles from a VA facility or have a wait time of ≥ 30 days an option to receive care in the local community with VA picking up the bill. Proposed access standards for the new program—Veterans Community Care Program (VCCP)—were made public in January 2019 and would allow veterans with ≥ 30-minute drive time and/or a wait time of ≥ 20 days for primary care or mental health appointments at a VA facility to use outside care. For specialty care eligibility, the drive time would increase to ≥ 60 minutes and ≥ 28 days for an appointment at a VA facility.

NOVA understands the need for community care partners: They are a crucial part of an integrated network designed to provide care for services that are not readily available within the Veterans Health Administration (VHA), but care that veterans receive in the community must be equal to VHA care. Equal care will require training and strict quality measures and standards verified for the VCCP providers. The VA also must remain the primary provider of care and the coordinator of care for all enrolled veterans.

NOVA identified 6 goals for VA Mission Act implementation. These include the following:

• Require that training, competency, and quality standards for VCCP providers are equal to those of VHA providers;
• Request third-party administrator to verify that providers meet those standards before assigning to VCCP panel;
• Simplify eligibility/access rules for community care without depleting VA funds;
• Ensure that VHA continues to be the first point of access and coordinator of all health care for enrolled veterans;
• Implement a care coordination system allowing veterans to return with ease to the VA when resources are available; and
• Employ mandatory training for VHA personnel and all community providers to improve the coordination of care, understanding of military culture, and health care needs across networks.

Other priorities include staffing/recruitment and retention—a longstanding issue within many VA facilities. Currently, the VHA has > 40,000 unfilled positions. It is no secret that the VA has had difficulty hiring essential staff at many levels. Complexities of job site databases and excessive time required to complete on-boarding, shortages in human resources personnel, and less than competitive salaries all add to the growing backlog. The inability for the VA to hire and train providers negatively impacts the access to VHA care and spurs increases in veterans using private sector care.

The VA modernization must include an electronic health record designed to support VHA’s model of health care delivery. It is crucial that Congress ensure proper IT funding to improve patient safety, software usability, and standardization of patient health care records across VHA.

VA nurses are the largest sector of employees within VHA with > 90,000 currently taking care of veterans. As VA continues its modernization, NOVA asks that nursing leadership be at the forefront of all strategic decision making.

In March, NOVA nurses shared their thoughts and views with members of Congress. They also continued discussions with the administration and VA leadership about how we can work together toward common goals—whether that be educating the next generation of nurses, providing innovative health care solutions, or engaging veterans in how they envision their health care in the future. Visit www.vanurse.org for more information about NOVA, the Legislative Priority Goals, or to become a member.

As nurses who are often the first face that a veteran sees, members of NOVA (Nurses Organization of Veterans Affairs) are committed to enhancing access, coordinating care, and improving health care at the US Department of Veterans Affairs (VA). NOVA also is the voice of VA nurses on Capitol Hill. Every year, the leadership and legislative committee members provide a list of critical issues identified in their Legislative Priority Goals. For 2019, the goals are divided into 3 areas of concern that either require legislation, funding, or implementation at the regulatory level within the VA.

At the top of the list is implementation of the VA Mission Act and its community care network. The 2018 VA Mission Act (Section 101 of Public Law 115-182) mandated the VA to consolidate existing community care programs and rewrite eligibility rules. Currently, the VA has at least 7 separate community care programs, including the Veterans Choice Program, which gives veterans who live ≥ 40 miles from a VA facility or have a wait time of ≥ 30 days an option to receive care in the local community with VA picking up the bill. Proposed access standards for the new program—Veterans Community Care Program (VCCP)—were made public in January 2019 and would allow veterans with ≥ 30-minute drive time and/or a wait time of ≥ 20 days for primary care or mental health appointments at a VA facility to use outside care. For specialty care eligibility, the drive time would increase to ≥ 60 minutes and ≥ 28 days for an appointment at a VA facility.

NOVA understands the need for community care partners: They are a crucial part of an integrated network designed to provide care for services that are not readily available within the Veterans Health Administration (VHA), but care that veterans receive in the community must be equal to VHA care. Equal care will require training and strict quality measures and standards verified for the VCCP providers. The VA also must remain the primary provider of care and the coordinator of care for all enrolled veterans.

NOVA identified 6 goals for VA Mission Act implementation. These include the following:

• Require that training, competency, and quality standards for VCCP providers are equal to those of VHA providers;
• Request third-party administrator to verify that providers meet those standards before assigning to VCCP panel;
• Simplify eligibility/access rules for community care without depleting VA funds;
• Ensure that VHA continues to be the first point of access and coordinator of all health care for enrolled veterans;
• Implement a care coordination system allowing veterans to return with ease to the VA when resources are available; and
• Employ mandatory training for VHA personnel and all community providers to improve the coordination of care, understanding of military culture, and health care needs across networks.

Other priorities include staffing/recruitment and retention—a longstanding issue within many VA facilities. Currently, the VHA has > 40,000 unfilled positions. It is no secret that the VA has had difficulty hiring essential staff at many levels. Complexities of job site databases and excessive time required to complete on-boarding, shortages in human resources personnel, and less than competitive salaries all add to the growing backlog. The inability for the VA to hire and train providers negatively impacts the access to VHA care and spurs increases in veterans using private sector care.

The VA modernization must include an electronic health record designed to support VHA’s model of health care delivery. It is crucial that Congress ensure proper IT funding to improve patient safety, software usability, and standardization of patient health care records across VHA.

VA nurses are the largest sector of employees within VHA with > 90,000 currently taking care of veterans. As VA continues its modernization, NOVA asks that nursing leadership be at the forefront of all strategic decision making.

In March, NOVA nurses shared their thoughts and views with members of Congress. They also continued discussions with the administration and VA leadership about how we can work together toward common goals—whether that be educating the next generation of nurses, providing innovative health care solutions, or engaging veterans in how they envision their health care in the future. Visit www.vanurse.org for more information about NOVA, the Legislative Priority Goals, or to become a member.