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Wednesday, January 15, 2020

Cardiac Rehab Reaches Fewer Than One in Four

Cardiac rehabilitation participation was woefully low among eligible Medicare patients with heart disease in 2016-2017, researchers said.
Just 24.4% of eligible beneficiaries ended up participating in cardiac rehabilitation, researchers led by Matthew Ritchey, DPT, MPH, of the CDC in Atlanta, showed in Circulation: Cardiovascular Quality and Outcomes.
And of those participants, only 24.3% initiated their rehabilitation programs in a timely manner (within 21 days of event) and 26.9% actually completed the program by the end of the year after becoming eligible.
“The low participation and completion rates observed in this study translate to upwards of 7 million missed opportunities to potentially improve health outcomes had 70% of eligible beneficiaries participated in cardiac rehabilitation and completed 36 sessions,” Ritchey’s group said, referring to the national Million Hearts Cardiac Rehabilitation Collaborative‘s goal of 70% utilization by the year 2022.
In their study, 366,103 Medicare fee-for-service beneficiaries became eligible for these programs in 2016 due to a qualifying event: acute MI hospitalization, coronary artery bypass surgery, heart valve repair or replacement, percutaneous coronary intervention, or heart/heart-lung transplant.
Records showed that participants averaged 24.8 cardiac rehab sessions in total.
Medicare patients in the study were responsible for roughly 20% of cost-sharing for cardiac rehabilitation, potentially racking up an estimated $828 in copays for a full course of 36 sessions.
“This amount, in addition to ancillary costs associated with transportation, missed employment, or arranging for alternative caregiving for family members, could serve as financial barriers for CR use, especially among beneficiaries without supplemental insurance and with low socioeconomic status,” Ritchey and colleagues suggested.
The study showed marked disparities in cardiac rehabilitation (CR) participation, the authors noted:
  • Lower utilization with increasing age
  • Lower utilization among women compared with men
  • Lower participation among Hispanics and blacks compared with non-Hispanic whites
  • Variation by geographic region (e.g., Southeast and Appalachia tended to have the lowest participation but the highest completion, while the Midwest had the highest participation and the lowest completion)
  • Variation by qualifying event type (e.g., lowest after acute MI hospitalization without revascularization, and highest with coronary artery bypass surgery)
“While additional work is needed to better understand these findings, it has been suggested that much of the regional variation in CR use can be addressed by hospitals and community-based practices integrating systematic CR referrals and other pro-CR processes within standardized treatment protocols, improving the capacity within existing CR programs, and addressing shortages in available programs, especially in rural areas,” according to Ritchey’s team.
It was possible that not all confounders were accounted for in the statistical analyses. The researchers were also unable to exclude all beneficiaries for whom cardiac rehabilitation was not appropriate, therefore potentially underestimating participation rates.
“A wealth of guidance exists that identifies the evidence-based strategies that can be used to increase CR use,” they noted. “Hospitals, CR programs, and other stakeholders can consider systematically integrating these strategies into their processes and tracking the effects of their implementation using established quality and performance measures.”
For example, they cited the Million Hearts Cardiac Rehabilitation Change Package, a list of process improvements that hospitals can implement to improve cardiac rehabilitation referral, enrollment, participation, and adherence.
Ritchey and colleagues reported no conflicts of interest.
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Mandatory Testing Shows Cognitive Deficits in Late-Career Clinicians

Mandatory testing at one of the nation’s top hospitals showed that nearly one in eight clinicians age 70 or older had cognitive deficits that were likely to impair their ability to practice medicine independently.
While 57% of 141 older physicians and practitioners who applied for renewal of hospital privileges at Yale New Haven Hospital demonstrated no cause for concern, the remainder faced yearly re-credentialing or further testing with possible outcomes that included proctored medical practice, resignation, or retirement, reported Leo Cooney, MD, a geriatric medicine professor at Yale Medical School, and Thomas Balcezak, MD, Yale New Haven’s chief medical officer, in JAMA.
This may be the first paper to report the results of cognitive testing of late-career clinicians, noted Cooney.
“We found that 12.8% of clinicians who applied for renewal of hospital privileges had cognitive deficits which gave us great concern about their ability to practice medicine independently,” he said. “None of these 18 clinicians had been previously brought to the attention of hospital authorities because of concern about their practice abilities,” Cooney told MedPage Today.
“When we started this process, I thought it was a good idea, but I wasn’t sure about its necessity,” he continued. “I now believe that it is essential to review older clinicians. While older clinicians can bring a great deal of experience and expertise to the practice of medicine, we must be sure that they have the cognitive ability to solve problems and make appropriate judgments.”
Every year, 20,000 more U.S. physicians turn 65, and, even though half retire by then, many continue practicing for years more, noted Jeffrey Saver, MD, of the University of California Los Angeles, in an accompanying editorial.
“U.S. policy makers are counting on these older physicians to do so to help mitigate the nation’s growing physician shortage,” he wrote. “Currently, an estimated 50 million to 70 million U.S. office visits and 11 million to 20 million hospitalizations each year are overseen by physicians older than 65 years.”
Age-based testing of medical professionals is a growing and controversial trend: Scripps Health Care, Intermountain Healthcare, Stanford Hospitals and Clinics, and Penn Medicine are among hospital systems that have implemented cognitive screens for older practitioners.
“Information about the outcomes of these programs is difficult to find, but it is clear that these processes have been challenging,” wrote Katrina Armstrong, MD, MS, and Eileen Reynolds, MD, both of Massachusetts General Hospital in Boston, in another editorial accompanying the paper. Stanford physicians rejected plans to use MicroCog, a 1-hour computerized test that assesses five cognitive domains, opting instead for a revised approach with rigorous peer review. And opposition by the Utah Medical Association to MicroCog led to a state law banning its use.
At Yale New Haven, all applicants for reappointment to the medical staff age 70 or older were required to have an objective evaluation of cognitive function as part of the 2-year reappointment process. A neuropsychologist developed a screening battery which was (and still is) kept confidential. The hospital medical executive committee decided that a pass/fail approach would not be used, but performance tests would be considered in the context of clinical privileges.
The battery consisted of 16 brief tests that encompassed information processing, visual scanning and psychomotor efficiency, processing speed and accuracy, working memory, concentration, verbal fluency, and executive function. Time to completion varied from 50 to 90 minutes. Applicants’ ages ranged from 69 to 82 and averaged 74. Most (86%) were men and 89% were physicians.
Global cognitive status scores and domain-specific scores were compared with peer, population, and age-group norms. A medical staff review committee that included the previous and current chief medical officer of the hospital, a faculty geriatrician, and the neuropsychologist performing the exams reviewed test results and made recommendations to the medical staff’s credentialing committee.
Of 141 applicants, 81 (57.4%) completed the testing requirements and continued the credentialing process; they would be retested in 2 years as part of the regular reappointment process. About 24% proceeded with the credentialing process but, because of minor abnormalities in test results, were scheduled for rescreening in 1 year. Several had limitations in specific domains and were re-tested; three of these applicants were determined to have significant problems and either retired or resigned from the active medical staff.
Eighteen clinicians (12.8% of the 141 tested) demonstrated cognitive deficits that were likely to impair their ability to practice medicine independently. None had been brought to the attention of medical staff leadership due to performance problems. All opted voluntarily to discontinue their practice or move to a closely proctored setting.
Screening programs are always challenging to implement, Armstrong and Reynolds observed. “Because the prevalence of the condition is generally low in the population being screened, false-positive screening results are common unless the test has near-perfect specificity,” they wrote. Full assessment of clinical competence, even for medical students and residents, is inexact and evidence that increasing clinician age is associated with worse patient outcomes is “weak at best,” they noted. Moreover, using age cutoffs for screening raises concerns about age discrimination, they added.
A policy like the one at Yale New Haven Hospital has several limitations, Saver pointed out. Because of confidentiality, impaired test performance cannot be correlated with poor medical practice, and independent individuals outside the institution were not involved in decision-making. In addition, the confidential nature of the test battery limited the ability to assess its validity.
Researchers and editorialists reported no conflicts of interest.
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Community Health sees improved fundamentals in 2020

Community Health Systems (CYH +14.7%) is up on average volume ahead of today’s presentation at JPM20 that includes its 2020 outlook. Shares have rallied over 25% this week.
Operating revenues expected to be $12.40B – 12.80B (current consensus: $12.9B), non-GAAP EBITDA: $1.65B – 1.80B, same-store adjusted admissions growth: 1.5 – 2.5%.
Non-GAAP EBITDA for 2019 should be near the midpoint of its previously announced guidance of $1.60B – 1.65B.
#JPM20
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FDA OK generic version of Lilly’s Jardiance

The FDA tentatively approves Alembic Pharmaceuticals’ marketing application for its generic version of Eli Lilly’s (NYSE:LLY) type 2 diabetes med Jardiance (empagliflozin), the first generic OK’d in the U.S.
Tentative approval means that Alembic’s marketing application met the requirements for approval, but patent issues need to be resolved before full approval is granted.
LLY is down a fraction after hours.
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Tandem Diabetes launches hybrid-closed loop insulin pump in U.S.

Tandem Diabetes Care (NASDAQ:TNDM) announces the commercial launch of its t:slim X insulin pump with Control-IQ technology, an advanced hybrid-closed loop feature designed to help increase blood sugar time in range (70-180 mg/dL).
The company says the system delivers automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar. The system integrates with Dexcom’s (NASDAQ:DXCM) G6 continuous glucose monitoring (CGM) which requires no fingersticks for calibration or diabetes treatment decisions.
TNDM is up 1% after hours.
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GeneTx advancing Ultragenyx joint-developed candidate

Privately held GeneTx Biotherapeutics LLC and development partner Ultragenyx Pharmaceuticals (NASDAQ:RARE) announce that GeneTx has filed an IND with the FDA seeking signoff for a Phase 1/2 clinical trial evaluating GTX-102 in patients with a rare inherited nervous system disorder called Angelman syndrome. Unless something unexpected happens, enrollment should begin in H1.
The companies are co-developing the antisense oligonucleotide under an August 2019 agreement. Under the terms of the deal, RARE has an option to acquire GeneTx any time prior to 30 days after the FDA accepts the IND.
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FDA Ad Com thumbs down on Intellipharmaceutics’ oxycodone ER

In a 2 -24 vote, two FDA advisory committees voted against approval of Intellipharmaceutics’ (OTC:IPCIF) extended-release oxycodone for the management of moderate-to-severe pain.
Yesterday, the same committees unanimously voted against Nektar Therapeutics’ oxycodegol.
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