DCMedical News: Tuesday, May 18, 2021
DCMedical News-DCMN
Washington, D.C.
Tuesday, May 18, 2021
DCMedical News is published every day both the House and the Senate are scheduled to be in session. Subscription information and archives from 2018 to the present at dcmedicalnews.org, here.
THE BIG STORY IN HEALTH CARE
U.S.-Approved Vaccines Go Global for a Global Pandemic
The President announced that the U.S. will send an additional 20 million doses of coronavirus vaccines abroad. Sixty million AstraZeneca doses had already been committed. The additional 20 million will be vaccines from Pfizer, Moderna and Johnson & Johnson, already authorized for domestic use, where supply is outstripping demand. Jeff Zients, White House pandemic coordinator, will be assigned to the international effort.
DOCTORS, NURSES AND OTHER HEALTH PROFESSIONALS
The Future of Nursing 2020-2030, From the National Academies, Calls for “Full Practice Authority” in All 50 States
The National Academies of Sciences, Engineering and Medicine released a report (here, 503 pgs.) on nursing in the next decade. They write that “Nursing in the next 10 years will demand a larger, more diversified workforce prepared to provide care in different settings, to address the lasting effects of COVID-19, to break down structural racism and the root causes of poor health, and to respond to future public health emergencies.” The report noted that “To expand access to health care during the COVID-19 pandemic, many states relaxed or waived restrictions on the care nurses may provide under their license. By 2022, all state and federal policy changes in response to the COVID-19 pandemic that expanded scope of practice should be made permanent, along with telehealth eligibility, insurance coverage, and equal payment for services provided by nurses.”
The writers said, “Nurses represent the largest segment of the U.S. health care workforce, with nearly 4 million nationwide.” Their report noted that “Under full practice authority — currently permitted in 23 states and D.C. — nurses can prescribe medication, diagnose patients, and manage treatments without a physician present. In these states, quality of care has improved and so has access to primary care . . . Federal authority should be used where available to supersede restrictive state laws, including those addressing scope of practice.”
HOSPITALS, NURSING HOMES AND OTHER HEALTH CARE FACILITIES
340B Hospitals and Eligible Entities Receive Backing from HRSA
The Acting Administrator of the Health Resources and Services Administration admonished (sample letter here) six pharmaceutical manufacturers (AstraZeneca, Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics) to stop withholding the 340B program’s discounts from hospitals and other entities eligible to participate. Hospitals had unsuccessfully sued HRSA in an attempt to force just such an action.
STAT summarizes the background: “At issue is the 340B drug discount program, which requires drug makers to offer discounts that are typically estimated to be 25% to 50% — but could be much higher — on all outpatient drugs to hospitals and clinics that serve low-income populations. There are approximately 12,400 so-called covered entities, including 2,500 hospitals, participating in the program.” The program began as one for safety net hospitals, the theory being that the hospitals could “buy low” from the manufacturers and “sell high” (to Medicare and other payers), using the difference to subsidize service to low-income communities. Manufacturers contend that the concept of services to “low-income communities” was left behind years ago, that 2500 hospitals (only 10% of which would qualify as “safety net”) use the drug profits as a general fund, that many hospitals now use “contract pharmacies” to distribute the profitable drugs, and that the contract pharmacies are not eligible participants in 340B.
HRSA contends, through its Acting Administrator, that “Section 340B(a)(1) of the Public Health Service (PHS) Act requires that manufacturers ‘shall…offer each covered entity covered outpatient drugs for purchase at or below the applicable ceiling price if such drug is made available to any other purchaser at any price.’ This requirement is not qualified, restricted, or dependent on how the covered entity chooses to distribute the covered outpatient drugs. Nothing in the 340B statute grants a manufacturer the right to place conditions on its fulfillment of its statutory obligation to offer 340B pricing on covered outpatient drugs purchased by covered entities.”
Outcome, Not Volume, Supported as Standard for Quality in TAVR
A study in Circulation (here) noted that Transcatheter Aortic Valve Replacement procedures (studied 2015-2017) varied widely in outcome, with 8% of the 301 hospitals having better-than-expected, and 11% worse-than-expected, outcomes, notwithstanding meeting volume thresholds. “Thirty-day mortality, stroke, major life-threatening or disabling bleeding, and moderate or severe peri-valvular leak were each substantially more common in sites with worse than expected performance as compared with other sites.”
New CMS Star Rating a “Notable Improvement,” With Room for More
Analysis and commentary on the newly revised CMS hospital “star” rating methodology by two quality experts appears in JAMA, here. Hospitals are still graded on a curve, data submitted by hospitals is still unaudited, but one major problem has been solved. “The inclusion of all types of hospitals in a single analysis led to small 20-bed critical access hospitals and specialty orthopedic hospitals being compared with 1000-bed quaternary academic medical centers, despite these hospitals reporting very different numbers and types of measures. For example, critical access hospitals and specialty hospitals were required to report a much lower number of metrics than larger, general, acute care hospitals. Metaphorically, this methodology graded hospitals on the same curve, although they took substantially different tests. The empirical result was that the more measures a hospital reported, the less likely it was to receive 5 stars. In 2016, the bulk of 4- and 5-star ratings were awarded to community hospitals (30% received 4 or 5 stars), critical access hospitals (33%), and specialty hospitals (87%), whereas 16% of major teaching hospitals received 4 or 5 stars.”
End of the “Savings” in CCJR
A report in JAMA (here) on the Comprehensive Care for Joint Replacement CMS experiment in bundling notes that “Savings observed in the second year of CJR largely dissipated by the fourth year owing to a combination of responses among hospitals to changes in the program. These results suggest a need for caution regarding the design of new alternative payment models.”
DRUGS & DEVICES
Another Experiment: The Unapproved Drug Initiative (UDI)
Researchers report in JAMA Internal Medicine (here) that “In 2006, the US Food and Drug Administration (FDA) launched the Unapproved Drug Initiative (UDI) to document supporting data for several thousand drugs that had remained on the US market continually since before the agency began reviewing safety and effectiveness in 1938. As an incentive, the FDA offered market exclusivity . . . In the short term, these market exclusivity periods drove up drug prices . . . In November 2020, the FDA announced that the UDI program was ending, citing concerns that the program raised prices without generating new clinical data for most drugs.” This longer-term study of 8 self-administered drugs found that “The number of manufacturers declined for 6 drugs. Prices increased for 5 drugs, with median relative increases of 157%.” The writers add, “The UDI disrupted market competition for many years. Our analysis raises concerns about market exclusivity periods as an incentive for such regulatory programs.”
READINGS & REFERENCES
Physician Assimilation In Another Era
This week’s Annals of Internal Medicine has an essay (here) on the work (following World War II) of the National Committee for the Resettlement of Foreign Physicians, “An organization that helped immigrant physicians pass licensing examinations, identify locations for employment, and overcome barriers to integration into American society.” The writers note “The medical profession reacted with hostility and erected formidable barriers to refugee physicians from Nazi-dominated Europe who sought to practice medicine in the United States. Yet, refugee physicians ultimately succeeded, with 77% of them working as doctors by 1945 and 98.6% by 1947.”
Select Coronavirus Public Health Resources and References (alphabetical) may be found here.
2021 CQ Congressional Calendar here.
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
May 19, 20
June 14, 15, 16, 17, 22, 23, 24, 25
July 19, 20, 21, 22, 26, 27, 28, 29, 30
Notes to: Fred Hyde, MD, JD, MBA; fredhyde@aol.com.