DCMedical News: Tuesday, September 8, 2020
DCMedical News-DCMN
Washington, D.C.
Tuesday, September 8, 2020
DCMedical News is published every day both the House and the Senate are scheduled to be in session this year. Subscription information and archives here.
THE BIG STORY IN HEALTH CARE
The (Presidential and Other) Campaigns
Bloomberg Law reports that President Donald Trump hinted Monday that the U.S. could approve a coronavirus vaccine in October, as former Vice President Joe Biden sought transparency in the approval process.
Debates: The New York Post reports (here) that “President Donald Trump and former Vice President Joe Biden will meet on the stage for the first of three debates on Sept. 29 in Cleveland, Ohio, while their running mates, Vice President Mike Pence and California Sen. Kamala Harris, will face off on Oct. 7 in Salt Lake City, Utah, the Commission on Presidential Debates announced Wednesday. All four debates will run for 90 minutes, from 9 p.m. ET until 10:30 p.m. ET.”
Coronavirus
Tracking by Johns Hopkins (here) shows on 9-7 at 8:00 p.m. EST worldwide 27,246,686 confirmed COVID-19 cases; 890,923 deaths worldwide; 189,168 U.S. deaths (21%). The University of Washington’s Institute for Health Metrics and Evaluation has projected (here) a grim winter, with “Cumulative deaths expected by January 1 total 2.8 million, about 1.9 million more from now until the end of the year. Daily deaths in December could reach as high as 30,000.” The “worst case” in which “mask usage stays at current rates and governments continue relaxing social distancing requirements, leading to 4.0 million total deaths by the end of the year,” with 620,029 deaths in the U.S. The “best case” where “mask usage is near-universal, and governments impose social distancing requirements when their daily death rate exceeds 8 per million” projects a total of 288,381 deaths in the U.S. The “most likely” case which “assumes individual mask use and other mitigation measures remain unchanged” projects 410,451 deaths in the U.S.
Business and government: the Financial Times reports (here) that “As coronavirus transmission resurges in different regions around the world, and national and local governments’ responses vary widely, businesses and individuals are increasingly taking matters into their own hands as they seek to return to normal life.”
HOSPITALS, NURSING HOMES AND OTHER HEALTH CARE FACILITIES
IPPS Final Rule Published, More Challenges, More Money for Hospitals
September 2 the Centers for Medicare & Medicaid Services published the final inpatient prospective payment system rule for FY 2021 (which begins October 1), CMS “fact sheet” here, Federal Register publication of the final rule (2,160 pgs., here). CMS estimates that the overall income to hospitals will increase in FY 2021 by 2.7% or approximately $3.5 billion.
In addition to more money, the final rule provides: a requirement for hospitals to report to CMS the median rate negotiated with Medicare Advantage organizations for inpatient services, setting the stage for “market-based” inpatient rates beginning in 2024; add-on payments for 24 new technologies; a new Medicare Severity-Diagnosis Related Group (MS-DRG) for CAR T-cell therapies; $8.3 billion in DSH payments, a decrease of $60 million from fiscal 2020; an expanded definition of who is considered a displaced resident when teaching hospitals and residency programs close (the Hahnemann problem), allowing funding to be transferred for some residents in a program winding down; and changes in the Inpatient Quality Reporting Program to increase the frequency of reporting electronic clinical quality measures and making them public beginning in 2022.
DRUGS & DEVICES
Drug Manufacturers, HRSA, Take Aim at 340B Program
Drug makers, compelled under section 340B to sell outpatient pharmaceuticals at a discount to hospitals and community health centers, have begun efforts to restrict access to the program. A sample letter (here), from Eli Lilly, shows such efforts beginning September 1. Hospitals, who “re-sell” the discounted drugs at higher reimbursement, for example to Medicare, have objected, AHA statement here. The Health Resources and Services Administration has announced efforts to see whether the drug makers are violating the 340B statute, or any other.
Drug Channels explains (here, “Walgreens and CVS Top the 28,000 Pharmacies Profiting from the 340B Program. Will the Unregulated Party End?”) that the discounts—intended to benefit low income patients of the eligible providers--are now being shared by “contract” pharmacies. “Our exclusive analysis of government data finds that 28,000 pharmacy locations—almost half of the U.S. industry—now act as contract pharmacies for the hospitals and other healthcare providers that participate in the 340B program . . . Despite this astonishing growth, the contract pharmacy component does not have—and has never had—a regulatory infrastructure. That’s because the sub-regulatory notice that created contract pharmacies wasn’t subject to any rulemaking procedures. Drug Channels’ report continues, “A covered entity [hospitals and others] can purchase and dispense 340B drugs through internal or external (contract) pharmacies. In 2010, HRSA decided that eligible entities (including those that have an in-house pharmacy) could access 340B pricing through an unlimited number of contract pharmacies. There was no rulemaking or public comment on the agency’s unilateral decision . . . Pharmacies profit by trading their third-party prescription margins for a share of the 340B discounts earned by covered entities.” GAO has explored these issues (e.g. here) in several reports on 340B.
FROM THE ARCHIVES
Readers who are subscribers can access DCMN from January 1, 2018 to the present, here.
One month ago: there were 151,794 COVID-19 deaths in the U.S. (July 31, DCMN here); plasma from recovered COVID-19 patients ramped up (White House announcement), the American College of Physicians checked in on hydroxychloroquine (negative).
One year ago: much ado about coming changes in medical education (September 9, 2019 DCMN here), also dependence of European countries (as in the U.S.) on “foreign” medical graduates.
READINGS & REFERENCES
Select Coronavirus Public Health Resources and References (alphabetical):
AMA resource page for physicians here. AMA guide to medical education and COVID-19, here.
American Public Health Association information here.
CDC information page for professionals here, Morbidity and Mortality Weekly Reports on Coronavirus, here.
CMS (Centers for Medicare & Medicaid Services) Current Emergencies website, here.
Council of State Governments, here.
The Guardian and Kaiser Health Network, report on health professionals dead from COVID-19, here.
JAMA Network’s COVID-19 resource center here.
Library of Congress Coronavirus Research Guide, (here) from the In Custodia Legis blog of the Library of Congress (LoC), with links to Congressional Research Service (CRS) reports.
New England Journal of Medicine update here, New England Journal of Medicine Journal Watch here.
The Lancet COVID-19 Resource Centre here and real-time dashboard to monitor clinical trials, here.
Reproduction rate (rt), website https://rt.live/ tracks the highest and lowest COVID-19 reproduction.
State actions, Kaiser Family Foundation, here.
UC Hastings College of Law’s “The Source” (on health care prices and competition) COVID-19 page, here.
U.S. House of Representatives:
Members at https://www.house.gov/representatives
Committees and Members at https://www.house.gov/committees
U. S. Senate:
Committees and Members at https://www.senate.gov/committees
CQ 2020 Calendar of Regularly Scheduled Sessions, here.
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
August, none
September 9, 10, 11, 14, 15, 16, 17, 22, 23, 24, 25, 30
October 1, 2
November 16, 17, 18, 19, 20
December 1, 2, 3, 4, 7, 8, 9, 10
Notes to: Fred Hyde, MD, JD, MBA; fredhyde@aol.com.