DCMedical News: Monday, May 18, 2020
DCMedical News-DCMN
Washington, D.C.
Monday, May 18, 2020
DCMedical News is published every day both the House and the Senate are in session and on pre-pandemic Regularly Scheduled Session days (see CQ calendar, below).
THE BIG STORY IN HEALTH CARE
Coronavirus News: (reference pages below under Reading & References)
Tracking by Johns Hopkins shows on 5-17 at 8:00 p.m. EST worldwide 4,710,614 confirmed cases; 315,023 deaths worldwide; 89,550 U.S. deaths (28%).
Science and COVID Society
The Wall Street Journal reports (here) that “Convalescent Plasma Is Safe to Treat Covid-19: First large-scale analysis of patients receiving experimental treatment for coronavirus is expected to lead to more trials to test effectiveness of therapy.” But also, “Doctors Fret as Coronavirus Keeps Heart, Stroke Patients Away From ER: Fewer patients seeking help for emergency treatments and regular conditions raises concerns about long-term health,” here. The social status of hospitals was the focus of the New York Times’ essay on Elmhurst Hospital (here), where “Even as Elmhurst faced ‘apocalyptic’ conditions, 3,500 beds were free in other New York hospitals, some no more than 20 minutes away,” followed by more than 300 comments (here) from readers. In the longer term, the unfolding financial calamity facing hospitals is reflected (here) in a story “Hospitals Knew How to Make Money. Then Coronavirus Happened. Surgeries are canceled. Business models are shifting. Some of the hardest-hit hospitals may close, leaving patients with fewer options for care.”
Retooling for the National Medical Stockpile (here), as the “President authorizes International Development Finance Corp. to invoke Defense Production Act.”
HOSPITALS, NURSING HOMES AND OTHER HEALTH CARE FACILITIES
HHS Researchers Focus on Commercial Corruption of Clinical Decision Making Through Electronic Medical Records
Three authors from the Department of Health and Human Services report (here) in JAMA Internal Medicine on the potential for corruption of clinical decision making by commercial interests having influence over the design and content of electronic medical records programs. Siddhartha Mukherjee in his essay on American medicine and COVID-19 (here) makes a broader observation, “That’s because clinical medicine is, among other things, an information system, and a central part of that system is broken. Patient records that once were scribbled on clipboards now sit in electronic medical-record (E.M.R.) systems, many of them provided by the Wisconsin-based software company Epic. A standardized digital database of patient-care records, searchable across hospital and medical care systems, could be an invaluable way of identifying effective approaches to a novel disease—like moving from a patchwork meteorological system where towns keep their own records of wind and rainfall to a national weather-tracking grid.” But, he laments, “We’ve been saddled with systems that cut into patient care (clinicians typically spend an hour feeding documentation into a computer for every hour they spend with patients) and, often, are too fragmented to allow a patient’s file to follow her from one medical center to another. The E.M.R., as a colleague of mine put it, is ‘electronic in the same sense that your grandfather’s radio is electronic.’ The energized, improvisatory role of medical Twitter inevitably draws attention to what our balky, billion-dollar systems should have been providing—to the cost, in dollars and lives, of the rapid clinical learning that we’ve forgone.”
MEDICARE, MEDICAID, AND COMMERCIAL HEALTH INSURANCE
The FY 2021 proposed payment rule known as the Inpatient Prospective Payment System has its own “home page,” here. The proposal (to be published in the May 29 Federal Register) is here, CMS FAQs here, HFM Executive Summary here. “The proposed changes, which would apply to approximately 3,200 acute care hospitals and approximately 360 LTCHs [Long Term Care Hospitals, formerly LTACs], would affect discharges occurring on or after October 1, 2020.”
One area of controversy in the proposed rule is the Administration’s continuing efforts to achieve hospital price transparency. “CMS is proposing to collect a summary of certain data already required to be disclosed by CMS’ 2019 price transparency rule, specifically hospitals’ median payer-specific negotiated inpatient services charges for Medicare Advantage organizations and third party payers. In addition, the agency is requesting information regarding the potential use of these data to set relative Medicare payment rates for hospital procedures.” Recent studies (RAND, Kaiser Family Foundation) have focused on the “multiple” by which commercial health insurance payments to hospitals exceed Medicare payments (e.g., here).
DRUGS & DEVICES
The proposed FY 2021 IPPS (see story above) has potential positive news (or at least higher payment rates) for new technologies paid for by hospitals, and especially for anti-microbial drugs. “In this proposed rule, CMS presents 24 new applications for new technology add-on payment for FY 2021. Of the 24 technologies, three technologies were submitted by applicants as a new medical device that is part of the FDA Breakthrough Devices Program and six technologies were submitted by applicants as a product that received FDA Qualified Infectious Disease Product (QIDP) designation. We are proposing to approve these nine alternative pathway applicant technologies. The remaining 15 technologies were submitted by applicants under the traditional new technology add-on payment pathway criteria . . . We are proposing to expand the alternative new technology add-on payment pathway for antimicrobial products designated by FDA as QIDPs to include products approved under FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway). The LPAD pathway encourages the development of safe and effective drug products that address unmet needs of patients with serious bacterial and fungal infections. As is the case for QIDPs, under this proposal an antimicrobial drug approved under FDA’s LPAD pathway would be considered new and not substantially similar to an existing technology and would not need to demonstrate that it meets the substantial clinical improvement criterion (the technology would need to meet the cost criterion). In order to allow eligible antimicrobial products to begin receiving the new technology add-on payment sooner, we are proposing to provide for conditional approval for antimicrobial products that otherwise meet the NTAP alternative pathway criteria but do not receive FDA approval in time for consideration in the final rule. Under this proposal, those antimicrobial products that would otherwise meet the applicable add-on payment criteria would begin receiving the new technology add-on payment, effective for discharges the quarter after the date of FDA marketing authorization instead of waiting until the next fiscal year, provided FDA marketing authorization is received by July 1 of the year for which the applicant applied for new technology add-on payments.”
READINGS & REFERENCES
Coronavirus Public Health Resources and References:
AMA resource page for physicians here. AMA guide to medical education and COVID-19, here. American Public Health Association information here. Association of American Medical Colleges Clinical Guidance Repository, here. CDC information page here. CMS (Centers for Medicare & Medicaid Services) Current Emergencies website, here. Council of State Governments, 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. NIH information page here. National Library of Medicine Coronavirus page here, 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. State actions, Kaiser Family Foundation, here. UC Hastings College of Law’s “The Source” COVID-19 page, here. The White House open research dataset (CORD-19) here. World Health Organization 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
May 19, 20, 21
June 1, 2, 3, 4, 9, 10, 11, 12, 15, 16, 17, 18, 23, 24, 25, 26
July 21, 22, 23, 24, 27, 28, 29, 30, 31
Notes to: Fred Hyde, MD, JD, MBA; fredhyde@aol.com.