DCMedical News: Monday, September 20, 2021
DCMedical News-DCMN
Washington, D.C.
Monday, September 20, 2021
DCMedical News is published every day both the House and the Senate are scheduled to be in session.
THE BIG STORY
Both Houses of Congress Reconvene Today
Congress returns to session today (schedule here) for a two-week sprint, leaving again after the session October 1.
DOCTORS, NURSES AND OTHER HEALTH CARE PROFESSIONALS
Bad News
Medscape summarizes (here) “Three ‘Bad News’ Payment Changes Coming Soon for Physicians,” including a 2022 Medicare physician fee schedule (here) in which (1) “The drive to maintain budget neutrality forced the federal agency to reduce Medicare payments, on average, by nearly 4%. Many physicians are outraged at the proposed cut”; (2) Sequestration will be back. Sequestration is the mandatory, pesky, negative 2% adjustment on all Medicare payments. It had been put on hold and is set to return at the beginning of 2022. Essentially, sequestration reduces what Medicare pays its providers for health services, but Medicare beneficiaries bear no responsibility for the cost difference”; and (3) shades of the Sustainable Growth Rate, with each year physicians “waiting in anticipation for a legislative body to save them from the dreaded income plunge” with signs now that “the payment landscape is in the midst of a fundamental transformation.”
Good News—a Gold Card!
The AMA reports (here) that a new Texas law will help physicians avoid the “spanner thrown into the works” impact of health insurers’ requirements of prior authorization for medical services. “For Texas physicians, the gold card indicates they consistently meet prior authorization requirements and that state-regulated insurance companies will not delay their patients’ care. Under a law that took effect this month and is the first of its kind in the U.S., physicians who have a 90% prior authorization approval rate over a six-month period on certain services will be exempt—or ‘gold carded’—from prior authorization requirements for those services. Prior authorization is a health plan utilization-management or cost-control process that requires physicians to get approval before a prescribed treatment, test or medical service qualifies for payment.”
An oncologist representing a 500-physician practice in Texas and Oklahoma reported that “For every three Texas Oncology doctors, there’s more than one staffer spending all day, every day on the job managing prior authorizations—200 people all told. ‘Prior authorization used to be an infrequent tool, and now it is a ubiquitous tool to manage utilization’ . . . [also] “noting that just about every test or scan she orders, and every treatment she prescribes, is subject to prior authorization. ‘Ultimately, they all get approved, so the fact that I have to spend 15 hours a week dealing with this is crazy.’”
Orthopedic Surgery, or Not
A review in the British Medical Journal (here) finds that “No strong, high quality evidence base shows that many commonly performed elective orthopedic procedures are more effective than non-operative alternatives. Despite the lack of strong evidence, some of these procedures are still recommended by national guidelines in certain situations.”
HOSPITALS AND OTHER HEALTH CARE FACILITIES
Procompetitive “Efficiencies,” Even if they Exist, No Defense Against Antitrust, Says FTC
AHLA’s Health Law Weekly reports that “A split Federal Trade Commission (FTC) voted 3-2 on September 15 to withdraw its approval of vertical merger guidelines [e.g. well-head to gas pump, hospital acquisition of physician practices, here] that were issued jointly with the Department of Justice (DOJ) in June 2020. According to an FTC press release, the guidelines, ‘include unsound economic theories that are unsupported by the law or market realities’ . . . However, the 2020 guidelines contravened the text of the Clayton Act in the approach to procompetitive efficiencies, which are not recognized by the statute as a defense to an unlawful merger . . . Until new guidance is issued, the FTC will analyze mergers in accordance with its statutory mandate, which does not presume efficiencies for any category of mergers.” The Department of Justice, on the other hand (here), said it was making no change in its use of the 2020 guidelines.
DRUGS & DEVICES
Antibiotics as Rifle, Not Shotgun
The Financial Times reports (here) that “US regulators have approved the first test that distinguishes rapidly and reliably between bacterial and viral infections, helping doctors to avoid unnecessary prescriptions that are fueling global antibiotic resistance.”
Not So Fast: CMS Rescinds Fast Track Payment, Under “Medicare Coverage for Innovative Technology” (MCIT)
A filing by CMS in the September 15 Federal Register (here) notes “CMS developed MCIT in part due to concerns that delays and uncertainty in Medicare coverage slowed innovation and impaired beneficiary access to important new technologies, specifically those designated as breakthrough devices by FDA. In response to these concerns, the rule provided 4 years of expedited coverage to FDA market authorized Breakthrough Devices on the first day of FDA market authorization or a select date up to 2 years after the market authorization date as requested by the device manufacturer.” Now CMS says that the final rule as currently drafted “is not in the best interest of Medicare beneficiaries” since it would likely cover payment without adequate clinical evidence on the breakthrough device’s use in the Medicare population, and in the face of anemic post-marketing surveillance of medical devices by both the FDA and manufacturers (see, for examples, here, here and here). A recent review of FDA regulation of medical devices from 1976 to 2020 (here) found that “important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products.”
Using the maximum Medicare new technology add-on payment of $22,425 per patient device use (at pgs. 51332-3), CMS estimated the 2025 impact to be $2 billion, assuming that only five manufacturers took advantage of MCIT for 6,500 patients (of the 55 million in Medicare).
Extensive discussion takes place in the proposed rule concerning the definition of “medically necessary,” with implications that many of the MCIT applications would not be. Comments on the proposed rule are due by October 15.
AI v. GI (Genuine Intelligence)
An essay in the AAAS’ Science magazine (here) says “Beware explanations from AI in health care,” and notes that “The benefits of explainable artificial intelligence are not what they appear.” STAT (here) has found that “Epic gives financial incentives to hospitals and health systems that use its artificial intelligence algorithms.” STAT+ also reports (here) “Epic’s AI algorithms, shielded from scrutiny by a corporate firewall, are delivering inaccurate information on seriously ill patients.”
READINGS & REFERENCES
Select Coronavirus Public Health Resources and References may be found here.
2021 CQ Congressional Calendar here.
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
September 21, 22, 23, 24, 27, 28, 29, 30
October 1, 19, 20, 21, 22, 25, 26, 27, 28
November 1, 2, 3, 4, 5, 15, 16, 17, 18, 30
Notes to: Fred Hyde, MD, JD, MBA; fredhyde@aol.com.