DCMedical News: Friday, October 14, 2022
DCMedical News is published every day both the House and the Senate are scheduled to be in session.
THE BIG STORY Friday, October 14, 2022
The Great Colonoscopy Debate: An Uncomfortable Waste of Time and Money?
A widely noted article published this week in The New England Journal of Medicine (here) based on research in Europe called into question the use of colonoscopy as a means of changing the outcome of colon cancer. The diplomatically stated introduction to the study says, “Although colonoscopy is widely used as a screening test to detect colorectal cancer, its effect on the risks of colorectal cancer and related death is unclear.” The “bottom line” appears to show miniscule and insignificant differences in “all cause” mortality. The article notes “Colonoscopy has not been adopted in many other parts of the world, partly because evidence from randomized trials regarding the benefits of this test is lacking.”
An editorial which appeared in the same edition of NEJM (here) is sensitive to the potential for controversy, and the revenues and incomes at stake. The American Society of Gastroenterologists (here) has denounced the research, contending that it was only relevant for European patients, not American, offering FAQ guides for members’ patients (here).
Now contrary voices (here) are claiming to debunk the GI community arguments and the NEJM editorial.
In the blog Sensible Medicine an anonymous physician commentator writes “Simply put colon cancer death is dwarfed by dying for any reason, and the benefits are tiny . . . If the issue of colonoscopy saving lives is settled already, why was this trial even done? We are not doing trials to determine if the Earth is round, because that is considered settled knowledge. We do trials to help with clinical issues which are not settled. If the trial had happened to show a positive finding, the same people getting worked up about methodological issues now would be championing the study -- I am very sure of this.”
“The truth is there are 3 more ongoing trials precisely because this is not settled science. We have no idea which colorectal cancer screening is best in 2022. I have never observed so many trainees (GI fellows and IM residents who want to do GI) get so worked up over a scientific issue on Twitter. I am sure that >80% of them don't even understand the nuances of the discussion. Some are doing it just to demonstrate they are on the ‘right team’ and advocating for the right cause (let alone the obvious COI that their salaries are highly dependent upon this approach to medicine).”
HOSPITALS, NURSING HOMES AND OTHER HEALTH CARE FACILITIES
Providence and Charity
The Seattle hospital chain has responded (here) to questions concerning charity care policies posed by influential U.S. Senator Patty Murray.
Senator Murray’s letter (here) followed on public explanations of its charity care policies by Providence (here). Those explanations, in turn, were made necessary by a front-page exposé (here) in The New York Times, alleging that Providence had automated referrals to debt collectors in a program dubbed “Rev Up” developed for Providence by McKinsey.
According to The Times, a spokesperson for Providence said, “The intent of Rev-Up was not to target or pressure those in financial distress. Instead, she said, it aimed to provide patients with greater pricing transparency’ . . . But employees who were responsible for collecting money from patients said the aggressive tactics went beyond the scripts provided by McKinsey. In some Providence collection departments, wall-mounted charts shaped like oversize thermometers tracked employees’ progress toward hitting their monthly collection goals.”
“On Halloween at one of Providence’s hospitals, an employee dressed up as a wrestler named Rev-Up Ricky, according to the Washington lawsuit. Another costume featured a giant cardboard dollar sign with ‘How’ printed on top of it, referring to the way the staff was supposed to ask patients how, not whether, they would pay.”
In Providence’s response to Senator Murray, CEO Dr. Rod Hochman ($10 million compensation in 2020 according to The Times) writes “The process of billing and helping patients navigate their insurance coverage is one of the most complex aspects of health care in the U.S. It has become even more challenging in recent years as insurers and employers shift more of the burden onto patients, requiring individuals to pay higher out-of-pocket costs. This puts providers like Providence in the position of having to help patients figure out what is due and carry out the collection of payment, which is required by law and per our insurance contracts.”
MEDICARE, MEDICAID AND COMMERCIAL HEALTH INSURANCE
Medicare Advantage: Some Legislators Want to Change the Name, Introduce “Distance” from Medicare
Open enrollment (begins tomorrow) pits Medicare Advantage (MA) plans against those who believe the plans to be “ripping off” the Medicare program through phony up-coding. Some legislators (here) want to change the name “Medicare Advantage” (which was originally known as Medicare Part C) to some other name which does not include the word “Medicare.”
DRUGS & DEVICES
Accelerated Approval for Medical Devices
The FDA, already under the spotlight for accelerated approval of “worthless” drugs (see DCMN 10-12, OIG report here), is now ready to roll out a program of accelerated approval for medical devices.
The existing approval process, known as the §510(k) program for that section of the medical device amendments in 1976, already requires very little information concerning the safety and efficacy of devices, in fact only that new devices are developed on “predicate” devices, ones previously approved (presumably in a more formal process). For example, the Intuitive Surgical robotically assisted devices now widely in use were never formally evaluated, but rather approved based on “pre-existent” products.
The proposed CMS program is described in a JAMA Internal Medicine article (here). CQ reports that “The proposed rule would relate to devices authorized by the FDA's Breakthrough Devices Program, which is intended to speed the development and review of medical devices that treat or diagnose life-threatening or irreversibly debilitating diseases. The Trump administration finalized a rule in 2021 that would automatically provide four years of Medicare coverage for breakthrough devices. The Biden administration rescinded the rule in November, arguing that there is frequently not enough evidence of the clinical benefit for newly approved medical devices.
According to CQ, “The process will be limited to medical devices that fall within the Medicare statute and are relevant to the Medicare population . . . The proposed rule will allow CMS to conduct early evidence reviews before devices receive marketing authorization from the FDA . . . CMS noted that it requires evidence of benefit in the Medicare population for a device to be covered, while trials designed for FDA approval often don’t include patients who are sick.”
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
October 17, 18, 19, 20, 21
November 14, 15, 16, 17, 18, 29, 30
December 1, 2, 5, 6, 7, 8, 12, 13, 14, 15
Notes to Fred Hyde, MD, JD, MBA, news@dcmedicalnews.org