Weekly Spotlight
Reports this week note that Elon Musk’s “Department” of Government Efficiency (DOGE) has the little-known Agency for Healthcare Research and Quality (AHRQ) in its sights. Stat reports that, “small government agency responsible for putting medical products and services to practical use and making health care safe is feared to be the latest target for mass layoffs by the Trump administration. Maybe, in the face of canceled research funding, elimination of healthcare and protections for trans individuals, and other recent horrors (and that’s just the domestic health sector) AHRQ may seem like a “nice to have” not a “need to save.” But dig a little deeper and you’ll see that AHRQ has a critical role in Medicare coverage policy.
The frequently-maligned but often misunderstood policy of Medicare “coverage with evidence development” depends on a delacate relationship with AHRQ. CMS’s mandate is to evaluate what items and services are “reasonable and necessary” to cover. Furthermore, CMS has frequently stated that it uses CED policy to extend Medicare coverage in cases when “the expectations of interested parties are not adequately supported by the evidence base.” (Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development). This statement implies that that in cases where CMS thinks the evidence does not support a “reasonable and necessary” determination, but public interest demands access, CMS has a way out: they can seek additional evidence in the form of a study that has been validated and supported by AHRQ while covering the item or service.
The savvy reader will note that deep within any coverage decision with CED proffered by the Medicare agency on behalf of of its beneficiaries there is an acknowledgment that “Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports (emphasis added) clinical research studies that meet the above-listed standards and address the above-listed research questions” (referencing the coverage decision in which this statement is contained).
The legal basis for CED resides in 42 U.S.C. 1395y:
(a) Notwithstanding any other provision of this title, no payment may be made under part A (Medicare hospital) or part B (Medicare outpatient) for any expenses incurred for items or services –…
(e) in the case of research conducted pursuant to section 1142 (AHRQ authority) which is not reasonable and necessary to carry out the purposes of that section.
Because of how the section is constructed, this citation reads with a tangle of double negatives, but it basically shakes out to a statement that CMS can pay for AHRQ-supported research that is deemed reasonable and necessary.
Critics have argued that that CMS’s use of CED is a stretch of its authority. They have also argued that CMS’s tenuous use of CED relies on a mistaken interpretation of AHRQ’s support for CED reseach. In fact, the previous Trump adminstration was known to be critical of CED.
That leaves this polcy wonk wondering about the future of an agency that may have a bigger target on its back than meets the eye… and also wondering what happens if AHRQ can no longer “support CED research. Critics would say that CMS would be forced to cover any items and services in question. Those critics seem to forget that non-coverage is, and always has been an option for Medicare. Furthermore, an agency looking for “efficiency” may have quite the incentive to eliminate access to care that is not yet demonstrated to be “reasonable and necessary.”
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
CMS approves coverage for transcatheter tricuspid valve replacement
CMS has approved Medicare and Medicaid coverage for transcatheter tricuspid valve replacement procedures for the treatment of symptomatic tricuspid regurgitation. The procedures will be subject to CMS’ coverage with evidence development guidelines, meaning coverage will be considered only in the context of a clinical study, according to a March 19 decision memo from the agency.
#Device,#Patient,#Provider
AHIP Paid for a Report Critical of MedPAC MA Data
A recently published study, paid for by AHIP assessed the findings contained in recent reports by the Medicare Payment Advisory Commission. MedPAC’s top line conclusion is that MA plans were paid 22% more in 2021 than what Medicare would have paid for those individuals under Fee-For-Service Medicare. However, MedPAC’s conclusions are based on data which limit the scope of their findings and methodologies that affect the accuracy of their estimates. MedPAC also elides significant countervailing facts and fails to account for plan bids, which affects the interpretation of their results.
#Payer
Accountable Care Organizations Still Play a Vital Role in Value-Based Care
Moving away from accountable care organizations (ACOs) will not lead to value-based care, according to Luke Hansen, M.D., M.H.S., and chief medical officer of Arcadia, a healthcare data analytics company.
#Provider,#Patient
Post-acute providers roll out game plans for TEAM demo
Post-acute providers are adding staff, investing in technology and gathering data to partner with hospitals ahead of the TEAM demonstration.
#Provider,#Patient
Food and Drug Administration (FDA)
FDA Staff Return to Crowded Offices, Broken Equipment, and Missing Chairs
Thousands of employees returned to the FDA’s headquarters Monday to find overflowing parking lots, long security lines, and makeshift office spaces without chairs and other basic supplies.
#All
Health and Human Services (HHS)
More research funding cuts and potential layoffs, from Columbia to AHRQ
Significant cuts to research funding are affecting various institutions, notably Columbia University, which shutdown of a major research program focused on myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The broader implications of these funding cuts, including potential layoffs and the impact on ongoing research initiatives across the country underscore concerns about the future of health research and the ability of institutions to sustain important studies amidst financial constraints.
#All
Trump Administration Weighing Major Cuts to Funding for Domestic HIV Prevention
The Trump administration is weighing major cuts to funding for the CDC’s HIV prevention programs.
#All
HHS files brief in 340B rebate model case: 4 takeaways
HHS has filed a legal brief urging a federal judge to dismiss lawsuits brought by pharmaceutical companies challenging the agency’s stance on 340B rebate models.
#Drug,#Hospital
Hill Happenings
Opinion: Congress must reject taxing employer-provided health care coverage
As the new Congress and administration are settling in, all eyes in Washington are focused on the trillion-dollar question: whether and how to pay for the expiring provisions of the 2017 Tax Cuts & Jobs Act (TCJA), signed into law in President Trump’s first term. Among the various revenue-generating proposals emerging from GOP circles — including some of the president’s most trusted advisers — is one that would increase taxes on American workers with employer-provided health care coverage.
#All
Democratic Physician House Members Launch Congressional Doctors Caucus
Six Democratic physician members of Congress are forming the Congressional Doctors Caucus, a group aimed at addressing a variety of healthcare concerns from potential Medicaid cuts to the reduction in the Medicare Physician Fee Schedule.
“For a long time, there were only two Democratic doctors in Congress: myself and [Rep.] Raul Ruiz, [MD],” Rep. Ami Bera, MD (D-Calif.) told MedPage Today in an interview Friday, the day the group was launchedopens in a new tab or window. Republican physicians in Congress — of which there are many more — “have their own GOP Doctors Caucus. They certainly would invite us to participate in some of their events, but often on policy issues — whether it’s protecting the Affordable Care Act or reproductive rights — we have policy differences at times. Now that we’ve actually got six Democratic doctors, it was important for us to get our own doctors’ caucus.”
#All
Site-neutral Medicare pay eyed to fund Trump tax cuts
Republicans eager to offset the cost of cutting taxes may see lower Medicare spending on outpatient care as a source of budgetary savings.
#Hospital,#Provider
Notable Notes
Opinion: I helped declare the U.S. measles-free in 2000. I’m dismayed by where we are now
My career as a family physician, educator, and researcher has been intimately intertwined with measles and immunization policy. I write on this anniversary to bear witness to the recent but potentially fleeting miracle of elimination. Speaking for my many past and current vaccine colleagues, living and dead, our desire has always been for the health and safety of the least of us — or in the words of naturalist Loren Eiseley: “a child or… a grownup past hope.”
#All
Opinion: The Entire Future of American Public Health Is at Risk
If that debate sounds familiar, it should, since arguments about natural versus vaccine immunity helped give shape to debate about whether the public-health establishment was overly cautious about Covid, too. As we exit what Siddhartha Mukherjee recently called America’s “privatized pandemic,” the country is feeling its way toward a new anti-establishment equilibrium — and anointing a new class of health leaders distinguished by their vocal skepticism and distrust.
#All
‘We’ve vanished’: U.S. aid cuts leave health workers around the world reeling
Many say they’re struggling personally with the impact, while also worrying about former patients
#All
The kids’ doctors aren’t all right
On Friday, medical students around the U.S. will learn what residency program they have matched into. Match Day is not just momentous for those students, though. It also tells the rest of us what fields of medicine are having trouble attracting new physicians. In 2024, about 8% of pediatrics positions went unfilled, an increase from about 3% in 2023.
#All
Johns Hopkins University to lay off more than 200 employees
The university’s Bloomberg School of Public Health and international nonprofit affiliate Jhpiego will cut 237 employees in May.
#All
WHO issues starkest warning yet on fallout from U.S. withdrawal of aid for global health
The World Health Organization on Monday issued its starkest warning yet on the consequences of the abrupt cessation of U.S. global health funding, saying it is threatening to reverse years of progress in the fight against diseases like HIV, tuberculosis, and measles.
#All
Abbott’s Amulet LAAO device linked to long-term safety, effectiveness
The Amplatzer Amulet Left Atrial Appendage Occluder (LAAO) from Abbott is safe and effective a full five years after treatment, according to new data published in the Journal of the American College of Cardiology.[1] The study’s authors reviewed data from more than 1,800 high-risk patients with nonvalvular atrial fibrillation (AFib). Patients were randomized to undergo LAAO with either the Amulet, which seals the left atrial appendage at the ostium and the neck, or Boston Scientific’s Watchman 2.5 single-closure device.
#Device,#Patient
SMART 2-year TAVR hemodynamic data: Medtronic Evolut is better compared to Edwards Sapien in small annulus patients
Howard Herrmann, MD, MSCAI, Hospital of the University of Pennsylvania, and lead invesigator for the SMART trial, explains details on the 2-year data comparing the Evolut vs. Sapien 3 for TAVR in small annulus patients.
#Device,#Patient,#Provider
TAVR or TAVI? Cardiologists want a single acronym for the popular heart procedure
Transcatheter aortic valve replacement (TAVR) and transcatheter aortic valve implantation (TAVI) are two popular acronyms commonly used to describe the same heart procedure: percutaneous aortic valve implantation in patients with aortic stenosis. In a new editorial for European Heart Journal, a trio of authors has asked the world’s medical societies to come together and agree on a single acronym instead of alternating between one and the other.[1]
#Device #Provider
Mitral valve repair vs. replacement: Surgeons track long-term outcomes in patients with infective endocarditis
Mitral valve repair was linked to a significant improvement in long-term survival when treating infective endocarditis. Some patients are not good candidates for a repair procedure, however, making replacement the best possible option.
#Patient,#Device,#Provider
American College of Cardiology shares new guidance focused on evaluation, management of cardiogenic shock
The new document represents the ACC’s first Concise Clinical Guidance; it was designed to be an easy-to-use reference for keeping track of a complicated topic.
#Patient, #Provider
Private equity buyouts increase physician turnover by 265%, study finds
A study by researchers at Brown University and Duke University analyzed the employment records of 200 practices acquired by private equity firms and compared them with unacquired practices to develop some observations.
#Provider
Cardiology ASCs: 5 notes to know
Cardiology is the fastest growing ASC specialty, according to Avanza’s “2022 Key ASC Benchmarks and Industry Figures” report.
#Provider,#Device,#Patient,#Hospital
Cardiologist questions FDA’s approval process for high-risk medical devices
Sanjay Kaul, MD, a cardiologist with Cedars-Sinai Medical Center in Los Angeles, shared his perspective in JACC: Cardiovascular Interventions, an American College of Cardiology journal.[1] Kaul pointed to several recent examples to make his point. He started with the 2024 approvals of the Evoque transcatheter tricuspid valve replacement system from Edwards Lifesciences and the TriClip transcatheter edge-to-edge valve repair system from Abbott.
#DEVICE,#PATIENT
