Weekly Spotlight
There’s snow on the ground in DC and, rumor has it, a bit more is on the way. The new Congress is here, and the excitement of swearing-in day has come and gone, as has the certification of the results of the 2024 presidential election results (with barely a murmur).
DC does know how to put on an event – whether it’s the somber pomp and circumstance of a former president lying in state at the Capitol ahead of a presidential funeral earlier this week or the frozen frenzy of inauguration day still to come – formal occasions are kinda our thing. By that I mean, many DC-ers happily hand over the city to an influx of tourists while we try to get a few things done from home and watch on TV. It’s only after everyone’s gone that the real work begins. Ahead of a second Trump Administration with a lot of questions about the future still looming, this writer is ready to rip off the bandaid already and get to work. Alas, we still have 10 more days until we can hope to start getting answers to all the questions we didn’t even know we had!
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
Mass General Brigham’s 2025 hospital-at-home plans
Mass General Brigham plans to expand its hospital-at-home program to more specialties in 2025 and evolve beyond episodic care toward a “seamless home-based care continuum.” Meanwhile, a new study in JAMA points out that hospital-at-home programs are largely concentrated at large, urban, nonprofit and academic hospitals.
#Hospital, #Patient
21 health systems dropping Medicare Advantage plans | 2025
Some hospitals and health systems are opting to end or not renew contracts with some MA plans over administrative challenges. Here are the 21 health systems we know about already this year. Among the most commonly cited reasons are excessive prior authorization denial rates and slow payments from insurers.
#Hospital, #Payer
What does Medicaid look like in a second Trump presidency?
Incoming President Trump has pledged to keep Medicare and Social Security intact. He hasn’t said much, or anything, about what happens to Medicaid. But to pay for promised tax cuts, without compromising those behemoth programs, some Republicans are eyeing Medicaid reforms that could see deep cuts to who is eligible and what is covered.
#Patient
Opinion: Most cancers have no screening test. Let’s change that
By mandating that Medicare and private insurers provide temporary coverage for any reasonably priced test that is approved by the Food and Drug Administration through the agency’s special Breakthrough Device program, transformative innovation can more readily benefit eligible Americans.
#Patient, #Device
Nearly 24 Million Consumers Have Selected Affordable Health Coverage in ACA Marketplace, With Time Left to Enroll
CMS reports that 23.6 million consumers selected plan year 2025 coverage through the Marketplaces since the start of the 2025 Marketplace Open Enrollment Period, including 3.2 million new consumers. That represents 11.6 million more enrollees compared to the 2021 Open Enrollment Period.
#Patient, #Payer
Do the New CMS Rules on Prior Authorization Go Far Enough?
The new CMS regulations on prior authorization have been heralded as a big step forward in reducing administrative burdens on physicians, but some people think it doesn’t go far enough.
#Patient, #Payer
Opinion: Keep Quality Measures Out of the Exam Room
The patient’s check-up begins, as most now do, by sitting down and typing my username and password into a computer. After a kind greeting, I launch into the growing checklist of tasks called quality measures, which now define quality in the eyes of insurance companies who decide on how much doctors get paid for our clinical services.
#Provider, #Patient
Food and Drug Administration (FDA)
Leaving FDA, Califf is unapologetic — and warns of staff departures
In a wide-ranging interview, Robert Califf, the departing commissioner of the Food and Drug Administration, defended the FDA’s record under his leadership, praised the progress that has been made in changing the way the agency regulates food, and worried about the impact of the coming Trump administration.
#All
FDA pushes makers of AI devices to disclose more details on testing, performance
The Food and Drug Administration wants the developers of medical devices that rely on artificial intelligence to disclose much more detail about how their devices were developed and tested, and what must be done to guard against safety risks in medical settings.
#Device
Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Evaluation of Sex- Specific and Gender-Specific Data in Medical Device Clinical Studies.” This document provides guidance on the study and evaluation of sex- and/or gender-specific data in clinical investigations or research involving one or more subjects to determine the safety or effectiveness of a device.
#Device, #Patient
Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Study of Sex Differences in the Clinical Evaluation of Medical Products.”
#Device, #Drug, #Patient
Hill Happenings
Lawmakers extend telemedicine coverage expansion through March 31
Medicare expanded its telemedicine coverage substantially in 2020, and the expansion has regularly been renewed. That could all have ended on Dec. 31. Finally, however, Congress approved a three-month extension. So telemedicine lives, at least until March 31.
#All
Crapo Named Chairman of Senate Finance Committee – Outlines His Healthcare Priorities
U.S. Senator Mike Crapo (R-Idaho) has been confirmed as Chairman of the powerful Senate Finance Committee in the 119th Congress. His healthcare priorities include PBM reform, rural health care, and doc pay.
#All
Lawmakers urge FTC to release newest report on pharmacy benefit managers
A bipartisan, bicameral group of lawmakers is calling on the Federal Trade Commission (FTC) to vote in favor of releasing an interim staff report on pharmacy benefit managers (PBM).
#Drug
Senate report slams private equity in healthcare
Private equity investment makes the healthcare system worse, according to the findings of a bipartisan Senate Budget Committee investigation published Tuesday. Sens. Sheldon Whitehouse (D-R.I.) and Chuck Grassley (R-Iowa) issued the report, which zeroes in on Apollo Global Management and Leonard Green & Partners and their healthcare holdings.
#Provider, #Hospital
Notable Notes
PHARMACEUTICAL NEWS
Trump Says World Is Free-Riding on U.S. Health Spending. He Has a Point.
The president-elect might bring back efforts to make other countries pay more for drugs, but there are pitfalls.
#DRUG, #PATIENT
CVS Health launches CostVantage model
CVS Health has announced that starting this year, all commercial prescriptions dispensed through CVS Pharmacy will be contracted through its new CVS CostVantage reimbursement model.
The CVS CostVantage model is designed to provide clearer pricing by factoring in the underlying cost of a drug, a defined markup and a dispensing fee that reflects the value of the pharmacy services provided.
#Drug, #Patient
Employers … defend PBM steering?
Cigna and two lobbying groups for large self-insured employers and unions sued the commissioner of Minnesota’s Department of Commerce. The groups alleged a state law that regulates pharmacy benefit managers is both unconstitutional and preempted by federal benefits law.
#PAYER
Walgreens targets PBM contracts, moves ahead with VillageMD sale
Walgreens is making progress renegotiating contracts with pharmacy benefit managers and selling its VillageMD stake, while continuing to trim down other parts of the business.
#Drug, #Patient
MEDICAL DEVICE NEWS
Medtronic’s Harmony TPVR system gains CE mark approval
The FDA-approved Harmony TPVR system is now available to patients across the EU. Nina Goodheart, president of Medtronic’s structural heart and aortic business, described the news as a “significant milestone.”
#Device
The primary reason Boston Scientific’s TAVR valve fell short in clinical trial
Michael Reardon, MD, co-principal investigator of the ACURATE IDE trial, discussed updated data on what may have impacted that study’s findings.
#Device
Trump’s tariff threat troubles medtech industry
Medtech companies are bracing for massive tariffs that could drive up costs, temporarily stifle innovation and force them to rethink supply chain strategies that protect their bottom lines.
One of the first actions President-elect Donald Trump has said he plans to do upon taking office this month is impose a 25% tariff on goods from Canada and Mexico and a higher tariff on goods from China.
#Device
CES 2025: Cardiologist check-ups, AI-powered smart mirrors coming to heart patients’ homes
Healthcare companies from all over the world are showing off their newest cardiovascular offerings at CES 2025 in Las Vegas.
#Device, #Patient
Surgery outperforms PCI in NSTEMI patients with multivessel CAD
CABG was associated with a 41% lower risk of long-term mortality than PCI in a new study of more than 57,000 patients. The full analysis was published in European Heart Journal.
#Patient, #Provider
Radial secondary access during TAVR limits complications
Radial access is already the primary choice for many cardiologists performing PCI due to a lower risk of complications. The same appears to be true for secondary access during TAVR.
#Provider, #Patient
HOSPITAL AND PROVIDER NEWS
90% of hospital execs anticipate financial gains in 2025: Report
Ninety percent of hospital leaders expect financial performance to remain similar to or better than 2024, driven by increased utilization (77%) and success with commercial contracting (56%), according to a VMG Health report published Jan. 9.
#Hospital
Joint Commission revamps survey process: 5 things to know
The Joint Commission has enhanced its survey process for 2025, after calls from member organizations to alleviate administrative burden with more modernized and improved tools.
#Hospital, #Patient
Massachusetts new law cracks down on private equity in healthcare
The bill’s passage is a rare success in a nationwide effort to crack down on private equity firms after a string of high-profile healthcare bankruptcies.
#Provider
Compensation, utilization keep rising for cardio APPs: 10 takeaways
Advanced practice provider compensation has continued to increase year over year, according to 2023 data reported by the American College of Cardiology’s consulting firm, MedAxiom.
#Provider
Aetna suit against private-equity radiologists tests No Surprises Act
Aetna has fired the health insurance industry’s first salvo against private equity-backed providers it alleges manipulate the No Surprises Act to inflate reimbursements by staying out of health plan networks.
#Provider, #Payer, #PATIENT
AND MORE
Medical schools see record-high enrollment as applications fall: 10 takeaways
While the total number of applications declined in the 2024-to-2025 academic year, enrollment in U.S. medical schools reached a new high, according to data released Jan. 9 by the Association of American Medical Colleges. Reoports also note that enrollment of Black and Hispanic students in medical schools dropped precipitously last year after the Supreme Court banned the consideration of race in admissions.
#All
Opinion: What Will it Take to Achieve Better Health in a Divided America?
The U.S. spends more on healthcare than any other developed nation, yet Americans are falling farther behind when it comes to health status and life expectancy
#All
How one foundation changed its approach to diversify grant recipient institutions
Concerned that we were perpetuating the concentration of grant funding at elite institutions, we tried something new
#All
Journal Editors Sound Alarm on Predatory Medical Journals
Action by all stakeholders is required to protect authors and the public from predatory medical journals, an international group of prominent medical journal editors said Monday.
“Predatory journals have developed strategies to profit by taking advantage of a climate that nurtures the growth of open access, author-pays publication models,” wrote Christina Wee, MD, MPH, secretary of the International Committee of Medical Journal Editors, and colleagues in an editorialopens in a new tab or window published simultaneously in JAMAopens in a new tab or window and the Annals of Internal Medicine.
#All
Rural healthcare in crisis: innovations for a brighter future
The U.S. healthcare system’s increasing complexity is taking an unbalanced toll on rural America. Shrinking access, growing health disparities and rising mortality rates put the well-being of 60 million people – roughly one in five Americans – at risk. The situation is dire, and immediate action is imperative to reverse that trajectory.
#Hospital, #Patient
Opinion: Economic ‘Shrinkflation’ Strikes Healthcare
With U.S. healthcare costs on track to make up one-fifth of the economy by 2031, and increases in healthcare spending consistently higher than GDP growth, healthcare consumers are increasingly facing effects of “shrinkflation” – the process of items shrinking in size or quantity while the prices remain the same or go slightly higher.
