Weekly Spotlight
America’s obsession with GLP-1s does not seem to be going away – especially if Oprah has anything to say about it. That leaves Medicare and other payers to figure out how they want to handle this blockbuster drug. In just these past few weeks, we have seen traditional Medicare clear Part D coverage of certain products for patients who have heart-related conditions. This week, a number of Medicare Advantage plans followed suit. How all of this plays out in the context of the debate over drug costs (and the first year of Medicare drug price negotiations for certain, pre-selected drugs) continues to be of interest. In fact, Senator Sanders has invited the CEO of Novo Nordisk, the manufacturer of Wegovy (and Ozempic), to meet to discuss why the company charges so much in light of new findings that purport to demonstrate the cost to manufacture the drugs.
Meanwhile, the latest publication from the Association of American Medical Colleges (AAMC) should not be missed. This is one of the first reports out of AAMC that attempts to paint a clear picture of the physician workforce shortage in a post-COVID era. These new estimates build on AAMC’s decades of work on this topic while adapting to the seismic change experienced by our health care system, and society at large, just a few short years ago. COVID didn’t just change how new physicians are trained, it dramatically altered healthcare demand, impacted retirement rates and the number of students electing to train to be physicians, and it also exposed and exacerbated physician burnout.
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
MA Insurers Petition for Bigger Payments
The Medicare Advantage final rule has reached OMB. As such, the public will soon find out whether the federal government is willing to meet the health insurance industry’s demands and deposit more money into the bank accounts of next year’s Medicare Advantage plans. Stat reports on the more than 40,000 comments received.
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Berwick Speaks to Medpage Today about the Rise in MA Enrollment
Donald Berwick, MD, MPP, the administrator of the Centers for Medicare & Medicaid Services (CMS) during the Obama administration and president emeritus and senior fellow at the Institute for Healthcare Improvement spoke to MedPage Today about his concerns that too many Medicare beneficiaries are being misled into enrolling into private Medicare Advantage plans, which he said should be slowed or stopped because the plans have gamed the system to receive billions more than what is spent for traditional Medicare beneficiaries’ care.
#All
First Medicare Health Plans to Start Paying for Weight-Loss Drug Wegovy
Medicare Advantage programs run by Elevance, Kaiser Permanente and CVS Health have decided to extend coverage of the GLP-1 weight loss drug Wegovy for people with heart-related conditions. The insurers’ decisions arose from new guidance issued last week by the Centers for Medicare and Medicaid Services, which administers Medicare for millions of people 65 and older, and younger people with certain disabilities and diseases. CMS said Part D plans, which are administered by private insurers, might cover anti-obesity medications if the drugs receive approval for an additional use that is considered medically accepted. Their use for weight-loss alone would still be excluded from coverage. (Paywall)
#Drug, #Patient
CMS Proposed Payment Rules Start Hitting the Presses
CMS has started to publish the first few annual payment rules impacting different parts of the Medicare program. Early take-aways:
- Inpatient Psychiatric Facilities: +2.7%
- Skilled Nursing Facilities: +4.1%
- Hospice Providers :+2.6% (lower than expected, revised quality reporting requirements in 2028).
- In addition, CMS will extended the deadline for the special enrollment period available to people who lost Medicaid coverage due to the unwinding of special coverage protections afforded during the COVID pandemic from July 31 to Nov. 30.
#ALL
Food and Drug Administration (FDA)
Accelerated Approval of Drugs – Faster Access to Breakthrough Treatments or Paying More for Less
Stat news hosted a panel discussion on the accelerated approval pathway.
Excerpt: Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated approval pathway, allowing regulators to speed access to drugs for thousands of dying patients. These days, though, Gonsalves sounds uneasy — if not mournful — of the world he helped build…
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Califf on “Harnessing the Potential of Artificial Intelligence “
FDA Commissioner Robert Califf penned a statement on the use of AI in medical products and in FDA operations.
#Device, #Drug
GAO Focuses on Clinical Research and Inspection Workforce
A new report from the Government Accountability Office looks at FDA oversight of clinical research in hospitals and clinics, stating that the number of inspections has fallen considerably in recent years, due to disruptions caused by the Covid pandemic and challenges finding and keeping investigators.
#Device, #Drug, #Hospital, #Patient, #Payer
Department of Health and Human Services (HHS)
In Celebration of 10 Years of ACA Marketplaces, the Biden-Harris Administration Releases Historic Enrollment Data
The U.S. Department of Health and Human Services (HHS) issued four new reports intended to show that President Biden’s efforts to strengthen the Affordable Care Act (ACA) are linked to historic gains in Americans’ health insurance coverage.
- 2024: Total Marketplace Plan Selections During 2024 Open Enrollment Period
- 2024: Coverage Under the Affordable Care Act: Current Enrollment Trends and State Estimates
- 2015-2023: ASPE Marketplace Enrollment by Race and Ethnicity Issue Brief
- 2014-2024: How the ACA Marketplaces have evolved in 10 years
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White House Readout of Biden-Harris Administration’s Follow Up Meeting with Insurers Concerning Cyberattack on Change Healthcare
Leaders from HHS, the White House, and health insurance companies convened to discuss ways to mitigate harms to patients and providers caused by the cyberattack.
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Hill Happenings
Sanders Statement on “Outrageous Cost of Ozempic” Following a New Analysis of Manufacturing Costs
Sen. Bernie Sanders (D-VT) has called on manufacturers to lower drug prices after new study shows relatively low manufacturing costs to produce popular weight loss drugs. Findings in an economic evaluation recently published in JAMA estimated cost-based prices per month were US $1.30 to $3.45 for SGLT2Is (except canagliflozin), and $0.75 to $72.49 for GLP1As, substantially lower than current market prices in nearly all comparisons. Sanders has reportedly asked to meet with Novo Nordisk CEo
#Drug, #Patient
Notable Notes
Payments by Drug and Device Makers to Doctors Remain Widespread, but also Vary Considerably
Stat news reports on findings in a new JAMA-published study that, from 2013 to 2022, pharmaceutical and device companies made more than 85 million payments totaling $12.1 billion to approximately 826,300 physicians. And 94% of those payments were associated with at least one marketed medical product. Among the products for which the most payments were made included blood thinners and a robotic surgical system. The analysis also revealed that 57% of all physicians — there were more than 1.4 million whose names were found in the Open Payments database maintained by the U.S. government — received a payment during that time. And the median payment was $48 across 39 medical specialties, although payments varied widely between specialties and between physicians within the same specialty. Indeed, orthopedic surgeons received the largest amounts at $1.36 billion, followed by neurologists and psychiatrists at $1.32 billion, and then cardiologists at $1.29 billion. Pediatric surgeons and trauma surgeons received the lowest sums — $2.89 million and $6.96 million, respectively.
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Hospitals Are Adding Billions in ‘Facility’ Fees for Routine Care
Excerpt from WSJ: Tim Ebel’s visit with an ear, nose and throat specialist at an Ohio clinic last October came to $348. At the same time, he got a second bill for $645.
The hospital system that owns the Avon, Ohio, clinic had charged him separately for use of the office where he met his physician. It is what is known as a facility fee, which included overhead for the system’s hospitals though Ebel hadn’t set foot in one. (PAYWALL)
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U.K. Becomes the First Country to Release Details on Sponsors that Fail to Register Clinical Trials
The United Kingdom has released comprehensive data showing which institutions have failed to register their clinical trials, a move that was hailed by transparency advocates who say this marks the first time that a country has taken such a step.
#Device, #Drug
Amgen Sues over CO PDAB
Amgen has filed a lawsuit accusing a Colorado state board of violating the U.S. Constitution over a plan to pursue a first-in-the-nation move to cap the cost of a pricey prescription medicine.
#Drug, #Patient
AAMC Unveils Latest Report Estimating Physician Workforce Shortage
According to the latest analysis from the Association of American Medical Colleges, Physician demand is projected to continue to grow faster than supply under the most likely scenarios, leading to a total projected shortage of between 13,500 and 86,000 physicians by 2036.
#Provider
