Weekly Spotlight

As we turn the calendar page over to June and summer begins in earnest, let’s pause to take stock of all we have to look forward to:

If the hearings, policy papers, requests for information, and discussion drafts of the past few weeks are to be believed, Congress is looking to squeeze out a last bit of work before the summer recess brings us to election season. Let’s just not tell the appropriators members of Congress from different parties are talking to one another. They’re still locked in a battle to the death and some of the more recent policy initiatives could prove fruitful, if not now, then in the new Congress.

Meanwhile, policy staff may be putting their IPPS comments to bed, but everyone knows that July 4^th weekend is just around the corner. While that may mean cookouts and cornhole for some, for regulatory staff, it means that the PFS is coming. Apparently, so are a hoard of zombie cicadas.

Here’s hoping CMS issues guidance on how to distinguish between these red-eyed, fungus-infected insects and your run of the mill policy geek just trying to get a day off in the summer.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Rising Concerns Over Future of Medicare and Social Security

According to a recent Gallup survey, 73 percent of U.S. adults under the age of 65 report that they are “worried” (41%) or “extremely worried” (32%) that Medicare will not be available when they are eligible to receive it. The increase in concern is sharpest among those aged 50 to 64 (up 13 points to 74%) and 40 to 49 (up nine points to 83%, the highest level of all age groups).

#Patient

Racial and Ethnic Disparities in Medicaid Disenrollment After the End of the COVID-19 Public Health Emergency

Since the continuous enrollment provision ended March 31, 2023, approximately 10 million people have lost Medicaid coverage as states began redetermining enrollees’ Medicaid eligibility.

#Patient, #Payer

Physicians take Medicare Advantage to task for rural patients’ care gaps

Commenters on a recent request for feedback said insurers will market aggressively even in areas where they don’t have any in-network providers. There were also complaints about prior authorizations and low payments and, disturbingly, reports of plans enrolling patients with dementia or other cognitive impairments without their knowledge or proper understanding.

#Patient, #Provider, #Hospital

SCAN wins Medicare Advantage star ratings lawsuit against CMS

SCAN Health Plan has prevailed in a widely watched federal lawsuit brought last year against the Centers for Medicare and Medicaid Services that alleged regulators did not appropriately calculate the insurer’s Medicare Advantage star rating. The federal government inappropriately lowered the 2024 Medicare Advantage star ratings of SCAN Health Plan, which led to the health insurance company in California losing hundreds of millions of dollars in bonuses from the government, a judge ruled Monday. The decision will lead to more than $250 million funneling back into SCAN, which covers 270,000 Medicare Advantage enrollees. And it opens the door for other Medicare Advantage plans to potentially recoup huge sums of taxpayer-funded bonuses — even though many independent experts believe the quality rating system is flawed and doesn’t appropriately gauge quality of care for older adults and people with disabilities.

#Payer, Patient

Food and Drug Administration (FDA)

Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority

This collection of information helps to implement provisions which set forth mandatory medical device recall authority provisions.

#Device

FDA Report on Drug Shortages CY 2023

FDA published its annual Report to Congress on Drug Shortages to Congress which finds that the number of shortages has increased over the past decade, most are lasting longer than ever before, and the problem is affecting medicines used to treat a wide range of maladies.

#Drug, #Patient, #Provider

Health and Human Services (HHS)

HHS Failing to Convert on GAO Recommendations

The Government Accountability Office said HHS has implemented just seven of 45 GAO recommendations it noted as priorities for the agency last May. In a letter released Tuesday, the GAO said HHS acted on recommendations to better prepare for emergencies and minimize dependence on foreign manufacturers for medical supplies, among others. But the watchdog said HHS still has a lot of work to do.

#All

Hill Happenings

Bucshon and DeGette Seek Input on New Legislation Building on Cures Act

Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) sent a letter to stakeholders Thursday (June 6) seeking input on how Congress should craft legislation building on the 21st Century Cures Act to bring next-generation medical treatments to market.

#All

House Energy & Commerce To Scrutinize CMMI At Hearing Next Week

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee on Health Chair Brett Guthrie (R-KY) announced a subcommittee hearing titled “Checking-In on CMMI: Assessing the Transition to Value-Based Care” on Thursday, June 13,

10:00 AM ET

#All

Patient Advocacy Groups Promote Generics as Solution to Drug Shortages

A large coalition of patient advocacy groups sent a letter encouraging Congress’ focus on mitigating the ongoing drug shortage crisis by addressing the systemic issues that contribute to the continuation of this issue.

#Drug, Patient

Notable Notes

Can Mitral Valve Innovators Dig Themselves Out of a Rut?

Speakers at “New York Valves” (formerly known as the TVT Conference) urged mitral valve technology developers to go back to the drawing board due to current-generation devices not meeting the needs of enough patients with mitral regurgitation (MR).

With lots of devices in development — including transseptal devices Sapien M3, HighLife Valve, Cephea, Intrepid, and AltaValve — transcatheter mitral valve replacement (TMVR) is in theory poised to help those ill suited for transcatheter edge-to-edge repair (TEER) and surgery. However, progress in TMVR continues to be hindered by slow trial enrollment. Every new TMVR device that comes out is met with some enthusiasm that is then dampened by higher-than-expected trial screen failures, lamented Gorav Ailawadi, MD, MBA, of the University of Michigan in Ann Arbor,

#Device

Brain-Protected TAVR Results in Fewer Real-World Disabling Strokes

Researchers demonstrated a small clinical benefit with the Sentinel cerebral embolic protection (CEP) device in transcatheter aortic valve replacement (TAVR) — and pointed to the patients more likely to benefit — on the basis of disabling strokes.

#Device, #Patient

Opinion: Angry at high drug prices? A letter in The Post is to blame (sort of).

According to this Opinion piece, in 2002, the Post published an Op-Ed arguing that the federal government should step in to lower high prescription drug prices using the Bayh-Dole Act, a 1980 law that created a mechanism known as “march-in rights” that allows the government to re-license drug patents to a generic manufacturer if the drug is not publicly available at a reasonable price.Not long after, The Post published a letter responding to that op-ed. It was written by the sponsors of the Bayh-Dole Act — then-former senators Birch Bayh of Indiana and Robert Dole of Kansas — and maintained that the law was not intended to be used in response to high drug prices.

WaPo                      

#Drug, #Patient

Which Specialty Gets the Most Behavior Complaints From Coworkers

Complaints of unprofessional behavior about a physician coworker were not uncommon in a 5-year retrospective cohort study, with surgeons most likely to be on the receiving end of those complaints.

#Provider