Weekly Spotlight

The long-awaited final appropriations deal for FY2024 has finally passed the House of Representatives, squeaking by with a 7 vote margin and sending the bill to the Senate with only hours to spare before the current funding bill expires. While most in DC are busying themselves sifting through the winners, the losers, and the in-betweens (the ones who didn’t get what they asked for but didn’t get buried either, meaning they didn’t win and can’t complain), the Senate is ramping up for an evening of drama. It only takes one member of the Senate to stall the final vote and it appears the Rand Paul, R-KY) is ready for his closeup once again. Citing his continued disdain for what he deems to be out-of-control spending, Paul says he will delay passage, shutting down the government for the weekend, at least.

At the same time, House Republicans are deciding what to do with yet another Republican Speaker of the House who chose compromise with Democrats, skirting a few House rules along the way, over a potential shut down. Rep. Marjory Taylor Green (R-GA) has already filed a motion to remove Speaker Mike Johnson (R-LA) from his post.

One highlight from Health and Human Services Appropriations report language that may be of interest to those familiar with Medicare coverage policy and the controversy over coverage monoclonal antibody treatments is a statement from Congress expressing their “disappointment” with CMS coverage decisions related to treatments for Alzheimer’s Disease. The statement reads:

The agreement notes disappointment with CMS’ decision to limit coverage of FDA-approved monoclonal antibodies for the treatment of Alzheimer’s disease. The agreement urges CMS to reconsider the National Coverage Determination policy to provide full access for Medicare beneficiaries to these FDA-approved Alzheimer’s treatments.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

MedPAC / MACPAC Publish March Reports to Congress

The 15-chapter MedPAC report includes

• a chapter that provides a broad context for the report, including the near-term consequences of the coronavirus pandemic and the longer-term effects of Medicare spending on the federal budget and the program’s financial sustainability;
• a chapter that describes the Commission’s analytic framework for assessing payment adequacy;
• seven chapters that describe the Commission’s recommendations on fee-for-service (FFS) Medicare payment rate updates and related issues to ensure that beneficiaries have access to high-quality care and the program achieves good value for taxpayers and beneficiaries;
• a chapter that describes FFS Medicare beneficiaries’ access to care in ambulatory surgical centers;
• a chapter that updates the trends in enrollment and offerings for plans that provide prescription drug coverage under Part D;
• a chapter that describes recent trends in enrollment, plan offerings, and payments to Medicare Advantage (MA) plans and discusses related issues such as coding intensity, favorable selection, and market concentration;
• a chapter that describes our methods for estimating coding intensity and favorable selection in the MA program; and
• two chapters containing the congressionally mandated reports on special needs plans for beneficiaries dually eligible for Medicare and Medicaid and the new REH provider designation.

MACPAC’s March 2024 Report to Congress on Medicaid and CHIP contains three chapters: (1) improving the Medicaid beneficiary experience through Medical Care Advisory Committees (MCACs), (2) increasing the transparency and improving the monitoring of the denials and appeals process in Medicaid managed care, and (3) the commission’s review of hospital payment policy for the nation’s safety-net hospitals.

#ALL

CMS Announces New Initiative to Increase Investments in Person-Centered Primary Care

CMS announced a new alternative payment model this week.The ACO Primary Care Flex Model (ACO PC Flex Model) is a voluntary model that will focus on primary care delivery in the Medicare Shared Savings Program (Shared Savings Program). It will test how prospective payments and increased funding for primary care in Accountable Care Organizations (ACOs) impact health outcomes, quality, and costs of care. The model, which starts January 1, 2025, aims to grow participation in ACOs and the Shared Savings Program and increase the number of people with Medicare in an accountable care relationship.

#PATIENT, #PROVIDER

Drugmakers give surprising response to Medicare drug price offers

Are pharmaceutical executives playing coy for their investors or are their surprisingly optimistic reactions to initial offers from Medicare in drug price negotiations a sign of a thaw? The Hill questions whether the proposed price reductions could be relatively modest.

#DRUG, #PATIENT

Leavitt Partners Floats Compromise on Site Neutral Pay

Leavitt Partners released a new policy framework that proposes a compromise path forward on implementing site-neutral payments. The compromise framework would lower out-of-pocket costs for Medicare beneficiaries, improve the financing of the Medicare program, and reinvest in hospitals through new targeted funding and inclusion of policy priorities. Many of these policies are long-standing advocacy priorities for hospitals, including targeted funding to rural hospitals and safety net hospitals, increasing inpatient reimbursement, permanently expanding telehealth flexibilities, and expanding Medicare-funded graduate medical education slots.

#ALL

Food and Drug Administration (FDA)

FDA Specifies How it Will Tackle AI

FDA released a report titled, “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines how FDA’s medical product centers are working to protect public health while fostering responsible innovation in artificial intelligence (AI) used in medical products and their development.

#ALL

FDA Publishes Guidance on Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products

FDA announced the availability of a draft guidance for industry entitled “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which discusses attributes regarding the design and analysis of a non-interventional study that sponsors should consider when proposing such a study to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of safety of a product. Examples of non-interventional study designs for evaluating the effectiveness and/or safety of a drug include, but are not limited to, cohort studies, case-control studies, and self-controlled studies.

#Drug, #Patient, #Provider

FDA Seeks Input On New Section In Medical Device Cybersecurity Guidance

FDA is asking for feedback on a proposal to add a new section to its 2023 final guidance on premarket cybersecurity that would give the agency the authority to refuse medical device submissions that lack cybersecurity information.

#Device

Strategies to Increase Clinical Trial Participation for Diverse Communities, A Panel Discussion with the OMHHE REACH Consortium

This National Minority Health Month, the FDA Office of Minority Health and Health Equity (OMHHE) are hosting a virtual event at 11:00 a.m. ET, on April 17, 2024, to discuss Strategies to Increase Clinical Trial Participation for Diverse Communities. The discussion will feature a keynote address from Principal Deputy Commissioner of FDA, Dr. Namandjé N. Bumpus. Sign up here to receive more information.

#ALL

Abiomed Recalls the Instructions for Use for Impella Left Sided Blood Pumps due to Perforation Risks

Abiomed is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart. During operations, the Impella device could cut through the wall of the left ventricle. The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death. There have been 129 reported serious injuries, including 49 reports of death. See also, additional coverage from Stat.

FDA Updates Breakthrough Devices Program Designations Data and Marketing Authorizations List

FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list. From launch of the Breakthrough Devices Program through December 31, 2023, in total, the FDA:

• granted 933 Breakthrough Devices designations, and
• authorized 95 Breakthrough Devices for marketing

The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to certain medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Through the program, manufacturers can interact with the FDA’s experts to receive feedback on device development, receive help navigating the path to the FDA’s marketing authorization, and obtain prioritized review on regulatory submissions.

#Device

Hill Happenings

Burgess and DeGette Seek 30 Year Savings Window for CBO Scores

The House passed a bill from Reps. Michael Burgess (R-Texas) and Diana DeGette (D-Colo.) by voice vote Tuesday night that would require the CBO to weigh whether a bill would save money over a 30-year budget window instead of 10, if Congress requests it. The nonpartisan CBO’s cost estimates can be crucial factors in whether a bill is signed into law.

#ALL

Notable Notes

Are Rural Emergency Hospitals a Solution or a Symptom?

A new kind of hospital is coming to rural America. To qualify, facilities must close their beds. The government, which classifies hospitals by type, rolled out the rural emergency option in January 2023. Only 19 hospitals across the U.S. received rural emergency hospital status last year, according to the University of North Carolina’s Sheps Center for Health Services Research. The majority are in the South, with some in the Midwest, and hospitals in Nebraska and Florida recently started to explore the option. As rural hospitals continue to struggle financially, a new type of hospital is slowly taking root, especially in the Southeast.

Rural emergency hospitals receive more than $3 million in federal funding a year and higher Medicare reimbursements in exchange for closing all inpatient beds and providing 24/7 emergency care. While that makes it easier for a hospital to keep its doors open, experts say it doesn’t solve all of the challenges facing rural health care.

#ALL

Pharma companies and their allies seek to exempt orphan drugs from state pricing limits

Stat reports, as more states create dedicated boards to cap the costs of medicines, some drugmakers and their allies are pushing back with a controversial tactic — lobbying for legislation to set exemptions for so-called orphan drugs, which are used to combat rare diseases that afflict relatively small groups of patients. The efforts, which are being joined by some lawmakers, reflect concerns that patients may lose access to these medicines if pharmaceutical companies halt sales or decide not to invest in developing such drugs. But opponents argue blanket exceptions would unnecessarily extend to numerous big-selling treatments for common conditions that — thanks to regulatory endorsements — also happen to have an orphan designation.

#Drug, #Patient, #Payer, #Provider