Weekly Spotlight

DC types are holding their collective breath to see if a) Speaker Johnson can get any combination of aid for Ukraine, aid for Israel, and a TikTok ban passed and b) if those efforts will cost him his job as House Republicans, eager to make a statement about government spending, are poised to oust yet another Speaker for making spending deals. WaPo will have more news as it breaks.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Shift to Value-Based Care Model Is CMS’ Top Priority

According to CMS, all Medicare beneficiaries are expected to be treated through value-based care by 2030.

#All

More prior authorization rules may be coming: CMS’ Brooks-LaSure

CMS is evaluating whether it needs to take further steps to crack down on health insurance companies’ prior authorization requirements.

#All

CMS to Delay Implementation of Data Access Restrictions

As reported earlier (See “The Reals COST of CMS’s New Data Use Requirements Coming to Light”)- CMS announced plans to limit access to the CMS Research Identifiable File to those with access to the CMS Virtual Research Data Center. This Monday, CMS announced that it would delay implementation of these restrictions.

#All

Medicare-Negotiated Drugs May Not Get Favorable Coverage In Part D: Will CMS Intervene?

Insurance plans put on notice that CMS is concerned about restrictions on drugs with negotiated prices, but it’s not clear what the agency can or will do about it. Negotiated drugs must be covered in Part D, but plans are not prohibited from putting them on non-preferred formulary tiers or imposing prior authorization of step therapy restrictions. CMS has stated its concern that plans might be incentivized to disadvantage negotiated drugs and said it will watch for situations that create problems for beneficiaries. But experts are uncertain about how much CMS can or will do because plans and even the government have incentives to allow formulary decisions to continue to be driven by rebates. Those incentives may push Part D plans to continue giving preferential treatment to drugs with high list prices and big rebates.

#Drug, #Hospital, #Patient, #Payer, #Provider

CBO Evaluates Medicare Accountable Care Organizations: Past Performance and Future Directions

This Congressional Budget Office report summarizes recent research findings about Medicare accountable care organizations (ACOs) and the factors that have contributed to or limited their ability to achieve net budgetary savings for the Medicare program. ACOs are groups of providers,

such as physicians and hospitals, that assume responsibility for the quality and cost of care for an assigned group of patients.1 Providers participate in Medicare ACO programs voluntarily. CBO found the following: Certain types of ACOs are associated with greater savings, and some factors limit the savings from Medicare ACOs.

#Hospital, #Provider, #Payer

PrEP NCD Progress

The Centers for Medicare & Medicaid Services (CMS) released a Fact Sheet for the potential National Coverage Determination (NCD) for Preexposure Prophylaxis (PrEP) Using Antiretroviral Drugs to Prevent HIV. CMS is sharing this information to encourage pharmacies and other interested parties to prepare for a potential National Coverage Determination (NCD) for Preexposure Prophylaxis (PrEP) Using Antiretroviral Drugs to Prevent HIV. A link to the fact sheet is available from the tracking sheet at https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?NCAId=310

#Patient

Food and Drug Administration (FDA)

FDA officials say FY 2025 budget increase needed to offset inflationary pay increases

The FDA is asking for a nearly 5% increase in its budget for fiscal year 2025, in part to provide its staff with pay increases to offset recent inflation, according to Regulatory Focus. During a webinar hosted earlier this week by the Alliance for a Stronger FDA, FDA officials said the lack of additional inflationary pay increases in the current budget has had detrimental effects on its ability to fulfill its public health mission. Such pay increases would be accounted for in the agency’s $7.2 billion budget request to Congress for fiscal year 2025, which includes about $3.7 billion in appropriations and $3.5 billion in user fee dollars.

#Device, #Drug

Medical Device Sterilization Town Hall: Topics and Formats for the Continuing Sterilization Series

On April 29, 2024, the FDA will host the next in a series of medical device sterilization town halls to discuss: Suggestions the FDA received on potential topics for the sterilization town hall series and how the FDA will pivot the format of the series to support more engaging discussions on topics of interest.

#Device

FDA Releases Two Companion Reports on Medical Device Safety and Innovation

The FDA Center for Devices and Radiological Health Center (CDRH) is releasing two reports on medical device safety and innovation. The “CDRH 2024 Safety Report” and the “CDRH 2024 Innovation Report” provide summaries of CDRH’s accomplishments and look ahead to future initiatives.

#Device, #Hospital, #Patient, #Payer, #Provider

FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries

A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA’s most serious recall, the agency announced Monday. The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. The devices are not currently being removed from the market. In an emailed response, Abbott said it had communicated the risk to customers this year. Additional coverage

#Device, #Hospital, #Patient, #Provider

Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments

FDA is announcing the following public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” The topic to be discussed is the financial transparency and efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.

#Drug

FDA establishes CDER Center for Clinical Trial Innovation (C3TI)

FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally.

#Drug, #Hospital, #Patient, #Provider

Health and Human Services (HHS)

Behavioral Health Parity – Pervasive Disparities in Access to In-Network Care Continue

The Mental Health Parity and Addictions Equity Act (MHPAEA) of 2008 aimed to eliminate discriminatory health plan coverage that prevents individuals from receiving effective mental health and substance use disorder treatment. MHPAEA requires that health plans not design or apply financial requirements and treatment limitations that impose a greater burden on access (that is, are more restrictive) to in-network mental health and substance use disorder benefits than plans and issuers impose on access to comparable medical/surgical benefits.

In this study, Research Triangle Institute (RTI) used 2019–2021 information from one of the largest commercial insurance claims databases to evaluate a key measure of health plan benefits that indicates whether individuals can access in-network behavioral health treatment as readily as medical/surgical treatment: the rate of use of out-of-network behavioral health providers.

#All

The 340B Program Isn’t Going Anywhere, Lawmaker Tells Hospital Executives

Congress has no intention of getting rid of the 340B drug discount program for hospitals and other healthcare facilities, Rep. Morgan Griffith (R-Va.) told hospital executives Thursday.

“There is no one I’ve run into that wants to eliminate 340B,” Griffith said Monday at the American Hospital Association’s (AHA) annual membership meeting here. “What we’re trying to do is figure out how we can make sure it’s being used the way [it’s] supposed to be used.”

#Drug, #Hospital, #Patient

Hospital price transparency rules are seeding a new crop of health tech startups

Hospital and health insurance pricing data surfaced by new federal transparency rules are creating an opportunity for startups to help patients fight exorbitant medical bills.

#Hospital, #Patient, #Payer, #Provider

Notable Notes

GAO Issues Report on ‘Selected States’ Regulation of PBMs

Private health plans contract with pharmacy benefit managers (PBM) to administer their prescription drug benefits and help control costs. According to the GAO, each of the five states selected for review—Arkansas, California, Louisiana, Maine, and New York—enacted a variety of laws to regulate PBMs.

• Fiduciary or other “duty of care” requirements.
• Drug pricing and pharmacy reimbursement requirements.
• Transparency, including licensure and reporting requirements.
• Pharmacy network and access requirements.

#Drug

Let’s Fix Maintenance of Certification

About 20 years ago, the American Board of Medical Specialties (ABMS), a member-based organization, established Maintenance of Certification (MOC), a system that allows for periodic examination of specialty physicians’ knowledge and practice. MOC was meant to indicate to patients and hospitals whether a particular doctor has kept up with the latest medical advances in their specialized field. Medpage today shares an OpEd on the current state of MoC.

#Provider