Weekly Spotlight

Although many have given up on reforming pharmacy benefit manager (PBM) practices this year, Senators Wyden and Crapo, Chair and Ranking member of the Senate Finance Committee, respectively, are said to be making one last push. In a letter to their own Finance Committee colleagues, the Committee leaders said they would continue to seek opportunities to have the Senate vote on reforms that have already been endorsed by the Committee. Perhaps the best, and only chance of doing that this year would be to have PBM reforms included in the final FY 2024 appropriations package that must be passed by March 22. However, partisan election politics continue to stand in the way of politicians passing any substantive policy changes that might impact voters’ pocketbooks and give one side a political victory.

Meanwhile, the Congressional Budget Office published estimates for the Protecting Patients Against PBM Abuses Act along with 21 other pieces of legislation passed by the House Committee on Energy and Commerce. The PBM bill, which aims to delink the compensation pharmacy benefit managers receive from drug makers from prescription drug list prices, would result in a $226 million decrease in the deficit over 10 years.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

More from CMS on Change Healthcare Cyberattack Plus HHS Opens an Investigation

CMS says it is continuing to monitor and assess the impact that the cyberattack on UnitedHealth Group’s subsidiary Change Healthcare has had on all provider and supplier types. CMS will also consider applications for accelerated payments for Medicare Part A providers Part B suppliers. AHIP has also published a statement on the HHS response as it pertains to prior authorizations in the Medicare Advantage (MA) program.

The Department of Health and Human Services Office for Civil Rights has also announced they will open an investigation into any HIPAA violations associated with this breach.

Meanwhile, Statnews reports that UnitedHealth is on a buying spree of outpatient surgery centers in geographic regions where it is the biggest MA payer.

#All

Food and Drug Administration (FDA)

EU parliament to extend new medicine data protection to 7.5 years, document says

European Union lawmakers proposed a compromise on exclusivity periods for new drugs in the biggest overhaul of pharmaceutical rules in 20 years, Reuters reports. The draft compromise would raise baseline data protection to 7.5 years with one extra year of incentives if a drug meets “unmet medical needs” and if studies are held in the EU. A company would also get three years of market protection from generics, raising exclusivity to 11.5 years, up from 10 years as proposed.

#Drug

Abbott Recalls HeartMate Touch Communication System for Unintentional Pump Start and Stop

FDA

Abbott is recalling their HeartMate Touch System (version 1.0.32) for risk of unexpected pump stop or start. Issues may occur if the HeartMate Touch System is disconnected from a patient’s HeartMate Controller while a “pump stop” command is running. When the HeartMate Touch is reconnected to the same or a new controller, depending on the status of the pump at connection the pump will either stop or start. If the pump was stopped at reconnection, the pump will restart. If the pump is running at reconnection, a pump stop will occur.  There are no alarms or indications that warn the user that the “pump stop” command is still in the command queue. The use of the affected system may cause serious adverse health consequences, including lightheadedness, sudden change in blood flow, loss of consciousness, and death. There have been 8 reported injuries and no reports of death.

#Device

FDA FY 2025 Legislative Proposals Include a Number of New Authorities

Along with budget recommendations (more below), FDA released legislative proposals for FY2025. The proposals include enhanced authorities related to supply chain resiliency for drugs, medical devices, and foods. For example, requirements for manufacturers to notify FDA when they will be unable to supply an increase in demand and to provide manufacturing amount and supplier information; supporting innovation and competition, such as amending certain exclusivity provisions for drugs to encourage meaningful innovation and timely competition; providing additional oversight tools, such as expanding authorities for information sharing with the states for requesting records or other information in advance of or in lieu of inspections to all FDA-regulated commodities, and for destruction of products which present a significant public health concern.

#All

FDA Publishes New Guidance on Early Alzheimer’s Disease: Developing Drugs for Treatment

FDA issued updated guidance Monday (March 11) on Alzheimer’s disease drug development that includes a new section emphasizing use of reduction in amyloid beta levels as a surrogate endpoint that’s predictive of clinical benefit, signaling its ongoing endorsement of amyloid reduction as a proxy for slowing disease progression as it prepares for an unexpected advisory meeting on Eli Lilly’s drug application that relies on that endpoint. But the guidance also cautions that acceptance of any surrogate endpoint hinges on various factors, and also stresses a need for post-market data collection and more research on the issue.

#Drug, #Patient, #Provider

Department of Health and Human Services (HHS)

HHS Budget

Full details on HHS budget recommendations (including FDA and CMS).

#All

Pharma loses a key battle over a state law concerning 340B pharmacies

A U.S. appeals court has upheld an Arkansas law that allows hospitals participating in the 340B drug discount program. As a result, other states can now be expected to pursue similar laws.

#Drug, #Hospital, #Patient

Notable Notes

MD PDAB to Set Upper Payment Limits 8 Medications

The Maryland Prescription Drug Affordability Board will meet this month to determine upper payment limits (UPLs) for eight medicines – including the Ozempic, Jardiance, and Trulicity, all treatments for diabetes as well as ADHD drug, Vyvanse, and Biktarvy for HIV. The board is chartered with setting UPLs to be paid for prescription drugs by state and local government agencies.

#Drug

EPA Publishes Long-Awaited EtO Final Rule

On March 14, 2024, EPA announced final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide Commercial Sterilizers. Since 2019, EPA has been gathering information about how to reduce people’s risk from exposure to ethylene oxide (EtO) while mitigating and managing any potential supply chain impacts. More coverage from Statnews.

These changes will be covered in a March 21 Medical Device Sterilization Town Hall

#Device