Controversial Alzheimer’s Drug Under CMS, FDA Watch; EO Looks to Prescription Drug Spending
CMS begins coverage determination for the controversial Alzheimer’s drug, Aduhelm, as the FDA investigates the drug’s approval process. And Biden’s latest executive order targets prescription drug spending.
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By - CMS announced it will begin coverage determination investigations for the controversial Alzheimer’s drug, Aduhelm, while the drug’s approval process is also being investigated by the FDA. Meanwhile, President Biden’s latest executive order calls into question prescription drug spending and healthcare consolidation.
CMS Funds Mobile Crisis Intervention for Medicaid Population
CMS announced $15 million in funding for community-based mobile crisis intervention services for the Medicaid population. The funding comes from the American Rescue Plan and aims to provide state Medicaid agencies the resources to develop crisis intervention programs. Resources can include screening and assessment, stabilization, de-escalation, and referral coordination for patients with mental health or substance use challenges. Applications are open through August 13. READ MORE
American Rescue Plan Funding Made Available to Rural Hospitals for COVID-19 Response
HHS and the Health Resources and Services Administration recently announced $398 million in American Rescue Plan funding for small, rural hospitals. The funding is allocated to COVID-19 testing and mitigation efforts at these small, 50-bed, critical access hospitals. In total, 1,540 hospitals will receive the aid. READ MORE
ONC Updates Interoperability Standards, Include Sexual Orientation, Gender Identity
HHS Office of the National Coordinator for Health Information Technology (ONC) updated the Core Data for Interoperability to include recommendations for standard capture of sexual orientation and gender identity. These additions aim to systemize how patient information is captured for the nationwide health information exchange. While the update does not require providers to capture this information or patients to share this information, it sets the stage for supportive and inclusive information exchanges. READ MORE
Executive Order Targets Prescription Drug Spending, Healthcare Consolidation
On July 9, President Biden released an executive order on promoting competition in the American economy. The order features two key targets to lower the cost of prescription drug spending: enforcement of antitrust laws to stop the delay of generic competition and authorizing Medicare to negotiate drug prices including imposing inflation caps. The order also calls hospital consolidation as a driving force behind increased healthcare spending and pushes for better regulation on mergers and acquisitions. READ MORE
Proposed Rule to Improve Diabetes Prevention Program, Physician Fee Schedule
CMS issued a proposed rule for calendar year 2022 to change the Medicare Diabetes Prevention Program. There are key features of the new rule:
- Waiving the provider enrollment Medicare application fee
- Shortening the service period to align with the CDC’s National Diabetes Prevention Program
- Increasing performance payments for beneficiary achievement of five percent weight loss
The goal of the changes is to make it easier for providers to participate in the program and for CMS to better evaluate the success of the model. READ MORE
CMS also proposed updates to the Medicare Physician Fee Schedule that establish a new conversion factor for physician Medicare reimbursement. The proposed rule would decrease the conversion factor to $33.58 starting January 1, 2022. The rule would also expand telehealth services and mental health visits in rural and vulnerable populations. READ MORE
CMS to Determine Coverage of Controversial Alzheimer’s Drug, FDA Investigates Approval Process
CMS announced it will open a national coverage determination (NCD) analysis for monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease, like the recently approved Aduhelm. The announcement comes about a month after the FDA’s approval of the Biogen drug that showed mixed outcomes in clinical trials. Throughout the NCD, CMS will determine national coverage for the drug and any similar therapies in the future. READ MORE
Meanwhile, the FDA recently opened an investigation into the approval process for Aduhelm after an unreported meeting in 2019 between a Biogen executive and the FDA’s lead reviewer for Alzheimer’s drugs. The meeting occurred shortly after Biogen stopped clinical trials of the drug, showing minimal effect on patient outcomes. READ MORE
