HHS Posts Timeline for Drug Negotiations, FDA Approves Alzheimer’s Drug

January 17, 2023 - In this week’s policy roundup, the Department of Health and Human Services (HHS) released its detailed timeline for drug pricing negotiations that will begin next year. Meanwhile, the FDA granted Eisai and Biogen accelerated approval for their drug Leqembi, which was shown to reduce amyloid plaques in Alzheimer’s patients.

HC3 Issues Ransomware Warning

The Health Sector Cybersecurity Coordination Center (HC3) issued a new warning on January 12, highlighting the tactics used by Royal and Blackcat ransomware. Both ransomware groups are financially motivated and known to target the healthcare sector. The HC3 brief recommended that organizations implement recovery plans, network segmentation, and multi-factor authentication to avoid being affected by ransomware groups like Blackcat and Royal. READ MORE.

FDA Accelerated Approval for Alzheimer’s Drug

Last week, FDA officials announced that the Alzheimer’s treatment Leqembi had been approved under the Accelerated Approval Pathway. The treatment, created by Biogen Inc. and Tokyo-based Eisai, demonstrated reduced accumulation of amyloid plaque in the brain in a Phase 2 clinical trial. Patients in the mild cognitive impairment or mild dementia stages of Alzheimer’s disease can now be prescribed Leqembi, with broader approval contingent upon the verification of clinical benefits. READ MORE.

Federal Court Sides With HHS on 340B Repayment

The US District Court for the District of Columbia decided this month that HHS would have the power to determine how to repay hospitals after years of 340B underpayments. After the Supreme Court ruled unanimously in June that the cuts were illegal, hospital groups rejoiced, expecting rectifying payments numbering in the billions of dollars. But the process may be less favorable after US District Judge Rudolph Contreras decided that HHS would be in charge of issuing the repayments instead of the courts. READ MORE.

HHS Posts Timeline for Price Negotiations

HHS has announced that it would begin drug price negotiations next year per the Inflation Reduction Act. According to the schedule detailed by HHS, the Centers for Medicare and Medicaid Services (CMS) will launch the 13-step process by publishing a proposed data collection process and requirements for the negotiation program in the winter of 2023.

“Under President Biden’s leadership, we will begin the process of negotiating lower prescription drug prices for millions of seniors and people with disabilities across the country,” HHS Secretary Xavier Becerra said about the potential of the plan. READ MORE.

CMS Funds Medical Residency Slots

CMS awarded its first graduate medical education residencies in an effort to increase care access and advance health equity. The 200 medical residency slots awarded this month will predominantly focus on primary care, mental health, and reproductive care.

“These graduate medical education residency slot awards will help address access to care challenges and workforce shortages in the highest need areas,” CMS Administrator Chiquita Brooks-LaSure said in the announcement. “The majority of the positions are for primary care and mental health specialists, who are the foundation of our health care system.” READ MORE.