CMS Issues Guidance on How to Handle Prescription Drug Prices that Increase Higher than Inflation
The 2022 Inflation Reduction Act (IRA), touted several times by President Biden in last week’s “State of the Union” address, requires prescription drug companies to pay rebates (penalties) to the federal government for raising prescription drug prices faster than the rate of inflation. The funds garnered from these “rebates” will supposedly be used to offset the cost Medicare beneficiaries pay for prescriptions. While there has been much speculation and confusion as to how Medicare will implement the program, CMS offered some insight to their initial thinking on February 9 when the agency released guidance on how it plans to the process to determine the number of drug units for “rebatable” drugs; reduction of rebate amounts for certain Part B and Part D rebatable drugs in shortage and in cases of severe supply chain disruptions; the process to impose civil monetary penalties on manufacturers of Part D rebatable drugs that fail to pay rebates; and assuring accuracy of the inflation rebate payments. The CMS announcement can be found here and the comment period will end on March 11.
COVID Public Health Emergency to End May 11; What Will Change?
On January 30, 2023, the Biden-Harris Administration announced its intent to end the national emergency and public health emergency (PHE) declarations related to the COVID-19 pandemic on May 11, 2023. Some things will change: Medicare will no longer cover at-home COVID tests and hospitals will lose their 20% reimbursement increase for treating patients with COVID. Some things will not: The end of the PHE does not impact the emergency use authorizations for COVID vaccines and therapeutics, and Congress made some of the initial telehealth flexibilities permanent. Yet, other issues remain unresolved. The Centers for Medicare & Medicaid Services has published updated resources to help prepare for the end of the PHE and a plethora of additional guidance is expected to come from HHS in the coming weeks leading up to the May 11 expiration.
Democrats and Republicans Press CMS to Loosen Limits on Alzheimer’s Treatment Coverage
A bipartisan group of 74 House lawmakers is urging CMS to reevaluate its decision to limit coverage for monoclonal antibodies used to treat Alzheimer’s disease to only patients who participate in clinical trials. The group of lawmakers, who represent both ends of the political spectrum, highlight the access barriers that CMS’ current coverage policy imposes on beneficiaries with Alzheimer’s disease, especially those living in rural areas of the country, saying the restrictions place physical and financial burdens on patients by requiring them to travel long distances to clinical trials. “This overdue CMS action will ensure Medicare beneficiaries living with MCI (mild cognitive impairment) due to Alzheimer’s disease and early-stage Alzheimer’s disease have immediate access to FDA-approved treatments if the patient and clinician decide it is right for them,” the lawmakers said in a Jan. 30 letter to HHS and CMS. CMS originally implemented the restrictions in response to Biogen’s Aduhelm® approval in 2022. The agency’s existing coverage policy can be accessed here. The letter was sent just after FDA granted accelerated approval to Biogen and Eisai’s Leqembi®, another monoclonal antibody medication used for the treatment of Alzheimer’s. CMS Administrator Chiquita Brooks-LaSure has indicated the agency is open to reconsidering the policy if new data emerges.
Virginia Physicians Push for Prescription Drug Affordability Board
Physicians in Virginia testified in support of legislation seeking to make Virginia the next state to form a Prescription Drug Affordability Board (PDAB). The boards, which currently exist in eight states, gather information on medicines with the highest cost to the state, seeking to impose an upper payment limit (the max a state health plan could pay for a medication) or recommending legislative action to address prescription drug pricing. The biopharmaceutical community and some patient advocates have expressed concern that the boards will negatively impact innovation by only focusing on cost as opposed to the value of medications to certain populations, especially those with few or no existing options. PDAB legislation is also being debated in Minnesota, New Mexico and New Jersey.
Who’s Driving Health Policy Discussions on Capitol Hill? Leaders Named to Congressional Committee Leadership
Republican Rep. Brett Guthrie (KY) will lead the House Energy & Commerce health subcommittee, respectively, Energy and Commerce Chair Cathy McMorris Rodgers (R-WA) announced January 25. Guthrie had been considered the likely choice to lead the powerful subcommittee. Other key Republican health policy voices will include Rep. Morgan Griffith (VA) who will spearhead any committee investigations as chair of the Oversight and Investigations subcommittee. Key health care Democrats in the House include longtime leaders Rep. Frank Pallone (NJ) and Anna Eshoo (CA). On the Senate side, Independent Sen. Bernie Sanders (VT) will lead the Health, Education, Labor & Pensions Committee. Other key Senate health policy voices will include Republican Sen. Bill Cassidy (LA), who is also a physician and Democratic Sen. Ron Wyden (WA), chair of the powerful Senate Finance Committee.
This monthly Health Policy Snapshot is the result of an ongoing partnership with Affinity Strategies and Gridiron Public Affairs. The blog’s host is Greg Chesmore, CEO of Gridiron, a public affairs firm committed to helping companies and organizations adopt holistic strategies to positively shape the public policy environment. To learn more about Gridiron Public Affairs visit www.gridirionpublicaffairs.com.