GOP to Increase Oversight on Medicare Drug Price Negotiations if Republicans Flip the House
If the House of Representatives flips to GOP control in the 118th Congress, Republican leadership plans (subscription required) to scrutinize implementation of the drug price controls in the Inflation Reduction Act. As of Friday afternoon, control of the House and Senate have yet to be called, but Republicans are favored to take back the House. Republicans on the House Energy & Commerce and Ways & Means Committees recently asked the Department of Health and Human Services (HHS) to provide monthly reports on what the Centers for Medicare & Medicaid Services (CMS) is doing to implement the Medicare drug price negotiations. Republican leaders on health-related committees may require agency heads to testify, too. According to lobbyists, the drug industry may try to get CMS to create price floors and exempt certain drug classes from negotiation. CBO expects the drug makers to raise launch prices to offset losses form price-inflation rebates and the Medicare price negotiation. However, Republicans are not expected to repeal the law.
PTO and FDA Announce Joint Listening Session on Drug Patent Collaboration Efforts
The Patent and Trademark Office (PTO) announced it will host a listening panel with the Food and Drug Administration (FDA) in January to discuss joint plans to combat drug patent abuse. Last year, President Joe Biden signed an executive order directing the two agencies to work together on curbing drug company patent practices that delay competition and increase prices. Last summer, the Senate Judiciary Committee passed bipartisan legislation to form a task force that coordinates efforts between the PTO and FDA. The agencies are requesting stakeholder comments to understand inform their implementation procedures. Specifically, they are looking to stakeholders to determine what publicly available FDA resources should be included when training PTO patent examiners, how PTO and FDA should reinforce their collaboration and information exchange, what policy considerations the agencies should explore regarding the method of use patents and associated FDA use codes, and the patenting of drug Risk Evaluation and Mitigation Strategies.
Top Republicans in line to chair important healthcare committees have stated (subscription required) that they intend to focus on how the Centers for Medicare and Medicaid Services (CMS) implements the drug pricing provisions included in the Inflation Reduction Act, but are not expected to attempt repealing the law. Control of the House has yet to be called, but Republicans may win the House by a small margin.
The Medicare Payment Advisory Commission (MedPAC) held its November public meeting to discuss a number of issues related to Medicare payment policy. The Commission discussed a range of topics, such as differences in quality measure results across Medicare populations, how to support Medicare safety-net hospitals, and standardizing Medicare Advantage plans’ non-Medicare supplemental benefits. Click here to access Healthsperien’s comprehensive summary.
- HHS released a proposed rule modifying standards for electronic retail pharmacy transactions and a subrogation standard under HIPAA, which currently outlines requirements for how state Medicaid agencies seek reimbursement for pharmacy claims from a corresponding health plan. The rule seeks to improve interoperability, improve patient care, and provide better data for drug utilization monitoring.
- The Medicaid and CHIP Advisory Commission (MACPAC) released a comment letter on a CMS proposed rule aiming to streamline Medicaid and CHIP eligibility, enrollment, and renewal processes. In their letter, MACPAC expresses broad support for the rule while also considering administrative burdens on states due to the impending redetermination process after the end of the COVID-19 Public Health Emergency (PHE).
- MACPAC released another letter outlining ways the agency could advance health equity and assess the effects of PHE waivers and flexibilities. Some of MACPAC’s recommendations included collecting race and ethnicity data as well as setting benchmarks for different populations, such as people of color and incarcerated individual, which would address existing data gaps and access issues among Medicaid beneficiaries.
The U.S. Supreme Court heard oral arguments in Health & Hospital Corporation of Marion County (HHC) v. Talevski, which raises the issue of whether Medicaid beneficiaries can seek recourse on state compliance with federal Medicaid rules, specifically the Federal Nursing Home Reform Act (FNHRA), which establishes minimum standards for nursing facilities to participate in Medicaid. If the Court decides individuals do not have the right to sue, the decision would overturn five decades of judicial precedent.
The CMS Innovation Center released a one-year report on the implementation of its refreshed strategic vision and objectives—originally announced in fall 2021. The one-year report outlines actions taken by CMS and CMMI to work toward better care for beneficiaries, through greater accountability for high-quality, person-centered care, more coordinated care, advancing health equity, increased access to care, and promoting transparency.
Cigna—through its subsidiary Evernorth Health Services—launched the Evernorth Vitality Index, billed as a “next generation” measure of patient health. The new measure uses eight elements of a patient’s health—physical, spiritual, emotional, environmental, social, occupational, financial, and intellectual—to better gauge a patient’s overall mental and physical health. Cigna plans to use this data to identify and address challenges to patient health to improve long-term health and well-being—including improved work and life engagement.