HealthCare Roundtable e-News – December 4, 2023

Register Now – Upcoming Webinar

How Public Sector Health Care Purchasers Are Addressing Rising Drug Costs

The National Institute for Public Employee Health Care Policy is releasing its first white paper on Tuesday, December 12th, 2023. The paper focuses on the strategies employed by public sector purchasers to address the rising costs of drugs and their relationships with pharmacy benefit managers.

Join the Institute on Tuesday, December 12, 2023, at 3:00 pm ET for a webinar discussing the new research.

Register here to attend.

Top News

FDA Rules on Exclusivity for Interchangeable Drugs, Emphasizing Timely Market Entry and Competition

The FDA’s biosimilars office, in an internal memorandum, declared that exclusivity periods for the first interchangeable drug in a class cannot be extended solely based on the manufacturer’s decision not to bring the drug to market. This decision, outlined in the memo sent from Mustafa Ünlü, Director of the Office of Therapeutic Biologics and Biosimilars (OTBB), Policy Staff, to Nikolay Nikolov, Acting Office Director of the Office of Immunology and Inflammation, on Sept. 29, overturns a previous Purple Book entry and provides insight into the FDA’s approach to the issue in upcoming guidance. The FDA’s interpretation aims to promote public health by encouraging timely submissions of biosimilarity or interchangeability applications, fostering competition, and ensuring access for patients while maintaining a reasonable incentive for applicants to pursue interchangeable status after biosimilar approval. The memorandum specifically discusses the application of the Public Health Service Act (PHS Act) concerning exclusivity periods for interchangeable products and addresses concerns related to potential market manipulation. While the FDA is planning to release official guidance on interchangeable exclusivity periods, the memo provides a preview of how the FDA is likely to handle the matter.


Survey Reveals Employers Are Acting to Support the Growing Demand for Mental Health Services

A recent survey fielded by Mercer reveals that American employers are taking action to improve the health and wellness of their employees. Survey results indicate that 94% of large employers (500 or more employees) reported that they have strengthened their coverage for mental health care, increased support, or put in place new programs or systems to help in the last three years. 72% of large companies surveyed reported that they have added virtual behavioral healthcare networks or telehealth options for their workers, 68% reported adding or enhancing supports like employee assistance programs, classes, or access to apps to help promote mental health, and 28% have expanded mental health coverage within their existing health plans. Regarding obstacles to facilitating access to mental health services, 65% of respondents cited the mental health professional shortage as a key challenge. Amidst efforts to address the ongoing mental health challenges facing the Nation, these findings indicate the crucial role employers can play in improving the health and wellbeing of their employees.


CY 2025 Medicare Advantage and Part D Proposed Rule Summary Now Available

The Centers for Medicare and Medicaid Services (CMS) released their annual Medicare Advantage (MA) and Part D Proposed Rule for 2025 (fact sheet) which governs requirements for MA and Part D plans. Among its provisions, the proposed rule promotes enrollment in aligned Dual Eligible Special Needs Plans (D-SNPs), includes additional flexibility in development of Part D formularies, requires additional outreach on supplemental benefits, institutes new network adequacy requirements for behavioral health providers, institutes new guardrails for agents and brokers, requires an annual health equity analysis of Utilization Management policies, and revises certain appeals processes. Comments on the rule are due January 5, 2024.  Healthsperien has developed a comprehensive section-by-section summary of the proposed rule, which can be found here.

Administrative Action

The Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG) recently released a data brief on the risk of misuse and diversion of buprenorphine for opioid use disorder in Medicare Part D using data from 2022. The OIG conducted this review to assess access to buprenorphine as it is a critical factor in treating individuals with opioid use disorder. Buprenorphine is the most common medication used to treat opioid use disorder and has been shown to decrease illicit opioid use and opioid-related overdose deaths. However, concerns over the potential misuse of the medication have led to the restriction of access to the lifesaving drug. The findings of the OIG 2022 review resembled the results of the 2021 data brief, which showed that almost all (97%) of Medicare Part D enrollees who received buprenorphine for opioid use disorder were given the correct amounts. Through their findings, OIG has concluded that the risk of misuse and diversion of buprenorphine continues to be low. OIG is encouraging the Centers for Medicare & Medicaid (CMS) and HHS to continue to take steps to improve access to the drug, while ensuring that the risks of misuse are minimized.

Executive Action

President Biden has announced approximately 30 new actions aimed at strengthening supply chains critical to America’s economic and national security. By strengthening these supply chains, the President hopes to reduce costs for families and ensure that Americans have access to essential goods. The newly established Council on Supply Chain Resilience, which is tasked with implementing a government-wide strategy to build enduring supply chain resilience, will include the Secretary of Health and Human Services (HHS). Notably, the authorities of HHS under Title III of the Defense Production Act will be expanded with the goal of increasing the manufacturing of essential medicines and medical countermeasures, to mitigate drug shortages. The Administration for Strategic Preparedness and Response (ASPR) will oversee these expanded authorities. In anticipation of future pandemics, biological threats, and other public health emergencies, HHS has identified $35 million for investments in domestic production of key starting materials for sterile injectable medicines. Furthermore, HHS will designate a new Supply Chain Resilience and Shortage Coordinator, tasked with reinforcing the resilience of medical product supply chains. Additionally, the Administration will continue its collaboration with allies and partners, including the World Health Organization, to strengthen global supply chains and enhance international early warning systems for detecting and responding to supply chain disruptions.

Congressional Action

The House Energy and Commerce Subcommittee on Health discussed the role of AI in technology innovation in the health care industry, hearing from the following panel of five leaders in AI health care. The hearing discussed the great potentials that artificial intelligence can have on the health industry, detailing the already occurring reduction in administrative burden for health professionals and advancements in medical screenings and imaging. Subcommittee members voiced their concern about privacy risks with medical data being released to train generative AI and the need for regulation supporting safeguards on artificial intelligence in the medical sector. The hearing also discussed the differences between different forms of AI development and what current practices AI is part of in hospitals, clinics, and other medical facilities.


Kaiser Family Foundation (KFF) released a brief that provides an overview of the findings from their Survey of Consumer Experiences with Health Insurance, describes Medicaid enrollees’ views of their health and health coverage, explores prevalent problems, compares Medicaid performance relative to Medicare and private coverage, and reviews variation in Medicaid experiences. Of the key takeaways, it was found that the large majority (83%) of Medicaid enrollees rate the overall performance of Medicaid positively despite reports of worse health status compared to those with other coverage. In addition, over half of Medicaid enrollees report having experienced a problem in the past year, and relative to Medicare and employer-sponsored insurance (ESI), Medicaid enrollees are more likely to report certain negative outcomes from insurance problems. However, Medicaid enrollees reported fewer cost-related problems relative to those with Marketplace coverage and ESI and more challenges with prior authorization and provider availability. Overall, most adults rate their insurance coverage favorably but the complex nature of health care and differences in insurance design and out-of-pocket costs lead to variations in beneficiary experiences. Proposed federal rules aimed at addressing some of these challenges such as streamlining prior authorization processes and impact wait times are discussed but have not been approved.

Healthcare Roundtable 2023 Corporate Sponsors