House Leaders Send Letter to CBO on IRA Drug Development and Limitations
House Budget Committee Chair Jodey Arrington and Budget Committee Health Care Task Force Chair Michael Burgess authored a letter (press release) to Director Phillip Swagel of the Congressional Budget Office (CBO) regarding their analysis of the impact of the Inflation Reduction Act (IRA) on drug development in the United States. The letter outlined concerns stemming from the impact of the IRA on the lack of new, innovative drugs entering the US marketplace. They referenced a previous CBO analysis that found that over the course of the next 30 years, 13 fewer drugs will come to market due in large part to the IRA. Members of Congress are seeking answers to several questions relating to CBO’s overview of the impact of the IRA on the drug market. Some of the questions included in the letter were:
- Is CBO tracking trends in investment in early-stage drug development by venture capital firms following the passage of the IRA?
- Are there additional updates or changes CBO is currently considering to the drug development model?
- Is CBO willing to work to expand the drug development model to forecast the impact of related policies on the total number of post-approval indications garnered by drugs that do come to market?
- Does CBO intend to incorporate the likelihood of firms moving away from small molecule indications?
- Has CBO shifted their assessment of the IRA’s impact as a result of actions taken by the Centers for Medicare and Medicaid Services (CMS)?
- Will CBO issue a blog post that asks for independent feedback on new research and data to help inform potential refinements to the drug development market?
The Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) announced an extension of timelines for the Federal Independent Dispute Resolution (IDR) process. Specifically, the Departments are announcing/authorizing:
- Disputing parties may request from a certified IDR entity additional time, beyond the current five business day deadline, to respond to the certified IDR entity’s requests for additional information. The Departments are instructing certified IDR entities to grant such requests through January 16, 2024.
- Certified IDR entities to provide parties, upon request, an additional 10 business days after the original offer deadline to submit an offer. Certified IDR entities may provide this extension so long as they have established an internal process to ensure that they are handling such requests consistently across parties. Certified IDR entities may provide parties this additional time, as needed, through January 16, 2024.
The Centers for Medicare & Medicaid Services (CMS) released their Marketplace 2024 Open Enrollment Period (OEP) report which provides a detailed breakdown of plan selections by state, distinguishing between new and returning consumers, and includes cumulative data for HealthCare.gov and State-based Marketplaces (SBMs). The report reveals that nearly 4.6 million Americans have signed up for 2024 individual market health insurance coverage through the Marketplaces since the OEP began on November 1, 2023. This includes 4.1 million plan selections in the 32 states using the HealthCare.gov platform for the 2024 plan year, through November 18, 2023 (Week 3), and 502,000 plan selections in the 17 states and the District of Columbia with State-based Marketplaces (SBMs) that are using their own eligibility and enrollment platforms, through November 11, 2023 (Week 2). Total nationwide plan selections include 920,000 consumers (20% of total) who are new to the Marketplaces for 2024, and 3.7 million consumers (80% of total) who have active 2023 coverage and returned to their respective Marketplaces to renew or select a new plan for 2024.
- Health Affairs published an article titled “Paving The Way For Prevention Over The Counter.” The article discusses how the Departments of Health and Human Services, Labor, and the Treasury issued a Request for Information (RFI) aimed at garnering input on enhanced coverage and access to over-the-counter (OTC) preventive services. Currently, insurance companies are not required to cover OTC products unless prescribed by a health care provider. The authors argue that there would be significant benefits in requiring insurance plans to cover OTC preventive interventions without a prescription. They believe this change would improve the uptake of those preventive interventions and thereby improve health outcomes and decrease health care costs. The article highlights that the RFI is focusing on the importance of OTC preventive interventions, particularly OTC contraceptive products. They believe that the inclusion of OTC preventive medicines under Section 2713 will play a crucial role in family planning and women’s health. Access to contraceptives also improves women’s health and economic outcomes by reducing maternal mortality.
- A recent article published by Health Affairs detailed the financial barriers that many Americans face. From high out-of-pocket spending on insurance premiums and medical care to medical debt and delays in care due to reasons involving cost, many face complications in finding financial freedom for their health care. This article analyzes these three financial situations and finds that 27% of non-senior adults lived in families with at least one of the three mentioned financial problems. The research in this article also notes that 45.4% of study participants were facing health-related financial burdens when asked to describe their situations more broadly. Study participants were noted to be more impacted across sociodemographic characteristic, family health care needs, insurance coverage, and financial capital. The article also notes that respondents felt a need for urgency in health care financing reform across the nation. Health Affairs analyzed data from the Medical Expenditure Panel Survey (MEPS), which is a nationally representative survey of the United States civilian noninstitutionalized population conducted annually by the Agency for Healthcare Research and Quality. Health Affairs used data from 2018 and 2019, consisting of 22,644 observations regarding people ages 19-64 living in families with no members who are 65 and older.