15 July 2024 This Week in Health Policy for July 15 FDA announces Cellular and Gene Therapies Interactive Site Tours Program. On Friday (July 12), the Food and Drug Administration (FDA) issued a notice detailing its plans for Cellular and Gene Therapies Interactive Site Tours Program, to enable Center for Biologics Evaluation and Research (CBER) regulatory project managers and/or reviewers to tour biotechnology manufacturing facilities developing cellular and gene therapy products. Senate passes bill to curb patent abuses. On Thursday (July 11), the Senate passed by unanimous consent the Affordable Prescriptions for Patients Act of 2023 (S. 150), which would place limits on the number of patents for certain biologics and prohibits so-called "product hopping" and authorizes the Federal Trade Commission (FTC) to take enforcement action against drug manufacturers who engage in the practice. House Republicans request details on rules impacted by Chevron. On Wednesday (July 10), House Republicans sent letters to federal agencies — including the Department of Health and Human Services (HHS), the Department of Veterans Affairs (VA), and the FTC — seeking information on rules that could be impacted by the Supreme Court's June 28 ruling overturning the Chevron doctrine. The letter asked agencies to provide a list of all pending judicial challenges to final rules, as well as non-challenged final rules and pending rulemaking since January 20, 2021, that could be impacted by the ruling. The lawmakers also want details on agency guidance and adjudications dating back to January 20, 2021. CMS issues CY 2025 OPPS/ASC proposed rule. On Wednesday (July 10), the Centers for Medicare & Medicaid Services (CMS) issued their Calendar Year (CY) 2025 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center (OPPS/ASC) Payment Systems Proposed Rule. The proposed rule would increase payments to hospital outpatient departments and ambulatory surgical centers by 2.6%. However, CMS notes in the rule that after accounting for all proposed changes in the rule facilities would see an increase of just 2.3%. The rule also includes new Conditions of Participation detailing baseline health and safety requirements for hospital and critical access hospital obstetrical services, shortened review timeframes for prior authorization requests, updates on remote services furnished by hospital staff to patients in their homes, new health equity quality reporting measures, and more. CMS is accepting comments on the proposed rule through September 9th. Click here for a Press release. Click here for a Fact sheet. Click here for a Proposed rule. CMS issues CY Medicare Physician Fee Schedule proposed rule. On Wednesday (July 10), CMS issued their CY 2025 Medicare Physician Fee Schedule (MPFS) Proposed Rule. The proposed rule would reduce the CY 2025 conversion factor by 2.8% compared with CY 2024 and overall proposed payment amounts under the PFS would be reduced, on average, by 2.93%. The rule includes several policies and coding and payment updates aimed at advancing the Biden administration's goals to improve health equity and access to behavioral health care, as well as provisions related to telehealth, implementing the Inflation Reduction Act's Inflation Rebate Programs, and more. CMS is accepting comments through September 9th. Click here for the Press Release. Click here for the fact sheet. Click here for the proposed rule. ONC issues public health interoperability proposed rule. On Wednesday (July 10), HHS' Office of the National Coordinator for Health Information Technology (ONC) issued a proposed rule that aims to improve interoperability and data sharing among patients, providers, payers, and public health agencies. The Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule would create two sets of certification criteria for health IT for public health and payers, require the adoption of US Core Data for Interoperability (USCDI) version 4 by January 1, 2028, implement a section of the Consolidated Appropriations Act, 2021, creating a new prescription benefit tool certification criterion, adjust certain information blocking exceptions, and more. CMS is accepting comments through September 9th. Click here for a fact sheet. CMS unveils Making Care Primary Model participants. On Wednesday (July 10), CMS announced 133 participants, representing 772 practices across eight states, that are taking part in the Making Care Primary Model. The model, which launched July 1 and runs through 2034, aims to improve care management and care coordination by enabling primary care clinicians to partner with health care specialists and other community-based resources. Joint Commission launches safety and wellness resource center for health care workers. On Wednesday (July 10), the Joint Commission launched a new resource for hospital and health care worker safety and wellness. The Workforce Safety and Well-Being Resource Center includes resources on workplace violence prevention, addressing burnout, and managing exposure to hazards. FTC publishes interim report on PBMs. On Tuesday (July 9), the FTC published an interim staff report looking into the role and business practices of pharmacy benefit managers (PBMs). The report found that PBMs operate in a highly concentrated market and hold "substantive influence over independent pharmacies." The report concluded, "PBMs wield enormous power over patients' ability to access and afford their prescription drugs, allowing PBMs to significantly influence what drugs are available and at what price." One commissioner published a dissenting statement criticizing the FTCs process for conducting the report. BIS to survey US API manufacturing capabilities. On Tuesday (July 9), the Commerce Department's Bureau of Industry and Security (BIS) announced plans to conduct a comprehensive assessment of the US active pharmaceutical ingredient industrial base to better understand limits on domestic manufacturing capabilities and support policymaking around securing the API supply chain. BIS said it will deploy the API Industrial Base Survey — which will include hundreds of U.S. API manufacturers, distributors, suppliers, and customers — in the winter of 2024. GOP publishes 2024 policy platform. On Monday (July 8), the Republican Party published its 2024 platform, outlining policy priorities ahead of the 2024 presidential election. The platform includes policy positions on a range of topics, including health care issues. Speaker Johnson renews focus on BIOSECURE. On Monday (July 8), House Speaker Mike Johnson (R-LA) told attendees at a Hudson Institute event that he plans to bring the BIOSECURE Act to the floor for a vote this fall. The bill was filed as an amendment to the National Defense Authorization Act ("NDAA"), but lawmakers are still exploring potential pathways forward. CMS unveils GUIDE model participants. On Monday (July 8), CMS announced the 390 organizations that are participating in the Guiding an Improved Dementia Experience (GUIDE) Model. The model, which launched July 1, is a voluntary nationwide model test that aims to support people with dementia and their unpaid caregivers. Biden administration publishes Spring regulatory agenda. On July 5, the Biden administration published the Spring 2024 edition of the "Unified Agenda of Regulatory and Deregulatory Actions," which details the regulations federal agencies plan to issue in the coming months and years. The list includes regulations implementing the No Surprises Act, the mental health parity final rule, rules related to interoperability and prior authorization for drugs, HIPAA and cybersecurity, and more. Click here for the HHS Unified Agenda. CMS publishes rule raising concerns on MSSP billing. On July 3, CMS published a proposed rule to address what they call "significant, anomalous, and highly suspect" billing activity within the Medicare Shared Savings Program. The rule aims to mitigate the impact of improper billing activity, including billing for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS), for CY 2023. Judge issues partial block on FTC's non-compete ban. On July 3, a federal judge granted a stay and preliminary injunction on the United States Federal Trade Commission's near-total ban on noncompete agreements. However, the judge declined to grant a nationwide injunction. CMS unveils AHEAD model participants. On July 2, CMS announced that Connecticut, Maryland, and Vermont will be the first states to participate in Advancing All-Payer Health Equity Approaches and Development (AHEAD) model. The population health-focused payment model aims to improve care management for patients with chronic disease and behavioral health conditions while controlling unnecessary spending. President signs Parkinson's bill into law. On July 2, President Biden signed into law the Dr. Emmanuel Bilirakis and Honorable Jennifer Wexton National Plan to End Parkinson's Act (HR 2365), which aims to accelerate research into Parkinson's disease. House Ways and Means Committee held a field hearing on "Access to Health Care in America: Unleashing Medical Innovation and Economic Prosperity." On Friday (July 12), the Committee held a field hearing at ARUP Laboratories in Salt Lake City, Utah, during which lawmakers and witnesses discussed ways to accelerate medical innovation and bring new treatments and services to patients. During the hearing, lawmakers discussed the breakthrough drug and medical device pathways, looming 2017 tax cuts expirations and the potential impact on medical innovation, including research and development activities, and more.
Senate Health, Education, Labor & Pensions Committee held a hearing on "What Can Congress Do to End the Medical Debt Crisis in America?" On Thursday (July 11), the Committee held a hearing during which members and witnesses discussed ways to reduce Americans' medical debt. While there was bipartisan support for addressing the burden of medical costs in the US, lawmakers remained divided on pathways forward. Some witnesses and Democratic members voiced support for universal coverage solutions and canceling existing medical debt, while others focused on policy solutions to address underlying factors, including the high cost of health care. Sen. Bill Cassidy (R-LA) and other lawmakers noted that hospitals are a root cause of medical debt and spoke about existing federal programs, including the 340B Drug Pricing Program, designed to offset hospitals' care costs.
Senate Committee on Aging held a hearing on "Health Care Transparency: Lowering Costs and Empowering Patients." On Thursday (July 11), the Committee held a hearing during which lawmakers and witnesses discussed ways to increase transparency across the health care system, including strengthening hospital price transparency rules. During the hearing, several lawmakers spoke favorably of the transparency provisions in the House-passed Lower Costs More Transparency Act and several Democrats discussed ways to build on the Inflation Reduction Act and extend out-of-pocket drug spending caps to the commercial market.
Senate Committee on Commerce, Science & Transportation held a hearing on "The Need to Protect Americans' Privacy and the AI Accelerant." On Thursday (July 11), the Committee held a hearing during which lawmakers heard from a panel of witnesses including policy and AI experts, an association representing small and medium-sized technology companies, and a software developer. While the hearing was not focused on health care issues, several lawmakers and witnesses raised concerns with health data privacy and discussed the use of AI in health care. During the hearing, several lawmakers expressed support for a national data privacy standard, but noted that any standard would need to account for small businesses.
Senate Appropriations Committee held a markup on "MilCon-VA, Agriculture-FDA, and Legislative Branch Appropriations Acts and Fiscal Year 2025 Subcommittee Allocations." On Thursday (July 11), the Committee unanimously advanced legislation to fund the FDA, Veterans Affairs, and other departments for FY 2025. The bill would allocate $6.87 billion in total funding for the FDA for FY 2025, including $3.54 billion in discretionary funding. The bill includes funding bumps related to food safety, antimicrobial research, federal nutrition assistance programs, and more.
House Appropriations Committee held a markup on "FY 2025 Labor, Health and Human Services, and Education, Transportation, Housing and Urban Development, and Agriculture, Rural Development, and Food and Drug Administration Bills and Revised Subcommittee Allocations." On Wednesday (July 10), the Committee voted 31-25 to advance legislation to fund HHS and voted 29-26 to advance legislation to fund FDA for FY 2025. The HHS funding bill allocates $107 billion in discretionary funds, which is 7% below the FY 2024 enacted level. The FDA bill allocates $6.75 billion in total funding, which is about 1% below the FY 2024 funding level.
House Veterans' Affairs Subcommittee on Disability Assistance and Memorial Affairs held a legislative hearing. On Wednesday (July 10), the Subcommittee discussed 18 bills intended to improve the delivery of benefits and services to veterans and their family members, including bills to ensure quality and efficiency in VA claims processing, streamlining documentation related to claims processing, and more.
Senate Health, Education, Labor & Pensions Subcommittee on Children and Families held a hearing on "Everyday Expenses and Everyday Americans: How High Costs Impact Children and Families." On Tuesday (July 9), the Subcommittee held a hearing during which members heard from a panel of witnesses representing consumers, small business owners, policy experts, and financial experts. During the hearing, lawmakers and witnesses discussed how rising health care costs are harming families and policies to limit incentives for consolidation, such as increased transparency and site-neutral payments. One witness also spoke about policies to ease the financial burden for consumers, such as extending the enhanced Affordable Care Act subsidies and proposals in the Inflation Reduction Act.
Senate Committee on Homeland Security and Governmental Affairs held a hearing on "Risky Research: Oversight of US Taxpayer Funded High-Risk Virus Research." On Thursday (July 11), the Committee held a hearing during which members and witnesses discussed ways to regulate high-risk government-funded virus research, with one witness calling for a ban on so-called gain-of-function research, as well as the potential origin on the virus that causes COVID-19. The witnesses included academics, legal experts, and Robert Redfield, who served as director of the Centers for Disease Control and Prevention when the COVID-19 pandemic began.
Congressional Budget Office: Budgetary Effects of Policies That Would Increase Hepatitis C Treatment. CBO concluded that health care cost savings that would result from increased hepatitis C treatment "would more than offset direct spending on the treatment and that additional outreach would be needed to increase testing and treatment rates. Government Accountability Office: Substance Misuse Treatment and Recovery: Federal Guidance Needs to Address Work Arrangements for Those Living in Residential Facilities. The report notes that some substance misuse recovery and treatment facilities require residents to have jobs and recommends that HHS develop guidance about the role work plays in treatment and recovery. Health Affairs: The Effect Of Next Generation Accountable Care Organizations On Medicare Expenditures. The study found that the Next Generation Accountable Care Organization (NGACO) model was associated with a $270 per beneficiary per year, or about $1.7 billion, decline in Medicare spending.
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