September 30, 2024 This Week in Health Policy for September 30 This Week (September 30 - October 4) The House and Senate are in recess until after the November 5 elections. Congress will return to a busy agenda with a looming December 20 deadline to avoid another federal shutdown, reauthorize the Farm bill, pass the National Defense Authorization Act and tackle any final policy items. Last Week (September 23 - September 27) Health Care Highlights Congress passes short-term funding bill. On Wednesday (September 26), the House and Senate passed a continuing resolution (HR 9747) to fund the federal government through December 20, with the House voting 341-82 and the Senate voting 78-18. The continuing resolution includes extensions for a few health items, including autism-related programs, FDA's authority for priority review of rare pediatric treatments, funding to implement the No Surprises Act, as well as a one-year delay to cuts to Medicare clinical laboratory test payments. Lawmakers will need to revisit the funding debate in December, after the November elections, when they will also be working to address the Farm bill reauthorization, the National Defense Authorization Act, Medicare telehealth extensions, and other expiring health care items. The outcome of the elections will play a key role in how motivated lawmakers are to pass broader health care reforms, such as pharmacy benefit manager reforms and price transparency. The House and Senate this week also took action on key health bills:
FTC takes action against deceptive AI claims. On Wednesday (September 25), the Federal Trade Commission (FTC) announced it has filed complaints against several companies for using AI "to supercharge deceptive or unfair conduct that harms consumers." The complaints, which are part of the FTC's new law enforcement sweep called Operation AI Comply, include Rite Aid, CRI Genetics, and others. CMS issues updated Medicaid/CHIP pediatric coverage guidance. On Thursday (September 26), the Centers for Medicare & Medicaid Services (CMS) issued updated guidance to help states ensure Medicaid and Children's Health Insurance Program coverage for children. The guidance clarifies Medicaid's Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) requirements, detailing the types of services — including preventive and treatment services, mental health services, dental, vision, and hearing services, transportation services, and more — that children covered by Medicaid and the Children's Health Insurance Program are eligible for and offers best practices to help states meet those coverage requirements. CMS issues grants to support health equity research. On Thursday (September 26), CMS' Office of Minority Health announced it has awarded a total of $1.4 million to six organizations to support health equity research capacities at minority-serving institutions. White House issues executive order on firearm safety. On Thursday (September 26), the White House issued a new executive order (EO) to combat emerging firearm threats and improve school-based active shooter drills. Among other things, the EO stated that by the end of October, CMS will issue guidance allowing state Medicaid programs to reimburse health care providers for counseling parents and caregivers on firearm safety and injury prevention, as well as for violence intervention programs. Harris outlines new economic and tax credit plans with implications for health. On Wednesday (September 25), Vice President Kamala Harris' unveiled a new economic plan, "A new Way Forward for the Middle Class" that includes policy proposals intended to lower health care costs for individuals, including expanding and making permanent the Affordable Care Act's enhanced subsidies, extending the Inflation Reduction Act's $35 insulin cap and $2,000 cap on out-of-pocket drug costs to the commercial market, accelerating Medicare drug price negotiations, and increasing competition and transparency in health care. The plan also calls for strengthening veterans' health care and addressing the opioid crisis. The Harris campaign also unveiled the "America Forward Tax Credits" plan that aims to target investment and job creation in key strategic industries, including health care. The plan, which the Harris campaign estimates would cast $100 billion paid for by international tax reform, discusses using tax credits to create registered apprenticeships in health care and other industries and reducing barriers to occupational licensing across state lines. The plan also discusses developing biotechnology that can help produce critical medicines and new sustainable materials, investing in Artificial Intelligence (AI) innovation and building new data centers. CMS issues final rule on ACO SAHS billing. On Tuesday (September 24), CMS issued a final rule that will carve out significant, anomalous, and highly suspect (SAHS) billing from Medicare Shared Savings Program calculations for calendar year 2023. The final rule holds ACOs harmless for SAHS catheter billing for 2023 and is part of a larger CMS strategy to address SAHS billing activity. The rule's changes will take effect on October 15. Click here for a fact sheet. Cassidy issues RFI amid 340B investigation. On Monday (September 23), Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) issued a request for information to Eli Lilly and Amgen as part of an ongoing investigation into the 340B Drug Pricing Program and ways covered entities may generate revenue from the program. Providers impacted by Change Healthcare get more time for MIPS reweighting requests. On Monday (September 23), CMS announced it has extended the deadline for providers to submit a request to reweight one or more 2023 payment year Merit-Based Incentive Payment System (MIPS) performance categories through October 11. CMS the hardship exception is for providers impacted by the Change Healthcare cyberattack. Hearings, Markups, and Other Committee Activity Senate Finance Committee held a hearing on "Chaos and Control: How Trump Criminalized Women's Health Care." On Tuesday (September 24), the Committee held a hearing during which lawmakers heard testimony from patients, OB-GYNs and legal experts on the ways in which the Supreme Court's decision to overturn Roe v. Wade and resulting state laws have impacted access to the full spectrum of reproductive health care. During the hearing, Democrats focused on the negative impacts of states abortion laws and the Supreme Court ruling, while Republicans criticized the hearing as partisan and highlighted ways in which state laws include exceptions for doctors to rely on medical judgement to determine when a woman's life is in imminent danger.
Senate HELP Committee held a hearing on "Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?" On Tuesday (September 24), the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing, "Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?" During the hearing, lawmakers heard testimony from Lars Fruergaard Jørgensen, the President and Chief Executive Officer of Novo Nordisk, who emphasized Novo Nordisk's commitment to diabetes and obesity research. During the hearing, Democratic members questioned Mr. Jørgensen on the price disparities for Ozempic and Wegovy between the US and other countries and several spoke critically about the role pharmacy benefit managers (PBMs) play in list prices. Republican members, meanwhile, spoke about the need to preserve pharmaceutical innovation, while also ensuring affordable costs for patients. Some Republicans, including Ranking Member Bill Cassidy (R-LA) and Sen. Mike Braun (R-IN) criticized the lack of transparency between US prices and those in other countries and spoke critically of the current system in which the US pays for innovation that benefits other nations.
Senate HELP Employment & Workplace Safety Subcommittee held a hearing on "Reading the Room: Preparing Workers for AI." On Wednesday (September 25), the Subcommittee held a hearing on AI during which they heard testimony from AI experts including those in the health industry. During the hearing, lawmakers and witnesses discussed both the potential benefits and risks of greater AI use, highlighting the need for appropriate oversight. Sen. Ed Markey (D-MA) discussed his AI Civil Rights Act that would add new testing requirements to prevent bias in algorithms.
Senate Committee on Homeland Security & Governmental Affairs held a markup of bills. On Wednesday (September 25), the Committee advanced several bills, including the S. 131, Improving Access to Workers' Compensation for Injured Federal Workers Act of 2023, which would enable physician associates (PAs) and nurse practitioners (NPs) to offer services to injured federal workers.
Reports, Studies, and Journals Washington Council EY: Prospects for budget reconciliation in 2025. The report highlights the congressional reconciliation process and ways in which Congress and the White House have used the legislative process to advance party priorities. Department of Treasury: Affordable Care Act Marketplace Coverage for the Self-Employed and Small Business Owners. According to the report a total of 3.3 million small business owners and self-employed workers ages 21-64 were covered by Affordable Care Act Marketplace coverage in 2022, representing 28% of all marketplace enrollees in this age range. HHS Office of Inspector General: Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Humana Health Plan, Inc. (Contract H2649) Submitted to CMS. The report suggests CMS overpaid Humana and recommends the insurer refund CMS an estimated $6.8 million in overpayments. Humana disagreed with some of the findings and all of the recommendations. HHS Office of Inspector General: Medicare Advantage Compliance Audit of Specific Diagnosis Codes That HealthAssurance, Pennsylvania, Inc. (Contract R5826) Submitted to CMS. The report suggests CMS overpaid HealthAssurance, a subsidiary of CVS Health, and recommends the insurer refund CMS an estimated $4.2 million in overpayments. HealthAssurance, through CVS Health, disagreed with some of the findings and the recommendations.
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