19 November 2024 This Week in Health Policy for November 18 House Appropriations Labor-HHS Subcommittee will hold a hearing on the National Institutes of Health
House Appropriations Military Construction, Veterans Affairs, and Related Agencies Subcommittee will hold an oversight hearing on Assessing the Veterans Health Administration FY 2025 Potential Shortfall
House Veterans' Affairs Technology Modernization Subcommittee to hold a hearing on "VA Cybersecurity: Protecting Veteran Data from Evolving Threats"
House Veterans' Affairs Health Oversight Subcommittee to hold a hearing on "Life After Limb Loss: Examining VA Amputee Prosthetics Care"
Congress returns for lame duck session. On (Tuesday) November 12, Congress returned from recess with items for consideration including FY 2025 government funding beyond December 20, farm bill provisions, disaster relief, and the National Defense Authorization Act (NDAA). Congress also is expected to address several health care expirations, including funding for community health centers, Medicare telehealth extensions, and Medicare physician fee schedule cuts set to take effect January 1, 2026. In a television appearance on Sunday (November 17), House Speaker Mike Johnson (R-LA) suggested he is open to another short-term funding extension, kicking the FY 2025 funding questions to the 119th Congress, when Republicans will control both the House and the Senate following the elections. During the week, House and Senate Republicans also elected next year's leadership teams, with House Speaker Johnson re-elected for 2025 and Sen. John Thune (R-SD) securing the role of Senate Majority Leader. House Democrats are scheduled to hold their leadership elections on November 19, and Senate Democrats have not yet announced a date for their leadership elections.
DEA extends telemedicine prescribing of certain controlled substances. On Friday (November 15), the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) issued a rule extending current telemedicine flexibilities for certain controlled substances through December 31, 2025. DEA said it needed more time to consider a permanent path forward for telemedicine prescribing of buprenorphine and other controlled substances. Drug manufacturers sue HHS over 340B rebate model. On Tuesday (November 12), Johnson & Johnson filed a lawsuit against HHS and the Health Resources and Services Administration (HRSA), alleging HRSA wrongfully blocked the drugmaker from adopting a rebate-style model for certain 340B drugs. On Thursday (November 14), Eli Lilly filed its own lawsuit challenging HRSA's rejections of its cash replenishment model. VA proposes to remove co-pays for telehealth. On Monday (November 11), the Department of Veterans Affairs issued a proposed rule to remove co-pays for veterans' telehealth services. The agency also said it would establish a grant program to fund telehealth access points for veterans in non-VA facilities in rural and "medically underserved" areas. CMS published Part A, Part B cost-sharing. On November 8, CMS announced Medicare Part B premiums will increase by 6%, to $185 for 2025 and the annual deductible for all Part B beneficiaries will increase by 7% to $257 for 2025. For Part A, CMS announced the annual deductible will increase by $44 to $1,676. CMS issues final CY 2025 Medicare PFS rule. On November 1, CMS issued the calendar year (CY) 2025 Medicare Physician Fee Schedule final rule, which includes a 2.83% reduction to the CY 2025 conversion factor (CF) and a 2.2% reduction to the anesthesia CF. CMS in the rule also finalized a new bundled payment for advanced primary care management services, extensions to certain Medicare telehealth policies, and expanding the add-on code for complexity to include evaluation and management services performed on the same day as Medicare Part B preventive services furnished in the office or outpatient setting. The rule also finalizes an add-on payment for ongoing social determinants of health (SDOH) risk assessments and updates to the Medicare Shared Savings Program (MSSP) and Merit-Based Incentive Payment System. The rule is effective on January 1, 2025. Click here for the fact sheet. Click here for the press release. Click here for the MSSP fact sheet. Click here for the Medicare Prescription Drug Inflation Rebate Program fact sheet. Click here for the Final rule. CMS issues final CY 2025 OPPS/ASC payment rule. On November 1, CMS issued the CY 2025 Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System final rule. CMS finalized a 2.9% payment bump for hospital outpatient departments and ambulatory surgical centers. CMS in the rule also finalized new conditions of participation for obstetric services and emergency readiness with a new two-year phase in period to ease the transition. Other policies finalized include separate payment for non-opioid treatments, shortened prior authorization review timelines for non-urgent services and procedures, and new quality measures targeting health equity and social determinants of health. The rule is effective on January 1, 2025. Click here for the fact sheet. Click here for the press release. Click here for the final rule. CMS issues final CY 2025 Home Health payment rule. On November 1, CMS issued the CY 2025 Medicare Home Health Prospective Payment System final rule, which includes a 0.5% payment increase for home health agencies, representing an increase of $85 million. The rule also includes updates the home health agency conditions of participation, quality reporting programs, and Home Health Value-Based Purchasing Model. The rule is effective on January 1, 2025. Click here for the fact sheet. Click here for the final rule. CMS issues final CY 2025 ESRD payment rule. On November 1, CMS issued the CY 2025 Medicare End-Stage Renal Disease (ESRD) Prospective Payment System final rule. The rule includes a 2.7% payment increase for ESRD facilities, as well as updates to the ESRD prospective payment system wage index, list of outlier services, and low-volume adjustment methodology. The rule is effective on January 1, 2025. Click here for the fact sheet. Click here for the final rule. DOJ issues proposed rule on US sensitive data sharing with countries of concern. On October 29, the Department of Justice (DOJ) published in the Federal Register a notice of proposed rulemaking that would prohibit or restrict transactions involving bulk sensitive personal data — including personal health data, human genomic data, and biometric identifiers — between US companies and individuals or entities located in DOJ-designated countries of concern. The rule implements Executive Order 14117, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern, and aims to address national security concerns surrounding countries of concern accessing the sensitive personal data of U.S. consumers and US government-related data. While the rule does include a long list of exempted transactions, it holds important implications for industries, including pharmaceutical and medical device companies, that share or transfer large amounts of sensitive data with companies located in countries of concern. Click here for the fact sheet. Click here for the press release. Click here for the proposed rule.
CMS issues proposed rule for over-the-counter contraceptives. On October 21, the Departments of Health and Human Services (HHS), Labor, and the Treasury issued a proposed rule to require group health plans and individual insurance issuers to cover over-the-counter contraception with no cost-sharing. The rule aims to address current rules, which require a provider prescription for no-cost coverage of contraceptives. The Departments are accepting comments until December 27. Click here for the fact sheet. Click here for the press release. Click here for the proposed rule. CMS issues 2025 MA, Part D star ratings. On October 10, CMS published the 2025 star ratings for Medicare Advantage (MA) and Part D plans, which impact MA quality bonus payments for 2026. The data show the number of 5-star plans fell from 38 in 2024 to 7 in 2025, with most plans achieving 3-4 stars. CMMI issues RFI on Medicare $2 Drug List Model. On October 9, the Center for Medicare and Medicaid Innovation (CMMI) released a request for information (RFI) and a sample list of 101 prescription drugs that could be included in the $2 Drug List Model. CMMI said the included drugs cover 15 clinical categories, including those for blood pressure and cardiovascular health, mental health, infections, and more. CMMI is accepting comments until December 9, 2024. CMS issues proposed NBPP for 2026. On October 4, CMS released the Notice of Benefit and Payment Parameters (NBPP) for 2026 proposed rule, which makes several changes to increase enrollment in the individual market, improve equity, and lower cost sharing for individuals. CMS proposes updates to the risk adjustment program, including a new model factor for Pre-exposure prophylaxis (PrEP), increased enforcement efforts and requirements for agents and brokers, modest updates to standardized and non-standardized plan requirements, and proposals to ensure affordable coverage, including an RFI on codifying the process known as "silverloading." CMS' comment window closed November 12. Click here for the fact sheet. CMS issues guidance for second drug price negotiations. On October 2, CMS issued final guidance for the second round of negotiations under the Medicare Drug Price Negotiation Program. The guidance outlines processes and requirements for CMS and drug companies during the second round of negotiations, which will occur in 2025, with negotiated prices taking effect in 2027. CMS issued FY 2025 interim final rule on IPPS hospital wage index. On September 30, CMS issued updates to the FY 2025 IPPS hospital wage index in response to a recent court decision (Bridgeport Hosp. v. Becerra) that found CMS lacked the authority to adopt the low wage index hospital policy it finalized in the FY 2020 IPPS rule. The interim final rule removes the low wage index for 2025, which CMS said could negatively impact hospitals that benefited from the FY 2020 policy. CMS created a narrow transitional exception to the calculation of FY 2025 payments for hospitals most impacted by the change. CMS is accepting comments on the rule, which took effect September 30, until November 29. HHS publishes federal health IT strategic plan. On September 30, HHS' Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the final 2024—2030 Federal Health IT Strategic Plan, which includes goals and objectives to ensure health IT and electronic health information are used to promote health and wellness, enhance care delivery, accelerate research and innovation, and foster an interoperable health system. CMS announces latest Part B drugs subject to inflation rebates. On September 30, CMS announced 54 Medicare Part B drugs that will be subject to rebates under the Medicare Prescription Drug Inflation Rebate Program. CMS said the latest round of rebated drugs are used to treat conditions such as cancer, osteoporosis, and pneumonia. CMS announces Medicare coverage for PrEP. On September 30, CMS issued its national coverage determination for PrEP, allowing Medicare Part B to cover PrEP and other related services, such as HIV screenings and risk assessments with no cost-sharing for those at increased risk for HIV. CMS unveils 2025 premiums for MA, Part D plans. On September 27, CMS announced average premiums for Medicare Advantage plans will decline by $1.23 from 2024 to 2025, while premiums for Medicare Part D prescription drug plans (PDPs) will decline by $7.45 from 2024 to 2025. House Oversight Select Subcommittee on the Coronavirus Pandemic held a hearing on "Preparing for the Next Pandemic: Lessons Learned and The Path Forward." On Thursday (November 14), the Select Subcommittee held a hearing during which they heard testimony from representatives of the Centers for Disease Control & Prevention (CDC), Food and Drug Administration (FDA), and National Institutes of Health (NIH). Discussions at the hearing primarily focused on ways to improve communication in the event of a new pandemic.
Republican committee chairs request GAO examination of federal lab safety programs. On Tuesday (November 12), House Energy & Commerce Chair Rodgers (R-WA), Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA), and Health Subcommittee Chair Brett Guthrie (R-KY) sent a letter to the Government Accountability Office requesting an examination of the structure of lab safety programs at the CDC, FDA, and NIH, and an examination of HHS's role overseeing the programs.
Senate Judiciary Committee held a field hearing on "Reducing Prescription Drug Prices: How Competition Can Make Medications Affordable for Patients." During the recess on October 29, Committee Chair Dick Durbin (D-IL) held a field hearing in Chicago, Illinois, during which he heard testimony from a panel of Democratic Members of Congress from Illinois and a panel of experts, lawyers, and a Medicare patient. The discussion focused on the Inflation Reduction Act's drug pricing provisions role in lowering drug prices for Medicare beneficiaries and ways to increase transparency into pharmacy benefit managers to better understand how they influence drug pricing.
Senators issue proposal to expand site-neutral payments. On November 1, Sens. Bill Cassidy (R-LA) and Maggie Hassan (D-NH) released a legislative framework to expand site-neutral payments and reinvest some of the savings into rural and safety-net hospitals and increase funding for hospitals to maintain certain services such as maternity care and trauma centers. Sen. Cassidy is expected to chair the Senate Health, Education, Labor and Pensions Committee next year.
Government Accountability Office: Healthcare Cybersecurity: HHS Continues to Have Challenges as Lead Agency. The report outlines recommendations for HHS to strengthen cybersecurity in the health care sector, including coordinating with the Cybersecurity and Infrastructure Security Agency (CISA) to assess the state of the sector's adoption of leading cybersecurity practices, develop evaluation procedures, expand risk assessments to include Internet of Things and operational technology devices, and more. Government Accountability Office: Health Care Transparency: CMS Needs More Information on Hospital Pricing Data Completeness and Accuracy. The report concluded that CMS "does not have assurance" that hospitals' pricing data are complete and accurate and recommends the agency conduct assessments to determine data completeness and accuracy and take enforcement actions as needed. CMS: Re-Imagining Rural Health: Rural Health Hackathon. The report from CMS' Innovation Center highlights lessons learned from previous Innovation Center models focused on rural health and ways in which the Innovation Center could explore rural communities. CMS: Report on the Study of the Acute Hospital Care at Home Initiative. The report examines the quality, cost, utilization, and patient experience of the Acute Hospital Care at Home Program, which is set to expire on December 31, and compares performance to patients who received care in inpatient facilities. CMS: 2021—2024 CMS Accomplishments. The report highlights CMS' work in the past four years to advance the agency's six strategic pillars: advancing equity, expanding access, engaging partners, driving innovation, protecting programs, and fostering excellence. Congressional Budget Office: How Would Authorizing Medicare to Cover Anti-Obesity Medications Affect the Federal Budget? The report projects that Medicare coverage of anti-obesity medications such as glucagon-like peptide 1s (GLP-1s) would increase federal spending by $35 billion from 2026 to 2034, while generating $1 billion in total savings.
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