THIS WEEK’S DOSE

• Senate HELP Committee Holds Hearing on Medical Debt. Members of the Senate Health, Education, Labor & Pensions (HELP) Committee explored potential solutions to the negative impacts of medical debt.
• Senate Aging Committee Holds Hearing on Healthcare Transparency. Senators focused on legislation to increase transparency in an effort to reduce healthcare prices.
• Senate Commerce, Science & Transportation Committee Holds Hearing on AI, Data Privacy. Senators and witnesses discussed solutions to protect data privacy and innovation.
• House Appropriations Committee Advances FY 2025 Labor-HHS Funding Bill. The bill was passed along party lines with a vote of 31 – 25.
• Senate Passes Bill to Address Anticompetitive Pharmaceutical Practices. The bill would make it easier to bring biosimilars to market.
• CMS Releases CY 2025 Medicare PFS Proposed Rule. The Centers for Medicare & Medicaid Services (CMS) proposed an almost 3% decrease in the Medicare Physician Fee Schedule (PFS) and additional changes to payment policies.
• CMS Releases CY 2025 Hospital Outpatient PPS Proposed Rule. CMS proposed a 2.6% payment rate increase for hospitals and ambulatory surgical centers.
• ONC Releases HTI-2 Proposed Rule. The Office of the National Coordinator for Health Information Technology (ONC) proposed new health IT policies around patient engagement, certification and information blocking.

CONGRESS

Senate HELP Committee Holds Hearing on Medical Debt. The hearing examined the negative impacts of medical debt and explored potential solutions to address the growing issue. Senators and witnesses highlighted the disparity between the United States and other industrialized nations in healthcare access and outcomes, with medical debt identified as a leading cause of personal bankruptcy in the United States. When discussing solutions, Democrats focused on systemic issues such as medical debt relief, healthcare affordability and the importance of comprehensive health coverage. In contrast, Republicans emphasized market-based solutions and regulatory reforms aimed at reducing healthcare costs and enhancing transparency. Their questions frequently probed the efficacy of existing programs such as the 340B Drug Pricing Program and focused on the value of products such as health savings accounts, which they argued empower patients to shop for lower-cost healthcare and thus reduce healthcare expenditures.

Senate Aging Committee Holds Hearing on Healthcare Transparency. The hearing examined the importance of transparency for affordable healthcare access, and there was agreement that lack of price transparency leads to higher healthcare costs and disempowers employers, unions and patients. Much of the hearing focused on support for S. 3548, the Health Care PRICE Transparency Act 2.0, which would mandate providers publish actual prices, ensure that group health plans can review and audit their own claims data and allow self-insured employers and unions make changes to their plans.

Senate Commerce, Science & Transportation Committee Holds Hearing on AI, Data data privacy. The hearing focused on how artificial intelligence (AI) has accelerated the push for a federal comprehensive privacy law. Senators and witnesses expressed concerns about the privacy risks posed by AI. Many senators expressed support for a national privacy standard, with the caveat that such a standard must appropriately consider the impacts on small businesses. Witnesses highlighted the importance of data minimization rules within any legislation, and some Republican senators expressed concerns that over-regulating AI could inhibit innovation.

House Appropriations Committee Advances FY 2025 Labor-HHS Funding Bill. The bill includes a 7% cut to the US Department of Health & Human Services (HHS) for fiscal year (FY) 2025, a proposal to restructure the National Institutes for Health, and several anti-abortion provisions, to list a few of the controversial components. The committee approved the bill along party lines with a vote of 31 – 25. It is unclear if the bill will move forward for consideration by the full House. Even if it does so, it is unlikely to be signed into law in its current form because of opposition from Senate Democrats. The bill report can be found here.

Senate Passes Bill to Address Anticompetitive Pharmaceutical Practices. S. 150, the Affordable Prescriptions for Patients Act of 2023, was passed using unanimous consent. The bill would address “patent thicketing” by pharmaceutical manufacturers by limiting the number of patents they can assert on a biologic, which would pave the way for earlier market entry of biosimilar competitors to reduce costs.

ADMINISTRATION

CMS Releases CY 2025 Medicare PFS Proposed Rule. CMS proposes to decrease the calendar year (CY) 2025 resource-based relative value scale conversion factor (CF) by 2.8% and the CY 2025 anesthesia CF by 2.1%. This decrease is based on a statutory 0% update schedule for the PFS in CY 2025, a 0.05% positive budget neutrality adjustment, and the expiration of funding patches passed by Congress that partially mitigated cuts to the CF for CY 2023 and 2024. Other key proposals include:

• Add-on Code for Complexity: CMS proposes to expand the useability of the add-on code for complexity, G2211, by allowing it to be billed when the underlying evaluation and management service is performed on the same day as an annual wellness visit, vaccine administration service, or any Medicare Part B preventive service furnished in the office or outpatient setting.]
• Telehealth: CMS maintains it has limited statutory authority to extend most Medicare telehealth policies as, without Congressional action, the major Medicare telehealth waivers will expire on December 31, 2024, and return to pre-COVID-19 public health emergency policies.
• Merit-Based Incentive Payment System (MIPS): The proposed rule maintains the MIPS performance threshold at 75 points but signals efforts to move reporting towards the MIPS Value Pathways by 2029.
• Medicare Shared Savings Program: CMS proposes to establish a new prepaid shared savings option, modify the financial methodology to encourage participation, align quality measure reporting with the Universal Foundation of quality measures, account for the impact of certain improper payments in performance year and benchmark expenditures, and more.

Public comments on the proposed rule are due September 9, 2024. The CMS fact sheet can be found here, and the press release and additional issue-specific fact sheets can be found here. The McDermottPlus PFS Dashboard can be found here.

CMS Releases CY 2025 Hospital Outpatient PPS Proposed Rule. CMS proposes to increase payment rates under the CY 2025 Hospital Outpatient Prospective Payment System (PPS) and the Ambulatory Surgical Center (ASC) Payment Systems by a factor of 2.6%. This increase factor is based on a proposed hospital market basket percentage increase of 3% reduced by a productivity adjustment of 0.4 percentage point. In continuation of an existing policy, hospitals and ASCs that fail to meet their respective quality reporting program requirements would be subject to a 2% reduction in the CY 2025 fee schedule increase factor. Other key proposals include:

• Prior authorization: CMS does not propose to expand the categories of services subject to prior authorization but does propose to harmonize the timeline for review for non-urgent services and procedures.
• Non-opioid pain treatment: To implement a policy recently passed by Congress, CMS proposes to make separate payment for certain non-opioid treatments (including drugs and devices) for pain relief, effective from January 1, 2025, through CY 2027.
• Colorectal cancer screening: CMS proposes to eliminate coverage of barium enemas as a screening technique but to otherwise expand coverage of colorectal cancer screening tests.
• Health equity: CMS proposes new quality measures on health equity and social determinants of health and seeks information on how to further address patient safety.

Public comments on the proposed rule are due September 9, 2024. The CMS fact sheet is available here, and the press release is available here. The McDermottPlus Hospital Outpatient PPS Dashboard can be found here.

ONC Releases HTI-2 Proposed Rule. The Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability proposed rule (known as HTI-2) includes policies that would impact patient engagement, IT certification and information blocking (a practice that interferes with access to electronic health information). The proposed rule includes the following key proposals:

• Two sets of new IT certification criteria that focus heavily on standards-based application programming interfaces to improve end-to-end interoperability between data exchange partners.
• Technology and standards updates that build on the HTI-1 final rule, ranging from the capability to exchange clinical images (e.g., X-rays) to the addition of multi-factor authentication support.
• Adoption of United States Core Data for Interoperability version 4 by January 1, 2028.
• Adjustments to certain “exceptions” to the information blocking regulations, including exceptions for actions taken when reducing risk of legal action based on lawfully accessed reproductive healthcare and following a requestor’s ask for restriction, as well as expanded application of the existing privacy exception.
• Establishment of new Trusted Exchange Framework and Common Agreement^TM (TEFCA^TM) governance rules, which include requirements that implement section 4003 of the 21st Century Cures Act.

Public comments are due 60 days after the proposed rule’s publication in the Federal Register. A fact sheet can be found here, and a press release and additional issue-specific fact sheets are available here.

QUICK HITS

• Administration Releases Spring 2024 Unified Regulatory Agenda. The agenda outlines regulatory actions federal agencies are planning over the next year and can be found here.
• CMS Hosts Webinar on Workforce Shortages in HCBS. The webinar discussed causes of home- and community-based services (HCBS) workforce shortages, including low wages and inadequate benefits. CMS spoke about state initiatives, such as expanding telehealth, increasing funding for compensation and promoting self-direction. The presentation slides can be found here.
• FTC Releases Report on Anticompetitive PBM Behavior. The Federal Trade Commission (FTC) interim staff report details several anticompetitive behaviors by pharmacy benefit managers (PBMs), including market concentration and vertical integration, significant power and influence, self-preferencing, unfair contract terms and efforts to limit access to low-cost competitors. It has been reported that the FTC may use this report to more aggressively pursue these PBM behaviors. The press release can be found here.
• CMS Innovation Center Launches GUIDE Model. The Guiding an Improved Dementia Experience (GUIDE) Model will test an alternative payment for dementia care programs that deliver support services and provide access to a care navigator. CMS announced that 390 providers across the country are signed up to participate. Read the model webpage here.
• CMS Posts First QPA Audit Report. The federal qualifying payment amount (QPA) audit of Aetna was the first of the reports required by the No Surprises Act. The report can be found here.
• House Committee Chairs Request That HHS, GAO Conduct Systematic Reviews of ACA Marketplace Enrollment. House Energy & Commerce Committee Chair Rodgers (R-WA), House Ways & Means Committee Chair Smith (R-MO), and House Judiciary Committee Chair Jordan (R-OH) emphasized the issue of improper enrollment and its underlying causes in letters to HHS Inspector General Grimm and US Government Accountability Office (GAO) Comptroller General Dodaro. The press release can be found here.
• GAO Releases Reports on HHS SUD Treatment Guidance, DOD TRICARE Directories. In its report on substance use disorder (SUD) treatment, GAO recommended that HHS develop guidance about incorporating work into treatment and recovery. In another report, GAO recommended that the US Department of Defense (DOD) improve the accuracy of behavioral health provider listings in TRICARE directories.
• SAMHSA Announces Funding for Women’s Behavioral Health. The $27.5 million in funding opportunities from the Substance Abuse and Mental Health Services Administration (SAMHSA) include the Community-Based Maternal Behavioral Health Services Program and the Women’s Behavioral Health Technical Assistance Center. The press release can be found here.
• HRSA Invests in Geriatric-Specific Healthcare. The Health Resources and Services Administration (HRSA) announced more than $200 million in investments through the Geriatrics Workforce Enhancement Program, which integrates geriatric training into primary care. The press release can be found here.
• White House Gender Policy Council Seeks Nominations for Girls Leading Change. Girls ages 14 to 18 who are tackling important issues in their communities may be nominated here for recognition for that work.

NEXT WEEK’S DIAGNOSIS

The House and Senate will be in recess next week for the Republican National Convention in Milwaukee, Wisconsin. (The Democratic National Convention is scheduled for the week of August 19, 2024, in Chicago, Illinois.) Given that Congress will not be in session, the Check-Up will take a break next week and return to your inbox on July 26, 2024.