House Ways & Means Health Subcommittee Holds Hearing on Value-Based Care. The hearing examined the challenges and opportunities associated with delivering better health outcomes and Medicare savings through value-based care. Members and witnesses agreed that value-based care has the potential to improve patient health outcomes and reduce costs, but implementation challenges persist. Suggestions to address these challenges included greater alignment, reduced regulatory burdens and improved data sharing. Members expressed concerns about healthcare consolidation, rural and preventative healthcare access, and the difficulty of transitioning to value-based payment systems, particularly in underserved and rural areas.
House Ways & Means Committee Advances Four Bills Impacting Medicare Coverage. The bills advanced with broad bipartisan support. More information on amendments and vote outcomes can be found here, and details on the bill outcomes can be found below:
House Energy & Commerce Committee Cancels Markup of Privacy, Telehealth Legislation. The markup was supposed to consider the American Privacy Rights Act (APRA), newly negotiated bipartisan privacy legislation that would create a national privacy standard, as well as several healthcare bills, including telehealth legislation that would extend Medicare flexibilities due to expire at the end of the year. In light of the committee’s ongoing discussions with Republican House leadership about their concerns with APRA as drafted, the markup was abruptly cancelled. Next steps on APRA and the health bills are unclear.
House Appropriations Labor-HHS Subcommittee Advances FY 2025 Funding Bill. The bill, passed by voice vote along party lines, would cut HHS spending by 7% and contains several controversial riders, including the elimination of Title X funding and a program that provides grants for family planning services. The legislation also would reorganize the National Institutes of Health (NIH) by reducing the number of its research centers from 27 to 15. A full committee markup has not yet been announced but will likely take place before the August recess.
ONC Issues Final Rule on Information Blocking Disincentives for Providers. The final rule establishes disincentives for healthcare providers who are found to have committed information blocking, and largely adopts the provisions as proposed. Despite comments from stakeholders, the rule does not provide a corrective action, an appeals process or protections against double penalties.
Under the final rule, if the HHS Office of Inspector General finds that a party has committed information blocking, the disincentives are as follows:
The final rule will become effective on July 31, 2024. A press release can be found here.
Administration Acts on Clinical Trials. The FDA issued draft guidance that aims to increase clinical study enrollment of historically underrepresented patient populations by assisting medical sponsors in submitting diversity action plans. The guidance details the format and content of diversity action plans, the circumstances in which they are required, and the timing and process for submitting them to the agency. The guidance also notes the criteria and process FDA will use to evaluate waiver requests. The draft guidance is open for public comment until September 26, 2024. Read the press release here.
On the same day, the White House held a clinical trials forum, which sought to identify effective strategies for increasing access, lowering barriers to participation in clinical trials and speeding discovery of effective therapies. The forum highlighted the positive impact of patient-centered approaches in clinical trials, such as integrating the patient voice into trial design, ensuring trials are equitable and treating patients as collaborators. The discussion also emphasized the importance of collaborative and community-driven research models, using the Advanced Research Projects Agency for Health’s agile funding approach and the NIH’s Care for Health initiative as examples.
CMS Releases CY 2025 Home Health PPS Proposed Rule. The proposed rule is estimated to decrease payments under the calendar year (CY) 2025 Home Health Prospective Payment System (PPS) by -1.7% (-$280 million). The decrease reflects a CY 2025 proposed home health payment increase of 2.5% ($415 million), an estimated decrease of -3.6% (-$595 million) from the permanent behavior assumption adjustment, and an estimated -0.6% (-$100 million) decrease from the updated fixed-dollar-loss ratio. CMS also proposed:
In the proposed rule, CMS requested information on future home health quality reporting program quality measure concepts and future HHVBP performance measure concepts. Public comment is open until August 26, 2024. A fact sheet can be found here.
CMS Releases CY 2025 End-Stage Renal Disease PPS Proposed Rule. The proposed rule is estimated to increase payments under the CY 2025 End-Stage Renal Disease (ESRD) PPS by 2.2% by increasing the base rate to $273.20, a change of $2.18. CMS estimates that hospital-based ESRD facilities will see a 3.9% increase in total payments and freestanding facilities will see a 2.1% increase in total payments. CMS also proposed several other provisions, including:
CMS also requested public comment on a potential future health equity payment adjustment and potential future updates to the data validation policy. Public comment is open until August 26, 2024. A fact sheet can be found here.
Supreme Court Issues Chevron Ruling. The Supreme Court issued a decision in two consolidated cases — Relentless v. Dept. of Commerce and Loper Bright Enterprises v. Raimondo — that could fundamentally impact the federal rulemaking process. The cases address what is formally known as the Chevron doctrine, initially established by the Supreme Court in 1984, that held that in cases where a federal statute is ambiguous, courts must give federal agencies deference in their interpretation of the law, as long as the interpretation is reasonable. The Chevron doctrine has been invoked in nearly every litigation challenging an agency action, and it has often meant a high bar for overturning agency interpretations by federal courts.
The Court ruled in favor of the plaintiffs, which essentially overturns the long-held use of Chevron deference. The majority opinion states that “The Administrative Procedure Act requires courts to exercise their independent judgment in deciding whether an agency has acted within its statutory authority, and courts may not defer to an agency interpretation of the law simply because a statute is ambiguous.” While the cases themselves related to fishing and not to health care, the decision is likely to have a significant implication on health care laws and regulations. With more limited deference, agencies will still be able to issue these interpreting regulations, but courts will have more discretion to reject agency expertise or interpretation.
Supreme Court Allows Idaho to Offer Emergency Medical Abortions. In its 6 – 3 ruling in Moyle v. United States and Idaho v. United States, without ruling on the merits, the Supreme Court left in place the lower court’s temporary order that bars Idaho from enforcing its abortion ban when it conflicts with the Emergency Medical Treatment and Labor Act. The case will now return to a federal district court judge, who had temporarily blocked the Idaho law from going into effect.
Congress will be in recess next week for the Fourth of July holiday. Following their lead, the Check-Up will take a brief pause and return on July 12, 2024. We are closely watching for release of the Physician Fee Schedule and Hospital Outpatient Prospective Payment System proposed rules, which are pending at the Office of Management and Budget.
For more information, contact Debra Curtis, Kristen O’Brien, Julia Grabo, Priya Rathakrishnan or Erica Stocker.
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