In this update:
- Federal Agencies
- CMMI Releases RFA for Enhancing Oncology Model
- GAO Releases Report on Medicaid Managed Care Prior Authorization
- CMS Opens ACO Primary Care Flex Model RFA/Application Portal
- FTC/DOJ Issue RFI on Serial Acquisitions and Roll-Up Strategies
- NIH Issues RFI on Taxpayer-Funded Inventions
- Other Updates
- AHCA Files Suit Over Nursing Home Staffing Rule
- Hospital Groups Ask FTC for Non-Compete Ban Delay
- New York State Updates
- DOH Releases 1332 State Innovation Waiver Draft Amendment to Implement Cost Sharing Reductions for QHP Consumers
Federal Agencies
CMMI Releases RFA for Enhancing Oncology Model
On May 30th, the Center for Medicare and Medicaid Innovation (CMMI) released a Request for Applications (RFA) for the second cohort of the Enhancing Oncology Model (EOM). The intent of the EOM is to reduce program spending while preserving or enhancing the quality of care for beneficiaries undergoing treatment for cancer. The second cohort will begin on July 1, 2025 and end on June 30, 2030, a five-year performance period. Eligible participants include Medicare-enrolled oncology physician group practices. For current and future participants, CMMI will introduce several program changes beginning January 1, 2025, including extension of the program by two years, making higher monthly payments for enhanced services, and establishing a higher threshold for recoupment.
Additional information on EOM is available here. The RFA is available here.
GAO Releases Report on Medicaid Managed Care Prior Authorization
On May 29th, the General Accountability Office (GAO) released a report, “Medicaid: Managed Care Plans’ Prior Authorization Decisions for Children Need Additional Oversight.” The report was originally requested by Rep. Frank Pallone (D-NJ), Ranking Member of the House Energy and Commerce Committee, and describes how selected Medicaid managed care plans authorize services, how states oversee plans’ service authorization, and what role CMS plays in state oversight.
The plans that GAO reviewed generally had similar processes for reviewing prior authorization requests, but required prior authorization for different services. GAO also found that CMS does not specify how states should monitor prior authorization decisions nor has CMS assessed if states are sufficiently monitoring plans. GAO recommends that CMS communicate expectations for how states should monitor plans’ prior authorization decisions, confirm that states meet these expectations, and clarify whether managed care plans can require prior authorization for Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) services when the state does not have such a requirement.
The Department of Health and Human Services (HHS) partially concurred with GAO’s recommendations, noting that CMS is collecting information on states’ prior authorization denial review and plans to use it to determine whether more oversight is needed.
The report is available here.
CMS Opens ACO Primary Care Flex Model RFA/Application Portal
On May 30th, CMS opened the Request for Application (RFA) and application portal for the Accountable Care Organization Primary Care Flex Model (ACO PC Flex Model). ACO PC Flex is a voluntary model within the Shared Savings Program that will test how prospective payments and increased funding for primary care could affect health outcomes, quality, and cost of care.
In order to participate in the ACO PC Flex Model, organizations must first apply to the Shared Savings Program (both new ACOs and those renewing), applications for which are due June 17th. Current Shared Savings Program participants must apply as Renewal Applicants and begin a new agreement period. Applicants may then submit a supplemental application to ACO PC Flex by August 1st, with participants selected by October 2024 for a January 1, 2025 start. The Model will run for five years.
CMS will host a webinar on June 6th to provide an overview of the program and the application process. More information on ACO PC Flex is available here, the RFA is available here, and webinar registration is available here.
FTC/DOJ Issue RFI on Serial Acquisitions and Roll-Up Strategies
On May 23rd, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) issued a Request for Information (RFI) to identify serial acquisitions and roll-up strategies across the U.S. economy that threaten competition. Serial acquisitions and roll-ups are non-sector-specific corporate consolidation efforts that involve acquiring smaller firms in the same or related sectors. Roll-up activities are particularly popular among private equity companies. These acquisitions can often fall below the minimum filing threshold for mergers, avoiding reporting. Recently, the FTC has challenged serial acquisitions of anesthesiology practices and dialysis clinics. The DOJ and FTC are seeking input from consumers, employees, trade associations, governments, and other relevant stakeholders.
The announcement is available here, and the RFI is available here. Comments must be submitted by July 22nd.
NIH Issues RFI on Taxpayer-Funded Inventions
On May 22nd, the National Institutes of Health (NIH) issued a Request for Information (RFI) on developing commercial products derived from taxpayer-funded interventions. Specifically, the NIH is working to develop a new policy within its Intramural Research Program (IRP) that would increase patient access to these products, given their origins, across the commercialization process. This has been a topic of conversation particularly regarding mRNA vaccine technologies.
The RFI is available here. Comments must be submitted by July 22nd.
Other Updates
AHCA Files Suit Over Nursing Home Staffing Rule
On May 23rd, the American Health Care Association (AHCA), the Texas Health Care Association, and three skilled nursing facilities filed a suit against HHS over the CMS national nursing home staffing mandate. AHCA argues that the new rule–which requires federally funded nursing homes to have a registered nurse on staff full-time and provide 3.48 hours of daily direct patient care–is “arbitrary and capricious” and oversteps the statutory authority of CMS under the Administrative Procedures Act. AHCA claims that these are “impossible-to-meet standards.” CMS intends to defend the rule.
The complaint is available here.
Hospital Groups Ask FTC for Non-Compete Ban Delay
On May 28th, a coalition of 230 national associations, including the American Hospital Association (AHA), sent a letter to the FTC requesting a delay in the implementation of the Non-Compete Clause Final Rule in light of ongoing judicial review. The final rule–which bans non-competes in most circumstances–is currently being challenged by several parties, including the U.S. Chamber of Commerce. The letter also cites a “lack of Commission guidance” that has caused confusion and uncertainty across several industries. The ban is currently set to take effect September 4, 2024.
The announcement is available here.
New York State Updates
DOH Releases 1332 State Innovation Waiver Draft Amendment to Implement Cost Sharing Reductions for QHP Consumers
On May 28th, the New York State (NYS) Department of Health (DOH) released a draft amendment to the State’s Section 1332 State Innovation Waiver, which was recently approved by the federal government to expand eligibility for the Essential Plan (details here). The amendment seeks approval to use passthrough funding to reduce the cost-sharing burden for individuals purchasing Qualified Health Plans (QHPs) by providing Cost Sharing Reduction (CSR) wraps for:
- Individuals with incomes up to 400% of the Federal Poverty Level (FPL) by expanding eligibility for existing Silver plans with CSR;
- Non-hospital-based diabetes services, supplies, and prescription drugs for all QHP consumers; and
- Outpatient pregnancy and postpartum care, including mental health services, for all QHP consumers.
To State will use passthrough funding to reimburse insurance plans for the cost sharing they would have otherwise received from their consumers based on claims. The State intends to implement the CSRs beginning January 1, 2025. The initiative is expected to cost an estimated $307 million in 2025, and will continue through the end of the waiver period on December 31, 2028.
The State will be hosting two upcoming virtual public forums to provide a status update and opportunity for public comment, as follows:
The draft waiver amendment is available here. Written public comments may be emailed to nysoh@health.ny.gov through June 27th.