In this update:
- Federal Agencies
- ARPA-H Announces POSEIDON Program
- FDA Announces Digital Health Advisory Committee Roster
- HRSA Releases Updated FQHC Program Data
- HRSA Awards $9 Million to FQHCs for Cancer Screenings
- Other Updates
- 5th Circuit Upholds Lower Court Ruling on No Surprises Act
- Peterson-KFF Release Rate Filing Analysis
- NCQA Announces Updates for 2025 HEDIS
- Bloomberg Gives $600 Million to Historically Black Medical School Endowments
- New York State Updates
- Governor Hochul Announces NYHER 1115 Waiver SCN Award Recipients
- DOH Accepting Public Comment on Proposed Regulations for the Licensure of PACE
- OMH Issues Revised Proposed Regulations for Hospitals Regarding Patients with Behavioral Health Needs
- DOH Issues Guidance to Hospitals on Clinical Staffing Surveillance Process
Federal Agencies
ARPA-H Announces POSEIDON Program
On August 1st, the Advanced Research Projects Agency for Health (ARPA-H) announced the Platform Optimizing SynBio for Early Intervention and Detection in Oncology (POSEIDON) program. This program aims to develop novel at-home synthetic Multi-Cancer-Early Detection (MCED) tests for stage I detection of 30+ solid tumors. These over-the-counter tests would use only breath and/or urine samples. More information, including the list of cancers, will be released in the program’s forthcoming Innovative Solutions Opening (ISO), which will include two technical areas. ARPA-H anticipates multiple awards under the ISO.
The announcement is available here.
FDA Announces Digital Health Advisory Committee Roster
On August 1st, the Food & Drug Administration (FDA) announced the roster for its Digital Health Advisory Committee, a new advising body that is poised to guide conversations around Digital Health Technologies (DHTs) and future regulatory action. The Committee is composed of nine voting members, including a Chair. The inaugural Chairperson is Dr. Ami Bhatt of Harvard Medical School with an expertise in cardiology. The Committee is set to hold its inaugural meeting on November 20-21st on the topic of generative AI usage in medical devices.
The full roster of Committee members is available here.
HRSA Releases Updated FQHC Program Data
This month, the Health Resources & Services Administration (HRSA) released updated outcomes data for the Health Center Program, including Federally Qualified Health Centers (FQHCs). In 2023, health centers served over 31 million patients across over 132.5 million visits. The overwhelming majority of patients served were uninsured or Medicare or Medicaid beneficiaries, consistent with the program mission. In addition, health centers served 1.1 million school-based service site patients, saw 585,000 prenatal care patients, and provided 26 million mental health visits. Health centers saw a 71% increase in community health workers since 2020, and hosted over 66,000 pre- and post-graduate trainees in 2023 alone.
The data is available here.
HRSA Awards $9 Million to FQHCs for Cancer Screenings
On August 7th, the Health Resources & Services Administration (HRSA) announced the award of nearly $9 million to 18 HRSA-funded health centers to improve access to cancer screenings in underserved communities. These health centers will partner directly with National Cancer Institute-Designated Cancer Centers, such as Memorial Sloan Kettering or centers within regional health systems, to enhance screening offerings. In New York, the Bronx Community Health Network, Sunset Park Health Council, and the Institute for Family Health will all receive $500,000 for these efforts.
The announcement is available here.
Other Updates
5th Circuit Upholds Lower Court Ruling on No Surprises Act
On August 2nd, the Fifth Circuit Court of Appeals upheld a lower court ruling that federal regulations implementing the No Suprises Act independent dispute resolution process favored health plans and that the departments’ exceeded their statutory authority in the regulatory process. Specifically, the Appeals Court upheld a ruling from the Eastern District of Texas Court, which sided with the Texas Medical Association and other health care providers. The court found that the final rule favors health plans by requiring arbiters to begin with the qualifying payment amount and then imposing restrictions – absent from the statute – on other factors arbiters might consider. The ruling directs the Department of Health and Human Services (HHS) to revise its final rule surrounding the dispute resolution process. HHS has not yet indicated how it may respond to the Appeals Court ruling.
The ruling is available here.
Peterson-KFF Release Rate Filing Analysis
On August 2nd, the Peterson Center on Healthcare and the Kaiser Family Foundation (KKF) released an analysis of preliminary 2025 rate filings from 324 Affordable Care Act-regulated health plans in the 50 states and the District of Columbia. The median proposed premium increase is 7%, with a wide distribution (-14% to 51%). The report’s appendix lists proposed rate changes by state/plan. The authors also conducted a more detailed analysis of insurer actuarial memoranda from 61 insurers in ten states (Hawaii, Indiana, Maryland, Maine, Michigan, New York, Oregon, Rhode Island, Vermont, Washington) and the District of Columbia to understand factors driving premium changes. The driving factors are: inflation/medical cost trend, hospital consolidation and workforce shortages; and GLP-1s and other specialty drugs. The authors found little to no premium impact due to Medicaid unwinding, Covid-19, No Surprises Act, or price transparency.
The report is available here.
NCQA Announces Updates for 2025 HEDIS
On August 1st, the National Committee for Quality Assurance (NCQA) announced a set of updates to the Healthcare Effectiveness Data and Information Set (HEDIS) for Measurement Year (MY) 2025. NCQA introduced three new measures, retired four, and made a number of smaller edits to other measures. The new measures, which address the use of certain breast cancer assessment technologies, abnormal breast cancer assessment follow-up, and blood pressure control, use Electronic Clinical Data Systems (ECDS) reporting. NCQA is retiring certain measures related to pain assessment for older adults and antidepressant medication management.
The announcement is available here.
Bloomberg Gives $600 Million to Historically Black Medical School Endowments
On August 6th, Michael Bloomberg, acting through Bloomberg Philanthropies, donated $600 million to four historically black medical schools. Bloomberg Philanthropies is giving $175 million each to Meharry Medical College, Morehouse School of Medicine, and Howard University College of Medicine; $75 million to Charles R. Drew University of Medicine and Science; and $5 million to Xavier University of Louisiana. These funds are specifically earmarked for medical school endowments to address medical student recruitment and admission. This donation builds on another Bloomberg Philanthropies gift to Johns Hopkins in July, which will allow the medical school to waive tuition for most students, and another 2020 donation to historically black medical schools.
New York State Updates
Governor Hochul Announces NYHER 1115 Waiver SCN Award Recipients
On August 7th, Governor Hochul announced the nine organizations selected to create new, regionally-based Social Care Networks (SCN) under the State’s New York Health Equity Reform (NYHER) 1115 Waiver. SCNs will be responsible for coordinating the delivery of social care services to Medicaid members, including by providing Health-Related Social Needs (HRSN) screening and maintaining a comprehensive network of community-based organizations (CBOs) to support the delivery of “Enhanced” HRSN services to eligible members in need. Such services may include housing, transportation, nutrition, and care management.
The State will provide $500 million in total funding to support SCN start-up and infrastructure costs. The following organizations were selected across nine regions statewide:
- Care Compass Collaborative (Southern Tier)
- Finger Lakes IPA, Inc. (Finger Lakes)
- Health and Welfare Council of Long Island (Long Island)
- Healthy Alliance Foundation, Inc. (Capital Region, Central NY, North Country)
- Hudson Valley Care Coalition, Inc. (Hudson Valley)
- Public Health Solutions (Manhattan, Queens, Brooklyn)
- Somos Healthcare Providers, Inc. (Bronx)
- Staten Island Performing Provider System (Staten Island)
- Western New York Integrated Care Collaborative, Inc. (Western NY)
The Governor’s press release is available here. Additional details on the SCN component of the waiver are available here.
DOH Accepting Public Comment on Proposed Regulations for the Licensure of PACE
On August 7th, the New York State (NYS) Department of Health (DOH) released for public comment proposed regulations that would implement a new licensure and application process for Programs of All-Inclusive Care for the Elderly (PACE). PACE organizations directly provide community-based medical care, home health care, and social support services to individuals over the age of 55 who are otherwise eligible for nursing home admission. Services are typically provided at a PACE Center, allowing individuals to remain in their home and community. The proposed regulations mirror those that were presented to the Public Health and Health Planning Council’s Committee on Codes, Regulations, and Legislation on June 20, 2024.
The updated process would consolidate the current requirements for PACE organizations under Article 28, Article 36, and Article 44 of New York’s Public Health Law into a single license under Article 29-EE. The proposed regulations outline criteria for PACE operations, a streamlined single PACE application process, codification of federal standards and definitions for comprehensive care, and updated parameters related to the governing authority of PACE programs.
Current PACE organizations would continue to operate as licensed until the transition process for Article 29-EE licensure is established. New PACE applications would be required to comply with the new licensure and application process established by these regulations.
The proposed regulations are available here. Public comment may be submitted to regsqna@health.ny.gov through October 7th.
OMH Issues Revised Proposed Regulations for Hospitals Regarding Patients with Behavioral Health Needs
On July 31st, the NYS Office of Mental Health (OMH) issued revised regulations outlining new requirements for hospital emergency departments to develop and implement policies and procedures for identification, assessment, and referral of patients with behavioral health presentations. In response to public comment received on the initial draft regulations, OMH made significant changes to the definition of “Individual with Complex Needs” to narrow the scope and facilitate identification of such individuals. No other substantial changes were made to the proposed regulations.
The revised proposed regulations are available here. Public comment may be submitted to regs@omh.ny.gov through October 2nd. A summary of previous comments received are available in the State Register here.
DOH Issues Guidance to Hospitals on Clinical Staffing Surveillance Process
On August 7th, DOH issued guidance to hospital administrators regarding the implementation of Public Health Law 2805-t, which requires hospitals to establish and maintain a Clinical Staffing Committee and develop policies and procedures to address clinical staffing complaints. The guidance addresses complaint management and the onsite survey process, including the information that DOH surveillance staff may request of a hospital during the onsite survey. Requested information must be provided within 72 hours of the request.
If violations are found, a statement of deficiency will be provided directly to the hospital’s Chief Executive Officer (CEO). The hospital CEO will work with the Clinical Staffing Committee to submit a plan of correction to DOH with 45 days.
The guidance is available here. Questions may be submitted to hospinfo@health.ny.gov.