Newsletters

05.15.24

Ways and Means Committee Advances Bipartisan Legislation to Extend Telehealth Flexibilities

On May 8, the House Committee on Ways and Means (W&M) held a markup to consider six health-related bills.


05.14.24

Health Care, AI and Antitrust: Analysis and Next Steps

As artificial intelligence (AI) continues to permeate the health care industry (and every other part of American life), the industry should be attentive to the risk of anticompetitive conduct arising from reliance on AI and cognizant of the watchful eyes of antitrust enforcers, including the ...


05.06.24

FDA Finalizes Rule to Phase Out Enforcement Discretion of Laboratory-Developed Tests

On April 29, the U.S. Food and Drug Administration (FDA) released a final rule that will gradually phase out FDA’s long-standing policy of enforcement discretion for laboratory-developed tests (LDTs), subjecting them to the same enforcement approach as other in vitro diagnostic (IVD) products.


05.06.24

Understanding the State Prescription Drug Affordability Board Landscape in Three Infographics

Several states are considering or have enacted legislation to create prescription drug affordability boards (PDABs).


05.02.24

CMS Finalizes Sweeping Regulations for Medicaid Access, Managed Care, and HCBS

On Monday, April 22, the Centers for Medicare & Medicaid Services (CMS) released two highly anticipated final rules.


05.02.24

HHS Finalizes Changes to the HIPAA Privacy Rule to Support Reproductive Health Care Privacy

On April 22, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) released a Final Rule to enhance the privacy of information related to reproductive health care.


05.01.24

New York’s 1332 Waiver Extends Affordable Coverage to Additional Groups

On March 1, the Departments of Health and Human Services (HHS) and the Treasury approved New York’s section 1332 waiver that expands affordable coverage to additional groups of New Yorkers.


04.30.24

HHS Finalizes Antidiscrimination Rules On Patient Care Decision Tools, Including AI

Last week, the Department of Health and Human Services (HHS) finalized antidiscrimination regulations implementing Section 1557 of the Affordable Care Act (ACA Section 1557).


04.25.24

Expanding Access to Telehealth for Medication Abortion Care in a Constrained Policy Environment

This is an excerpt of a recent report prepared by Manatt and RHITES (the Reproductive Health Initiative for Telehealth Equity & Solutions). Click here to read the full report and recommendations.  


04.24.24

CMMI’s Innovation in Behavioral Health: Promoting Physical and Mental Well-being

On January 18, 2024, the Centers for Medicare and Medicaid Services’ (CMS) Innovation Center (CMMI) announced Innovations in Behavioral Health (IBH), a new eight-year model focused on adult Medicaid and Medicare enrollees with moderate to severe mental health conditions and substance use ...