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Government Agencies Regulatory Requirements Healthcare Reform

Health Care Compliance Association (HCCA)

Amid Seeming Error, HHS Finalizes Klote’s Termination As Director of Crippled OHRP; She Issues a Warning

In the end, the final termination letter arrived in the mail on July 18. For nearly three months—about half of the length of time she was director of the HHS Office for Human Research Protections (OHRP)—Molly Klote, M.D.,...more

King & Spalding

CMS Escalates Aggressive Rates Cut in Home Health Prospective Payment System Proposed Rule for CY 2026

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On June 30, 2025, CMS issued its annual Home Health Prospective Payment System Proposed Rule for Calendar Year (CY) 2026 (the Proposed Rule). The Proposed Rule continues the agency’s policy of using provisions of the...more

Smart & Biggar

CDA opens consultation on proposed list of drugs to inform development of national formulary

Smart & Biggar on

On June 19, 2025, Canada’s Drug Agency (CDA) opened a public consultation on a proposed process for preparing a list of essential prescription drugs and related products. As required by the Pharmacare Act, the CDA must...more

Robinson+Cole Health Law Diagnosis

Connecticut Budget Bill Includes Notable Changes to CON Laws

On June 30, 2025 Connecticut Governor Ned Lamont signed a bill implementing the state budget through June 30, 2027, Public Act No. 25-168 (PA-168).  PA-168, among other things, contains changes to the state’s Certificate of...more

Alston & Bird

Health Care Week in Review | Congress Passes One Big Beautiful Bill Act; CMS Releases Proposed Payment Rules for ESRD and Home...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Stevens & Lee

Pennsylvania to Join Three Interstate Health Care Licensure Compacts

Stevens & Lee on

Pennsylvania Governor Josh Shapiro recently announced that, effective July 7, 2025, Pennsylvania will commence full participation in three interstate health care licensure compacts: the Interstate Medical Licensure Compact,...more

Sheppard Mullin Richter & Hampton LLP

HRSA Announces New Requirements for FQHCs to Provide Insulin and Epinephrine at or below 340B Price

On June 24, HRSA announced that it had issued new grant award terms to its HRSA-funded health centers to provide insulin and injectable epinephrine at or below the 340B price paid by the health center for the drugs. HRSA...more

McDermott Will & Schulte

CMS Requests Hospitals Submit Gender-Affirming Care Data

On May 28, 2025, the Centers for Medicare & Medicaid Services (CMS) sent a letter to “select hospitals” that provide gender-affirming care services, requesting information about how those hospitals adhere to quality standards...more

Mintz - Health Care Viewpoints

CMS Announces Sweeping Changes to RADV Audits

On May 21, 2025, the Centers for Medicare & Medicaid Services (CMS) announced significant changes in its risk adjustment data validation (RADV) audits. The changes focus on speed, the volume of targeted contracts, and...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

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