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Final Rules Department of Health and Human Services (HHS) Social Security Act

Fisher Phillips

Minimum Staffing Rules for Long-Term Care Facilities Tossed Out by Federal Courts and Budget Bill: Key Points for Medicare and...

Fisher Phillips on

A federal judge in Iowa recently struck down key parts of a Biden-era final rule that set new minimum staffing standards for long-term care facilities as a condition of participation in Medicare or Medicaid programs. The June...more

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

King & Spalding

CMS Issues IPPS and LTCH PPS Final Rule for FY 2024

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On August 1, 2023, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule for FY 2024 (the Final Rule). In the Final Rule, CMS,...more

King & Spalding

HHS Finalizes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

King & Spalding on

Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more

Mintz - Health Care Viewpoints

HHS Drug Pricing Disclosure Rule: Chance at a Renewed Life Following District Court Appeal?

Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court. On August 21, 2019, the U.S. Department of Health and Human Services (HHS) filed a notice of appeal against a federal judge’s decision to...more

Robinson+Cole Health Law Diagnosis

Federal Judge Vacates Final Rule on Drug Pricing Transparency in Consumer Advertising

In a Memorandum Opinion, Judge Amit P. Mehta, of the U.S. District Court for the District of Columbia, vacated a U.S. Department of Health and Human Services (HHS) Final Rule, just days before its July 9 effective date. The...more

Holland & Knight LLP

Healthcare Law Update: July 2019

Holland & Knight LLP on

CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more

Dorsey & Whitney LLP

Court Invalidates Final Rule Requiring Advertisements to List Drug Prices Finding that CMS Exceeded Its Statutory Authority

Dorsey & Whitney LLP on

In a much anticipated decision, a federal judge ruled this week that the Trump Administration’s rule requiring drug manufacturers to list drug prices in television advertisements exceeds the agency’s authority. Back in May...more

Faegre Drinker Biddle & Reath LLP

Final Drug Pricing DTC Advertising Rule to Take Effect July 9 – But Faces Challenges from Pharmaceutical Companies

This winter we discussed new regulatory guidelines intended to increase transparency in Direct-to-Consumer (DTC) advertising including a proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would...more

McDermott Will & Emery

New OIG Exclusion Regulations About to Go into Effect

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

Hogan Lovells

HHS OIG Finalizes New Exclusion Rules as Administration Exits

Hogan Lovells on

With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

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