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Quality of Care Considerations in OIG’s Nursing Facility Compliance Guidance

In November 2024, the U.S. Department of Health and Human Services’ Office of the Inspector General (“OIG”) published the long-awaited Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (“Nursing...more

The Status of Providing Gender-Affirming Care to Minors in NY

In recent months, Executive Orders issued by the current Administration regarding gender-affirming care of minors have been the subject of much debate and litigation. The crux of these lawsuits is largely two Executive...more

HHS-OIG Issues Nursing Facility Compliance Program Guidance

On November 20, 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released the “Nursing Facility ICPG,” an industry-specific compliance program guidance for nursing facilities....more

Elevance Health Sues HHS and CMS Over Star Ratings System

On October 31, Elevance Health filed suit against the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) to challenge the 2025 Star Ratings system used for Medicare...more

HRSA to J&J: Cease Implementation of New 340B Rebate Model

As previously discussed , Johnson & Johnson (J&J) recently announced its intention to change its 340B Drug Pricing Program discount available to disproportionate share hospital (DSH) Covered Entities on purchases of STELARA...more

Montefiore Medical Center Settles HIPAA Breach for $4.75 Million

On February 6, the U.S. Department of Health and Human Services (HHS) announced a $4.75 million settlement with Montefiore Medical Center (MMC) for a breach of unsecured electronic protected health information (ePHI). The...more

Pharma Coalition Files Suit Against HHS over OIG Advisory Opinion

On November 9, the Pharmaceutical Coalition for Patient Access (PCPA) filed an action against the U.S. Department of Health and Human Services (HHS) after HHS’s Office of Inspector General (OIG) determined that a proposed...more

Transparency in Coverage Final Rule Took Effect on July 1

The Centers for Medicare & Medicaid Services’ Transparency in Coverage Final Rule took effect on July 1, following a six-month delay in implementation to allow payers to come into compliance....more

HHS Issues Guidance on Provider Use of Audio-Only Telehealth

On June 13, the U.S. Department of Health and Human Services (HHS) issued guidance to explain how audio-only telehealth can comply with HIPAA, while also emphasizing that this mode of telehealth services can expand healthcare...more

OIG Permits Arrangement Involving Physician-Owned Medical Device Company

In a recent Advisory Opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined that an arrangement involving certain physicians who have an ownership interest in a medical device...more

HHS Issues Guidance Clarifying Obligations of HIPAA Covered Entities

On March 22, the U.S. Department of Health and Human Services (HHS) issued guidance clarifying the obligations of covered entities to require their business associates to comply with HIPAA Administrative Simplification...more

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