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Patient Access Regulatory Requirements Department of Health and Human Services (HHS)

Quarles & Brady LLP

HIPAA Reproductive Health Rule Vacated Nationally

Quarles & Brady LLP on

A federal judge in Texas has vacated almost all of the 2024 HIPAA Rule to Support Reproductive Health Care Privacy that created special protections for reproductive health care information, finding that the U.S. Department of...more

Seyfarth Shaw LLP

Time to Revisit Your HIPAA Documents After Reproductive Health Privacy Rule Vacated

Seyfarth Shaw LLP on

In the wake of a recent federal District Court decision, the reproductive health care HIPAA Privacy rules finalized during the Biden Administration have been vacated and plan sponsors should re-evaluate the language included...more

Quarles & Brady LLP

Departments Will Not Enforce 2024 Final Rule under MHPAEA

Quarles & Brady LLP on

The Trump Administration has just announced that it will pause enforcement of the September 2024 final rule (“Final Rule”) under the Mental Health Parity and Addiction Equity Act (“MHPAEA”)....more

Seyfarth Shaw LLP

Parity in Peril? Plan Sponsors Breathe Easier As Trump Administration Hits Pause on Enforcement of Mental Health Parity Final Rule

Seyfarth Shaw LLP on

On May 15, 2025 the Departments of Labor, Health and Human Services, and Treasury (the “Departments”) announced they will temporarily not enforce their new standards published under the mental health parity Final Rule last...more

Carlton Fields

Executive Order Seeks to Eliminate Discrepancies in Drug Pricing Between United States and Other Countries

Carlton Fields on

President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more

Arnall Golden Gregory LLP

Fourth Circuit Upholds OIG’s Unfavorable Advisory Opinion on Patient Assistance Program

On January 23, 2025, the U.S. Court of Appeals for the Fourth Circuit affirmed a federal district court’s ruling against the Pharmaceutical Coalition for Patient Access (“Coalition”), rejecting its challenge to an unfavorable...more

DLA Piper

DEA and HHS Propose Telemedicine Special Registration and Finalize Buprenorphine Telemedicine Prescribing Rules

DLA Piper on

On January 17, 2025, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) published two rules regarding telemedicine prescribing of controlled substances: a proposed rule...more

Epstein Becker & Green

HHS Recommends Re-Classification of Marijuana as a Schedule III Controlled Substance – A Bellwether for the Future of...

Epstein Becker & Green on

On August 30, an official at the United States Department of Health and Human Services (HHS) released one of the most significant announcements made at the federal level concerning marijuana reclassification. In a letter...more

Bricker Graydon LLP

HHS releases final rules on interoperability and information blocking

Bricker Graydon LLP on

On March 9, 2020, two final rules on electronic health information were issued by the Office of National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS)....more

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