News & Analysis as of

Patient Access Department of Health and Human Services (HHS)

Seyfarth Shaw LLP

SCOTUS on ACA Challenge: Seriously Guys, We’re Doing This Again?

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In a closely watched decision, the Supreme Court has upheld the authority of the U.S. Preventive Services Task Force (Task Force), preserving the Affordable Care Act’s (ACA) requirement that health plans cover preventive...more

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

Bass, Berry & Sims PLC

OIG Approves Proposal that Expands Patient Access to Covered Telehealth Services

Bass, Berry & Sims PLC on

On June 11, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03, approving a proposal by a management services organization (MSO) and its friendly PC...more

Seyfarth Shaw LLP

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

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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

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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

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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

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

Jones Day on

No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more

Saul Ewing LLP

OCR Imposes $200,000 Civil Money Penalty Against HIPAA-Covered Entity

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On March 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a civil money penalty (“CMP”) of $200,000 against Oregon Health & Science University (“OHSU”) for failing to...more

Seyfarth Shaw LLP

HHS’ Withdrawal of 2022 Guidance Raises Questions about Coverage for Gender-Affirming Care

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In a move with potentially significant implications for entities subject to the Affordable Care Act, the Department of Health and Human Services (HHS) has reversed course and now contends that Section 1557 of the Affordable...more

Quarles & Brady LLP

Trump Administration Rescinds HHS Guidance on Privacy of Gender Affirming Care Data

Quarles & Brady LLP on

On February 20, 2025, the U.S. Department of Health and Human Services (“HHS”) took action pursuant to President Trump’s Executive Order 14187 (“EO 14187”), which is aimed at ending gender affirming care for minors. EO 14187...more

Seyfarth Shaw LLP

Executive Order on Health Care Access for Gender-Affirming Treatments for Minors

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Following through on a campaign theme focused on transgender issues and access to gender-affirming health care, on Friday, January 28, President Trump signed an Executive Order, titled “Protecting Children from Chemical and...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

Holland & Knight LLP

OCR Shores Up Access to Healthcare with Nondiscrimination Protections

Holland & Knight LLP on

Access to quality healthcare services has long been a priority of the U.S. Department of Health and Human Services (HHS), and through its Office for Civil Rights (OCR) this agency has, since at least 2001, sought to provide...more

Quarles & Brady LLP

Uncertainty on Health Care Rules Amid Administration Change

Quarles & Brady LLP on

In recent months, several changes to healthcare rules regulations focusing on reproductive health care have been introduced. These include (1) privacy protections for reproductive health data under HIPAA, (2) expanding access...more

Vorys, Sater, Seymour and Pease LLP

Just Say No!  HIPAA and Requests for Reproductive Health Information

On April 22, 2024, the Office of Civil Rights issued a Final Rule titled HIPAA Privacy Rule to Support Reproductive Health Care Privacy (2024 Final Privacy Rule). Originally Published by the American Bar Association....more

Nelson Mullins Riley & Scarborough LLP

Biden Administration Finalizes Stronger Rules On Mental Health Coverage Parity

Summary: Under a final rule released by the Biden administration on Sept. 9, 2024, health insurers will be required to cover mental health care and addiction services on par with other medical conditions. This rule is part of...more

Sheppard Mullin Richter & Hampton LLP

Continuity in Coverage: CMS Extends the Unwinding SEP & Issues Final Rule for Medicaid and CHIP Enrollment

On March 28, 2024, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced that it is extending the temporary special enrollment period (the Unwinding SEP)...more

Polsinelli

New SAMHSA Rule Expands Access to Medications for the Treatment of Opioid Use Disorder

Polsinelli on

On February 2nd, the U.S. Department of Health and Human Services (HHS) released a final rule expanding patient access to medications for the treatment of opioid use disorder (“OUD”). This new final rule implements changes...more

Burr & Forman

Telehealth Prescribing Flexibilities for Controlled Substances Extended Through End of 2024

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The rule allowing for providers to prescribe controlled substances via telehealth, set to expire for new patient-provider relationships on November 11, has been extended through the end of 2024....more

Nelson Mullins Riley & Scarborough LLP

OIG Issues Unfavorable Opinion About Bundling Free Items with Reimbursable Services

On Oct. 25, 2023, the Office of Inspector General (OIG) for the Department of Health and Human Services (DHHS) issued an unfavorable opinion in response to a manufacturer’s proposal to offer and provide a free compatible...more

Epstein Becker & Green

Dr. Jack of All Trades? OCR’s New Telehealth Guidance Suggests High Expectations on Providers

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On October 18, 2023, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”), which is tasked with enforcing the Health Insurance Portability and Accountability Act (“HIPAA”), issued two new...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

King & Spalding

OIG Publishes Strategic Plan for Managed Care Oversight on New Featured Webpage

King & Spalding on

On August 28, 2023, OIG released a new webpage on managed care oversight, which features the HHS-OIG Strategic Plan for Oversight of Managed Care for Medicare and Medicaid. OIG has designated oversight of managed care as a...more

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