News & Analysis as of

Patient Access

Mintz - Health Care Viewpoints

OIG Issues Another Favorable Advisory Opinion on Patient Recruitment Efforts by Community Health Centers

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion on a proposed arrangement by a community health center (Health Center) designated under...more

Quarles & Brady LLP

Arkansas Law Prohibits Pharmacy Benefit Managers from Obtaining or Holding Pharmacy Permits

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On April 16, 2025, Arkansas House Bill 1150 (the “Bill”) was signed by Governor Huckabee Sanders. The Bill will have substantial implications for pharmacy benefit managers (“PBMs”) and pharmacies across the country....more

DLA Piper

Keeping Watch on the Inflation Reduction Act: Medicare Poses Part D Formulary Access Challenges

DLA Piper on

Key points include access to medicines in medicare is reduced as the IRA is implemented; fewer drugs are covered on Medicare Part D formularies in 2025 relative to 2024; medicines for serious conditions with high unmet needs...more

Foley & Lardner LLP

New Mexico Becomes Third State in the U.S. to Legalize Access to Psilocybin

Foley & Lardner LLP on

On April 7, 2025, New Mexico Governor Michelle Lujan Grisham signed into law SB-219, the Medical Psilocybin Act (the Act), making New Mexico the third state in the country to create a legal pathway for patients to access...more

Dinsmore & Shohl LLP

You’ve Got A Friend In Me: House Bill 236 Requires Providers to Accommodate Patient’s Chosen Advocates

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Stemming from concerns raised during the COVID pandemic, the Ohio General Assembly recently passed House Bill 236, dubbed the “Never Alone Act,” (“Act”) which became effective March 20, 2025. The law requires a wide range of...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

Saul Ewing LLP on

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

Pullman & Comley, LLC

Is a Civil Rights Lawsuit by Private Parties a Means to Enforce a Federal Free Choice of Medicaid Provider Provision? A Spending...

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CASE AT A GLANCE - In 2018, Planned Parenthood South Atlantic (PPSAT) and one of its patients, Julie Edwards, sued the administrator of South Carolina’s Medicaid program to enforce the “free choice of Medicaid provider”...more

Benesch

Dialysis & Nephrology Digest - March 2025

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As Medicare physician reimbursement continues in 2025 to suffer from damaging shortfalls due to budget neutrality and lack of an inflation adjuster, steps are being taken in Congress to address the issue. On January 31, the...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

Morgan Lewis - As Prescribed

FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

McDermott Will & Emery

Trump Administration May Expand Access to IVF Services

McDermott Will & Emery on

On February 18, 2025, US President Donald Trump signed an executive order directing his administration to develop policy recommendations within 90 days to increase access to in vitro fertilization (IVF) services and to reduce...more

Quarles & Brady LLP

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

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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

Seyfarth Shaw LLP on

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

Keeping Watch on Medicare as the IRA is Implemented: Formulary Management Practices

DLA Piper on

The Inflation Reduction Act (IRA), passed in 2022, made changes to the way drugs are covered and reimbursed in Medicare. While some of the changes taking effect this year could save the government money, beneficiaries may...more

Dickinson Wright

FCC Updates Broadband Map to Highlight Health Disparities

Dickinson Wright on

On December 13, 2024, the Federal Communications Commission (FCC) announced significant updates to its Mapping Broadband Health in America platform. This enhanced tool, now incorporating a range of new health metrics, aims to...more

Blake, Cassels & Graydon LLP

Des développements législatifs touchent le secteur québécois des soins de santé

Une nouvelle politique fédérale et des modifications législatives au Québec amènent des changements au sein du secteur québécois des soins de santé. Un éventail varié d’entreprises dans ce secteur pourrait devoir s’adapter en...more

Jones Day

Immigration Enforcement Directives Create New Hurdles for Hospitals Advancing Standard Patient Care

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While hospitals will no longer be formally considered sensitive locations under new immigration directives, health care facilities and providers maintain responsibility to protect access to patient care and confidentiality....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

Robins Kaplan LLP

Silent Dangers: The Link Between Depo-Provera, Brain Tumors, and Health Inequities

Robins Kaplan LLP on

For decades, Depo-Provera has been presented as a game-changing contraceptive—a quick injection every three months that promised simplicity and effectiveness. For millions of women worldwide, it seemed like the perfect...more

Dickinson Wright

Arizona’s New Behavioral Healthcare Laws – Part 1

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In 2024, the Arizona legislature passed five new Arizona laws directly affecting behavioral health care in Arizona. These laws run the gamut between refining definitions, requiring peer specialist trainings, new requirements...more

Holland & Knight LLP

OCR Shores Up Access to Healthcare with Nondiscrimination Protections

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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

Proskauer - Proskauer For Good

The Reproductive Healthcare Landscape Two Years Post-Dobbs

Just before the 2024 U.S. Election, Proskauer’s Reproductive Rights Steering Committee hosted a panel discussion addressing the current state of reproductive rights two years post-Dobbs....more

Sands Anderson PC

New HIPAA Reproductive Health Rule Requires Compliance by December 23, 2024

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A new HIPAA rule that goes into effect on December 23, 2024 requires each healthcare provider (and other HIPAA covered entities and business associates) to implement new workflows, policies, and procedures in responding to...more

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