News & Analysis as of

Patient Access Biden Administration

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

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

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

Polsinelli

Medicare Changes to Make Drug Coverage More Manageable in 2025

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Within the last few months, the Centers for Medicare and Medicaid Services (CMS) has issued guidance that will reduce the financial burdens of paying for prescription drug coverage for Medicare patients. The guidance outlines...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

Robinson & Cole LLP

HHS Seeks to Strengthen Protections of Reproductive Health Information with Proposed Changes to HIPAA

Robinson & Cole LLP on

On April 12, 2023, the U.S. Department of Health & Human Services (HHS) released a Notice of Proposed Rulemaking (Proposed Rule) that seeks to enhance safeguards of reproductive health care information through changes to the...more

Foley Hoag LLP

Recent Biden Administration Actions on Access to Medication Abortion

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In the first week of 2023, the Biden administration announced two actions centered on expanding access to medication abortion. The first involves a policy change by the FDA regarding the ability of retail pharmacies to...more

Polsinelli

Fall Congressional Forecast: Eye on Federal Funding and Health Care

Polsinelli on

Congress faces a crowded agenda this fall comprised of must-pass policy initiatives and potential political messaging opportunities in the lead up to the November midterm elections. With control of both chambers at stake, the...more

Morgan Lewis

Evolving Laws and Litigation Post–Dobbs: The State of Reproductive Rights as of August 30

Morgan Lewis on

Federal litigation was in the spotlight last week with two major decisions related to the Biden-Harris administration’s Emergency Medical Treatment and Labor Act (EMTALA) guidance on providing abortion services as emergency...more

Wyrick Robbins Yates & Ponton LLP

Patient Privacy and Reproductive Health Data in the Dobbs Aftermath

The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and Planned Parenthood v. Casey, raises new issues regarding the privacy of reproductive health data. That’s because...more

Stinson LLP

CMS Says That EMTALA Overrides State Law in Pregnancy Emergencies

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On July 11, 2022, United States Secretary of Health and Human Services, Xavier Becerra, issued a letter to hospitals stating that the Federal Emergency Medical Treatment and Active Labor Act (EMTALA) requires physicians and...more

Proskauer - New Media & Technology

FTC Blog Post Highlights Regulatory Focus on Collection of Location and Health Data

On July 11, 2022, the Federal Trade Commission (FTC) published “Location, health, and other sensitive information: FTC committed to fully enforcing the law against illegal use and sharing of highly sensitive data,” on its...more

Nelson Mullins Riley & Scarborough LLP

HHS Issues Reminder about EMTALA Obligations to Pregnant Women Post-Dobbs

The Secretary of the Department of Health and Human Services (“Secretary”) issued a letter to healthcare providers ("Letter") and associated guidance on July 11, 2022, reminding applicable providers of their EMTALA...more

Nelson Mullins Riley & Scarborough LLP

REACHing for More - Benefit Enhancements in the ACO REACH Model

The new, value-based ACO REACH Model reflects the Biden-Harris Administration’s mission in promoting health equity, with a strong focus on improving access to healthcare for individuals in underserved communities. Payments to...more

Jones Day

U.S. Federal Actions Support Continued Telehealth Services for Medicare Beneficiaries

Jones Day on

On March 15, 2022, President Biden signed into law the Consolidated Appropriations Act, 2022 (the "Act"), extending certain Medicare telehealth reimbursement flexibilities for 151 days following the end of the declared...more

Polsinelli

Telehealth Policy Update

Polsinelli on

There have been several significant developments with regard to Federal government telehealth policy. These include the recently enacted appropriations bill funding the Federal government for the balance of the fiscal year, a...more

Proskauer - The Patent Playbook

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more

Jones Day

Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending

Jones Day on

Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more

Burr & Forman

Health Care E-Note - May 2021

Burr & Forman on

Updated CDC COVID-19 Guidance - The CDC has updated its guidance regarding masking and physical distancing for fully vaccinated individuals. Once fully vaccinated, people can resume activities without wearing masks or...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, May 2021 # 7

Hogan Lovells on

In Washington: President Biden announced Monday that the U.S. will share an additional 20 million doses of domestically-authorized coronavirus vaccines with foreign countries by the end of June. The U.S. will export doses of...more

Morgan Lewis

Mechanics of COVID-19 Vaccine IP Waiver in View of Trade-Related Aspects of IP Rights

Morgan Lewis on

The Biden-Harris administration announced on May 5 its intent to support a waiver on intellectual property protections on COVID-19 vaccines. The scope of any potential waiver is subject to further negotiation at the World...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, May 2021 # 4

Hogan Lovells on

In Washington: The Food and Drug Administration (FDA) has authorized the use of the Pfizer vaccine for 12 - 15 years old. An advisory committee of the Centers for Disease Control and Prevention is expected to meet shortly to...more

Hogan Lovells

Ramping up the drug pricing debate: Dueling bills and paying for health care infrastructure

Hogan Lovells on

The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 16

Hogan Lovells on

In Washington: The White House may split a $3 trillion economic recovery proposal into two bills, The New York Times reported Monday. The proposal comes as the economy struggles through the coronavirus pandemic-caused...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 10

Hogan Lovells on

In Washington: Congressional Democrats are urging the Treasury Department and IRS to “take every effort” to implement a new tax exemption for unemployment benefit recipients. The just-signed coronavirus relief law makes...more

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