News & Analysis as of

Health Insurance Healthcare Drug Pricing

Alston & Bird

Health Care Week in Review: Agencies issued Requirements Related to the Mental Health Parity and Addiction Equity Act final rules;...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Manatt, Phelps & Phillips, LLP

Oregon PDAB Discusses Draft UPL Report

On August 21, Oregon’s Prescription Drug Affordability Board (PDAB) reviewed a draft upper payment limit (UPL) constituent engagement report, which captured feedback from patients, providers, health plans, manufacturers, and...more

Mintz - Health Care Viewpoints

2024 Pre-Election Analysis: Health Care Issues

In recent elections, health care has been one of the most hot-button issues with consequences for millions of Americans, and this election is no exception. The next administration and the 119th Congress have the potential to...more

Manatt, Phelps & Phillips, LLP

Maryland PDAB Releases Draft Upper Payment Limit Action Plan

On August 9, Maryland’s Prescription Drug Affordability Board (PDAB) released its draft action plan for establishing upper payment limits (UPLs) for drugs identified as causing or likely to cause affordability challenges. The...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2024 #2

News Briefs - State Governments Taking Steps to Make Rules on Healthcare AI - In the absence of federal guardrails on artificial intelligence in healthcare, state governments are figuring out their own rules of the road....more

Manatt, Phelps & Phillips, LLP

CMS Announces Part D Premium Parameters, New Policy to Stabilize Standalone Part D Premiums

The Centers for Medicare & Medicaid Services (CMS) released the Part D national average bid amount and Part D base beneficiary premiums for 2025. These figures set the premium costs and government subsidies for Medicare...more

Manatt, Phelps & Phillips, LLP

CMS Finalizes Part D Cost-Sharing Smoothing Guidance

The Centers for Medicare & Medicaid Services (CMS) finalized the second part of its guidance on implementation of the IRA’s Medicare Prescription Payment Plan (MPPP), known informally as Part D monthly out of-pocket...more

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

Manatt, Phelps & Phillips, LLP

Patient Impact of the Inflation Reduction Act - Administrative Options to Address Changed Incentives for Formulary and Utilization...

Executive Summary- The Inflation Reduction Act (IRA) makes significant changes to the Medicare Part D prescription drug benefit and also directs the Centers for Medicare and Medicaid Services (CMS) to enforce...more

McDermott+

Regs During an Election Year: What’s on the Menu?

McDermott+ on

Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when...more

Manatt, Phelps & Phillips, LLP

CMMI Issues Report on Status of Pending Drug Models

The Center for Medicare and Medicaid Innovation (CMMI) has provided new updates on CMS’ planned initiatives to address prescription drug costs in a blog post from Director Liz Fowler. One test, the Accelerating Clinical...more

Robinson+Cole Health Law Diagnosis

HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics

On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA...more

Manatt, Phelps & Phillips, LLP

Anti-Obesity Medications as Medicare Part D Drugs - Legal and Health Policy Rationales

Obesity is a complex, multifactorial disease that has serious health consequences, affects millions of Americans and drives hundreds of billions of dollars in annual health care spending. Scientific understanding of the...more

Burr & Forman

CMS Proposes to Resolve 340B Illegal Rate with $9M Pay-Out for Traditional Medicare; Medicare Advantage to be Negotiated Privately

Burr & Forman on

In July 2023, the Centers for Medicare and Medicaid Services (“CMS”) proposed a final rule to address illegal traditional Medicare rates paid in the 340B Drug Pricing Program from 2018-2022. CMS’ proposal would see CMS pay...more

Burr & Forman

Medicare Announced First 10 Drugs for Upcoming Price Negotiations

Burr & Forman on

In 2024, Medicare will, for the first time, have authority under the Inflation Reduction Act passed in 2022 to negotiate drug prices with pharmaceutical manufacturers. On August 29, the Centers for Medicare and Medicaid...more

Epstein Becker & Green

CMS Names Its First Ten Negotiated Part D Drugs: Inflation Reduction Act Updates

On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few...more

Epstein Becker & Green

SuperValu’s Effect on the FCA Scienter Standard and Impact to Future Litigation

Epstein Becker & Green on

n June 1, 2023, the U.S. Supreme Court unanimously settled a long-standing dispute over a subjective versus objective standard for scienter under the False Claims Act (FCA), holding that a defendant’s own subjective belief is...more

Akin Gump Strauss Hauer & Feld LLP

What a Difference a Year Makes: IRA’s Drug Pricing Provisions Turn One

This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more

Dickinson Wright

False Claims Act “Knowledge” Is a Subjective Standard

Dickinson Wright on

The Federal False Claims Act (“FCA”) allows private parties to bring lawsuits in the name of the federal government against defendants who allegedly “knowingly” present a false claim to the government for payment. The...more

Epstein Becker & Green

Local Law Amends New York City Charter and Establishes an Office of Healthcare Accountability

On June 8, 2023, the New York City Council passed a bill focused on healthcare accountability, with the goal of increasing access to healthcare services for New Yorkers. Entitled the Healthcare Accountability & Consumer...more

Knobbe Martens

Merck Sues Federal Government Over Medicare Drug Price Negotiation Program

Knobbe Martens on

On June 6, 2023, Merck & Co. filed a lawsuit against the U.S. government in federal court over the Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices...more

Mintz - Health Care Viewpoints

Senate HELP Committee Eyes Drug Pricing and PBM Regulation Beyond Federal Programs

On April 25, 2023, the Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders and Ranking Member Bill Cassidy introduced a package of legislation aimed at lowering prescription drug prices. The...more

King & Spalding

President’s Proposed Budget Emphasizes Existing Healthcare Priorities Ahead of 2024 Election

King & Spalding on

Released on March 9, 2023, President Biden’s proposed fiscal year (FY) 2024 budget focuses on existing healthcare initiatives while attempting to lower healthcare costs with an emphasis on prescription drug prices, seeking to...more

Robinson+Cole Health Law Diagnosis

340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court Win

We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary...more

Polsinelli

Health Care Reimbursement and Payor Dispute Update Special Edition - Year End Regulatory Review

Polsinelli on

The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like...more

34 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide