News & Analysis as of

Patient Protection and Affordable Care Act (PPACA) › Prescription Drugs

The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal... more +
The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal subsidies to reduce the number of uninsured citizens. less -
ArentFox Schiff

New ADR Rule to Govern Disputes Between 340B Covered Entities and Drug Manufacturers

ArentFox Schiff on

Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more

Wiley Rein LLP

Recent Developments in Pharmacy-Related Legislation and Regulations

Wiley Rein LLP on

Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...more

McDermott Will & Emery

CMS Advises Preparatory Steps for Anticipated PrEP Coverage Transition to Medicare Part B

McDermott Will & Emery on

On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS...more

Bass, Berry & Sims PLC

Caution! Contents Hot: Key Benefits Issues to Watch During the Remainder of 2024

Bass, Berry & Sims PLC on

While the sweltering roil of temporary regulatory changes related to the COVID-19 pandemic may have cooled and the initial burst of SECURE 2.0 steam begins to dissipate, sponsors of employee benefit plans should keep their...more

Hogan Lovells

CMS finalizes regulation specifying all covered prescriptions drugs are essential health benefits

Hogan Lovells on

On April 2, 2024, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Notice of Benefit and Payment Parameters (NBPP) final rule (Final Rule), finalizing policies applicable to qualified health plans offered...more

Holland & Knight LLP

Holland & Knight Health Dose: March 12, 2024

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Groom Law Group, Chartered

This Week From the Hill (March 10 – 16, 2024)

Groom Law Group, Chartered on

Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more

Cozen O'Connor

Cozen Currents: Populism is Popular

Cozen O'Connor on

The Cozen Lens- • Regardless of which candidate is victorious in November’s presidential election, populism will be sure to shape the next administration’s policies. • In an age of populism, Big Tech has increasingly...more

Holland & Knight LLP

Holland & Knight Health Dose: February 27, 2024

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

ArentFox Schiff

Top Legal Considerations for the GCs and CFOs in the Life Sciences Industry in 2024

ArentFox Schiff on

The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more

Ballard Spahr LLP

HHS Announces Temporary Copay Accumulator Non-Enforcement Policy

Ballard Spahr LLP on

The United States Department of Health and Human Services (HHS) has filed court pleadings stating that it does not intend to initiate enforcement actions against plans that maintain copay accumulator programs....more

Mintz - Health Care Viewpoints

HHS Court Filings Indicate that Agency Intends to Preserve Copay Accumulators

Mintz - Health Care Viewpoints on

As we wrote about in our prior blog post, on September 29, 2023, John D. Bates of the U.S. District Court for the District of Columbia struck down a federal rule that permitted health plans and pharmacy benefit managers...more

Maynard Nexsen

Federal Court Strikes Down HHS Rule on Copay Accumulator Programs

Maynard Nexsen on

Last month, in HIV and Hepatitis Policy Institute et al v. HHS, Case No. 1:22-cv-02604-JDB (D.C. Sept. 29, 2034), the U.S. District Court for the District of Columbia struck down a Department of Health and Human Services...more

Ballard Spahr LLP

Prescription for Chaos: Copay Accumulator Programs Called Into Question

Ballard Spahr LLP on

Summary - Employers taking advantage of copay accumulator programs now face unexpected administrative complications following a recent federal court decision....more

Snell & Wilmer

Enforcement Back On: Departments Rescind Enforcement Relief for Machine Readable File Requirements under Transparency in Coverage...

Snell & Wilmer on

On September 27th, the Departments released FAQs about Affordable Care Act Implementation Part 61 (“FAQ 61”), announcing that the Departments are rescinding prior-issued enforcement relief for certain machine-readable file...more

Holland & Hart - The Benefits Dial

The Time Has Come, A Fact’s A Fact: Consider Adding a Welfare Plan Committee

Holland & Hart - The Benefits Dial on

The time may have come to add a welfare plan committee to your company’s governance of employee benefit plans. New legal obligations and other developments impose fiduciary risks for welfare plans similar to what already...more

McDermott+

McDermottPlus Check-Up: May 19, 2023

McDermott+ on

The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more

McGuireWoods Consulting

President Biden’s Budget Invests in Healthcare

McGuireWoods Consulting on

Although President Biden’s budget is almost always dead on arrival on Capitol Hill, it serves as an outline of the administration’s priorities. In the budget process, the House and Senate are to work separately on budget...more

Brownstein Hyatt Farber Schreck

Biden Reveals Health Care Priorities in FY 2024 Budget

Brownstein Hyatt Farber Schreck on

Today, Thursday, March 9, President Biden unveiled his Fiscal Year (FY) 2024 budget request, the third of his presidency. The $6.1 trillion proposal calls for $1.9 trillion in discretionary spending and $4.2 trillion in...more

Cozen O'Connor

Democratic AGs Ask CDC to Help Ensure Access to No-Cost HIV Prevention Drugs

Cozen O'Connor on

A group of 22 Democratic AGs submitted a letter to the CDC and the National Center for Health Statistics (NCHS) urging the agencies to ensure patients are not improperly charged copays for HIV prevention services by creating...more

McDermott Will & Emery

Welcome (But Last Minute) Relief for Prescription Drug Reporting Originally Due December 27

McDermott Will & Emery on

Section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 amended the Internal Revenue Code, the Employee Retirement Income Security Act of 1974 and the Public Health Service Act to add rules...more

Keating Muething & Klekamp PLL

Benefits Monthly Minute UPDATE: RxDC Reporting Relief

Keating Muething & Klekamp PLL on

On December 23, 2022, FAQs were released outlining late-breaking RxDC Reporting Relief. Of note - 1. For the 2020 and 2021 data submissions that are due by December 27, 2022, the Departments will not take enforcement...more

Alston & Bird

Health Care Week in Review: CMS Issues Prior Authorization Proposed Rule

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

Holland & Knight LLP

Holland & Knight Health Dose: December 6, 2022

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include: -...more

Patrick Malone & Associates P.C. | DC Injury...

U.S. judge cites religious freedoms in striking down insurance coverage for HIV drugs

Patrick Malone & Associates P.C. | DC Injury... on

​​​​​​​While increasing numbers of Americans tell pollsters that they are forgoing religion and seeing its practice diminish in importance in their lives, those with religious fervor are finding a federal judiciary willing to...more

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