News & Analysis as of

Department of Health and Human Services (HHS) Prescription Drug Coverage

Holland & Knight LLP

Holland & Knight Health Dose: March 5, 2024

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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

Venable LLP

February 29 Deadlines for Group Health Plans

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February 29 brings two annual deadlines for employers that sponsor a group health plan for their employees. Medicare Part D—Creditable Coverage Disclosure to CMS - An employer with a group health plan that provides...more

Manatt, Phelps & Phillips, LLP

Executive Summary: Tracking Telehealth Changes State-by-State in Response to COVID-19 - December 2023

S. 3430: Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 Introduced December 7, 202- This bill would require the Secretary of Health and Human Services to: Establish requirements for a code or...more

Ballard Spahr LLP

Prescription for Chaos: Copay Accumulator Programs Called Into Question

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

J.S. Held

AHLA Takeaway: Healthcare Executives, Is Your House In Order?

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Walking away from the American Health Law Association’s annual conference, I’m feeling energized from (re)connecting with friends and colleagues, inspired by the complex and transformational work being done throughout the...more

Foley Hoag LLP

HRSA ADR Panel Dismisses NACHC's 340B Complaint Against Two Drug Manufacturers

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The 340B program requires drug manufacturers to offer outpatient pharmaceuticals to statutorily defined covered entities (including certain hospitals and certain federal grantees, such as federally qualified health centers)...more

McDermott Will & Emery

Agencies Provide Guidance on Transparency in Coverage Rule Implementation

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On April 19, 2022, the US Departments of Labor, Health and Human Services, and the Treasury (collectively, the Departments) released Frequently Asked Questions (FAQs) regarding the implementation of certain reporting...more

Foley & Lardner LLP

Group Health Plans Subject to New Prescription Drug and Health Care Spending Reporting Requirements

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Under the Consolidated Appropriations Act, 2021 (the “CAA”), group health plans and health insurance issuers are required to submit certain information related to prescription drug and other health care spending to the...more

Polsinelli

Medicare 340B Payment Cut Déjà vu – Biden Administration Continues Trump Administration Part B Payment Reductions

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On Monday, July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the CY 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule). While the Proposed Rule...more

Foley Hoag LLP - Medicaid and the Law

Summer Reruns: ‘340B Contract Pharmacy Saga’ Back in the Spotlight as OGC Withdraws Advisory Opinion

Like the Brood X cicadas emerging from their 17-year chthonic slumber, summer 2021 saw the reemergence of something else set to dominate headlines: 340B contract pharmacies.  Given the link between the Medicaid drug rebate...more

King & Spalding

Federal Judge Blocks Implementation of 340B ADR Final Rule

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On March 16, 2021, a federal judge issued a preliminary injunction blocking HHS from implementing the 340B administrative dispute resolution final rule (the Final Rule) released in December 2020. The blocked Final Rule would...more

Fisher Phillips

Overview Of Employee Benefit Provisions In The Consolidated Appropriations Act

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The Consolidated Appropriation Act of 2021 was signed into law on December 27, 2020 and is an impressive 5,593 pages. According to the Senate Historical Office, the Act is the longest bill ever passed by Congress. Buried...more

Sheppard Mullin Richter & Hampton LLP

Trump Administration Finalizes The Transparency in Coverage Rule

On October 29, 2020, the Department of Health and Human Services (“HHS”), the Department of Labor, and the Department of the Treasury (collectively, the “Departments”) released the Transparency in Coverage Final Rules (the...more

White & Case LLP

Uncertainty on Drug Pricing Remains Following Trump Administration Executive Orders

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On July 24 2020, President Trump signed three Executive Orders targeting prescription drug prices and proposed a fourth.  The Orders represent the Trump Administration's latest effort to implement previously outlined...more

Bass, Berry & Sims PLC

Trump Administration Proposes Transparency Rule for Group Health Plans and Insurers

Bass, Berry & Sims PLC on

On November 15, 2019, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury (collectively, the Departments), unveiled a proposed rule (scheduled to be published on November...more

The Volkov Law Group

Avanir Pharmaceuticals Pays More than $108 Million to Settle Kickback Violations

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Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act.  While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more

King & Spalding

District Court Order Paves Way for HHS to Appeal Decision Finding 340B Rate Cut Unlawful Without First Providing a Proposed Remedy...

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On July 10, 2019, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia granted HHS’ request for a final judgment, clearing the way for the government to immediately appeal his earlier decision that...more

Baker Donelson

New PACE Rules Reduce Oversight, Increase Flexibility for Participating Organizations

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For the first time since 2006, CMS has issued updated rules affecting the Program for All-Inclusive Care for the Elderly, or PACE organizations. The final rule, published in the June 3, 2019 issue of the Federal Register,...more

ArentFox Schiff

Congress Moves Forward on Legislation to End Surprise Medical Bills

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The Senate Health, Education, Labor, and Pensions Committee recently voted to advance bipartisan legislation, called the Lower Health Care Costs Act (the Act), aimed at, among other things, curbing surprise medical bills. ...more

Baker Donelson

Government Appeals Decision Declaring 340B Payment Cuts Unlawful; District Court Continues to Consider Question of Relief

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The U.S. government has appealed a federal district court decision issued in December 2018 that found the Department of Health & Human Services (HHS) exceeded its authority by reducing Part B drug reimbursement to certain...more

BakerHostetler

Capitol Hill Healthcare Update

BakerHostetler on

Highlights this week: Democrats’ takeover of the House will yield big changes for healthcare policy in 2019; several GOP lawmakers active in healthcare policy are defeated; pharma pushes for Part D changes in the lame duck;...more

Baker Donelson

Administration Drug Pricing Proposals Could Reduce Provider Payments

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As the Trump Administration moves forward with proposed policy changes to address high drug prices, a common theme is emerging: a number of the proposals have the potential to reduce Medicare reimbursement to hospitals and...more

Farrell Fritz, P.C.

Medical Marijuana 104: Responsibilities of Health Insurers

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It will come as no surprise that patients who are thinking about getting certified for medical marijuana use have a number of questions relating to the cost of obtaining medical marijuana products....more

Mintz - Health Care Viewpoints

The Four Things That Surprised Us in the EpiPen False Claims Settlement

On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug...more

Mintz - Health Care Viewpoints

The Latest in the Epipen Medicaid Drug Rebate Saga – Where Are We Now?

The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by...more

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