News & Analysis as of

Department of Health and Human Services (HHS) Rulemaking Process Prescription Drugs

Faegre Drinker Biddle & Reath LLP

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more

McCarter & English, LLP

DEA Telemedicine Update

The Drug Enforcement Administration (DEA), in concert with other federal agencies, has taken various steps in the past few months to strengthen a practitioner’s ability to prescribe controlled substances via telemedicine, a...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...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

Foley Hoag LLP

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

Foley Hoag LLP on

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

Sheppard Mullin Richter & Hampton LLP

Federal Government Announces Enforcement Discretion, Deferral For Certain Price Disclosures And Future Rulemakings

Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...more

ArentFox Schiff

Drug Importation Lawsuit Stays Alive, For Now

ArentFox Schiff on

In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the...more

McDermott Will & Schulte

White House Directs HHS to Model “Most-Favored-Nation” Price Caps for Part B and D Drugs

On September 13, 2020, the White House issued an Executive Order titled “Lowering Drug Prices by Putting America First” (the Executive Order), which directed the Secretary of the US Department of Health and Human Services...more

Mintz - Health Care Viewpoints

Trump Signs Executive Orders Aimed at Tying Domestic Drug Prices to Foreign Prices

President Trump has followed through on his threat to pharmaceutical manufacturers, signing new executive orders on Sunday that take a preliminary step toward the President’s goal of tying domestic drug prices to the prices...more

Mintz - Health Care Viewpoints

Administration Finally Releases Proposed Drug Importation Policies for Stakeholder and Public Comments

At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more

Robinson+Cole Health Law Diagnosis

Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to...

On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...more

Polsinelli

CY 2020 OPPS Proposed Rule – HHS Seeks Comments on 340B Payment Reductions and Remedies

Polsinelli on

This past week, CMS confirmed it will continue the 2018 and 2019 underpayment policy for certain 340B covered entities unless the D.C. Court of Appeals upholds the lower court’s ruling that it is unlawful. In that case, CMS...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Dorsey & Whitney LLP

Court Invalidates Final Rule Requiring Advertisements to List Drug Prices Finding that CMS Exceeded Its Statutory Authority

Dorsey & Whitney LLP on

In a much anticipated decision, a federal judge ruled this week that the Trump Administration’s rule requiring drug manufacturers to list drug prices in television advertisements exceeds the agency’s authority. Back in May...more

Gray Reed

Proposed Revisions To The Anti-Kickback Regulatory Discount Safe Harbor: What Does This Mean For The Drug Industry And For Your...

Gray Reed on

Continuing the Trump administration’s efforts to lower drug prices and reduce patient out-of-pocket costs, on February 6,2019, the U.S. Department of Health and Human Services Office of Inspector General (“HHS”) released a...more

Akerman LLP - Health Law Rx

TV Drug Commercials Must Disclose the Drug's List Price if HHS Adopts Proposed Rule

We are all familiar with prescription drug television commercials where it sounds like they hired a professional auctioneer to recite the drug side effects so fast you can hardly understand them....more

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