News & Analysis as of

Regulatory Agenda Department of Health and Human Services (HHS) Rulemaking Process

ArentFox Schiff

Post-Chevron Health Care Regulations: The Dawn of a New Day

ArentFox Schiff on

On June 28, the US Supreme Court overturned the Chevron doctrine — the legal principle that the judiciary should defer to a federal agency’s reasonable interpretation of an ambiguous statute. Chevron reflected the view...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

Akin Gump Strauss Hauer & Feld LLP

ONC Steps into AI Regulation by Imposing Requirements for ‘Predictive Decision Support Interventions’; Also Updates Information...

On December 13, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a wide-ranging final rule, Health Data, Technology, and...more

McDermott+

Departments Propose Broader Batching and IDR Process Changes for Surprise Billing Claims

McDermott+ on

On October 27, 2023, the US Departments of Health and Humans Services, Labor and the Treasury (the Departments), along with the Office of Personnel Management, issued a proposed rule titled Independent Dispute Resolution...more

McDermott Will & Emery

HHS, DOL and Treasury Issue a Proposed Rule Increasing Federal IDR Fees

McDermott Will & Emery on

On September 20, 2023, the US Departments of Health and Human Services (HHS), Labor (DOL) and the Treasury (collectively, the departments) issued a proposed rule related to the No Surprises Act’s (NSA’s) federal independent...more

McDermott+

Implementation of the No Surprises Act Is Full of Surprises: What We Do and Don’t Know

McDermott+ on

It’s likely no surprise to anyone who has been following the implementation of the No Surprises Act over the last couple of years that we again find ourselves on an uncertain path. While Regs & Eggs has focused on some of the...more

Hogan Lovells

HHS announces polices related to future rulemaking procedures

Hogan Lovells on

On 24 November 2020, the Department of Health and Human Services (HHS) issued Notices in the Federal Register announcing two new policies related to future rulemaking procedures for all HHS agencies....more

Hogan Lovells

Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations

Hogan Lovells on

The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations issued by HHS or its constituent...more

Hogan Lovells

HHS proposes to sunset regulations Issued by FDA, CMS, and other regulatory agencies

Hogan Lovells on

Our team wanted to highlight a proposed rule issued by the U.S. Department of Health and Human Services (HHS) on 4 November 2020 - with only a 30-day comment period - that would establish sunset (expiration) dates for...more

Manatt, Phelps & Phillips, LLP

President Trump Signs Drug Pricing Executive Orders: How Will They Impact Pharma and Providers?

Prescription drug pricing is emerging as one of several healthcare issues that may become a focus of the presidential race as well as contested congressional races this fall. With pending legislative attempts to control drug...more

Bricker Graydon LLP

Changes coming to the Stark Law and Anti-Kickback Statute regulations

Bricker Graydon LLP on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued long-awaited proposed changes “to modernize and clarify the...more

Ballard Spahr LLP

Health Care and Price Transparency: The Latest Summary

Ballard Spahr LLP on

Federal executive agencies recently published two rules, one final and one proposed, aimed at publicizing the various costs associated with health care. A final rule, promulgated by the Department of Health and Human Services...more

Polsinelli

Analyzing the Proposed 2019 Stark Reforms

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The United Stated Department of Health and Human Services (“HHS”) published a notice of proposed rulemaking (NPRM) containing proposed changes to the Physician Self-Referral Law (“Stark Law,” or “Stark”) on October 17, 2019....more

Burr & Forman

Top Three Challenges Health Care Payers and Providers Will Face in 2020

Burr & Forman on

Health care providers operate in one of the most highly regulated industries in terms of compliance and governmental oversight. As a result, providers face a number of regulatory and compliance challenges each year....more

Robinson+Cole Health Law Diagnosis

HHS Proposes Changes to Permit Donation of Cybersecurity Technology

On October 17, 2019, the Department of Health and Human Services (HHS) published proposed rules to update the regulatory Anti-Kickback Statute (AKS) safe-harbors and exceptions to the Physician Self-Referral (PSR) Law, known...more

Polsinelli

Unique Opportunity to Influence Anti-Kickback Statute Rules

Polsinelli on

Starting today, the industry has 75 days to provide input on the proposed rules published in the Federal Register regarding the future enforcement of the Anti-Kickback Statute (AKS). ...more

Ballard Spahr LLP

CMS and OIG Release Long-Awaited Stark Law and Anti-Kickback Statute Proposed Rules

Ballard Spahr LLP on

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) recently released two proposed rules restructuring the Physician Self-Referral...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

Mintz - Health Care Viewpoints

Changes Ahead for HIPAA?

As we discussed last week, the Department of Health and Human Services (HHS) recently published its semi-annual regulatory agenda. In addition to the proposed rules on fraud and abuse, drug pricing, digital health, and...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

Mintz - ML Strategies

Federal Regulatory Agenda Update - June 2014

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Federal regulatory activity is at an all-time high, with more than 3,700 regulations in just the past year. This has caused the Code of Federal Regulations to grow to 238 volumes with nearly 175,000 pages – 4,000 of which...more

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