News & Analysis as of

Department of Health and Human Services (HHS) Advanced Notice of Proposed Rulemaking (ANPRM)

Manatt, Phelps & Phillips, LLP

FTC Regulation Tracker – August 2023 Update

The FTC took a bit of a break in August, issuing only one Notice of Proposed Rulemaking on a relatively low-profile topic—Power Output Claims for Amplifiers Used in Home Entertainment Products. While the Proposed Rule is...more

Sheppard Mullin Richter & Hampton LLP

Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets

On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment...more

King & Spalding

He Actually Did It: Trump Administration Implements Medicare Part B “Most Favored Nation” Drug Pricing Reform

King & Spalding on

On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more

Manatt, Phelps & Phillips, LLP

President Trump Signs Executive Order Seeking to Link U.S. Drug Reimbursement to Foreign Prices

The Big Picture - In the latest election year action to address politically salient concerns with high drug costs, President Trump on Sunday signed an “Executive Order on Lowering Drug Prices by Putting America First.”...more

King & Spalding

Trump Signs Executive Order Calling for Increased Transparency and Upfront Disclosure of Hospital Charges and Out-of-Pocket Costs

King & Spalding on

On Monday, June 24, 2019, President Trump issued an executive order requiring HHS and other agencies to propose regulations designed to promote transparency and upfront disclosure by hospitals to patients of the charge prices...more

Holland & Knight LLP

New Proposed Medicare Part B Drug Reimbursement Model Raises Questions

Holland & Knight LLP on

• The Centers for Medicare & Medicaid Services (CMS) has announced a new proposed reimbursement model for certain Medicare Part B drugs and biologicals. • The proposed structure, called the International Pricing Index (IPI)...more

Mintz - Health Care Viewpoints

Trump Administration Proposes to Lower Drug Prices Through Medicare Part B

On Wednesday, October 25th, President Trump, along with HHS Secretary Alex Azar, introduced the administration’s new proposal to lower drug prices through Medicare Part B. The announcement follows ASPE’s morning release of a...more

Chambliss, Bahner & Stophel, P.C.

HIPAA Changes May Be on the Way

Since the major HIPAA overhaul implemented in 2013, there have been few changes to HIPAA privacy, security, and breach notification regulations. However, several HIPAA regulatory changes may now be on the way...more

Clark Hill PLC

Window On Washington - Vol. 2, Issue 25

Clark Hill PLC on

Outlook for This Week in the Nation's Capital - Senate Floor. The Senate is schedule to finish its work this evening on the minibus appropriations bill, a three-bill spending package that includes Energy and Water...more

Mintz - Health Care Viewpoints

Privacy and Security Round-up – Colorado Data Breach Law, Guidance from OCR

Privacy and security compliance obligations for health care companies remain hot topics this spring. Health care companies must now contend with data breach laws in all 50 states as well as keeping on top of federal HIPAA...more

Holland & Knight LLP

A New HIPAA Accounting Rule on the Horizon?

Holland & Knight LLP on

Under HIPAA, patients have a right to information about certain disclosures, referred to as an accounting. Under the current iteration of the regulations, covered entities and business associates need not account for...more

Hogan Lovells

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

Hogan Lovells on

On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...more

McDermott Will & Emery

OMB Reviewing Common Rule Overhaul

On January 4, 2017, the Department of Health and Human Services (HHS) submitted a draft final rule to amend the federal human research regulations to the Office of Management and Budget (OMB). These regulations, often...more

McDermott Will & Emery

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

McDermott Will & Emery on

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

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