News & Analysis as of

Medicare Public Comment Department of Health and Human Services (HHS)

Arnall Golden Gregory LLP

U.S. Department of Health and Human Services Rescinds "Richardson Waiver" Policy

On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...more

Foley Hoag LLP

CMS Releases Request for Information on Medicare Advantage Data

Foley Hoag LLP on

On January 30, 2024, CMS published in the Federal Register an RFI to seek input from the public regarding increased public releases of MA data to improve transparency in the program. CMS stated responses to this RFI may be...more

Troutman Pepper Locke

New Proposed Rules to Combat Health Information Blocking

Troutman Pepper Locke on

The U.S. Department of Health and Human Services (HHS) has just unveiled a proposed rule designed to penalize health care providers engaging in information blocking. Information blocking is a practice where health care...more

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

Holland & Knight LLP

HHS Releases Four Major Rules to Lower Drug Prices, Amend Anti-Kickback and Stark Laws

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) issued four major rules on Nov. 20, 2020, which was the final day for the Trump Administration to issue a rule with a 60-day implementation period for it to take effect...more

Baker Donelson

Oral Arguments Scheduled in Challenge to 340B Payment Cuts While HHS Solicits Comments on Potential Remedy for 340B Hospitals

Baker Donelson on

The D.C. Circuit Court of Appeals has scheduled oral arguments for November 8, 2019 in the ongoing lawsuit challenging Medicare payment cuts to hospitals in the 340B drug pricing program. The court is considering an appeal by...more

McDermott Will & Emery

CMS Publishes Proposed Amendments to Stark Law Advisory Opinion Regulations

McDermott Will & Emery on

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) published the CY 2020 Medicare Physician Fee Schedule Proposed Rule, which included substantial changes to the physician self-referral law (Stark Law)...more

Jones Day

Certain Pharmaceutical Discounts No Longer Safe Under the "Safe Harbors"?

Jones Day on

The proposed rule evidences the HHS' and the Administration's continued interest in reducing federal spending for pharmaceutical products. On February 6, 2019, the Department of Health and Human Services ("HHS") published...more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

Skadden, Arps, Slate, Meagher & Flom LLP

Sweeping Changes Proposed to Safe Harbors for Drug Discounts to Health Plans

The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more

Bass, Berry & Sims PLC

OIG Proposed Rule Seeks to Address Drug Pricing Concerns – But Will It?

In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more

Holland & Knight LLP

Administration Proposes Changes to the Drug Rebate Program

Holland & Knight LLP on

On Jan. 31, 2019, the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) issued a long-awaited proposed rule that would, if finalized, remove the existing legal "safe harbor" that protects...more

Foley & Lardner LLP

HHS Proposes New Rules To Eliminate Drug Rebates and Encourage Direct Discounts for Federal Beneficiaries

Foley & Lardner LLP on

On January 31, 2019, the United States Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) announced a proposed rule, which would eliminate certain drug rebates and encourage direct discounts for...more

McDermott Will & Emery

HHS Proposes to Revise Discount Safe Harbor Protection for Drug Rebates

On January 31, 2019, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (the Proposed Rule) as part of ongoing administration drug pricing reform efforts. The Proposed Rule would modify...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

Baker Donelson

OIG Releases RFI Focused on Removing Barriers to Value-Based Care

Baker Donelson on

The Department of Health and Human Services, Office of Inspector General (OIG) recently released a request for information (RFI) seeking public input on "how to address any regulatory provisions that may act as barriers to...more

Holland & Knight LLP

Healthcare Law Update: September 2018

Holland & Knight LLP on

Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

Dorsey & Whitney LLP

Calls for Modernizing the Stark Law Continue; CMS Seeks Public Input on Stark Law Reforms

Dorsey & Whitney LLP on

Many regulatory and legislative calls for modernizing the federal physician self-referral law (or “Stark Law”) in light of the move to value-based payment under Medicare have been made in recent months. Most recently, a...more

K&L Gates LLP

CMS Requests Public Comments on the Stark Law to Facilitate Care Coordination

K&L Gates LLP on

On June 25, 2018, the Centers for Medicare and Medicaid Services (“CMS”) published a request for information (“RFI”) seeking public input on how to address “undue regulatory impact and burden” of the federal physician...more

Mintz - Health Care Viewpoints

President Trump Delivers Much Anticipated Drug Pricing Speech

On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration’s plan to lower drug prices and reduce out-of-pocket costs....more

King & Spalding

Also In The News - Health Headlines - August 2016 #3

King & Spalding on

CMS Releases Medicare Outpatient Observation Notice For Public Comment – CMS announced that the public has the opportunity to comment on the Medicare Outpatient Observation Notice (MOON). The MOON is a standardized form...more

Epstein Becker & Green

CMS Releases Proposed Rule Reforming Medicare CLFS Payment Rates

Epstein Becker & Green on

The Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule [CMS-1621-P] in accordance with Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which establishes a new payment methodology...more

Mintz - Health Care Viewpoints

“Two-Midnight” Rule Needs Tweaking, Says Federal Judge

A Federal Judge found that the Department of Health and Human Services (DHHS) failed to comply with the Administrative Procedure Act (APA) when it cut hospital inpatient payments by 0.2% as part of its “two-midnight” rule. ...more

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