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Department of Health and Human Services (HHS) Anti-Kickback Statute Patient Protection and Affordable Care Act (PPACA)

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Goodwin

Health Headlines: January 2025

Goodwin on

Welcome to the second issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice. In this issue, we cover expected changes under the new Trump administration, the Food and Drug Administration’s...more

Stevens & Lee

Welcome to the Post-Chevron World: HHS on the Defensive

Stevens & Lee on

The Supreme Court’s recent ruling in Loper Bright Enterprises v. Raimondo (and its companion case, Relentless v. Department of Commerce), in which it overruled the Chevron doctrine, has received a great deal of attention...more

Akin Gump Strauss Hauer & Feld LLP

Updates in Co-Pay Assistance and Accumulators Legal Developments

Key Points - Patient advocacy groups have filed suit challenging the legality of the 2020 HHS Final Rule permitting co-pay accumulator adjustment programs. The Second Circuit has upheld HHS’ prohibition of co-pay...more

Foley & Lardner LLP

Latest Open Payments Data Released Under Heightened Government Scrutiny

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On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more

Seyfarth Shaw LLP

Xavier Becerra, Biden’s HHS Appointee, Anticipated to Support ACA, Access to Care, and Reproductive Rights

Seyfarth Shaw LLP on

Xavier Becerra was recently named by President Elect Joe Biden as his appointee to be Secretary of the Department of Health and Human Services. Now that Mr. Biden has been inaugurated, and coupled with the recent change in...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

King & Spalding

New Risks, New Rewards, New Exposure

King & Spalding on

Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

Foley & Lardner LLP

Healthcare Law Review: Overview of the U.S. Healthcare System

Foley & Lardner LLP on

The U.S. healthcare industry remains at a crossroads. The healthcare reform legislation passed under President Barack Obama in 2010, officially called the Patient Protection and Affordable Care Act (ACA) but widely referred...more

K&L Gates LLP

K&L Gates Triage: Triage in 2019: Health Care Topics to Watch in the New Year

K&L Gates LLP on

As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more

Mintz - Health Care Viewpoints

Health Care Weekly Preview from ML Strategies – September 2018 #2

With the first wave of Kavanaugh confirmation drama complete, the Senate is expected to vote on an opioid package this week. It’s a noteworthy step for the Senate although it’s still not entirely clear what a final package...more

Bass, Berry & Sims PLC

Stark Under the Microscope: Congress and HHS Examine Reform of the Stark Law for a Value-Based System

Bass, Berry & Sims PLC on

On July 17, 2018, the U.S. House of Representatives' Ways and Means Committee Subcommittee on Health ("Subcommittee") expressed its commitment to modernizing the Stark Law during a hearing in which industry and government...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Sheppard Mullin Richter & Hampton LLP

Lifting the Limits on Physician-Owned Hospitals: Can Regulators Prevail Where Legislators Have Stalled?

We reported, in early 2017, on what was then the latest legislative effort to repeal the Affordable Care Act’s amendment to the Stark Law’s whole hospital exception, which amendment has effectively prevented new...more

McDermott Will & Schulte

New OIG Rules Change Patient Incentive Program Landscape: Where Are the Limits Now?

With health care becoming more consumer-driven, health care providers and health plans are wrestling with how to incentivize patients to participate in health promotion programs and treatment plans. As payments are...more

McDermott Will & Schulte

New OIG Exclusion Regulations About to Go into Effect

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

Arnall Golden Gregory LLP

Stretching the Rules: HHS-OIG Expands its Exclusionary Authority

On January 12, 2017, the Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule expanding its authority to exclude providers from participation in federal healthcare programs. This...more

Bradley Arant Boult Cummings LLP

OIG Expands Exclusionary Authority

The Department of Health and Human Services, Office of Inspector General (OIG) published a final rule on January 12, 2017, expanding the OIG’s authority to exclude providers from participation in federal healthcare programs....more

Roetzel & Andress

Health Law Insights: January Newsletter

Roetzel & Andress on

ALERT: Health Reform Outlook for 2017: A Year of Major Uncertainty - Fulfilling their promises, Congressional Republicans moved to repeal the Affordable Care Act (ACA) on the first day of the new Congress when Senate...more

Akerman LLP

New Year, New Resolutions, New Safe Harbors

Akerman LLP on

As we welcome the new year and its endless possibilities, we also welcome some new Anti-Kickback Statute safe harbors and concomitant business possibilities. In December, the U.S. Department of Health and Human Services...more

Hogan Lovells

HHS OIG Finalizes New Exclusion Rules as Administration Exits

Hogan Lovells on

With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

McDermott Will & Schulte

Money Talks: Important Takeaways from the OIG’s Civil Monetary Penalties Final Rule

McDermott Will & Schulte on

In a burst of rulemaking in December 2016, the US Department of Health and Human Services, Office of Inspector General, issued two new final rules containing significant changes to OIG’s Civil Monetary Penalty authorities....more

BakerHostetler

Providers Breathe Sigh of Relief with New Anti-Kickback Safe Harbors and CMP Exceptions

BakerHostetler on

On December 7, 2016, the HHS Office of Inspector General (OIG) finalized a set of rules first proposed in 2014 adding new anti-kickback law safe harbors and protecting additional conduct from enforcement under the civil...more

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