News & Analysis as of September 19, 2024

Patient Protection and Affordable Care Act (PPACA)

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

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

Stevens & Lee on 7/29/2024

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

Updates in Co-Pay Assistance and Accumulators Legal Developments

Akin Gump Strauss Hauer & Feld LLP on 10/17/2022

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

Latest Open Payments Data Released Under Heightened Government Scrutiny

Foley & Lardner LLP on 7/9/2021

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

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

Seyfarth Shaw LLP on 1/22/2021

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

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

King & Spalding on 11/24/2020

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

New Risks, New Rewards, New Exposure

King & Spalding on 6/24/2020

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

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

Foley & Lardner LLP on 10/11/2019

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 Triage: Triage in 2019: Health Care Topics to Watch in the New Year

K&L Gates LLP on 1/31/2019

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

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

Mintz - Health Care Viewpoints on 9/11/2018

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

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

Bass, Berry & Sims PLC on 7/19/2018

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

Healthcare Law Update: May 2018

Holland & Knight LLP on 5/30/2018

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

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on 3/13/2018

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

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

Sheppard Mullin Richter & Hampton LLP on 3/5/2018

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

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

McDermott Will & Emery on 4/11/2017

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

New OIG Exclusion Regulations About to Go into Effect

McDermott Will & Emery on 3/3/2017

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

Stretching the Rules: HHS-OIG Expands its Exclusionary Authority

Arnall Golden Gregory LLP on 2/15/2017

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

OIG Expands Exclusionary Authority

Bradley Arant Boult Cummings LLP on 1/31/2017

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

Health Law Insights: January Newsletter

Roetzel & Andress on 1/27/2017

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

New Year, New Resolutions, New Safe Harbors

Akerman LLP on 1/24/2017

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

HHS OIG Finalizes New Exclusion Rules as Administration Exits

Hogan Lovells on 1/13/2017

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

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

McDermott Will & Emery on 12/22/2016

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

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

BakerHostetler on 12/20/2016

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

OIG Revises and Adds Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Rules

Saul Ewing LLP on 12/19/2016

In what may be one of the final federal health care revisions implemented during the Obama Administration, on December 7, 2016 the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”),...more

OIG Revises Safe Harbors under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

McDermott Will & Emery on 12/14/2016

On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary...more

At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

Mintz - Health Care Viewpoints on 12/12/2016

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...more

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