News & Analysis as of

Regulatory Standards Fraud and Abuse

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

Proskauer - Health Care Law Brief

Recent FCA and AKS Litigation Highlights Use of Different Standards in Different Circuits

In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of...more

Ervin Cohen & Jessup LLP

GAO Report: Federal Regulation of Food-Related Issues Is Fractured

The U.S. Government Accountability Office (“GAO”) issued a July 2022 report to urging federal agencies to better coordinate regulatory guidance on food-related challenges, including diet-related chronic health conditions and...more

Jones Day

Fourth Circuit Limits Who Can Act "Knowingly" Under False Claims Act

Jones Day on

Health care industry participants frequently operate under nuanced legal frameworks that apply to the receipt of government funds. A breach of these regulations can open the door to draconian liability under the FCA even when...more

Polsinelli

Senate to Consider Pared Down, But Still Unfavorable, Amendments to FCA

Polsinelli on

As we wrote on July 28, 2021, Senator Chuck Grassley has sponsored a bill (S. 2428) that would amend the False Claims Act (FCA) in several significant ways that are unfavorable to defendants. On October 28, 2021, the Senate...more

Akerman LLP - Health Law Rx

Caveat Emptor: Private Equity Firms Are Increasingly Vulnerable to Qui Tam Lawsuits

The U.S. Department of Justice (“DOJ”) has settled six qui tam lawsuits brought in various jurisdictions by whistleblowers against a private equity firm and its portfolio healthcare companies. ...more

The Volkov Law Group

Drug and Medical Device Fraud Risks Increase in Pandemic Era

The Volkov Law Group on

The drug and medical device/testing industry is under significant pressure to develop new products to address the COVID-19 pandemic.  The federal government is increasing spending and support of drug and device companies in...more

McDermott Will & Emery

Special Report - 2019 Digital Health Year in Review - January 2020

McDermott Will & Emery on

Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...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

Thomas Fox - Compliance Evangelist

King Lear Week: Part II – Engaging Your Audience

Today, I want to consider how health regulatory agencies are engaging their audiences through independent monitoring, to serve important public policy goals – specifically to help ensure a ready supply of quality health care...more

Akerman LLP - Health Law Rx

New Consequences for Unpaid Medicare Overpayments

For years, CMS has had the authority to refuse to enroll new Medicare providers if they or their owners have an unpaid Medicare overpayment, but CMS was not exercising this authority. Now, it appears that CMS is going to...more

Bradley Arant Boult Cummings LLP

Designing Clinical Studies To Avoid Regulatory Scrutiny

Practical advice following the Primex Clinical Laboratories settlement - Earlier this year, the Department of Justice (DOJ) announced a $3.5 million settlement against Primex Clinical Laboratories, a California laboratory...more

Robinson+Cole Health Law Diagnosis

“Brand Memo” from the U.S. Department of Justice: Reading Between the Lines

On January 25, 2018, Associate Attorney General Rachel Brand issued a memo on behalf of the U.S. Department of Justice (DOJ) prohibiting certain DOJ uses of federal agency guidance documents in affirmative civil enforcement...more

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