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Articles by Jesse Witten
The Latest on Pharmaceutical Company-Sponsored Diagnostic Testing Programs | JD Supra
March 21, 2025 To embed, copy and paste the code into your website or blog: The OIG concluded that the requestor’s arrangement implicates the Anti-Kickback Statute (AKS) because it results in remuneration to patients and health care professionals that may induce the purchase or prescription of the requestor’s drug.
Construction Company Settles False Claims Act Allegations Relating to Small Business Subcontracting for $2.8 Million
On May 12, the U.S. Department of Justice announced a $2,804,110 settlement with Hensel Phelps Construction Company to resolve allegations that it violated the False Claims Act (FCA) by circumventing federal regulations designed to encourage contract awards to service-disabled veteran owned small businesses (SDVOSBs).
OIG Issues Favorable Advisory Opinion for Free Genetic Testing and Counseling Program Offered by a Pharmaceutical Company | JD Supra
On April 11, 2022, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion No. 22-06 (AO 22-06), which approved a biopharmaceutical company’s proposed arrangement to provide free genetic testing and genetic counseling to patients.
HHS-OIG Updates Its Self-Disclosure Protocol | JD Supra
On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (OIG) updated and renamed its Self-Disclosure Protocol (SDP). The OIG had last updated the SDP in 2013. The update changes and clarifies several features of the SDP. Name Change The OIG has changed the name of the protocol from the “Provider Self-Disclosure Protocol” to the “Health Care Fraud Self-Disclosure Protocol” (SDP).
OIG Issues Advisory Opinion Allowing Pharmaceutical Company’s Payment of Travel, Food and Lodging Expenses for Indigent and Rural Patients | JD Supra
In its final Advisory Opinion of 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) approved a pharmaceutical company’s request to provide financial assistance to patients who were prescribed a cancer drug that the company manufactured.
CMS Overhauls Stark Law Regulations as Part of Regulatory Sprint to Coordinated Care
Saturday, December 12, 2020 On November 20, 2020, in addition to new Stark Law regulations intended to accommodate value-based financial arrangements with physicians, the Centers for Medicare and Medicaid Services (CMS) issued final regulations that significantly overhaul existing Stark Law exceptions, special rules and definitions. Published in the Federal Register on December 2, these regulatory changes will make it easier for health care entities to comply with the Stark Law.
Sweeping Stark Law and Anti-Kickback Statute Final Rules Published | JD Supra
As part of its Regulatory Sprint to Coordinated Care, on November 20, 2020, the Department of Health and Human Services (HHS) published two final rules which make significant and sweeping changes to regulations relating to the Physician Self-Referral Law (Stark Law) and the Anti-Kickback Statute. Links to the final rules are available online through HHS and will be published in the Federal Register on December 2. The preambles and final rules together amount to 1,676 pages.
OIG Publishes Fraud Alert for Pharmaceuticals Speaker Programs
November 20, 2020 Did the OIG Just End In-Person Speaker Programs? by: Jesse Witten Beltway Buzz: 2021 Labor and Employment Forecast by: James J. Plunkett CFTC Unanimously Approves Final Rule for Granting Exemptions From DCO... by: Kevin M. Foley and Stanley V.
HHS-OIG: Pharma Manufacturer’s Proposed Copayment Assistance Program ‘Highly Suspect’ Under Federal Anti-Kickback Statute | JD Supra
On September 23, 2020, the Office of Inspector General of the United States Department of Health and Human Services (OIG) publicly released Advisory Opinion 20-05 (AO 20-05), a significant, adverse opinion rejecting a proposal by a pharmaceutical manufacturer to provide copay assistance to Medicare Part D beneficiaries who were prescribed medications that the company manufactures.
CMS Issues Explanatory Guidance Regarding Stark Blanket Waivers | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
Fifth Circuit Affirms Dismissal of Qui Tam Complaint Due to Lack of Materiality in Significant False Claims Act Decision | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
The Elimination of Kickbacks in Recovery Act and COVID-19: Clinical Laboratory Compliance With EKRA in Current Pandemic | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
CMS’ Blanket Waivers To The Stark Law Offer Relief To Providers During COVID-19 Emergency | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
601 Charged in Record-Breaking Annual Health Care Fraud and Opioid “Takedown”
On June 28, the Department of Justice (DOJ) announced another record-breaking annual nationwide health care fraud “takedown.” The action, led by the Criminal Fraud Section of the Department of Justice, includes charges against 601 individuals, including charges against 156 doctors, nurses and other licensed medical professionals.
More Than 400 Charged in Largest-Ever Health Care Fraud Enforcement Action, While Hundreds More Face Potential Exclusion
The Department of Justice (DOJ) announced on July 13 what it’s calling the largest-ever health care fraud enforcement action. The action, led by the Medicare Fraud Strike Force, involves criminal charges against 412 defendants—including 115 physicians, nurses and other licensed medical professionals—for allegedly participating in health care fraud schemes involving approximately $1.3 billion in supposed false billings.
Circuit Courts Limit Reach of Federal False Claims Act in Two Defense Contractor Cases
Two recent federal circuit court decisions demonstrate the importance to defense contractors of the “rigorous” materiality standard for False Claims Act (FCA) cases announced by the Supreme Court last year in Universal Health Services, Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016).
Fourth Circuit Leaves Undisturbed a District Court Decision Against the Use of Statistical Sampling, and Holds that the United States Has the Unfettered Power to Veto FCA Settlements | The National Law Review
The Fourth Circuit recently decided an interlocutory appeal raising important issues arising under the False Claims Act (FCA). See United States ex rel. Michaels v. Agape Senior Community, Inc., No. 15-2145, 2017 WL 588356 (4th Cir. Feb. 14, 2017). The court held that the government has the unreviewable power to veto a proposed settlement in a qui tam action even though it declined to intervene in the case.
Sixth Circuit Rules That Relators Are Not Entitled to a “Relaxed” Rule 9(b) Standard
In a recent blow to relators, the Sixth Circuit held that courts cannot “relax” the heightened pleading requirements of Federal Rule of Civil Procedure 9(b) in False Claims Act (FCA) cases. Rule 9(b) requires that the “circumstances constituting fraud” be pled with “particularity.” Some courts have held that a “relaxed” Rule 9(b) standard should be applied where relators lack access to all of the facts necessary to enable them to plead fraud with particularity. In United States ex rel. Hirt v.
Ninth Circuit Court Limits False Claims Act Liability for Alleged Unlawful Marketing of Pharmaceuticals
A U.S. District Court recently issued a wide-ranging opinion that pharmaceutical companies should consider when evaluating whether their speaker programs comply with the Anti-Kickback Statute (AKS). The ruling also provides one of the first judicial interpretations of the “recommendation” prong of the AKS, an interpretation that contradicts the government’s position on the statute. In United States ex rel. Brown v. Celgene Corp., No. 10-cv-03165, 2016 U.S. Dist. LEXIS 180628 (C.D. Cal. Dec.
Chicago Ordinance Requires Licensing of Pharmaceutical Representatives
The City of Chicago has amended its municipal code to add “pharmaceutical representative” to the long list of business activities requiring occupational licensing. In the face of strong industry opposition, the City Council approved an ordinance amending Chicago Municipal Code § 4-6-010(c)(30) on November 16, 2016. Set to take effect July 1, 2017, the ordinance requires all individuals who market or promote pharmaceuticals to health care professionals to pay an annual licensing fee of $750.
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