News & Analysis as of

Medicare Patient Assistance Programs

Arnall Golden Gregory LLP

OIG Approves Arrangement Regarding Patient Assistance Funds for Patients With Certain Rare Diseases, Pending Medicare Part D...

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...more

Akerman LLP - Health Law Rx

Teva FCA Decision Sheds Light on Varying Interpretations of the Elements of an FCA Claim

How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District...more

Holland & Knight LLP

OIG Advisory Opinion Highlights Further Concerns for Patient Assistance Programs

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Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more

Epstein Becker & Green

OIG’s Latest Advisory Opinion Raises Questions About Patient Assistance Programs

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On September 18, 2020, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) issued Advisory Opinion 20-05. In this unfavorable Advisory Opinion, OIG declined to approve a pharmaceutical...more

Robinson+Cole Health Law Diagnosis

Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more

Troutman Pepper

OIG Advisory Opinion Has Key Takeaways for Programs Designed to Assist Needy Patients

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Can a pharmaceutical manufacturer provide free items or services to financially needy Medicare and Medicaid beneficiaries without running afoul of the Beneficiary Inducements Civil Monetary Penalty (CMP) or the Anti-Kickback...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Holland & Knight LLP

OIG Issues Letter Declining to Impose Administrative Sanctions for Provision of Certain Free Drugs

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On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...more

Robinson+Cole Health Law Diagnosis

OIG Rescinds Advisory Opinion Due to Requestor’s Failure to Disclose Information

On November 28, 2017, the Office of Inspector General (OIG) rescinded advisory opinion 06-04, in which it had previously determined that a charity’s (Requestor) proposal to provide assistance to financially needy Medicare...more

Holland & Knight LLP

OIG Rescinds Advisory Opinion

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The Department of Health and Human Services Office of Inspector General (the OIG), on November 28, 2017, issued a Rescission Letter terminating Advisory Opinion Number 06-04 (Advisory Opinion 06-04). In Advisory Opinion...more

Cooley LLP

Blog: Nevada Enacts Transparency Bill Targeting Diabetes Drug Price Increases, Sales Representatives, PBMs, Nonprofit...

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As we discussed last week, Nevada’s Governor has signed into law SB 539, which provides sweeping transparency legislation related to several aspects of the pharmaceutical industry. Nevada joins several other states in...more

The Volkov Law Group

Drug Companies and Charitable Patient Foundations

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Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more

Baker Donelson

OIG Approves Charitable Program Providing Financial Assistance for MRIs in Advisory Opinion 15-14

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On November 13, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-14. The Arrangement at issue is a charitable program designed to assist financially needy...more

Patrick Malone & Associates P.C. | DC Injury...

Why Industry Drug-Assistance Programs Are a Sham

You probably heard about the recent price hike for a drug critical to AIDS patients when the manufacturer sold it to an evil hedge fund manager who promptly marked it up 5,000%. This prompted Los Angeles Times columnist...more

Locke Lord LLP

Locke Lord QuickStudy: Recent Health Care Updates

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On January 29, the Centers for Medicare & Medicaid Services (CMS) announced its plan to propose changes to the Electronic Health Record Incentive Program (EHR Incentive Program). According to CMS, the rule will address...more

Baker Donelson

OIG Supplemental Special Advisory Bulletin Raises New Concerns About Independent Charity Patient Assistance Programs

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In an effort to address new concerns about the independence of charity patient assistance programs (PAPs), the Office of Inspector General (OIG) released its Supplemental Special Advisory Bulletin: Independent Charity Patient...more

Epstein Becker & Green

OIG Supplemental Advisory Bulletin on Patient Assistance Programs Leaves Open Questions for High-Cost Breakthrough Drugs in...

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On May 21, 2014, the Office of the Inspector General ("OIG") of the Department of Health and Human Services issued a Supplemental Special Advisory Bulletin ("Supplemental Bulletin") addressing the risks that Independent...more

Cozen O'Connor

Ruminations on Observation

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On July 29, 2013, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) released a memorandum report finding that Medicare paid more on average for short inpatient stays than for...more

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