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Jessica Christensen

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The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion No. 25-09 on August 12, 2025. The favorable opinion that found that a medical device manufacturer that was partly physician-owned qualified for the small entity investment safe harbor of the Anti-Kickback Statute (“AKS”).

The entity—a non-public developer, manufacturer, and seller of devices relating to emergency stroke treatment—sought an advisory opinion regarding whether the fact that it is owned in part by physicians, including the creator of the medical devices, who may “order or purchase [the] devices or recommend a hospital order and purchase [the] devices[]” would constitute grounds for exclusion from Federal health programs or the imposition of civil monetary penalties based on whether the arrangement ran afoul of the AKS.Continue Reading HHS-OIG Issues Favorable Advisory Opinion to Device Manufacturer under the Small Entity Safe Harbor

The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a favorable advisory opinion that relates to whether two drug assistance programs would run afoul of the Federal anti-kickback statute (“AKS”).

In good news for the entity that requested the opinion, a United States corporate affiliate of a pharmaceutical manufacturer of the drug at issue (the “Requestor”), the OIG stated that it would not impose administrative sanctions for either program, despite the potential to generate prohibited remuneration under the AKS.  Although the advisory opinion is only applicable to the specific programs at issue and can be relied upon only by the Requestor, there are some potential considerations that could be applied more broadly to other arrangements.Continue Reading OIG Issues Favorable Opinion on Drug Assistance Programs

On September 28, 2023, the Office of Inspector General of the Department of Health and Human Services (OIG) issued Advisory Opinion 23-06, involving a proposed services arrangement between a pathology laboratory (the Requestor) and third-party referring pathology laboratories. 

The OIG determined that, if the requisite intent were present, the proposed purchase of the technical component of anatomic pathology services from certain laboratories would generate prohibited remuneration under the federal Anti-Kickback Statute (AKS). In doing so, the OIG highlighted the proposal’s lack of commercial reasonableness and reaffirmed its longstanding suspicion over arrangements that “carve out” federal health care program business.Continue Reading OIG Issues Unfavorable Advisory Opinion Concerning Pathology Lab’s Proposed Purchased Services Arrangements

Good news for Medicare-eligible patients: the Centers for Medicare & Medicaid Services (CMS) is making it easier for individuals with limited income to apply and reenroll in Medicare Savings Programs (MSPs).

On Sept. 21, CMS issued a final rule that will streamline the enrollment and eligibility processes for the MSPs and align them with the requirements and processes for other public programs. The rule will also serve to reduce the complexity of the application and reenrollment process for eligible individuals. Continue Reading CMS Final Rule Streamlines Medicare Savings Program Eligibility and Enrollment

On February 16, 2023, the Federal Bar Association (FBA) kicked off its sixth annual Qui Tam Conference with its customary “Year in Review” panel, which spotlighted the key False Claims Act (FCA) decisions and developments from 2022. Consistent with the annual press release and FCA recovery statistics issued by the U.S. Department of Justice (DOJ) earlier this month, the panel made clear that despite lower recoveries, 2022 was a busy and important year for FCA enforcement.

For the fiscal year ending September 30, 2022, total FCA recoveries surpassed $2.2 billion. Although this number represented a drop of more than 50% from 2021 when FCA recoveries exceeded $5.7 billion due to several high-profile settlements, 2022 saw a record amount of FCA enforcement activity, with 948 new FCA matters initiated, and 351 settlements and judgments under the FCA: the second-highest number recorded in a single year.Continue Reading FCA enforcement going strong in 2022, particularly in declined health care qui tams

During a press conference on Monday, March 29, 2021, Florida Governor Ron DeSantis signed Senate Bill 72, which grants civil immunity to corporations, hospitals, nursing homes, government entities, schools, and churches from COVID-19-related lawsuits, except in cases of gross negligence or intentional misconduct.  Plaintiffs who file suit in Florida alleging coronavirus-related injuries will face…

Earlier this week, the Department of Health and Human Services (HHS) Office of General Counsel issued Advisory Opinion 20-02, which declared that the Public Readiness and Emergency Preparedness Act (PREP Act), combined with the HHS Secretary’s March 10, 2020 declaration, preempts state or local requirements that would prevent pharmacists from ordering or administering COVID-19 tests…

With portions of the country beginning to reopen, on May 18, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its recommendations to state and local officials for best practices regarding the reopening of nursing homes. Because nursing homes have been severely impacted by COVID-19, CMS issued a memorandum to state officials regarding the…

According to the U.S. Centers for Disease Control and Prevention (CDC), although there have been imported cases of Covid-19 detected in the United States, “at this time, the virus is NOT currently spreading in the community in the United States.”[1]  However, on Tuesday, February 25, 2020, Nancy Messonier, the CDC’s Director of National Center for Immunization and Respiratory Diseases, urged American businesses and families to start preparing for the possibility of a large outbreak, noting that the virus spread quickly once it appeared in other countries.[2]  Although the World Health Organization (WHO) still has not called Covid-19 a pandemic, Mike Ryan, head of WHO’s health emergencies program, suggests that countries need to be doing everything they can to contain the virus, at least in order to buy some time.[3]

To that end, the CDC has been tapping some of its quarantine powers.  CDC has authority to oversee quarantine and isolation of persons who carry communicable diseases, derived from the Commerce Clause of the Constitution, and codified in section 361 of the Public Health Service Act (42 U.S.C. § 264).[4]  The CDC’s authority, however, is limited to persons arriving in the United States or traveling between states.  Each state has its own laws regarding quarantine powers, and the CDC also relies on state authorities to implement and enforce quarantine orders.  There is some risk that state health authorities could act in a manner that is inconsistent with the intentions of the CDC (to be more or less restrictive).  The CDC has not issued a large-scale isolation and quarantine since the Spanish influenza pandemic of 1918-1919.[5]Continue Reading Potential Tensions Lie Ahead Between Federal and State Authorities Over the Application of CDC Quarantine Powers