On January 10, 2025, OIG posted a favorable advisory opinion approving a proposed program (Program) to provide patients who meet certain financial need criteria with free access to a pharmaceutical product that has limited...more
The HHS Office of Inspector General (OIG), in connection with its enforcement responsibilities, must exclude a party from the federal health care programs if the party is found to have violated certain federal laws. This type...more
UCHealth Settles FCA Violations for $23 Million - On November 12, the US Department of Justice (DOJ) announced that University of Colorado Health (UCHealth) agreed to resolve allegations that it violated the False Claims...more
Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional - On September 30, US District Judge Kathryn Kimball Mizelle of the Middle District of Florida held in a historic decision that the federal...more
As a general rule, healthcare employers are required to pay employed physicians and other contracted providers fair market value (FMV) for their services, but many employers do not understand relevant regulatory standards. ...more
On June 28, 2024, the Supreme Court overruled Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., and consequently invalidated the “Chevron Deference” — a cornerstone of administrative law since 1984. In the 6-3 decision...more
On June 28, 2024, the Supreme Court rejected the doctrine of Chevron deference in the closely watched case of Loper Bright Enterprises v. Raimondo. In a 6-3 decision, the Court held that Chevron’s rule that courts must defer...more
Senate Finance Health Subcommittee Holds Roundtable on Substance Use Disorder Care. Panelists and members discussed how to improve treatment in federal health programs. House Energy & Commerce Health Subcommittee Holds...more
On December 21, 2023, the OIG issued a favorable advisory opinion (Advisory Opinion 23-11) regarding the proposed subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial. The...more
The Centers for Medicare and Medicaid Services’ (CMS) new program Making Care Primary (MCP), is anticipated to begin July 1, 2024. In a previous blog post Foley breaks down major highlights of the new model. On...more
On October 20, 2023, OIG issued a negative Advisory Opinion in response to a proposal from a cochlear implant manufacturer (Requestor) to offer and provide free compatible hearing aids to certain patients (Proposed...more
In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online...more
On October 21, 2022, CMS announced new actions to increase accountability and scrutiny on nursing homes in the Special Focus Facilities Program (SFF Program), an oversight program for the poorest performing nursing homes in...more
SCOTUS Denies Cert In Cases Addressing FCA Pleadings Requirements - On Monday, October 17, 2022, the US Supreme Court rejected three petitions asking the Court to resolve a circuit split regarding the Rule 9(b)...more
In Advisory Opinion 22-17, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) concluded that a proposed restructuring of a loan and other contractual relationships between a health system...more
The Department of Health and Human Services’ Office of Inspector General (“OIG”) has offered an opinion on providing a gift card to certain Medicare Advantage plan enrollees who complete specific steps in an online patient...more
This opinion regards the provision of a gift card to certain Medicare Advantage (“MA”) plan enrollees who complete specific steps in an online patient education program....more
On May 2, 2022, OIG posted Advisory Opinion 22-10, regarding a proposal to provide financial assistance and free items to individuals with a particular disease. The Requestor, a non-profit organization dedicated to providing...more
Deputy Secretary and CMS Administrator Picks Would Fill Two Critical Policy Positions - On Thursday, the Senate Finance Committee held a confirmation hearing for two of the most important health policy officials nominated...more
2022 AG Elections- Former South Dakota Attorney General Steps Back into Contention for AG’s Office- •Marty Jackley, who formerly served as U.S. Attorney for South Dakota, South Dakota AG, and President of the National...more
Report on Medicare Compliance 29, no. 35 (October 5, 2020) - In a major national enforcement action, the Department of Justice (DOJ) and other federal agencies said Sept. 30 they have charged 345 people, including more...more
HHS has published additional Terms and Conditions associated with the acceptance of payments made from the $100 Billion Provider Relief Fund established pursuant to the Coronavirus Aid, Relief, and Economics Security Act...more
Report on Medicare Compliance 28, no. 38 (Oct. 28, 2019) - - Doctors Hospital of Augusta in Georgia agreed to pay $180,000 in a civil monetary penalty settlement over alleged violations of the Emergency Medical Treatment...more
The federal Anti-Kickback Statute prohibits the practice of knowingly and willfully offering, paying or receiving anything of value to encourage the referral of, or the recommendation of or arranging for the referral of,...more
Most health care providers recognize that submitting a knowingly false claim to a federally funded health care program violates the False Claims Act (FCA). However, it is less well known that indirectly "causing" someone else...more