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
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 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
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
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
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
OIG maintains a list of all currently excluded individuals and entities called the "List of Excluded Individuals/Entities," or LEIE. Covered entities that hire – or continue to employ or work with – an individual or entity on...more
In what is becoming a steady trend, the Office of Inspector General (OIG) published another favorable opinion for an arrangement seeking to implement programs that support and engage family members who are increasingly...more
Last fall, CMS published a booklet, “Medicare Fraud & Abuse: Prevention, Detention, and Reporting.” It was prepared by the CMS Office of Inspector General to assist in combatting fraud and abuse in federal health care...more
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
On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more
In 2013, the HHS Office of Inspector General issued revised protocols outlining the process through which health care providers are able to self-disclose and resolve potential liability under the OIG’s civil monetary penalty...more
On April 18, 2016, the Office of Inspector General of the United States Department of Health and Human Services (“OIG”) issued a revised policy statement containing the new criteria that OIG intends to use in implementing its...more
Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more