Office of the Inspector General ("OIG")

The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department of Health and Human Services, Office of the Inspector General (“OIG”) concerning pharmaceutical manufacturers’ offers of cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries. The opinion under review was Advisory Opinion No. 22-19,[1] which we previously wrote about[2] and in which the OIG advised that if pharmaceutical manufacturers offered the proposed cost-sharing subsidies to Part D beneficiaries via PCPA, they could be subject to liability under the Federal health care program Anti-Kickback Statute (the “AKS”), even though the proposed subsidies would not violate the Civil Monetary Penalty Law’s Beneficiary Inducement Prohibition (“BIP”).Continue Reading District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

On December 28, 2023, the Office of Inspector General (the “OIG”) issued a favorable Advisory Opinion (No. 23-15) (the “Opinion”) to a consulting vendor (the “Requestor”) that wanted to provide up to $75 in gift cards to physician practices in exchange for referring the Requestor’s practice optimization services (e.g., workflow and performance assessment, data analytics, and certain Medicare eligibility and performance assistance). Among other things, the Requestor: (i) did not itself provide any services that were eligible for reimbursement under any Federal healthcare program to any of its clients, (ii) did not have an ownership or investment interest in any entity that provided items or services paid for by any Federal healthcare program, and (iii) received compensation from the physician practices that did not vary based on whether the physician practices received a greater or lesser reimbursement from Medicare based on the Requestor’s services. The Opinion concluded that this proposed arrangement would not generate prohibited remuneration under Section 1128B(b) of the Social Security Act (the “Act”), also known as the Federal Anti-Kickback Statute (“Anti-Kickback Statute”), and thus OIG would not impose administrative sanctions under Section 1128A(a)(7) (exclusion) or Section 1128(b)(7) (civil monetary penalty) of the Act on the Requestor. As always, the Opinion stipulated that it may only be relied on by the Requestor on the specific facts presented to OIG, and that certain state and federal laws may continue to limit similar arrangements. However, the Opinion indicates that the tight scope of potential marketing options for physician practice vendors could expand a bit for those who are similarly situated to the Requestor.Continue Reading New Marketing Possibilities for Vendors Contracted with Medicare Providers and Suppliers Following OIG’s Favorable Advisory Opinion on Limited Referral Bonuses

In late April this year, the Office of Inspector General, Department of Health and Human Services (OIG) announced that it would make changes to its existing body of healthcare compliance program guidance (CPGs) as part of its current Modernization Initiative.[1] These CPGs were directed at various segments of the health care industry and provided specific guidance on risks posed by industry practices. To kick off the initiative, OIG indicated that it would first issue a new general compliance program guidance (GCPG) by year end applicable to individuals and entities in all segments of the health care industry that would address overarching compliance elements regarding federal fraud and abuse laws, compliance program basics, compliance program effectiveness and general process and procedures. Thereafter, OIG said it planned to update existing industry-specific compliance program guidance (ICPG), which would include tailoring each to address fraud and abuse risk areas specific to a particular industry and describing the compliance measures that industry could take to reduce these risks[2].Continue Reading OIG General Compliance Program Guidance November 2023

Late last week, the Department of Health and Human Services Office of the Inspector General (“OIG”) posted Advisory Opinion No. 23-07 affirming the broad protection available for compensation to employed physicians under the bona fide employee exception and safe harbor to the federal Anti-Kickback Statute (the “AKS”). The opinion highlights flexibility for healthcare providers seeking to compensate employees in ways that align incentives with their employers, and particularly for physician practices to align employed physicians with use of the practices’ ambulatory surgery center (“ASC”) capabilities.Continue Reading OIG Confirms the Broad Protection of Employee Safe Harbor

On August 21, 2023, the New York State Office of the Medicaid Inspector General (OMIG) announced updates to the Medicaid overpayment self-disclosure program, which now includes an abbreviated process for reporting and explaining overpayments that are considered routine or transactional in nature and have been already voided and adjusted.Continue Reading New York Medicaid Providers Now Have Two Pathways to Self-Disclose Overpayments to the Office of the Medicaid Inspector General

Industry stakeholders have been eagerly waiting for the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Secretary of HHS to provide more clarity on federal information blocking enforcement rules since the Office of the National Coordinator for Health Information Technology (ONC) issued its final information blocking rules in 2020.[i] Continue Reading HHS OIG Publishes Eagerly-Anticipated Federal Information Blocking Enforcement Final Rule

The Department of Health and Human Services Office of Inspector General (OIG) recently announced changes to its process for informing healthcare industry stakeholders of new or updated Compliance Program Guidance (CPG). Historically, sector-specific CPG has been published in the Federal Register. Going forward, the OIG will publish all current and updated CPG on its website.Continue Reading OIG’s Modernization of Compliance Program Guidance: What to Expect

On March 24, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion 23-03 (the “Opinion”), in which it decided not to impose sanctions on an Arrangement to provide prepaid gift cards to patients for certain preventative screening tests (the “Arrangement”).Continue Reading New OIG Opinion Permits Gift Cards to Beneficiaries in Limited Circumstances

The Office of Inspector General (“OIG”) within the U.S. Department of Health and Human Services (“HHS”) is responsible for detecting and preventing fraud, waste, and abuse in federal health care programs. The OIG has authority to enforce the federal Anti-Kickback Statute (“AKS”) and the Beneficiary Inducements Civil Monetary Penalty law (“CMPL”). One of the ways that the OIG utilizes its enforcement authority is through the issuance of advisory opinions. Continue Reading OIG 2022 Advisory Opinions: Year in Review

On Thursday, February 23, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued its first Advisory Opinion (“AO”) of the new year – OIG AO No. 23-01 – permitting a drug manufacturer to provide financial assistance for transportation, lodging, meals, and other out-of-pocket expenses to eligible patients receiving the manufacturer’s drug (the “Arrangement”). Overall, OIG concluded that: (1) the risk of fraud and abuse presented by the manufacturer’s Arrangement was sufficiently low under the Federal anti-kickback statute; and (2) the remuneration offered under the Arrangement was not likely to influence a beneficiary to order the manufacturer’s drug (the “Drug”) from a particular provider and therefore did not constitute grounds for the imposition of sanctions under the Beneficiary Inducements CMP. Ultimately, the crux of this decision came down to the unique manufacturing and distribution of the Drug, which (i) is the only available potentially curative treatment for an ultra-rare disorder; (ii) pursuant to its FDA approval, can only be manufactured at a single facility, located on the campus of a treatment center (the “Treatment Center”); (iii) can only be administered within 3 hours after being manufactured; and thus, can only be administered at the single Treatment Center site.Continue Reading OIG Advisory Opinion Alert: Medical Flights for Patient Access

On December 5, 2022, the Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”), released their Semiannual Report to Congress for the period beginning on April 1, 2022, and ending on September 30, 2022 (the “Semiannual Report”).[1]Continue Reading OIG Shines a Spotlight on Nursing Homes, Opioid Misuse, and Health Equity in the FY2022 Semiannual Report