OIG

Subscribe to OIG

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

The Biden Administration has expressed a deep concern about nursing home owners and related parties excessively profiting off of the residents they serve to the detriment of quality care. To address this concern, President Biden has asked Congress to implement laws that will empower federal agencies such as the Centers for Medicare and Medicaid Services (CMS) to increase accountability for facility ownership and expand enforcement authority at the ownership level. In addition, the federal agencies that regulate and oversee nursing homes (and some states[1]) have or plan to take action to ensure more transparency, compliance and enforcement regarding nursing facility ownership. Indeed, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) announced last week that it will undertake an audit of skilled nursing facility Medicare payments to related parties. Facility owners and operators should heed these developments, which as discussed below, focus on several fronts, and ensure that their relationships and operations are in accord with existing federal and state related party laws and regulations.…

Continue Reading Nursing Homes Beware: the Government has Increased Its Scrutiny of Related Parties

On August 19, the Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable advisory opinion, AO 22-16, with respect to the provision of gift cards to Medicare Advantage (“MA”) plan enrollees who complete certain steps in an online patient education program. This opinion underscores potential flexibility for with Medicare Advantage Organizations (“MAOs”) and their vendor partners to offer incentives to patients to engage in learning and health care engagement activities that may improve health outcomes without inappropriately steering patients toward particular providers or MA plans.…

Continue Reading OIG Blesses Gift Cards for Patient Engagement with Education Tool

The Office of the Inspector General (“OIG”) recently issued Advisory Opinion 22-08 (the “Advisory Opinion”), concluding that the provision of limited use smartphones by a federally qualified health center (“FQHC”) to existing, low-income patients (the “Arrangement”) lacked the intent required to violate the federal Anti-Kickback Statute (“AKS”)[1] and was not likely to generate remuneration prohibited under the federal Civil Monetary Penalties Law prohibiting inducements to health care program beneficiaries (“Beneficiary Inducement CMP”)[2].…

Continue Reading OIG Issues Favorable Advisory Opinion For Federally Qualified Health Center’s Smartphone Loan Program

On July 20, 2022, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert warning physicians and other practitioners to exercise caution when entering into telemedicine arrangements that have certain suspect characteristics.…

Continue Reading OIG Warns Physicians About Entering into Arrangements with Telemedicine Companies

On March 2, 2022, the Department of Health and Human Services (“HHS”) Office of the Inspector General (the “OIG”) issued a new advisory opinion (“AO 22-04”) related to a program through which the Requestor would provide certain individuals access to digital contingency management (“CM”) and related tools to treat substance use disorders (“Program”).  The OIG advised that it would not impose administrative sanctions under the Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements Civil Monetary Penalty Law (“CMPL”).
Continue Reading HHS OIG Signs Off on Substance Use Recovery Incentive Program

On February 4, 2021, the Department of Justice (“DOJ”), Office of Public Affairs, issued a Press Release (the “DOJ Press Release”) announcing that Kelly Wolfe, President of Regency, Inc., a medical billing company located in Florida, pleaded guilty to conspiracy to commit healthcare fraud through a “pernicious telefraud scheme”[1] involving fraudulent Medicare and CHAMPVA (Civilian Health and Medical Program of the Department of Veterans Affairs) claims for medically unnecessary durable medical equipment (“DME”) supplies.  As a result of Wolfe’s criminal plea, Wolfe could face up to 13 years in federal prison.  …
Continue Reading OIG Warns Telehealth Industry: “With Great Power Comes Great Responsibility”

On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) promulgated much-anticipated and significant final rules intended to “modernize” and “clarify” regulations regarding the Physician Self-Referral Law (“Stark Law Final Rule”) and the Anti-Kickback Statute (“AKS Final Rule”).  In the immediate future, Sheppard Mullin will post on this Healthcare Law Blog a comprehensive critical analysis of both the Stark Law Final Rule and the AKS Final Rule and their practical impacts.
Continue Reading Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays

Earlier this month, the U.S. Department of Health and Human Services Office of the Inspector General (the “OIG”) released a report highlighting concerns about the extent to which Medicare Advantage Organizations (“MAOs”) are using health risk assessments (“HRAs”) to improve care and health outcomes under the Medicare Advantage Program (“MA”), as intended, and about the sufficiency of oversight by the Centers for Medicare & Medicaid Services (“CMS”).
Continue Reading HHS OIG Issues Report Critical of Medicare Advantage Risk Adjustment Practices

On October 9, 2019, the Department of Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released proposed rules in conjunction with HHS’ “Regulatory Sprint to Coordinated Care.” The Regulatory Sprint to Coordinated Care “aims to remove potential regulatory barriers to care coordination and value-based care created by four key Federal health care laws and associated regulations: (1) the physician self-referral law [(“Stark Law”)]; (2) the anti-kickback statute [(“AKS”)]; the Health Insurance Portability and Accountability Act of 1996 [(“HIPAA”)]; and (4) the rules… related to opioid and substance use disorder treatment.”…
Continue Reading CMS and OIG Propose Regulatory Changes Impacting the Scope of the Stark Law and the Federal Health Care Program Anti-Kickback Statute

In Advisory Opinion No. 18-11, the Department of Health and Human Services Office of the Inspector General (the “OIG”) addressed a Medicaid managed care organization’s (“MCO”) proposal to pay its contracted providers and clinics (“Network Providers”) to increase the amount of Early and Periodic Screening, Diagnostic, and Treatment (“EPSDT”) services they provide to the MCO’s Medicaid members. Under the State’s MCO program, MCOs are required to provide EPSDT services and face liquidated damages for failing to do so. Under the proposed arrangement, the MCO would provide per member incentive payments (“Incentive Payments”) to Network Providers that meet certain benchmarks for increasing the amount of EPSDT services they provide to MCO members. The amount of the Incentive Payments would be determined based on the percentage increase of EPSDT services provided to the MCO’s existing members from one year to the next.
Continue Reading How Broad is the Managed Care Safe Harbor?