Office of the Inspector General ("OIG")

Last month, the U.S. Department of Health and Human Services Office of Inspector (“OIG”) released a report that studied prior authorization denials and payment denials by Medicare Advantage Organizations (“MAOs”) (the “Report”). While the Report found that the “vast majority” of prior authorizations and payment requests were approved, the Report focused on the finding that MAOs “sometimes” denied prior authorization and payment requests that met Medicare coverage rules claiming that the denials delayed or denied beneficiaries’ access to medically necessary services.
Continue Reading HHS OIG Report On Prior Authorizations Under Medicare Advantage

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 Thursday, March 16, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued OIG Advisory Opinion (“AO”) No. 22-05, relating to subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial involving medical devices (the “Proposed Arrangement”). This is the third AO in a recent series of AOs (see AO 21-17 on November 19, 2021 and AO 21-13 on October 4, 2021) focused on Medicare cost subsidies in a clinical trial setting for serious conditions that affect large portions of the population in the US. Like these other AOs, OIG found that while the Proposed Arrangement could generate fraud and abuse risks under both the Federal anti-kickback statute (i.e., Section 1128A(a)(7) and 1128B(b) of the Social Security Act (“Act”)) and the Beneficiary Inducements CMP (i.e., Section 1128A(a)(5) of the Act), the Proposed Arrangement nevertheless presented a minimal risk of fraud and abuse under the law on the facts presented. Medical device manufacturers should pay close attention to this trend when considering trial designs and patient populations.

Continue Reading OIG Advisory Opinion Alert: Yet Another Favorable Decision for Medical Device Manufacturers

The United States Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a report concerning the use of telehealth to render behavioral health services to Medicaid enrollees, calling for greater evaluation and oversight in the hopes of encouraging states to implement changes to improve how their Medicaid programs use telehealth for behavioral health services, including mental health assessments, individual therapy, and medication management.

Continue Reading HHS OIG Studies State Medicaid Programs’ Use of Telehealth

On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute (“AKS”) safe harbor regulations as such regulations relate to the cost of prescription drugs as covered by the Medicare and Medicaid programs.  More specifically, the Final Rule amends the AKS discount safe harbor (“Discount Safe Harbor”) at 42 C.F.R. §1001.952(h) to eliminate safe harbor protection for drug discounts and rebates offered by pharmaceutical manufacturers to pharmacy benefit managers (“PBMs”) and  Medicare Part D prescription drug plan (“Medicare Part D”) sponsors.  In addition to making significant changes to the Discount Safe Harbor, the Final Rule creates two new pharmaceutical-related safe harbors: (i) a safe harbor applicable to certain prescription drug point-of-sale discounts as offered to Medicare and Medicaid beneficiaries to reduce their direct out-of-pocket prescription drug costs (the “Point-of-Sale Safe Harbor”) and (ii) a safe harbor applicable to flat fee arrangements paid by drug companies directly to PBMs for PBM services (the “PBM Service Fees Safe Harbor”).

Continue Reading Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates and Creates Two New Safe Harbors for Point-of-Service Discounts and PBM Fixed-Fee Arrangements

OIG Advisory Opinion No. 19-03

On March 6, 2019, the Department of Health & Human Services, Office of the Inspector General (“OIG”) published a new advisory opinion, No. 19-03 (the “AO”), addressing a proposed arrangement to provide free post-discharge support to patients. The OIG determined that it would not impose sanctions under either the Civil Monetary Penalties law (“CMPL”) or the federal health care program Anti-Kickback Statute (“AKS”), offering some comfort to providers who seek to implement – or who have already implemented – similar programs. However, the OIG’s assertion that the proposed program would not fall within the “promotes access to care” exception to the CMPL indicates a potentially worrisome and narrow interpretation of a facially broad statutory exception.
Continue Reading OIG Advisory Opinion No. 19-03: The OIG Puts the Healthcare Benefits of Free In-Home Care and the Risks of Patient Steering in the Balance

On January 12, 2017, just a week prior to President Trump’s Inauguration, the Department of Health and Human Service (HHS) Office of Inspector General (OIG) published a final Rule (Rule) regarding one of its most important enforcement mechanisms: its exclusion authority. The Rule, published nearly three years after it was initially proposed by the OIG back in May 2014, expands the OIG’s authority to exclude individuals and entities participation in federal healthcare programs and codifies certain provisions of the Affordable Care Act (ACA). The Rule’s original effective date was February 13, 2017, but due to the Trump Administration’s administrative freeze on the effective date of regulations that had not yet gone as of January 20, 2017, the Rule’s effective date is now set for March 21, 2017.
Continue Reading New OIG Exclusion Authority Rule Set To Go Into Effect on March 21, 2017

A recent Senate Finance Committee hearing investigated the effects of physician-owned distributorships (“PODs”) on costs of care and patient safety, suggesting that the momentum for greater oversight of such business arrangements continues to build.[1]
Continue Reading Federal Spotlight Continues to Shine on Physician-Owned Distributorships

The Office of Inspector General for the Department of Health and Human Services (OIG) recently defended its practices pertaining to hospital compliance reviews in a published response to a letter from the American Hospital Association (AHA), while simultaneously announcing a voluntary suspension of reviews of inpatient short stay claims after October 1, 2013.[1]
Continue Reading Medicare Hospital Compliance Reviews are Legal and Sound, According to OIG

The Health and Human Services (HHS) Office of Inspector General (OIG) provides health care providers an opportunity to disclose potential violations of certain Federal civil and criminal laws in relation to HHS contracts or subcontracts, pursuant to which OIG offers a means for facilitated resolution. A new publication issued by OIG offers guidance on completing the self-disclosure form, and has been posted alongside an FAQ on the protocol.[1]
Continue Reading New Guidance on Contractor Self-Disclosure

The Health and Human Services Office of the Inspector General (OIG) recently issued a Special Fraud Alert on laboratory payments to referring physicians.[1]  Specifically, the alert is concerned with Specimen Processing Arrangements and Registry Arrangements, which OIG believes pose substantial risks of fraud and abuse under the federal anti-kickback statute.
Continue Reading OIG issues Special Fraud Alert on laboratory payments to referring physicians