Office of the Inspector General ("OIG")

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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.
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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”).
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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

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently issued Advisory Opinion No. 13-03, declining a clinical laboratory company’s proposed plan to provide various laboratory services to physician practice groups for those patients of the physician practices not covered by a federal healthcare program. Although the proposed arrangement only includes patients who are not covered by federal health care programs, the OIG opined that the physician practices would receive prohibited remuneration and that the proposed arrangement could affect the decision-making of the practices’ physicians, leading to prohibited referrals for laboratory services covered by a federal healthcare program.
Continue Reading OIG Opinion 13-03

The Office of Inspector General has published its Work Plan for the 2013 Fiscal Year. This provides health care industry players with an insight into the activities that OIG plans to initiate or continue with respect to federal health care programs and operations in the upcoming fiscal year. Some new areas that OIG plans on investigating include:…
Continue Reading OIG Publishes Work Plan for 2013 Fiscal Year