On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries via 501(c)(3) charities without running afoul of the Federal Anti-Kickback Statute (the “AKS”).
On April 25, 2022, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 22-07 which evaluated the risk of fraud and abuse under the federal anti-kickback statute (“AKS”) posed by an arrangement involving physician-ownership of a medical device company. The opinion identified six characteristics of the arrangement which greatly reduced the risk of fraud and abuse.…
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
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
The U.S. Department of Defense (“DOD”) claims that fraud and abuse is inhibiting the ability of the Defense Health Agency (“DHA”), the agency responsible for administering TRICARE, to support and deliver “integrated, affordable, and high quality health service to all DOD beneficiaries” and to be “a responsible steward of taxpayer dollars.” Noting that the Department of Justice (“DOJ”) has limited resources to prosecute those who commit fraud and abuse against the TRICARE program, the DOD now seeks to step in and ramp up enforcement.
Continue Reading The Military Health Care Fraud and Abuse Prevention Program: The Department of Defense Issues Proposed Regulations regarding TRICARE and Civil Monetary Penalties
On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its current form, would (i) amend the Anti-kickback Statute (“AKS”) Discount Safe Harbor to explicitly exclude discounts relating to price reductions or other remuneration offered by a pharmaceutical manufacturer to a Medicare Part D plan sponsor (“Plan Sponsor”), a Medicaid managed care organization (“MCO”), and/or a pharmacy benefit manager (“PBM”) under contract with such a sponsor or organization; and (ii) add two new safe harbors: a “Discounts Offered at the Point-of-Sale” safe harbor (“Point of Sale Safe Harbor”) and a PBM Fee Arrangement Safe Harbor (“PBM Safe Harbor”).
Continue Reading HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates
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
By Karie Rego
The Office of the Inspector General ("OIG") recently published several reports finding that prestigious east coast hospitals incorrectly billed the Medicare program for replacement medical devices. These are not new problems. In fact, it has been reported that providers often bill the Medicare program for replacement devices without accounting for the related credit which is refunded by the manufacturer to the provider.
The mission of the Office of the Inspector General ("OIG") is to protect the integrity of the programs and operations of the Department of Health & Human Services, for example Medicare, by detecting and preventing waste, fraud and abuse, and identifying opportunities to improve program economy, efficiency and effectiveness. The Work Plan describes both the ongoing and new audits and evaluations that the OIG plans to address in fiscal year 2011.