In what may prove to be the most substantial fraud and abuse rulemaking in over a decade, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) published on
anti-kickback statute
CMS and OIG release sweeping proposals to modernize Stark Law and AKS regulations
On Thursday, October 17, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) will publish in the Federal Register two proposals to implement major changes to…
US regulators to align key health care regulations with transformation to value-based care system; CMS and OIG propose major overhaul of Stark Law and AKS regulations
On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued two sweeping proposals aimed at revising the Stark Law and Anti-Kickback Statute (AKS)…
DOJ intervenes in FCA lawsuit against Life Spine for an illegal kickback scheme
This week, the Department of Justice (DOJ) intervened in a False Claims Act (FCA) lawsuit against Life Spine and two of its executives, filed in the U.S. District Court for the Southern District of New York. The lawsuit alleges that Life Spine violated the Anti-Kickback Statute by paying more than $7 million in consulting fees, royalties, and intellectual property acquisition fees to surgeons to induce them to use Life Spine products in spinal surgeries. According to the complaint, the payment of these illegal kickbacks caused the submission of false claims to federal healthcare programs, including Medicare and Medicaid, under the theory that any claim for payment submitted in connection with an illegal kickback is “false” within the meaning of the FCA.
OIG proposes to eliminate safe harbor protection for drug manufacturer rebates to PBMs; proposes two new safe harbors
On January 31, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a proposed new rule that, if finalized, would eliminate existing protection under the Anti-Kickback Statute (AKS) “discount” safe harbor (42 C.F.R. 1001.952(h)) for…
OIG considers new safe harbors and other incentives to promote coordinated care
As part of the Health and Human Services Department’s (“HHS”) “Regulatory Sprint to Coordinated Care” efforts aimed at alleviating unnecessary regulatory barriers to coordinated care while protecting against fraud and abuse, the Office of Inspector General (“OIG”) issued a Request…
OIG rescinds advisory opinion to charity
For the first time, the OIG has rescinded an advisory opinion issued to a charity.
According to the OIG, the advisory opinion – issued in 2006 and modified in 2015 – was revoked because the charity “failed to comply with…
Physicians’ compensation structure results in $17M Stark Law fine and CIA for hospital
Lexington Medical Center (“LMC”), a 428-bed hospital in South Carolina, has agreed to pay $17 million to resolve allegations that it violated the federal False Claims Act (“FCA”), 31 U.S.C. §§ 3729 et seq., and Physician Self-Referral Law (“Stark Law”), 42 U.S.C. § 1395nn, by allegedly providing improper financial incentives to 28 physicians for referrals.
OIG finds ED drug-discount program would not trigger kickback sanctions
On June 27, 2016, the OIG posted Advisory Opinion No. 16-07 stating that an erectile dysfunction (ED) drug manufacturer would not face sanctions for a planned discount-card promotion for the drug.
Free introductory visits by home health provider are not a kickback, says OIG
A home health provider may offer free “introductory visits” to new patients without fear of implicating the Anti-Kickback Statute or Civil Monetary Penalties law, so long as those patients have already chosen it as their home health provider, OIG said…