Tag archives: anti-kickback statute

Healthcare Regulatory Landscape Transformed by Stark, AKS Final Rules

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 November 20, 2020 long-awaited final rules changing the regulations addressing the Anti-Kickback Statute (“AKS”) and … Continue reading

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 Stark Law and Anti-Kickback Statute (AKS) regulations. We have summarized a portion of those proposed … Continue reading

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) regulations to adapt to and promote the US health care system’s transformation to value-based payment … Continue reading

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, … Continue reading

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 drug manufacturers’ rebates to plan sponsors or pharmacy benefit managers (PBMs) acting under contract with plan … Continue reading

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 for Information (“RFI”) on August 27, 2018, requesting public input on the following items: Care … Continue reading

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 certain factual certifications” about independence from donors, potentially steering Medicare beneficiaries toward certain prescription drugs. … Continue reading

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.… Continue reading

OIG approves free 30-day supply of drugs for patients experiencing coverage delay

The OIG released an advisory opinion stating that it would not impose administrative sanctions against two drug manufacturers or their affiliated pharmacy for offering a free 30-day supply of an antineoplastic drug to patients who experience a delay in the insurance approval process. Although the advisory opinion addresses the provision of a limited free supply … Continue reading

Feds unveil sweeping Medicare fraud “takedown”

On June 18, Federal officials announced criminal enforcement actions against 243 individuals across the country. The nationwide arrests mark the largest criminal health care fraud takedown in history and came as a result of Medicare Fraud Strike Force investigations. The Attorney General, HHS Secretary, and FBI Director announced the charges, which allege various health care … Continue reading

OIG cautions physician compensation must reflect only FMV for bona fide services provided

In its June 9, 2015 Fraud Alert, the OIG cautions that physician compensation arrangements must reflect only the fair market value for bona fide services that physicians actually provide. Even legitimate compensation arrangements may violate the anti-kickback statute if “one purpose of the arrangement is to compensate a physician for his or her past or … Continue reading

OIG approves charitable cost-sharing subsidies to financially-qualified patients

In an Advisory Opinion posted on June 4, 2015, the Office of Inspector General for the Department of Health and Human Services advised that a proposed arrangement involving financial assistance to individuals with chronic diseases would not constitute grounds for sanctions under either the provisions prohibiting inducements to beneficiaries or the Anti-Kickback statute. Advisory Opinion … Continue reading

OIG okays manufacturer’s subsidies to Medicare subjects in a study benefiting commercial product

In its recently published Advisory Opinion 15-07, the OIG approved a medical device manufacturer’s (Manufacturer’s) subsidies to Medicare patients in a clinical trial (Study) designed to test the effectiveness of a procedure using the Manufacturer’s specific commercial product. The OIG’s most recent opinion is significant because it pertains to a product-specific clinical trial sponsored by … Continue reading

Neurosurgeon’s $11M Guilty Plea Illustrates Potential Dangers of PODs

On Friday, May 22, a Detroit-area neurosurgeon accused of performing medically unnecessary spinal surgeries pleaded guilty to health care fraud in two federal criminal cases. Dr. Aria Sabat, 39, admitted Friday before U.S. District Judge Paul Borman that his participation in a physician-owned device distributorship (“POD”) caused him to compromise his medical judgment and to … Continue reading

Medigap plans can pass on in-network discounts to policyholders

The OIG released an advisory opinion April 29th stating that a Medigap plan would not face administrative sanctions for discounting up to 100% of policyholders’ inpatient deductibles at network hospitals for which it otherwise would be liable and then passing on a part of those savings to policyholders in the form of premium credits. Under the proposed … Continue reading

OIG holds that fee-waiver arrangement between labs and physician practices may violate Anti-Kickback Statute

In an Advisory Opinion posted on March 25, 2015, the Office of Inspector General for the Department of Health and Human Services stated that a proposed fee-waiving arrangement between a laboratory and physician practice could violate the federal anti-kickback statute and result in administrative sanctions, as well exclusion from participation in federal health care programs, … Continue reading

Hospital executives found guilty of kickback scheme

Three former hospital executives have been convicted of defrauding federal healthcare programs through an alleged kickback scheme to pay doctors to refer patients to the hospital. An Illinois federal jury returned guilty verdicts on March 19, 2015 against the former owner and CEO of Chicago’s Sacred Heart Hospital on 26 counts alleging payment of kickbacks … Continue reading

OIG Advisory Opinion: Free items provided by Maternal Health Program won’t trigger AKS or CMP liability

OIG Advisory Opinion 15-01, released February 2, concludes that an arrangement under which a privately-owned provider advertises and provides free diapers and portable playpen cribs to Medicaid beneficiaries in connection with services it provides under a state’s Maternal Infant Health Program (Program) could potentially generate prohibited remuneration under the anti-kickback statute (AKS). However, the advisory … Continue reading

Expanded protections proposed for AKS and CMP laws

New safe harbors to the Anti-Kickback Statute (AKS) have been proposed by the Department of Health and Human Services Office of Inspector General (OIG), as well as expansions and clarifications to the conduct exempted from civil monetary penalties (CMPs). The new safe harbors that the OIG proposed would cover: pharmacy cost-sharing waivers for Medicare Part … Continue reading

Proposed legislation would apply Stark Law to Medicaid

On May 15, 2014, Representative Jim McDermott (D. Wash.) introduced legislation that would extend the same limitation on reimbursement for designated health services reimbursed under the Medicaid program as currently applies under the federal prohibition on physician self-referrals commonly known as the Stark Law. The legislation, entitled the Medicaid Self-Referral Act of 2014, would prohibit … Continue reading

CMS seeks comments on burdens of Self-Referral Disclosure Protocol

The Centers for Medicare & Medicaid Services (“CMS”) has requested comments on the burdens of collecting information under the Self-Referral Disclosure Protocol (“SRDP”). The SRDP, released by CMS in September 2010 and revised in May 2011, gives providers a way to resolve actual or potential violations of the physician self-referral statute (known as the Stark … Continue reading

OIG finds no anti-kickback violations in a referral arrangement that shows no intent to generate Federal healthcare program business

On January 13, the Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 14-01, in which the OIG stated it would not impose sanctions against an independent placement agency referring seniors to two senior communities for a fee based on a percentage of each new resident’s charges for the first … Continue reading