New and Revised Federal Health Care Program Anti-Kickback Statute Safe Harbors I. Value-Based Framework for Value-Based Arrangements OIG provides background and a high-level description of its framework for value-based arrangements protected under the proposed new and revised safe harbors. The new safe harbors were originally proposed in 1993. The Situation: As health care providers transition to value-based care models, they have often been forced to rely on exceptions and safe harbors under the Stark Law and Anti-Kickback Statute ("AKS") that were never designed with value-based payment arrangements in mind. New Safe Harbors; Point-Of-Sale Safe Harbor and the PBM Service Fee Safe Harbor . ANTI-KICKBACK STATUTE “SAFE HARBORS” There are also some referrals that do not violate the Anti-Kickback Statute, which is called “safe harbors.” It is a provision for the Anti-Kickback statute that is deemed not violating the rule. Serving All U.S. Cities. The Anti-Kickback Statute, 42 U.S.C. November 24, 2020 - New safe harbors proposed for the Stark Law and Anti-Kickback Statute could help providers expand their telehealth and remote patient monitoring platforms.. A Final Rule issued last week by the Health and Human Services’ Office of the Inspector General creates seven new safe harbors for value-based arrangements, and modifies five already in place. Anti-Kickback Statute Safe Harbors. The federal anti-kickback statute created criminal penalties for knowingly and willfully paying for business referrals for services covered by any federal healthcare program. As indicated above, the final rule also creates two new safe harbors to the Anti-Kickback Statute. On December 7, 2016, the Department of Health and Human Services Office of the Inspector General (OIG) issued a final rule to establish new safe harbors under the anti-kickback statute and civil monetary penalty (CMP) rules, as well as update existing safe harbors. New Safe Harbors for Remuneration Exchanged Under Value-Based Arrangements In the Final Rule, OIG provides new flexibility for organizations engaged or considering involvement in value-based The proposed rule would establish five safe harbors, three of which are based on pre-existing statutory exceptions. Anti-Kickback Statute Safe Harbors / Anti-Kickback Statute Safe Harbors 877-789-9707. On October 9, 2019, the Office of Inspector General (OIG) published proposed revisions to the federal Anti-Kickback Statute (AKS). Experienced healthcare lawyers can explain what actions and relationships qualify for safe harbor protection. The first is point-of-sale reductions, by which the rule creates a new safe harbor for discounts that are offered on Part D drugs or drugs covered by Medicaid MCOs at … The Anti-Kickback Statute is rigid in interpreting the safe harbors for cases to be exempted. B. The Final Rule issued several new safe harbors and modified existing safe harbors under the Anti-Kickback Statute. In addition, the proposed rule would make a technical correction to an existing safe harbor. Stakeholder reaction was largely New Safe Harbors. We are finalizing the proposed new and modified anti-kickback statute safe harbors and exception to the Beneficiary Inducements CMP, with modifications and clarifications explained 3 84 FR 55766 (Oct. 17, 2019). The session will provide an overview of the Anti-Kickback Statute (AKS) and review what it prohibits, as well as review the Statute's available safe harbors. The OIG added a new safe harbor that permits eligible entities to provide free or discounted local transportation to established patients in order to access medically necessary services. Stark & Anti-Kickback Revisions Finalized: New Safe Harbors On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) issued two final rules to modernize and clarify the Stark Law and the Anti-Kickback Statute (AKS). On the same day, the OIG also promulgated an interim final rule relating to two additional safe harbors for shared risk arrangements. It also discusses the interplay between the AKS and other laws, including the False Claims Act and Stark Law. It will also show how violation of the AKS can raise FCA concerns, and it will provide an assessment of enforcement activities, … (fn1) As a result, there are now a total of 23 safe harbors to the anti-kickback statute. Value-Based Arrangement Exceptions: OIG finalized three new safe harbors for remuneration exchanged between eligible participants in a value-based arrangement that fosters better coordinated and managed patient care. First, the proposed rule would create two new safe harbors with no pre-existing statutory basis: Healthcare Financial Management Association 4 The medical device lobby is recommending three new safe harbors to the Anti-Kickback Statute in response to a Request for Information by the HHS Office of Inspector General. § 1320a-7b(b) (“AKS”), prohibits anyone from knowingly and willfully offering, paying, soliciting, or receiving remuneration in order to induce reimbursable business under federal or state healthcare programs.. Although some types of arrangements previously were offered “safe harbor” from prosecution, others had to be approved on a case-by-case basis. On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations. By Eric D Fader, Geoffrey Kaiser, Chris J Kutner, Ada Kozicz and Benjamin P Malerba III Tuesday, February 2, 2021. (“OIG”) issued a sweeping set of final rules to amend the safe harbors under the Federal anti-kickback statute (“AKS”)1 and to amend the civil monetary penalty law (“CMP”) by codifying a revision to the definition of “remuneration.”2 These final rules were published in … The federal Anti-Kickback Statute contains a statutory exception or “safe harbor” providing that the AKS will not apply to “any amount paid by an employer to an employee (who has a bona fide employment relationship with such employer) for employment in the provision of covered items or services.” 42 U.S.C. On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations. 3. In Short. The association also recommended that the requirement that recipients share at least 15 percent of the cost be reduced or completely eliminated. Federal Anti-Kickback Statute Safe Harbors . Sweeping new federal physician self-referral law (referred to as the “Stark” law) regulations and federal anti-kickback statute safe harbors released November 20, 2020 contain broad new exceptions for “value based arrangements,” and ease regulatory compliance in other areas, as well as adding welcome clarity to both sets of laws. The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published a final rule to modify and add new safe harbors under the federal Anti-Kickback Statute (AKS) and to codify a new Civil Monetary Penalty law (CMP) exception for beneficiary inducements related to healthcare system improvements. The Department of Health and Human Services has enacted safe harbor regulations that define practices that are not subject to the AKS. The Federal Anti-Kickback Statute and Safe Harbors: A Practical Guide covers all safe harbors currently in place, as well as the interplay between the Anti-Kickback Statute and other laws. The new safe harbors to the Anti-Kickback Statute will be effective January 19, 2021. The Federal Anti-Kickback Statute and Safe Harbors (2020) This book covers all safe harbors currently in place, including investments, office and equipment leases, personal and management services, warranties, discounts, and many others. Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements. The Anti-Kickback Statute laws do create “safe harbors,” which are ways/conduct that won’t qualify as violations of the Anti-Kickback Statute. In other words, only those arrangements that precisely meet all of the conditions set forth can only afford the safe harbor protection. 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