There are many variations and modifications with respect to these safe harbor and rental exception parameters. Specifically, leases of space in hospitals or hospital-owned medical office buildings implicate theAnti-Kickback Statute and Stark Law. In the preamble to the 1991 final safe harbor rules, the OIG explained that the anti-kickback statute “on its face prohibits offering or acceptance of remuneration, inter alia, for the purposes of ‘arranging for or recommending purchasing, leasing, or ordering any... service or item’ payable under Medicare or Medicaid.” The lease arrangement is set out in writing, is signed by the parties, and specifies the premises it covers. § 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. In addition, the timeshare exception, like the Stark rental of office space exception and the Anti-Kickback Statute space rental safe harbor, still requires that all elements used by the licensee (premises, supplies, equipment personnel) be set in advance and … • The closer you come to satisfying regulatory requirements, the safer you will be. The U.S. Department of Health and Human Services (HHS) adopted certain regulatory leasing safe harbors for both the Anti-Kickback Statute, commonly referred to as the “space rental safe harbor,” and Stark Law, commonly referred to as the “office space rental … All arrangements must be in ONE contract. Commercial Leasing: Understanding the Business Deal Webinar Recording, States Enact Statutes that Protect Landlords from COVID-19 Premises Liability Claims, Update on Texas Foreclosures Given Statewide Rise in COVID-19 Cases, Part 1: Healthcare Leases: Anti-Kickback Statute and Stark Law. This article first appeared in Building Operating Management in March 2015. Safe harbors to the anti-kickback statute The Anti-Kickback Statute laws do create “safe harbors,” which are ways/conduct that won’t qualify as violations of the Anti-Kickback Statute. and . If You Believe a Person or Entity is Committing Healthcare Fraud, Contact an Experienced Berger Montague Attorney for a Free, Confidential Evaluation of Your Claim. The arrangement must serve a commercially reasonable business purpose. On November 20, 2020, the US Department of Health and Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) and the Anti-Kickback Statute (AKS) and Beneficiary Inducement Civil Monetary Penalty Law (CMPL) (collectively, AKS Rule).The Stark and AKS Rules finalize, with some modifications, most of the … Accordingly, it is critical to document the methodology used to establish fair market value at that time. (v) The entity may not use space, including, but not limited to, operating and recovery room space, located in or owned by any hospital investor, unless such space is leased from the hospital in accordance with a lease that complies with all the standards of the space rental safe harbor set forth in paragraph (b) of this section; nor may it use equipment owned by or services provided … One such AKS safe harbor is for personal services and management contracts. Anti-Kickback Statute Safe Harbor: Personal Services and Management Contracts The Anti-Kickback Statute, 42 U.S.C. To be protected by a safe harbor, an arrangement must fit squarely in the safe harbor. The safe harbors set forth specific conditions that, if met, assure entities involved of not being prosecuted or sanctioned for the arrangement qualifying for the safe harbor. The Anti-Kickback rule changes include a safe harbor for cybersecurity donations. signed. Republished with permission. Compensation must be fair market reasonable, fair market value and determined through arm’s length negotiations. “General market value” has been defined as the rate that would result from bona fide bargaining between well-informed parties who are not otherwise in a position to generate business for the other party on the date of the agreement. The Anti-Kickback Statute The Anti-Kickback Statute broadly prohibits the exchange of any value in an effort to induce or reward referrals. There are many unique obstacles when leasing healthcare properties. 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 point of sale. The safe harbor regulations, in … Due to the broad language of the anti-kickback statute, the Office of Inspector General has developed “safe harbor” regulations that protect arrangements that might otherwise violate the statute. The Stark Law. False Unlike the mandatory exceptions under the Stark Law, compliance with safe harbors is voluntary and, therefore, not recommended. Anti-Kickback Safe harbor for payments made by a lessee to a lessor for the use of space . • Not required to fit within safe harbor because ultimate question is whether “one purpose” of remuneration is to induce or reward referrals. These laws significantly ‘up the ante’ because the ramifications of mistakes in healthcare leasing are far more extensive than in typical leasing transactions. -This provision is intended to ensure that the terms of an agreement cannot be adjusted periodically to take into account referrals or other business between the parties simply by scrapping one agreement and entering into a new agreement with different compensation terms. In its original 1972 form, the AKS specifically targeted “kickbacks or bribes” and “rebates.” In 1977, Congress expanded the statute’s scope by prohibiting “any remuneration” exchanged for purchasing or referring federally funded goods or services.In the decades since the 1977 expansion, Congress has, from time to time, added “safe harbor” provisions to the AKS to ensure that providers do not face criminal liability for beneficial or innocuous types of remunerations.In … Fair market value is one of the most important aspects of the foregoing exceptions. Recently finalized changes to rules implementing the Stark Law and Anti-Kickback Statute — effective in January — drew support from provider groups. This website contains attorney advertising. Safe Harbor Regulations The "safe harbor" regulations describe various payment and business practices that, although they potentially implicate the Federal anti-kickback statute, are not treated as offenses under the statute. If you share their questions and concerns, rest assured that in many cases supposed kickbacks are actually covered under federal safe harbor statutes. There are three easy ways to contact our firm for a free, confidential evaluation with one of our whistleblower attorneys: Your submission will be reviewed by a Berger Montague qui tam attorney and remain confidential. There is no rule of thumb that will suffice in all situations to determine the amount of documentation required to confirm fair market value, so whether a lease rate is consistent with fair market value is a question of fact that must be determined on a case-by-case basis. Stark and Anti-Kickback Law Exception and Safe Harbor Anti-Kickback Statute – Space Rental Safe Harbor • The lease agreement is set out in . These laws place specific limitations on the manner in which certain healthcare providers may lease space to physician tenants. Patient Engagement Tools and Supports: Analysis of the New Anti-Kickback Statute Regulatory Safe Harbor PDF Share . APPLICATION OF THE ANTI-KICKBACK STATUTE DISCOUNT SAFE HARBOR TO BUNDLED SALES. For purposes of the office space rental exception, the fair market value for the rental of a medical office building cannot be based solely on the rental rate for other medical office buildings. covered by the lease • The term of the lease is for not less than . Experienced healthcare lawyers can explain what actions and relationships qualify for safe harbor … specifies the premises. As indicated above, the final rule also creates two new safe harbors to the Anti-Kickback Statute. Therefore, leasing space to a clinic that may refer patients to the healthcare system from time to time could violate the Anti-Kickback Statute unless carefully structured. The Anti-Kickback Statute provides that doctors, hospitals, and other healthcare providers can’t induce medical providers to refer patients based on illegal inducements and incentives. Compensation must not be determined in a manner that takes into account volume or value of referrals. leased between the parties for the term of the lease and . © 2021 Berger Montague All Rights Reserved, Remuneration Under the Anti-Kickback Statute Includes Intangible Economic Benefits, The Anti-Kickback Statute vs. As a general rule, safe harbor regulations set protection between financial and business relations and referring parties conducted at fair market view. The Anti-kickback Statute •Remuneration paid with the intent to induce referrals violates the Statute •Presumption that payment in excess of FMV or below FMV is payment for referrals •FMV is component of certain AKS safe harbors Use of space -the term “set in advance” is not defined in the safe harbor protection afforded! 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