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 … You have likely heard of the Anti-Kickback Statute (42 U.S.C. All arrangements must be in ONE contract. Exception and Safe Harbor: Overview Stark and Anti-Kickback Law •Stark: In order for a lease arrangement with a referral source to be compliant with the Stark law, the leasing arrangement must meet all elements of the applicable Stark law exception •AKS: While failure to comply with the applicable AKS safe harbor provision does not There cannot be multiple overlapping contracts to circumvent the one-year rule. The arrangement must serve a commercially reasonable business purpose. Highlights from Anti-Kickback Statute Changes: New safe harbor for certain point-of-sale (POS) price reductions for prescription pharmaceutical products by a manufacturer to a Medicare plan sponsor or Medicaid managed care organization Thus a short term contract which may be necessary or desirable for business purposes will not qualify for anti-kickback safe harbor protection. The equipment rental safe harbor is pertinent to the lease of a HST device to a physician. See 42 C.F.R. There are many unique obstacles when leasing healthcare properties. Anti-Kickback Statute (AKS) •Safe harbors protect certain payment and business practices that could otherwise implicate the AKS from criminal and civil prosecution. Compensation must be fair market reasonable, fair market value and determined through arm’s length negotiations. These laws significantly ‘up the ante’ because the ramifications of mistakes in healthcare leasing are far more extensive than in typical leasing transactions. 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 … Anti-Kickback Statute – Space Rental Safe Harbor • The lease agreement is set out in . Agreement must specify aggregate payment, and such payment must be set in advance. Recently finalized changes to rules implementing the Stark Law and Anti-Kickback Statute — effective in January — drew support from provider groups. and . Purchases of Equipment, Consumables, and Data Access made under Sofia (and Virena) Agreements (the “Agreement”) constitute a bundled sale arrangement, whereby the receipt of goods and services at reduced or no charge is conditioned upon the purchase of other goods … 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 … Exceptions to anti-kickback statutes Anti-kickback laws prohibit you from receiving any sort of financial remuneration regarding the referral of patients. 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. Accordingly, it is critical to document the methodology used to establish fair market value at that time. § 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. Thus, compensation arrangements based on an hourly rate, where the hours of service can vary, will not qualify for safe harbor protection. 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. Patient Engagement Tools and Supports: Analysis of the New Anti-Kickback Statute Regulatory Safe Harbor PDF Share . Compensation must not be determined in a manner that takes into account volume or value of referrals. © 2021 Berger Montague All Rights Reserved, Remuneration Under the Anti-Kickback Statute Includes Intangible Economic Benefits, The Anti-Kickback Statute vs. Specifically, leases of space in hospitals or hospital-owned medical office buildings implicate theAnti-Kickback Statute and Stark Law. 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 lease agreement is set out in writing and signed by the parties. § 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. The Anti-Kickback Statute is a criminal statute, but it provides both civil and criminal penalties for violations that do not fall within one of its safe harbors. As indicated above, the final rule also creates two new safe harbors to the Anti-Kickback Statute. The safe harbor regulations, in … The Anti-Kickback rule changes include a safe harbor for cybersecurity donations. Republished with permission. Prior results do not guarantee a similar outcome. The safe harbor regulations in the Anti-Kickback Statute focus on payments and business activities identified as lawful inducement of payments by Medicare or Medicaid programs. 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 exception.” They are: (a) the lease agreement must be in writing; (b) the lease agreement must have at least a one-year term; (c) the rental rate is set in advance, is consistent with fair market value, and is not determined in a manner that will change based on the volume or value of referrals flowing between the parties; (e) the lease agreement covers and specifies all of the leased premises; (f) if the lease agreement is intended to provide the physician tenant with access to the leased premises for periodic intervals (instead of on a full-time basis) the lease agreement must specify exactly the schedule of such intervals; (g) the lease agreement would be commercially reasonable even if no referrals were made between the parties; and (h) the leased premises must not exceed that which is reasonably necessary for the legitimate business purposes of the physician tenant and is used exclusively by such physician tenant. 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