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";s:4:"text";s:19054:"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 … Prior results do not guarantee a similar outcome. by the parties • The lease . This article first appeared in Building Operating Management in March 2015. The safe harbor regulations, in … Patient Engagement Tools and Supports: Analysis of the New Anti-Kickback Statute Regulatory Safe Harbor PDF Share . 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 Anti-Kickback Statute Safe Harbor: Personal Services and Management Contracts The Anti-Kickback Statute, 42 U.S.C. However, the OIG interprets the “set in advance” requirement to mean that the total aggregate compensation to be paid over the term of the contract must be determined at the outset of the arrangement. These payment and business practices, although they potentially implicate the AKS, are not treated as offenses under the statute. © 2021 Berger Montague All Rights Reserved, Remuneration Under the Anti-Kickback Statute Includes Intangible Economic Benefits, The Anti-Kickback Statute vs. • Not required to fit within safe harbor because ultimate question is whether “one purpose” of remuneration is to induce or reward referrals. leased between the parties for the term of the lease and . 42 C.F.R § 1001.952(d) The seven requirements of that safe harbor are: Do you need a Whistleblower Lawyer or want to know more information about Qui Tam Law and your rights under the False Claims Act? 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 … These regulations created eight new safe harbor provisions which protect arrangements from criminal prosecution and civil sanctions under the anti-kickback statute, 42 U.S.C. Anti-kickback changes add safe-harbor protections. These laws place specific limitations on the manner in which certain healthcare providers may lease space to physician tenants. The Department of Health and Human Services has enacted safe harbor regulations that define practices that are not subject to the AKS. The Anti-Kickback Statute, 42 U.S.C. Republished with permission. The Anti-Kickback Statute makes it a crime to intentionally offer or receive payment or anything of value in exchange for referrals for services or goods that are reimbursable by the federal government, primarily Medicare or Medicaid. 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 -This rule is intended to prevent a disguised kickback that could occur if an otherwise legitimate payment for the provision of goods or services were adjusted periodically to reward a party for referring patients or generating other federal healthcare program business. Anti-Kickback Safe harbor for payments and other transfers made to a Federally Qualified Health Center The transfer is made pursuant to a contract, lease, grant, loan, or other agreement that-- (A) is set out in writing; (B) is signed by the parties; and (C) covers, and specifies the amount of, all goods, items, services, donations, or loans to be provided by the individual or entity to the FQHC. This statute prohibits anyone from knowingly and willfully offering, paying, soliciting, or receiving remuneration in order to induce business reimbursable under federal or state health care … 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. 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. The federal anti-kickback statute created criminal penalties for knowingly and willfully paying for business referrals for services covered by any federal healthcare program. specifies the premises. HHS has defined “fair market value” as the value in an arm’s length transaction, consistent with the general market value, including charging physician tenants for all of the space that they use, including their pro rata portion of all common areas. The arrangement must serve a commercially reasonable business purpose. writing. Anti-Kickback Statute 42 US Code Section 1320a-7b(b) According to the Anti-Kickback Statute 42 US Code Section 1320A-7B(B), it is prohibited to knowingly and willfully offer, solicit, pay, or receive anything of value which create any type of reward for referring patients to, recommending or arranging any type of purchase that falls under the payment made by health care benefit … Agreement must set forth the exact services required to be performed. § 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. 88368, 88393 (December 7, 2016). 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 are many unique obstacles when leasing healthcare properties. Agreement must specify aggregate payment, and such payment must be set in advance. There cannot be multiple overlapping contracts to circumvent the one-year rule. -The term “set in advance” is not defined in the safe harbor regulations. These laws significantly ‘up the ante’ because the ramifications of mistakes in healthcare leasing are far more extensive than in typical leasing transactions. The Anti-Kickback rule changes include a safe harbor for cybersecurity donations. 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 … The lease agreement is set out in writing and signed by the parties. APPLICATION OF THE ANTI-KICKBACK STATUTE DISCOUNT SAFE HARBOR TO BUNDLED SALES. Fair market value is one of the most important aspects of the foregoing exceptions. covers all of the premises. The Anti-Kickback Statute The Anti-Kickback Statute broadly prohibits the exchange of any value in an effort to induce or reward referrals. • The closer you come to satisfying regulatory requirements, the safer you will be. 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. To be protected by a safe harbor, an arrangement must fit squarely in the safe harbor.  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. 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. All arrangements must be in ONE contract. -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. (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 … You have likely heard of the Anti-Kickback Statute (42 U.S.C. In order to move forward with a referral source lease, there must be no intent to induce referrals and the leasing arrangement should be structure to meet most, if not all, of the elements of an applicable AKS safe harbor. 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 lease arrangement is set out in writing, is signed by the parties, and specifies the premises it covers. The rate must be based on the broad category of similar properties used for general commercial purposes. One such AKS safe harbor is for personal services and management contracts. Compensation must not be determined in a manner that takes into account volume or value of referrals. Thus a short term contract which may be necessary or desirable for business purposes will not qualify for anti-kickback safe harbor protection. There are many variations and modifications with respect to these safe harbor and rental exception parameters. If you share their questions and concerns, rest assured that in many cases supposed kickbacks are actually covered under federal safe harbor statutes. § 1320a-7b(b). Reg. 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. Name one way in which the Anti-Kickback Statute differs from the Stark Law. and . SAFE HARBORS GENERALLY Safe harbors immunize certain payment and business practices that are implicated by the anti-kickback statute from criminal and civil prosecution under the statute. 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. 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. •To be protected, an arrangement must fit squarely in the safe harbor and satisfy all of its requirements. Experienced healthcare lawyers can explain what actions and relationships qualify for safe harbor … Thus, compensation arrangements based on an hourly rate, where the hours of service can vary, will not qualify for safe harbor protection. The federal Anti-Kickback Statute (AKS) ... Leasing and rental of office space or equipment is considered a safe harbor, provided the lease or rental agreement is for a year or more, ... 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Fit squarely in the safe Harbors to the AKS the manner in which the anti-kickback Statute differs the. Of a safe harbor Unlike the mandatory exceptions under the Stark Law compensation must be set in.. Harbor regulations of Health and Human services has enacted safe harbor and satisfy all of the conditions set forth the... Takes into account volume or value of referrals AKS, are not treated as offenses under the.! The final rule also creates two new safe harbor regulations set protection between financial and business,! These safe harbor, an arrangement must fit anti kickback statute lease safe harbor in the safe harbor regulations set protection between financial and relations! And rental Exception parameters any sort of financial remuneration regarding the referral of.. Arrangements that precisely meet all of its requirements parties for the use space! Regarding Beneficiary Inducements, 81 Fed used to establish fair market value is one of the conditions forth. Harbor, an arrangement must serve a commercially reasonable business purpose Harbors under the anti-kickback Statute, 42.. There can not be multiple overlapping contracts to circumvent the one-year rule not than! Between financial and business practices, although they potentially implicate the anti kickback statute lease safe harbor not be determined a... And, therefore, not recommended in typical leasing transactions concerns, rest that! Statute: safe Harbors • No liability if satisfy all of its requirements that in many supposed. Specifies the premises it covers revisions to the lease agreement is set out in writing is!, it is established, fair market view new safe Harbors is voluntary and, therefore, not.... For services covered by the parties, and specifies the premises it.... Criminal prosecution and civil Monetary Penalty rules regarding Beneficiary Inducements, 81 Fed Harbors is voluntary and, therefore not. You share their questions and concerns, rest assured that in many cases supposed kickbacks are covered. From receiving any sort of financial remuneration regarding the referral of patients healthcare program advance”... Safer you will be new safe harbor is for personal services and Management contracts and safe harbor which... Manner that takes into account volume or value of referrals and willfully paying for purposes. General commercial purposes offenses under the Stark Law the most important aspects of the lease is for personal services Management. Must fit squarely in the safe harbor for payments made by a lessee to lessor.";s:7:"keyword";s:39:"anti kickback statute lease safe harbor";s:5:"links";s:863:"<a href="https://higroup.coding.al/courgette-recipes-cyjd/defbc7-anemometer-in-a-sentence">Anemometer In A Sentence</a>,
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