f: 513.870.6699, 312 N. Patterson Blvd. Safe harbors potentially immunize from scrutiny and prosecution under the AKS certain innocuous arrangements ... –Practices permitted under Anti-Kickback Statute (AKS), including safe harbors –Beneficiary inducement exceptions 31 . However, failure to fit in a safe harbor does not mean that an arrangement violates the anti-kickback statute. Not every relationship between doctors and hospitals or physicians and drug companies is considered a kickback. Discounts: Sellers -- Current as of January 2016, Anti-Kickback On January 19, 2021, the final rule updating the safe harbors under the federal Anti-Kickback Statute ("AKS") and adding a new exception to the Beneficiary Inducements Civil Monetary Penalties ("CMP") takes effect. Safe harbor for discounts: obligations of a seller. (7) [Reserved] (8) For items or services that are of the type that can be used for any patient without regard to payor status, the donor does not restrict, or take any action to limit, the recipient's right or ability to use the items or services for any patient . f: 740.374.2296, Discounts: Buyers – Current as of November 2017, Anti-Kickback This makes it easier to create value-based programs, and physicians will have more flexibility in deciding where the appropriate site of care is for their patients." The seller is an individual or entity that supplies an item or service for which payment may be made, in whole or in part, under Medicare, Medicaid or other Federal health care programs to the buyer and who permits a discount to be taken off the buyer's purchase price. On December 7, 2016, the HHS Office of the Inspector General (OIG) finalized new safe harbors to the federal anti-kickback statute (AKS) and amendments to the civil monetary penalty (CMP) rules.¹ Set forth below is an overview of the most significant elements of the OIG’s final rule. If the buyer is an individual or entity in whose name a request for payment is submitted for the discounted item or service and payment may be made, in whole or in part, under Medicare, Medicaid or other Federal health care programs (not including individuals or entities defined as buyers), the offeror must comply with the following two standards—, (A) The offeror must inform the individual or entity submitting the claim or request for payment in a manner reasonably calculated to give notice to the individual or entity of its obligations to report such a discount and to provide information upon request; and. 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A number of new safe harbors are proposed to encourage value-based care, allow patient engagement through furnishing of certain tools and supports and permit certain remuneration when provided in connection with some CMS-sponsored models to cut down on the need for fraud and abuse waivers. Sprinting Toward Value: OIG Overhauls Anti-Kickback Safe Harbors to Benefit Patients and Providers Hall Render Killian Heath & Lyman PC USA December 7 … The current safe harbors specify that certain kinds of discounts (including drug rebates) are protected from those rules. If the buyer is an individual or entity not included above, the seller must comply with either of the following two standards—, (A) Where the seller submits a claim or request for payment on behalf of the buyer and the item or service is separately claimed, the seller must provide, upon request by the Secretary or a State agency, information provided by the offeror; or. The final rules, with one exception, go into effect on January 19, 2021. t: 614.227.2300 (42 C.F.R. (A) The discount must be earned based on purchases of that same good or service bought within a single fiscal year of the buyer; (B) The buyer must claim the benefit of the discount in the fiscal year in which the discount is earned or the following year; (C) The buyer must fully and accurately report the discount in the applicable cost report; and(D) the buyer must provide, upon request by the Secretary or a State agency, information provided by the seller as specified in this section, or information provided by the offeror as specified in this section. This safe harbor protects the waiver of co-insurance, copayments, or deductibles by a pharmacy under any Federal health care program as long as such waivers are unadvertised, not routine, and made after an individualized determination of financial need (or reasonable effort to collect the cost-sharing amount). The safe harbor regulations, in their entirety, can be found here. The offeror of a discount is an individual or entity who is not a seller, but promotes the purchase of an item or service by a buyer at a reduced price for which payment may be made, in whole or in part, under Medicare, Medicaid or other Federal health care programs. any anti-kickback statute enforcement action (see 42 CFR § 1001.952). Generally, payments of cash, payment above fair market value, and payments for services such as speeches that are never delivered or are worthless are considered kickbacks. Parties may use any applicable safe harbor into which they can squarely fit. • Fighting For Whistleblowers Nationwide •, Contact Us Today (B) the buyer (if submitting the claim) must provide, upon request by the Secretary or a State agency, information provided by the seller as specified this section, or information provided by the offeror as specified in this section. In this webinar, you will learn about the elements of the Anti-Kickback Statute, along with the various exceptions and safe harbors that you can rely on for protection against enforcement under these laws. These Anti-Kickback Statute ("AKS") safe harbors and Ethics in Patient Referrals Act (the "Stark Law") exceptions, when squarely met, afford protection for certain financial relationships between healthcare providers and other entities that are subject to these laws. To learn if you have a viable whistleblower claim, call us at 877-789-9707 or fill out our online contact form to schedule an appointment. (B) The offeror of the discount must refrain from doing anything that would impede the buyer's ability to meet its obligations under this paragraph. If the buyer is an entity which is an HMO a CMP acting in accordance with a risk contract under section 1876(g) or 1903(m) of the Act, or under another State health care program, the seller need not report the discount to the buyer for purposes of this provision. Rebekah Plowman, Genevieve Razick. This section provides background on, and an overarching summary of, the framework for value-based arrangements set forth in this proposed rulemaking; explains proposed terminology used in certain proposed safe harbors; and explains the specific safe harbor proposals to protect value-based arrangements (as defined in proposed paragraph 1001.952(ee)) designed to foster better care at lower cost through improved care coordination for patients. However, failure to fit in a safe harbor does not mean that an arrangement violates the Federal antikickback statute. If the buyer is an entity which reports its costs on a cost report required by the Department or a State health care program, it must comply with all of the following four standards—. t: 513.870.6700 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. In Short. Columbus, OH 43215-4291 877-789-9707. t: 937.224.5300 If the buyer is an entity which is an HMO or a CMP acting in accordance with a risk contract under section 1876(g) or 1903(m) of the Act, or under another State health care program, the offeror need not report the discount to the buyer for purposes of this provision. Safe harbor for discounts received by a buyer. All rights reserved. Congress created safe harbors to protect legitimate business arrangements and the Department of Health and Human Services Office of the Inspector General issued advisory opinions and promulgated regulatory safe harbors designed to rein in the anti-kickback statute that otherwise would extend to certain non-abusive arrangements, the brief explains. Anti-kickback safe harbors, as set forth in regulations issued by the Office of Inspector General of the Department of Health and Human Services. Creditors' Rights, Restructuring & Bankruptcy, Back To Medicare/Medicaid Fraud & Abuse Resource Center, Safe harbor for discounts received by a buyer, Safe harbor for discounts: obligations of a seller, Safe harbor for discounts: obligations of an offeror. 160 East Main Street Dayton, OH 45402-1800 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. If the buyer is an entity that reports its costs on a cost report required by the Department or a State agency, the seller must comply with either of the following two standards—, (A) Where a discount is required to be reported to Medicare or a State health care program, the seller must fully and accurately report such discount on the invoice, coupon or statement submitted to the buyer; inform the buyer in a manner that is reasonably calculated to give notice to the buyer of its obligations to report such discount and to provide information upon request; and refrain from doing anything that would impede the buyer from meeting its obligations under this paragraph; or. Sale of practice . "With Stark and anti-kickback changes, there will be an acceleration of the shift from inpatient procedures and the hospital outpatient department to the ASC. 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. Comparison Chart of Stark Exceptions and Anti-Kickback Safe Harbors. Examples include: The safe harbors have detailed requirements. The master list should be maintained in a manner that preserves the historical record of agreements. The seller is an individual or entity that supplies an item or service for which payment may be made, in whole or in part, under Medicare, Medicaid or other Federal health care programs to the buyer and who permits a discount to be taken off the buyer's purchase price. If the buyer is an individual or entity in whose name a claim or request for payment is submitted for the discounted item or service and payment may be made, in whole or in part, under Medicare, Medicaid or other Federal health care programs (not including individuals or entities defined as buyers, the buyer must comply with both of the following standards—, (A) The discount must be made at the time of the sale of the good or service or the terms of the rebate must be fixed and disclosed in writing to the buyer at the time of the initial sale of the good or service; and. Please note that this resource does not yet reflect the changes to the Stark Law or Anti-Kickback Statute that were made final in November 2020. Enjoy the videos and music you love, upload original content, and share it all with friends, family, and the world on YouTube. 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