(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. 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. Dayton, OH 45402-1800 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. Practitioner recruitment . 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: 937.224.5300 Violations of the Anti-Kickback Statue that involve federal healthcare agencies may qualify as a violation of the False Claims Act. Example Safe Harbors under the Anti-Kickback Statute. Sale of practice . The Anti-Kickback Statute is a healthcare fraud and abuse statute that makes it illegal to exchange remuneration for referrals of services that are payable by Medicare and other federal program. 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. 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. 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. Recent Anti-Kickback Safe Harbor Revisions: What Hospices Should Know. Bills that are false or fraudulent may be subject to whistleblower complaints under the False Claims Act. 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. If the buyer is an entity which is a health maintenance organization (HMO) or a competitive medical plan (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, it need not report the discount except as otherwise may be required under the risk contract. 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. You can review these changes in our recent publication. f: 740.374.2296, P.O. Suite 200 f: 216.523.7071, 201 East Fifth Street Equipment rental . However, failure to fit in a safe harbor does not mean that an arrangement violates the anti-kickback statute. To receive safe harbor protection, an arrangementmust squarely meet each requirement of an applicable safe harbor. Discounts: Offeror -- Current as of January 2016, Anti-Kickback Barnesville, OH 43713 The sales rep may be entitled to a percentage of any sums the drug company is ordered to pay for the improper Medicare payments and for any statutory damages. The California Law Offices of Stephen A. Danz and Associates has the experience and resources to help whistleblowers file a properly drafted False Claims Act case. Safe Harbors. Cincinnati, OH 45202-4152 f: 937.224.5301, 258 Front Street Safe harbor for discounts received by a buyer. Embed. The final rules, with one exception, go into effect on January 19, 2021. It will also show how violation of the AKS can raise FCA concerns, and it will provide an assessment of enforcement activities, showing how participants may be at risk. This is important because under recently enacted health care laws, enforcement and health care fraud task forces have been greatly enhanced. Examples include: Referrals made as part of a professional services agreement Discounts: Sellers -- Current as of January 2016, Anti-Kickback There are numerous safe harbors under the Anti-Kickback Statute, many of which are extremely detailed and technical in nature. f: 614.227.2390, 1001 Lakeside Avenue East However, failure to fit in a safe harbor does not mean that an arrangement violates the Federal antikickback statute. The current safe harbors specify that certain kinds of discounts (including drug rebates) are protected from those rules. Generally, safe harbor protection requires that the financial agreement be placed in writing, be for fair market value, and that the agreement is not based on the amount or the quantity of the referrals. Safe harbor for discounts: obligations of an offeror. Anti-Kickback Statute Safe Harbors. The bona fide employee anti-kickback safe harbor excepts from its reach “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.” Under this statute, an employee is any worker that satisfies the common law rules for establishing employer-employee relationship. Parties may use any applicable safe harbor into which they can squarely fit. Group purchasing organizations . any anti-kickback statute enforcement action (see 42 CFR § 1001.952). (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 . 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. Commonly Used Anti-Kickback Statute Safe Harbors* Investment interests . 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 addition, the proposed rule would make a technical correction to an existing safe harbor. In order to alleviate concerns associated with the 1972 AKBS, Congress amended the statute in 1987 to provide “safe harbors,” which are activities or arrangements that are protected from prosecution. Price reductions offered to health plans . The safe harbor regulations, in their entirety, can be found here. Doctors, health providers, and health companies that bill Medicare and other healthcare agencies can be liable under the False Claims Act if they fail to comply with any of the requirements. They also provide guidance aimed at clarifying when compensation provided to a doctor by … Discounts . Anti-kickback safe harbors, as set forth in regulations issued by the Office of Inspector General of the Department of Health and Human Services. 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. 100 South Third Street 1003.101.) 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. 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. Anti-Kickback Safe harbor for payments made to a practitioner by another practitioner where first practitioner is selling a practice to the second practitioner : The period from the date of the first agreement pertaining to the sale to the completion of the sale is not more than one year. 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. Sprinting Toward Value: OIG Overhauls Anti-Kickback Safe Harbors to Benefit Patients and Providers Hall Render Killian Heath & Lyman PC USA December 7 … Fact Sheet-Final Rule The proposed rule would establish five safe harbors, three of which are based on pre-existing statutory exceptions. Waiver of beneficiary coinsurance and deductible amounts . Rebekah Plowman, Genevieve Razick. 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. The new proposal would revoke most of these safe harbors for biopharma. Employees . will not be subject to sanctions under the anti-kickback statute. New AKS Safe Harbors . t: 614.227.2300 AHA: Anti-Kickback Changes Too Narrow to Promote Value-Based Care Proposed safe harbors under the Anti-Kickback Statute are too focused on risk-based models to truly promote value-based care, AHA argued. t: 513.870.6700 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. "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. Columbus, OH 43215-4291 Personal services and management contracts . Anti-Kickback Safe harbor for discounts: obligations of an offeror : 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. I. 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. 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. 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 . Howard Young. After publication of the two new rules, there will be a total of 23 anti-kickback safe harbors consolidated in the Code of Federal Regulations in 21 subparagraphs. The full list of safe harbors can be found in 42 CFR § 1001.952. The AKS allows for safe harbors – essentially agreements that will not be considered kickbacks. Box 270 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. Morgan Lewis + Follow Contact. 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. | All Rights Reserved. Links to Federal Register notices containing preambles to the safe harbor regulations appear below. (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. This is spelled out in a “safe harbor” to the AKS. Safe harbor for discounts: obligations of a seller. Knows/ Should know Includes deliberate ignorance or reckless disregard – no proof of specific intent is required. 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. (B) Where the value of the discount is not known at the time of sale, the seller must fully and accurately report the existence of a discount program on the invoice, coupon or statement submitted to the buyer; inform the buyer in a manner reasonably calculated to give notice to the buyer of its obligations to report such discount and to provide information upon request; when the value of the discount becomes known, provide the buyer with documentation of the calculation of the discount identifying the specific goods or services purchased to which the discount will be applied; and refrain from doing anything which would impede the buyer from meeting its obligations under this paragraph. 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