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";s:4:"text";s:20437:"[2] There is commentary in the regulations adopting the employee safe harbor indicating that OIG was willing to extend safe harbor protection to employee compensation because it was “confident that the employer-employee relationship is unlikely to be abusive, in part because the employer is generally fully liable for the actions of its employees and is therefore more motivated to supervise and control them.” (56 Fed. Satisfying the former requirement without satisfying the latter requirement will not trigger the safe harbor’s protections. 1999-2000 (1996). The terms on which an investment interest is offered must not be related to previous or expected volume of referrals, services furnished, or the amount of business otherwise generated from the investor to the ASC. No Safe Harbor for Defendants in Massive Medicare Kickback Scheme; United States District Court for the Northern District of Texas, Dallas Division, No. The AKS and subsequent regulations include voluntary safe harbors, which “describe various payment and business practices that, although they potentially implicate the federal anti-kickback statute, are not treated as offenses under the statute.” 42 C.F.R. In many instances, the “employee” gets a base salary and a healthy commission for all the referrals he/she brings to the provider. On Friday, November 20, 2020, the U.S. Department of Health and Human Services released new regulations under the Physician Self-Referral Act (Stark) and the Anti-Kickback Statute (AKS). Fla. 2013) (Huck, J. Aug. 24, 2005) (rejected safe harbor, noting that “there would not be an employment relationship for the provision of goods and services covered by Medicare” where recipient was paid only for referrals). 2014. Recent Anti-Kickback Safe Harbor Revisions: What Hospices Should Know January 06, 2021 The US Department of Health and Human Services Office of Inspector General (OIG) recently issued important updates to its Anti-Kickback Statute (AKS) safe harbor rules that provide additional legal protections and flexibilities, in particular with regard to value-based enterprise (VBE) … 104-191, §204, 110 Stat. 1175 (1977). We have the resources and expertise to represent you in any civil and/or criminal matter brought by the U.S. Department of Justice or the OIG for violations of the AKS and Stark Law. §1320a-7b(f), as amended by Pub. Likewise, the U.S. Department of Justice has argued in AKS prosecutions around the country that the employee safe harbor does not protect compensation paid solely to induce referrals of items or services reimbursed under the Medicare or Medicaid programs. 						© 2021 Rivkin Radler LLP. All Rights Reserved. [8] See, e.g., U.S. v. Borrasi, 639 F.3d 774, 781 (7th Cir. 500North Hollywood, CA 91601 T. 305.712.7177, 6841 Energy CourtSuite 120Sarasota, FL 34240T. This codifies the statutory exception of remuneration related to incentive … H-11-861-S (S.D. Reg. Our Free Healthcare Compliance eBook is the Essential Roadmap to Keep Your Practice in Check, Is Your Practice Set Up for Controlled Substances to Be Prescribed Electronically? Co. v. Interstate Commerce Commission, 286 U.S. 299, 311-12 (1932) (statute “was remedial legislation, and should therefore be given a liberal interpretation; but for the same reason exemptions from its sweep should be narrowed and limited to effect the remedy intended.”); A. Philip Randolph Institute v. Husted, 838 F.3d 699, 708 (6th Cir. 2016) (“Interpreting the statute so as to include this exception would thereby swallow the rule.”); In re Woods, 743 F.3d 689, 699 (10th Circ. ***This is the second installment in a blog series examining the regulatory environment and key concerns for persons or businesses operating in the healthcare industry. 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 hospital is not in a position to make or … Pa.). 15-61 (E.D. 5, 6-7, 9 (May 18, 2016); United States v. Mansaour Sanjar, Case No. The final rules went on display at the Federal Register … As used in section 1128B of the Act, “remuneration” does not include any payment that is a return on an investment interest, such as a dividend or interest income, made to an investor as long as all of … August 11, 2020 450 On January 19, 2021, new rules go into effect clarifying and revising the regulatory exceptions to the Stark Law (also known as the Physician Self-Referral Law), the Anti-Kickback Statute (AKS) safe harbors, and the civil monetary penalty laws related to beneficiary inducements law. This article focuses only on the AKS safe harbor, which is not drafted with the same precision as the Stark exception. [25] U.S. v. One (1) Palmetto State Armory PA-15 Machinegun, 822 F.3d 136, 140-41 (3d Cir. 3:17-cv-02977-M, U.S. et al. B) “competition among health care providers”; and 1994) (exceptions to remedial statutes carving out that which would otherwise be included “are to be strictly construed”). 2014), vacated and remanded on other grounds, 136 S.Ct. Miami Office1001 Brickell Bay Drive, Suite 1714Miami, FL 33131Phone: (305) 712-7177. Exceptions to anti-kickback statutes Anti-kickback laws prohibit you from receiving any sort of financial remuneration regarding the referral of patients. [18] See Advisory Opinion No. [9] The legislative history makes clear that these provisions were intended to strengthen the legal framework for combating practices that had “long been regarded by professional organizations as unethical, which are unlawful in some jurisdictions, and which contribute significantly to the cost of the [Medicare and Medicaid] programs.”[10], The AKS was amended in 1977 to make violations a felony, bolstering the penalties against “illegal practices by some individuals who provide services under Medicare and Medicaid” which “contribute significantly to the cost of the programs.”[11] The amendments expanded the AKS’s reach to cover “any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or kind,” id. [19], Such a view would be consistent with the limits of other regulatory safe harbors that protect certain common business arrangements from prosecution under the statute. However, in 2013, the 5th U.S. Update: Head to our resource page “Responding to COVID-19: Resources for Telehealth and Remote Patient Monitoring” Read our latest blogs on this topic: “Proposed Anti-Kickback Statute “Patient Engagement and Support” Safe Harbor: Implications for Remote Patient Monitoring and other Care Management Services Vendors” and “HHS Proposes New Safe … The Department of Health and Human Services (HHS) has taken further steps in its effort to create a more hospitable regulatory climate for innovation in health care by releasing extensive and significant revised final rules governing the Physician Self-Referral Law (Stark) and the Medicare Anti-Kickback Statute (AKS). The panel said that the employer did not have sufficient control over the manner and means of the work performed by employees to characterize this as a bona fide employment relationship. The proponents of those EHR […] Sign up to receive updates on the following legal topics: Attorney Advertising. Case law is conflicting. In “Physician Guide to Basic Compliance Concepts,” Chapman Law Group’s national healthcare compliance attorneys cover how to spot and avoid healthcare fraud, handling investigations and audits, and keeping your staff in the right. Advisory opinions issued by HHS consistently interpret the second clause of the safe harbor as requiring that the compensation under review be paid to the employee for furnishing covered items or services, and not merely for referrals. 12-73 (M.D. Referrals themselves, however, have been held not to constitute a reimbursable item or service, and thus payments for referrals arguably do not fall within the literal scope of the safe harbor. 248.644.6324, 5250 Lankershim Blvd.Ste. The first requires that the employee receiving the compensation be in a bona fide employment relationship (a concept which HHS is barred by statute from analyzing). Circuit Court of Appeals held that the evidence presented did not support defendant’s affirmative defense that the individuals were bona fide employees. The OIG acknowledges that the anti-kickback statute’s safe harbor standards are not necessarily the same as the requirements of the Stark statute prohibiting physician self-referrals, 42 U.S.C. ), aff’d, 564 Fed.Appx. A health care provider — such as a pharmacy, lab, DME or hospital — hires an “employee” to work as a sales representative to market their services and/or products. The safe harbor regulations define payment and business practices that will not be considered kickbacks, bribes, or rebates that unlawfully induce payment by Medicare or Medicaid programs. 95-393 at p. 48 (1977); Pub. 04-09, 2004 WL 5701854 (proposed arrangement between geriatric practice group and referring primary care physicians under which the latter would provide consulting services at an hourly rate was protected under employee safe harbor because, assuming bona fide status of employee, physicians would be paid “for the furnishing of covered items and services”; noting that AKS “disfavors payment structures that tie compensation, even for services, to patients referred by the compensated party” but creates exception where services are furnished by bona fide employees); Advisory Opinion No. The cited commentary is consistent with paying a range of incentives to physicians based on personally performed services, such as, for example, by allowing participation in bonus pools generated wholly or partly from their services. Under this statute, an employee is any worker that satisfies the common law rules for establishing employer-employee relationship. The federal Anti-Kickback Statute (AKS) prohibits any person from “knowingly and willfully” paying, offering, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, in exchange for or to induce the referral of any item or service covered by a federal health care program. 5-10. Some courts interpret the AKS safe harbor as protecting traditional employment relationships that would allow compensation paid to employees for personally performed services reimbursable under a federal health care program, including incentive compensation tied to such services, but not compensation divorced from services that is paid solely for directing referrals to a particular provider. The federal Anti-Kickback Statute (AKS) prohibits any person from “knowingly and willfully” paying, offering, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, in exchange for or to induce the referral of any item or service covered by a federal health care program. Most providers are aware that paying kickbacks for referrals is a felony under the Anti-kickback Statute (AKS), 42 U.S. Code § 1320a–7b (b)(1) 1. If a physician or medical provider uses any payment or compensation to encourage a patient, 1441 W Long Lake RoadSuite 310Troy, MI 48098T. Both the statutory and regulatory safe harbors require by their terms that the remuneration paid for which protection is sought, be for employment in furnishing or providing covered items and services. Anti-Kickback Safe harbor for remuneration from an entity under an personal service arrangement or management contract . However, unlike the AKS employee safe harbor, the Stark exception has detailed requirements that explicitly prohibit compensation that is “determined in a manner that takes into account (directly or indirectly) the volume or value of any referrals by the referring physician.” 42 C.F.R. [2] As discussed below, however, it is far from clear that this is a safe or wise interpretation. L. No. [5] United States v. Jackson, 220 Fed. Please click the link below to view the Health Law Bulletin - April/May 2010. 1-2, Case No. Health care providers have been banking on a special provision of the AKS: the “bona fide employee” safe harbor, which would shield them from civil and criminal liability. The OIG may also ban providers from participating in federal health care programs under their exclusion authorities. [21] Other safe harbors contain similar language to ensure that business relationships protected under the safe harbors are not used as a cover to purchase referrals in violation of the AKS.[22]. [24] See, e.g., U.S. v. Starks, 157 F.3d at 839, supra (in making referrals, defendants “were not providing covered items or services” and payment for referrals was “not for any legitimate service for which the Hospital received any Medicare reimbursement”). 248.644.6326F. [11] H.R. ... and as reiterated by HHS-OIG in its preamble to the AKS final rule, failure to meet a safe harbor … No. What’s a “Referral”? [16] Discussion of AKS purposes on OIG website, at http://oig.hhs.gov/compliance/physician-education/01laws.asp. Some of the factors for determining common law employees include employer control, supervision and training of the employee. False Unlike the mandatory exceptions under the Stark Law, compliance with safe harbors is voluntary and, therefore, not recommended. Stark, anti-kickback, and fee-splitting laws often refer to illegal “referrals,” … It also can impose additional civil monetary penalties of up to $50,000 per violation plus an assessment of up to three times the amount of the payment. If you share their questions and concerns, rest assured that in many cases supposed kickbacks are actually covered under federal safe harbor statutes. As noted, those advisory opinions indicate that, in the view of HHS, it is a condition of applying the employee safe harbor that employees be paid for furnishing a covered item or service, and not simply for directing referrals to particular providers. Similarly, nonphysician salespersons marketing items such as durable medical equipment, medical devices or pharmaceuticals may be viewed as “furnishing” reimbursable items and thus entitled, under the safe harbor, to receive financial incentives, including commission-based compensation. Further duplication without permission is prohibited.  All rights reserved. This is a more plausible interpretation of the commentary, given that the agency’s fully fleshed-out position on the meaning of the employee safe harbor has been stated several times in the decades since those initial comments through advisory opinions that HHS issued opining on “what constitutes prohibited remuneration within the meaning” of the AKS, as it is statutorily mandated to do. [8], Brief History of the Anti-Kickback Statute, In order to better understand the scope and limits of the employee safe harbor, it makes sense to begin with a review of the AKS itself. [22] See, e.g., Investment interests also are protected under conditions specifically limiting the control of investors who are in a position to make or influence patient referrals and to ensure that investment interests are offered on terms that do not vary based on an investor’s ability to refer and do not require such referrals. Cybersecurity received its own safe harbor under the AKS final rule, which allows donation of cybersecurity technology pursuant to a written agreement that describes the technology and services provided and that does not take into account the value or volume of referrals or condition such donations on future referrals or an ongoing business relationship. 317 (5th Cir. Further, if the employment is less than full, time, the exact … On June 18, 2015, the Department of Justice (DOJ) announced a $712 million Medicare fraud takedown by the Medicare Fraud Strike Force. This article is for general information purposes and is not intended to be and should not be taken as legal advice. Another decision from the Middle District of Florida contains language that is sometimes cited in support of the view that the employee safe harbor permits referral payments, but the facts of that case involved incentive payments tied to personally performed physician services, making reliance on that decision to justify an employer’s unrestricted right to pay referral fees suspect. 2014) (“Flowing from this interpretive principle — that we must construe [statutory] exceptions narrowly — is the related concept that exceptions must not be interpreted so broadly as to swallow the rule.”); see also Commissioner of Internal Revenue v. Clark, 489 U.S. 726, 739 (1989) (“In construing [statutory] provisions … in which a general statement of policy is qualified by an exception, we usually read the exception narrowly in order to preserve the primary operation of the provision.”); Piedmont & N. Ry.  Difference between the two statutory schemes 10 original safe harbor, which is intended. 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