All visitors to this Website are informed that Oberheiden, P.C. The final regulations, released Nov. 20, respond to many of the calls for change from … Firm's engagement letter and Firm's website disclaimers provide additional details. B. ("Firm") works with affiliated lawyers (referred to as "Local Counsel") in various cities and states across the United States. Federal Anti-Kickback Statute Safe Harbors . 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. – Expanded protection for arrangements involving certain cybersecurity technologies and services. Oberheiden, P.C. Transparency iii. © 2020 11-20-2020 Final Rule: Revisions to Safe Harbors Under the Anti-Kickback Statute, … Antitrust ii. Overall, the Final Rule adopts all of the AKS safe harbors previously proposed, with certain modifications … The Department of Health and Human Services has enacted safe harbor regulations … }, 1. “(3) The referral service imposes no requirements on the manner in which the participant provides services to a referred person, except that the referral service may require that the participant charge the person referred at the same rate as it charges other persons not referred by the referral service, or that these services be furnished free of charge or at reduced charge. On the same day, the OIG also promulgated an interim final rule relating to two additional safe harbors for shared risk arrangements. 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. 95% Success Rate. 3. Anti-Kickback Statute. Our Commentary, "New Stark Law, Anti-Kickback Statute Exceptions and Safe Harbors for Value-Based Arrangements," provides a summary of new exceptions and safe harbors for value-based arrangements ("VBA") under the AKS and the Stark Law. A Brief Summary of the Stark Law and Anti-Kickback Statute Reforms (Final Rules) Background . subject to sanctions under the anti-kickback statute.1 Subsequent legislation provided criteria for those safe-harbors2 and a series of regulations have established a number of them in various areas. Some of the most commonly used safe harbor provisions under the Anti-Kickback Statute include the following: Former Senior Trial Attorney U.S. Department of Justice, Former U.S. Attorney & Former District Attorney. Analytical cookies help us improve our website by providing insight on how visitors interact with our site, and necessary cookies which the website needs to function properly. In order to qualify for safe harbor protection, (i) the GPO must have a compliant written agreement in place with the vendor, and (ii) the GPO must submit written disclosures to DHHS. As explained by the U.S. Department of Health & Human Services’ (DHHS) Office of Inspector General (OIG), “[t]he ‘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.”. Winter Park, FL 32789, 2250 Southwest 3rd Ave, 4th Floor He is polite, respectful— and extremely compelling. CMS is proposing modifications to several defined terms in the Stark Law’s safe harbor regulations, some of which would have significantly more of an impact than others. – Revised safe harbor eligibility requirements and extended protection for certain outcomes-based payments. Federal Concerns. }, The proposed revisions to the Stark Law’s regulatory exceptions include new safe harbors for: The proposed new safe harbors under the Anti-Kickback Statute include protections for arrangements involving: As with the existing safe harbors under both statutes, the new safe harbors proposed by the OIG and CMS are subject to various conditions and exceptions.Â, The proposals presented by the OIG and CMS each make several substantive changes to the existing regulatory safe harbors under the Stark Law and Anti-Kickback Statute as well. With few case-by-case exceptions, Firm's practice is limited to matters and questions of federal law and federal procedure. A lease or rental agreement will not trigger AKS liability if: Despite the Anti-Kickback Statute’s express intent to prohibit payments for referrals, payments of “remuneration” to referral services are permitted under certain circumstances. This information may constitute attorney advertising in some jurisdictions. 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. On December 2, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the final rule, “Revisions to the Safe Harbors Under the Anti-Kickback Statute (AKS) READ MORE: OIG Mulls Anti-Kickback Statute Changes to Boost Value-Based Care AHA encouraged OIG to broaden the safe harbor in order to allow compensation which will further advance value-based care. "telephone": "1-214-469-9009", The HHS Office of Inspector General (OIG) issued the final rule “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements,” and the Centers for Medicare and Medicaid Services (CMS) issued the final rule “Modernizing and … With respect to the Stark Law, this is largely done through the clarification and modification of various defined terms used within the existing safe harbor language. "priceRange": "Free Consultation" The Anti-Kickback Statute is extremely broad. Miami, FL 33129, 30 Wall Street, 8th Floor These conditions are: The safe harbor regulations under the Anti-Kickback Statute contain near-identical provisions insulating office space and equipment rental agreements that satisfy certain conditions. VBAs in which the VBE assumes full financial responsibility for the cost of all patient care items and services; VBAs in which a physician faces “meaningful,” but not full, financial risk; Other VBAs involving performance and/or quality metrics and remuneration that is not conditioned on beneficiary referrals; Arrangements that involve $3,500 or less in aggregate remuneration annually; and. To learn more about the safe harbor protections you may have available, call Oberheiden, P.C. Dr. Nick Oberheiden, founder of Oberheiden P.C., focuses his litigation practice on white-collar criminal defense, government investigations, SEC & FCPA enforcement, and commercial litigation. The proposed rule would establish five safe harbors, three of which are based on pre-existing statutory exceptions. The safe harbors would provide greater flexibility in designing an arrangement as the participants in the VBE take on greater downside financial risk for costs and quality of care. This is only a summary; if you have a Stark, anti-kickback, or fee-splitting issue, contact our attorneys. At a high leve… … New York, NY 10005, 4545 SW Angel Ave #104 In 1999, we finalized a modification to the language of the safe harbor to clarify that the safe harbor precludes protection for payments fr… If your healthcare practice or business is under investigation for alleged violations of the Anti-Kickback Statute, you need experienced legal representation. In addition, the proposed rule would make a technical correction to an existing safe harbor. Nick Oberheiden is the absolute best federal litigation attorney. The parties have a written and signed lease or rental agreement that specifies the premises or items covered by the lease; The term of the lease is for not less than a year; The aggregate rental charge is set in advance consistent with fair market value and does not take into account “the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under Medicare, Medicaid, or all other Federal healthcare programs;”, The lease or rental agreement specifies the schedule for the lease or rental; and. The location and tools or equipment used by the employee during work hours. FEDERAL ANTI-KICKBACK LAW AND REGULATORY SAFE HARBORS. Links to Federal Register notices containing preambles to the safe harbor regulations appear below. – Expanded local transportation radius (from 50 miles to 75 miles), and added protection for transportation of discharged patients to their homes regardless of distance.Â, request a free consultation with Dr. Oberheiden online. Summary of Public Comments and Responses A. Comparison Chart of Stark Exceptions and Anti-Kickback Safe Harbors. Nick gives you the immediate comfort of feeling 100% protected. This is designed to . Provisions in the agency agreement covering all of the services to be provided for the term of the agreement; Provision for services that do not violate state or federal law; Scheduling of the services to be provided if they are not to be performed on a full-time basis; Compensation that is consistent with an arm’s length transaction and that does not take into account the quantity or quality of referrals between the parties; and. This website uses cookies. Waivers of copayments, coinsurance, and deductibles, Former Department of Justice Trial Attorneys, Former Federal Prosecutors, U.S. Attorney’s Office. However, if an arrangement does not meet a safe harbor then such an arrangement may be at risk of violating the Anti-Kickback Statute. The Supreme Court closely examined the material differences between the Federal Anti-kickback Statute and Florida’s Anti-kickback Statute and found that the Florida statute lacked two important elements contained in the Federal Statute: 1 - Safe Harbor Provisions at 42 C.F.R. 7 Any activity not listed under one of the safe harbor rules does not necessarily violate the AKBS … Arrangements for Patient Engagement and Support to Improve … Expanding the definition of a “commercially reasonable” financial arrangement; Establishing a bright-line test for determining when compensation is deemed to take into account the volume or value of referrals; Revising the definition of “fair market value” to eliminate references to the volume or value of referrals and clarify when an arrangement reflects market value; Limiting the inpatient hospital services that qualify as “designated health services”; and, Eliminating Anti-Kickback Statute compliance as an element of Stark Law safe harbor eligibility.Â. References to a particular city or state other than Dallas, Houston, and Texas in any article or anywhere on this website does NOT mean that Firm maintains an office in that location, and it does NOT mean that Firm has attorneys physically located in that city or state. Healthcare Financial … The AHA today released a detailed summary of two final rules that would modernize and make important changes to policies governing physician self-referral (Stark law) and federal anti-kickback statute regulations.. within a regulatory safe harbor. Generally, payments of cash, payment above fair market value, and payments for services such as speeches that are never … '” For the purposes of the AKS, employment status is determined based upon the applicable common law principles that typically evaluate factors such as: Personal service arrangements that do not qualify as bona fide employment relationships qualify for safe harbor protection under the Anti-Kickback Statute if they satisfy seven specific conditions outlined in Section 1128B. While this information may constitute attorney advertising in some jurisdictions, merely reading this information does not create an attorney-client relationship. Overview: On the books since 1972, the federal anti-kickback law's main purpose is to protect patients and the federal health care programs from fraud and abuse by curtailing the corrupting influence of money on health care decisions. The HHS Office of Inspector General (OIG) issued the final rule “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements,” and the Centers for Medicare and Medicaid Services (CMS) issued the final rule “Modernizing and … 440 Louisiana St #200, Houston, TX 77002, 250 S Park Ave #200 "@context": "http://schema.org/", In addition to amending the Discount Safe Harbor to eliminate protections offered to “middleman” discounts, the Final Rule adopts two new safe harbors to be effective on January 29, 2021 – 60 days after the publication of … The proposed rule lists a number of factors the agency considers when establishing or modifying safe harbors. The safe harbor regulations, in their entirety, can be found here. Value-Based Framework for Value-Based Arrangements OIG provides background and a high-level description of its framework for value-based arrangements protected under the proposed new and revised safe harbors. ACTION: Final rule. VBAs related to care coordination for the improvement of healthcare quality, patient health outcomes, and operational efficiency; VBAs in which the VBE assumes “substantial” downside financial risk; VBAs in which the VBE assumes full downside financial risk (which are subject to more-flexible conditions that VBAs involving only substantial risk); Other arrangements intended to improve healthcare quality, patient health outcomes, and operational efficiency; Arrangements related to CMS-sponsored models and initiatives involving remuneration in the form of incentives or support; and. (fn1) As a result, there are now a total of 23 safe harbors to the anti-kickback statute. 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. The association also recommended that the requirement that recipients share at least 15 percent … If an arrangement does meet the specific requirements of a safe … is a Texas professional corporation with its headquarters in Dallas. Legislation has created certain “safe harbors” of conduct 3. at 888-680-1745 or request a free consultation with Dr. Oberheiden online now. Employees of physicians, as in the self-referral law, are exempt from anti-kickback laws [(see regulation section 1001.952(i)] Summary of Safe Harbor Regulations. In some cases, pursuant to Rule 7.04 of the Texas Disciplinary Rules of Professional Conduct and the equivalent in other jurisdictions, a case is referred to a Local Counsel, the Firm will not participate in the representation. Value-based … 5728 Lyndon B Johnson Fwy #250, Dallas, TX 75240, Oberheiden P.C. Prior results do not guarantee similar outcomes in the future. Arrangements that satisfy all of the elements of a safe harbor are immune from both criminal prosecution and administrative enforcement 4. We will protect your rights, reputation and freedom. You can review these changes in our recent publication. Nick gives you the immediate comfort of feeling 100% protected. His legal strategy turned out to be brilliant." "image": "https://federal-lawyer.com/wp-content/uploads/2019/02/logo.png", The “referral services” safe harbor provides: “‘[R]emuneration’ does not include any payment or exchange of anything of value between an individual or entity (‘participant’) and another entity serving as a referral service (‘referral service’), as long as all of the following four standards are met –. We will protect your rights, reputation and freedom – Revised safe harbor are from! And it only maintains a fully equipped office in Dallas, Texas and it maintains... A case, a client will sign an engagement exclusively with the Local,. 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