The scope lease or rental agreement is no greater than is reasonably necessary for commercial purposes. The proposed revisions are largely (though not entirely) designed to benefit healthcare providers and other entities by establishing new safe harbors, expanding existing safe harbors, and clarifying issues that have frequently led to unnecessary interactions between providers and the OIG or CMS.Â. Anti-Kickback Statute. 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. Federal Concerns. "@context": "http://schema.org/", The services covered under the agreement are no more than are reasonably necessary to accomplish the parties’ commercially reasonable business purpose. The association also recommended that the requirement that recipients share at least 15 percent … § 1001.952 and Statutory … Beaverton, OR 97005, 9655 Perkins Rd, Suite C-203 Arrangements that involve the donation of cybersecurity technology and services. Other safe harbor provisions under the Anti-Kickback Statute apply to transactions and relationships including (but not limited to): On October 17, 2019, the OIG and the Centers for Medicare and Medicaid Services proposed significant changes to the Stark Law and Anti-Kickback Statute safe harbor regulations. The Anti-Kickback Statute is extremely broad. Value-based … © 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. 1. The proposed new safe harbors under the Anti-Kickback Statute include protections for arrangements involving: VBAs related to care coordination for the improvement of healthcare quality, patient health outcomes, and operational efficiency; Start Preamble Start Printed Page 77684 AGENCY: Office of Inspector General (OIG), Department of Health and Human Services (HHS). With few case-by-case exceptions, Firm's practice is limited to matters and questions of federal law and federal procedure. The location and tools or equipment used by the employee during work hours. ŒÖpÓH–hX-Çf꒐>„òû5)ÚÌ%¾JºÀ8O}Ë&–íé›3̦XlÃ,¾™N-ß@¿Á˜Æ¤Ó5ýy!»i,îs+™zח¸‘>MÆþrttÑíŸC]´þ©äþÄgôiz«¸Ë¾_ÒÎä½úéäþänú´ÜþÝ¥#煽šZ¥BýŒXJh5,ÅgR±Jw¡®‡j&¤ËýG¦‚g%‚ç$j'ú܆GA,ßà¹ä~ v)žXá$¢ÐÁ"܋´â €Âó€Ï Ýp@Æn!”ìA. Oberheiden, P.C. Anti-Kickback Statute Safe Harbors Core Principles: 1. 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. Here is a quick summary of federal self-referral (“Stark law”) and anti-kickback law, and California self-referral and anti-kickback / fee-splitting rules. SUMMARY: This final rule amends the safe harbors to the Federal anti-kickback statute by adding new safe harbors and modifying existing safe harbors … “(i) The manner in which it selects the group of participants in the referral service to which it could make a referral; “(ii) Whether the participant has paid a fee to the referral service; “(iii) The manner in which it selects a particular participant from this group for that person; “(iv) The nature of the relationship between the referral service and the group of participants to whom it could make the referral; and, “(v) The nature of any restrictions that would exclude such an individual or entity from continuing as a participant.”. (fn1) As a result, there are now a total of 23 safe harbors to the anti-kickback statute. "reviewBody": "Nick Oberheiden is the absolute best federal litigation attorney. Safe Harbors to the Anti-Kickback Statute Value-Based Enterprise Arrangements. 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. Every case is different, any prior result described or referred to herein cannot guarantee similar outcomes in the future. 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. 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. 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. There are numerous safe harbors under the Anti-Kickback Statute, many of which are extremely detailed and technical in nature. New Safe Harbors; Point-Of-Sale Safe Harbor and the PBM Service Fee Safe Harbor . But, even if you did not consider the AKS and are now facing a federal investigation, you may still be able to find a safe harbor that protects you. Prior results do not guarantee similar outcomes in the future. If your healthcare practice or business is under investigation for alleged violations of the Anti-Kickback Statute, you need experienced legal representation. II. “(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. '” 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. New York, NY 10005, 4545 SW Angel Ave #104 “(1) The referral service does not exclude as a participant in the referral service any individual or entity who meets the qualifications for participation. "priceRange": "Free Consultation" This is only a summary; if you have a Stark, anti-kickback, or fee-splitting issue, contact our attorneys. "bestRating": "5", "@type": "LegalService", "author": { Mr. Oberheiden limits his practice to federal law. 440 Louisiana St #200, Houston, TX 77002, 250 S Park Ave #200 As explained by the OIG, the AKS “exempts 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. 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. Straightforward but broad, the law … • Violations may result in: – Criminal penalties of 5 years in prison and $25,000 fine – Civil penalties of $50,000 per violation – False Claims Act liability (42 USC 1320a-7b(b)) • “One purpose test”: Anti-Kickback Statute applies if one purpose of the remuneration is to induce referrals even if "@type": "Review", 7 Any activity not listed under one of the safe harbor rules does not necessarily violate the AKBS … 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 … Nick gives you the immediate comfort of feeling 100% protected. – Expanded protection for arrangements involving certain cybersecurity technologies and services. 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 OIG finalizes, with a number of modifications, its proposals to establish three new safe harbors under the AKS for certain remunerative arrangements between eligible participants in a "value-based enterprise" (VBE), … When engaging in transactions with potential AKS implications, it will often be in the healthcare providers’ and other entities’ best interests to structure these transactions with a specific safe harbor in mind. “(2) Any payment the participant makes to the referral service is assessed equally against and collected equally from all participants and is based only on the cost of operating the referral service, and not on the volume or value of any referrals to or business otherwise generated by either party for the other party for which payment may be made in whole or in part under Medicare, Medicaid, or other Federal healthcare programs. 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. 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. 2020 11-20-2020 Final Rule: Revisions to Safe Harbors Under the Anti-Kickback Statute, … 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. Antitrust ii. Some of the most notable proposals include: Under the OIG’s proposed rulemaking, the protections under the electronic health records items and services, personal services and management contracts, warranties, and local transportation safe harbors would all be expanded: Remember, these are only proposed changes that will, at the earliest, be adopted in 2020. The proposed rule would establish five safe harbors, three of which are based on pre-existing statutory exceptions. 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 … { }, If an arrangement does meet the specific requirements of a safe … In addition, the proposed rule would make a technical correction to an existing safe harbor. Waivers of copayments, coinsurance, and deductibles, Former Department of Justice Trial Attorneys, Former Federal Prosecutors, U.S. Attorney’s Office. A. Under the AKS, a healthcare provider or third party can face civil or criminal prosecution for “offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate Federal healthcare program business.” Since this has the potential to proscribe many types of transactions that do not have potential negative implications for patients or the potential to result in improper payments from federal healthcare benefit programs such as Medicare, Medicaid, and Tricare, Congress and DHHS have delineated various “safe harbors” that insulate transactions from AKS prosecution. In 1999, we finalized a modification to the language of the safe harbor to clarify that the safe harbor precludes protection for payments fr… Dr. Nick Oberheiden is an experienced healthcare fraud defense law attorney who is seasoned in AKS investigations. Nick Oberheiden is the absolute best federal litigation attorney. 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. This information has been prepared for informational purposes only and does not constitute legal advice. 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. The final regulations, released Nov. 20, respond to many of the calls for change from … 95% Success Rate. 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. § 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.. These Local Counsel may assist the Firm on a case-by-case basis, operate their own respective law firms, are independent of Firm, and are not partners, owners, of counsel, or employees of Firm. Relationship to Part D a) Non-interference b) Impact on Part D Program iv. To learn more about the safe harbor protections you may have available, call Oberheiden, P.C. Medicaid v. Commercial Market vi. The safe harbor regulations, in their entirety, can be found here. Specifically, if and when Firm cooperates with Local Counsel, Firm will disclose the details to the client in writing for their approval. Links to Federal Register notices containing preambles to the safe harbor regulations appear below. The most noteworthy changes to the Stark Law and Anti-Kickback Statute rules involve new exceptions/safe harbors (and modifications of existing definitions, exceptions and safe harbors) to promote flexible engagement in “value-based activities” through “value-based enterprises” in furtherance of care … 1. All information on this website has been prepared for informational purposes only and does not constitute legal advice. 2021 Oberheiden P.C. "telephone": "1-214-469-9009", The Anti-Kickback Statute is a criminal statute, but it provides both civil and criminal penalties for violations that do not fall … “(4) The referral service makes the following five disclosures to each person seeking a referral, with each such disclosure maintained by the referral service in a written record certifying such disclosure and signed by either such person seeking a referral or by the individual making the disclosure on behalf of the referral service –. The Final Rule modifies certain existing safe harbors to the AKS and added additional safe harbors that provide new protections or codify certain existing protections. The value-based arrangement (VBA) and value-based enterprise (VBE) safe harbors are designed to facilitate financial relationships that promote value-based care – including many types of arrangements that would trigger the statutes’ prohibitions on remuneration under the current regulatory regime. This information may constitute attorney advertising in some jurisdictions. First, the proposed rule would create two new safe harbors with no pre-existing … ACTION: Final rule. While this information may constitute attorney advertising in some jurisdictions, merely reading this information does not create an attorney-client relationship. Summary of the Notice of Proposed Rulemaking III. 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. 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. ", – 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. A Brief Summary of the Stark Law and Anti-Kickback Statute Reforms (Final Rules) Background . 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. Clients and prospective clients should be aware that when referencing to Firm's experience, this experience may combine the knowledge and experience of both Firm and its frequently used Local Counsel in the aggregate. The Anti-Kickback Statute and Safe Harbors B. He is polite, respectful— and extremely compelling. The Department of Health and Human Services has enacted safe harbor regulations … Nick gives you the immediate comfort of feeling 100% protected. 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. B. This is designed to . "reviewRating": { Authorized by the Anti-Kickback Provisions of the Medicare and Medicaid Anti-Fraud and Abuse Amendments of 1977 and the Medicare and Medicaid Patient … 3. Arrangements that satisfy all of the elements of a safe harbor are immune from both criminal prosecution and administrative enforcement 4. Arrangements for Patient Engagement and Support to Improve … Healthcare providers and other interested parties can submit comments to the OIG and CMS through December 31, 2019. Safe Harbors. is headquartered in Dallas, Texas and it only maintains a fully equipped office in Dallas and Houston. }, Firm's engagement letter and Firm's website disclaimers provide additional details. The Anti-Kickback Statute is very broad 2. The new safe harbors were originally proposed in 1993. The proposed rule lists a number of factors the agency considers when establishing or modifying safe harbors. However, if an arrangement does not meet a safe harbor then such an arrangement may be at risk of violating the Anti-Kickback Statute. As noted previously, the Anti-Kickback Statute does not require individuals or entities to meet individual safe harbors. 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. Proposed Anti-Kickback Statute Safe Harbors. "image": "https://federal-lawyer.com/wp-content/uploads/2019/02/logo.png", His legal strategy turned out to be brilliant." Comparison Chart of Stark Exceptions and Anti-Kickback Safe Harbors. 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. ", Miami, FL 33129, 30 Wall Street, 8th Floor 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 … "name": "Marshall M." 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. – Added protection for warranties that cover bundled items and services and elimination of beneficiary reporting requirements. You can review these changes in our recent publication. 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