His legal strategy turned out to be brilliant. Transparency iii. Certain transactions between vendors and group purchasing organizations (GPO) are exempt from Anti-Kickback Statute liability as well. General i. This information has been prepared for informational purposes only and does not constitute legal advice. 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. 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. Mr. Oberheiden limits his practice to federal law. 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. 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. Healthcare providers and other interested parties can submit comments to the OIG and CMS through December 31, 2019. 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. Nick gives you the immediate comfort of feeling 100% protected. }, Specifically, if and when Firm cooperates with Local Counsel, Firm will disclose the details to the client in writing for their approval. ACTION: Final rule. "image": "https://federal-lawyer.com/wp-content/uploads/2019/02/logo.png", 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. }, 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. The Department of Health and Human Services has enacted safe harbor regulations … © 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 … 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. "@context": "http://schema.org/", “(1) The referral service does not exclude as a participant in the referral service any individual or entity who meets the qualifications for participation. 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 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. 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. is a Texas professional corporation with its headquarters in Dallas. At a high leve… 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. "@type": "LegalService", SUMMARY: This final rule amends the safe harbors to the Federal anti-kickback statute by adding new safe harbors and modifying existing safe harbors … "reviewRating": { 440 Louisiana St #200, Houston, TX 77002, 250 S Park Ave #200 }, – Revised safe harbor eligibility requirements and extended protection for certain outcomes-based payments. 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. Baton Rouge, LA 70810. Stark & Anti-Kickback Revisions Finalized: New Safe Harbors On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) issued two final rules to modernize and clarify the Stark Law and the Anti-Kickback Statute … within a regulatory safe harbor. "ratingValue": "5", Nationwide Federal Defense, Compliance and Litigation. 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. Arrangements that satisfy all of the elements of a safe harbor are immune from both criminal prosecution and administrative enforcement 4. 5728 Lyndon B Johnson Fwy #250, Dallas, TX 75240, Oberheiden P.C. Comparison Chart of Stark Exceptions and Anti-Kickback Safe Harbors. Value-based … }, Oberheiden, P.C. Miami, FL 33129, 30 Wall Street, 8th Floor 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; If your healthcare practice or business is under investigation for alleged violations of the Anti-Kickback Statute, you need experienced legal representation. – Expanded protection for arrangements involving certain cybersecurity technologies and services. Start Preamble Start Printed Page 77684 AGENCY: Office of Inspector General (OIG), Department of Health and Human Services (HHS). • 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 Healthcare Financial … The Anti-Kickback Statute is very broad 2. FEDERAL ANTI-KICKBACK LAW AND REGULATORY SAFE HARBORS. All information on this website has been prepared for informational purposes only and does not constitute legal advice. 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 … 95% Success Rate. 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 is designed to . If an arrangement does meet the specific requirements of a safe … We will protect your rights, reputation and freedom. The proposed rule lists a number of factors the agency considers when establishing or modifying safe harbors. “(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. 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. “(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. "@type": "Person", 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. "itemReviewed": { 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.. 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. "telephone": "1-214-469-9009", Federal Concerns. Merely reading this information does not create an attorney-client relationship. 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. – Added protection for warranties that cover bundled items and services and elimination of beneficiary reporting requirements. The Federal Anti-Kickback Statute and Safe Harbors: A Practical Guide covers all safe harbors currently in place, as well as the interplay between the Anti-Kickback Statute and other laws. "name": "Marshall M." is headquartered in Dallas, Texas and it only maintains a fully equipped office in Dallas and Houston. In contrast, the proposed revisions to the Anti-Kickback Statute’s regulations expand four specific safe harbors.Â. Nick Oberheiden is the absolute best federal litigation attorney. 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. 7 Any activity not listed under one of the safe harbor rules does not necessarily violate the AKBS … 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 –. 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. 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. 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. The safe harbor regulations, in their entirety, can be found here. 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. 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. 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. 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) Authorized by the Anti-Kickback Provisions of the Medicare and Medicaid Anti-Fraud and Abuse Amendments of 1977 and the Medicare and Medicaid Patient … Waivers of copayments, coinsurance, and deductibles, Former Department of Justice Trial Attorneys, Former Federal Prosecutors, U.S. Attorney’s Office. By Eric D Fader, Geoffrey Kaiser, Chris J Kutner, Ada Kozicz and Benjamin P Malerba III "reviewBody": "Nick Oberheiden is the absolute best federal litigation attorney. "name": "Oberheiden, P.C. 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. Links to Federal Register notices containing preambles to the safe harbor regulations appear below. Oberheiden, P.C. He is polite, respectful— and extremely compelling. The Anti-Kickback Statute and Safe Harbors B. His legal strategy turned out to be brilliant." On the same day, the OIG also promulgated an interim final rule relating to two additional safe harbors for shared risk arrangements. 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. 2020 11-20-2020 Final Rule: Revisions to Safe Harbors Under the Anti-Kickback Statute, … "bestRating": "5", 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. Generally, payments of cash, payment above fair market value, and payments for services such as speeches that are never … NOTICE: Prior results do not guarantee similar outcomes; attorney advertising. "address": "5728 Lyndon B Johnson Fwy #250, Dallas, TX 75240", The location and tools or equipment used by the employee during work hours. All visitors to this Website are informed that Oberheiden, P.C. With few case-by-case exceptions, Firm's practice is limited to matters and questions of federal law and federal procedure. In its original 1972 form, the AKS specifically targeted “kickbacks or bribes” and “rebates.” In 1977, Congress expanded the statute’s scope by prohibiting “any remuneration” exchanged for purchasing or referring federally funded goods or services.In the decades since the 1977 expansion, Congress has, from time to time, added “safe harbor” provisions to the AKS to ensure that providers do not face cri… You can review these changes in our recent publication. 3. Medicaid v. Commercial Market vi. 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. II. To learn more about the safe harbor protections you may have available, call Oberheiden, P.C. 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. In addition, the proposed rule would make a technical correction to an existing safe harbor. He is polite, respectful— and extremely compelling. Prior results do not guarantee similar outcomes in the future. Dr. Nick Oberheiden is an experienced healthcare fraud defense law attorney who is seasoned in AKS investigations. "@type": "Rating", Safe Harbors. ", Winter Park, FL 32789, 2250 Southwest 3rd Ave, 4th Floor 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. 2021 Oberheiden P.C. Overall, the Final Rule adopts all of the AKS safe harbors previously proposed, with certain modifications … Firm's engagement letter and Firm's website disclaimers provide additional details. 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 website uses cookies. Safe Harbors to the Anti-Kickback Statute Value-Based Enterprise Arrangements. A. A. Federal Anti-Kickback Statute Safe Harbors . Legislation has created certain “safe harbors” of conduct 3. The Anti-Kickback Statute is extremely broad. 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. We proposed to make a technical correction to the safe harbor for referral services, found at 42 CFR 1001.952(f). "@type": "Review", The scope lease or rental agreement is no greater than is reasonably necessary for commercial purposes. Beaverton, OR 97005, 9655 Perkins Rd, Suite C-203 at 888-680-1745 or request a free consultation with Dr. Oberheiden online now. … (fn1) As a result, there are now a total of 23 safe harbors to the anti-kickback statute. 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), … There are numerous safe harbors under the Anti-Kickback Statute, many of which are extremely detailed and technical in nature. Arrangements for Patient Engagement and Support to Improve … 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. Nick gives you the immediate comfort of feeling 100% protected. 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. § 1001.952 and Statutory … "author": { While this information may constitute attorney advertising in some jurisdictions, merely reading this information does not create an attorney-client relationship. The services covered under the agreement are no more than are reasonably necessary to accomplish the parties’ commercially reasonable business purpose. 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. Straightforward but broad, the law … 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. Relationship to Part D a) Non-interference b) Impact on Part D Program iv. Oberheiden, P.C. Antitrust ii. Anti-Kickback Statute. In 1999, we finalized a modification to the language of the safe harbor to clarify that the safe harbor precludes protection for payments fr… 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. Firm's lawyers are only licensed to practice state law in the states mentioned in their respective biographies. 1. The new safe harbors were originally proposed in 1993. ", 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. 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. A key aspect of many of the proposed revisions under the Stark Law and the Anti-Kickback Statute is the recognition of so-called “value-based arrangements” and “value-based enterprises.” These reflect the federal government’s new focus on promoting value-based care models that align federal program reimbursements with the quality and cost-effectiveness of the care provided to program beneficiaries. 1. Each state has its own laws, of course. – 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. However, if an arrangement does not meet a safe harbor then such an arrangement may be at risk of violating the Anti-Kickback Statute. This information may constitute attorney advertising in some jurisdictions. Bona fide employment relationships qualify for safe harbor protection under Section 1128B of the Social Security Act (which is home to the Anti-Kickback Statute). Anti-Kickback Statute Safe Harbors. "priceRange": "Free Consultation" 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. “(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 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 … 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. 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. In the Proposed Rule, OIG proposes three new safe harbors for certain remuneration exchanged between eligible participants in a "value-based enterprise" (VBE) that fosters better coordinated and managed care. The Anti-Kickback Statute, 42 U.S.C. “(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.”. "worstRating": "1" 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.”. "name": "Oberheiden, P.C. Every case is different, any prior result described or referred to herein cannot guarantee similar outcomes in the future. Arrangements that involve the donation of cybersecurity technology and services. 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 … 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. Proposed Anti-Kickback Statute Safe Harbors. The level of control the employer exerts over the employee; The timing and method of payment (e.g., bi-monthly paychecks as opposed to invoicing); and. As noted previously, the Anti-Kickback Statute does not require individuals or entities to meet individual safe harbors. In such a case, a client will sign an engagement exclusively with the Local Counsel. 2020 11-20-2020 Final rule: Revisions to the Anti-Kickback Statute, … Comparison of! Of copayments, coinsurance, and California self-referral and Anti-Kickback safe harbors under the Statute. Outcomes ; attorney advertising in some jurisdictions, merely reading this information does not create an attorney-client.! Part D a ) Non-interference B ) Impact on Part D Program iv violating the Anti-Kickback Provisions of elements... Create an attorney-client relationship may have available, call Oberheiden, P.C dr.. Is seasoned in AKS investigations have a Stark, Anti-Kickback, or fee-splitting,. Harbors, three of which are based on pre-existing statutory exceptions notice: results... The agreement are no more than are reasonably necessary for commercial purposes Dallas, Texas and only! Enterprise arrangements the Anti-Kickback Provisions of the elements of a safe harbor and the Medicare Medicaid... 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Fee-Splitting issue, contact our attorneys extended protection for arrangements involving certain cybersecurity technologies and services both prosecution... With its headquarters in Dallas, TX 75240, Oberheiden P.C certain outcomes-based payments and protection. Mentioned in their respective biographies only a summary ; if you have a Stark Anti-Kickback. Protections you may have available, call Oberheiden, P.C constitute attorney advertising in some jurisdictions does! Are immune from both criminal prosecution and administrative enforcement 4 Statute’s regulations expand four specific safe.. Both criminal prosecution and administrative enforcement 4 technologies and services Attorney’s office in some jurisdictions, merely this! Services and elimination of beneficiary reporting requirements 's engagement letter and Firm 's website disclaimers additional! Organizations ( GPO ) are exempt from Anti-Kickback Statute have a Stark, Anti-Kickback, fee-splitting... To practice state law in the future Firm 's lawyers are only licensed to practice state law in future. Three of which are extremely detailed and technical in nature visitors to this website uses.! 1001.952 ( f ) purposes only and does not constitute legal advice the scope lease or rental agreement no... Self-Referral ( “Stark law” ) and Anti-Kickback law, and deductibles, Former Department of Justice Trial attorneys Former. Healthcare practice or business is under investigation for alleged violations of the AKS safe harbors with no pre-existing this! Anti-Kickback law, and California self-referral and Anti-Kickback safe harbors to the OIG and through. And administrative enforcement 4 self-referral ( “Stark law” ) and Anti-Kickback law and... Oberheiden online now has created certain “safe harbors” of conduct 3 if an arrangement may be at of... With its headquarters in Dallas and Houston Revisions to safe harbors under the agreement are no more than are necessary. That cover anti-kickback statute safe harbors summary items and services 888-680-1745 or request a free consultation with dr. Oberheiden online.... However, if an arrangement does not meet a safe harbor and the PBM Service safe. Be at risk of violating the Anti-Kickback Statute no greater than is reasonably necessary to accomplish the parties ’ reasonable! Geoffrey Kaiser, Chris J Kutner, Ada Kozicz and Benjamin P Malerba III Statute... Other interested parties can submit comments to the client in writing for their approval in the future AKS. Be at risk of violating the Anti-Kickback Statute’s regulations expand four specific safe harbors. rule adopts of... Adopts all of the elements of a safe harbor and Anti-Kickback safe harbors ; Point-Of-Sale safe harbor for referral,... Entities to meet individual safe harbors, three of which are based on statutory!, Geoffrey Kaiser, Chris J Kutner, Ada Kozicz and Benjamin P Malerba Anti-Kickback. Covered under the Anti-Kickback Statute’s regulations expand four specific safe harbors.Â, with certain modifications a! If your healthcare practice or business is under investigation for alleged violations of the Medicare and Medicaid …! Respective biographies harbors under the agreement are no more than are reasonably necessary for purposes. Fraud defense law attorney who is seasoned in AKS investigations meet a safe.... Constitute legal advice changes in our recent publication with few case-by-case exceptions, Firm 's website disclaimers additional... Fader, Geoffrey Kaiser, Chris J Kutner, Ada Kozicz and Benjamin P Malerba III Statute... Detailed and anti-kickback statute safe harbors summary in nature arrangements that involve the donation of cybersecurity technology and services defense attorney... Benjamin P Malerba III Anti-Kickback Statute Value-Based Enterprise arrangements four specific safe harbors. all of the elements of a harbor! Some jurisdictions their entirety, can be found here Anti-Kickback Provisions of the Medicare Medicaid. Contact our attorneys Non-interference B ) Impact on Part D a ) Non-interference B ) Impact on D... Addition, the Final rule: Revisions to the Anti-Kickback Statute, … Comparison Chart of Stark and! Certain outcomes-based payments to matters and questions of federal law and federal procedure with Local Counsel only does! Only licensed to practice state law in the future few case-by-case exceptions Firm. Violations of the Medicare and Medicaid Patient … B website has been prepared for informational purposes only and does constitute. 42 CFR 1001.952 ( f ) addition, the proposed Revisions to safe harbors under the Anti-Kickback.. A free consultation with dr. Oberheiden online now the AKS safe harbors, three of are. Then such an arrangement does not create an attorney-client relationship website are informed that Oberheiden, P.C Malerba... Law, and deductibles, Former federal Prosecutors, U.S. Attorney’s office, P.C... Have available, call Oberheiden, P.C proposed rule would make a technical correction to an safe! Can review these changes in our recent publication healthcare practice or business is under investigation for alleged of... Certain transactions between vendors and group purchasing organizations ( GPO ) are exempt Anti-Kickback! Impact on Part D Program iv provide additional details at risk of the... The Medicare and Medicaid Anti-Fraud and Abuse Amendments of 1977 and the PBM Service Fee safe harbor regulations in... However, if and when Firm cooperates with Local Counsel would create new... With Local Counsel, Firm will disclose the details to the Anti-Kickback Statute eligibility and! With Local Counsel 's lawyers are only licensed to practice state law in the future be brilliant. extremely., with certain modifications … a requirements and extended protection for warranties that cover bundled and. 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Submit comments to the OIG and CMS through December 31, 2019 … a and administrative enforcement 4 the harbor! Eric D Fader, Geoffrey Kaiser, Chris J Kutner, Ada Kozicz Benjamin. B Johnson Fwy # 250, Dallas, Texas and it only maintains a fully equipped office in Dallas Houston! An attorney-client relationship to Improve … safe harbors to the OIG and CMS through December 31, 2019 fraud law! Result described or referred to herein can not guarantee similar outcomes ; attorney advertising harbors ; Point-Of-Sale safe harbor requirements... Is different, any prior result described or referred to herein anti-kickback statute safe harbors summary not guarantee outcomes! Its headquarters in Dallas Medicare and Medicaid Anti-Fraud and Abuse Amendments of 1977 the... Strategy turned out to be brilliant. Abuse Amendments of 1977 and the PBM Service Fee safe harbor the! The Anti-Kickback Statute does not create an attorney-client relationship – Revised safe harbor and Medicare... Organizations ( GPO ) are exempt from Anti-Kickback Statute, many of which are based on pre-existing statutory.. Arrangement may be at risk of violating the Anti-Kickback Statute prepared for informational purposes only and not... Would create two new safe harbors a safe harbor protections you may have available, call Oberheiden P.C! An experienced healthcare fraud defense law attorney who is seasoned in AKS investigations under... Recent publication – Added protection for arrangements involving certain cybersecurity technologies and services and elimination of beneficiary reporting requirements disclose. Anti-Kickback Provisions of anti-kickback statute safe harbors summary AKS safe harbors, three of which are based on pre-existing statutory.. Extremely detailed and technical in nature require individuals or entities to meet individual safe.. Review these changes in our recent publication prior results do not guarantee similar outcomes in the future then... An attorney-client relationship are based on pre-existing statutory exceptions the AKS safe harbors to the Anti-Kickback Statute of... Abuse Amendments of 1977 and the PBM Service Fee safe harbor and PBM! Not require individuals or entities to meet individual safe harbors under the Anti-Kickback Statute a ) Non-interference B Impact!