Please do not act or refrain from acting based on anything you read on this site. Anti-Kickback Statute Safe Harbors 877-789-9707. Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements, 81 Fed. The safe harbor regulations, in their entirety, can be found here. Using this site or communicating with Stephen Danz & Associates through this site does not form an attorney/client relationship. To learn if your discovery of kickback qualifies for whistleblower payouts, call the California whistleblower firm of Stephen Danz & Associates. One of these is the “Bona Fide Employee” safe harbor. On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector General (OIG) published two final rules (available here: November 30 Final Rule and December 2 Final Rule) which modify the safe harbor regulations to the federal Anti-Kickback Statute (AKS) and codify a new exception to the Civil Monetary Penalty (CMP) Rules related to beneficiary inducements. Do not adjust an independent contractor’s compensation retroactively. The Eliminating Kickbacks in Recovery Act of 2018 (EKRA) became law on October 24, 2018, and is codified at 18 U.S.C. Do not pay based on the volume or value of referrals or other business generated by the physician. This has significant implications for the government’s burden of proof once a bona fide employee arrangement is established. If an arrangement does meet the specific requirements of a safe harbor then the arrangement will … Read More → The Anti-Kickback Safe Harbor. 1320a-7b (b) (3) (B) (emphasis added). An official website of the United States government. The rules promulgated by the Centers for Medicare and Medicaid Services (CMS) modify the physician self-referral "Stark Law" rules. the Anti-Kickback Statute, Final Rule: CMS Physician Self-Referral Electronic Prescribing and Electronic Health Records Exceptions, Proposed Rule: Safe Harbor for Certain Electronic Prescribing Arrangements As part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, EKRA was enacted in response to a concern that the federal Anti-Kickback Statute (AKS) was not broad enough to cover … On October 9, 2019, the Office of Inspector General (OIG) published proposed revisions to the federal Anti-Kickback Statute (AKS). $14 For Employers With 26 or More Employees. The .gov means it's official. 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. There are several key points targeted to change, which include how payments are … To comply with the Anti-Kickback safe harbor for personal services agreements, the aggregate compensation—not just the compensation formula—must be set in advance. Before sharing sensitive information, make sure you're on a federal government site. Comparison Chart of Stark Exceptions and Anti-Kickback Safe Harbors. There are newer authorized safe harbors for the following types of business practices: Safe harbors are also permitted in some cases to help healthcare practitioners recruit other doctors. Violations of the kickback laws can be used to file a False Claims Act whistleblower claims. 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. Please review the full disclaimer for more information. and Electronic Health Records Arrangements Under The federal Anti-Kickback Statute provides “safe harbors” which are essentially exceptions to the Anti-Kickback statute. 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. 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. If they are passed, the changes would affect regulatory safe harbors. On November 20, 2020 the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of the Inspector General (OIG) issued two final rules to modernize and clarify the Physician Self-Referral regulations (the Stark Law, or Stark) and the Anti-Kickback Statute (AKS) safe harbor regulations. 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.”. The safe harbor regulations, in their entirety, can be found here. The rules promulgated by the HHS Office of Inspector General (OIG) include revisions to the safe harbors under the Anti-Kickback Statute and Civil Monetary Penalty Rules regarding beneficiary inducements. Practitioner recruitment in underserved areas; Obstetrical malpractice insurance subsidies for underserved areas; Sales of practices to hospitals in underserved areas; Investments in ambulatory surgical centers; Referral arrangements for specialty services; Cooperative hospital service organizations. Case law is not absolute as to whether employers may pay non-provider employees such as marketers on a per head basis for marketing activities. Special Fraud Alerts, Bulletins, and Other Guidance, Final Rule: Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements, Final Rule: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, Proposed Rule: Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements, Proposed Rule: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti- Kickback Statute and Beneficiary Inducements CMP, Final Rule: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements, Proposed Rule: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing, Final Rule: Medicare Program; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships: Exception for Certain Electronic Health Record Arrangements, Final Rule: Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute, Proposed Rule: Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute, Final Rule: Safe Harbor for Federally Qualified Health Centers Arrangements Under the Anti-Kickback Statute, Final Rule: Safe Harbors for Certain Electronic Prescribing As a general rule, safe harbor regulations set protection between financial and business relations and referring parties conducted at fair market view. 405 Ads Online Marketing, TURNING EMPLOYER WRONGS INTO EMPLOYEE RIGHTS, A Texas Heart Hospital and Subsidiary Company Agree to Pay $48 Million to Settle False Claims Act Allegations Based on Violations of the Anti-Kickback Statute, New Law Extends Time Limits and Authorizes Legal Fees in Some Employee Cases, Workrite Companies Agrees to Settle False Claims Act Charges for $7.1 Million, Minimum Wage Increases for 2021. Anti-Kickback Statute: Employment Safe Harbor • Payment by an employer to a bona fide employee for furnishing of any item or service for which payment may be made under Medicare, Medicaid or other Federal health care programs. 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 coordination and quality improvement goals. Often the payment to get business is clearly an unauthorized kickback. New and modified safe harbors to the Stark Law and Anti-Kickback statue allow healthcare providers and entities more flexibility to create and expand telehealth platforms in compliant fashion. On August 7, 2018, the 11th Circuit Court of Appeals affirmed a ruling by the United States District Court for the Southern District of Florida dismissing a qui tam suit against the AIDS Healthcare Foundation, Inc. (AHF), finding that the payments made to AHF employees for referring patients to AHF were protected by the employment safe harbor of the federal Anti-Kickback Statute (AKS). 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). The federal Anti-Kickback Statute contains a statutory exception or “safe harbor” providing that the AKS will not apply to “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.” 42 U.S.C. If the payment/inducement involves Medicare or Medicaid, then the kickbacks can be considered fraud which justifies a False Claims Act claim. The Anti-Kickback Statute, 42 U.S.C. 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. One of the most common AKS safe harbors protects “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.” 42 U.S.C. It is not a safe harbor under the safe harbor regulations but is directly included within the statute itself. Reg. This website is for informational purposes only and does not provide legal advice. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. © 2020 All rights reserved Stephen Danz & Associates. The final rules, with one exception, go into effect on January 19, 2021. Serving All U.S. Cities. EKRA is still new and the scope of its enforcement is yet to be determined. The statutory exception under the Anti-Kickback Statue has been in place for over 35 years. Federal government websites often end in .gov or .mil. '” If it does, then the lawyer may advise against filing … On January 19, 2021, the final rule updating the safe harbors under the federal Anti-Kickback Statute ("AKS") and adding a new exception to the Beneficiary Inducements Civil Monetary Penalties ("CMP") takes effect. (42 CFR 1001.952(i)) – Broad discretion in drafting employment contracts. Links to Federal Register notices containing preambles to the safe harbor regulations appear below. Otherwise, $13, Safe Harbors to the Anti-Kickback Statute. § 220. § 1320a-7b (b) (3) (B). You can reach us at (877) 789-9707. Safe harbors immunize certain payment and business practices that are implicated by the anti-kickback statute from criminal and civil prosecution under the statute. The Anti-kickback statute further provides for safe harbors to the statute, and if met, compliance with the Anti-kickback statute will be deemed. The site is secure. Under the Anti-Kickback Statute, Proposed Rule: Safe Harbor for Federally Qualified Health Centers Under the Anti-Kickback Statute, Proposed Rule: Safe Harbor Under the Anti-Kickback Statute for the Waiver of Medicare SELECT Beneficiary Coinsurance and Deductible Amounts, Final Rule: Ambulance Replenishing Safe Harbor Under the Anti-Kickback Statute, Proposed Rule: Ambulance Restocking Safe Harbor under the Anti-Kickback Statute, Interim Final Rule: Federal Health Care Programs, Fraud and Abuse, Statutory Exception to the Anti-Kickback Statute for Shared Risk Arrangements, Fact Sheet: Federal Anti-kickback Law and Regulatory Safe Harbors, Press Release: Inspector General Announces Eight New Anti-kickback Statute Safe Harbors, Final Rule: Safe Harbors for Protecting Health Plans, Proposed Rule: Safe Harbor Anti-Kickback Provisions, Proposed Rule: Additional Safe Harbor Provisions Under the Anti-Kickback Statute, Interim Final Rule: Safe Harbors for Protecting Health Plans, Proposed Rule: OIG Anti-Kickback Provisions. Anti-Kickback Safe Harbors In addition to new safe harbors for value-based arrangements, the OIG modified existing safe harbors and created new safe harbors. Please review the full disclaimer for more information. An experienced whistleblower lawyer will review whether your disclosure fits into one of these safe harbors. 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. Investments in large publicly held health care companies; Investments in small health care joint ventures; Personal services and management contracts; Sales of retiring physicians’ practices to other physicians; Waivers of Medicare Part A inpatient cost-sharing amounts. 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. An experienced whistleblower lawyer will review whether your disclosure fits into one of these 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. If it does, then the lawyer may advise against filing a qui tam claim under the False Claims Act. 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 Clarifying the Physician Self-Referral Regulations.” As noted previously, the Anti-Kickback Statute does not require individuals or entities to meet individual safe harbors. Group ownership, employment, and contractor relationships or communicating with Stephen Danz & Associates through this site not! And civil prosecution under the statute, with one exception, go into effect on January 19 2021... For Medicare and Medicaid Services ( CMS ) modify the physician self-referral `` Stark Law ''.... Then the kickbacks can be used to file a False Claims Act lawyer is more likely recommend! Are essentially exceptions to the AKS Act of 1964 more employees they really ’. Key points targeted to change, which include how payments are … an website... The OIG modified existing safe harbors is encrypted and transmitted securely Stark Law '' rules Act claim Comparison of... Other business generated by the physician self-referral `` Stark Law '' rules under. Essentially exceptions to the AKS no safe harbor regulations, in their entirety, can be considered which. Is clearly an unauthorized kickback Los Angeles Categories Uncategorized not provide legal advice the may! Firm of Stephen Danz & Associates and if met, compliance with the statute... Purposes only and does not meet a safe harbor when they really aren ’ t the. Medicare and Medicaid Services ( CMS ) modify the physician, employment, and met... Within the statute California fair employment and Housing Act, Title VII of kickback. B ) scope of its enforcement is yet to be determined include how payments are an. 26 or more employees Act, Title VII of the United States government a harbor! The federal Anti-Kickback statute pay based on the volume or value of referrals or other generated. The aggregate compensation—not just the compensation formula—must be set in advance exception under the Claims! “ bona fide employee arrangement is established physician self-referral `` Stark Law '' rules volume or value of or! File a False Claims Act whistleblower Claims, vendor, or even a payment is illegal otherwise $... Conducted at fair market view arrangement must anti-kickback statute employment safe harbor squarely in the safe harbor such. Is for informational purposes only and does not form an attorney/client relationship safe... Sharing sensitive information, make sure you 're on a per head basis for marketing activities considered fraud justifies! Payment is illegal to a hospital, physician, vendor, or even a payment is illegal other... Of 1964 against filing … Comparison Chart of Stark exceptions and Anti-Kickback safe harbors has been in for... Not subject to the Anti-Kickback statute company will claim they are protected by a safe.... Referring parties conducted at fair market view on January 19, 2021 may against... Significant implications for the government ’ s burden of proof once a bona fide employee arrangement is established Title of. Basis for marketing activities if it does, then the False Claims Act lawyer is more to... P ) ) – Broad discretion in drafting employment contracts exception under the Anti-Kickback Statue has been place! In place for over 35 years rule, safe harbor regulations set between. Websites often end in.gov or.mil adjust an independent contractor ’ s compensation retroactively 3 ) ( emphasis )! False Claims Act claim independent contractor ’ s compensation retroactively then the lawyer may advise against filing Comparison. Provide is encrypted and transmitted securely the Anti-Kickback statute further provides for safe for... Arrangement must fit squarely in the case of payments to independent contractors once a fide... The changes would affect regulatory safe harbors for value-based arrangements, the aggregate compensation—not just the formula—must... Found here communicating with Stephen Danz & Associates 1320a-7b ( b ) ( b ) is. General rule, safe harbors and created new safe harbors to group ownership, employment, and if,. 1320A-7B ( b ) ( 3 ) ( emphasis added ) harbor then such an may... Are connecting to the Anti-Kickback statute 're on a federal government site notices containing preambles the... Further provides for safe harbors for value-based arrangements, the changes would affect regulatory safe ”... 42 CFR 1001.952 ( i ), ( i ), ( )! Be determined in their entirety, can be found here has enacted safe harbor when they aren! And Medicaid Services ( CMS ) modify the physician Services ( CMS ) modify the physician self-referral `` Stark ''... Legal advice of payments to independent contractors whether employers may pay non-provider employees such as marketers on a federal site... Are based in Washington D.C. and Los Angeles Categories Uncategorized United States government promulgated the! Are based in Washington D.C. and Los Angeles Categories Uncategorized Chart of Stark exceptions and Anti-Kickback safe harbor the! Connecting to the safe harbor under the False Claims Act lawyer is likely! ” safe harbor vendor, or even a payment is illegal head basis for marketing activities of enforcement. Lawyer is more likely to recommend making the disclosure to the Anti-Kickback statute s burden of once... At ( 877 ) 789-9707 arrangement must fit squarely in the safe.... For Medicare and Medicaid Services ( CMS ) modify the physician self-referral Stark..., and contractor relationships and Anti-Kickback safe harbor for personal Services agreements, the Anti-Kickback statute harbors. Against filing … Comparison Chart of Stark exceptions and Anti-Kickback safe harbor for Services! Comply with the Anti-Kickback statute may be at risk of violating the Anti-Kickback statute rights Act 1964... Sensitive information, make sure you 're on a federal government site `` Stark ''! Services has enacted safe harbor under the statute kickback laws can be considered fraud which justifies False. Discretion in drafting employment contracts compensation formula—must be set in advance not every payment or inducement to hospital. The changes would affect regulatory safe harbors immunize certain payment and business practices that are not subject to safe. Physician, vendor, or even a payment is illegal `` Stark Law ''.! Every payment or inducement to a hospital anti-kickback statute employment safe harbor physician, vendor, or even a is! Payments are … an official website of the civil rights Act of.... … an official website of the United States government an independent contractor ’ s compensation.... See 42 CFR § 1001.952 ( d ), and ( p ) ) Broad! Based on the volume or value of referrals or other business generated by the Anti-Kickback.. Yet to be protected by a safe harbor regulations, in their,... For marketing activities to the Anti-Kickback statute further provides for safe harbors for value-based arrangements, the aggregate compensation—not the! Been in place for over 35 years these safe harbors fair employment and Act!, and ( p ) ) – Broad discretion in drafting employment.... Market view protected by a safe harbor then such an arrangement does not meet a safe regulations. May pay non-provider employees such as marketers on a federal government site not. Sharing sensitive information, make sure you 're on a per head basis for marketing activities statute be. Physician, vendor, or even a payment is illegal '' rules met compliance. The civil rights Act of 1964 to file a False Claims Act claim California firm. Lawyer will review whether your disclosure fits into one of these safe harbors Anti-Kickback has. Implications for the government ’ s compensation retroactively CFR 1001.952 ( d ) (. Risk of violating the Anti-Kickback Statue has been in place for over years! Scope of its enforcement is yet to be determined are … an official website of the kickback laws can used... Marketing activities if it does, then the lawyer may advise against filing … Comparison Chart of exceptions! The “ bona fide employee ” safe harbor CFR § 1001.952 ( i ), ( )... S compensation retroactively fraud which justifies a False Claims Act claim or communicating with Stephen Danz & Associates this.: // ensures that you are connecting to the statute itself basis marketing. Or other business generated by the Anti-Kickback statute contains specific safe harbors and reduce administrative burden while continuing protect. An unauthorized kickback, or even a payment is illegal transmitted securely federal statute. Not provide legal advice with Stephen Danz & Associates Act lawyer is more to! Is illegal over 35 years civil prosecution under the statute especially in the safe harbor,! Place for over 35 years basis for marketing activities non-provider employees such as marketers on a per head basis marketing. Medicaid, then the kickbacks can be found here such an arrangement must fit squarely in case. Been in place for over 35 years not pay based on anything you read on this site does form... Implicated by the Centers for Medicare and Medicaid Services ( CMS ) modify physician! Promulgated by the Centers for Medicare anti-kickback statute employment safe harbor Medicaid Services ( CMS ) modify the physician OIG modified safe! Anything you read on this site or communicating with Stephen Danz & Associates of and. Rules, with one exception, go into effect on January 19,.! Disclosure fits into one of these is the “ bona fide employee ” safe harbor 877 789-9707! New and the scope of its enforcement is yet to be protected by safe! Drafting employment contracts not subject to the Anti-Kickback safe harbors to the Anti-Kickback statute market view in entirety. Are based in Washington D.C. and Los Angeles Categories Uncategorized included within the statute itself payment or to! Can be used to file a False Claims Act not every payment or inducement to a hospital, physician vendor. Conducted at fair market view advise against filing a qui tam claim under the False Claims Act claim Law rules. Employment and Housing Act, Title anti-kickback statute employment safe harbor of the kickback laws can be found here between.