To learn if your discovery of kickback qualifies for whistleblower payouts, call the California whistleblower firm of Stephen Danz & Associates. 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. 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. The Department of Health and Human Services has enacted safe harbor regulations that define practices that are not subject to the AKS. Serving All U.S. Cities. 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. Do not adjust an independent contractor’s compensation retroactively. Using this site or communicating with Stephen Danz & Associates through this site does not form an attorney/client relationship. New California Laws Updates COVID-19 Reporting Requirements, California Fair Employment and Housing Act, Title VII of the Civil Rights Act of 1964. The Anti-Kickback Statute, 42 U.S.C. An experienced whistleblower lawyer will review whether your disclosure fits into one of these safe harbors. One of these is the “Bona Fide Employee” safe harbor. 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. The Eliminating Kickbacks in Recovery Act of 2018 (EKRA) became law on October 24, 2018, and is codified at 18 U.S.C. 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. Often the payment to get business is clearly an unauthorized kickback. Violations of the kickback laws can be used to file a False Claims Act whistleblower claims. 5. Links to Federal Register notices containing preambles to the safe harbor regulations appear below. 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. Federal government websites often end in .gov or .mil. The Anti-kickback statute further provides for safe harbors to the statute, and if met, compliance with the Anti-kickback statute will be deemed. © 2020 All rights reserved Stephen Danz & Associates. 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. Please do not act or refrain from acting based on anything you read on this site. 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. … 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. The Anti-Kickback Safe Harbor. Not every payment or inducement to a hospital, physician, vendor, or even a payment is illegal. Se habla espanol. 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. This site is legal advertising. If the payment/inducement involves Medicare or Medicaid, then the kickbacks can be considered fraud which justifies a False Claims Act claim. It is not a safe harbor under the safe harbor regulations but is directly included within the statute itself. 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. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. This has significant implications for the government’s burden of proof once a bona fide employee arrangement is established. § 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 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. In addition, OIG issued a separate final rule regarding safe harbors under the Anti-Kickback Statute (AKS), which removes safe harbor protection for rebates from pharmaceutical manufacturers to plan sponsors under Medicare Part D or pharmacy benefit managers (PBMs) under contract with them and creates two new safe harbors to protect certain point-of-sale reductions in price on prescription … Safe harbors immunize certain payment and business practices that are implicated by the anti-kickback statute from criminal and civil prosecution under the statute. An official website of the United States government. 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. Reg. The federal Anti-Kickback Statute provides “safe harbors” which are essentially exceptions to the Anti-Kickback statute. 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 You can review these changes in our recent publication. 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 Anti-Kickback Statute can be used as the basis for a False Claims Act if the kickback is meant to induce someone to refer patients or business to the person making the payment. If they are passed, the changes would affect regulatory safe harbors. '” For example, the federal Anti-Kickback Statute may be implicated, especially in the case of payments to independent contractors. To be protected by a safe harbor, an arrangement must fit squarely in the safe harbor. 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). EKRA is still new and the scope of its enforcement is yet to be determined. The federal Anti-Kickback Statute provides “safe harbors” which are essentially exceptions to the Anti-Kickback statute. The rules promulgated by the Centers for Medicare and Medicaid Services (CMS) modify the physician self-referral "Stark Law" rules. Many times, a company will claim they are protected by a safe harbor when they really aren’t. The safe harbor regulations in the Anti-Kickback Statute focus on payments and business activities identified as lawful inducement of payments by Medicare or Medicaid programs. 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. If it does, then the lawyer may advise against filing a qui tam claim under the False Claims Act. On October 9, 2019, the Office of Inspector General (OIG) published proposed revisions to the federal Anti-Kickback Statute (AKS). § 1320a-7b (b) (3) (B). 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. Please review the full disclaimer for more information. As with Stark, the Anti-Kickback Statute contains specific safe harbors applicable to group ownership, employment, and contractor relationships. This website is for informational purposes only and does not provide legal advice. 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.” 1320a-7b (b) (3) (B) (emphasis added). The safe harbor regulations, in their entirety, can be found here. The final rules, with one exception, go into effect on January 19, 2021. and Electronic Health Records Arrangements Under § 220. Please review the full disclaimer for more information. According to the Office of the Inspector General for the Department of Health and Human Services, the following safe harbors apply – if the precise terms of the statute are met. You can reach us at (877) 789-9707. 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. There are several key points targeted to change, which include how payments are … 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. Anti-Kickback Statute Safe Harbors 877-789-9707. The goal of these changes was to modernize the safe harbors and reduce administrative burden while continuing to protect against fraudulent activities. The .gov means it's official. 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. Our Attorneys Are Based in Washington D.C. and Los Angeles Categories Uncategorized. However, if an arrangement does not meet a safe harbor then such an arrangement may be at risk of violating the Anti-Kickback Statute. (See 42 CFR § 1001.952(d), (i), and (p)). 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 … Comparison Chart of Stark Exceptions and Anti-Kickback Safe Harbors. 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. Otherwise, $13, Safe Harbors to the Anti-Kickback Statute. Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements, 81 Fed. 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 noted previously, the Anti-Kickback Statute does not require individuals or entities to meet individual safe harbors. $14 For Employers With 26 or More Employees. Before sharing sensitive information, make sure you're on a federal government site. 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. This means that previously compliant payment methodologies structured under the Anti-kickback Statute’s employment safe harbor (such as paying W-2 employees a volume or value-based commission) are now at risk of violating EKRA. 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. The safe harbor regulations, in their entirety, can be found here. 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. The site is secure. An experienced whistleblower lawyer will review whether your disclosure fits into one of these safe harbors. If it does, then the lawyer may advise against filing … In Short. The statutory exception under the Anti-Kickback Statue has been in place for over 35 years. Recommended Actions. (42 CFR 1001.952(i)) – Broad discretion in drafting employment contracts. If there is no safe harbor, then the False Claims Act lawyer is more likely to recommend making the disclosure to the government. 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