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</html>";s:4:"text";s:22573:"Please review the full disclaimer for more information. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. You can reach us at (877) 789-9707. 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. 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. 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 … If the payment/inducement involves Medicare or Medicaid, then the kickbacks can be considered fraud which justifies a False Claims Act claim. 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. Before sharing sensitive information, make sure you're on a federal government site. If it does, then the lawyer may advise against filing a qui tam claim under the False Claims Act. 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 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. Do not adjust an independent contractor’s compensation retroactively. If it does, then the lawyer may advise against filing … You can review these changes in our recent publication. 5. The goal of these changes was to modernize the safe harbors and reduce administrative burden while continuing to protect against fraudulent activities. 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 "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. and Electronic Health Records Arrangements Under
It is not a safe harbor under the safe harbor regulations but is directly included within the statute itself. (42 CFR 1001.952(i)) – Broad discretion in drafting employment contracts. One of these is the “Bona Fide Employee” safe harbor. An experienced whistleblower lawyer will review whether your disclosure fits into one of these safe harbors. 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. Please review the full disclaimer for more information. If an arrangement does meet the specific requirements of a safe harbor then the arrangement will … Read More → 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.”. § 1320a-7b (b) (3) (B). § 220. The Anti-Kickback Statute, 42 U.S.C. There are several key points targeted to change, which include how payments are … This has significant implications for the government’s burden of proof once a bona fide employee arrangement is established. 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. This website is for informational purposes only and does not provide legal advice. Otherwise, $13, Safe Harbors to the Anti-Kickback Statute. (See 42 CFR § 1001.952(d), (i), and (p)). '” Violations of the kickback laws can be used to file a False Claims Act whistleblower claims. 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
If there is no safe harbor, then the False Claims Act lawyer is more likely to recommend making the disclosure to the government. 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. 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. Do not pay based on the volume or value of referrals or other business generated by the physician. Federal government websites often end in .gov or .mil. Please do not act or refrain from acting based on anything you read on this site. 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. © 2020 All rights reserved 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. The Anti-kickback statute further provides for safe harbors to the statute, and if met, compliance with the Anti-kickback statute will be deemed. Anti-Kickback Statute Safe Harbors 877-789-9707. 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 Eliminating Kickbacks in Recovery Act of 2018 (EKRA) became law on October 24, 2018, and is codified at 18 U.S.C. The rules promulgated by the Centers for Medicare and Medicaid Services (CMS) modify the physician self-referral "Stark Law" rules. Links to Federal Register notices containing preambles to the safe harbor regulations appear below. To learn if your discovery of kickback qualifies for whistleblower payouts, call the California whistleblower firm of Stephen Danz & Associates. The safe harbor regulations, in their entirety, can be found here. 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. Our Attorneys Are Based in Washington D.C. and Los Angeles Categories Uncategorized. An experienced whistleblower lawyer will review whether your disclosure fits into one of these safe harbors. Using this site or communicating with Stephen Danz & Associates through this site does not form an attorney/client relationship. To be protected by a safe harbor, an arrangement must fit squarely in the safe harbor. 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 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. As noted previously, the Anti-Kickback Statute does not require individuals or entities to meet individual safe harbors. 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 federal Anti-Kickback Statute provides “safe harbors” which are essentially exceptions to the Anti-Kickback statute. 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. As with Stark, the Anti-Kickback Statute contains specific safe harbors applicable to group ownership, employment, and contractor relationships. New California Laws Updates COVID-19 Reporting Requirements, California Fair Employment and Housing Act, Title VII of the Civil Rights Act of 1964. EKRA is still new and the scope of its enforcement is yet to be determined. Comparison Chart of Stark Exceptions and Anti-Kickback Safe Harbors. 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. The site is secure. 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). 35 years 14 for employers with 26 or more employees ( i ) ) – Broad in. Violations of the kickback laws can be found here over 35 years is illegal § 1320a-7b ( b ) 3! 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