The changes to rules initially designed for a fee-for-service (FFS) system aim to allow broader value-based payment (VBP) arrangements. While the new protections for care coordination agreements require little or no assumption of financial risk and apply only to remunerative in-kind services, protections for VBP arrangements with substantial or full financial risk cover both in-kind services and monetary remuneration. The OIG's Self-Disclosure Protocol. In addition, CMS provides long sought guidance on key requirements for Stark law compliance. Noncommercial use of original content on www.aha.org is granted to AHA Institutional Members, their employees and State, Regional and Metro Hospital Associations unless otherwise indicated. The agency said the rules have impeded the move toward VBP in Medicare and across all types of health plans. 0 1,095. Industry watchers said providers will need to analyze both existing and prospective VBP arrangements to understand how they are affected by the new provisions. 10 . Anti-Kickback Statute Toolkit This Toolkit is provided as a member benefit to members of AHLA's Fraud and Abuse Practice Group. Weitere Informationen. HHS OIG Issues Policy Statement Regarding Temporary Federal Anti-Kickback Statute Waivers in Wake of COVID-19. These programs are defined in the law. Stark Law and Anti-Kickback Statute enforcement. This can undermine the quality of care that is provided…. The OIG adds several other new AKS safe harbors related to VBAs and expands other existing safe harbors. On November 20, 2020, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule (scheduled to be published in the Federal Register on November 30 th) that amends the Anti-Kickback Statute (AKS) discount safe harbor, removing … © 2021 by the American Hospital Association. The new Stark regulations will provide substantially broader protections for VBAs than the AKS regulations. Improving billing and collections processes for better cashflow. With respect to the anti-kickback statute, we proposed seven new safe harbors and modifications to four … AHA releases summary of changes to Stark law, anti-kickback statute, HHS releases final rules removing barriers to coordinated care, FDA issues final guidance on insanitary conditions for compounding facilities, Appropriate Use Criteria (AUC) Program: Requirements for Furnishing Professionals, Appropriate Use Criteria (AUC) Program: Requirements for Ordering Professionals, New AHA Report: Building Value for the Future Through Integration, The Future of Collaboration in Health Care, Legal (Fraud and Abuse) Barriers To Care Transformation and How to Address Them ("Wayne's World"), American Organization for Nursing Leadership. The January meeting of the Medicare Payment Advisory Commission included policy discussions about some of the most pressing issues in healthcare, including coverage of telehealth services. The AKS changes “are foundational to providers’ work to engage, manage and coordinate patient care so as to achieve optimal outcomes,” Blair Childs, senior vice president for Premier, said in a statement. Also on Nov. 20, the HHS Office of Inspector General issued a final rule with changes to the enforcement of the Anti-Kickback Statute (AKS), which is a criminal statute that prohibits any form of remuneration, whether monetary or in-kind, in exchange for referrals or other federal healthcare program business by any person or entity. OIG describes the anti-kickback statute, including the penalties and fines applicable to whomever knowingly and willfully offers, pays, solicits, or receives remuneration to induce or reward the referral of business reimbursable under any of the federal health care programs. Jun 27 2011. Records company to pay $18M to settle kickback allegations. 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Home Legal News Oig Arrangements Between Dme Supplier And Idtfs May Trigger Sanctions And Implicate Anti Kickback Statute. AHA comments on CMS’ proposed rule on prior authorization. On November 20, 2020, in a joint effort, the Department of Health and Human Services (“ HHS ”) Office of Inspector General (“ OIG ”) and the Centers for Medicare & Medicaid Services (“ CMS ”) issued final rules to revise and modernize the Physician Self-Referral Law (“ Stark Law ”), Anti-Kickback Statute (“ AKS ”) and Civil Monetary Penalties Law (“ CMP ”). The final rules are effective Jan. 19, 2021. Reg. On October 2, 2014, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) published a proposed rule containing revisions to both the Anti-Kickback Statute (AKS) safe harbors and the civil monetary penalty (CMP) rules. The Anti-Kickback Statute (AKS) is a criminal statute that can also result in significant civil penalties and exclusion by HHS-Office of Inspector General (OIG). December 11, 2018; Share this: facebook. Late this afternoon, the Centers for Medicare & Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released long-awaited and highly anticipated Stark and Anti-Kickback Statute final rules (“Final Rules”) aimed at modernizing and streamlining key fraud and abuse regulations under the federal Stark, Anti-Kickback and Civil Monetary Penalties Laws. While the MA Stars Rating program is a bonus program where plans can earn additional revenue for achieving high scores, quality in the Geographic Direct Contracting program is treated more like a penalty, says HFMA's Chad Mulvany. By Rich Daly, HFMA Senior Writer and Editor. For those arrangements identified in the OIG’s announcement (namely, remuneration that is covered by section II.B. The OIG fact sheet describing the final rule for the Anti-Kickback Statute (AKS) and Beneficiary Inducement Civil Monetary Penalty (CMP) Law is on OIG’s website. The principal focus of both regulations is the expansion of protections for value-based arrangements (VBAs). By Adrienne Dresevic, Esq. Three of the new safe harbors focused on: OIG defined substantial downside financial risk as one of three scenarios in a VBP arrangement: The safe harbor protections reflect each party’s degree of participation. Improving billing and collections processes for better cashflow. On September 23, 2020, the Office of Inspector General of the United States Department of Health and Human Services (OIG) publicly released Advisory Opinion 20-05 (AO 20-05), a significant, adverse opinion rejecting a proposal by a pharmaceutical manufacturer to provide copay assistance to Medicare Part D beneficiaries who were prescribed medications that the company manufactures. Follow Rich on Twitter: @rdalyhealthcare. The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) Nov. 20 released two final rules that will modernize and make important changes to physician self-referral (Stark law) and federal Anti-kickback statute (AKS) regulations. Jan. 29, 2021 Updated: Jan. 29, 2021 11:01 a.m. Facebook Twitter Email. The Anti-Kickback Statute (AKS) is a criminal statute that can also result in significant civil penalties and exclusion by HHS-Office of Inspector General (OIG). twitter. Final Rule: Clarification of the Initial OIG Safe Harbor Provisions and Establishment of Additional Safe Harbor Provisions under the Anti-Kickback Statute (64 Fed. It also includes insights on the critical impacts of the coronavirus pandemic on people already adversely affected by social determinants, and on the need to address administrative was in the healthcare caused by onerous prior authorization processes. Rich Daly, HFMA Senior Writer and Editor, How top health systems are reducing bad debt and denials. is based in the Washington, D.C., office. © 2021 Healthcare Financial Management Association, Healthcare Financial Management Association. For the Medicare Shared Savings Program and other Center for Medicare and Medicaid Innovation models, the AKS final rule creates a new safe harbor for exchange of anything of value between or among participants, provided that the exchange of value does not induce the parties to participate in the model agreement or other suppliers to furnish medically unnecessary items or services. The final rule added some safe-harbor limitations, such as a fixed-dollar cap on protected tools and supports provided to patients and enhanced restrictions on marketing and patient recruitment. On Nov. 20, CMS finalized changes to the Physician Self-Referral Law, commonly known as the Stark Law, which generally prohibits physician referrals to services by any entity to which a physician has a financial relationship. Download the report. Introduction. Recently finalized changes to rules implementing the Stark Law and Anti-Kickback Statute — effective in January — drew support from provider groups. The NASA OIG investigates allegations of violations of the Anti-Kickback Act and refers these violations to the U.S. Department of Justice, which could result in fines, penalties, and/or jail time. Which of the following disclosure protocols should be used by providers when disclosing an Anti-Kickback Statute violation? Recently, [when?] AHA does not claim ownership of any content, including content incorporated by permission into AHA produced materials, created by any third party and cannot grant permission to use, distribute or otherwise reproduce such third party content. BOSTON (AP) — A … The Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) has identified the anti-kickback statute (AKS) and beneficiary inducements civil monetary penalty (CMP) as potential barriers to arrangements that could promote better patient care coordination and value-based arrangements. The Federal Anti-kickback Statute prohibits rewarding referrals or generating Federal health care program business. 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.” OIG said in a fact sheet that the Anti-Kickback changes are designed to eliminate provisions “potentially inhibiting beneficial arrangements that would advance the transition to value-based care and improve the coordination of patient care across care settings in both the Federal health care programs and commercial sector.”. HHS-OIG develops and distributes resources to assist the health care industry in its efforts to comply with the nation's fraud and abuse laws and to educate the public about fraudulent schemes so that it can protect itself and report suspicious activities. On November 20, 2020, the Health and Human Resources Office of Inspector General (“OIG”) issued the long-awaited final rule to overhaul various aspects of the Anti-Kickback Statute and Civil Monetary Penalties Laws (“Final Rule”). The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) Nov. 20 released two final rules that will modernize and make important changes to physician self-referral (Stark law) and federal Anti-kickback statute (AKS) regulations. This means that the law only applies to Federal health care programs. AHA comments on the Centers for Medicare & Medicaid Services’ proposed changes to the hospital and hospital health care complex cost report. HHS seeks input on making COVID-19 regulatory flexibilities permanent. “Outdated regulations created unnecessary roadblocks to the kind of collaboration and coordination that enables caregivers to meet all of their patients’ health care needs, whether in the hospital, the doctor’s office or their own homes,” Tom Nickels, executive vice president of the American Hospital Association, said in a written statement. and Arturo Trafny, Esq. Toolkit Overview. of The Health Law Partners, P.C. Greenbaum, Rowe, Smith & Davis LLP Client Alert . Comments. The AKS regulations are effective Jan. 19, 2021. The final rules are effective Jan. 19, 2021. By Thomas Sullivan Last updated Nov 24, 2020. You have [n] free articles remaining this month. “When we kicked off our Patients Over Paperwork initiative in 2017, we heard repeatedly from front-line providers that our outdated Stark regulations saddled them with costly administrative burden and hindered value-based payment arrangements,” CMS Administrator Seema Verma said in a release. 63518; November 19, 1999) 11-18-1999 Fact Sheet: Federal Anti-kickback Law and Regulatory Safe Harbors (1)-(11) of the blanket waivers), nursing facilities can rest assured that they will not be subject to sanctions by the OIG for violation of the Anti-Kickback Statute for any conduct occurring after April 3, 2020, through the termination of the blanket waivers. The latest Updates and Resources on Novel Coronavirus (COVID-19). Bricker & Eckler’s health care attorneys will publish a more detailed summary of the two final rules as a follow-up to this brief update. The rule finalizes many of the proposed policies from an October 2019 notice of proposed rulemaking, including: The changes echoed many that have been long sought by hospital groups. Health plans often inappropriately delay or decline coverage for medically necessary care. Two examples are Medicare and Medicaid. OIG Proposes Expanding Anti-Kickback Statute Safe Harbors an... Überblick . According to the Office of Inspector General, the Anti-Kickback Statute was enacted based upon the government's belief that kickbacks in health care cause which of the following? On November 20, 2020, the Department of Health and Human Services ("HHS") Office of Inspector General ("OIG") and the Centers for Medicare & Medicaid Services ("CMS") concurrently issued final rules modifying regulations for the Physician Self-Referral Law (the "Stark Law") and the Anti-Kickback Statute ("AKS"). Share. On October 9, 2019 the Centers for Medicare & Medicaid Services (CMS), issued a Proposed Rule to Update the Physician Self-Referral (Stark) Law.On the same day, the Office of Inspector General for the Department of Health and Human Services (OIG), issued a Proposed Rule to Update the Anti-Kickback … Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP, 83 FR 43607 (Aug. 27, 2018), available at The Anti-Kickback Law may be enforced criminally by the Department of Justice, or administratively by the OIG. The US Department of Health and Human Services, Office of Inspector General has created an information portal and established a process to provide guidance on the application of the Anti-Kickback Statute and Beneficiary Inducement Statute to COVID-19-connected arrangements. On November 20, 2020, the Office of the Inspector General ("OIG") and Centers for Medicare & Medicaid Services ("CMS") issued final rules (the "Final Rules") revising and expanding exceptions and safe harbors under the federal Stark Law ("Stark") and Anti-Kickback Statute ("AKS") as part of the Department of Health and Human Services' "Regulatory Sprint to Coordinated Care." Any person who knowingly and willfully engages in a kickback scheme could face imprisonment for up to 10 years. (“OIG”) issued a sweeping set of final rules to amend the safe harbors under the Federal anti-kickback statute (“AKS”) 1 ... OIG is likely to conclude that it does not violate the AKS. Beneficiary inducements are barred by a civil administrative statute that prohibits knowingly offering something of value to program beneficiaries to induce them to select a particular provider, practitioner or supplier. The HHS OIG recently published a final rule to modify and add new safe harbors under the federal Anti-Kickback Statute (AKS) and to codify a new Civil Monetary Penalty law (CMP) exception for beneficiary inducements related to healthcare system improvements. The safe harbors detail voluntary payment and business practices that allow providers to avoid AKS violations even if the underlying transactions or relationships implicate a provider. HHS Office of Inspector General issued a final rule, Business Partner & Marketing Opportunities, Creating new, permanent exceptions for VBP arrangements, Providing additional guidance on key requirements for exceptions to the physician self-referral law, Providing protection for non-abusive, beneficial arrangements in both FFS and VBP systems, Adding a new exception to civil monetary penalties contained in a statute on beneficiary inducements, VBP arrangements with substantial downside financial risk, VBP arrangements with full financial risk, At least 30% of any loss based on a comparison of current expenditures against bona fide benchmarks to approximate the total cost of care, At least 20% of any loss based on a comparison of current expenditures against bona fide benchmarks to approximate the total cost of care for defined clinical episodes agreed upon by the parties, A prospective, per-patient payment that is designed to produce material savings and is paid at least annually for a defined set of services or items furnished to the patient population, and that is anticipated to cover the costs of those items and services. On the same day, the Department of Health and Human Services Office of Inspector General (HHS-OIG) issued its final rule modifying existing safe harbors to the Federal Anti-Kickback Statute (AKS) and finalizing a new exception to the civil monetary penalty (CMP) law prohibiting inducements to beneficiaries. The AKS is a criminal law that prohibits the knowing and willful payment of \"remuneration\" to induce or reward patient referrals or the generation of business involving any item or service payable by the Federal health care programs (e.g., drugs, supplies, or health care services for Medicare or Medicaid patients). In the OIG RFI, we sought feedback on ways in which we might modify or add new safe harbors to the Federal anti-kickback statute and . Published on April 15, 2016 Updated on June 20, 2018 Updated on December 11, 2018 - Does not contain any rulemaking by OIG after this date. 4.23.20. While it’s been rumored that the Center for Medicare & Medicaid Innovation was working on a hospital-at-home model, this is a short-term waiver designed to address COVID-19-driven capacity issues, said HFMA’s Chad Mulvany. All rights reserved. AHA letter urging HHS to exercise enforcement discretion with respect to the hospital price transparency rule. Stark Law compliance annually costs millions of dollars and hundreds of hours of time, providers told CMS. The final rule also revises the definition of remuneration set forth in the civil monetary penalty law. The rule goes into effect 60 days from its pending publication in the Federal Register. To request permission to reproduce AHA content, please, CMS, OIG Finalize Changes to Stark Law and Anti-kickback Statute to Encourage Value-Based Care and Reduce Technical Trip Wires, At A Glance linkedin. The final rule modifies the safe harbor for personal services agreements and management agreements by adding new protections for outcomes-based payments. On November 20, 2020, the Health and Human Resources Office of Inspector General (“OIG”) issued the long-awaited final rule to overhaul various aspects of … Anti Kickback HHS-OIG. The Federal anti-kickback statute provides for criminal penalties for whoever knowingly and willfully offers, pays, solicits, or receives remuneration to induce or reward the referral of business reimbursable under any of the Federal health care programs, including Medicare and Medicaid. Also on Nov. 20, the HHS Office of Inspector General issued a final rule with changes to the enforcement of the Anti-Kickback Statute (AKS), which is a criminal statute that prohibits any form of remuneration, whether monetary or in-kind, in exchange for referrals or other federal healthcare program business by any person or entity. Cybersecurity received its own safe harbor under the AKS final rule, which allows donation of cybersecurity technology pursuant to a written agreement that describes the technology and services provided and that does not take into account the value or volume of referrals or condition such donations on future referrals or an ongoing business relationship. “The changes finalized should help to replace numerous waivers of these same regulations needed to experiment with collaborative and innovative care and remove ‘impediments to robust, innovative programs’ noted in a 2016 report from the Department [of Health and Human Services] to Congress.”. OIG: Arrangements between DME Supplier and IDTFs May Trigger Sanctions and Implicate Anti-Kickback Statute . The January Financial Sustainability Report, sponsored by Kaufman Hall, examines the recent expanded interest in hospital-at-home programs, and their potential benefits. 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