Email Facebook LinkedIn Twitter. 2 0 obj The amount of goods, items, services, donations, or loans specified in the agreement may be a fixed sum, fixed percentage, or set forth by a fixed methodology. /ModDate (D:20071004021302) /Resources 6 0 R t: 216.523.5405 Comments to OIG’s Solicitation of New Safe Harbors and Special Fraud Alerts are due by March 2, 2015. On December 7, 2016, the Department of Health and Human Services Office of the Inspector General (OIG) issued a final rule to establish new safe harbors under the anti-kickback statute and civil monetary penalty (CMP) rules, as well as update existing safe harbors. The New AKS Safe Harbors As you all know (because we're constantly repeating this, over and over, and wonder why no one wants to talk to us at holiday parties), the Anti-Kickback Statute (AKS) makes it a criminal offense to exchange anything of value with intent to induce or reward the referral of health care program business. Cleveland, OH 44114-1142 endobj The agreement must not restrict the FQHC's ability, if it chooses, to enter into agreements with other providers or suppliers of comparable goods, items, or services, or with other lenders or donors. Protection under the anti-kickback safe harbors is extended in certain circumstances to cost-sharing waivers by pharmacies and for emergency ambulance services, remuneration between Medicare Advantage Organizations and federally qualified health centers, certain drug discounts, and free and reduced-cost local transportation services. Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute; Final Rule, 78 Fed. 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. OIG Changes to Anti-Kickback Safe Harbor Provisions and the CMP Beneficiary Inducement Prohibition Today’s faculty features: 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific WEDNESDAY, NOVEMBER 1, 2017 Clinton Mikel, Partner, The Health Law Partners, Southfield, Mich. Charles B. Oppenheim, Partner, Hooper Lundy & Bookman, Los Angeles Jill S. Wright, … The federal Anti-Kickback Statute (AKS) restricts the kinds of contractual arrangements health centers may make with specialist providers, but also provides “safe harbors” for certain /Subject (Extracted Pages) The final rule: Clarifies the definition of ''remuneration'' for purposes of the safe harbor endobj The FQHC reasonably expects the arrangement to contribute meaningfully to the FQHC's ability to maintain or increase the availability, or enhance the quality, of services provided to a medically underserved population served by the FQHC, and the FQHC documents the basis for the reasonable expectation prior to entering the arrangement. t: 614.227.2300 >> The transfer is made pursuant to a contract, lease, grant, loan, or other agreement that-- (A) is set out in writing; (B) is signed by the parties; and (C) covers, and specifies the amount of, all goods, items, services, donations, or loans to be provided by the individual or entity to the FQHC. Cincinnati, OH 45202-4152 249, 79202, 79220 (Dec. 27, 2013). /Type /Page 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 amount may not be conditioned on the volume or value of federal health care program business generated between the parties. f: 216.523.7071, 201 East Fifth Street /Kids [ 68 0 R 67 0 R ] Suite 1350 In Depth. Anti-Kickback Safe harbor for payments and other transfers made to a Federally Qualified Health Center The transfer is made pursuant to a contract, lease, grant, loan, or other agreement that-- (A) is set out in writing; (B) is signed by the parties; and (C) covers, and specifies the amount of, all goods, items, services, donations, or loans to be provided by the individual or entity to the FQHC. (AKS), which will go into effect January 6, 2017. You can review these changes in our recent publication. >> /Type /Catalog Box 270 Creditors' Rights, Restructuring & Bankruptcy, Back To Medicare/Medicaid Fraud & Abuse Resource Center, Safe harbor for payments and other transfers made to a Federally Qualified Health Center. There are, however, exceptions and safe harbors to the Anti-Kickback Statute designed specifically for FQHCs. Comparison Chart of Stark Exceptions and Anti-Kickback Safe Harbors. The individual or entity may impose reasonable limits on the aggregate volume or value of the goods, items, or services furnished under the arrangement with the FQHC, provided such limits do not take into account a patient's payor status or ability to pay. The safe harbor regulations, in … In accordance with this authorit… On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule establishing new Anti-Kickback Statute (AKS) safe harbor protections and codifying regulatory exceptions to the Civil Monetary Penalties Law (CMP).. Local Transportation Safe Harbor §1001.952 (w) are met. Barnesville, OH 43713 The FQHC may, at its option, elect to require that an individual or entity charge a referred FQHC patient the same rate it charges other similarly situated patients not referred by the FQHC or that the individual or entity charge a referred FQHC patient a reduced rate (where the discount applies to the total charge and not just to the cost-sharing portion owed by an insured patient). Reg. Enjoy the videos and music you love, upload original content, and share it all with friends, family, and the world on YouTube. On December 7, 2016, the HHS Office of the Inspector General (OIG) finalized new safe harbors to the federal anti-kickback statute (AKS) and amendments to the civil monetary penalty (CMP) rules.¹ Set forth below is an overview of the most significant elements of the OIG’s final rule. Kusserow on Compliance: HHS Office of Inspector General adopts new Anti-kickback safe harbors December 29, 2016 by Richard Kusserow In a Final rule effective January 6, 2017, the HHS Office of Inspector General OIG amended the rules to the Anti-Kickback Statute (AKS) by adding new safe harbors that protect certain payment practices and business arrangements … << f: 513.870.6699, 312 N. Patterson Blvd. We have divided the public comment summaries and our responses into sections pertaining to the individual saf… The Office of Inspector General, Department of Health and Human Services (OIG) has finalized new safe harbors and modifications of existing safe harbors under the federal Anti-Kickback Statute (AKS) to reflect a policy priority favoring a value-based health care system that “pays for health and outcomes” and that will “remove potential barriers to more effective … On December 7, 2016, the Office of Inspector General of the US Department of Health … Marietta, OH 45750-2908 For example, contributions of goods, donations, loans, and services to an FQHC that would otherwise implicate Anti-Kickback Statute may be statutorily excepted when they further a core purpose of the FQHC to provide increased availability or … Federally Qualified Health Centers Dayton, OH 45402-1800 endobj New Anti-Kickback Statute Safe Harbors Due to the broad language of the anti-kickback statute 2 , in 1987, Congress directed the Secretary of HHS to create safe harbors to specify certain payment and business practices that would not be subject to … (v) The entity may not use space, including, but not limited to, operating and recovery room space, located in or owned by any hospital investor, unless such space is leased from the hospital in accordance with a lease that complies with all the standards of the space rental safe harbor set forth in paragraph (b) of this section; nor may it use equipment owned by or services provided … The Health and Human Services Office of Inspector General (OIG) has adopted a new, extremely broad safe harbor that allows certain providers to … In addition, existing safe harbors have been revised to grant further protections to providers from criminal prosecution and civil damages. These new regulations and safe harbors … ANTI-KICKBACK STATUTE AND SAFE HARBORS The Anti-Kickback Statute makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce referrals or services reimbursable by the federal or state health care programs (e.g., Medicare, Medicaid). Effective January 6, 2017, the Final Rule modifies certain existing safe harbors and adds additional safe harbors to the Anti-Kickback Statute and incorporates Affordable Care Act-mandated exceptions into the definition of remuneration under the civil monetary penalty rules. Patient Engagement Tools and Supports: Analysis of the New Anti-Kickback Statute Regulatory Safe Harbor PDF Share . Compliance Advisory Services; Compliance Program Design & Implementation; Compliance Program Effectiveness Evaluation ; Related Resources. /Title (Document) The changes to the regulations go … /Pages 2 0 R The OIG recently posted a safe harbor for federally qualified health centers (FQHC) arrangements under the Anti-Kickback Statute. /Creator (ACOMP.exe WinVer 1c15 Aug 31 2005) 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. Columbus, OH 43215-4291 Pursuant to section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987 and its legislative history, Congress required the Secretary of Health and Human Services (the Secretary) to promulgate regulations setting forth various “safe harbors” to the anti-kickback statute, which would be evolving rules that would be periodically updated to reflect changing business practices and technologies in the health care industry. << >> t: 740.374.2284 << /Length 4137 /Filter /FlateDecode >> f: 937.224.5301, 258 Front Street 4 0 obj All rights reserved. The goods, items, services, donations, or loans are medical or clinical in nature or relate directly to services provided by the FQHC as part of the scope of the FQHC section 330 grant (including, by way of example, billing services, administrative support services, technology support, and enabling services, such as case management, transportation, and translation services, that are within the scope of the grant). This final regulation establishes safe harbor protection under the anti- kickback statute for certain arrangements involving Federally qualified health centers. Commenters generally supported our proposals, but many commenters recommended certain changes or requested certain clarifications. Many of these individuals and entities provided comments on multiple topics. We received responsive comments from 88 distinct commenters, including, but not limited to, individuals, trade associations, providers, and suppliers. New Safe Harbors (December 7, 2016) Section Brief Summary 1001.952(f) Technical correction to the referral services safe harbor. Related Services. Section I of this preamble contains a brief background discussion addressing the anti-kickback statute and safe harbors; a discussion of section 330-funded health centers; a H��Wۖ�8]��W��E9��&O�[O����0�� lJ�EKvQ|F���'�o�>�/rI*I�#�\��g+d?�B�3�g1;�(d����B��^��!b;3��d�Y��ٌF�L�Ľ�w�}�j5z��El�E��爑m�����o�ѯ�h�����n�y�Κ��Aw+�8�'���ȅ�{/v�TBӺ�Rw�"�0��7���w��< ���"`i. /Type /Pages %���� /Count 13 Arrangements must not be renewed or renegotiated unless the FQHC reasonably expects the standard to be satisfied in the next agreement term. /CreationDate (D:20071004021302) In addition, the FQHC must disclose the existence and nature of an agreement to any patient who inquires. Each year the HHS Office of Inspector General (OIG) solicits recommendations for new or modified safe harbor provisions under the Anti-Kickback statute, as well as comments on developing Special Fraud Alerts. The FQHC must provide effective notification to patients of their freedom to choose any willing provider or supplier. /MediaBox [ 0 0 612 792 ] The documentation must be made available to the Secretary upon request. Featured … << >> Build a custom email digest by following topics, people, and firms published on JD Supra. f: 614.227.2390, 1001 Lakeside Avenue East Copyright © 2021 Bricker & Eckler LLP. 4/1/2013 2 • Understand the AKS (Anti-Kickback Statute) • Understand Safe Harbors • Recognize transactions that might implicate the AKS • Learn about common pitfalls and how to avoid them LEARNING … f: 740.374.2296, Federally Qualified Health Centers – Current as of November 2017, Anti-Kickback << At reasonable intervals, but at least annually, the FQHC must re-evaluate the arrangement to ensure that the arrangement is expected to continue to satisfy the standards, and must document the re-evaluation contemporaneously. While providers have had the option of using flexible waivers of the Stark Law and Anti-Kickback … endobj /Author (U.S. Government Printing Office) t: 740.374.2248 5 0 obj In Short. The individual or entity making the payment or transfer does not (i) require the FQHC (or its affiliated health care professionals) to refer patients to a particular individual or entity, or (ii) restrict the FQHC (or its affiliated health care professionals) from referring patients to any individual or entity. t: 937.224.5300 160 East Main Street This Final Rule implements, with some modifications suggested by commenters, safe harbors that were … The electronic health record safe harbor is an important safe harbor that can be used when hospitals or other entities donate electronic health record systems to physicians and other practitioners without triggering the Anti-Kickback Statute. Individuals and entities that offer to furnish goods, items, or services without charge or at a reduced charge to the FQHC must furnish such goods, items, or services to all patients from the FQHC who clinically qualify for the goods, items, or services, regardless of the patient's payor status or ability to pay. 3 0 obj Renewed or renegotiated agreements must comply with the requirements of this paragraph. Most importantly, the final rule adds five new AKS safe harbors, as well as five new exceptions to the CMPL. Five new safe harbors have been added to the Anti-Kickback Statute (AKS) in the final rule, issued on December 17, 2016 by the Health and Human Services Office of the Inspector General (OIG). On December 7, 2016, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) issued a final rule to implement revisions to certain Anti-Kickback Statute (AKS) safe harbors, as well as revisions to the regulations corresponding to the Civil Monetary Penalties Law (CMPL). stream OIG posts safe harbor for FQHCs Compliance Monitor, October 10, 2007. If you have questions about how these final changes impact your organization, please contact Beth … 1 0 obj In a federal investigation under the Anti-Kickback Statute (AKS), a key defense strategy will often be to assert a statutory or regulatory safe harbor. The FQHC must provide such notification or disclosure in a timely fashion and in a manner reasonably calculated to be effective and understood by the patient. /Contents 5 0 R f: 740.374.2296, P.O. /Parent 67 0 R 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 criminal liability for beneficial or innocuous types of remunerations.In … Suite 200 On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule creating additional “safe harbors” for the Federal Anti-Kickback Statute (42 USC § 1320a-7b(b) et seq.) /Producer (Acrobat Distiller 4.0 for Windows) 1001.952(k)(3) Interprets statutory exception to the anti‐kickback statute permitting pharmacies to waive cost‐sharing based on financial need or failure to collect. Federal anti-kickback and conflict-of-interest laws are complex terrains that FQHCs must negotiate to establish specialty services. The documentation must be made available to the Secretary upon request. Where a FQHC has multiple individuals or entities willing to offer comparable remuneration, the FQHC must employ a reasonable methodology to determine which individuals or entities to select and must document its determination. Each offense under the Anti-Kickback Statute is punishable by a fine of up to $25,000 and … %PDF-1.3 Providers have a new tool in their toolbox to promote population health. OIG Implements New Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Regulations Sara M. Lord and Samuel M. Shapiro On December 7, 2016, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) issued a final rule to implement revisions to certain Anti-Kickback Statute (AKS) safe harbors, as well as revisions to the regulations … Safe harbor for payments and other transfers made to a Federally Qualified Health Center. t: 513.870.6700 100 South Third Street 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. ANTI-KICKBACK STATUTE 101 April 23, 2013 Robert S. Brown Senior Compliance Specialist UW Medicine Compliance SEATTLE, WASHINGTON 2 SEATTLE, WASHINGTON 3. Safe Harbor Regulations. With the exception of safe harbors for … Suite 1110 If relying on the FQHC Safe Harbor to the Anti-Kickback Statute, make sure that all of the elements under 42 C.F.R. Existing safe harbors have been revised to grant further protections to providers criminal! 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