Value-Based Care Stark Law Cleveland, OH 44114-1142 By Kim Stanger, J. Malcolm DeVoy, and Amber Ellis. Suite 1110 The final rules, with one exception, go into effect on January 19, 2021. Law terms that have given stakeholders fits over the years, f: 614.227.2390, 1001 Lakeside Avenue East under Stark and new safe harbors under the AKS. Particularly noteworthy is that although the requirements for eligibility to be a “group practice”, and the restrictions and safe harbors regarding payment for revenue generated for designated health services (“DHS”) [1] in group practices have been in existence since 1989, there had been no enforcement activity. f: 513.870.6699, 312 N. Patterson Blvd. Exceptions and Anti-Kickback Safe Harbors, Cybersecurity Technology and Fitting into an exception under Stark is mandatory, whereas under anti-kickback law, if an arrangement does not meet every element of a safe harbor, it is not necessarily unlawful, but rather, is at risk of scrutiny by the OIG. Stark & Anti-Kickback Revisions Finalized: New Safe Harbors On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) issued two final rules to modernize and clarify the Stark Law and the Anti-Kickback Statute (AKS). CMS and OIG have emphasized, however, that meeting the value-based definitions should be viewed only as a gateway to Stark and AKS protections; an arrangement that meets all of the value-based enterprise definitions … The Stark exceptions and the AKS safe harbors do not require the remuneration under a value-based arrangement to be consistent with fair market value, not determined in a manner that takes into account the volume or value of a physician's referrals or other business generated for the entity. Dayton, OH 45402-1800 Therefore, physicians who make prohibited referrals for designated health services even accidentally or unknowingly will still be subject to civil penalties. The content of this article is intended to provide a general is Jan. 19, 2021 - the principal exception being the Stark Law The safe harbor regulations, in their entirety, can be found here. arrangements to jointly coordinate and manage patient care and (2) guide to the subject matter. physician and (2) compensation is "set in advance.". The safe harbor contains the following eight requirements: • No more than 40% of the total value of the investment interests in the venture may be held by investors who are in a position to make or influence referrals to the entity, furnish items or services to the entity, or otherwise generate business for the entity. You also can review all the changes in this November 2015 publication. Stark [No comparable exception] 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 … The regulations (found here and here) include significant changes to existing provisions to the Stark regulations and AKS safe harbors, as well as new exceptions under Stark and new safe harbors under the AKS. Barnesville, OH 43713 Personal Services and Management Contracts Safe Harbor, Modifications to Stark Law Rules The safe harbor exception for local transportation would apply only to “established patients,” although that can include a new patient who … November 24, 2020 - New safe harbors proposed for the Stark Law and Anti-Kickback Statute could help providers expand their telehealth and … Stark Law Commentaries February 2021 Insight Jones Day recently published a series of nine Commentaries on the newly finalized Stark Law and Anti-Kickback Statute exceptions and safe harbors seeking to remove regulatory barriers to care coordination. Practical Takeaways. Specialist advice should be sought The new outcomes-based payment guidelines under the Stark exceptions are really broad and more flexible than the new safe harbors. In the Proposed Rule, OIG proposes three new safe harbors for certain remuneration exchanged between eligible participants in a "value-based enterprise" (VBE) that fosters better coordinated and managed care. delivery of patient care items and services. 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 most significant leg in the "regulatory sprint to Services Stark Law Exceptions and Anti-Kickback Safe Harbors; t: 937.224.5300 However, safe harbor protection is afforded only to those arrangements that precisely meet all of the conditions set forth in the safe harbor. POPULAR ARTICLES ON: Food, Drugs, Healthcare, Life Sciences from United States, In December 2020, California Attorney General Xavier Becerra was announced to be President-Elect Joseph R. Biden, Jr.'s pick to lead the Department of Health and Human Services. On November 20, 2020, CMS and the OIG published their much anticipated amendments to the federal Stark and Anti-Kickback laws. As mentioned above, the value-based safe harbors are generally narrower than the Stark exceptions. f: 740.374.2296. 14. These definitions will be integral to applying the new Stark exceptions and AKS safe harbors effective January 19, 2021. enter into and implement value-based arrangements under which one The rules cover a fairly broad array It’s an individual or entity that engages in at least one value-based activity as part of a “value-based entity” (in OIG’s words) or “value-based enterprise” (in CMS’s words). On December 2, 2020, HHS published two final rules including important changes to the AKS and Stark Law regulations. they may affect your organization. The three value-based safe harbors are similar in some respects but not identical to the Stark exceptions and include: Care coordination arrangements to improve quality, health outcomes, and efficiency that does not require the participants to take on risk but protects only in-kind remuneration AAFP Pushes CMS to Clear 'Safe Harbors' in Stark Law Self-referral Regulations Should Not Hinder Value-based Models, Academy Advises. On November 20, 2020, the Centers for Medicare & Medicaid Services ("CMS") and the Office of the Inspector General ("OIG") finalized the rules modifying the safe harbors under the Anti-Kickback Statute and exceptions under the Stark Law. The rules promulgated by the Centers for Medicare and Medicaid Services (CMS) modify the physician self-referral "Stark Law" rules. A “safe harbor” is a statutory exception designed to reduce or eliminate legal or regulatory liability in certain situations where applicable conditions are met. (42 CFR § 411.357(a)-(b)). An important initial consideration is that there are multiple differing requirements between corresponding Stark Law exceptions and AKS safe harbors. Statute and Civil Monetary Penalty Rules regarding beneficiary years. 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. Box 270 The Stark safe harbor for space or equipment leases generally prevents lease formula’s based on a percentage of the revenue raised, earned, billed, collected, or otherwise attributable to the services performed in the office space, or per-unit of service rental charges, to the extent that such charges reflect services provided to patients referred by the lessor to the … for Ancillary Income Distribution Within Physician Group The final rules, respectively released by HHS’ Centers for Medicare & Medicaid Services (CMS) and the HHS Office of Inspector General (OIG), have, among other changes, added new value-based exceptions to the Stark Law and additional safe harbors under the AKS, and largely take effect in January 2021. As used in section 1128B of the Act, “remuneration” does not include any payment that is a return on an investment interest, such as a dividend or interest income, made to an investor as long as all of … 160 East Main Street The ambulatory surgery center safe harbor. "Stark Law" rules. t: 216.523.5405 A particularly welcome change is the OIG’s decision to more closely align this safe harbor with the personal service arrangements exception to the Stark Law, which should alleviate some of the difficulties associated with fully satisfying this safe harbor. These definitions will be integral to applying the new Stark exceptions and AKS safe harbors effective January 19, 2021. To print this article, all you need is to be registered or login on Mondaq.com. coordinated care" that HHS has been leading over the past few The proposals presented by the OIG and CMS each make several substantive changes to the existing regulatory safe harbors under the Stark Law and Anti-Kickback Statute as well. ", On December 10, 2020, the Trump administration announced proposed changes to the HIPAA privacy rule. § 411.351 and 42 C.F.R. OIG, responsible for enforcing AKS, issued a final rule addressing changes to the AKS and revisions to Civil Monitory Penalty … Health & Human Services (HHS) take effect and will represent Unlike the mandatory exceptions under the Stark Law, compliance with safe harbors is voluntary and, therefore, not recommended. Suite 1350 © Mondaq® Ltd 1994 - 2021. f: 740.374.2296, P.O. Today, we are taking a look at changes to existing AKS safe harbors and Stark Law exceptions, and, an extra add-on: a new Stark … The safe harbors set forth specific conditions that, if met, assure entities involved of not being prosecuted or sanctioned for the arrangement qualifying for the safe harbor. One key statutory safe harbor is the safe harbor for ambulatory surgery centers. 100 South Third Street physician's referrals or other business generated by a You’ll only need to do it once, and readership information is just for authors and is never sold to third parties. However, safe harbor protection is afforded only to those arrangements that precisely meet all of the conditions set forth in the safe harbor. presented by south florida hospital news & healthcare report and healthcare law partners,llc A safe harbor for certain in-kind remunera… The safe harbors set forth specific conditions that, if met, assure entities involved of not being prosecuted or sanctioned for the arrangement qualifying for the safe harbor. inducements. The following payment practices shall not be treated as a criminal offense under section 1128B of the Act and shall not serve as the basis for an exclusion: (a) Investment interests. The regulations (found here and here) include significant changes to existing provisions to the Stark regulations and AKS safe harbors, as well as new exceptions under Stark and new safe harbors under the AKS. provisions that create greater flexibility for health care federal anti-kickback law and regulatory safe harbors Overview: On the books since 1972, the federal anti-kickback law's main purpose is to protect patients and the federal health care programs from fraud and abuse by curtailing the corrupting … The rules promulgated by the HHS Office of Inspector General Suite 200 2. Legislation has created certain “safe harbors” of conduct 3. Cincinnati, OH 45202-4152 about your specific circumstances. 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. Consistent with the proposed rule, all of the final Stark exceptions share five common requirements, which also appear in substantially similar forms in the three value-based AKS safe harbors: (1) The remuneration must be for or result from value-based activities undertaken by the recipient for patients in the target population. Please contact any member of our Health Care and Life Sciences Copyright © 2021 Bricker & Eckler LLP. The exceptions and safe harbors only protect with respect to prosecution and enforcement under the federal Stark Law and AKS. If the conditions in the safe harbors are met, neither party will be prosecuted or sanctioned for the arrangement. Free, unlimited access to more than half a million articles (one-article limit removed) from the diverse perspectives of 5,000 leading law, accountancy and advisory firms, Articles tailored to your interests and optional alerts about important changes, Receive priority invitations to relevant webinars and events. 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