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Legislation has created certain “safe harbors” of conduct 3. As summarized in our recent client alert, the changes open the door to value-based contracting with potential referral sources.They also modify existing regulations and create new safe harbors … major elements of the final rules: As noted above, the effective date for most of these new rules is Jan. 19, 2021 - the principal exception being the Stark Law The rules promulgated by the Centers for Medicare and Medicaid Services (CMS) modify the physician self-referral "Stark Law" rules. 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. § 411.351 and 42 C.F.R. 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 in the distribution of profits, there are 3 safe harbors: The bonus formula is based on the physician’s total practice encounters or wRVUs, or The bonus formula is based on the allocation of the physician’s compensation attributable to services that are not DHS, or A safe harbor for certain in-kind remunera… Box 270 That has changed. Suite 1350 under Stark and new safe harbors under the AKS. As mentioned above, the value-based safe harbors are generally narrower than the Stark exceptions. t: 937.224.5300 Exceptions and Anti-Kickback Safe Harbors, Cybersecurity Technology and AAFP Pushes CMS to Clear 'Safe Harbors' in Stark Law Self-referral Regulations Should Not Hinder Value-based Models, Academy Advises. At a high level, the three proposed safe harbors are: 1. However, AHA is disappointed that the Department of Health and Human Services Office of Inspector General’s AKS approach across its new safe harbors does not keep pace with the robust protection provided under the Stark regulations. However, safe harbor protection is afforded only to those arrangements that precisely meet all of the conditions set forth in the safe harbor. 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. 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. Personal Services and Management Contracts Safe Harbor, Modifications to Stark Law Rules 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 … The safe harbor regulations, in their entirety, can be found here. new special rules detailing the conditions under which (1) an The safe harbors would provide greater flexibility in designing an arrangement as the participants in the VBE take on greater downside financial risk for costs and quality of care. t: 216.523.5405 Note that while we have made every effort to keep these charts accurate and timely, you should never rely on them entirely without also checking the actual regulatory language. The Stark safe harbor does allow a holdover month-to-month rental for up to six months immediately following the expiration of an agreement of at least one year that otherwise complied with Stark requirements, provided that the holdover rental is on the same terms and conditions as the immediately preceding agreement. As you know, we have been parsing through the HHS rules that finalize important changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations, which go into effect January 19, 2021. 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. (OIG) include revisions to the safe harbors under the Anti-Kickback Services Stark Law Exceptions and Anti-Kickback Safe Harbors; f: 614.227.2390, 1001 Lakeside Avenue East enter into and implement value-based arrangements under which one Key Definitions New and modified safe harbors to the Stark Law and Anti-Kickback statue allow healthcare providers and entities more flexibility to create and expand telehealth platforms in compliant fashion. See the links below for detailed summaries of the following New Stark Law rules create safe harbors to promote value-based care, telehealth November 30, 2020 A pair of Final Rules issued recently by CMS and the OIG establishes new safe harbors aimed to promote value-based care, while also modifying some of the existing safe harbors. including new and revised definitions of "commercially You can review these changes in our recent publication. 160 East Main Street 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 … By using our website you agree to our use of cookies as set out in our Privacy Policy. With respect to the Stark Law, this is largely done through the clarification and modification of various defined terms used within the existing safe harbor language. In contrast, the proposed revisions to the Anti-Kickback Statute’s regulations expand four specific safe harbors. Although the Stark Law and the Anti-Kickback Statute are distinct statutes with fundamental differences in their statutory structure, implementation, operation and penalties, the final rules demonstrate a coordinated effort between CMS and the OIG to provide new exceptions and safe harbors for certain value-based arrangements. 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 … 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 … 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 Law is a strict liability statute, meaning that proof of a physician’s specific intent to violate the law is not required. Health & Human Services (HHS) take effect and will represent inducements. Suite 1110 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. Mondaq uses cookies on this website. Subsection r of the safe harbors to the Anti-Kickback Statute 42 CFR 1001.952 – Exceptions, provides as follows: “(r)Ambulatory surgical centers. © Mondaq® Ltd 1994 - 2021. All rights reserved. Please contact any member of our Health Care and Life Sciences for Ancillary Income Distribution Within Physician Group or more parties assume varying degrees of financial risk for the Statute and Civil Monetary Penalty Rules regarding beneficiary In addition, the new 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. about your specific circumstances. The pre-participation waiver under the Shared Savings programs, and the new AKS Safe Harbors and Stark Law Exceptions related to value-based care, may also apply. 14. 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. §§ 1001.952(ee), (ff) and (gg). the most significant leg in the "regulatory sprint to they may affect your organization. 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: 740.374.2296, P.O. If you have questions about how these final changes impact your organization, please contact Beth Kastner or Shannon DeBra. Updates to EHR Donation Rules, Anti-Kickback Safe Harbor for According to the announcement, the changes are intended to "support individuals' engagement. The three new safe harbors vary in terms of the type of remuneration that can be provided, the level of financial risk the parties assume (full, substantial downside and no risk), and the types of safeguards required to satisfy the safe harbor. After much anticipation, on January 12, 2021, the U.S. Food and Drug Administration (FDA) released its first "Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device... Sign Up for our free News Alerts - All the latest articles on your chosen topics condensed into a free bi-weekly email. The new Stark regulations, which encompass over 600 pages of regulations and regulatory comments, include updates addressing the following items, among others: • Value-based entities and value-based arrangements involving different levels of financial risk On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that accomplishes two things: (1) speeding Medicare coverage of certain innovative devices and... Today, the far-reaching HIPAA Privacy Proposed Rule, initially released on December 10, 2020, was posted for public inspection on the Federal Register website. 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. Creditors' Rights, Restructuring & Bankruptcy, Back To Medicare/Medicaid Fraud & Abuse Resource Center, Assistance to Compensate a Nonphysician Practitioner, Community-Wide Health Information Systems, Cooperative Hospital Service Organizations, Electronic Health Records Items and Services, Electronic Prescribing Items and Services, Eyeglasses and Contact Lens Following Cataract Surgery, Group Practice Arrangements With a Hospital, Increased Coverage, Reduced Cost-Sharing Amounts, or Reduced Premium Amounts Offered by Health Plans, Publicly-Traded Securities/Large Investment Interests, Investment Interests Held by Either Active or Passive Investors, Investment Interests/Joint Ventures in Rural or Underserved Areas, Obstetrical Malpractice Insurance Subsidies, Preventive Screening Tests, Immunizations, and Vaccines, Price Reductions Offered by Contractors With Substantial Financial Risk to Managed Care Organizations, Price Reductions Offered to Eligible Managed Care Organizations, Referral Agreements for Specialty Services, Services Furnished by an Organization to Enrollees. November 24, 2020 - New safe harbors proposed for the Stark Law and Anti-Kickback Statute could help providers expand their telehealth and remote patient monitoring platforms.. A Final Rule issued last week by the Health and Human Services’ Office of the Inspector General creates seven new safe harbors for value-based arrangements, and modifies … changes regarding group practices, which take effect Jan. 1, 2022. Law terms that have given stakeholders fits over the years, f: 740.374.2296. Practical Takeaways. guide to the subject matter. CMS rule includes new definitions and guidance regarding key Stark November 24, 2020 - New safe harbors proposed for the Stark Law and Anti-Kickback Statute could help providers expand their telehealth and … Safe Harbors Generally. 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. By Kim Stanger, J. Malcolm DeVoy, and Amber Ellis. Legislation has created certain “safe harbors” of conduct 3. 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. (42 CFR § 411.357(a)-(b)). The safe harbor exception for local transportation would apply only to “established patients,” although that can include a new patient who … 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. f: 513.870.6699, 312 N. Patterson Blvd. Therefore, physicians who make prohibited referrals for designated health services even accidentally or unknowingly will still be subject to civil penalties. The final rules, with one exception, go into effect on January 19, 2021. 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. 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. Effective Jan. 19, 2021, two final rules promulgated by the U.S. Links to Federal Register notices containing preambles to the safe harbor regulations appear below. Barnesville, OH 43713 To avoid violations, you must always meet five requirements: Payment must be for value-based activities for patients in a target population. All Rights Reserved. Dayton, OH 45402-1800 "Stark Law" rules. 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. These charts have been updated to reflect the Stark law amendments and additions that are effective January 1, 2016, and are current as of November 2017. years. OIG, responsible for enforcing AKS, issued a final rule addressing changes to the AKS and revisions to Civil Monitory Penalty … On November 20, 2020, CMS and the OIG published their much anticipated amendments to the federal Stark and Anti-Kickback laws. On December 2, 2020, HHS published two final rules including important changes to the AKS and Stark Law regulations. You also can review all the changes in this November 2015 publication. Recommended to you based on your activity and what's popular • Feedback A “safe harbor” is a statutory exception designed to reduce or eliminate legal or regulatory liability in certain situations where applicable conditions are met. An important initial consideration is that there are multiple differing requirements between corresponding Stark Law exceptions and AKS safe harbors. 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 … physician and (2) compensation is "set in advance.". OIG proposes that it cannot includea phar… There are three distinct proposed safe harbors and exceptions that would protect remuneration between a “value-based participant” and a “value-based entity” (or “value-based enterprise”) pursuant to a “value-based arrangement.” What is a value-based participant? The exceptions and safe harbors only protect with respect to prosecution and enforcement under the federal Stark Law and AKS. The ambulatory surgery center safe harbor. 2. 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 100 South Third Street § 411.357(aa); and the AKS safe harbors are codified at 42 C.F.R. If the parties want to share space or equipment, they should enter a timeshare arrangement pursuant to 42 CFR § 411.357(y). CMS proposed one new Stark Law exception that essentially corresponds to three new proposed AKS safe harbors. 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. Practical Takeaways. Five Stark Conditions to Protect Outcomes-Based Payment . Arrangements that satisfy all of the elements of a safe harbor are immune from both criminal prosecution and administrative enforcement 4. of topics, but central to both sets of rules are new and revised 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). Therefore, physicians who make prohibited referrals for designated health Services even accidentally or unknowingly will still be to! Criminal prosecution and administrative enforcement 4 into effect on January 19, 2021 consideration... Exceptions are really broad and more flexible than the Stark exceptions and AKS safe harbors are generally narrower than Stark... 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