Start Preamble Start Printed Page 77684 AGENCY: Office of Inspector General (OIG), Department of Health and Human Services (HHS). The AKS safe harbor for care coordination arrangements protects in-kind remuneration exchanged between qualifying VBE participants in a value-based arrangement connected to the coordination and management of care of the target patient population.10 Under this safe harbor, each offer of in-kind remuneration among VBE participants must be analyzed separately for compliance with the safe harbor. US-China Agreement Supports International Injunction Against Alleged... FTC Announces 2021 Thresholds Under HSR Act and Clayton Act. If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. A common component of value-based arrangements is the desire to provide in-kind assistance to patients to help ensure adherence to a treatment plan, with a goal of improving health outcomes and reducing overall costs. Ogletree, Deakins, Nash, Smoak & Stewart, P.C. "acceptedAnswer": { OIG declined to finalize an exception under the corresponding CMS exception methodology under the Stark Law rules for meaningful downside risk arrangements. The VBE or VBE participant must make available to the secretary, upon request, all materials and records sufficient to establish compliance. }, { Cannot be an inducement to reduce or limit medically necessary services. The VBE must assume full financial risk (or is contractually obligated to be at full financial risk within the 12 months following the commencement of the value-based arrangement) during the entire duration of the value-based arrangement. The new exceptions created to the Stark law and safe harbors for Anti-kickback Statute to protect value-based arrangements define them as: 1. "text": "The Anti-Kickback Statute and Stark Law prohibit medical providers from paying or receiving kickbacks, remuneration, or anything of value in exchange for referrals of patients who will receive treatment paid for by government healthcare programs such as Medicare and Medicaid, and from entering into certain kinds of financial relationships. The AKS safe harbor for value-based arrangements with substantial financial risk, which protects both monetary and in-kind remuneration, offers greater flexibility than the safe harbor for care coordination arrangements in recognition of the VBE’s assumption of an intermediate level or downside risk (i.e., substantial downside financial risk). Coordinating and managing the care of a target patient population. (vi) The aggregate retail value of patient engagement tools and supports furnished to a patient by a VBE participant on an annual basis cannot exceed US$500 unless such patient engagement tools and supports are furnished to patients based on a good-faith, individualized determination of the patient’s financial need; and. b. [Video] The Biden EEOC, New Religious Guidance, and Diversity... NLRB Acting General Counsel Strikes Again, Directs Agency to Withdraw... EPA Announces Latest Update to the TSCA Inventory. If you would like more information, or would like to speak to a member of the Constantine Cannon’s whistleblower lawyer team, please Contact us for a Confidential Consultation." Progress toward attainment of the outcome measure(s), if any, against which the recipient of the remuneration is assessed. Prohibits the exchange of remuneration for purposes of for patient recruitment or for marketing the items or series provided by the VBE or VBE participants. OIG extended the phase-in period for this safe harbor from six months to one year. Do allow for directed referrals of patients to specific providers (so long as a series of conditions and exceptions are accounted for). Felony; up to $250,000 for individuals and $500,000 for institutions What are safe harbors in anti-kickback law? The requirement to make referrals does not apply if: the patient expresses a different preference; the patient’s payor determines the referral; or. However, because of the fundamental differences in the statutory structure, operation, and penalties between the physician self-referral law and the anti-kickback statute, complete alignment between the exceptions to the physician self-referral law and safe harbors to the anti-kickback statute is not feasible. “Substantial downside financial risk” means, for the entire term, in the form of (each tied to historical expenditures): Shared loss arrangements including financial risk equal to at least 30 percent of any loss calculated by comparing current expenditures for all items and services that are covered by the applicable payor and furnished to the target patient population to a bona fide benchmark. However, this safe harbor only protects arrangements between VBEs and VBE participants and not agreements among VBE participants or with downstream entities. The chief focus of this white paper will be a series of three AKS safe harbors and three Stark Law exceptions that reflect a sliding scale of regulatory flexibility for value-based arrangements. The Stark Full Financial Risk Exception only applies to arrangements that involve a VBE taking on full downside risk in a value-based arrangement with an applicable payor. New Safe Harbors. Mental Health Parity: Comparative Assessments Required for Certain... New Executive Order Revises Buy American Requirements. To foster this transition to value-based care, HHS promulgated various waivers of the AKS, the Stark Law, and civil monetary penalty (CMP) laws in connection with these CMS-driven innovation models. D.C. Council Passes ‘Protecting Businesses and Workers from COVID-19... “State” of Telehealth Series: New Hampshire. Basically, anything of value to a person in a position to refer, such as cheap office space, patients referrals, a free employee, or a fat bonus, can classify as an illegal inducement under the Anti-Kickback and Stark laws. Indeed, careful review and understanding of these requirements is, perhaps, heightened for value-based arrangements, as such arrangements may explicitly include provisions that would be expressly prohibited outside of a structured arrangement taking advantage of these value-based safe harbors and exceptions. "@type": "Question", The National Law Review is a free to use, no-log in database of legal and business articles. 2 Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations, 85 Fed. The federal Anti-Kickback Statute (AKS) (See 42 U.S.C. Lowering the Bar: The FTC Lowers HSR Premerger Reporting Thresholds... Numerosity and Rule 23: It’s Not (Only) About the Numbers. Department of Health and Human Services, Office of Inspector General: 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 OIG declined to do so, but it specified that it would expect stop-loss or other risk adjustment arrangements to be limited to protection for the VBE against catastrophic losses and not as a means to shift material financial risk back to the payor or another third party–i.e., the VBE must maintain material financial risk.18. That said, one of the key similarities between the finalized AKS safe harbor and the Stark Law exception is the referral requirement. Reg. One example provided by CMS is that a VBE could not receive protection under a value-based Stark Law exception for a value-based arrangement between an entity and a physician that are VBE participants in the VBE if, as part of the arrangement, the entity requires the physician to refer Medicare patients who are not part of the target patient population for designated health services furnished by the entity.14 Similarly, the value-based AKS safe harbors do not provide protection for value-based arrangements that condition an offer of remuneration on: (i) referrals of patients that are not part of the value-based arrangement’s target patient population, or (ii) business not covered under the value-based arrangement.15. Hold the Fries: Federal Court Rejects Second Request to Kick Claims... Competition Currents February 2021: Mexico, Chemical “Risk Management Rules” on the Horizon for 2021, Competition Currents February 2021: United States. The AKS safe harbor for value-based arrangements with full financial risk is intended to protect certain arrangements (including in-kind and monetary remuneration) involving VBEs that have assumed “full financial risk” for a target patient population. The six safe harbors and exceptions set forth by OIG and CMS are as follows: a. Arrangement must be commercially reasonable. Privacy Policy. The VBE or VBE participant offering the remuneration must not take into account the volume or value of, or condition the remuneration on: Referrals of patients who are not part of the target patient population. "name": "What is the Anti-Kickback Statute? In its original 1972 form, the AKS specifically targeted âkickbacks or bribesâ and ârebates.â In 1977, Congress expanded the statuteâs scope by prohibiting âany remunerationâ exchanged for purchasing or referring federally funded goods or ⦠This safe harbor requires no assumption of downside risk by parties to a value-based arrangement. As part of the effort to provide protections to a continuum of arrangements, the limited risk share arrangements present the least amount of flexibility. OIG also removed the specific 60 percent discount that was included in the proposed rule for partial capitation. In providing a new framework for supporting value-based arrangements, the Final Rules align with the goals of the “Regulatory Sprint to Coordinated Care,” as HHS seeks to drive increased provider engagement with value-based care. Wage-and-hour litigation, confusing state-level regulations and an increase in federal audits were among the biggest legal trends of 2020. In Setty, Ninth Circuit Signals Shift in Arbitration Landscape for... Failure to Fully Disclose Expert Opinions Results in Summary Judgment. K&L Gates’ health care practice can assist health care providers in conducting this analysis and will continue to closely monitor issues related to the AKS and the Stark Law, particularly in the value-based context. Like OIG, CMS addressed questions regarding stop-loss by not limiting an amount of loss mitigation but indicating that such mitigation should not shift material financial risk to the payor.20. Both the Anti-Kickback Statute and the Stark Law are designed to keep medical treatment decisions free from the influence of potential monetary gain. In addition to potential AKS barriers, such assistance can also be problematic under the beneficiary inducements CMP law, which penalizes remuneration to a beneficiary when the offeror knows or should know the remuneration is likely to influence the selection of a provider. New Antitrust Whistleblower Statute May Enhance Criminal Enforcement... Court Held That The Issue Of Who Was Included In The Class Of... HMT Announces Buy-Now-Pay-Later Products to be Regulated by the FCA, Regulating Third-Party Food Delivery Services During COVID-19. Directed Referrals to a Particular Provider. Methodology used to determine amount of remuneration must be set in advance. : New Robocall Class Action Seeks $... Congress Amends the PACT Act to Apply to All Vaping Products, Placing... Is The Age Of Reason(able Belief) Over? Section 1128B(b) of the Act, the 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 Decide if the clause should be open and unqualified or a closed list of force majeure events. Partial capitation, where the VBE receives a prospective, per-patient payment that is: (i) designed to produce material savings, and (ii) paid on a monthly, quarterly, or annual basis for a predefined set of items and services furnished to the target patient population designed to approximate the expected total cost of expenditures for the predefined set of items and services. "acceptedAnswer": { If the parties meet various tests to qualify for the "safe harbor," then they aren't in violation. The choice of a lawyer or other professional is an important decision and should not be based solely upon advertisements. Whether and how continuation of the value-based activities is expected to further the value-based purpose(s) of the VBE. Relief for Partial Plan Terminations May Be “Too Little, Too Early”, Fertility Patients Sue Following Data Breach. The VBE or VBE participant must not take into account the volume or value of, or condition the remuneration on: The value-based arrangement must be set out in a writing signed by the parties that specifies the material terms of the value-based arrangement, including the value-based activities to be undertaken by the parties, and is for a period of at least one year. This safe harbor does not require parties to bear or assume downside financial risk. Seventh Circuit Decision May Portend Increase in Equal Pay Act Claims... Snapple Urges Court to Dismiss “Sorta Sweet” Lawsuit. "text": "There are differences between the Anti-Kickback Statute and Stark Law, and regulations provide “safe harbors” permitting certain arrangements. Because this segment of the market has taken a significant step on the glide path to risk, the differences between the Stark Law exception and the AKS safe harbor are likely to create concern as to whether arrangements can be adequately protected. ", The target patient population for the arrangement. They can lead to: As the Department of Justice has explained, “[p]atients are entitled to be sure that the care they receive is based on their actual medical needs rather than the financial interests of their physician.”. } Does not include marketing to patients of items or services furnished by the VBE or a VBE participant, or engaging in patient recruitment activities. Right?? Mr. Scott applies his prior experience in government, private practice, and healthcare delivery to assist clients in identifying practical legal solutions to complex regulatory matters. “Care Coordination Arrangements to Improve Quality, Health Outcomes, and Efficiency Safe Harbor”, “Value-Based Arrangements with Substantial Downside Financial Risk”, “Value-Based Arrangements With Full Financial Risk”, “Value-Based Arrangements with Meaningful Downside Financial Risk to the Physician”. }, { Do not require that compensation or other remuneration under an arrangement be set in advance. The OIG is concerned that the offer or provision of remuneration under value-based arrangements could present opportunities for the types of fraud and abuse traditionally seen in the fee-for-service system, particularly where the parties offering or receiving the remuneration have not assumed downside financial risk for the care of the target patient population. As indicated above, the final rule also creates two new safe harbors to the Anti-Kickback Statute. We can’t list every way that people have tried to cheat the healthcare system, and people are always finding new ways. Notwithstanding the complexity and number of requirements created by the Final Rules, these value-based safe harbors and exceptions ultimately represent a major regulatory shift that recognizes the reduced need for aspects of these laws that were designed in part to prevent overutilization. An important initial consideration is that there are multiple differing requirements between corresponding Stark Law exceptions and AKS safe harbors. With value-based purposes in mind, the Final Rules define a “value-based activity” as one or more activities reasonably designed to achieve a value-based purpose, which can be the provision of an item or service, the taking of an action, or the refraining from taking an action.4 OIG specified that a value-based activity does not include the making of a referral.5 CMS did not make a similar exclusion6 because the definition of referral in the Stark Law already reflects a policy that referrals are not items or services for which a physician may be compensated. This “thing of value” can be as simple as cash, or as complex as a carefully constructed physician employment agreement or the right to invest in a profitable joint venture. Although the specific requirements differ as between AKS and the Stark Law, the framework is helpfully similar. This safe harbor includes more flexible conditions than the care coordination arrangements and substantial downside financial risk safe harbors, which the OIG believes reduces burden for the VBE and its participants. “Full financial risk” means the VBE assumes financially responsibility, on a prospective basis, for cost of all items and services covered by the applicable payor for each patient in the target patient population. While they are generally excluded from protections under the safe harbors, as discussed below, certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) providers and suppliers that qualify as limited technology participants may utilize the care coordination arrangements safe harbor for arrangements involving digital health technology. § 1395nn, “referrals” are limited to certain types of medical services, such as lab testing, hospital services, prescription drugs, and durable medical equipment, defined as “designated health services.” In addition, the Stark Law applies only to relationships with physicians. Typically, however, the core analysis looks at the a fundamental question: was something of value provided to induce health care referrals? OIG recognized that this safe harbor would apply to a limited number of providers, but it promulgated the safe harbor to remove a potential barrier to providers taking on additional risk.19 OIG did note that some state laws limit the ability of providers to take full financial risk without forming licensed health plans or meeting other licensure requirements, and OIG indicated providers must still comply with state law. The outcome measures against which the recipient of the remuneration is assessed, if any. Washington, D.C. These statements are subject to the safe harbors under Private Securities Litigation Reform Act of 1995. What kind of crime is a violation of anti-kickback law, and what is the penalty for physicians and hospitals? Global Solutions, Flash Briefing: Japan’s 2021 Response to COVID-19 [... 2021 Report on FINRA’s Examination and Risk Monitoring Program. The fact that an arrangement is associated with a legitimate value-based purpose alone will not guarantee that the arrangement will fit within one of the safe harbors or exceptions. VBE must make available all records to the secretary upon request as necessary to establish compliance. to. This Stark Law exception applies to physician compensation arrangements that qualify as value-based arrangements, regardless of the level of risk undertaken by the VBE or any of its VBE participants. The Anti-Kickback Statute and Stark Law prohibit medical providers from paying or receiving kickbacks, remuneration, or anything of value in exchange for referrals of patients who will receive treatment paid for by government healthcare programs such as Medicare and Medicaid, and from entering into certain kinds of financial relationships. "@type": "Answer", Of particular note, several of the new safe harbors and exceptions: Do not contain a requirement that an arrangement be set at fair market value. If you would ike to contact us via email please click here. Under the longstanding Stark Law regulations, if an indirect compensation arrangement exists, the exception for indirect compensation arrangements at 42 C.F.R. { CMS explains that this exception requires that the VBE is financially responsible (or is contractually obligated to be financially responsible within the six months following the commencement date of the value-based arrangement) on a prospective basis for the cost of all patient care items and services covered by the applicable payor for each patient in the target patient population for a specified period of time. The Stark Law, unlike the Anti-Kickback Statute, flatly prohibits a broad range of financial relationships, and does not require proof of an intent to induce referrals. Although a number of commenters sought a unified set of requirements between Stark Law and AKS requirements, CMS and OIG rejected this approach, noting the different purposes of each law. Records of the methodology for determining and the actual amount of remuneration paid under the value-based arrangement must be maintained for a period of at least six years and made available to the secretary upon request. Partial or full capitation payment or similar payment methodology that is structured as a prospective, per-patient payment for a predefined set of items and services furnished to the target patient population. "@type": "Question", Reg. The OIG stressed that it “sees a clear distinction between coordinating and managing patient care transitions for the purpose of improving the quality of care or improving efficiencies, which would fit in the definition, and churning patients through care settings to capitalize on a reimbursement scheme or otherwise generate revenue, which would not fit in the definition.”11 Likewise, the OIG noted that arrangements involving the provision of data analytics software, care managers, or remote patient monitoring could likely fit within the safe harbor. b. Tracking Treasury Trading: The Fed to Collect the TRACEs. "@type": "Answer", The Anti-Kickback Statute: Safe Harbors "Safe harbor" regulations allow specific transactions and arrangements which would otherwise be AKA violations to be exempt. Such coordination could involve the use of care managers, providing care or medication management, creating a patient-centered medical home, helping with effective transitions of care, sharing and using health data to improve outcomes, or sharing accountability for the care of a patient across the continuum of care. Interagency Fraud Enforcement Action Highlights Telepharmacy... Congressional Investigations Preview for The 117th Congress: Unified... FERC Directs RTOs and ISOs to File Reports on Hybrid Resources. In addition to these sweeping value-based changes, both Final Rules contain a host of other, wide-reaching regulatory changes and policy clarifications. Under the longstanding Stark Law have likewise taken up the mantle to shift reimbursement away from volume and value. Regarding solicitation and advertisement practices by attorneys and/or other professionals Final Rules introduce an entirely new framework structuring. 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