On Wednesday, October 9, HHS proposed highly anticipated reforms to regulations implementing the Physician Self-Referral Law and the Federal Anti-Kickback Statute, as well as related civil . Download a PDF Version of the Article as Published in AHLA's 2021 . 2 A discussion of Stark's application to Medicaid claims is beyond the scope of this broad overview. This safe harbor permits patient engagement tools and/or other support furnished directly by a VBE to a patient in a target patient population that are directly connected to the coordination and management of care. What is downstream revenue? On December 2, 2020, the Centers for Medicare & Medicaid Services ("CMS") finalized long-awaited changes to the rules under the Physician Self-Referral Law, known as the "Stark Law." As discussed in our publication in 2019, CMS proposed the regulatory revisions in part to resolve uncertainty surrounding the terms "commercially reasonable . The Stark Law prohibits physicians from referring a patient to an entity with which the physician has a financial relationship when the referral is for the furnishing of certain designated health services (e.g., lab, PT, OT, radiology, DME . Unlike fair market value determination, commercial reasonableness is not as readily determined by standardized methodologies, practices, or sources. Finalized protection for arrangements that will apply regardless of whether the parties operate in a fee-for-service or value-based payment system, such as donations of cybersecurity technology. The exception cannot be utilized for the rental of office space though. The AKS Final Rule further codifies statutory revisions by adding the statutory exception to remuneration related to Accountable Care Organization Beneficiary Incentive Programs for the Medicare Shared Savings Program. On January 19, long-awaited adjustments to the Centers for Medicare and Medicaid Services' ("CMS") Physician Self-Referral Law (commonly referred to as the "Stark Law") and the Department of Health and Human Services Office of Inspector General's ("OIG") Anti-Kickback Statute ("AKS") took effect that make it easier for hospitals and health systems to transition from volume . Their concern has been financial, yes, but also an increasing concern of compliance risk. Also, a quantitative analysis of revenue cycle should be conducted to determine if the anticipated transaction acquires any referrals during the process and to ensure that healthcare organization complies with the regulatory statutes. In what situation is a written agreement NOT required under Stark? Introduction. Non-profit hospitals face additional requirements under the Internal Revenue Code that they must satisfy to maintain their tax-exempt status. Therefore, the analysis is recommended to be conducted by an independent valuation expert to establish a value that is consistent with independently published surveys that are comparable for similar services. Again, job posting sites have been invaluable to determining fair market value for high-demand services. The writing specifies the compensation that will be provided under the arrangement. 411.351. ; (2) How can it be fixed? Financial arrangements should be based on comparable data and should be set in advance by members who have no conflict of interests. 411.353 Prohibition on certain referrals by physicians and limitations on billing. The compensation must be set in advance, consistent with fair market value, and not determined in a manner that takes into account the volume or value of referrals or other business generated by the referring physician. For example, celebrities and professional athletes negotiate contracts without any specific compensation regulations. The Department of Health and Human Services has released extensive and significant revised final rules governing the Physician Self-Referral Law 1 (the Stark law) and the Medicare Anti-Kickback Statute 2 (AKS) in furtherance of its efforts to create a more hospitable regulatory climate for innovation in health care. \text{Regression} & \text{1} & \text{41587.3}\\ This is not to say that organizations and individuals cant achieve high levels of income but it is to say that the aims in healthcare are much different than you might see in investment banking, entertainment industries, or in sporting industries. The exception permits both monetary and nonmonetary remuneration between the parties. Formally establishes a definition of commercial reasonableness, while deleting outdated Stark Law references and updating key definitions such as fair market value, designated health services, physician, referral, remuneration, and transaction. While this exception may be utilized in some instances, it is likely organizations will utilize the employment exception or personal services exception. The reader is also cautioned that this material may not be applicable to, or suitable for, the readers specific circumstances or needs, and may require consideration of nontax and other tax factors if any action is to be contemplated. HSG has written articles about practice losses and how to address them. healthlawyers.org. The reader should contact his or her Carnahan Group or other tax professional prior to taking any action based upon this information. The definitions of fair market value and commercial reasonableness have been updated and established as follows: Regarding commercial reasonableness, CMS clarified that , As it relates to fair market value compensation, CMS clarifies several important items. 6 Mark O. Dietrich, CPA/ABV Stark II -Statutory Guidance Stark Statute - 42 U.S.C. document.write(year) 1320a-7b(b), applies to all individuals and companies. TheregressionequationisY=20.0+7.21XPredictorConstantXAnalysisSOURCERegressionResidualTotalCoef20.0007.210ofDF1Error8SECoef3.22131.3626VarianceSS41587.3751984.1T6.215.29. In June 2022, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) released OIG Advisory Opinion No. \text{Total} & \text{8} & \text{51984.1}\\ Special Rules for Profit Shares and Productivity Bonuses ( 411.352(i)) a. The fair market value of equipment and office space leases is determined without taking into account intended use or, in the case of office space, proximity to the lessor if the . Our fixed asset valuation services serve a variety of purposes for our clients, including: Anti-Kickback Statute and Stark Law Compliance Building High-Performing Physician Networks. The concept of fair market value under the Stark Law is different than the concept of fair market value in an otherwise normal business arrangement (where parties do realize they can generate business for one another). Through the Final Rule, CMS has addressed the topic of losses and profitability, stating the determination that an arrangement is commercially reasonable does not turn on whether the arrangement is profitable; compensation arrangements that do not result in profit for one or more of the parties may nonetheless be commercially reasonable. CMS offers several examples of reasons parties may enter into an arrangement or transaction despite financial losses to one or more parties. According to CMS, those reasons include, community need, timely access to health care services, fulfillment of licensure or regulatory obligations, including those under the Emergency Medical Treatment and Labor Act, the provision of charity care, and the improvement of quality and health outcomes. In our opinion, this means health care organizations must go the extra mile to document their reason(s) for compensating physicians and APPs, if those arrangements and transactions are exhibiting or are expected to yield financial loses. The arrangement is commercially reasonable (taking into account the nature and scope of the transaction) and furthers the legitimate business purposes of the parties. This ensures that there is maximum compliance of regulatory statutes and prevents any violation of healthcare laws. The new Stark rule revises this, stating the fair . Within the Healthcare industry, there are rules and regulations to ensure that . The Stark law prohibits a physician with a financial relationship in an entity from making a referral for designated health services covered by Medicare and Medicaid to that entity even if the services are billed to an individual or other third party payer. At WilliamsMarston, our team of valuation experts are readily available to assist you with your most important financial transactions, including navigating Stark Law and fair market value (FMV) matters. Carry out the indicated operation and give your answer with the specified number of significant digits. 411.353 Prohibition on certain referrals by physicians and limitations on billing. They are: (a) the lease agreement must be in writing; (b) the . 411.356 Exceptions to the referral prohibition related to ownership or investment interests. https://www.healthlawyers.org/Events/Programs/Materials/Documents/PHS15/kk_homchick_hutzler_shay.pdf, https://www.bdo.com/blogs/healthcare/april-2015/commercial-reasonableness-analysis?feed=8799bc52-2237-4688-aeac-83e40e623b56, http://www.americanbar.org/content/dam/aba/events/health_law/2015_Meetings/DocLaw/Papers/10_valuation_03.authcheckdam.pdf, http://www.worldservicesgroup.com/publications.asp?action=article&artid=2086, http://www.healthcapital.com/hcc/newsletter/10_12/HCVAL.pdf, New Timeshare Arrangement Exception under Stark Law. 411.357 Exceptions to the referral prohibition related to compensation arrangements. In turn, CMS is willing to accept any commercially reasonable methodology that demonstrates compensation is comparable to what is ordinarily paid for services in an arms-length transaction. var year = today.getFullYear() While this expansive list of Stark Law changes will take some time for the industry to digest, we wanted to promptly share three changes and corresponding takeaways as it relates to fair market value and commercial reasonableness in physician/ hospital relationships. 5, A regular assessment should be conducted to determine if the healthcare transactions are commercially reasonable. healthcapital.com. Key PYA Takeaway: CMS is clarifying that the Big 3 (fair market value, commercial reasonableness, and the volume or value standard) are separate and distinct concepts. This would be incorrect. J. William Bookwalter, III, M.D. Using the example of celebrities above, many contracts with celebrities include a portion of ticket sales to that movie. With the increased rate of mergers and acquisitions, healthcare organizations are vulnerable to federal scrutiny. The law provides that "fair market value" is the value in arms' length transactions concerning rentals or leases and the value of a rental property for general commercial purposes. Guidance on reconciliation of payment variances. For bona fide employment as long as all other requirements are met. The following requirements must be [] Fair market value is a pinnacle issue for compliance under the Stark Law and Anti-Kickback Statute. Many of these reasons are out of the hospital or health systems control. Previous Definition of Fair Market Value (42 U.S.C. In order to qualify for the recruitment exception, the arrangement must _________________________ . Carnahan Group. Civil penalties of the AKS include False Claims Act liability, civil monetary penalties (CMP) and program exclusion, up to $50,000 CMP per violation, and civil assessment of up to three times the amount of kickback. Compliant compensation methodologies: Advanced Stark. This has also been true in markets in which the demand and competition for CRNAs has exploded. Eliminating the period of disallowance rules and correcting discrepancies during the arrangement. The definitions are as follows: Central to the definition of fair market value is the definition of general market value. General market value is also restated in the Final Rule. A "Stark" Difference in Fair Market Value and Commercial Reasonableness Is Coming in 2021. General market value is the compensation that would be included in a service agreement as the result of bona fide bargaining between well-informed parties who are not otherwise in a position to generate business for the other party. In addition, CMS removed the "volume or value" and the "other business generated" standards . 1320a-7b) prohibit payments and receipt of payments given with an intent to influence the purchase of a product or services for which Medicare or Medicaid reimbursement is sought. Finalized a new exception to protect compensation not exceeding an aggregate of $5,000 per calendar year to a physician for the provision of items and services, without the need for a signed written agreement and compensation that is set in advance if certain other conditions are met (i.e., fair market value and does not take into account volume and value of referrals). The CMS Self-Referral Disclosure Protocol (SRDP). New Value-Based Exceptions. The Situation: The isolated transactions exception under the Stark Law has been used by some providers and entities to retroactively protect services arrangements that do not qualify for personal services or fair market value compensation exceptions because, for example, the arrangements were not reduced to writing before services were rendered. The Department of Health and Human Services (HHS) defines commercial reasonableness as a sensible, prudent business arrangement, from the perspective of the particular parties involved, even in the absence of any potential referrals. Which of the following are exceptions under Stark? While this exception may be utilized in some instances, it is likely organizations will utilize the employment exception or personal services exception. However, we agree with the commenter that asserted that a hospital may find it necessary to pay a physician above what is in the salary schedule, especially where there is a compelling need for the physicians services. Despite the request and urging of commenters, CMS declined to establish rebuttable presumptions that compensation is fair market value or safe harbors that would deem compensation to be fair market value if certain conditions are met. Bottom line, CMS affirmed that there is no guarantee to fair market value determinationthere is no universal formula or proverbial rubberstamp as it pertains to provider compensation. In a simple example, we can determine that fair market value for compensation of a medical director for a cardiac catheterization laboratory is $150 per hour. A general journal is given in the Working Papers. These historic reforms became effective January 19, 2021 and are part of HHS's "Regulatory Sprint to . As to its civil penalties, the Anti-Kickback Statute includes monetary penalties up to $50,000 per violation, civil . Under the Stark Law, one of the critical elements of compliance for many exceptions includes the requirement that the financial arrangement is representative of fair market value. The law makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive anything of value (not just money) in order to induce or reward referrals or the generation of business paid for by federal healthcare programs. Provides new exceptions for value-based compensation arrangements that meet certain financial risk requirements and provides new definitions for value-based activity; value-based arrangement; value-based enterprise (VBE); value-based purpose; VBE participant; and target patient population. CMS' stated purpose is to establish bright-line, objective regulations that would be more easily applied. bdo.com. We also believe there has to be a limit to what is reasonable in terms of losses. The Federal Anti-Kickback Statute, codified at 42 U.S.C. For most Stark Law exceptions to apply, a(n) ___________________ is required. Referring to survey data regarding practice losses per physician and per provider can be enlightening. With respect to the rental of office space, fair market value means the value in an arms-length transaction of rental property for general commercial purposes (not taking into account its intended use), without adjustment to reflect the additional value the prospective lessee or lessor would attribute to the proximity or convenience to the lessor where the lessor is a potential source of patient referrals to the lessee, and consistent with the general market value of the subject transaction. A Stark violation is punishable by civil money penalties; an anti-kickback violation is punishable by exclusion from federal health care programs, criminal penalties of up to $25,000 in fines or . Stark Law provides this definition: The term "fair market value" means the value in arm's length transactions, consistent with the general market value(42 USC 1395nn) 42 CFR 411.351 -"general market value" means the price that an asset would bring or that would be included in a Contact our expert, Neal D. Barkeratnbaker@hsgadvisors.com or call (502) 814-1189. ), commonly referred to as the Stark law, is a set of regulations that pertain to physician self-referral under current United States (US) federal law. Thus, "compensation substantially above $450,000 per year may be fair market value," according to . Bottom line, 2021 surveys, based on 2020 data, are likely going to be challenging. Since the Stark Law was enacted in 1989 this been a compliance concern in the back of the minds of hospital executives. Three new safe harbors for remuneration exchanged between or among participants in value-based arrangements: Value-based arrangements with full financial risk. Third, fair market value as a concept is also dictated by relevant government enforcement actions as well as lawsuits. While the hypothetical fair market value is $450,000, the general market value may exceed that. Fixed asset valuations include fair market value, orderly and forced liquidation valuations of medical equipment, office and computer equipment, software, leasehold improvements and supplies inventory. These statutes currently reside under the purview of Centers for Medicare & Medicaid Services (CMS) fraud and abuse laws. In healthcare, the patient would have received the care regardless of the physician and the complexity of healthcare with patients moving to different sites of service and within different specialties creates impossible scenarios for tracking who is responsible for what.
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