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Government scrutiny around healthcare transactions has heightened in recent years due to an increase in the volume of violations of healthcare fraud and abuse laws. 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. Not only was the definition of general market value amended, but it was also given three unique definitions related to the context of a specific type of transaction. Hospital-Physician Leasing Arrangements As you can see, the definition of fair market value does not provide details with respect to what is fair market value. Eliminating the period of disallowance rules and correcting discrepancies during the arrangement. Providing additional flexibility related to signature and writing requirements. Second, downstream financial incentives in healthcare, as in most industries, is extremely hard to quantify. 3) Specify an aggregate payment, which is set in advance. 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. worldservicesgroup.com. 22-14.HHS OIG was responding to a written request for an advisory opinion regarding a proposed continuing medical education program for local optometrists conducted by an ophthalmology group practice and four potential funding options for the programs. Sign Up for HSG's Physician Strategy News and Notifications on New Thought Leadership, Advanced Practice Provider (APP) Utilization, Fair Market Value and Commercial Reasonableness Opinions, Advanced Practice Provider (APP) Compensation, Download a PDF Version of the Article as Published in AHLAs 2021 Transactions Resource Guide to Share With Your Team, HSG Advisors Expands Consulting Services and Data Analytics Capabilities in Response to National Outpatient Utilization Trend, Creating a Win/Win System of Advanced Practice Provider Oversight, FPM Practice Pearls: HSG Advisors Shares How to Make APP Reviews Mutually Beneficial, Healthcare Provider Compensation in a Post-COVID, New MPFS Reality, Best Practices in Patient Attraction and Retention Strategies. In fact, studies done by the government in the 1980s and early 1990s discovered that this was a real issue and it not only represented a significant increase in costs but also created significant patient risk. The bottom line is that in the context of fair market value and the Stark Law, normal business negotiations allowing for leverage between parties is not necessarily the same in the healthcare context (because the parties cannot take into account that they generate business for one another). \text{Total} & \text{8} & \text{51984.1}\\ The "value-based arrangements exception" to the Stark Law protects value-based arrangements that are set forth in a writing (signed by the parties) that details the following: the value-based activities to be undertaken under the arrangement; how the value-based activities are expected to further the value-based purpose(s) of the VBE; 1877nn(h)(3) Value in arms-length transactions, consistent with general market value Rentals or Leases - value of rental property for general commercial purposes, not taking into account its intended use Space Lease - not taking into account the value the lessee or On February 9, 2018, Congress passed and President Trump signed into law H.R. Allows the electronic health records (EHR) exception to be unending and allows limited donations of cybersecurity that are necessary for EHR, flexible physician payment schedules, and donations of replacement EHR items. Grabbing a 2021 survey and finding a percentile might be enough, then again, it might not. What Is the Stark Law, and How Can You Avoid Violating It? 7. This would be incorrect. While this exception may be utilized in some instances, it is likely organizations will utilize the employment exception or personal services exception. A "Stark" Difference in Fair Market Value and Commercial Reasonableness Is Coming in 2021. Fair Market Value ( 411.351) C. Group Practices ( 411.352) 1. PDF Establishing Fair Market Value under the Anti-kickback and Stark Laws 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. Kickbacks And Other Illegal Arrangements: The Anti-Kickback Statute OIGs proposed new safe harbors are: Additionally, OIG is finalizing changes to the following existing safe harbors: CMS modifications and additions to the Stark Law rules were equally significant. 411.353 Prohibition on certain referrals by physicians and limitations on billing. Reflecting on Recent Regulatory Changes to the Stark Law: A Real Estate and Equipment Valuation Perspective, Part 2. The proposed rule would create new, permanent exceptions to the Stark Law for value-based arrangements. Many of the changes in the Stark Law are aimed at eliminating regulatory restrictions that could deter or even potentially eliminate some novel arrangements as the industry continues its move towards a value-based health care system. \end{matrix} Thursday, October 20, 2022. The Stark Law prohibits physician referrals of Medicare patients for certain "designated health services" to entities with which the physician has a financial relationship, unless an exception under the law applies. The new Stark rule revises this, stating the fair . The anti-kickback regulations apply only to services reimbursed by Medicare or Medicaid. 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. Specifically, the aim of healthcare delivery is to provide high-quality care, high levels of access, and at the most cost-effective price. We also think this is an appropriate reflection and representation of what CMS recognized and articulated when it said: It is not CMS policy that salary surveys necessarily provide an accurate determination of fair market value in all cases.. Although many compensation arrangements are legitimate, a compensation arrangement may violate the anti-kickback statute if even one purpose of the arrangement is to The Stark law does maintain a definition of fair market value but it does not dictate actual numbers. document.write(year) On November 20, 2020, the U.S. Department of Health and Human Services (HHS) published Final Rules for the Physician Self-Referral Law (Stark Law), the federal AKS, and the Civil Monetary Penalties (CMP) Law. 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. They are: (a) the lease agreement must be in writing; (b) the . ensure that those arrangements reflect fair market value for bona fide services the physicians actually provide. The general market value definitions are: What does it mean for a compensation arrangement to be commercially reasonable? A and B - not be conditioned on referrals & allow the physician to establish medical staff membership at other hospitals. Clarifies the period of disallowance for referrals and billing following a self-referral law violation, the satisfaction requirements for set-in-advance compensation, when an entity may direct a physicians referrals to a provider, the requirement for exclusive use of office space/ equipment, and the exception for payment by a physician to an entity. The Stark Law (42 U.S.C. For more information on Stark Law Exceptions, see our dedicated page. 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. The Anti-Kickback Statute. TheregressionequationisY=20.0+7.21XPredictorConstantXAnalysisSOURCERegressionResidualTotalCoef20.0007.210ofDF1Error8SECoef3.22131.3626VarianceSS41587.3751984.1T6.215.29. J. William Bookwalter, III, M.D. Fair Market Value and Commercial Reasonableness Applied to Healthcare Transactions. Sec. Their concern has been financial, yes, but also an increasing concern of compliance risk. Developing your contracts and fair market value Spidey sense for 5, A regular assessment should be conducted to determine if the healthcare transactions are commercially reasonable. Anti-Kickback Statute and Stark Law - Constantine Cannon The 2021 Stark Law and Anti-Kickback Statute: Fair Market Value and Commercial Reasonableness (American Health Law Association Publication) Noteworthy 2021 stark law revisions and modifications: specifically areas impacting provider compensation and transactions valuation. Carnahan Group. which allows healthcare organizations to analyze physician compensation arrangements for fair market value and commercial reasonableness instantly. The Anti-Kickback Statute, 42 U.S.C. Within the Healthcare industry, there are rules and regulations to ensure that . 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. Compensation arrangements that are required to be representative of . Referring to survey data regarding practice losses per physician and per provider can be enlightening. Non-profit hospitals face additional requirements under the Internal Revenue Code that they must satisfy to maintain their tax-exempt status. Due to a complex regulatory environment, an in-depth analysis should be performed to ensure that the healthcare transactions are legally permissible at FMV and are commercially reasonable. Q & A: Self-Referral/Stark Law And Anti-Kickback Regulations Downstream revenue may include referrals for laboratory services, referrals for imaging services, referrals for hospital services, or even referrals to other specialists. Q. stark law fair market value industry best practice There are numerous laws across the country that have been created to remove this unethical practice. 2 Healthcare transactions must be commercially reasonable and should be comparable to what is paid ordinarily for similar services in the area. 1320a-7b (b) and the regulations and guidance promulgated thereunder. Rather, each case must be evaluated and considered in the context of the situation. Key PYA Takeaway: Since the Stark II, Phase II regulations, CMS has introduced the use of salary surveys to help in determining fair market value compensation, even going so far in the Stark II, Phase III regulations to comment reference to multiple, objective, independently published salary surveys remains a prudent practice for evaluating fair market value. However, salary surveys by themselves may be limited in establishing fair market value. Structuring legally compliant hospital-physician leases and establishing fair market value (FMV) rental rates can be challenging. New "Fair Market Value" and "General Market Value" Definitions. 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. 1892, the Bipartisan Budget Act of 2018 (the "Budget Act"), which included changes to the federal physician self-referral law (commonly known as the "Stark law").Among these revisions are allowing indefinite holdovers in two notable exceptions to the Stark law: (1) personal services arrangements and (2 . The Anti-Kickback Statute (AKS), 42 U.S.C. The Federal Anti-Kickback Statute, codified at 42 U.S.C. Too often, they have hindered, rather than . 7 Things Hospitals Should Know About Professional Services Agreements Stark Law - an overview | ScienceDirect Topics How to Define Fair Market Value Rate of Return in Health Care \text{The regression equation is}\\ The Stark Law defines FMV as the value in arms length transactions, consistent with general market value. These Stark Law updates may not alter the approach to production of a compensation fair market value and commercial reasonableness opinion (i.e., we are still going to consult industry salary surveys), but it certainly has us doubling down on the lengths to which we go to describe and document the uniqueness of a provider, the market, or the situation. Chapter 25. 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. There is no fair market value calculator that takes in a couple datapoints and spits out a positive or negative fair market value answer. Introduction. This field is for validation purposes and should be left unchanged. 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. Using the example of celebrities above, many contracts with celebrities include a portion of ticket sales to that movie. 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. We are uncertain why the commenters believe that it is CMS policy that compensation set at or below the 75th percentile in a salary schedule is always appropriate, and that compensation set above the 75th percentile is suspect, if not presumed inappropriate. 411.354 Financial relationship, compensation, and ownership or investment interest. An assessment of transactions should be done to analyze if it is reasonable to pay for the services in the first place, in order to prevent violation of the Anti-Kickback Statute. Helps identify compensation formulas that take into account the volume or value of a physicians referrals as well as those that are allowed to distribute profits from designated health services within a group practice. Healthcare organizations should consider both qualitative and quantitative components for FMV and commercial reasonableness analyses of financial transactions. In addition to fair market value, most applications of the anti-kickback statute and Stark law also require commercial reasonableness. Many of the new and revised regulations apply beyond financial arrangements related to care coordination initiatives, and thus are crucial for all CMS Waives Stark Law Limits to Hospital-Physician Arrangements During Record the following closing entries on page 19 of the general journal. 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. For example, if a physician is paid at the 75th percentile under a specific survey then fair market value must be met. 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. You can contact me at 800-270-9629. Bottom line, 2021 surveys, based on 2020 data, are likely going to be challenging. The waivers, which are numerous and fairly broad, offer health care entities significant flexibility to combat COVID-19 in ways . Arrangements for patient engagement and support to improve quality, health outcomes, and efficiency. The US Court of Appeals for the Third Circuit endorsed two controversial interpretations of the Stark Law's "volume or value" standard, known as the correlation theory and the practice "loss" theory in U.S. ex rel. With regard to fair market value (FMV), industry best practice suggests that you _____ in order to better withstand government scrutiny. Fair market value is defined to mean the "value in an arm's length transaction, consistent with general market value of the subject transaction" (42 CFR 411.351). Carnahan Group assumes no obligation to inform the reader of any changes in tax laws or other factors that could affect the information contained herein. Whether it's an outright acquisition or a lease or service agreement, and whether it is the business or the underlying tangible assets (real estate and equipment), the transaction must be consistent with Fair Market Value. Key Issues in Cardiology Valuation: Anti-Kickback and Stark Law Federal physician self-referral prohibition (42 USC 1395nn. Establishing fair market value physician compensation in a - MGMA Key PYA Takeaway: Guidance from prior court decisions, as well as certain previous governmental representatives, have questioned commercial reasonableness if arrangements are not profitable. 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. 411.355 General exceptions to the referral prohibition related to both ownership/investment and compensation. 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). According to CMS, we continue to believe that the fair market value of a transactionand particularly, compensation for physician servicesmay not always align with published valuation data compilations, such as salary surveys. Attendees may ask questions in advance. According to CMS in the Final Rule, We continue to believe that this determination should be made from the perspective of the particular parties involved in the arrangement. Another key factor to commercial reasonableness is answering the question: Does the arrangement make sense to accomplish the parties goals? 7. The information contained herein is general in nature and is not intended, and should not be construed, as legal, accounting, investment or tax advice or opinion provided by Carnahan Group to the reader. thousands of dollars) for apartment buildings. Stark Law Final Rule Summary - Strategic Management Services, LLC