health services directly attributable to a physicians participation in a value-based arrangement are deemed not to take into account the volume or value of the physicians referrals. 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 some cases, the alignment between compensation and production may be distorted. T. Z, R. C. Healthcare Valuation Series: A look at fair market value and commercial reasonableness. You can contact me at 865-673-0844. 411.354). 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. Catherine Short converses with Rachel V. Rose, JD, MBA, principal with Rachel V. Rose - Attorney at Law, P.L.L.C. Makes clear that signatures may be electronic under the same applicable federal/ state laws while allowing parties to an agreement to obtain the writing requirement documentation within 90 days. Previous Definition of Fair Market Value (42 U.S.C. The Stark Law defines FMV as the value in arms length transactions, consistent with general market value. and Don Barbo, Managing Director with VMG Health, on the topic of "New Stark Law and AKS Final Rules -Valuation Considerations." On January 19, 2021, a new era was ushered in as the CMS Stark Law Final Rule and the HHS-OIG Anti-Kickback Statute Final Rule became effective. Below is a listing of some of the key changes: For those in the physician and APP compensation valuation arena, and for any hospital or health system that compensates a health care provider for administrative and/or professional services (which would be all hospitals and health systems in the country), there are other aspects of the Stark Law revisions that are of particular interest. Many hospitals and health systems across the country have drawn a line in the sand and set a base compensation threshold at the 75th percentile for physician compensation. have been significantly impacted by decreased patient volume. The AKS Final Rule creates new safe harbors for entities participating in a value-based enterprise (VBE) and amends existing safe harbors. The arrangement is in writing, signed by the parties, and covers only identifiable items or services, all of which are specified in writing. For bona fide employment as long as all other requirements are met. 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. 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. A qualitative analysis of the nature and scope of services performed, necessity of services, and comparability of services should be performed. Fair market value, and specifically as it relates to compensation arrangements, is defined as The value in arms-length transaction, consistent with the general market value of the transaction. General market value means with respect to compensation for services, the compensation that would be paid at the time the parties enter into the service arrangement as the result of bona fide bargaining between well-informed parties that are not otherwise in a position to generate business for each other., Commercially reasonable means that the particular arrangement furthers a legitimate business purpose of the parties to the arrangement and is sensible, considering the characteristics of the parties, including their size, type, scope, and specialty. TheregressionequationisY=20.0+7.21XPredictorCoefSECoefTConstant20.0003.22136.21X7.2101.36265.29AnalysisofVarianceSOURCEDFSSRegression141587.3ResidualError7Total851984.1\begin{matrix} 7. the value in an arm's-length transaction that is consistent with general market value. Introduction. Y=20.0 + 7.21X\\\\ CRNAs are only one examplethe same challenges could easily apply to any physician specialty or market. \text{Predictor} & \text{Coef} & \text{SE Coef} & \text{T}\\ Carnahan Group provides a unique platform. Removes the timeframe limitations for modifications to the financial terms of a compensation arrangement. This article is intended to highlight some of the most noteworthy revisions, clarifications, and modifications provided by the Centers for Medicare & Medicaid Services (CMS) through the Stark Law Final Rule and by the Office of Inspector General (OIG) through the Anti-Kickback Statute (AKS) Final Rule. This revenue generation includes downstream revenue. A general journal is given in the Working Papers. 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. This safe harbor is designed to facilitate improved cybersecurity in health care through donations of cybersecurity technology and services. CMS indicated that many of the changes to the Stark Law rules are intended to provide new flexibility and reduce administrative burden on health care organizations and providers in the structuring of arrangements, making it easier and less expensive to comply with the Stark Law. Documentation of all aspects of relationship. document.write(year) Care coordination arrangements to improve quality, health outcomes, and efficiency without requiring the parties to assume any financial risk. Its criminal penalties include fines up to $25,000 per violation, and up to 5 years in federal prison. These historic reforms became effective January 19, 2021 and are part of HHS's "Regulatory Sprint to . 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. Reflecting on Recent Regulatory Changes to the Stark Law: A Real Estate and Equipment Valuation Perspective, Part 2. 3. Further, the concept of fair market value has become much more than a financial analysis. The final rule creates new exceptions to the Stark Law for value-based arrangements that satisfy specified requirements based on the characteristics of the arrangement and the level of financial risk assumed by the . CMS further clarifies that commercial reasonableness is whether an arrangement makes sense as a means to accomplishing the parties goals. var today = new Date() 4) Have a payment or salary provision that is reasonable and is at fair market value. ; . Although many compensation arrangements are legitimate, a compensation arrangement may violate the anti-kickback statute if even one purpose of the arrangement is to Because of increased enforcement, it is very common for organizations to work with legal professionals who specialize in fair market value and the Stark Law for the purpose of creating compliant and defensible financial arrangements. a non-profitable arrangement) may present a problem, it is not expressing a definitive opinion on the matter as each arrangement is facts and circumstances specific, and it could see certain arrangements with facts and circumstances whereby a non-profitable arrangement is commercially reasonable. 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. The anti-kickback regulations apply only to services reimbursed by Medicare or Medicaid. 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? 2) Be in writing and signed by both parties. For example, the guaranteed compensation for a physician under an employment arrangement would have to be at levels consistent with what other physicians make within those specialties. Interested in learning about what is a referral? 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. The three types of transactions are asset acquisition, compensation, and rental of equipment or office space. 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). New Arrangement Best Practices Consult with a valuation expert on whether financial arrangements satisfy the new Stark Law fair market value and commercial reasonableness standards. \text{Analysis} & \text{of} & \text{Variance}\\\\ Please join us on September 13 th! The Stark and AKS Final Rules became effective January 19, 2021, with the exception of certain changes to the definition of a group practice that have an effective date of January 1, 2022 to give physician practices time to adjust their compensation methodologies. On the other hand, an arrangement must be considered fair market value in order to be commercially reasonable. 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. Current, Three-Part Definition of Fair Market Value (42 C.F.R. <p> Fair Market Value (FMV) has become an industry standard in accordance with regulations and statutes such as the US Sunshine Act, False Claims Act, and Anti-Kickback Statute, as well as international transparency reporting and anti-corruption legislations. Office-based primary care has been significantly affected as offices were closed for a period of time and then had to adjust to telehealth and virtual visits. v. UPMC et al.In particular, the court held that the relators had made out a plausible allegation of an indirect compensation . Bottom line, 2021 surveys, based on 2020 data, are likely going to be challenging. Financial arrangements should be based on comparable data and should be set in advance by members who have no conflict of interests. Healthcare Regulatory and Stark Law/Fair Market Value and Commercial Reasonableness attorney. 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. 7. Factors affecting the specific company risk of a practice can include the physician's age, specialty, location, market position, payer mix, payer contracts, size, and other factors. Download a PDF Version of the Article as Published in AHLA's 2021 . If the AKS is addressing criminal penalties, the consequences include fines up to $25,000 per violation and up to a five-year . Key PYA Takeaway: Guidance from prior court decisions, as well as certain previous governmental representatives, have questioned commercial reasonableness if arrangements are not profitable. 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. B and C - obtain a certified valuation from an expert, third party & conduct an in-house valuation. This article was originally published by the American Health Law Association in April 2021 as part of their 2021 Health Care Transactions Resource Guide. For example, it is very common for recruitment agencies to publicize the perceived revenue generation of certain specialties. 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 . Rather, each case must be evaluated and considered in the context of the situation. On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued blanket waivers to the Stark Law that permit certain arrangements between physicians and health care providers implemented in response to COVID-19 that would otherwise violate the Stark Law. 2 Healthcare transactions must be commercially reasonable and should be comparable to what is paid ordinarily for similar services in the area. Healthcare organizations should consider both qualitative and quantitative components for FMV and commercial reasonableness analyses of financial transactions. With the increased rate of mergers and acquisitions, healthcare organizations are vulnerable to federal scrutiny. The arrangement does not violate the anti-kickback statute (section 1128B(b) of the Act), or any Federal or State law or regulation governing billing or claims submission. Compensation arrangements that are required to be representative of . 6 Carnahan Group provides a unique platform FMVMD,which allows healthcare organizations to analyze physician compensation arrangements for fair market value and commercial reasonableness instantly. According to CMS, some of the commenters on the Final Rule asserted that, a safe harbor based on a range of values in salary surveys would be consistent with what they stated was established CMS policy that compensation set at or below the 75th percentile in a salary schedule is appropriate and compensation set above the 75th percentile is suspect, if not presumed inappropriate. To these comments CMS responded, For the reasons explained in Phase I, Phase II, and Phase III, we decline to establish the rebuttable presumptions and safe harbors requested by the commenters. Answer Choices A. obtain the valuation from legal counsel B. obtain a certified valuation from an expert, third party C. conduct an in-house valuation D. B and C On December 2, 2020, the Department of Health and Human Services ("HHS") Office of Inspector General ("OIG") issued final rules including a host of reforms to the AKS, including three changes to the personal services and management contracts safe harbor ("Safe Harbor"). which allows healthcare organizations to analyze physician compensation arrangements for fair market value and commercial reasonableness instantly. 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. Another key Stark Law change that will certainly influence fair market value and commercial reasonableness opinion approach and deliverable is the uncoupling or disentanglement of the volume or value standard (and the other business generated standard) from the definitions of fair market value and commercial reasonableness. Q. Cimasi, R. Z T. Traversing the threshold of commercial reasonableness in the healthcare industry. Always engage a competent appraiser who understands the Stark definition of fair market value and be sure the appraisal report addresses that. 3 See 42 U.S.C. 1 The payments that exceed FMV are viewed as potential referrals, which is a violation of Stark Law that can lead to penalties and a healthcare systems exclusion from participation in federal health programs. May 10, 2022 at 11:37 AM 6 minute read 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. That is a topic for another day. Our hypothesis is that COVID-19 will appreciably affect the salary, production, and other data reported by physicians and their practicesin some instances, to a significant degree. A qualitative analysis of the nature and scope of services performed, necessity of services, and comparability of services should be performed. In 2004, CMS noted that valuation methods under Stark Law "must exclude valuation where the parties to the transaction are at arms-length but in a position to refer each other." 6 Because FMV under Stark Law does not "necessarily comport with the usage of the term in standard valuation techniques and methodologies," 7 a purely market . Jana will be discussing the Stark Law changes, and Angie will be providing related valuation examples during the September 13, 2022 Let's Talk Compliance webinar entitled Stark Law Changes and Impact on Physician Compensation Part 2. There are numerous regulatory statutes, such as Stark Law and Anti-Kickback Statute that need to be considered while structuring financial transactions for physicians and other staff to ensure that compensation is within fair market value (FMV) and is commercially reasonable. Which of the following is TRUE about the Stark Law? The exception cannot be utilized for the rental of office space though. 411.354 Financial relationship, compensation, and ownership or investment interest. Rely on Our Experts for Stark Law and Fair Market Value Matters. Strategy, market growth, and larger referral bases were not among the examples. The same survey data that many compensation valuators rely on as a central component to their fair market value analysis and opinion. This ensures that there is maximum compliance of regulatory statutes and prevents any violation of healthcare laws. Some providers in these four specialties may have seen an increase in compensation to reflect their increased workload, while others, those paid salary and shift rates, may not have seen an increase in compensation. The same is not true for physicians and other entities when the Stark Law applies. 4, It is important to maintain documents of services provided by healthcare professionals and have agreements in writing, along with documents supporting the financial transaction at FMV, for actual duties performed to standardize financial transactions and to prevent violation of fraud and abuse laws. Second, from a fair market value standpoint it is often the case that there are true limits on reasonable income and compensation under a financial arrangement with a physician. 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. The regulations are part of the HHS Regulatory Sprint to Coordinated Care and . This is the art and the work involved in determining fair market value. Do our losses mean the compensation we are paying, while fair market value, is not commercially reasonable? For most Stark Law exceptions to apply, a(n) ___________________ is required. Sec. The reason the simplicity of this is not correct is that many lawsuits and government enforcement actions have established what are the risks associated with fair market value. The Stark "in-office ancillary" exception permits a physician or group practice to order and provide DHS in the office, provided that the DHS is ancillary to the professional medical services provided by the practice. Thanks for reaching out. 201 East Fifth Street Suite 1110 Cincinnati, OH 45202-4152 t: 513.870.6700 f: 513.870.6699. info@bricker.com. These are two critical questions that must be answered. The Anti-Kickback Statute, 42 U.S.C. \text{Residual} & \text{Error} & \text{7}\\ 411.354). The Stark Law defines FMV as "the value in arm's length transactions, consistent with general market value". You can contact me at 800-270-9629. 1320a-7b(b), covers a broader range of activity than the Stark Law, and extends to all medical providers in a position to arrange or recommend medical services."Referrals" under the Anti-Kickback Statute include "any item or service for which payment may be made in whole or in part under a Federal health care program." If a payment is made that cannot be shown to have been fair . In addition to fair market value, most applications of the anti-kickback statute and Stark law also require commercial reasonableness. Ultimately, valuators likely will have to be creative and look back into past years surveys to evaluate trends and validate current survey data. Consult with healthcare counsel to review compensation arrangements to identify any structures that take into account the volume or value of referrals or business The following requirements must be [] They go as follows: Cost or selling price: If the item has been recently bought or sold, that can be a good indicator of its fair market value. 4 See 42 CFR 411.354. 5, A regular assessment should be conducted to determine if the healthcare transactions are commercially reasonable. There are numerous laws across the country that have been created to remove this unethical practice. An arrangement may be renewed any number of times if the terms of the arrangement and the compensation for the same items or services do not change. As stated above in our discussion of fair market value, CMS continues to make it clear that the commercial reasonableness determination is also accomplished through consideration of an arrangements context and from the perspective of those involved. In the final Stark rule, despite being asked by commenters, CMS specifically refused to establish a rebuttable presumption or safe harbor that guaranteed an arrangement was within fair market value if the arrangements compensation was set at a certain salary survey percentile. They are: (a) the lease agreement must be in writing; (b) the . Three new safe harbors for remuneration exchanged between or among participants in value-based arrangements: Value-based arrangements with full financial risk. The case underscores that the OIG cares about technical as well as substantive compliance with the Stark law. The payments that exceed FMV are viewed as potential referrals, which is a violation of Stark Law that can lead to penalties and a healthcare systems exclusion from participation in federal health programs. A hospital lends money to a physician practice to offset lost income resulting from the cancellation of elective surgeries to ensure capacity for COVID-19 needs. An arrangement may be commercially reasonable even if it does not result in profit for one or more of the parties.. The Anti-Kickback Statute. 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. Specifically, the Final Rule includes new or modified regulatory definitions for the terms "commercially reasonable," "fair market value," and "general market value" as well as terms particular to the definition of a "Group Practice." 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. Specialties like critical care, hospital medicine, emergency medicine, and pulmonary medicine may have experienced increases in patient volume due to the pandemic. Expands the 411.357(1) exception to fair market value payments for rental office space, notably when the arrangement is for less than one year. To accommodate patient surge, a hospital rents office space or equipment from a physician practice at below fair market value or at no charge. The proposed rule would create new, permanent exceptions to the Stark Law for value-based arrangements. Sec. 411.356 Exceptions to the referral prohibition related to ownership or investment interests. 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. Which of the following is a government sanction provided under the Stark regulation? CMS is clarifying here that while such a situation (e.g. 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 . Downstream revenue may include referrals for laboratory services, referrals for imaging services, referrals for hospital services, or even referrals to other specialists. 411.362 Additional requirements concerning physician ownership and investment in hospitals. Financial arrangements are commercially reasonable if they are at FMV, services provided are documented and deemed necessary, and when the services cannot be provided at a lesser value. As to its civil penalties, the Anti-Kickback Statute includes monetary penalties up to $50,000 per violation, civil . Home Fair Market Value and Commercial Reasonableness Applied to Healthcare Transactions, An Informational Article
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