In addition to fair market value, most applications of the anti-kickback statute and Stark law also require commercial reasonableness. 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. 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. The Court concluded that the payment above fair market value for the services that were actually required to be performed would serve some other purpose, such as compensation for referrals. If a payment is made that cannot be shown to have been fair . As to its civil penalties, the Anti-Kickback Statute includes monetary penalties up to $50,000 per violation, civil . In our prior article, we provided a basic overview of Fair Market Value (FMV) assessments and how these have become a key aspect in compensation contracts for cardiologists.We also reviewed how practices should focus on demonstrating their value to hospitals and health systems by showcasing leadership efforts within the practice and hospital, attention to strategy, financial performance . The key elements of a robust FMV practice continue, however, to evolve. 6 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.10 Financial arrangements should be based on comparable data and should be set in advance by members who have no conflict of interests. 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. CMS further clarifies that commercial reasonableness is whether an arrangement makes sense as a means to accomplishing the parties goals. Downstream revenue may include referrals for laboratory services, referrals for imaging services, referrals for hospital services, or even referrals to other specialists. 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? Please join us on September 13 th! Considerations for Determining Fair Market Value Physician Compensation 6 Mark O. Dietrich, CPA/ABV Stark II -Statutory Guidance Stark Statute - 42 U.S.C. \end{matrix} HHS Finalizes New Protections Under the Stark Law for Value-Based 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. 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. The three types of transactions are asset acquisition, compensation, and rental of equipment or office space. Carry out the indicated operation and give your answer with the specified number of significant digits. Stark Law: An Ultimate Guide against Medicare Fraud We also believe there has to be a limit to what is reasonable in terms of losses. 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 argument is that but for the celebrity being in the movie the consumer would not purchase the ticket. Interpretation of the "Volume or Value Standard" for Purposes of the Group Practice Regulations ( 411.352(g)) 2. Again, job posting sites have been invaluable to determining fair market value for high-demand services. The Stark Law prohibits physicians from referring patients for services to entities in which the physician or _____ has a financial interest. The answer to that question has often been more elusive and not as immediately apparent as fair market valueand we know how nebulous and elusive fair market value can be at times. Fair Market Value and Commercial Reasonableness Applied to Healthcare Transactions. 1395nn). Organizations who may have carte blanche physician compensation review policies set at certain thresholds should be careful that the totality of the facts and circumstances support each transaction (versus the entirety of all transactions). 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. Typical compensation per Work Relative Value Unit rates could be significantly off from traditional levels for given specialties. thousands of dollars) for apartment buildings. 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. For example, if a physician is paid at the 75th percentile under a specific survey then fair market value must be met. Refines when a physician practice is required to sign a recruitment agreement between a hospital and a physician as well as timing issues for arrangements between a physician and non-physician practitioner (NPP) when a hospital is involved in compensating the NPP. Stark 101 for Physicians - KJK | Kohrman Jackson Krantz Stark Law: Clarification of Key Terms - Dinsmore & Shohl LLP 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. Industry stakeholders have informed us that, because the consequences of noncompliance with the Stark Law are so dire, physicians and other healthcare providers may be discouraged from entering into innovative arrangements that would improve . In December 2020, it was stated in the Stark Law Final Rule that the Centers for Medicare & Medicaid Services (CMS) expressly disavowed having any policy that compensation set at or below the 75th percentile of the physician compensation survey data is always appropriate, and that compensation above the 75th percentile is "suspect, if not . However, there are a few core concepts that are applicable when establishing fair market value. 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 . 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. 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 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. 3. Documentation of all aspects of relationship. var year = today.getFullYear() The case underscores that the OIG cares about technical as well as substantive compliance with the Stark 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. As you can see, the definition of fair market value does not provide details with respect to what is fair market value. ; . 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. Too often, they have hindered, rather than . 411.354 Financial relationship, compensation, and ownership or investment interest. The primary regulations governing physician compensation arrangements are the Stark Law and AKS. The following requirements must be [] The primary reasons that the Stark Law prevents organizations and individuals from including downstream revenue are numerous. That is a topic for another day. \text{Analysis} & \text{of} & \text{Variance}\\\\ 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. 4) Have a payment or salary provision that is reasonable and is at fair market value. Personal services and management contracts and outcomes-based payments safe harbor creates protection under safe harbor for part-time or intermittent arrangements and arrangements for which total compensation is not known in advanceit eliminates a requirement that part-time arrangements have a schedule of services specifically set out in advance in the agreement. There are numerous laws across the country that have been created to remove this unethical practice. The same survey data that many compensation valuators rely on as a central component to their fair market value analysis and opinion. 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. A comprehensive, but not all inclusive, list of the items covered in the final rule follows. \text{X} & \text{7.210} & \text{1.3626} & \text{5.29}\\\\ The fair market value exception is a compensation exception that is flexible depending on the arrangement. All Rights Reserved. The Stark Law safe harbor provision has seven components. 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. See our dedicated page. New Stark Law and AKS Final Rules -Valuation Considerations 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. 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. The AKS Final Rule creates new safe harbors for entities participating in a value-based enterprise (VBE) and amends existing safe harbors. Compensation arrangements that are required to be representative of . This piece concludes with thoughts regarding the COVID-19 pandemics effect on the immediate future of physician and APP compensation valuation. 411.357 Exceptions to the referral prohibition related to compensation arrangements. Fair market value is a pinnacle issue for compliance under the Stark Law and Anti-Kickback Statute. Anti-Kickback Statute | Everything You Need to Know - Khouri Law Valuation Triage: Stark/Anti-Kickback Valuation Issues within the For more information on Stark Law Exceptions, see our dedicated page. HAND Children are the Future. Thus, "compensation substantially above $450,000 per year may be fair market value," according to . \text{Predictor} & \text{Coef} & \text{SE Coef} & \text{T}\\ 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. 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. 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. 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. Thanks for reaching out. Introduction. PDF The New Stark and AKS Final Rules: Implications and Considerations for An extension has been granted until January 1, 2022 for compliance related to certain changes required in group practice compensation methodologies. As a result, fair market value, commercial reasonableness, and the volume or value standard are separate and distinct requirements, each of which must be satisfied when included in an exception to the physician self-referral law. CMS refers to these three cornerstones of the exceptions to the Stark Law as the Big Three. CMS redefined the Big Three as follows: In addition to the general definition of fair market value above, CMS revisions to the Stark Law also provide definitions of fair market value that are specific to the rental of equipment and the rental of office space. Thanks for reaching out. CMS Completes Sprint to Modernize the Stark Law-Part III 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 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. A qualitative analysis of the nature and scope of services performed, necessity of services, and comparability of services should be performed. 98810.3;2988 \div 10.3 ; 298810.3;2 significant digits. 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 . It says, . ; (2) How can it be fixed? For most Stark Law exceptions to apply, a(n) ___________________ is required. 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. Modifying the definition of set in advance used in many Stark exceptions to allow modification of compensation during the term of an arrangement (including in the first year). 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"). The proposed rule would create new, permanent exceptions to the Stark Law for value-based arrangements. 7 Things Hospitals Should Know About Professional Services Agreements Key PYA Takeaway: Guidance from prior court decisions, as well as certain previous governmental representatives, have questioned commercial reasonableness if arrangements are not profitable. According to CMS in the Final Rule, 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. In the Final Rule, CMS also reiterated that the determination of commercial reasonableness is not one of valuation. An arrangement can be fair market value, but that does not mean that it is commercially reasonable. 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. If the AKS is addressing criminal penalties, the consequences include fines up to $25,000 per violation and up to a five-year . 411.354 Financial relationship, compensation, and ownership or investment interest. Carnahan Group. With the increased rate of mergers and acquisitions, healthcare organizations are vulnerable to federal scrutiny. 411.353 Prohibition on certain referrals by physicians and limitations on billing. Rather, each case must be evaluated and considered in the context of the situation. The services to be performed under the arrangement do not involve the counseling or promotion of a business arrangement or other activity that violates a Federal or State law. Suite 201 Sec. HSG is not a law firm; we are a health care consulting and compensation valuation firm, so this article is not an exhaustive legal interpretation, summary, or review of all of CMS and OIGs updates, but rather a review of selected areasparticularly those elements and areas we view as having the most impact in the world of physician and advance practice provider (APP) compensation and transactions valuation. In doing so, CMS offered helpful commentary for health care entities structuring real estate arrangements. Yes, consulting multiple, objective, independently published salary surveys remains a prudent practice for evaluating fair market value, as stated in Stark II, Phase III, but salary surveys are not automaticregardless of the percentile at which the compensation in question falls. Three new safe harbors for remuneration exchanged between or among participants in value-based arrangements: Value-based arrangements with full financial risk. Isolated financial transactions, such as a one-time sale of property or a practice, or a single instance of forgiveness of an amount owed in settlement of a bona fide dispute, if all of the following conditions are met: (1) The amount of remuneration under the isolated financial transaction is. On November 20, the Centers for Medicare & Medicaid (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued a 627-page final rule which will serve to modernize and clarify Stark Law regulations. var today = new Date() Proceduralists such as dermatologists, orthopedic surgeons, ophthalmologists, otolaryngologists, plastic surgeons, urologists, etc. Real Estate Leasing in the Healthcare Industry: Understanding the Stark While this exception may be utilized in some instances, it is likely organizations will utilize the employment exception or personal services exception. This safe harbor is designed to facilitate improved cybersecurity in health care through donations of cybersecurity technology and services. The commercial division of a real estate firm is conducting a regression analysis of the relationship Cybersecurity technology and services safe harbor for remuneration in the form of cybersecurity technology and services. In the interim, for more information regarding these matters, contact a PYA executive below at (800) 270-9629. 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. 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. Executive Session: Fair market value and the shift to value - MGMA 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 Anti-Kickback Statute (AKS), 42 U.S.C. 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. Financial arrangements should be based on comparable data and should be set in advance by members who have no conflict of interests. v. UPMC et al.In particular, the court held that the relators had made out a plausible allegation of an indirect compensation . 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 . Avoiding Illegal Service Referrals: The Stark Statute Explained 1 For purposes of this article, "Stark" refers to 42 U.S.C. Healthcare transactions must be commercially reasonable and should be comparable to what is paid ordinarily for similar services in the area. Final Rules also provide guidance related to fundamental concepts under the Stark Law, including commercial reasonableness, the volume or value standard, and fair market value. Y=20.0 + 7.21X\\\\ Stark Law - StatPearls - NCBI Bookshelf Structuring legally compliant hospital-physician leases and establishing fair market value (FMV) rental rates can be challenging. Do our losses mean the compensation we are paying, while fair market value, is not commercially reasonable? The new Stark rule revises this, stating the fair . OIG also amended the definition of remuneration in the Beneficiary Inducements CMP statute to integrate a new statutory exception to the prohibition on beneficiary inducements for certain telehealth technologies.. <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. CMS Clarifies Key Valuation Terms in the Stark Law | Jones Day The Stark Law defines FMV as the value in arms length transactions, consistent with general market value. White Paper: CMS Finalizes Updates to the Stark Law to Reduce United States. On February 9, 2018, Congress passed and President Trump signed into law H.R. What Is Fair Market Value and How Is It Calculated? - SmartAsset Email (required), Healthcare eNewsletterTax & Assurance eNewsletterWebinars. 411.353 Prohibition on certain referrals by physicians and limitations on billing. the value in an arm's-length transaction that is consistent with general market value. 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 . In June 2022, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) released OIG Advisory Opinion No. 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. New Stark Regulations Further Clarify Definitions of Fair Market Value The Stark Law defines FMV as the value in arms length transactions, consistent with general market value. document.write(year) For example, it is very common for recruitment agencies to publicize the perceived revenue generation of certain specialties. 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. stark law fair market value industry best practice 5. 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.. How can we lose so much money and still consider our arrangement commercially reasonable? 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. The Stark Law (42 U.S.C. 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. May 10, 2022 at 11:37 AM 6 minute read Current Definition of General Market Value (42 C.F.R. Provided additional guidance on key requirements of the exceptions to the Stark Law to make it easier for healthcare providers to take steps to ensure compliance, such as: Guidance on identifying compensation formulas that take into account the volume or value of a physicians referrals.
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