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Preparing For 2025 Stark Enforcement Regarding Compensation and Productivity Bonuses

In 2024, Stark enforcement remains a critical focus for healthcare providers and regulatory bodies, with a continued focus on excessive compensation and productivity bonuses. Compliance with Stark Law is essential to avoid significant penalties, including repayment obligations, civil monetary penalties, and potential exclusion from federal healthcare programs. Significant developments have been made in the last few years and providers should have already taken steps to review and revise arrangements and practices to maintain compliance and be prepared to defend against, especially regarding financial arrangements and compensation. With the complex history of this piece of legislation in mind and recent developments, this article offers the below with a key focus on compensation and productivity bonuses:

• A review of the basic historical structural components of Stark including supporting regulatory citations for definitions, exceptions, liabilities, and the self-disclosure program;
• A review of the latest and key regulatory revisions from June 2021;
• A review and analysis of current liability theory regarding Stark;
• A review of landmark Stark cases and a recent case to watch;
• An analysis of the impact of 2024 Supreme Court of the United States (SCOTUS) rulings on Stark;
• Highlights of the 2023 Office of Inspector General (OIG) for the United States Health and Human Services (HHS) General Compliance Program Guidance for Healthcare Entities;
• Advice and Takeaways for Providers.
   

Overview of Stark Law
The Stark Law, codified at 42 U.S.C. § 1395nn, prohibits a physician from making referrals to an entity which the physician or immediate family member has a financial relationship for designated health services (DHS) when reimbursement is sought by federal healthcare programs.[i] The specific definitions and details of these DHS can be found at 42 CFR § 411.351. General categories include:

• Clinical laboratory services,
• Physical therapy services,
• Radiology and certain other imaging services,
• Radiation therapy services and supplies,
• Durable medical equipment,
• Parenteral and enteral nutrients,
• Equipment and supplies,
• Prosthetics,
• Orthotics,
• Prosthetic devices and supplies,
• Home health services,
• Outpatient prescription drug services, and
• Inpatient and outpatient hospital services.[ii]

The law includes several exceptions, such as the bona fide employment relationships exception which allows certain financial arrangements if specific criteria are met and Stark has evolved clarifying and adding new exceptions along the way.

Key CFR Citations
The regulatory citations below are crucial for Stark compliance as they outline the boundaries of permissible “financial relationships” and the conditions under which exceptions apply to evade Stark liability.

1. 42 C.F.R. § 411.351: This section provides key definitions, including the definitions of commercially reasonable and fair market value.
   
   Commercially reasonable is defined as an arrangement that 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. An arrangement may be commercially reasonable even if it does not result in profit for one or more of the parties.
   
   Generally, fair market value is defined as an arms-length transaction, consistent with the general market value of the subject transaction.[iii]
   
   General market value, regarding compensation, is defined as 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.[iv]
    

2. 42 CFR § 411.354: The section defines financial relationships, including direct and indirect compensation arrangements.
   
   A financial relationship is defined as either a direct or indirect ownership or investment interest in any entity that furnishes DHS; or a direct or indirect compensation arrangement with an entity that furnishes DHS.
   
   Direct compensation is defined as a relationship where there is a remuneration that passes between the referring physician (or immediate family member) and the entity furnishing DHS without any intervening persons or entities between the two. 
   
   An indirect compensation arrangement is defined as a referring physician and an entity furnishing the DHS with an unbroken chain of financial relationships between the referring physician and the entity furnishing the DHS and in that chain, the referring physician directly receives aggregate compensation from an entity that varies with, or takes into account, the volume or value of referrals or other business generated by the referring physician for the entity furnishing the DHS.

3. 42 C.F.R. § 411.357: Lists exceptions to the Stark Law.
   
   One exception for direct compensation arrangements is the bona fide employment relationships exception, which protects compensation paid by an employer to a physician if, among other requirements, the compensation is not determined in a manner that takes into account (directly or indirectly) the volume or value of any referrals of DHS by the referring physician to the employer. This prohibition on basing compensation on the volume or value of a physician’s DHS referrals does not prohibit payment of compensation in the form of a productivity bonus based on services personally performed by the physician. Also, a physician’s personally performed services are not considered referrals under the Stark Law. However, neither the statute nor the regulation clarifies whether the technical component associated with a physician’s personally performed inpatient or outpatient hospital service (usually billed as a separate code and charge) is considered a referral under Stark, but several technical component codes are found on the List of DHS services on the CMS website.

4. 42 C.F.R. § 411.351: Provides additional definitions for terms used in the Stark Law, including "referral" and "designated health services."

Possible Liabilities of Stark and the Self-Disclosure Program
Also, while legal counsel that regularly works in this area is aware of the strict liability standard of Stark and the possible liabilities and penalties, for all other audiences it is worth highlighting that as Stark prohibits submitting claims to CMS for prohibited DHS, Stark violations also carry the possibility of False Claims Acts (FCA) violations brought by the DOJ. Stark liabilities generally include denial of payment, refund of payments, CMPs of up to $15,000 per service, and up to $100,000 for circumvention schemes, as well as possible exclusion from participating in Medicare, Medicaid, and other federal health care programs. FCA liability has a recovery of three times the amount of damages sustained by the government due to the fraudulent activity, possible CMP ranging from $11,665 to $23,331 (adjusted annually for inflation), exclusion from participating in federal health care programs, and possible criminal charges, resulting in additional fines and imprisonment.
 
Note, that CMS does maintain a self-disclosure program (SDP) for Stark law violations where providers can voluntarily disclose violations. When a healthcare provider or entity discloses a potential or actual violation of the Stark Law, they are required to review and report any non-compliance that occurred within six years before the date of the disclosure. By self-disclosing, providers may benefit from reduced penalties compared to those that might be imposed following a government-initiated investigation. CMS reviews the disclosure, determines the appropriate resolution, and negotiates a settlement concerning Stark violations with the disclosing party.
 
The process encourages transparency and cooperation between providers and CMS. While CMS may offer reduced penalties, there is no guarantee of specific settlement terms. Each case is evaluated on its own merits, and the final settlement amount is determined by CMS. Additionally, the CMS Stark SDP does not protect from actions by other federal or state agencies. The DOJ has separate jurisdiction to enforce the FCA. A self-disclosure to CMS under Stark SDP does not preclude the DOJ from investigating or pursuing FCA claims.
 
However, the CMS Stark SDP is a tool for providers to consider when finding themselves having stumbled upon a possible Stark violation in their practice of entity and maintaining the possibility of settlement by sustaining as compliant practices as possible which is key to navigation of Stark liabilities and penalties.

Stark Revisions June 2021
The latest Stark revisions and explanations were published on December 2, 2020 (85 FR 77492), but there are still several providers lagging with the updates. The revisions clarified the definition of "commercially reasonable," stating that "an arrangement is commercially reasonable if it furthers a legitimate business purpose and is sensible, even if it does not result in profit for one or more of the parties involved.” The definition of "fair market value" was updated to provide more flexibility and clarity, particularly in the context of value-based arrangements and compensation for physician services. The revisions clarified that compensation will not be considered to take into account the volume or value of referrals if it is not directly correlated with the number or value of referrals.

The revisions also relaxed certain writing and signature requirements, allowing for more flexibility in documenting arrangements. The revisions provided guidance on when the period of disallowance for non-compliant financial relationships begins and ends, offering more clarity for providers. An exception was added for limited remuneration to physicians, allowing for certain payments up to an annual aggregate limit without requiring a written agreement. There were also revisions to introduce new exceptions for value-based arrangements, allowing healthcare providers to enter into financial relationships that promote coordinated care and improve patient outcomes without violating the Stark Law.

Regarding profit share and productivity bonuses, the revisions provided new guidance on how group practices can distribute both without violating the Stark Law. This includes specific methodologies that are deemed compliant.

For Profit Share, Stark now allows:

1. Equal Division: Profits can be divided equally among all physicians in the group practice or among physicians in a component of the group practice that consists of at least five physicians.
2. Per Capita Distribution: Profits can be distributed on a per capita basis, meaning each physician receives an equal share regardless of their individual productivity or the volume or value of their referrals.
3. Distribution Based on Non-Referral Services: Profits can be distributed based on the distribution of revenues derived from services that are not designated health services (DHS) or based on the distribution of revenues from DHS that are not directly correlated with the volume or value of referrals.

For Productivity Bonuses, Stark now allows:

1. Services Personally Performed: Productivity bonuses can be based on the total value of services personally performed by the physician, including DHS, provided that the bonus is not directly correlated with the volume or value of referrals.
2. Incident-to Services: Bonuses can include services that are incident to the physician's personally performed services, as long as these services are billed under the physician's name and meet the incident-to-billing requirements.
3. Non-Referral Services: Bonuses can be based on the distribution of revenues derived from services that are not DHS or based on the distribution of revenues from DHS that are not directly correlated with the volume or value of referrals.

An important note regarding incident-to-billing is not all DHS services can be billed-incident-to. Incident to billing is laid out in Section 1861(s)(2) of the Social Security Act located under Medical and Other Health Services. The Medicare Benefit Manual Chapter 15 clarifies several times that services not under (s)(2) cannot be billed-incident-to, and the manual specifically calls out diagnostics as not being able to be billed incident-to. Additionally, to meet the requirements of incident-to-billing the supervising physician must be present in the office suite and immediately available to provide assistance and direction throughout the time the non-physician practitioner is performing services; the service must be part of an established care plan for a patient that was initiated by a physician meaning the physician must have seen the patient first, established a diagnosis, and created a plan of care; the services provided by the NPP must be within their scope of practice under state law and also within the scope of practice of the supervising physician; and the services must be of a type that are commonly furnished in a physician's office and are included in the Medicare benefit.

A common trap for providers is where a service has both a professional component and a technical component billed and the technical component profits are distributed not in accordance with the June 2021 Stark. I have seen providers try to find a compliant Stark arrangement on the tail-end by trying to recategorize the profits of the technical component as a productivity bonus. However, the provider did not personally perform the technical component and will try to look to incident-to billing as an exception, just to find that that technical component is not allowed to be billed incident-to. This example reminds me of the following:

• You cannot back into compliance or by chance luck into an exception with the complexities of Stark.
• Additionally, thorough compliance requires upfront analysis, initial documentation in some form of the targeted exception, and ongoing monitoring that the exception continues to meet all the criteria.

Theories of Liability for Compensation Arrangements Under Stark
Stark cases surrounding direct and indirect compensation before 2021 generally relied upon correlation theory based on:

1. The arrangement does not fit entirely into the Stark Law’s employment exception because the compensation arrangement takes into account the volume or value of referrals (the “volume or value” standard”), or
2. The arrangement constitutes a prohibited indirect compensation arrangement that varies with or takes into account the volume or value of referrals so that the arrangement does not fit squarely into an exception.

The above claims have effectively allowed relators to claim most hospital-physician arrangements in some part implicate Stark by violating the “volume or value” standard with every procedure of a physician tied to some sort of compensation and productivity bonus; therefore, resulting in false claims for the relator to proceed on.  Under correlation theory, the argument followed that either approach would violate Stark as compensating physicians for professional services with these arrangements would at a minimum correlate to resulting hospital services income from DHS. Showing a casual relationship is not required. What is commonly at issue for outpatient hospital services is the facility fees charged alongside a physician’s professional fee. This theory has been contentious, with courts and CMS offering differing interpretations. The correlation theory has been largely dismissed by CMS in its rulemaking commentary from June 2021 for compensation arrangements only, but the theory has not been ruled out for productivity bonuses (indirect compensation). DOJ and OIG have examined correlation theory and its application to both in previous cases, such as Tuomey and Bookwalter. These cases are discussed later, but regardless of the theory used to form liability, there is still much insight to glean on best compliance practices from past cases using correlation theory. However, given the contentious status of correlation theory and the June 2021 revisions to Stark, providers should analyze arrangements against the following rules:

1. Correlation Theory does not apply to direct compensation that is based on the physician making a referral of DHS to another provider where compensation or formula for compensation is made prospectively. The compensation may take into account the volume or value of anticipated or required referrals if neither agreement of compensation itself is contingent on the number or value of the referrals to a DHS provider.

2. Correlation Theory still applies to indirect compensation arrangements, such as productivity bonuses and unit-based incentives (productivity bonuses) tied to referral metrics, where the aggregate compensation “varies with” the number or value of the physician’s referrals or other business generated to a downstream DHS entity if the individual unit of compensation, not FMV or subject to an adjustment based on the number or value of the physician’s referrals to the DHS entity.

Notable Stark Cases
As you prepare for Stark enforcement in 2025 or at any time, the following cases are notable examples that give insight into behavior to avoid in maintaining compliance with Stark surrounding direct and indirect compensation.

U.S. ex rel Drakeford v. Tuomey Healthcare System (D.S.C.), (Tuoemy)
Tuomey employed physicians on part-time contracts with remunerative terms. Notable facts and influential facts include the below.

1. Tuomey paid physicians a base salary which changed annually based on the physicians' net professional collections for outpatient procedures. Physicians’ net cash collections from outpatient procedures (the DHS), plus a productivity bonus of 80% of their collections under a 10-year term contract. 
2. Tuomey examined the facility fee billed with each physician-performed service and the net collections methodology that allowed physicians to receive compensation from that facility fee.
3. The agreements also contained an additional bonus of up to 7% of the physician’s earned productivity bonus. Tuomey also paid for physicians' malpractice, health insurance, and their practice groups' shares of employment taxes. Additionally, Tuomey took on each practice group's billing and collections costs as physicians assigned their rights to bill to Tuomey.
4. The agreements contained non-compete provisions restricting the physicians from performing outpatient surgical procedures within a 30-mile radius of Tuomey both during the term of the agreement and for two years after termination.
5. The case was brought by a qui tam relator physician who did not want to go along with the proposed arrangement.

Tuomey had tried to argue that it relied in good faith on its due diligence to determine appropriate physician arrangements based on advice and research that the arrangements were Stark compliant, asserting defense-of-counsel and a valuation to show that the agreements were set at fair market value. Thus, Tuomey argued, it did not "knowingly" violate the False Claims Act.

In reality, Tuomey sought advice from multiple outlets. After Tuomey’s original counsel could not agree on the compliance of the arrangement, it sought advice from a third attorney who was a former Chief of the Industry Guidance Branch of the OIG. This attorney was instrumental in drafting and implementing Stark.  The attorney emphasized to Tuomey that the proposed agreements were on their face glaring red flags that presented targets ripe for action. Unsatisfied with the advice, Tuomey sought advice from a fourth attorney, who advised that the arrangements did not violate Stark. However, according to court documents, the fourth attorney was given only parts of the relevant information and history. The Fourth Circuit rejected the advice-of-counsel defense in light of the multiple opinions received; not just the advice and valuations cherry-picked to rely on by Tuomey. The Fourth Circuit said Tuomey was opinion shopping and trying to steer counsel to provide advice in favor of its proposal.

The Fourth Circuit also held that any referrals made during the term of a non-compliant financial relationship are prohibited, including services not mentioned in the agreement, like inpatient services. Lastly, the court held that by violating Stark, the hospital's certifications to Medicare and its claim forms became false.

U.S. ex rel. Bookwalter v. University of Pittsburgh Medical Center (UPMC) 
In this case, UPMC had agreements with its subsidiary physician practice entities and various neurosurgeons that compensated with earned base salaries and potential incentive bonuses tied to physicians’ personally performed work relative value units (wRVUs). The parties agreed on the nature and chain of entities with financial relationships for the definition of indirect compensation in Stark. The Third Circuit granted a petition for rehearing the false claims case as it related to practices of compensation and work productivity bonuses. There were particularly egregious facts at play in this case.

1. Physicians engaged in several fraudulent activities that inflated wRVU volumes, including falsely reporting acting as assistants on surgeries, acting as teaching physicians when they did not, and billed for parts of surgeries that never happened.
2. While the arrangement was in place, the Neurosurgery Department had growth rates of 20–50%. In 2009, it was the highest-grossing neurosurgical department in the United States.
3. After reviewing time reporting, the Third Circuit noted that the report reflected “superhuman” rates of productivity.
4. Many of the surgeons received total compensation at or above the 90^th percentile, with one surgeon also getting a bonus that exceeded the 90^th percentile of total compensation in some surveys.
5. Three surgeons were identified as having been paid more than their individual collections and their productivity bonus conversion factors exceeded what UPMC typically collected on a per-wRVU basis for the physicians’ services.
6. UPMC previously settled with the government when it intervened in this case as to certain claims involving the physicians’ professional billings in 2016 for $2.5 million.  The previous settlement did not include allegations of false claims. 

The Third Circuit at one point agreed that the surgeons’ salaries did not pass correlation theories' original application to productivity bonuses noting that the surgeon’s overall salary rose and fell depending on the volume of referrals based upon the wRVUs. The Third Circuit also found the relator pleaded sufficient facts to demonstrate compensation both varied with and took into account the volume or value of their DHS referrals to UPMC’s hospitals which implicated a prohibited compensation practice under Stark which almost effectively made it so all productivity bonuses were prohibited under Stark. However, the court revised its final opinion on December 20, 2019, so that productivity bonuses are not wholly prohibited as it removed the note that “wRVU compensation by default ‘varies with’ the volume or value of referrals”. The revised opinion maintains the required nuanced analysis and heightened attention that is needed to maintain compliance with Stark indirect compensation. The Third Circuit emphasized that:

• We need not resolve the meaning of varies with here.  Regardless, the complaint plausibly alleges that the surgeons’ compensation takes into account the volume or value of their referrals.  Under the Stark Act and its regulations, compensation takes into account referrals if there is a causal relationship between the two.  And here, the surgeons’ suspiciously high compensation suggests causation.

The Erlanger Health Complaint (Filed July 2024)
DOJ filed an FCA complaint claiming Stark law violations against Murphy Medical Center, Inc. (d.b.a. Erlanger Western Carolina Hospital) and Chattanooga-Hamilton County Hospital Authority (d.b.a. Erlanger Health System and Erlanger Medical Center) (collectively, Erlanger) in the U.S. District Court for the Western District of North Carolina. The complaint alleges that Erlanger knowingly submitted false claims for referrals received from physicians Erlanger was paying above fair market value to secure referrals for 2014 to at least 2021.  Erlanger's compensation model included uncapped productivity bonuses, which were not always based on actual work performed by physicians. The complaint also alleges Erlanger knowingly submitted false claims as evidenced by Erlanger’s decisions to relax or eliminate compensation oversight to attract revenue-generating physicians.
 
Erlanger reiterates the lessons from Tuomey that some might not have learned: do not ignore (1) internal developing and maintaining an effective compliance program, (2) legal advice you are not pleased to hear, or (3) fair market valuations that disagree with your proposed or current plans.

Impact of 2024 Supreme Court of the United States (SCOTUS) Cases

The Loper Bright Enterprises v. Raimondo (Loper Bright)[v]
The Loper Bright overturned the longstanding Chevron Doctrine and now requires courts to independently interpret statutes without deferring to administrative agencies’ regulations and interpretations when there is ambiguity in the statute.
 
While it is widely held that Loper Bright will lead to more challenges of Stark interpretations, courts are not prohibited from considering an agency's interpretation of a statute and SCOTUS noted that an agency's interpretation could still be informative and that deference may still be given to "agency policymaking and factfinding." SCOTUS also noted that if Congress expressly delegates an agency discretion to resolve ambiguities or to "fill up the details of a statutory scheme," any resulting decisions receive deference.
 
Since the decision, there has been at least one qui tam action arguing that the defendant’s violation of the Stark Law and accompanying regulations gave rise to FCA liability, where the judge ruled that liability cannot be determined without subjecting the applicable Stark provisions to a thorough judicial review under Loper Bright. The judge ordered both parties to submit briefs with their analysis.[vi] The court noted the application of Stark has been largely ambiguous and that liability cannot be found alone on past Stark regulations.  For providers with no clear path or dissatisfied with a path to fitting into a current exception, this case could be a ticket to new opportunities for innovative or at least previously prohibited arrangements. However, this outlook rests on the idea that a court would create a more favorable outcome for some contemplated arrangements under Stark.

On the flip side, providers that have taken the time to rely on the guidance of Stark exceptions are facing the possibility of an exception defense closing if a court finds an interpretation of Stark to not be the best reading of the law. 

Jarkesy v. Security and Exchange Commission (SEC) (Jarkesy)
SCOTUS found in Jarkesy that the SEC's authority to impose civil monetary penalties violated the Constitution's Seventh Amendment protections (preserving the right to a jury trial where the amount in controversy exceeds $20) because CMPs served as a form of punishment, the action was legal in nature, and not a matter in equity which has no constitutional right to a jury trial.[vii] SCOTUS also held the CMP authority of the SEC violated the Constitution’s separation of powers because the current framework allows administrative law judges (ALJ)  to serve in “the roles of prosecutor, judge, and jury. This decision undoubtedly allows for new avenues to challenge CMPs under Stark Law. The ruling may lead to stricter scrutiny of agency enforcement actions and the need for clear statutory justification for penalties.
 
Even with this new avenue open, providers should still consider the CMS Stark SDP where a risk assessment has been done that demonstrates clear violations of Stark and where predicted settled amounts of a self-disclosure are relatively low in comparison to the cost of continued litigation and possible court rulings not in the provider’s favor.

Executing Compliance and Ongoing Due Diligence
By this point, it should be clear that to avoid Stark liability, it is imperative for healthcare entities to proactively plan and analyze how their activities, especially physician arrangements, will meet Stark requirements. To do this, providers must develop a compliance program that performs due diligence on proposed arrangements at inception, performs regular monitoring of financial relationships, and has mechanisms in place to correct situations that begin to fall out of bounds of what Stark allows.  Both OIG and DOJ have provided insight into what is considered when contemplating if proper safeguards are in place when scrutinizing an entity for Stark and FCA enforcement. Two key documents from OIG and DOJ to consider when developing a healthcare compliance program are below.

Yates Memo
Deputy Attorney General Sally Q. Yates of the DOJ issued “Individual Accountability for Corporate Wrongdoing” in September 2015 which is more commonly referred to as the “Yates Memo” to guide DOJ attorneys when handling corporate matters.  The memo outlined six significant steps in Department policy to ensure that corporate investigations are handled consistently across the department. [viii]  The Yates Memo has been around for almost a decade and it is still essential for healthcare providers to understand what is taken into consideration by DOJ when determining liabilities and penalties, especially if considering the CMS SDP and DOJ might get involved. The memo makes it clear that individual actors and the provider entity are separately examined for liability. To help guard for both, the presence of comprehensive compliance programs that include written policies, effective training, and robust monitoring and auditing processes help both prevent bad actors and lessen possible liabilities if facing self-disclosure under Stark or an investigation.
 
When working with providers of all sizes, it is common to hear leadership refer to the compliance department or a compliance officer, but it is rarer to hear any leadership has more in-depth knowledge of what is being produced by the department.

OIG General Compliance Program Guidance for Healthcare Entities 2023
The OIG issued guidance in November 2023 that allows for an individual approach to programs to help each provider maintain compliance with Stark (in addition to other Anti-kickback and FCA). Key questions and areas to look at for this guidance concerning Stark compliance include:

1. Nature of the Relationship: How much influence does the relationship have over the parties involved, directly or indirectly, to generate additional claims to federal healthcare programs?
2. Federal Program Impact: How much does the arrangement impact federal healthcare programs and could it lead to overutilization?
3. Clinical Decision-Making: Does the arrangement interfere with clinical decision-making, patient safety, and singling out patients to keep or drop because of certain conditions?
4. Patient-Steering: Does the practice steer patients for a particular item or service?
5. Conflict of Interest: Would acceptance of the referral diminish the objectiveness of the physician’s professional judgment?
6. Documentation: Is the arrangement documented to maintain compliance with Stark and other applicable laws or to meet specific exceptions or safe harbors? Is there regular monitoring of the relationship to ensure compliance with Stark is maintained? Is the relationship conducted the same on paper as it is in execution?

Advice and Takeaways for Providers
While Stark law guidance and enforcement has evolved over time, a number of best practices have prevailed throughout the changes. For those looking to prepare for continued regulatory scrutiny and enforcement in 2025 surrounding compensation and productivity bonuses, healthcare providers should:

1. Target Compliance and Exceptions Initially: Again, the complexities of Stark are such that lucking into compliance is difficult. Develop and document a plan from the outside for Stark compliance, specifically regarding physician compensation and bonuses.
2. Conduct Regular Audits: Regularly review financial relationships and compensation arrangements to ensure compliance with Stark Law. Develop a regular schedule for audits and follow through on the schedule.
3. Implement Robust Compliance Programs: Develop and maintain comprehensive compliance programs that include training, monitoring, and auditing.
4. Engage External Experts: Utilize external experts for fair market value assessments and legal reviews to ensure objectivity and compliance. Take care in selecting qualified experts as once selected, you should not ignore warnings or produce conduct after receiving the opinion that indicates the organization is searching for whatever opinion approves its position regarding Stark.
5. Document Thoroughly: Maintain detailed documentation of compliance efforts, including compensation arrangements and due diligence processes both at the outset of the arrangement and over time.
6. Stay Informed: Maintain a mechanism to stay abreast of legal developments and regulatory changes to adapt compliance strategies accordingly.

Stark compliance has historically been a vast and complex matter, and now several decades into the area’s development, the SCOTUS cases open up more ambiguity of how to proceed while already still trying to implement the revisions from June 2021. Compliance can be made more manageable with competent advisors and counsel. If you need assistance reviewing an arrangement that implicates Stark, please feel free to reach out to rcarey@whitefordlaw.com.