The Top 10 Best and Worst of the Stark II, Phase II Regulations

By Karl A. Thallner, Jr.

Thallner is a partner in the Philadelphia office of Reed Smith LLP, where he heads the firm's Philadelphia health care law practice. His practice is focused on providing business and regulatory advice to hospitals and other clients in the health care industry, including assisting on compliance with the federal Anti-Kickback Law and Stark II. He can be reached at (215) 851-8171 or kthallner@reedsmith.com

The much-anticipated Stark II, Phase II final regulations were published in the Federal Register on March 26, 2004 (69 Fed. Reg. 16053). The federal statute known as the Stark II prohibits referrals for Medicare-reimbursed "designated health services" by physicians to entities with which the physician or a family member has a financial interest, unless an exception exists. Since physician relationships - and therefore the scope of the law - sweep broadly across the entire health care industry, each party will need to evaluate how the Phase II regulations impact its particular activities.

Nevertheless, the Phase II regulations, issued by the Centers for Medicare & Medicaid Services ("CMS") as an interim final rule, include some interpretations that clearly will be helpful to many in the industry, and also include some approaches that are disappointing. This article critiques some of the most significant favorable and regrettable aspects in the Phase II regulations.

1. Retention of Significant Phase I Interpretations.

The Stark II, Phase I regulations, which were published in 2001 and became effective in 2002, represented a radical departure from the approach that CMS took in its 1998 proposed Stark II regulations. Compared with the proposed regulations, the Phase I regulations included interpretations that significantly narrowed and simplified the law. These important interpretations include excluding from the definition of "referral" services personally performed by the referring physician; establishing a definition of "indirect compensation arrangements" and a related indirect compensation arrangement exception; allowing per-unit-of-service compensation arrangements (such as "per click" arrangements) to meet the "set in advance" and "volume or value" requirements contained in many exceptions; clarifying which entity would be regarded as an entity receiving a referral for designated health services; and using Medicare payment rules as the basis for physician supervision standards under Stark II. Significantly, the Phase II regulations retained these and other fundamental concepts adopted in Phase I, thereby containing the potential complexity and burden of Stark II.

2. Limited Reporting Obligations.

By statute, Stark II requires entities providing Medicare covered items or services to make reports to CMS concerning their financial relationships with referring physicians. CMS's 1998 proposed regulations would have implemented this provision in an enormously burdensome manner. In short, nearly every such entity would have had to report each covered service that it provides and every financial relationship that it has with a referring physician, whether or not a Stark exception applies to the financial relationship. Forms were to be developed for use in such reporting, which would have had to be updated annually. In Phase II, CMS abandoned this approach and interpreted the Stark II provisions on reporting to require that entities providing Medicare covered services must report such information only upon the request of CMS. Although entities are required to retain reportable information in order to respond to any request for information, the recordkeeping requirement is not intended to be more onerous than that which an entity would ordinarily and prudently maintain, and entities are not required to complete and file annual forms. In view of the broad definition of "financial relationship", this new approach is a welcome relief from the proposed reporting requirements for entities, such as hospitals, that deal frequently with physicians.

3. Guidelines on Physician Recruitment.

In many markets, with increasing physician malpractice insurance costs and low physician payment rates, access to physician services is threatened, and more hospitals are exploring ways to recruit physicians to serve their communities. One of the impediments to hospitals' recruitment activities has been Stark II. Although Stark II includes a statutory exception for physician recruitment by hospitals, it is limited to incentives for physicians to relocate to the hospital's geographic area, and allows only payments to a recruited physician herself.

The Phase II regulations provide some beneficial guidelines to facilitate many common physician recruitment structures. First, in contrast to the proposed regulations, the Phase II regulations interpret the relocation requirement to relate to the physician's practice location, not his residence. Second, residents and physicians practicing for less than one year are not subject to this relocation requirement, so hospitals are not prohibited from recruiting their own residents under Stark.

Third, Phase II allows so-called "co-recruitment" arrangements by which a hospital may support the recruitment of a physician to work in an existing medical practice. These co-recruitment arrangements are subject to several conditions to ensure that the hospital's support does not inappropriately benefit physicians in the existing practice, including a requirement that the hospital subsidize no more than the existing practice's incremental or marginal costs attributed to the recruited physician in those cases where it provides an income guarantee. It is noteworthy that, unlike requirements imposed under tax law applicable to exempt organizations and under the Anti-Kickback Statute, Stark II imposes no requirement that the hospital be able to demonstrate need in the community for the recruited physician's services.

4. Academic Medical Exception More Meaningful.

In the Phase I regulations, CMS created a new exception that was intended to allow transfers of funds among components of a single academic medical center (such as from a teaching hospital to a faculty practice plan) without having that transfer cause Stark compliance problems. The exception received immediate criticism as being unduly restrictive. Among other things, the Phase I regulations included a requirement that each physician's compensation be "set in advance"; as that standard was initially defined, the exception would have been unavailable where AMC physicians are compensated based on a percentage of collections for their personally performed services - a common compensation formula.

Phase II's permanent modification of the "set in advance" definition to allow percentage compensation, discussed further below, goes a long way toward making this exception more meaningful. In addition, CMS modified several other conditions in the academic medical center exception, which will make the exception applicable to a broader range of teaching hospitals. For example, an academic medical center is no longer required to include a medical school (it simply must include a hospital that sponsors four or more teaching programs), and there is more flexibility in the documentation of the relationship among AMC components. Although this exception is now more useful, some academic medical centers may find that a less burdensome means to comply with Stark will still be to rely on the analysis associated with CMS's definition of indirect compensation arrangements and the related exception.

STARK II, PHASE II AUDIOCONFERENCE BNA is sponsoring a May 7 audioconference to explain and clarify the new Stark II final rule on physician self-referrals. "Understanding the Stark II Final Rules: Changes, Definitions & Effect on Group Practices" will be held Friday, May 7, from 2:00 p.m. to 3:30 p.m. (EST). Featured speakers are: • Kevin G. McAnaney, attorney, Law Offices of Kevin G. McAnaney, Washington, D.C.; • Robert J. Saner, principal, Powers, Pyles, Sutter & Verville P.C., Washington, D.C., and Counsel to the Medical Group Management Association; and • Thomas S. Crane, partner, Mintz Levin Cohn Ferris Glovsky and Popeo P.C., Boston and Washington, D.C. Join BNA and our expert faculty to discuss changes from the proposed rule to the final rule and analyze key aspects of the final rule, including its impact on physician group practices. A question and answer period will follow the presentation and attendees will receive helpful expert-written materials to guide them through the complicated rule. Fees are $225 for BNA subscribers and $275 for nonBNA subscribers. For more information and to register, please visit the Web site at http://healthcenter.bna.com/pic2/hc.nsf/Frontpage or call (800) 401-5937 ext. 1.

5. Early Termination of Leases, Personal Services Agreements.

Among the most commonly used exceptions under Stark II are the exceptions for leases and personal services. In essence, these exceptions allow common commercial contracts, at fair market value compensation, between a designated health service provider and referring physicians. One of the statutory requirements of these exceptions is that the arrangement, which has to be set forth in writing, must be of at least one-year duration.

In the proposed regulations, CMS acknowledged that a provision in such an agreement giving a party the right to early termination "for good cause" would not cause the agreement to violate the one year requirement, as long as the parties do not enter into an new arrangement within the originally established one-year time period. In a helpful additional interpretation in the Phase II regulations, CMS has indicated that even early without cause termination provisions will not prevent compliance with the one-year requirement of these exceptions, as long as the parties do not enter into the same or substantially the same arrangement during the first year of the original term.

6. Relaxation of "Same Building" Requirements for In-Office Ancillary Services Exception.

Stark II includes an "in office ancillary services" exception that allows physicians to refer for designated health services that are provided by them or under their supervision or that of another member of their group practice. This exception includes three sets of requirements relating to supervision, location and billing. The location requirements can be satisfied if the services are provided in the same building in which substantial physician services are provided, or in a centralized location.

Prior to the Phase I regulations, CMS became concerned that physicians may be operating ancillary services enterprises that are not truly a part of their medical practices. To deal with this, in the Phase I regulations, CMS required (among other things) that any centralized building be used exclusively by the medical practice (thereby prohibiting so-called "block leasing" arrangements) and established as a condition to the same building standard that a patient's primary reason for coming to the medical practice may not be the receipt of designated health services (thereby prohibiting "outside referrals").

In Phase II, CMS sticks with the Phase I centralized building requirements, but revamps the same building requirements. In its reformulation, CMS has eliminated the "primary reason" test, and established three alternative tests that attempt to assure that some level of physician services are provided at any location that will be treated as the same building where the medical practice provides physician services. The new approach is advantageous to many physician practices providing ancillary services.

7. Installment Payments for Isolated Transactions.

Stark II includes an exception for "isolated transactions," such as a one time sale of property or a practice, if the remuneration is consistent with fair market value, is not determined directly or indirectly in a manner that takes into account the volume or value of referrals, and is commercially reasonable.

In order to ensure that the transaction is truly "isolated," the 1998 proposed regulations would have made this exception unavailable if any additional transaction between the parties (not covered by another exception) takes place within six months. In addition, due to concerns that deferred payment obligations to a physician could coerce referrals, the exception would have been unavailable where the physician is paid on an installment basis.

Phase II modifies the first of these conditions by allowing commercially-reasonable post-closing adjustments within the six month period if they do not take into account the volume or value of any referrals. More significantly, the Phase II regulations indicate that CMS will allow the exception to apply even in the case of an installment purchase.

Seemingly still concerned about the impact of installment payment obligations on referral patterns, CMS limits the use of installment payments to situations where the payments are "immediately negotiable or otherwise secured so that the seller is guaranteed payment in the event of the purchaser's default or bankruptcy." This condition on installment payments is puzzling, however, since a negotiable note is simply one that is permitted to be transferred and is not necessarily secured, and a note, whether or not negotiable, by itself provides no certainty that the obligations will be paid.

8. Clarification on How to Analyze "Common Ownership" Situations.

CMS's guidance had been confusing on the application of Stark II to joint ventures that themselves do not provide designated health services, but that may have owners who refer to each other for such services. An example of this would be an entity, jointly owned by a hospital and physicians on the medical staff, that operates an ambulatory surgical center. In the proposed Stark regulations, CMS concluded that such common ownership would create neither an ownership interest nor a compensation arrangement between the owners. In the Phase I regulations, CMS stated that it had revisited this issue, and, without further explanation, advised "that such relationships should be analyzed in the same manner as any indirect financial relationship."

Happily, Phase II spelled out this method of analysis. In essence, such common ownership arrangements will not create an indirect compensation arrangement between the owners as long as the aggregate return on a physician-owner's investment does not vary or otherwise take into account the volume or value of referrals to, or other business generated for, a co-owner that provides designated health services. This clarification removes any doubt about Stark compliance for many ASC and other hospital/physician joint ventures, since such ventures are typically structured in a way that would satisfy this condition.

9. Nuclear Medicine and Lithotripsy are Out.

Referrals for services that are not "designated health services" are not covered by the Stark self-referral prohibition. There has been uncertainty as to whether two services, in particular - nuclear medicine and lithotripsy - are covered by Stark. For the time being, at least, both of these services are out. The Phase I regulations excluded nuclear medicine services from the categories of radiology and radiation therapy services. However, CMS' May 27, 2003, semiannual regulatory agenda disclosed plans to propose to amend the regulations to include diagnostic and therapeutic nuclear medicine services and supplies. Phase II retains the exclusion for nuclear medicine, but CMS cautions that it is continuing to consider whether these services should be covered by Stark II.

Conversely, in Phase I, CMS asserted that lithotripsy services furnished by a hospital constitute designated health services. Thereafter, as a result of a case brought by a urology society, a federal district court held in that when lithotripsy is furnished "under arrangements" with a hospital, it is not a "designated health service" and thus referrals by physicians for lithotripsy are not subject to the Stark II prohibitions. Without making reference to the case, in Phase II, CMS changed its position, and now does not consider lithotripsy to be a hospital service under Stark. CMS cautions, however, that any financial relationship between a physician and a hospital regarding lithotripsy, such as an equipment lease, will have to meet an exception if the physician is referring to the hospital for other designated health services.

10. Exceptions for Ownership of Publicly-Traded Securities.

Stark II contains an exception for physician investment in publicly traded securities of an entity to which the physician refers, but requires that the investment be "purchased on terms generally available to the public." In Phase II, CMS reconsidered its earlier interpretation of this requirement, and now requires that the ownership interest must be in securities that are generally available to the public at the time of the DHS referral, rather than at the time the physician or family member acquired the ownership interest. In addition, in accordance with the position indicated in the Phase I rule, CMS will not consider stock options received as compensation to be ownership or investment interests until the options are exercised. CMS also has eliminated certain shareholder reporting requirements. These changes should make Stark compliance easier for publicly traded companies providing designated health services.

Top Ten Worst Features of Phase II

1. Missed Opportunity to Reconcile Variable Compensation.

Many Stark exceptions for compensation arrangements include requirements that the compensation must be set in advance, may not vary based on the volume or value of referrals, and must be consistent with fair market value. CMS has been struggling with the extent to which variable compensation arrangements can meet these requirements. In the 1998 proposed regulations, CMS indicated that per-unit-of-service arrangements satisfy the "volume or value" standard only if the units of service do not include services provided to patients referred by the physician receiving the payment. The Phase I regulations represented a change in course; there, CMS concluded that unit of time or unit of service compensation formulas could satisfy the "volume or value" standard. Thus, under Phase I, a urologist who leases a lithotripter to a hospital in exchange for rent determined on a "per click" basis could still refer patients to the hospital for lithotripsy services, even though his aggregate rent would increase with his referrals.

Oddly, CMS expressed concern about percentage compensation arrangements, such as percentage of collections, where a fixed percentage is applied to a "indeterminate amount." This was manifested mainly by a sentence in the regulations in which CMS said that such percentage compensation arrangements do not meet the "set in advance" standard. Before the Phase I regulations became effective, CMS suspended the effective date of that sentence, and has eliminated the sentence in the Phase II regulations. A consequence of this change is that entities may compensate physicians based on a percentage of their personally performed services and still meet the requirements of the personal services arrangements and academic medical centers exceptions.

While this clarification is useful, Phase II leaves unanswered many questions concerning percentage compensation. For example, Phase II does not address whether percentage compensation arrangements (for services other than those that are personally performed by the physician) satisfy the volume or value standard. Thus, it is not clear whether a lithotripter lease would pass muster under the circumstances described above if the lease payments were based on a percent of collections, rather than per click. Similarly, it is unclear whether a physician in a management position could be incented based on a percentage of revenue of the business unit for which he is responsible. Further, because of the OIG's reluctance to issue favorable advisory opinions under the Anti-Kickback statute for common percentage compensation arrangements, many in the health care industry had hoped for some clearer articulation of the extent to which legitimate concerns about percentage arrangements exist. Unfortunately, Phase II does nothing more than address the narrow issue of percentage compensation for personally performed services.

2. The Compliance Lapse Provision is Illusory.

Stark II was meant to create clear and sharp distinctions between non-abusive financial relationships with physicians from those that are improper. Sharp lines can cut both ways, however. One of the most troubling aspects about Stark II is that even a minor deviation of an entity's financial relationship with a physician from the requirements of a Stark exception will render all of the physician's Medicare referrals for designated health services to that entity prohibited, and all resultant Medicare claims for payment for those services to be improper. With the potential not only for civil money penalties through government enforcement, but also for civil false claims liability in actions brought by private "whistleblowers," the stakes for providers are high indeed. With that in mind, providers sought a bit of slack for minor, inadvertent or temporary Stark compliance lapses.

In response, in the Phase II regulations, CMS did create a new exception for compliance lapses. Unfortunately, however, the provision is so heavily conditioned that it will not help even the most conscientious providers sleep at night. In particular, the compliance lapse provision would apply only if the lapse arises for reasons beyond the control of the provider of designated health services, is limited to a period of 90 days, and is unavailable more than one time every three years. Many innocent and immaterial lapses will not meet these conditions.

3. Not Much Help on FMW.

Many of the Stark exceptions for compensation arrangements require that the remuneration be consistent with fair market value, and in the Phase I regulations, CMS issued a new regulatory exception for fair market value compensation arrangements. When discussing the concept of fair market value in Phase I, CMS seemed to recognize the imprecision inherent in seeking to ascertain fair market value, and advised that it intended "to accept any method that is commercially reasonable and provides us with evidence that the compensation is comparable to what is ordinarily paid for an item or service in the location at issue, by parties in arm's-length transactions who are not in a position to refer to one another." As an example of a commercially reasonable method to determine fair market value, CMS wrote, "We would also find acceptable an appraisal that the parties have received from a qualified independent expert." These statements provided some comfort to providers who sought to ensure that payments to physicians could be supported as within the range of fair market value.

Phase II may increase the concerns of these providers. First, CMS appears to have backpedaled from its statements concerning expert appraisals. Responding to comments requesting a presumption of reasonableness when compensation is based on an independent third party opinion, CMS took on a cautionary tone: "While good faith reliance on a proper valuation may be relevant to a party's intent, it does not establish the ultimate issue of the accuracy of the valuation figure itself."

Second, CMS did establish a "safe harbor" for hourly physician compensation rates. The safe harbor is available if the hourly rate is either (a) less than or equal to the average hourly rate for emergency room physicians in the relevant physician market, if there are at least three hospitals providing emergency room services in the market, or (b) determined by averaging the 50th percentile national compensation level for physicians in the same specialty in at least four of six identified compensation surveys and dividing by 2,000 hours (data for general practice physicians may be used if the specialty is not identified in the survey). Despite CMS's assurances that compliance with these methodologies is entirely voluntary, and that fair market value can be established through other methods, the hourly rates contemplated by the safe harbor will likely become a benchmark against which actual rates are evaluated, and thereby may increase the compliance risk when rates exceed the safe harbor rates.

4. Requirements and Limitation of Personal Services Exception.

Phase II establishes requirements impacting the availability of the personal services exception, an exception of import because it permits independent contractor arrangements with referring physicians. By statute, a personal service arrangement must cover all services to be provided. In the proposed regulations, CMS implemented this mandate by requiring either a single writing or a provision in each writing by which each other arrangement between the parties is incorporated by reference. In Phase II, CMS is allowing as an alternative a provision in which each arrangement cross-references a master list of such arrangements, as long as the list preserves the historical record of the contracts, and is maintained and updated centrally. Such a list may be somewhat burdensome to maintain.

More significantly, Phase II limits the availability of the personal services exception to those services provided by the physician or employees, but not independent contractors.

5. Significant Narrowing of Requirement to Refer Provisions.

A surprising interpretation in the Phase I regulations was that a contract with a physician that requires referrals would not be regarded as violating the "volume or value" standard, even though a breach of that requirement would give rise to a right to terminate (and therefore to cease paying the physician's compensation). The only limitation that CMS then imposed was to ensure that such a provision does not prohibit referrals to alternative providers due to patient choice, insurance limitations or physician judgment.

In Phase II, CMS materially narrowed the circumstances in which physicians may be required to refer. First, a requirement to refer may relate only to the services that a physician performs while acting under the scope of his arrangement with an entity - that is, he cannot be required to refer for services furnished by others. Second, Phase II injects the question-begging limitation that any referral requirement must be reasonably necessary to effectuate the legitimate business purposes of the arrangement. In short, the door to required referrals that CMS opened in Phase I has been slammed shut in Phase II.

6. Highly-Technical Indirect Compensation Analysis.

Since Stark II applies to indirect, as well as direct, financial relationships, the method of analysis applicable to such arrangements is hugely important. The good news is that, as indicated above, CMS adhered to its basic framework, first articulated in Phase I, to determine whether an indirect compensation arrangement exists, allowing the application of an indirect compensation arrangement exception in those cases where it does exist. CMS's approach is highly technical, however, and this could cause confusion and compliance issues.

For example, CMS instructs that, to determine whether an indirect compensation arrangement exists in the first place, one should assess whether the aggregate compensation from the entity with which the physician has a direct relationship varies with or otherwise reflects the volume or value of referrals to the entity furnishing designated health services. Where such an arrangement does exist, to determine whether the indirect compensation arrangement exception applies, one must determine whether the compensation received by the physician is determined in any manner that takes into account the volume or value of referrals. Application of these standards requires a nuanced understanding of CMS's distinction between "aggregate compensation" in the definition (which focuses on total payments) and "compensation" in the exception (which involves compensation methodology), and its interpretation of the "volume or value" standard.

7. Gutting of "Unrelated to Provision of DHS" Exception.

Stark II contains a statutory exception for a hospital's compensation arrangement with a physician if the remuneration "does not relate to the provision of designated health services." Many hospitals have been reluctant to rely on this is exception because of the uncertainty of its scope. Nevertheless, in the face of a complex law that seems to be reinterpreted every time CMS issues a new set of proposed or final regulations, hospitals were reassured in knowing it was there as a back-up in case the exception that the hospital primarily relied upon was found not to apply. Further, because some hospitals' non-abusive and beneficial arrangements, such as assisting physicians' malpractice insurance costs in some markets, do not fit neatly into the cubbyhole of another exception, this exception was believed to be the one most likely available.

By contrast, CMS has been concerned that this exception is potentially so broad that it would swallow-up the Stark self-referral prohibition itself. In Phase II, CMS took another step toward making the exception virtually useless by interpreting it to be unavailable if any item, service, or cost that could be allocated in whole or in part to Medicare or Medicaid is related directly or indirectly to the provision of designated health services, or if the remuneration is furnished in any preferential manner to physicians in a position to make or influence referrals. The narrow scope is evidenced by CMS's withdrawal of its Phase I suggestion that the exception could be available for a hospital's payment for general administrative or utilization review services, and its implication that malpractice insurance support would not fit into this exception.

8. Application of "Volume or Value" Standard to Gainsharing Arrangements.

Both the personal services exception and the employment exception are limited by a requirement that physician compensation cannot be related to the volume or value of referrals. Clearly, this limitation was meant to ensure that physicians are not paid more merely because they make referrals to the party to which they are providing services. A provision in the statutory personal services exception specifically permits physician incentive payments by managed care entities to encourage physicians to control utilization or costs, but it is less clear how the volume or value standard applies in the case of hospital "gainsharing" arrangements.

In Phase II, CMS takes the unequivocal position that hospital gainsharing arrangements cannot satisfy the volume or value standard --at least to the extent that such gainsharing arrangements would not comply with the civil money penalty provision that prohibits a hospital from paying physicians to reduce or limit care to hospital patients. As a result, hospitals with arrangements that violate the CMP provision will face additional legal exposure under Stark. Whether a gainsharing arrangement that does not violate the CMP provision could satisfy the volume or value standard is not addressed by CMS.

9. No "Incident to" Productivity Bonuses Outside of Group Practice.

As indicated above, in the Phase I regulations, CMS excluded personally performed services from the definition of referral, with the result that the "volume or value" standard contained in many exceptions does not preclude paying a referring physician based on services that the physician personally performs. However, for employed and independent contractor physicians, CMS refused to permit bonuses that take into account "incident to" services that are personally supervised by the referring physician. By contrast, under the in office ancillary services exception, physicians in a group practice may be compensated based on any incident to services that they supervise.

Despite comments seeking consistency in permissible compensation approaches across various settings, the Phase II regulations do not allow the same flexibility for employed or independent contractor physicians outside of the group practice setting to receive compensation based on the supervision services that they provide.

10. Additional Regulatory Exceptions are Quite Limited.

Phase II includes several new exceptions created under CMS's regulatory authority, including exceptions for physician retention arrangements, professional courtesies, and charitable donations by physicians. Although it is a good sign that CMS continues to be willing to add new exceptions to deal with physician arrangements that are non-abusive, the new exceptions that it has developed will generally be useful in only limited circumstances.

First, some of the exceptions, such as a new exception that allows a physician to refer patients in rural areas to a family member if no one else can provide the referred service in a timely manner, contemplate a unique set of facts that will arise only rarely.

Second, other exceptions are so heavily conditioned that their breadth is quite narrow. For example, among other conditions, the exception for hospital retention arrangements applies only if the geographic area served by the hospital is a health professional shortage area or CMS issues an advisory opinion conforming that there is a demonstrated need for the physician in the area, and if the physician has a bona fide recruitment offer to relocate from the area.

The Phase II regulations represent an attempt by CMS to develop a reasonable regulatory approach to Stark II. Fundamentally, however, the agency has been required to bear a monumental burden in making sense of an extraordinarily broad, highly complex and not-fully-consistent statute. The Phase II regulations - the latest of CMS's evolving interpretations - include many features that are helpful to enable the health care industry comply with the law.

Even so, there continues to be room for improvement. Applying law to particular facts in the face of these regulations continues to be a highly technical task, and the result does not always comport with one's intuition nor will it always be consistent with the outcome under seemingly similar facts.

The industry can only hope that CMS continues to refine the regulations so as to further simplify compliance and reduce undue exposure to legal risks.

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