United States: CMS Eases Regulatory Burdens And Creates New Exceptions In "Phase V" Of The Stark Regulations

INTRODUCTION

On November 16, 2015, the Centers for Medicare and Medicaid Services ("CMS") published the most significant changes to the physician self-referral law ("Stark Law" or "Stark") regulations since 2008. Because this rulemaking is the fifth substantive rulemaking under the Stark Law amendments of 1993, it will likely become known as Stark Phase V. This rule, which is part of a larger package of annual regulatory adjustments to the Medicare Physician Fee Schedule, contains important changes that ease the burden of existing exceptions, solicits comments on the possibility of new exceptions in light of health care reform, introduces two new exceptions, and clarifies and cleans up the regulatory text. Below is a summary and analysis of Phase V. Our discussion is ordered based on what we believe is most important to stakeholders.

EASING REGULATORY BURDENS

With Phase V, CMS aims to reduce a number of regulatory compliance burdens that have plagued providers' attempts to comply with Stark. Specifically, CMS addresses various requirements for compensation arrangements, including the writing requirement, the length of term requirement, the duration of acceptable holdover arrangements, the signature requirement, and the definitions of the terms remuneration, stand-in-the-shoes ("SITS"), and locum tenens.

Writing, Term, Holdover and Signature Requirements

Phase V clarifies a number of issues that routinely arise within the context of documenting compliance with the requirements that compensation arrangements be in writing and signed by the parties. As discussed below, these clarifications collectively will likely be very helpful in avoiding petty infractions that may have led to self-disclosures under the Self-Referral Disclosure Protocol ("SRDP"), but they should not be relied upon as best practices in drafting agreements at the outset of compensation arrangements.

The Writing Requirement

Summary. A number of Stark's exceptions for compensation arrangements contain a requirement that the arrangement be documented in writing. Through CMS's experience in administering the SRDP, CMS concluded that there is substantial uncertainty and confusion in the provider community as to what exactly is required by the writing requirement. In particular, CMS was often asked whether an arrangement must be reduced to a single "formal" written contract.

In its commentary to Phase V, CMS confirms that there is no requirement under the Stark Law that an arrangement be documented in a single formal contract, and reiterates its existing policy that "a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties, may satisfy the writing requirement..." Importantly, CMS explains that the relevant analytical inquiry is whether the available contemporaneous documents (that is, documents that are contemporaneous with the arrangement) would permit a reasonable person to verify compliance with the applicable exception at the time that a referral is made. CMS gave examples such as board meeting minutes, written communication, invoices, and other accounting documents.

In furtherance of better effectuating the above policy, Phase V revises the wording in a number of the Stark Law's exceptions by either removing the word "agreement" or by replacing it with the word "arrangement." Likewise, Phase V revises other exceptions by replacing the word "contract" with the word "arrangement" and by replacing the phrase "contracted for" with the phrase "covered by the arrangement."

Comment. CMS's clarification of its existing policy will be helpful in deciding whether materials in the possession of a provider or entity allow it to satisfy the writing requirement. Such analyses are typically retrospective in nature, and often occur within the context of due diligence in a transaction, an internal audit, or the response to a government investigation. However, it should be noted that CMS's clarification of its existing policy towards the writing requirements should not be viewed as best practices in creating arrangements on a going-forward basis. For example, CMS underscores that all requirements of an exception must be met at the time a referral is made, and that parties cannot rely upon contemporaneous documents to protect referrals that predate those documents.

The Term Requirement

Summary. A number of the Stark Law's exceptions for compensation arrangements require that the arrangement spans at least one year. Again through the SRDP process, CMS concluded that there is continuing confusion as to how to meet this requirement. As a result, CMS clarifies existing policy that the one year requirement will be satisfied "as long as the arrangement clearly establishes a business relationship that will last for at least 1 year." Further, CMS clarifies that an arrangement that lasts as a matter of fact for at least one year satisfies the term requirement. CMS has revised the relevant compensation exceptions to provide that "the duration of the lease arrangement" needs to be one year.

Comment. For the same reasons discussed above in the context of the writing requirement, stakeholders should not view CMS's attempts at clarification of the term requirement as the best practices in drafting ongoing compensation arrangements.

Amendment to the Holdover Arrangement Provisions

Summary. The rental of office space, rental of equipment and personal service arrangements exceptions have historically permitted "holdover" arrangements for up to six months after the expiration of the term of an arrangement, provided that (i) the original arrangement was for at least one year, (ii) it otherwise satisfies the requirements of the exception, and (iii) it continues on the same terms and conditions after its expiration. CMS chose to address the treatment of holdover arrangements in response to numerous SRDP submissions of rentals and personal service arrangements that failed to satisfy an exception solely because the parties continued the arrangement after the six month holdover period. In Phase V, CMS revises these exceptions and other exceptions to include an indefinite holdover period.

Comment. Again, these changes are helpful in avoiding petty infractions that may have led in the past to the filings of self-disclosures under the SRDP. However, there are a number of reasons why stakeholders should not routinely rely on holdover arrangements to achieve compliance. For example, the holdover provisions require that all other requirements in an exception – including any requirement that the arrangement's compensation reflect fair market value – must be satisfied. As CMS states in the commentary to Phase V "[w]e caution that rental payments may cease to be consistent with fair market value in long-term arrangements...Parties relying on a holdover provision bear the risk of fluctuations in the relevant market that may cause an arrangement to no longer satisfy the applicable fair market value requirement." As we stated above in the context of other exceptions, the most straightforward way of ensuring ongoing compliance is to enter into a new agreement in a timely manner after a contract expires, and to reassess fair market value to the extent necessary at the time of any renewal.

Temporary Noncompliance with the Signature Requirement

Summary. A number of the Stark Law's exceptions require that an arrangement be signed by the parties. Existing Stark regulations include a special provision to permit arrangements involving temporary noncompliance with an exception's signature requirements. Existing regulations require an analysis of whether the reason for noncompliance is inadvertent: if so, parties have up to 90 days to obtain signatures; if not inadvertent, the parties only have 30 days. Phase V eliminates this distinction and instead applies a blanket 90 day window to obtain the necessary signatures in all cases. CMS also clarifies that it does not expect every document in a collection of documents to bear the signature of one or both parties. To satisfy the signature requirement, a signature is required on a contemporaneous writing documenting the arrangement.

Comment. Although Phase V simplifies this temporary noncompliance rule, the regulation continues to limit the availability of this special rule to once every three years for the same referring physician. In addition, CMS reminds stakeholders that this special rule does not avoid the requirement, applicable to some exceptions, that the compensation be set in advance.

Definitions

Remuneration

Summary. Phase V addresses what CMS identified as two areas of potential confusion with the definition of "remuneration." The Stark Law creates a specific "carve out" from the definition of "remuneration" (i.e., things that are not remuneration) for items, devices, or supplies that are "used solely" to collect, transport, process, or store specimens for the entity providing the items, devices, or supplies, or to order or communicate the results of tests or procedures for such entity. With the disjunctive "or," there has been confusion, particularly with laboratory and pathology providers and their customers, as to whether the exception applies if an arrangement involves one or more of these specified uses, but no other purpose. CMS reiterated its existing policy that as long as the arrangement is used for "one or more" of these statutorily exempt purposes, but solely for these purposes, the exception still applies.

Phase V also clarifies potential confusion regarding so-called "split bill" arrangements where a physician makes use of a provider's resources (e.g., exam rooms, supplies) to treat the entity's patients, but bills for his own professional services, with the entity billing its technical fee. In the commentary to Phase V, CMS clarifies that it does not believe that such arrangements involve remuneration between the parties because no financial benefit is provided to either party. But, CMS takes the opportunity to note that, in contrast, if a physician or a DHS entity bills a non-Medicare payor globally, and pays the physician for his/her professional service, remuneration is paid, and a compensation exception must be met.

Comment. The changes CMS made several years ago to the anti-mark-up rule ended the economic incentive for global billing arrangements involving Medicare patients. Nevertheless, CMS appeared sufficiently concerned to warrant comment about how these arrangements operate with private pay arrangements where the parties refer Medicare business (therefore triggering Stark). One example is pathology arrangements where the physician bills the payor globally, and pays the outside pathology provider for the technical fee, typically on a discounted basis. CMS doesn't say so directly, but when it restates the obvious fact that remuneration is involved because one party is paying the other party for services, CMS means that the compensation must meet the fair market value test, among other requirements.

SITS ("Relevant Referrals")

Summary. In Phase V, CMS addresses confusion over the implications of the FY 2009 IPPS changes published in August 2008 ("Phase IV") to the "stand in the shoes" ("SITS") doctrine.

As background, Phase III of Stark, which was promulgated in 2007, provided that a physician standing in the shoes of his or her physician organization ("PO") is deemed to have the same compensation arrangements (with the same parties and on the same terms) as the PO. Phase III also provided that, when a physician stands in the shoes of the PO, the relevant referrals and other business generated "between the parties" correspond to the referrals and other business generated between the DHS entity and the PO, including all members, employees and independent contractor physicians. In other words, the referral analysis encompasses more than just the referrals and business of the physician to which SITS applies.

Phase IV limited the SITS doctrine so that only physicians with an ownership or investment interest in their PO (aside from physicians with mere titular ownership or investment interests) were deemed to stand in the shoes of their PO. (Physicians without an ownership interest can voluntarily elect to stand in the shoes of their PO for purposes of determining compliance with the Stark Law.) Stakeholders have inquired to CMS whether, when applying SITS to the Stark exceptions, the only "parties" to consider are the physicians with ownership or investment interests in the PO, and not all physicians. That is, does the referral analysis apply only to the narrow group of physicians to which SITS is deemed to apply?

Phase V clarifies that CMS did not intend for Phase IV to narrow the scope of referrals and other business generated when SITS applies. However CMS does acknowledge that only physicians to which SITS applies are considered parties to the arrangement for the purposes of the signature requirements of the applicable exceptions.

Comment. While there is nothing particularly new in this section of Phase V, CMS has restated an important requirement it has placed on the application of SITS going back to Phase III: Although a group practice may have an arrangement with a DHS entity to provide services of only one member of the group, in CMS's view, if the arrangement is not compliant, referrals of all the group's physicians become tainted.

Locum Tenens

Summary. Phase V revises the definition of "locum tenens" to remove the definition's use of the phrase "stand in the shoes," in order to remove confusion with the entirely distinct stand in the shoes doctrine, discussed above.

SOLICITATION OF COMMENTS ON POTENTIAL NEW EXCEPTIONS TO BETTER ENCOURAGE STAKEHOLDER PARTICIPATION IN HEALTH CARE REFORM INITIATIVES

In its Final Rule, CMS acknowledged the rapidly changing landscape of health care reimbursement. These changes are due in no small part to alternative payment models ushered in by the federal government, such as accountable care organizations ("ACOs") under the Medicare Shared Savings Program ("MSSP"), and other Center for Medicare and Medicaid Innovation ("CMMI")-sponsored care delivery and payment models. These initiatives, and the integration that they require between health care entities, such as hospitals and physicians, trigger concerns that participation in such initiatives could run afoul of existing fraud and abuse laws, including violations of the gainsharing prohibition, the Stark Law and the Anti-Kickback statute. To mitigate these fears, and encourage ACO participation in the MSSP, CMS and the Office of Inspector General released a final rule on October 29, 2015, updating the 2011 MSSP waivers in certain circumstances. These waivers, however, do not apply to the many other CMMI initiatives by CMS. CMS notes in Phase V that the fraud and abuse concerns apply equally to participation of physicians and entities furnishing health care services in models sponsored and paid for solely by non-federal payors, where care is provided solely to non-federal program patients. This is because, in CMS's view, the financial arrangements between the parties that result from participation in these models must satisfy the requirements of an applicable Stark exception to avoid Stark's referral and billing prohibition for Medicare beneficiaries. Such arrangements with non-federal payors cannot take advantage of the MSSP waivers. In the commentary to Phase V, CMS indicates that it continues to analyze these issues. While Phase V does not contain any guidance or rules regarding the foregoing, CMS does note that, pursuant to the Medicare Access and CHIP Reauthorization Act of 2015 ("MACRA"), it will be required to undertake two studies related to the application of fraud and abuse laws in the context of alternative payment models and gainsharing arrangements. As a result, CMS seeks further comments, which are due by December 29, 2015.

Comment. It is a disappointment that CMS has offered no regulatory relief in this important area and it has taken an act of Congress through MACRA to get CMS to seek comments yet again. This comment period is another important opportunity for the provider community to suggest approaches to align the Stark law with the incentives created by health care reform and other CMMI initiatives. At the very least, CMS should be encouraged to interpret the exception for remuneration unrelated to DHS (Soc. Sec. Act § 1877(e)(4)) to apply to private payor ACOs, bundled payments and similar initiatives. In the alternative, CMS should utilize its rulemaking authority to create new Stark exceptions for such arrangements. Such small steps may help start a larger dialogue of the ongoing place of the Stark law in today's rapidly changing health care climate focused on quality and cost-control incentives that little resemble the health care system in place at the time the law was enacted.

NEW EXCEPTION FOR TIMESHARE ARRANGEMENTS

Summary. Phase V also addresses the issue of timeshare arrangements, through the creation of a new exception. Under a timeshare arrangement, a hospital or other provider may, for example, request the assistance of a specialist on a limited or as-needed basis. In such cases, the specialist will be provided with such space and equipment to enable the specialist to provide services. Unlike a lease, these timeshare arrangements are often mere licenses that do not provide for exclusive use of the property, but instead confer a privilege to use (during specified periods of time) the premises, equipment, items, supplies and services that are subject to the arrangement. Since these arrangements do not provide for exclusive use, in CMS's view they cannot satisfy the exclusive use requirement of the rental of office space exception. Further, CMS's longstanding policy has been that such arrangements could not satisfy the exceptions for fair market value or payments by a physician.

Phase V provides a new exception for such timeshare arrangements ("Timeshare Exception"). The Timeshare Exception at 42 C.F.R. 411.357(y) contains requirements that are commonly found in other Stark exceptions, including, for example, the requirements that: (a) the arrangement be set out in writing, signed by the parties, and specify the premises, equipment, personnel, items, supplies and services covered by the timeshare; (b) the timeshare must not be conditioned on, or take into account, referrals; and (c) the compensation must be set in advance, and consistent with fair market value. The exception also contains the following limitations: (i) percentage-based compensation formulas and per-click arrangements are not permitted; (ii) the timeshare arrangement must be commercially reasonable even if no referrals were made between the parties; (iii) the arrangement may not violate the anti-kickback statute or any federal or state law or regulation governing billing or claims submission; (iv) the exception is limited to arrangements between certain physicians, POs and hospitals; (v) the timeshare arrangement must be predominantly for the provision of evaluation and management ("E&M") services to patients; and (vi) certain location and equipment requirements and limitations are imposed.

Comment. The new Timeshare Exception adds a potentially useful exception, and, as noted by CMS, will help to ensure adequate access to health care services, particularly in rural and underserved areas. Stakeholders may view this as a long overdue exception, especially given that issues related to the sharing of office space have been raised as early as the first phase of Stark regulations and as late as Phase III. In both cases, CMS refused to explicitly account for the sharing of space or other services within Stark's regulations. The Timeshare Exception marks a departure from CMS's historical reluctance to address the sharing of space. However, this departure is limited. The Timeshare Exception is structured to be narrowly applied to scenarios predominantly for the provision of E&M services, and thus may not be available to protect arrangements that include a large number of referrals for designated health services.

NEW EXCEPTION FOR ASSISTANCE TO COMPENSATE NON-PHYSICIANS

Summary. CMS uses Phase V to help address the growing shortage of primary care and mental health professionals by creating an exception for compensation paid to non-physician practitioners ("NPP Exception"). This exception will allow hospitals, federally qualified health care centers ("FQHCs") and rural health clinics ("RHCs") to provide remuneration to physicians in order to assist the physicians in compensating NPPs. The NPP Exception (42 CFR 411.357(x)) is limited to situations where "substantially all" of the NPPs' services are for primary care services or mental health care services. The exception contains typical requirements found in other exceptions, including requirements that the arrangement be in a signed writing, and that the compensation be fair market value, and not conditioned on or take into account referrals or other business generated between these parties. CMS also places restrictions on the total amount and duration of the remuneration. Finally, the NPP may not have, within one year of the commencement of the compensation arrangement, practiced in the geographic area.

Comment. The NPP Exception is a welcome addition to the Stark Law, but is highly complex and should be studied thoroughly by any party attempting to use it.

CLARIFICATION AND LANGUAGE CLEANUP

CMS uses Phase V to address several areas of Stark that require clarification or clean up in the regulatory text, including: (1) making uniform references to the phrase "takes into account"; (2) clarifying how permissible retention payments are calculated; (3) clarifying how FQHCs and RHCs calculate their geographic areas; (4) adding a catch-all category of securities for the publicly traded securities exception; and (5) clarifying certain restrictions placed on physician ownership of hospitals.

The Term "Takes Into Account"

Summary. A number of Stark's statutory compensation exceptions include a requirement that the arrangement not "take into account" the volume or value of the physician's referrals or other business generated. However, the phrase "take into account" is not used consistently in the regulatory exceptions, with some exceptions using words like: "based on" or "without regard to" instead of "takes into account." CMS stated that in Phase V it reviewed four exceptions with the volume or value standard and revised them so that they contain the same "takes into account" language. CMS explicitly declined to define "takes into account."

Retention Payments

Summary. Stark contains an exception that permits a hospital, FQHC or RHC to make retention payments to a physician on its medical staff to retain the physician's medical practice in the geographic area served by the entity. In Phase III, CMS explained in its commentary that it was limiting the amount of permissible retention payments, with one measure limiting the amount to 25 percent of the physician's current annual income (averaged over the previous 24 months). However, the Phase III regulations appeared to permit entities to calculate this average by considering only part of the prior 24-month period instead of the entire period, as CMS had intended. To avoid confusion, CMS has amended the relevant section to clarify that entities must base their payments on the physician's annual income averaged over the previous 24 months.

Geographic Area Served by FQHC and RHC

Summary. Phase V clarifies the Stark Law recruitment exception that permits hospitals to pay physicians to induce them to move their practices into the geographic area served by the hospital in order to become a member of the hospital's medical staff. See 42 C.F.R. 411.357(e). In Phase III, CMS expanded this exception to include payments made by FQHCs and RHCs. However, the phrase "geographic area serviced by a hospital" did not provide FQHCs and RHCs with guidance on how to determine the geographic area applicable in their situations. To clarify this ambiguity, Phase V specifically defines "geographic area served by an FQHC or RHC" as the lowest number of contiguous or noncontiguous zip codes from which the FQHC or RHC draws at least 90 percent of its patients, as determined on an encounter basis.

Publicly Traded Securities

Summary. The Stark Law provides an exception for ownership in certain publicly traded securities and mutual funds. 42 C.F.R. 411.356(a). In defining the types of securities that would be protected by the exception, the law and regulations provided that the exception would cover securities traded under the automated interdealer quotation system operated by the National Association of Dealers (NASD). However, the NASD no longer exists. Consequently, in Phase V, CMS has added a third category of excepted securities. This new category corresponds to securities listed for trading on an electronic stock market or over-the-counter quotation systems in which quotations are published on a daily basis and trades are standardized and publicly transparent.

Physician-Owned Hospitals

Summary. The Affordable Care Act placed restrictions on the ability of physician-owned hospitals to take advantage of the rural provider or hospital ownership exceptions by including requirements that such hospitals: (a) disclose physician ownership and investment interests on a public website and in any public advertising for the hospital, and (b) cap the total value of ownership or investment interests of a hospital that is held by physicians. Phase V clarifies regulations to effectuate these requirements that were originally promulgated in the CY 2011 OPPS/ASC final rule.

With respect to the public disclosure requirement, Phase V clarifies that "public advertising for the hospital" refers to public communications paid for by the hospital that are primarily intended to persuade individuals to seek care at the hospital. CMS has also clarified that any language that would put a reasonable person on notice that the hospital may be physician-owned would be deemed a sufficient statement of physician ownership or investment.

With respect to the cap on ownership and investment interests, Phase V clarifies that calculations of ownership or investment interests must include direct and indirect ownership and investment interests held by a physician if he or she satisfies Stark's definition of "physician," regardless of whether he or she is a referring physician. CMS also revised its definition of "ownership or investment interest" within the context of physician-owned hospitals.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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