2010 American Health Lawyers Association October 01, 2010 Vol. VIII Issue 38 The New Stark Voluntary Disclosure Protocol Does It Help Providers? By Gerald Griffith and Frank Sheeder, Jones Day[1] On September 23, 2010, the Department of Health and Human Services (HHS), in cooperation with the Office of Inspector General (OIG), issued its Voluntary Self-Referral Disclosure Protocol (SRDP).[2] The SRDP was developed in response to a mandate in the Affordable Care Act[3] (ACA) directing the Secretary of HHS (Secretary) to establish a Medicare self-referral protocol that articulates a process for providers and suppliers to self-disclose actual or potential violations of the Stark Law. This Commentary: Identifies the statutory mandate for the SRDP; Sets forth the required contents of a disclosure; Discusses the questions that are engendered by the SRDP; and Generally compares the SRDP to the long-standing OIG Provider Self-Disclosure Protocol (OIG Protocol) and the OIG s Open Letters about it.[4] The Secretary notes that the SRDP is intended to facilitate the resolution of... actual or potential violations of the physician self-referral law. [5] It reinstates an option for dealing with possible Stark Law violations voluntary disclosure to HHS that has not existed for pure Stark Law violations since March 24, 2009, when the OIG limited its program to cases involving colorable violations of the Anti-Kickback Statute. In our view, the SRDP is not a revolutionary promulgation that materially alters the Stark or voluntary disclosure landscape. Rather, it provides more confounding choices for entities that may wish to disclose problematic circumstances because it does not clearly indicate how to proceed. Thorough legal analysis and thoughtful, informed consideration of the alternatives are in order before deciding whether or not to utilize the SRDP.
Background Section 6409 of the ACA required the Secretary to develop a self-disclosure protocol regarding actual or potential violations of the Stark Law[6] within six months of the ACA s passage. The ACA required that the SRDP include direction to healthcare providers of services and suppliers about how to disclose such violations and that the protocol be published on the Centers for Medicare and Medicaid Services (CMS) website. Congressionally mandated provisions include direction on the specific person, official, or office to whom such disclosures shall be made, as well as instruction on the implications of the SRDP on corporate integrity agreements (CIAs) and corporate compliance agreements (CCAs). Section 6409 of the ACA gave the Secretary authority to reduce the amount due and owing for all violations of the Stark Law with no particular requirement to tie the settlement or amount of payment to the value of submitted claims or any other particular benchmark. Congress provided, however, that the Secretary may consider the following when resolving disclosed matters: the nature and extent of the improper or illegal practice; the timeliness of the disclosure; the cooperation of the disclosing party in providing additional information related to the disclosure; and such other factors as the Secretary deems appropriate. Section 6409(a)(3) of the ACA confirms that the SRDP is separate from the established advisory opinion process.[7] A provider or supplier may not disclose circumstances under the SRDP while simultaneously requesting an advisory opinion relating to the same circumstances. Section 6402 of the ACA establishes a deadline for reporting and returning identified overpayments as the later of (1) 60 days after the date on which the overpayment was identified; or (2) the date any corresponding cost report is due, if applicable. When a party electronically submits a disclosure under the SRDP and receives confirmation of receipt by CMS, the 60-day deadline is suspended until the disclosed matter is settled, the disclosing party withdraws from the protocol, or CMS removes that party from the SRDP. The Protocol Availability The SRDP is available to all healthcare providers of services and suppliers, whether individuals or entities. It is not limited to any industry, medical specialty, or type of
service. A disclosing party that is already subject to government inquiry through investigations, audits, or routine oversight may still avail itself of the SRDP in good faith. A disclosing party that endeavors to circumvent an ongoing inquiry or fails to fully cooperate in the self-disclosure process, however, will be removed from the SRDP. Advisory Opinions Providers and suppliers cannot use the SRDP to obtain an advisory opinion as to whether certain circumstances violate the Stark Law; the SRDP is explicitly separate from the Stark advisory opinion process. Accordingly, a disclosing party operating under the SRDP should do so with the intention of resolving its overpayment liability exposure for the exposure identified. As provided in the physician self-referral law, no payment may be made for designated health services that are provided in violation of the physician selfreferral law. [8] The sharp differentiation from the advisory opinion process also highlights the difficulty of avoiding a legal admission of a violation, or at least a more constrained position, in a submission to CMS through the SRDP. Although the SRDP does contemplate disclosure of potential violations of the Stark Law, CMS will neither confirm nor deny that a violation occurred unless the provider or supplier has requested an advisory opinion. In effect, CMS expects the provider or supplier to be willing to settle as if there were a violation. Furthermore, the risks will increase if the matter is not resolved though the SRDP, because CMS can provide the information in the disclosure to other agencies. CMS Review CMS will review the matter to determine an appropriate resolution. [9] In some cases, Medicare contractors may be responsible for processing any identified overpayment. The SRDP notes, however, that CMS is not bound by any conclusions made by the disclosing party under this protocol and is not obligated to resolve the matter in any particular manner. [10] On the other hand, the SRDP also notes that CMS will work closely with a disclosing party that structures its disclosure in accordance with the SRDP to reach an effective and appropriate resolution. [11] A disclosing party must agree that no appeal rights attach to claims relating to the disclosed matter if the matter is settled. If the disclosing party withdraws or is removed from the protocol, however, it may appeal any overpayment demand letter in accordance with applicable regulations. Disclosing parties also give up another important right: if a disclosing party is denied acceptance into the SRDP, withdraws from the SRDP, or is removed from it by CMS, the reopening rules[12] apply from the date of the initial disclosure to CMS.
Cooperation with the OIG and DOJ The SRDP is limited to actual or potential violations of the Stark Law. The OIG Protocol remains available to address potential liabilities under other federal criminal, civil, or administrative laws. If conduct that is an actual or potential Stark Law violation also presents Civil Monetary Penalty or Anti-Kickback Statute risks, it should be disclosed through the OIG Protocol, and not the SRDP. Parties should not attempt to use both protocols simultaneously. CMS will coordinate its handling of disclosures under the SRDP with the OIG and the Department of Justice (DOJ). CMS can decide that the matter warrants referral to law enforcement under civil and criminal authorities. CMS may use the information in the disclosure as part of that referral: When appropriate, CMS may use a disclosing party s submission(s) to prepare a recommendation to OIG and DOJ for resolution of False Claims Act, civil monetary penalty, or other liability. [13] In the first instance, the provider or supplier decides on the agency to which it will submit a voluntary disclosure. That agency, however, may share the disclosure with other agencies or may decline to accept the disclosure, in either case potentially delaying resolution of the matter and adding uncertainty. In what can best be described as an understatement, the SRDP says: Accordingly, the disclosing party s initial decision of where to refer a matter involving non-compliance with section 1877 of the Social Security Act should be made carefully.[14] Notably, the same language appears in the OIG Protocol: Accordingly, the provider s initial decision of where to refer a matter involving non-compliance with program requirements should be made carefully.[15] There are several considerations related to where to refer the matter. For example, in some cases, the provider or supplier may wish to seek an advisory opinion before concluding whether there has been a Stark Law violation. If a provider or supplier decides to make a disclosure under the SRDP, the implication is that it has already determined that the circumstances constitute a probable Stark Law violation. Even if the disclosing party goes through the SRDP, however, it will not be able to resolve civil, criminal, or administrative issues such as Civil Monetary Penalty, exclusion, or False Claims Act liability, because those matters are in the province or the OIG and DOJ, and not CMS. Accordingly, in a problematic case, the disclosing party may find itself dealing separately with all these agencies under separate protocols or no protocol at all.
Existing Obligations Disclosing parties that currently have CIAs or CCAs with the OIG should also comply with any reportable event requirements under those agreements. A reportable event related solely to a Stark issue, however, should be disclosed to CMS under the SRDP. Parties to such agreements can contact their OIG monitor with questions about this issue. It is unclear how CMS and OIG will coordinate SRDP disclosures by parties with CIAs or CCAs. The Contents of the Disclosure Submission The disclosure must be submitted by email, and an original and one copy also must be submitted by mail. CMS will email a confirmation that it has received the disclosure. After reviewing the disclosure, CMS will send a letter to the disclosing party or its representative either accepting or rejecting the disclosure. Required Information The disclosure must: Identify the disclosing party and related entities. Include contact information. Include a description or diagram that explains the pertinent relationships. Describe the nature of the matter being disclosed, including: o the type of financial relationships; o the periods in which the disclosing party may have been out of compliance; o the dates or a range of dates whereby the conduct was cured; and o the type of designated health service claims at issue. Include the type of transaction or other conduct giving rise to the matter. Identify the names of entities and individuals believed to be implicated and an explanation of their roles in the matter. State why the disclosing party believes a violation of the physician self-referral law may have occurred. Provide a complete legal analysis of the application of the physician self-referral law to the conduct and any physician self-referral exception that applies to the conduct and/or that the disclosing party attempted to use. o The analysis must identify and explain which elements of the applicable exceptions were met and not met. Include a description of the potential causes of the incident or practice, such as: o intentional conduct; o lack of internal controls; or o circumvention of corporate procedures or government regulations. Describe the circumstances under which the disclosed matter was discovered and the measures taken upon discovery to address the issue and prevent future abuses. State whether the disclosing party has a history of similar conduct, or has had any prior criminal, civil, regulatory enforcement actions or payment suspensions.
Contain a description of the adequacy of a pre-existing compliance program that the disclosing party had, and all efforts to prevent a recurrence of the incident or practice in the related division and any related healthcare entities, such as: o new accounting or internal controls; o increased internal audits; o increased supervision by higher management; or o training. Disclose the measures or actions taken to restructure the arrangement or noncompliant relationship. Describe any notices of the disclosed matter provided to the Internal Revenue Service, the Securities and Exchange Commission, or other government agencies. Indicate whether the disclosing party knows that the matter is currently subject to government inquiry. If it has such knowledge, the disclosing party must identify the agencies or individuals involved. Indicate whether the disclosing party is under investigation or inquiry relating to any other federal healthcare program matters, along with details about the matters. Financial Analysis The disclosing party is expected to conduct a financial analysis and disclose its findings to CMS. A disclosing party should demonstrate that it has fully examined the disclosed conduct. The financial analysis should: Set forth the total amount, itemized by year, that is actually or potentially due and owing based on the appropriate look back period. That period is defined in the SRDP as the time during which the disclosing party may not have been in compliance with the physician self-referral law. Note that the SRDP does not limit the look back period to years that are still subject to reopening by CMS (generally four years). Instead, CMS appears to require providers and suppliers to go back to the beginning of the arrangement, thus setting up an even larger potential damages amount. Describe the methodology used to calculate the amount that is potentially or actually due, including a discussion of whether estimates were used. Summarize auditing activity and the documents the disclosing party relied upon. Certification The disclosing party, or in the case of an entity, its Chief Executive Officer, Chief Financial Officer, or other authorized representative, must submit a signed certification that, to the best of the signer s knowledge, the disclosed information is truthful and based on a good faith effort to bring the matter to CMS attention to resolve any potential Stark Law liabilities. Verification CMS will verify the information in the disclosure. As with the OIG Protocol, the extent of verification will depend on the quality and thoroughness of the submission. New matters
that are identified during the verification process may be treated separately and outside the SRDP. CMS must have access to all financial statements, notes, disclosures, and other supporting documents without the assertion of privileges or limitations on the information produced. CMS will not request written attorney-client communications. However, there may be information covered by the work product doctrine that CMS believes is critical to resolving the disclosure. CMS is prepared to discuss how to gain access to information without waiving appropriately asserted privileges. CMS also may request financial statements, tax returns, and other documents, and the disclosing party will have at least 30 days to provide them. Payments CMS will not accept payments of presumed overpayments before it has completed its inquiry. The disclosing party may be encouraged, however, to place funds in an interestbearing escrow account to ensure adequate resources have been set aside to repay amounts owed. If CMS does consent to payment while a disclosure is pending, the disclosing party must acknowledge in writing that by accepting the payment, the government does not agree to the loss amount and does not waive any criminal, civil, or civil monetary penalty liability. Moreover, payment does not provide a defense to further actions. CMS reminds disclosing parties that any amounts collected from individuals that were billed in violation of the Stark Law must be refunded to the individuals on a timely basis. Reduction of Amounts Owed In considering whether to reduce the amounts owed, CMS may consider: the nature and extent of the improper or illegal practice; the timeliness of the self-disclosure; the cooperation in providing additional information related to the disclosure; the litigation risk; and the financial position of the disclosing party. CMS has no obligation to reduce any amounts due and owing. It will make individual determinations based on the facts and circumstances of each matter.
Questions That Are Raised by, or Persist After, the SRDP What Is the Best Path? Those of us who regularly deal with Stark issues understand that there are many gray areas, nuances, and differences of opinion that come into play when analyzing arrangements and relationships. Given this ambiguity, providers and suppliers are sometimes not certain whether they clearly have a violation or not. Yet, the choice of whether and how to report potential violations can have drastic implications for the disclosing party. If a provider or supplier decides not to disclose problematic circumstances, it is faced with additional potential civil, criminal, and administrative consequences. In fact, with the ACA s changes to the False Claims Act, a zealous prosecutor could argue that the decision of how, when, what, and to whom to disclose a potential Stark violation can implicate False Claims Act liability. The path also is rocky because on March 24, 2009, the Inspector General pronounced in an Open Letter[16] that the OIG would not accept self-disclosures of potential Stark Law violations under the OIG Protocol unless the circumstances also demonstrated a colorable violation of the Anti-Kickback Statute. The Inspector General also stated that it would require a minimum settlement amount of $50,000. By providing an avenue for disclosure of actual or potential Stark Law violations while also prohibiting simultaneous disclosures under both the SRDP and the OIG Protocol, the SRDP effectively dovetails with the Open Letter meaning that disclosures of arrangements that potentially violate both the Anti- Kickback Statute and Stark Law remain within the purview of the OIG. There is no provision, however, for obtaining a release of potential Stark Law liability from CMS if the disclosure is made pursuant to the OIG Protocol rather than the CMS SRDP. Unlike the Open Letter, the SRDP contains no minimum payment requirement. It speaks about the need for a disclosing party to conduct a financial analysis, but it does not shed light on what the measure of damages should be for example, would it be based on the amount of potentially improper benefit to the provider (a more reasonable approach) or the dollar amount of paid claims based on potentially prohibited referrals (a more draconian approach). In public comments at the AHLA/HCCA Fraud & Compliance Forum, one CMS official clarified that the intent of the SRDP is to require a calculation based on the paid claims i.e., the higher amount but that CMS is willing to exercise its compromise authority in appropriate cases. CMS position on this issue alone may discourage providers and suppliers from using the SRDP in light of the significant costs of conducting such a financial analysis and the uncertainty as to the extent, if any, to which CMS will be willing to compromise liability at an amount closer to the level of potentially inappropriate benefits.[17] Importantly, the SRDP does indicate that disclosing parties should plan on repaying individuals who may have made payments in relation to claims
submitted in violation of the Stark Law something that the government has not always required in the past. Providers have been reluctant to disclose potential Stark Law violations because it is difficult to answer the following questions: What is a substantial violation versus a technical violation? What is the measure of damages? What is the proper avenue for disclosure where there is no corresponding Anti- Kickback concern? The SRDP does not fully address these points. For example, there is no discussion of how CMS will handle disclosures of potential non-compliance regarding documentary shortcomings caused by lack of signatures, expired leases, and the like. In fact, it appears that CMS did not concur with the American Hospital Association s (AHA) July 16, 2010 letter[18] to CMS that suggested a two-track process distinguishing between documentary shortcomings and more serious Stark Law violations. The AHA s concern seems legitimate: While originally intended to provide a bright line standard to assure hospitals and others clear guidance, the self-referral law has evolved into a series of increasingly complex, confusing and continually changing rules. Form and audittype requirements are given the same weight as the core requirements of a legitimate arrangement for compliance purposes. As a result, hospitals are at risk for draconian compliance penalties that have no relationship to the harm, if any, to the Medicare program. But the problems stemming from the law s current implementation go beyond individual compliance. Health reform initiatives that call for closer working relationships between hospitals and physicians only heighten the importance of fair and workable implementation of the self-referral law. The AHA urges the Secretary to make full use of the new authority granted by Congress in Section 6409 to address the unintended consequences of the current rules and assure fairness in enforcement of the self-referral law. The AHA also recommended expedited review, consideration of additional mitigating factors beyond those listed in the ACA, compromised standards that look at actual harm, and careful consideration of the interplay between the Stark Law and other laws. By and large, CMS did not incorporate these concepts into the SRDP. We believe this could lead to a missed opportunity. Without explicit standards and some predictability, providers and suppliers may be reluctant to place their potentially problematic circumstances in the hands of CMS under this protocol particularly with the SRDP s position on waiver of work product protection and certain evidentiary privileges. One need only look at the relatively low number of voluntary disclosures under the OIG s long-standing Protocol, with
corresponding low recoveries, to obtain support for the proposition that more clarity and certainty would lead to more disclosures.[19] The lack of certainty also may lead providers and suppliers to seek advisory opinions instead of submitting voluntary disclosures when it is a close call as to whether the Stark Law was violated. Because CMS has indicated that the SRDP and advisory opinion process are mutually exclusive, it may be less risky to seek an advisory opinion first though neither option is without risk. The SRDP is not clear as to whether or under what circumstances CMS will accept a disclosure under the SRDP after an unfavorable advisory opinion has been issued. However, given that the SRDP may be available to providers or suppliers already under investigation, it would seem to follow that an unfavorable advisory opinion should not be a bar to participating in the SRDP.[20] The advisory opinion process has produced only sporadic guidance to date, and CMS has not issued a single advisory opinion on the Stark Law since June 2008. Moreover, the SRDP may, in essence, require disclosing parties to admit that they have violated the Stark Law. This is a monumental step in light of the highly complex regulatory scheme. Because CMS can refer disclosed circumstances to the OIG and DOJ, it may very well be that disclosing parties who try in good faith to resolve matters under the SRDP will be saddled with troublesome admissions that will make defense of subsequent enforcement actions much more problematic. The SRDP does not require an absolute and unequivocal admission, but it does call for a statement from the disclosing party that a violation may have occurred. The protocol requires such a significant level of detail (not only the facts, but also a complete legal analysis of how the Stark Law applies to the facts) that it will be highly difficult, if not impossible, both to meet the disclosure standards of the protocol and to avoid a potentially damaging admission. No Assurances While the OIG Protocol does not contain any guarantees as to the manner in which the OIG will treat disclosing parties, the OIG has sent many messages that following its protocol will lead to kinder and gentler results. Many disclosing parties have experienced just that, while others have regretted the decision to disclose. Counsel for providers and suppliers often reasonably disagree on this point. Moreover, even when a final settlement is reasonable in dollar terms, the associated expenses (such as attorney fees, preparation of the financial analysis, and possible retention of an Independent Review Organization) make it a costly process. The SRDP, in contrast, does not articulate any hope of solace for a party that is considering a disclosure. CMS will make its decisions on a case-by-case basis and will reserve its right to refer cases for enforcement. It also requires disclosing parties to give
up certain administrative and legal rights in order to facilitate verification and validation of the disclosure. In that regard, the SRDP requires a disclosing party to provide CMS with access to all financial statements, notes, disclosures, and other supporting documents without the assertion of privileges or limitations on the information produced. Although the SRDP states that CMS would not require disclosure of written communications subject to the attorney-client privilege, it does not accord the same deference to materials that are protected by the work product doctrine (which typically would include reports of a consultant retained by legal counsel). The SRDP states that: There may be documents or other materials, however, that may be covered by the work product doctrine, but which CMS believes are critical to resolving the disclosure. CMS is prepared to discuss with a disclosing party s counsel ways to gain access to the underlying information without the need to waive the protections provided by an appropriately asserted claim of privilege. Providers and suppliers should be aware, however, that depending on the law in the relevant jurisdiction, it may or may not be possible to effect a limited waiver of work product protection. Disclosure to the government could waive that protection as to the entire document or subject matter in future dealings with any adverse party or agency. Financial Calculation The SRDP requires disclosing parties to calculate the financial impact of the potential noncompliance. This will be an arduous task that will necessitate engagement of qualified professionals. While there is hope that CMS will see fit to compromise disclosed matters for less than the maximum potential exposure, disclosing parties must still calculate that exposure. One can see how even a documentary Stark Law violation such as an expired contract, for example, could cause a disclosing hospital to feel the need to trace all Medicare reimbursements the hospital received in connection with referrals for designated health services from the physician(s) in question. Disclosing parties cannot make repayments of any presumed overpayments determined by the disclosing party while a disclosure is pending, unless CMS consents otherwise. CMS does encourage, however, disclosing parties to put an amount equal to that potential liability in escrow to ensure that there are funds available to resolve the issue. The challenge with the escrow approach is that, especially in the case of documentary violations, the SRDP may be seen to encourage the escrow of the maximum potential exposure if the disclosing party has no reasonable basis for concluding that CMS will accept a measure tied to the amount of the potentially problematic remuneration (e.g., the amount of free rent) rather than the total amount reimbursed for all potentially tainted claims. When one considers the minimal harm to the system that could result
from operating under an expired physician lease for a short period, versus tracing all Medicare reimbursement for designated health services referred by the physician, the escrow amount could be enormous. Even if a documentary violation is ultimately settled on reasonable terms relating to the documentary failure alone, just having to escrow the potential liability may cause disclosing parties financial difficulties the exact thing they may be endeavoring to avoid by availing themselves of the SRDP. Participation in SRDP The SRDP does not provide guidance as to how a disclosing party is accepted into the protocol. Although the SRDP does say that CMS reserves the right to remove disclosing parties from the process, it does not indicate how a party may be removed from the protocol other than suggesting that it could be due to a lack of good faith or cooperation, such as by not meeting the timing deadlines for voluntarily providing information. Moreover, the SRDP contemplates that parties may withdraw from the process, but it does not say how. It will be difficult for parties to withdraw once they have disclosed, especially because they cannot recant or reserve their rights based on the information that they have already voluntarily provided under the SRDP. As noted above, it may be highly difficult at best to equivocate on any disclosure or potential admission and still meet the standards in the protocol. This uncertainty may cause providers and suppliers to be reluctant about making disclosures in the first place, or to provide sufficient information to meet the standards for participation in the protocol. Look Back Period The look back period is defined as the time during which the disclosing party may not have been in compliance with the physician self-referral law. The SRDP does not make reference to any statute of limitations or other standard relating to liability for violations, claims reopening period, or the like. Disclosing parties will continue to be challenged by conflicting standards and opinions as to how far they should go back in resolving potential Stark Law violations. Conclusion At best, the SRDP is a mixed blessing. On the positive side, it does provide another option to providers and suppliers who are contending with a potential Stark Law violation. The wide array of questions concerning the consequences and operation of the protocol, however, are likely to dissuade many providers and suppliers from participating in the protocol. Many of these uncertainties may be resolved in favor of a more attractive voluntary disclosure option that offers the prospect of both (1) reasonable payments commensurate with the seriousness of the potential violation; and (2) a means of
fostering a higher level of voluntary compliance with the Stark Law. Those changes, if they occur, may only come to pass after the SRDP has been in place for an extended period. [1] Gerald Griffith and Frank Sheeder are partners in the law firm of Jones Day. Mr. Griffith is the President-Elect of the American Health Lawyers Association. Mr. Sheeder is the First Vice President of the Health Care Compliance Association. The views set forth herein are the personal views of the authors and do not necessarily reflect those of Jones Day, any client, or any other organization. The authors reserve the right to advance different positions. [2] OMB Control No. 0938-1106 is available at https://www.cms.gov/physicianselfreferral/downloads/6409_srdp_protocol.pdf. [3] Pub. L. No. 111-148, 124 Stat. 119, to be codified as amended in various sections of 42 U.S.C. [4] 63 Fed. Reg. 58399-58403 (Oct. 21, 1998). [5] The Press Release is available at https://www.cms.gov/physicianselfreferral/65_self_referral_disclosure_protocol.asp#to pofpage. [6] Social Security Act, Section 1877; 42 U.S.C. 1395nn. [7] 42 C.F.R. 411.370 389. [8] SRDP, p. 2. [9] Id. [10] Id. [11] Id. [12] 42 C.F.R. 405.980 986. [13] SRDP, p. 2. [14] Id.
[15] 63 Fed. Reg. 58401. [16] The OIG Open Letter (Mar. 24, 2009) is available at http://oig.hhs.gov/fraud/docs/openletters/openletter3-24-09.pdf. [17] CMS has not yet decided whether and to what extent it will publicize settlement terms or amounts. [18] The AHA Letter is available at http://www.aha.org/aha/letter/2010/100716-clppaca.pdf. [19] Semi-annual reports from OIG reflect total recoveries nationally pursuant to the Protocol of $17.5 million for 10/1/08 to 3/31/09, $12.7 million for 4/1/09 to 9/30/09, and $27.1 million for 10/1/09 to 3/31/10. OIG has not included the number of settlements achieved through the Protocol in its semi-annual report since the report for the six-month period ending 3/31/06. In fact, in the subsequent six-month period the dollar amount of recoveries had dropped from $104.2 million to $4.3 million. [20] Another option, depending on the circumstances, may be to file a declaratory judgment action seeking an interpretation of the contract as between the parties to resolve possible payment/repayment obligations between the parties by seeking a ruling that the arrangement does or does not comply with the Stark Law and that payments thus were or were not prohibited by public policy or similar grounds. Although CMS would not be a party to that action, unless perhaps the government sought to intervene, it would seem difficult as a practical matter for CMS to routinely ignore the interpretation of a court of competent jurisdiction. 2010 American Health Lawyers Association 1620 Eye Street NW Washington, DC 20006-4010 Phone: 202-833-1100 Fax: 202-833-1105