CMS Voluntary Self-Referral Disclosure Protocol: Latest Developments

Transcription

1 Presenting a live 90-minute webinar with interactive Q&A CMS Voluntary Self-Referral Disclosure Protocol: Latest Developments Evaluating If, When and How to Report Potential Noncompliance With the Stark Law TUESDAY, JULY 17, pm Eastern 12pm Central 11am Mountain 10am Pacific Today s faculty features: Jesse A. Witten, Partner, Drinker Biddle & Reath, Washington, D.C. Renee M. Howard, Partner, Perkins Coie, Seattle Thomas S. Schroeder, Partner, Faegre Baker Daniels, Minneapolis The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions ed to registrants for additional information. If you have any questions, please contact Customer Service at ext. 10.

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5 CMS Voluntary Self-Referral Disclosure Protocol: Latest Developments Evaluating If, When & How to Report Potential Noncompliance with the Stark Law July 17, 2012 Renee M. Howard

6 Stark Law Prohibited Conduct The Stark law prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which a physician (or immediate family member) has a financial relationship, unless an exception applies. Strict liability; intent to comply is irrelevant. 42 U.S.C. 1395nn 6

7 Payment denial Mandatory refund Enforcement Risks Civil Monetary Penalties Up to $15,000 per service plus 3x reimbursement claimed/received Up to $100,000 for circumvention schemes 7

8 Enforcement Risks, Cont. False claims liability for failure to report and return overpayment $5,500 - $11,000 per claim + treble damages Criminal liability for concealing known overpayment Felony charges and fine of up to $25,000, or imprisonment for up to five years or both 8

9 Enforcement Risks Federal program exclusion State law sanctions for prohibited Medicaid referrals Reporting obligations under Corporate Integrity Agreement 9

10 So You Identified a Potential Stark Violation Now What? Is there really a Stark violation? If yes: Take no action (not advised) Repayment to Medicare contractor U.S. Attorney's Office disclosure CMS Self-Referral Disclosure Protocol (SRDP) If other issues present (e.g., kickbacks), additional disclosures may be needed OIG Self-Disclosure Protocol (no longer option for Stark-only) 10

11 CMS Voluntary SRDP Intended to facilitate disclosure and resolution of actual or potential Stark violations CMS has authority to decrease overpayment liability Suspends 60-day report and return obligation SRDP sets forth, among other things: Detailed information to be disclosed Procedural process for resolving matter with CMS Factors considered in reducing amounts owed 11

12 CMS Report to Congress 9/10 6/4/12: 171 disclosures 3 referred to law enforcement 10 reported settlements as of July 5, 2012 Remaining disclosures: Still under CMS review Administrative holds Additional information requested Withdrawal by disclosing party 12

13 Saints Medical Center Settlement 1st SRDP settlement and largest to date $579,000 payment; local media reported liability could be as high as $14.5M PSA not satisfied for: (1) dep't chief and medical staff "leadership services" agreements and (2) hospital coverage agreements with physician groups 13

14 Remaining Nine Settlements Settlement Range: $60 - $130,000 Nature of Stark Violation: Failure to comply with PSA exception (3) Exceeded calendar year non-monetary compensation limit for physicians (3) Other (3) Disclosing Entities: 7 hospitals (including one CAH) and 2 physician group practices 14

15 Who is Disclosing? 15

16 Settlement Agreements Limited release from liability under CMS administrative authority for disclosed violation SRDP settlement does not: Constitute agreement on Medicare losses Relieve criminal, civil or CMP liability Defend against future administrative, civil or criminal action against disclosing party Expect little negotiation on settlement amount 16

17 CMS Self-Referral Disclosure Protocol: Latest Developments July 17, 2012 Jesse A. Witten Drinker Biddle & Reath LLP (202)

18 Was There Really a Violation? > Holdover exception > Late signature provisions > Hospital-based providers Definition of referral carveouts See United States ex rel. Kosenske v. Carlisle HMA, 554 F.3d 88, 93 (3d Cir. 2009) > Does the stand-in-the-shoes provision apply? > Language requiring physicians to refer to hospital Self-Referral Disclosure Protocol: Latest Developments July 17,

19 Practical Tips > Certification requirement > When is a Stark Law overpayment identified? > Dealing with investigation creep > Mixed Anti-Kickback and Stark Law issues > Structuring the Disclosure Report Self-Referral Disclosure Protocol: Latest Developments July 17,

20 Practical Tips > Legal Analysis How much to admit? Element by element review of most relevant exception FRE 408 > Statement of the Cause > Ability to Pay, Corrective Action, Compliance Program & Other Exculpatory Facts Self-Referral Disclosure Protocol: Latest Developments July 17,

21 Practical Tips > SRDP does not require that Medicaid data be provided Stark Law does not bar referral of Medicaid patients or billing for those patients. See 63 Fed. Reg. 1659, 1704 (Jan. 9, 1998). Physician may not make a referral for DSH to an entity for which payment may otherwise be made under this subchapter. 42 U.S.C. 1395nn(a)(1)(A). State may not recover FFP if Stark Law violation. See 42 U.S.C. 1396b(s). But, conduct may also have violated State version of Stark Law. United States ex rel. Baklid-Kunz v. Halifax Hosp. Med. Ctr., 2012 WL (M.D. Fla. Mar. 19, 2012) Self-Referral Disclosure Protocol: Latest Developments July 17,

22 Practical Tips > Corporate Integrity Agreements Requirement that overpayments be refunded can be satisfied via SRDP SRDP requires that copy be sent to OIG monitor > Assume that information disclosed will eventually become public, but assert a FOIA exemption. > If prompt resolution is needed, such as to complete a transaction, notify CMS. Self-Referral Disclosure Protocol: Latest Developments July 17,

23 CMS Self-Referral Disclosure Protocol: Latest Developments Part III: Financial Analysis July 17, 2012 Tom Schroeder, Partner Faegre Baker Daniels LLP Direct:

24 Elements of SRDP Financial Analysis The disclosing party must conduct a financial analysis setting forth: Total amount owing based on look back period (IV.B.2.a) Calculation methodology, including any estimation (IV.B.2.b) Total amount of remuneration a physician(s) received as a result of an actual or potential violation(s) (IV.B.2.c) Summary of any auditing done and documents relied upon (IV.B.2.d) 24

25 Practical tips in dealing with client Provide business office personnel clear parameters for calculation: Specify Stark entity under analysis Search by physician name/npi Start/end date of each look-back period Use dates of service (as surrogate for referral ), not dates paid Define the approach to handling DRG, bundled payments For non-hospital DHS, refer to CMS list of DHS by CPT/HCPCS codes See 76 FR (Nov. 28, 2011) 25

26 Determine the Stark entity For multi-provider/supplier systems, the Stark entity may not be a corporate/legal entity Stark definition includes persons and unincorporated associations that furnish DHS Look to Medicare enrollment status, not legal status or tax IDs A noncompliant arrangement with one provider/supplier does not, by itself, taint referrals to all affiliated (but separate) provider/ suppliers What about commonly enrolled clinics with separate NPIs? 26

27 Determine the tainted physician(s) Whose referrals count? What if the contract does not reflect the actual Stark relationship? Contract with group for exchange of items/services with individual group member Contract specifies payment to group, but check and 1099 go to individual group member (or vis versa) Does stand-in-the-shoes apply? Pay attention to SITS effective date and grandfathering provision Remember that non-shareholder physician-employees don t SITS But identifying them through time may prove difficult Don t assume your EHR s definition of admitting or referring physician is the same as Stark s. 27

28 Look back period defined CMS initially defined the look back period as the full period of non-compliance Could have extended beyond applicable FCA and Medicare statutes of limitation CMS clarified new position in four FAQs posted 4/12: Total amount owing (IV.B.2.a) can now be based on 4-year reopening period described in 42 CFR (b) Total remuneration physician received (IV.B.2.c) can also based on 4-year reopening period NOTE: this applies until the proposed rule [77 FR 9179] is finalized Proposed would amend reopening period for reported overpayments to 10 years 28

29 What about DRG claims? Example: Physician A has a non-compliant arrangement with Hospital. Physician A orders a CT scan for a patient admitted by Physician B. For purposes of your SRDP calculation, do you include in the amount owing: A. The entire DRG payment? B. The calculated value of the scan alone (perhaps based on outpatient fee schedule)? C. Neither of the above (because Physician A did not refer the DHS at issue (i.e., inpatient services, the DRG); and Physician A s scan order did not affect reimbursement under the DRG)? What if the Hospital is a Critical Access Hospital? 29

30 Calculating remuneration to physician SRDP requires calculation of remuneration a physician(s) received as a result of an actual or potential violation(s) FAQ clarifies calculation based on 4-year reopening period But how is this calculation made when: The physician didn t receive any payment under the arrangement (e.g., lease of space to physician)? The remuneration is not the result of the violation (e.g., there is a legitimate fmv exchange, but one party fails to sign)? Where SITS applies, and payment was to the group, how do you calculate the remuneration imputed to each (or a particular) physician? 30

31 Practical tips dealing with CMS Be cooperative; preserve credibility For disclosures involving multiple arrangements, consider: Aggregating financial analyses in a spreadsheet Describing financial methodologies/estimation approaches common to multiple arrangements in one summary memo Submitting disk with electronic data Discuss preferred organization/format with CMS analyst Pre- disclosure (Part IV(B)(1)), followed by financial analyses? Submission will not be deemed complete, but may optimize defenses under FCA and/or reduce likelihood of DOJ intervention 31