OIG and CMS Voluntary Self Disclosures: Weighing the Risks and - PowerPoint PPT Presentation

Presenting a live 90-minute webinar with interactive Q&A OIG and CMS Voluntary Self Disclosures: Weighing the Risks and Rewards of Self Reporting THURSDAY, OCTOBER 1, 2015 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: Samuel C. Cohen, Esq., Arent Fox , Washington, D.C. Anjali N.C. Downs, Esq., Epstein Becker and Green , Washington, D.C. Albert W. Shay, Partner, Morgan Lewis & Bockius , Washington, D.C. The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10 .

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OIG and CMS Voluntary Self- Disclosures Weighing the Risks and Rewards of Self Reporting

Presented by Albert W. Shay Partner, Morgan Lewis ashay@morganlewis.com (202) 739-5291 Anjali N.C. Downs Associate, Epstein Becker Green adowns@ebglaw.com (202) 861-1899 Samuel C. Cohen Associate, Arent Fox samuel.cohen@arentfox.com (202) 857-6322 6

CMS Self- Referral Disclosure Protocol (“SRDP”)  Historically, CMS had limited authority to compromise or waive physician self-referral sanctions (or any other claims liability) under the Stark Law  Affordable Care Act significantly expanded CMS authority and required the Secretary to create a Medicare self-referral disclosure protocol (ACA § 6409)  SRDP posted on CMS web site on September 23, 2010; revised May 6, 2011 • http://www.cms.gov/PhysicianSelfReferral/65_Self_Referral_Disclosure_P rotocol.asp#TopOfPage • https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral 7

SRDP Basics  Applicable only to physician self-referral violations • Does not supersede OIG Self-Disclosure Protocol (SDP) • Violations falling under both SRDP and SDP should be disclosed only to OIG • Comply with CIA/CCA disclosure obligations.  For resolution of actual and potential violations of the physician self-referral law  Separate from the physician self-referral advisory opinion process. 8

SRDP Basics  Open to all health care providers & suppliers • Current government audit or investigation is not a bar to disclosure under SRDP  CMS reserves right to refer matters to OIG or to DOJ  Stay of ACA § 6402 overpayment return requirement until settlement, withdrawal, or removal • Do not make interim payments to CMS 9

SRDP Process  Preparation of Materials by Disclosing Party  Disclosure Submission (email, original, & one copy) • Must submit electronically for automatic stay email  Acceptance / Request for Additional Information • Law enforcement screening process  CMS Review & Assessment  Settlement Process • “Ability to pay” consideration 10

Tips on Disclosure Submissions  CHOWs, Mergers, & Acquisitions • Clearly Identify Timing Issues & Contact CMS • Assignment of Provider Agreement o Remember: Liability remains with Provider Agreement  Provide a complete legal analysis for each disclosed noncompliant arrangement/relationship • Group noncompliant events (“Clean House” Disclosure)  Provide certifications & supporting documentation 11

Tips on Disclosure Submissions  Demonstrate cure or termination of noncompliant arrangement/relationship  Remember “period of disallowance” rules  Provide an appropriate financial analysis • Use definition of “Referral” at 42 C.F.R. § 411.351 • Provide amounts due and owing by (1) disclosed arrangement/relationship; (2) referring individual/entity; and (3) year • Describe methodology used; a comment about estimates  See SRDP FAQs 12

SRDP – FAQs  On May 17, 2012, CMS published four SRDP FAQs addressing: • “Look Back” Period • Calculating Amount Due & Owning • Calculating Total Remuneration • Section 6402(a) of the ACA (60 day rule)  SRDP FAQs (pdf): https://www.cms.gov/Medicare/Fraud-and- Abuse/PhysicianSelfReferral/Downloads/FAQsPhySelfRef.pdf  Physician Self-Referral FAQs: https://questions.cms.gov/ 13

SRDP – FAQs  “Look Back” Period – Period during which the disclosing party may not have been in compliance  Calculating Amount Due & Owing – Will satisfy Section IV.B.2.a of the SRDP by submitting a financial analysis setting forth total amount actually or potential due & owing for claims improperly submitted and paid within the time frame for reopening determinations at 42 C.F.R. § 405.980(b)  Calculating Total Remuneration – Will satisfy Section IV.B.2.c of the SRDP by disclosing total remuneration received by a physician based upon the time frame for reopening determinations at 42 C.F.R. § 405.980(b)  42 C.F.R. § 405.980(b) – A contractor may reopen an initial determination on its own motion within 4 years from the date of the determination for good cause 14

SRDP – FAQs  Section 6402(a) of the ACA • Combined with the Fraud Enforcement and Recovery Act of 2009 (“FERA”), creates FCA liability for knowingly retaining (i.e., not reporting and returning) any overpayment within 60 days of the date on which the overpayment was identified • Proposed rule implementing Section 6402(a) included proposed revisions to the reopening regulations • “However, until the proposed rule [ see 77 FR 9179] is finalized, providers and suppliers of services disclosing actual or potential violations . . . under the [SRDP] may perform the financial analyses required under section IV.B.2 of the SRDP using the applicable time frame and requirements for reopenings established in the existing reopening regulations at 42 C.F.R. § 405.980(b).” 15

Resolutions Under the SRDP  CMS is not bound by disclosing party’s conclusions  CMS is not obligated to resolve a disclosure in any particular manner  No appeal rights for disclosed claims resolved through the SRDP • If removed/withdraw, disclosing party may appeal any subsequent overpayment demand  Resolutions are only of CMS authorities • No CMP or FCA release via the SRDP 16

Resolutions Under the SRDP  Reductions are based on facts and circumstances of disclosed actual or potential violation(s), including: • 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 associated with the matter disclosed • The financial position of the disclosing party  Should you make a settlement offer? 17

Number of Settlement under the SRDP by Year  2011: 3  2012: 14  2013: 24  2014: 24  2015: 4 (as of 9/16)  Why such small numbers in 2015? 18

Settled SRDP Disclosures  Since establishing the SRDP, 69 settlements  Average settlement by year: o 2011: approximately $242,353 (but skewed) o 2013: approximately $78,000 o 2013: approximately $195,000 o 2014: approximately $125,000 o 2015 (as of 09/16): approximately $200,000  Largest Settlement: $584,700  Smallest Settlement: $60.00  More Information about SRDP settlements: https://www.cms.gov/Medicare/Fraud-and- Abuse/PhysicianSelfReferral/Self-Referral-Disclosure-Protocol- Settlements.html 19

SRDP Challenges and Developments  Increasing number of self-disclosures and increasing backlogs • In 2014, CMS updated its estimates - doubled the average number of self-disclosures it anticipated receiving annually and doubled the estimated time for review of each disclosure submission  CMS requested comments on establishing expedited SRDP review process for certain disclosures that have no indicia of fraud and that involve common arrangements, such as leasing and personal service arrangements 20