Physician Contracting and Compliance: To Disclose or Not to Disclose December 7, 2011 Steven R. Smith, Sarah E. Swank &

1. Physician Contracting and Compliance: To Disclose or Not to Disclose December 7, 2011 Steven R. Smith, Sarah E. Swank & Craig Holden

2. Welcome • Today’s speakers • Upcoming Ober|Kaler Health Care General Counsel webinars • Overview of the topic • Discussion • Questions

3. Meet Today’s Speakers Steven R. Smith Principal, Ober|Kaler ssmith@ober.com | 202.326.5006 Moderator Sarah E. Swank Principal, Ober|Kaler seswank@ober.com | 202.326.5003 Speaker S. Craig Holden Principal, Ober|Kaler scholden@ober.com | 410.347.7322 Speaker Steve and Sarah are cofounders of the Ober|Kaler Health Care General Counsel Institute. LOOK FOR US ON LINKEDIN: Ober|Kaler Health Care General Counsel Institute Group

4. Physician-Hospital Relationships Series • Part 1: Courting Physicians: Pros and Cons of Six Integration Models (October 20, 2011) • Part 2: Physician Contracting and Compliance: To Disclose or Not to Disclose (December 7, 2011) • Part 3: Disruptive Physicians: A Roadmap to Avoid Dangerous Behavior (January 18, 2012) Visit www.healthcaregcinstitute.com for more information.

5. Voluntary Disclosure of Physician Contracting Issues: If, When and How • Outline of presentation. • Legal obligations to disclose. • Potential benefits/risks of disclosure. • Where to disclose. • OIG Self-Disclosure Protocol. • CMS Self-Referral Disclosure Protocol. • Tough disclosure decisions. • Compliance and auditing issues and best practices. • Hypotheticals.

6. Sources of Legal Obligation to Disclose • Medicare statute. • Felony for anyone “having knowledge of the occurrence of any event affecting his initial or continued right to any such benefit or payment, or the initial or continued right to any such benefit or payment of any other individual in whose behalf he has applied for or is receiving such benefit or payment” from concealing or “failing to disclose” such an event with an “intent fraudulently to secure” payment which is excessive or unauthorized. • 42 U.S.C. §1320a-7b(a)(3). • 2002 CMS proposed rule purporting to implement the statute “clarified” that providers must return excess payments within 60 days of “identifying or learning of the excess payment.” (67 Fed. Reg. 3,662 (Jan. 25, 2002).) Regulation never finalized. • No known prosecutions.

7. Sources of Legal Obligation to Disclose • False Claims Act – Changes to the FCA language made as part of Fraud Enforcement and Recovery Act of 2009 (FERA). • Effective June 2009 it is illegal to “knowingly conceal…or knowingly and improperly avoid…or decrease…an obligation to pay or transmit money or property to the Government…” • 31 U.S.C. § 3729(a)(1)(G). • Eliminated the old statutory requirement for a “false statement or record” – mere knowledge arguably is apparently enough.

8. Sources of Legal Obligation to Disclose • PATIENT PROTECTION AND AFFORDABLE CARE ACT. • § 6409 of the ACA. • Protocol to disclose actual or potential violations. • Secretary is authorized to reduce amounts due and owing for all violations under section 1877 of the Social Security Act. • § 6402 of the ACA. • Must report and return overpayment within 60 days of either identification of overpayment or date on which any corresponding cost report is due, whichever is later. • CMS implementing regulations under development.

9. Potential Benefits of Disclosure • Potential to avoid criminal liability. • Self-disclosure unlikely to result in criminal investigations or prosecutions of the disclosing entity. • Potential to minimize civil exposure. • Fines and penalties are reduced more often than not, and may actually be eliminated. • In 2007, OIG statistics indicated it had referred more than half of its Self-disclosures to Medicare contractors for resolution, presumably without penalty. • Potential to avoid Corporate Integrity Agreements. • Potential to neutralize qui tam suits.

10. What Does Disclosure Guarantee? • While disclosure can minimize penalties, fines, and criminal liability, no reduction in penalties is guaranteed, and the OIG reserves the right to make criminal referrals. • Changes announced in OIG’s most recent “open letter” mean that no self-disclosure can be settled in the self-disclosure program for less than $50,000. • May not eliminate vulnerability to qui tam suits. • U.S. ex rel. Rost v. Pfizer, Inc. and Pharmacia Corporation.

11. To Whom To Disclose? • DOJ? • OIG? • CMS? • CMS contractors?

12. What Gets Disclosed? • To the OIG – only “potential fraud against the Federal health care programs, rather than merely an overpayment.” “Potential fraud” does not include Stark violations only – there must be at least a “colorable” violation of the anti-kickback statute. • “Merely an overpayment” – disclose to the Contractor. • To CMS – Stark Violation only. • Contractor an option?

13. OIG’s Self-Disclosure Protocol • First Displayed in the Federal Register in 1998. 63 Fed Reg. 58,399 (October 30, 1998). • Created out of a pilot program operated by the HHS-OIG and the Department of Justice. • Based on the belief that “providers must be willing to police themselves, correct underlying problems and work with the Government to resolve these matters.”

14. OIG’s Self-Disclosure Protocol • For disclosure of matters that the provider believes are “violative of Federal criminal, civil, or administrative laws.” • Not for matters which “exclusively involv[e]…overpayments or errors that do not suggest that violations of law have occurred.” • Such matters “ should be brought directly to…[a Medicare contractor].” • OIG will refer criminal matters to the DOJ, as appropriate, but will also report the provider’s level of cooperation. • Prior experience under the OIG protocol.

15. March 24, 2009 Open Letter. “Narrowed the scope” of the protocol’s application to Stark and Anti-Kickback. Requires a “colorable” violation of AKS – no self-disclosure of Stark-only violations. AKS violations now require a minimum $50,000 settlement (the statutory maximum penalty for each kickback, not including 3x assessment). Reaffirmed inclination to settle matters at “lower end” of damages “continuum.” OIG’s Self-Disclosure Protocol 15

16. CMS Self-Referral Disclosure Protocol • Mandated by the Affordable Care Act. • Purpose is to resolve actual or potential violations of the Stark self-referral law. • Separate from the advisory opinion process. • Large number of disclosures have been made. • No solid indicators of how CMS will compromise potential Stark disclosure.

17. CMS Self-Referral Disclosure Protocol • Stated factors considered in compromising overpayments. • Nature and extent of the improper or illegal practice. • Timeliness of the self-disclosure. • Cooperation in providing additional information. • Litigation risk to CMS. • Ability to pay.

18. Self-Referral Disclosure Protocol • First Stark Settlement. • Saints Medical Center. • $579,000 • Reserves apparently were between $14.5 million and $785,000. • Issues with written agreements for call coverage, night coverage and stipends. • Issue was raised in due diligence. 18

19. CMS Self-Referral Disclosure Protocol Cooperation among the OIG & DOJ. CMS only accepts violations or potential violations of self-referral law. If additional violations or potential violations of other criminal, civil, and administrative laws send to OIG. Cannot submit disclosure concurrently under SRDP and OIG’s Self-Disclosure Protocol. Coordination with Law Enforcement.

20. CMS Self-Referral Disclosure Protocol • Required Elements of Submission. • Description of Actual or Potential Violation(s). • Identifying Information of party disclosing. • Description of the nature of the matter being disclosed. • Duration of violation. • Disclosing party’s legal analysis of how the matter is a violation. • Specify Stark exception AND which elements are/are not met. • Circumstances under which the matter was discovered and measures taken to address the issue and prevent future abuses. • Statement identifying a history of similar conduct or enforcement action. • Description of any compliance program. • If applicable, a description of appropriate notices provided to other government agencies. • Whether the matter is under current inquiry by the government.

21. CMS Self-Referral Disclosure Protocol • Core Stark Compliance Analysis. • Is there remuneration? • Is there a compensation arrangement? • Direct? • Indirect? • Is there a referral, as defined by the regulations, for DHS? • Is the organization furnishing the DHS an “entity” (as defined in the regulations)? • Is Medicare the payor?

22. CMS Self-Referral Disclosure Protocol • Core Stark Analysis (cont’d). • Apply rules that were in effect during the various periods of the arrangement. • The Stark rules have changed a number of times and the analysis may be different during certain points in the arrangement. • Give proper, but not excessive, weight to preamble language. • Statutory and regulation text govern. • Focus on Period of Disallowance.

23. Self-Referral Disclosure Protocol • Exceptions to Consider: • Temporary Noncompliance (42 C.F.R. 411.353(f)). • Compensation Unrelated to DHS (42 C.F.R. 411.357(g)). • Payments by a Physician (42 C.F.R. 411.357(h)). • “Grace Periods” (42 C.F.R. 411.353(g)). • Isolated Transactions (42 C.F.R. 411.357(f)).

24. Self-Referral Disclosure Protocol • Overpayment Calculation. • With respect to physician-hospital arrangements: • Is the referring physician the admitting physician? • Did furnishing the improperly referred DHS affect the DRG payment? • Does this impact the amount of the overpayment? • Consider the SRDP “look back” period (in contrast to the reopening period for cost reports or Part B claims). • Which programs do you consider? • Medicare FFS. • Medicare Advantage. • Medicaid FFS. • Medicaid Managed Care.

25. Tough Decisions Disclose to OIG or CMS, but not both. • In cases where there is a potential or actual anti-kickback statute violation, entity could choose OIG self-disclosure protocol in lieu of theStark SRDP. • Conduct that raises liability risks under the physician self-referral statute may also raise liability risks under the OIG’s civil monetary penalty authorities regarding the federal anti-kickback statute and should be disclosed through the OIG’s Self-Disclosure Protocol. Disclosing parties should not disclose the same conduct under both the SRDP and OIG’s Self-Disclosure Protocol. • Effect on overpayment obligation. • OIG cannot release the 1877(g) liability, so party disclosing under the OIG protocol arguably still has CMS/Stark overpayment liability and failure to return the overpayment is an FCA violation. • Will CMS sign off on mixed Stark/AKS settlements reached under the OIG protocol?

26. Compliance • Maintain a compliance policy and plan. • Not necessary to include copy with disclosure. • If not, call counsel NOW. • Set a compliance audit plan. • Look to OIG work plan (http://oig.hhs.gov/reports-and-publications/archives/workplan/2012/Work-Plan-2012.pdf). • Consider adding physician contracting and arrangements to this year’s audit list. • Ongoing monitoring and evaluation key. • NOTE: sprinkle in privacy, security and EHR issues. • Provide clear guidance to the compliance officer and audit team.

27. Compliance • Compliance Committee. • You need the right people in the room. • Look to job specific positions for membership. • Regular meetings. • Track attendance. • Minutes. • Perhaps a standardized form. • Should be reviewed. • Legal should attend and participate. • Promote open discussion while maintaining privilege. • Create subcommittees that report to the larger group.

28. Compliance • Link Compliance and Governance. • Transactional or compensation committee of the Board. • Statement of the role of members. • Consider who staffs the committee from executive team. • Frequency of meetings. • Preapproval of certain arrangements? • Oversight of the packets. • Detailed agenda or chart of agreements. • Include list of other contracts and financial relationships. • Copy of agreement may not be necessary. • FMV and other documentation – perhaps a summary. • Legal review of minutes.

29. Compliance • Linking Compliance and Governance (cont’d). • Reports on compliance issues to full Board. • Important to including legal. • Good governance. • Work through difficult issues. • Preserve privilege. • Sometimes include outside counsel.

30. Compliance • ACOs – What is on CMS’s mind? • Hot off the presses – Final Regs. October 20, 2011. • Emphasized flexibility on plan development. • Need for reporting to ACO. • Need for reporting on fraud to federal agencies. • Periodically update plan. • Example: changes in the law. • Lawyer cannot be the compliance officer. • But can go to law school.

31. Auditing Physician Agreements • Why? • Determine compliance level. • Stop the bleeding. • Under a corporate integrity agreement (CIA). • Acquisitions and due diligence. • Whistleblowers.

32. Auditing Physician Agreements • When? “There is no time like the present!” Vs. “What you don’t know can’t hurt you.”

33. Auditing Physician Agreements • Where do I start? • Gather all your written agreements. • Select your “look back” period. • Pull AR. • Pull timesheets and FMV documentation. • Find tax forms (e.g., W-9s). • Understand your legal obligations. • 60 day repayment period. • Working knowledge of requirements. • Use an organizational tool to track. • At the direction of an attorney. HINT: Follow the money.

34. Auditing Physician Agreements • Some Auditing Pitfalls. • Mismatched names. • Physicians with multiple agreements and payments. • Finding the agreement. • Amendments and holdover provisions. • Commencement and termination. • Are amendments bandages that fix non-compliance periods? • Finding a signature and agreement together. • Reviewing emails, invoices and other documentation. • Contract under state law. • FMV and other documentation issues. • Family members and office staff.

35. Auditing Physician Agreements • Auditing Surprises. • Medical director timesheets. • Real Property leases with annual increases. • Defining set in advance. • CME (on site vs. off site). • A contract for a muffin. • Board retreats. • Advocacy activities. • Expert witness. • Research.

36. Physician Contracting Best Practices • Maintain a Contract policy. • Create a work flow. • All signatures before services start. • Is it possible? Required? • To date or not to date? • Determine documentation requirements. • Centralize storage of physician agreements and documentation (perhaps electronic). • Set reminders of expiring agreements. • Retention – a plug for Record Retention policies.

37. Physician Contracting Best Practices • Stopping others from providing “stuff” or contracting with physicians outside your process. • Gift baskets. • “Side” contracts. • Process with safeguards for payments to physicians. • Integrate contract approvals into compliance plan and governance. • Employed physicians . • Consistent intake process with HR. • Compliant recruitment process. • Educate.

38. Auditing – EHRs • Revenue informatics positions. • Differs from compliance. • Pay-back obligations. • Sample size. • Committee and team approach. • Government audits become proactive. • Pattern of noncompliance or worse yet – fraud. HINT: If you are making a lot of $, better to double check.

39. In-House Perspective • Get executive buy in and set expectations for audits. • Engage appropriate departments and individuals. • Conduct audits under privilege. • You or outside counsel? • Set a work schedule. • When it looks bad, keep digging. • If it looks really bad, have the disclosure conversation. • Don’t let people play the blame game. • Create “learning opportunities.”

40. In-House Perspective • An ounce of prevention is worth a pound of cure. • Get a seat at the table. • Legal involved in physician contracting process and governance from the beginning. • Keep an open-door policy. • Be visible along with the compliance officer. • Walk the halls. • Eat lunch in the cafeteria. • Round on certain days if you have multiple sites or are off site.

41. Hypothetical 1 In the course of its general compliance activities, Community Heart Hospital has an outside consultant conduct a review of procedures performed at the hospital by cardiac surgeons and interventional cardiologists. The results indicate that two of the physicians have unusually high rates of stent use. A chart review for these two physicians procedures finds an error rate of 19% over the past 12 months which results a Medicare overpayment of $38,000.

42. Analysis of Hypothetical 1 • Disclose or just repay? • If disclose, to whom? • FI? • CMS? • OIG? • DOJ/AUSA? • Additional audit work? • How far back do you go? • Notify the physicians?

43. Hypothetical 2 Same facts as Hypothetical 1, except that the error rate is 48% with an overpayment of $376,000. Further, one of the physicians in question has significantly increased his rate of stenting procedures in the last year. The beginning of this increase roughly coincides with when he began to be heard muttering that he needed to make more money because of his divorce.

44. Analysis of Hypothetical 2 • Disclose or just repay? • If disclose, to whom? • FI? • CMS? • OIG? • DOJ/AUSA? • Additional audit work? • How far back do you go? • Notify the physicians?

45. Hypothetical 3 A large health system has agreed to purchase a failing community hospital. In the course of the due diligence, you find the following: Several issues exist with MOB leases. One lease expired 7 months ago. The physician tenant remains in the space paying rent at the lease rate. The lease has a hold-over clause, but it calls for a 5% rent increase if triggered. One lease remains in effect, but has a rent escalator clause based on CPI that was to take effect 4 months ago, has not been implemented. Their highest admitting neurosurgeon’s group has been getting paid for her services as a medical director even though the contract expired 7 months ago. Medicare payments to the Hospital for the surgeon’s patient’s over this period total $2.5 million. The CEO took Dr. Smith, a cardiac surgeon, to dinner and things got out of control with the wine list. The total dinner tab totaled $425. Dr. Smith has already received $275 in non-monetary compensation this year.

46. Hypothetical 3 Analysis Lease and Personal Services exceptions permit 6-month holdover terms. For amendments to compensation, CMS recommends (requires?) terminating existing agreement and entering into new agreement.

47. Non-monetary Compensation Exception expressly permits repayment by physician. Amount repaid limited to 50% of limit. Repay within earlier of end of calendar year or 180 days. Once per physician every 3 years. Apply limit by hospital, not by health system. Hypothetical 3 Analysis

48. Temporary non-compliance rule. In compliance for 180 days preceding non-compliance. Fell out for reasons beyond control of entity & promptly corrected upon discovery. Within 90 days of non-compliance. Missing Signature Rule. Only for failure of “signature” requirement . 30 days for “non-inadvertent”; 90 days for inadvertent. Hypothetical 3 Analysis 48

49. Period of Disallowance. “begins at the time the financial relationship fails to satisfy the requirements of an applicable exception.” Ends “no later than” (i) date FR satisfies an exception; (ii) excess comp is returned and FR satisfies exception; or (iii) any below-FMV payments are remedied and FR satisfies exception. Hypothetical 3 Analysis 49

50. Indirect Compensation. The compensation received by the referring physician from the entity with which he has a direct financial arrangement must be FMV and not take into account the value or volume of referrals or other business generated by the physician for the DHS entity. Where the physician’s direct financial arrangement is an ownership interest, such as an LLC investment, the compensation test is applied to the compensation arrangement closest to the physician. Hypothetical 3 Analysis