Navigating Self-Disclosure Charlie Fletcher, CHC Chief Compliance Officer MAURY REGIONAL MEDICAL CENTER Matthew M. Curley BASS BERRY & SIMS PLC John N. Joseph POST & SCHELL, P.C. Self-Disclosure: Legal Obligations to Disclose Why Disclose? Legal and ethical duties Effective compliance program Avoid risk of further liability Affordable Care Act (ACA), 42 U.S.C. 1128J(d) Providers must report and return overpayments within 60 days of identification of overpayment Retention of overpayment after 60-day deadline results in an obligation under the False Claims Act (FCA) False Claims Act, 31 U.S.C. 3129(a)(1)(G) Violation of the FCA if a person knowingly conceals or knowingly and improperly avoids or decreases an obligationto pay or transmit money or property to the government FCA violations subject to treble damages and penalties 1
Self-Disclosure: Legal Obligations to Disclose Common issues that might arise: When is an overpayment identified CMS proposed rule: when provider has actual knowledge or acts in reckless disregard or deliberate indifference of the overpayment Duty to make reasonable inquiry using all deliberate speed E.g., Significant increase in Medicare revenue for no apparent reason How far back must the provider look for overpayments? CMS proposed rule contemplates 10 year look-back period Proposed rule has not been finalized OIG Self-Disclosure Protocol Self-Disclosure Protocol issued in 1998 Matters must involve potential violations of federal criminal, civil or administrative laws Overpayments or errors must be processed through contractor Supplemented by Open Letters in 2006, 2008, and 2009 Updated SDP issued by OIG in April 2013 Supersedes previous protocol issued in 1998 and Open Letters 2
OIG Self-Disclosure Protocol 2013 Updated SDP Contains Significant Changes: Available for: Providers seeking to disclose potential violations of federal criminal, civil or administrative laws for which exclusion or CMPs are authorized Not available for: Overpayments or errors Stark law violations Requirements for disclosure under SDP Must acknowledge conduct is a potential violation and explicitly identify the laws that were potentially violated Waive statute of limitations Ensure that corrective actions are implemented and misconduct has stopped Must complete internal investigation within 90 days of submission (no longer 90 days from acceptance) Avoid CIA and typical multiplier of 1.5 applied to single damages Acceptance into protocol suspends obligation to return overpayment OIG Self-Disclosure Protocol Mechanics of Disclosure: 11 categories of information, including: Concise statement of details of misconduct Statement regarding laws potentially violated Description of corrective action Estimation of damages Conduct specific information for: False billing Excluded parties Violations of AKS and Stark 3
CMS Self-Referral Disclosure Protocol Section 6409 of the ACA Required HHS to establish protocol to enable providers to disclose actual or potential Stark violations Authorized HHS to reduce the amounts owed for Stark violations based upon: Nature and extent of the improper or illegal practice Timeliness of the self-disclosure Cooperation in providing additional information Other relevant factors CMS Voluntary Self-Referral Disclosure Protocol issued on September 23, 2010 CMS Self-Referral Disclosure Protocol Under the SRDP, each disclosure must contain: Description of actual or potential violations & legal analysis Financial analysis Certification Submission of a disclosure suspends ACA obligation to return overpayment until settlement or withdrawal of disclosure SRDP may not be used to obtain determination from CMS whether Stark violation occurred 4
CMS Self-Referral Disclosure Protocol Congressional Report to Congress March 2012 150 self-referral disclosures under SRDP by 148 providers 125 hospitals; 11 clinical labs; 8 physician practice groups Most commonly reported violations: Personal service arrangement exception Fair market value Space rentals, physician recruitment, non-monetary compensation Through September 2013, 320 provider disclosures under SRDP: 35 providers (32 hospitals) have settled cases for a total of $3.7 million and averaging > $100,000 per settlement Disclosure to U.S. Attorney or U.S. Department of Justice False Claims Act, 31 U.S.C. 3729 Prohibits knowingly presenting or causing presentment of false claims for payment to United States Prohibits knowing retention of any overpayment PPACA requires return of overpayments within 60 days FCA liability often turns on whether provider had requisite knowledge Actual knowledge Reckless disregard 5
Disclosure to U.S. Attorney/ U.S. Department of Justice Consideration of whether to self-disclose to DOJ: What is the likelihood an FCA violation has occurred only DOJ can release FCA liability Was the conduct a mere mistake, or reckless? Prepare for full and complete disclosure Has the conduct at issue ceased? Can the provider quantify potential FCA damages? Negotiating the Settlement Defining Covered Conduct Arriving at settlement amount Disclosure to U.S. Attorney/ U.S. Department of Justice April 3, 2013 Intermountain Health Care Inc. Pays U.S. $25.5 Million to Settle False Claims Act Allegations Intermountain Health Care Inc. has agreed to pay the United States $25.5 million to settle claims that it violated the Stark Statute and the False Claims Act by engaging in improper financial relationships with referring physicians, the Justice Department announced today. Intermountain operates the largest health system in the state of Utah. The Stark Statute restricts the financial relationships that hospitals may have with doctors who refer patients to them. The relationships at issue in this matter that the United States alleged were prohibited by the Stark Statute included employment agreements under which the physicians received bonuses that improperly took into account the value of some of their patient referrals; and office leases and compensation arrangements between Intermountain and referring physicians that violated other requirements of the Stark Statute. These issues were disclosed to the government by Intermountain. 6
Disclosure to U.S. Attorney/ U.S. Department of Justice June 29, 2012 Maury Regional Hospital to Pay $3.59 Million to Settle False Claims Act Allegations Maury Regional Medical Center, has agreed to pay the United States $3,594,451.90 to settle False Claims Act allegations, announced Jerry E. Martin, U.S. Attorney for the Middle District of Tennessee. Maury Regional submitted a voluntary self-disclosure to the U.S. Attorney s Office and the Office of Inspector General for the Department of Health and Human Services. The self-disclosure, discovered by the hospital s compliance program, prompted an investigation into the hospital s billing for ambulance transport as part of its emergency medical services. Maury Regional is to be commended for the manner in which the hospital handled the disclosure of these billing issues once the issues came to light through the hospital s compliance program, said U.S. Attorney Jerry E. Martin. After notifying this office that the billing issues had been discovered, Maury Regional outlined its plan to determine the scope of these issues, followed through on that plan, and worked closely with us to bring this matter to resolution. Self-disclosure by providers is critical to the protection of the integrity of the federal health care system and this office is committed to bringing voluntary disclosures to resolution as quickly and as efficiently as is reasonably possible. MRMC Self-Disclosure Routine monitoring of ADR s and denial activity by the Compliance Department identified potential EMS billing problems. Billing was done by an expert 3rd party biller who received a percentage of the payments received. Engaged an outside consultant. Probe audit results noted an unacceptable number of errors mostly related to poor documentation by the ambulance crews. Medical necessity not documented, missing signatures, missing physician certifications, coding errors (ALS vs. BLS). 7
MRMC Self-Disclosure After reviewing the audit results and consulting with legal counsel, management decided to contact the U.S. Attorney s Office: Engaged experienced outside counsel; Terminated relationship with billing company; Engaged outside consultants; Brought billing in-house; Conducted training and education for crews and billing personnel; and Began formulating self-disclosure plan/process. MRMC Self-Disclosure Met with U.S. Attorney/Assistant U.S. Attorney seeking approval of self-disclosure audit plan. Disclosure would head off potential qui tamlawsuits and toll the 60-day repayment requirement. Covered 2004 through 2009. A statistically valid random sample of 100 Medicare claims would be pulled for each year using the RATSTAT software. Results would be extrapolated to the universe of Medicare claims for each year in question. 8
MRMC Self-Disclosure Audit plan was approved and we proceeded with the sample selection and review of 2009 claims. The results of the 2009 audit were presented to OIG/DOJ and a time-out was taken so that OIG could verify the accuracy and completeness of the 2009 audit. Our ZPIC (Advance-Med) reviewed a sample of 20 of the 100 claims included in our 2009 audit. Once the accuracy and completeness of the 2009 audit was verified by the OIG, we were allowed to proceed with auditing the other years in question (2008-2004). The further we went back in time, the more difficult it became to locate and produce medical records due to system changes, change in billing company, and other factors. MRMC Self-Disclosure In order to complete the review in a timely manner, we were authorized to extrapolate our 2005 results to 2004 due to the difficulty in locating all relevant documentation from 2004. In addition, a second, much smaller satellite facility was included in the self-disclosure (Wayne County EMS). A single stratified sample of 180 claims (30 per year) was reviewed and extrapolated for this facility. Mutually agreeable settlements were negotiated for each facility (Maury EMS and Wayne EMS). U.S. Attorney s Office was fair, and willing to accommodate reasonable requests to changes in our audit plan, as was the case with Wayne County EMS and MRH for 2004. 9
MRMC Corrective Action and Commitment to Compliance In order to ensure future compliance MRMC continues to: Perform EMS billing in-house; Have outside consultants conduct 30 record probe samples every six months for both facilities; and Implement training and education as needed after each semiannual audit. In addition, we have implemented a thorough pre-submission claim review process using documentation checklists plus the knowledge and experience that our EMS billing supervisor gained throughout this process. Summary Entire process lasted almost 2 yearsfrom the initial probe audit until the signing of the settlement agreements. Difficult and time consuming project, but it was the right thing to do! MRMC CEO never hesitated to do the right thing and provided encouragement and support throughout the process. MRMC was the first voluntary self-disclosure in the Middle District of Tennessee in recent memory. MRMC obtained release and settlement of FCA liability: Released MRMC from civil or administrative monetary claims. Released MRMC from any administrative action seeking exclusion. PROTECTION FROM WHISTLEBLOWERS! Received some consideration for the cost of legal fees and consulting fees incurred as a result of the disclosure. 10