American Bar Association Washington Health Law Summit Self-Disclosure: Why, When, Where and How December 8, 2015 Margaret Hutchinson U.S. Attorney s Office for the Eastern District of Pennsylvania Kaitlyn Dunn HHS Office of the Inspector General Matthew Edgar CMS Center for Medicare Management Linda Baumann Arent Fox, LLP 12567843.1
OVERVIEW The DOJ Perspective: Self Disclosure, the False Claims Act and the 60 Day Rule The OIG Self-Disclosure Protocol The CMS Self-Referral Disclosure Protocol Discussion and Questions 2
What Is The Act? The False Claims Act imposes liability on one who: Knowingly presents or causes to be presented a false or fraudulent claim for payment or approval o 3729 (a)(1)(a) Knowingly makes, uses or causes to be made or used, a false record or statement material to a false or fraudulent claim o 3729 (a)(1)(b) Knowingly and Improperly avoids or decreases an obligation to pay or transmit money or property to the US o 3729 (a)(1)(g) 3
What Is A Claim? Definition: Any request or demand, whether under a contract or otherwise, for money or property whether or not the US has title to it if it is presented to the US or is presented to a contractor etc. if it is to be spent on the Government's behalf 31 U.S.C. 3729(b)(2) This remedial statute reaches beyond claims which might legally be enforced, to all fraudulent attempts to cause the Government to pay out sums of money. Neifert-White Co., 390 US 228 (1968) 4
What Is An "Obligation"? Definition: An established duty, whether or not fixed, arising from an express or implied contractual, grantor-grantee or licensorlicensee relationship... or from the retention of any overpayment. 31 U.S.C. 3729 (b)(3) 5
What Makes a Claim False? Knowingly: has actual knowledge of the information, OR acts in deliberate ignorance of the truth or falsity, OR acts in reckless disregard of the truth or falsity No specific proof of intent to defraud is required o 3729 (b)(l) 6
Obligation and the FCA 42 U.S.C. 1320a-7k(d)(1)-(3): The 60 day rule Retaining an identified overpayment beyond 60 days constitutes an obligation under the FCA 7
Overpayment Improper retention of an overpayment leads to False Claims Act liability Increase in voluntary disclosures to USAO community regarding overpayments 8
OIG Provider Self- Disclosure Protocol (SDP) 9
SDP History Originally issued in October 1998 Updated in April 2013 with the goals of: Increasing transparency Setting clear guidelines and expectations Simplifying process by addressing common issues Consolidating previous guidance 10
Matters Appropriate for SDP Instances of potential fraud involving Federal health care programs (as defined in 42 U.S.C. 1320a-7b(f)) All providers subject to 42 C.F.R. Part 1003 may use Cases resolved under the Civil Monetary Penalties Law, 42 U.S.C. 1320a-7a, and Exclusion Statute, 42 U.S.C. 1320a-7(b)(7) Have to acknowledge potential liability; no admission necessary 11
Matters Ineligible for SDP Overpayments, errors, or negligence Should be resolved with the contractor Requests for an opinion on whether a potential violation has occurred Request advisory opinion from Industry Guidance Branch Stark Law - only matters Must be submitted to CMS through the Self-Referral Disclosure Protocol OIG can resolve if colorable violation of the Anti-Kickback Statute ( AKS ) 42 U.S.C. 1320a-7b(b) 12
SDP Benefits Lower multiplier (1.5) Presumption of no CIA Timely resolution Avoid government-initiated investigation May mitigate 60-day rule liability 13
Content of Submission 11 elements, plus case-specific information depending on type of conduct False billing Employment of excluded persons Arrangements implicating the AKS and Stark Law Allowed initial submission and one supplement Investigation must be completed and estimation of damages provided w/in 90 days 14
Other Considerations Minimum settlement amounts False billing or employment of excluded person = $10,000 AKS / Stark violation = $50,000 Coordination with DOJ on submissions Ability to pay should be raised early on, and financial disclosures will be required Full cooperation expected 15
CMS VOLUNTARY SELF- REFERRAL DISCLOSURE PROTOCOL (SRDP) 16
SRDP Legislative Background Section 6402 of the Affordable Care Act Obligation to report and return overpayments by the later of o o 60 days after the overpayment is identified, or The date any corresponding cost report is due, if applicable When a provider submits a disclosure under the SRDP, the 60-day report and return obligation is suspended until a settlement is entered, the provider withdraws from the SRDP, or CMS removes the provider from the SRDP 17
SRDP Legislative Background Section 6409 of the Affordable Care Act SRDP enables health care providers of services and suppliers to disclose an actual or potential violation of section 1877 of the Social Security Act. Authorizes the Secretary to reduce the amount due and owing for violations of section 1877 of the Act. In reducing the amount due and owing, the Secretary may consider: o o o o The nature and extent of the improper or illegal practice The timeliness of such self-disclosure Cooperation in providing additional information Other factors the Secretary deems appropriate 18
Instructions for submission Physician Self-referral Disclosure Protocol Instructions (Revised Dec. 22, 2014), available on the CMS website Description of actual or potential violation(s) Financial analysis of amount potentially due and owing Note the special instructions for failure of a physicianowned hospital to disclose physician ownership in public websites and advertisements. 19
SRDP FAQs Reopening rules and the look back period Period of noncompliance: The disclosing party must specify the duration of any period of noncompliance, even when the period of noncompliance exceeds the time frame established for reopening determinations under 42 CFR 405.980(b). Financial analysis: The financial analysis need only set forth the total amount actually or potentially due and owing for claims improperly submitted and paid within the time frame established for reopening determinations at 42 C.F.R. 405.980(b). Scope of release under SRDP: Release of overpayment liability under 1877(g)(1) ONLY No release of CMPs under 1877(g)(3) or 1877(g)(4) No FCA release No release for violations of the anti-kickback statute SRDP FAQs available on CMS website 20
2015 Physician Self-referral Updates May Reduce Self-Disclosures [A] collection of documents, including contemporaneous documents evidencing the course of conduct between the parties, may satisfy the writing requirement of the leasing exceptions and other exceptions that require that an arrangement be set out in writing. 80 Fed. Reg. 70886, 71315. Standard: [T]he relevant inquiry is whether the available contemporaneous documents (that is, documents that are contemporaneous with the arrangement) would permit a reasonable person to verify compliance with the applicable exception at the time that a referral is made. Id. Clarification of existing policy: Parties considering submitting selfdisclosures to the SRDP for conduct that predates the proposed rule may rely on guidance provided in the proposed rule to determine whether the party complied with the writing requirement of an applicable exception. Id. 21
DISCUSSION/QUESTIONS 22
SPEAKERS Margaret L. Hutchinson Margaret L. Hutchinson, Chief of the Civil Division of the U.S. Attorney's Office for the Eastern District of Pennsylvania, supervises all civil affirmative and defensive litigation, including Title VII, tort, environmental and fraud cases. Ms. Hutchinson has prosecuted health care fraud related to teaching hospitals, partial hospitalization programs, Medicare secondary payment issues, HMO credentialing, pharmaceutical pricing, off label promotion of drugs and quality of care concerns. She is a frequent lecturer and teaches Health Care Fraud at Drexel University Law School and Villanova University Law School. She received the Attorney General's award for her work in fighting fraud and the Director's award from the Executive Office of US Attorneys for her service as an Assistant US Attorney. Kaitlyn Dunn Kaitlyn Dunn serves as Associate Counsel in the Administrative and Civil Remedies Branch, Office of Counsel to the Inspector General, U.S. Department of Health and Human Services. During her time at the OIG, Kaitlyn has worked extensively with the Department of Justice and U.S. Attorney's Offices around the country to resolve civil False Claims Act matters. Kaitlyn has negotiated and monitored several Corporate Integrity Agreements. She also litigates exclusion appeals and pursues affirmative cases under the OIG's Civil Monetary Penalties Law. Kaitlyn earned her B.A. from Syracuse University, her J.D. from Northeastern University School of Law, and her M.P.H. from Tufts University School of Medicine. 23
SPEAKERS Matt Edgar Matt Edgar is a Health Insurance Specialist in the Division of Technical Payment Policy at the Centers for Medicare & Medicaid Services (CMS) within the U.S. Department of Health and Human Services. His primary focus is the physician self-referral (Stark) law. Mr. Edgar drafts regulations and advisory opinions; analyzes submissions to the CMS Voluntary Self-Referral Disclosure Protocol (SRDP); and works on reforming the SRDP to improve and streamline the process. Before joining CMS, Mr. Edgar was a litigation associate at Hughes Hubbard & Reed. He graduated cum laude from Georgetown University Law Center in 2010. Linda Baumann Linda Baumann is a partner at Arent Fox LLP and heads the Washington, DC office of the Health Care Group. She concentrates her health law practice on matters involving fraud and abuse, government and internal investigations, compliance, and Medicare/Medicaid reimbursement. She counsels clients nationwide on False Claims Act cases, the Stark Law, the Anti-Kickback Statute and regulatory compliance. She also has helped clients submit various types of self-disclosures. Ms. Baumann is the former Chair of the ABA Health Law Section and the Editor in Chief of Health Care Fraud and Abuse: Practical Perspectives (3rd ed. 2013). She received her J.D. from Columbia University Law School and her B.A. from Brown University. 24