The OIG s Approach to CMP Cases

Transcription

1 The OIG s Approach to CMP Cases HCCA Compliance Audio Conference March 28, 2006 Arthur S. Di Dio, M.D., J.D. Administrative and Civil Remedies Branch Office of Inspector General - HHS Howard J. Young, Esq. Sonnenschein Nath & Rosenthal LLP Agenda Intro to ACRB CMPL Overview Administrative enforcement trends Recent developments/settlements CMP Defense Observations Defenses in CMPL cases Settlement strategies 2 1

2 Administrative and Civil Remedies Branch Administrative component of govt global health care fraud enforcement Administrative remedies (exclusion and CMPs) Prospective protection for Federal health care programs (i.e., exclusion or CIA) Statutory authorities: Exclusion (Section 1128) and CMPL (Section 1128A) OIG generally party to all FCA settlements (resolve administrative liability with FCA liability) 3 Exclusion Overview: Section 1128 of the SSA Affirmative cases initiated by OIG/ACRB Addition to civil action No DOJ authorization necessary Forum: ALJ -> DAB -> Fed. D.C. Burden of proof: preponderance of evidence Single remedy: exclusion (no monetary remedy) 15 bases mostly derivative Section 1128(b)(7): Fraud, kickbacks, and other prohibited activities Intent: generally knows or should know 4 2

3 CMPL Overview: Section 1128A of the SSA Affirmative cases initiated by OIG/ACRB Alternative to civil action (i.e., FCA) Initiate as authorized by DOJ Forum: ALJ-> DAB -> Fed. Cir. Burden of proof: preponderance of evidence Intent: generally knows or should know Remedies: May seek exclusion in nearly all CMPL cases CMPs up to $50K per violation depending on nature Assessments/damages generally 3X amount claimed 5 CMPL Overview: Broad Range of Prohibited Conduct False or fraudulent claims Items/services not provided as claimed Pattern of medically unnecessary services Excluded person billing Employer of excluded person billing Violations of Federal Anti-kickback Statute Violations of Stark Law Patient dumping (EMTALA) Misuses of names or symbols Etc. 6 3

4 Factors Favoring Administrative Enforcement Conduct for which explicit remedy exists under CMPL Anti-kickback Statute violation Stark Law violation Billing while excluded NB: FCA also remedy just not explicit OIG seeks exclusion Provider may have little incentive to settle FCA liability in case where OIG seeks exclusion CMPL case allows govt to address monetary and exclusion remedies/sanctions in single proceeding 7 Factors Favoring Administrative Enforcement Part 2 Limited jury appeal, e.g., no allegation of Unnecessary services Services not provided Substandard care Damages issues CMPL damages based on amounts claimed not reimbursed e.g., managed care case, prospective payment method of reimbursement Practical considerations, e.g., Resources Amount at issue 8 4

5 CMPL Enforcement Trends 2001 through 2005 Number of cases steady (30 49) Includes affirmative and self-disclosure cases Annual recovery dramatic increase $1.1 M in 2001 $12.9 M in 2005 Expect trend to continue in 2006 Increase selectivity better/stronger/bigger cases Anti-kickback Statute and Stark Law cases account for majority of increase 9 Drs. G and J: Settlement : Drs. G and J received $15K and $7K in free gifts from DME supplier Gifts: meals, professional sports tickets, gift certificates Largest referral source in geographical area for particular supplier Purpose: reward for referrals Evidence Documentary: Supplier record excellent referral source; gets anything and everything at no charge Gifts violated supplier s own policies Witness testimony: former supplier employee everybody knew purpose was to reward for referrals 10 5

6 Drs. G and J: Settlement Settled in February 2006 Monetary component Dr. G: $65K Dr. J: $57K 3 year Integrity Agreement Focus on Anti-kickback Statute violations Relationships with referral sources 11 Dr. Ron H. Ruff: Settlement Member of Oregon Anesthesiology Group (OAG) OAG self-disclosed that Dr. Ruff Recorded early (false) anesthesia start times Left anesthesia/or to perform pain management services OAG submitted internal audit results to OIG 12 6

7 Dr. Ron H. Ruff: Settlement Settled in December 2005 OAG $130K 3 year Certification Agreement Dr. Ruff $50K 5 year Integrity Agreement 13 CMPL Settlements Generally 2 components Monetary Basis generally not explained in Settlement Agreements Integrity requirements In exchange for section 1128(b)(7) release Scope of release -? FCA release No admission of liability standard provision Settlement documents available Settlement Agreements FOIA-ble CIAson OIG website 14 7

8 Defenses to CMPL Case Same as for FCA or AKS/Stark cases FCA defenses Claim not false Falsity not material to payment Not knowing AKS Violation not knowing and willful Purpose not to induce referrals Stark Not knowing Met an exception (e.g., was FMV) Insufficient regulatory guidance 15 Settlement Strategies Does OIG settle for doubles or rule of thumb in CMPL cases? Damages in AKS case may not be primary measure Try to resolve CMPL and exclusion authorities concurrently CMPL cases often involve individuals and smaller companies exclusion more viable in such cases Certain CMPL offenses are not excludable Are integrity agreements any different in CMPL case versus FCA case? No, but may be different on account of selfdisclosure 16 8

9 The OIG s Approach to CMP Cases The End Q&A 17 9