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An Update on Government Enforcement Actions from the OIG HCCA - Southwest Regional Annual Conference February 21, 2014 Karen Glassman, Senior Counsel Office of Counsel to the Inspector General What is the HHS OIG? One of many operating divisions of the U.S. Department of Health and Human Services (HHS) (OIG) focuses on preventing and detecting fraud and abuse in HHS programs 2 1

Relevant components of OIG Office of Evaluation and Inspections Office of Audit Services Reports of both components are on OIG website: oig.hhs.gov Office of Investigations Investigative agents Office of Counsel to the Inspector General (OCIG) 3 OCIG OIG Attorneys - Internal and External Exclusions/Civil Monetary Penalties/Corporate Integrity Agreements False Claims Act Support 4 2

Numbers FY 2013 National $5.8 billion expected recoveries CY 2013 Dallas Region $677,768,026 expected recoveries OIG Statistics OIG Action FY09 FY10 FY11 FY12 FY13 Total Criminal Actions 671 647 723 778 960 3,779 Civil Actions 394 378 382 367 472 1,993 Exclusions 2,556 3,340 2,662 3,131 3,214 14,903 6 3

7 Notable Recent Civil Cases in the Region Global Medical Dallas County Hospital District d/b/a Parkland Health and Hospital System LifePoint Hospitals Baptist Health System Saint Anthony Hospital 8 4

OIG Administrative Sanctions OIG Exclusion Authority 1128 of the Social Security Act Civil Monetary Penalties Law (CMP) 1128A of the Social Security Act 9 Types of Exclusions There are two types of exclusions: 1. Mandatory 2. Permissive 10 5

Mandatory Exclusions No OIG discretion shall exclude Four authorities Section 1128(a) of the Social Security Act 1. conviction of federal health care program-related crime 2. conviction relating to patient abuse or neglect 3. felony conviction relating to health care fraud 4. felony conviction relating to controlled substances 5-year mandatory minimum with possible adjustment upward based on factors at 42 C.F.R. 1001.102(b) and related mitigating factors at 42 C.F.R. 1001.102(c) Conviction includes certain arrangements that might not be considered convictions under state law (i.e., deferred adjudication, first offender programs, and other cases when the judgment of conviction is withheld) Process 42 C.F.R. 1001.2001 2007 11 Permissive Exclusion Section 1128(b) of the Social Security Act OIG has discretion may exclude 16 authorities Term of exclusion varies based on grounds for permissive exclusion 12 6

Permissive Exclusion Section 1128(b) of the Social Security Act Misdemeanor convictions (b)(1) and (3) responsible corporate officer doctrine Fraud and kickbacks (b)(7) FCA Cases, CMP cases CIA, Exclusion Agreement, Reservation Loss of license (b)(4) most by volume professional competence, performance, financial integrity length of exclusion and reinstatement Quality of care (b)(6)(b) furnished items or services substantially in excess of the needs of the patients or failed to meet professionally recognized standards of care 13 Most Common Exclusions License revocation or suspension (1128(b)(4)) - 23,983 Program-related conviction (1128(a)(1)) - 13,604 Patient abuse or neglect (1128(a)(2)) - 5,489 Felony health care (non-medicare/medicaid) fraud conviction (1128(a)(3)) - 2,665 Health Education Assistance Loan default (1128(b)(14)) - 2,304 Felony controlled substance conviction (1128(a)(4)) - 2,075 14 7

Effect of Exclusion No Federal health care program payment may be made for items or services: Furnished by an excluded individual or entity Directed or prescribed by an excluded individual, where person furnishing the item or service knew or had reason to know of the exclusion Applies to indirect providers 15 NEW Special Advisory Bulletin on the Effect of Exclusion Liability Excluded individual: CMP, criminal liability Employ/contract with excluded individual: CMP liability All Federal health care funds Goes beyond direct patient care. Examples: Preparation of surgical trays in a hospital Person inputting prescription information for pharmacy billing Transportation services ambulance company Administrative and management services Ownership issues Section 1128(b)(8) of the Social Security Act 16 8

Clarifications in Bulletin An excluded provider can refer a patient to a non-excluded provider so long as the excluded provider does not order any service and the non-excluded provider bills independently Can be liable under the CMP for contract employees Example: Staffing agency and excluded nurse 17 Bulletin Screening Guidance Check the LEIE not other debarment lists Check before hire and monthly Check all names + confirm with SSN or EIN Keep records Talk to staffing agencies about checks 18 9

Billing while excluded Kickbacks Physician self-referral ( Stark ) violations False or fraudulent claims Select agents Patient dumping (EMTALA) CMP Case Types About 40 other OIG CMPs 42 C.F.R. 1003.102 catalogues available CMPs 42 C.F.R. 1003.103 catalogues the amount of penalty and assessment available for each CMP 19 CMP Type: Excluded Person Section 1128A(a)(6) of the Social Security Act cannot arrange or contract with an individual or entity you know or should know is excluded for the provision of items or services paid for by Federal health care programs assessment of 3 times amount claimed and penalties of up to $10,000 per item or service Regional Case Examples Conroe Healthcare - $145,000 Mercy Clinic Oklahoma Communities - $51,000 Valley View Regional Hospital - $44,000 20 10

CMP Type: Kickbacks Section 1128A(a)(7) of the Social Security Act anyone who commits an act described in the Anti-Kickback Statute penalty of $50,000 per act + 3 times total remuneration Examples Henry Schein settlement - $1.3 million United Shockwave settlement - $7,359,500 ForTec Medical settlement - $126,000 21 CMP Type: False or Fraudulent Claims Section 1128A(a)(1) of the Social Security Act knowingly presenting or causing to be presented false or fraudulent claims $10,000 penalty per item/service + 3 times amount claimed Regional Case Examples Humana Inc. - $1.8 million Seton Family of Hospitals d/b/a Towers Nursing - $1.14 million North Arkansas Regional Medical Center - $395,000 City of El Paso - $1.16 million 22 11

Key CMP Points Standard of proof: preponderance of the evidence Respondent has the burden to prove any mitigating factors and affirmative defenses Six-year statute of limitations CMPL is most often used by OIG as an alternative to civil action under the False Claims Act 23 More Key CMP Points Penalties, assessments, and exclusion available for most CMP cases Administrative Law Judge proceeding/hearing, 42 U.S.C. 1320a-7a(c)(2) Not bound by Federal Rules of Evidence Hearsay admissible Statistical sampling may be used 24 12

CMP Referrals Hotline referrals Patients Employees Competitors Letters of referral from the public Data mining Audit, inspection, or investigation Spin-offs from other criminal and civil investigations 25 Coordinated Enforcement Efforts- Data Mining CMS Opened Program Integrity Command Center in Baltimore $3.6 million facility to help detect and prevent overpayments and fraud Fraud Prevention System Computer program that uses predictive analytics to identify and prevent improper claims. In first year, stopped, prevented or identified $115 million in fraudulent payments. Flags from the system helped to initiate 536 new investigations. 13

Coordinated Enforcement Efforts- Data Mining OIG component collaboration Case Examples Employment of Excluded Individuals Urine Drug Testing 27 Self-Disclosure New Guidance issued in 2013 Lower multiplier No integrity obligations Tolling of 60-day rule Shorter resolution 28 14

OIG Self-Disclosures Average Time in Protocol 19 months 2008 13 months 2010 10 months 2013 29 OIG Outreach Website: oig.hhs.gov Follow us: @OIGatHHS 15

Thank you. Karen Glassman, Senior Counsel Office of Counsel to the Inspector General U.S. Department of Health and Human Services karen.glassman@oig.hhs.gov Phone: (214) 767-8469 31 16