Federal Administrative Sanctions

Transcription

1 FEDERAL AND STATE ADMINISTRATIVE SANCTIONS HCCA COMPLIANCE INSTITUTE April 23, 2007 Chicago, IL Edgar D. Bueno Pillsbury Winthrop Shaw Pittman LLP John W. O Brien Office of Counsel to the Inspector General U.S. Department of Health & Human Services Exclusion Federal Administrative Sanctions Civil Monetary Penalties Law Other Administrative Sanctions

2 Exclusions 42 USC 1320a-7; Section 1128 of SSA (42 CFR Part 1001 ) Mandatory Exclusion (1) Conviction for a Medicare or Medicaid Related Criminal Offense (2) Conviction Related to Neglect or Abuse of a Patient (3) Felony Conviction Related to Fraud, Theft, Embezzlement, Breach of Fiduciary Responsibility, or Other Financial Misconduct (4) Felony Conviction Relating to the Unlawful Manufacture, Distribution, Prescription, or Dispensing of a Controlled Substance (5) One or More Convictions Subject to Mandatory Exclusion (6) Failure to Repay Health Education Assistance Loans (HEAL) (42 USC 1395ccc) Exclusions Permissive Exclusion (1) Misdemeanor Conviction Related to Fraud (may include private health insurance) (2) License Revocation or Suspension (3) Conviction Relating to Obstruction of an Investigation (4) Misdemeanor Conviction Relating to the Unlawful Manufacture, Distribution, Prescription, or Dispensing of a Controlled Substance The Underlying Basis Cannot Be Attacked

3 Exclusions Affirmative Exclusions OIG has to Prove All Elements of the Underlying Offense 42 USC 1320a-7(b)(7) For Fraud, Kickback, and Other Prohibited Activities Case Example - Dr. C plead guilty to offense that did not trigger mandatory exclusion, but the OIG pursued an exclusion under 1128(b)(7) permissive authority Exclusions The Effect of Exclusion No payment will be made by any Federal health care program for any items or services furnished, ordered, or prescribed by an excluded individual or entity. Federal health care programs include Medicare, Medicaid, and all other plans and programs that provide health benefits funded directly or indirectly by the United States (other than the Federal Employees Health Benefits Plan). This payment prohibition applies to the excluded person, anyone who employs or contracts with the excluded person, any hospital or other provider where the excluded person provides services, and anyone else. The exclusion applies regardless of who submits the claims and applies to all administrative and management services furnished by the excluded person. OIG Special Advisory Bulletin (Sept. 1999)

4 Exclusions The Duration of Exclusion If Mandatory Minimum 5 years If Permissive Minimum 1 to 3 years Adjustments Based on Aggravating and Mitigating Factors Set Forth by Regulations Exclusions Required Notice and Appeal Rights Waiver of Exclusion Reinstatement (Not Automatic) Person or Entity that Submits Claims During Exclusion Is Subject to Civil Penalties, Criminal Liability, and Extension of Exclusion (or Denial or Reinstatement)

5 Civil Monetary Penalties Law (CMPL) Overview 42 USC 1320a-7a and Section 1128A of SSA Affirmative cases initiated by OIG Alternative to civil action (e.g., FCA) Initiate as authorized by DOJ Forum: ALJ -> DAB -> Fed. Cir. Burden of proof: preponderance of evidence Intent: generally knows or should know Remedies Exclusion CMPs up to $50K per violation depending on nature of violation Assessments/damages generally 3X amount claimed CMPL Overview: Broad Range of Proscribed Conduct False or fraudulent claims Items/services not provided as claimed Pattern of medically unnecessary services Excluded person billing Employer of excluded person billing

6 CMPL Overview: Broad Range of Proscribed Conduct (cont.) Violations of Federal Anti-Kickback Statute Violations of the Stark Law Violations of assignment agreement (charging benes in excess of coinsurance amounts) CMPL Overview: Factors Favoring CMPL Cases No other explicit remedy Anti-Kickback Statute (AKS) violation Exclusion sought 3 X Amount Claimed + Assessments No need to prove damages for AKS violations Jury appeal issues

7 CMP Enforcement Trends: Recoveries FY Year # Cases Total (M) $ $ $ $ $12.9 CMPL Enforcement Trends: AKS and Stark Recoveries Year # Cases Total $391K $561K $2.2M $741K $10.9M $11.3M

8 Lincare: The Facts Lincare marketed to existing and potential referral sources by giving them: Sporting and entertainment event tickets Gift certificates Meals Rounds of golf Golf equipment Fishing trips Advertising costs and practice promotional materials Medical equipment: O2 tanks, neb kits, medications, office table, stools, scale Lincare: The Facts Expense reports contained the freebies thank you for referrals word referral no longer used, but marketing freebies continued Lincare tracked referrals from physicians Tracking info appended to expense reports to justify approval

9 Lincare: Proof of Knowledge October 1996: Lincare settles AKS allegations with DOJ/OIG for $1M 1997: Lincare implements a compliance program Compliance Program Manual kickbacks include: Offering or giving valuable property, equipment or services, gifts, or other benefits to a person in exchange for the referral of patients to Lincare Offering or giving anything of value to induce someone to buy or rent a Lincare product, item or service Expense report exception list forbids giving presents to physicians and/or their families and season tickets to sporting events Compliance video depicts DME supplier jailed for providing free basketball tickets to a physician in exchange for referrals Expense reports containing prohibited expenses (e.g., tickets) reviewed and approved by Corporate Compliance Officer As part of compliance training, CCO directed sales reps not to use words like thank you for referrals on expense reports Lincare: Evidence Compliance Program documents Expense reports Some with thank you for referrals Some with referral info included Some approved by CCO/VP Same physicians, month after month, receiving freebies Freebies sometimes went to physician family members Testimony Physicians Former sales reps Former CCO and compliance staff

10 Lincare s Settlement with OIG Settled in May 2006 $10 million Largest ever administrative (OIG) CMP settlement Eclipses 2005 s $6 million PharMerica settlement (also based on AKS violation) 5 year CIA AKS and Stark policies/procedures Lincare to track in database all freebies given to referral sources IRO to review Lincare s tracking Drs. G and J: Settlement Largest Lincare referral source in geographical area September 1999: Drs. G and J each received 4 Miami Dolphins Tickets valued at $ : Drs. G and J received $15K and $7K in free gifts meals and tickets - from Lincare Evidence Lincare document - excellent referral source; gets anything and everything at no charge Gifts violated Lincare s own policies Former Lincare sales rep testified that everybody knew that the gifts were illegal and purpose was to reward Drs. G and J for referrals Settled in February 2006 Dr. G: $65K Dr. J: $57K 3 year Integrity Agreement with OIG

11 Other Civil Administrative Sanctions OIG Civil Monetary Penalties for: EMTALA Violations Violations of Requirements for Possession, Use and Transfer of Select Agents and Toxins Misuse of Names and Symbols Suspension, Offset and Recoupment (CMS) Program Fraud Civil Remedies Act of 1986 (PFCRA) State Issues and Other Collateral Consequences Disclosure Obligations Disciplinary Proceedings Under State Law for Licensed Individuals Status with Managed Care Organizations Medical Staff Requirements

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