Exclusion from Participation in Federal Health Care Program s

1. Exclusion from Participation in Federal Health Care Programs TAANA 33rd Annual Meeting – Post Conference Seminar October 11, 2014 – Las Vegas, NV Judy Ringholz, RN,JD,CHC Vice President, Internal Audit and Compliance Services

2. OIG Exclusion Program • Purpose: “For many years, the Congress of the United States has worked diligently to protect the health and welfare of the nation's elderly and poor by implementing legislation to prevent certain individuals and businesses from participating in Federally funded health care programs.”

3. OIG has EXCLUSIVE Authority • The OIG has the exclusive authority to exclude individuals and entities from participation in Medicare, Medicaid and ALL other Federal health care programs. • Medicare • Medicaid • Children’s Health Insurance Program (CHIP) • Tricare • Veterans’ Health Administration • Indian Health Services • FHCPs pay for health care services for about one-third of Americans

4. Federal Health Care Programs • In 2013, Medicare, Medicaid and the Children’s Health Insurance Program (CHIP), together, spent $772 billion. • Nearly two-thirds of this amount or $498 billion was paid by Medicare. • Covers 54M people (> 65 or disabled) • Medicaid and CHIP cover 70M low-income children, parents, elderly, and disabled. Both require states to match.

5. The Impact of Fraud • No one knows for certain. • Medicare fraud costs taxpayers an estimated $60 billion to $90 billion each year (approximately 20%). • Medicaid – Estimated to be the same

6. Early Statutory Background • In 1977, Congress first mandated the exclusion of physicians and other practitioners convicted of program-related crimes from participation in Medicare and Medicaid (now codified at section 1128 of the Act). • HHS began implementing exclusions. • OIG has been implementing exclusions since 1981.

7. Under Congressional mandate, the OIG: • Established a program to exclude individuals and entities. • Described in sections 1128 and 1156 of the Social Security Act (the Act). • Maintains a list of currently excluded parties called the List of Excluded Individuals/Entities (LEIE) on its website.

8. Special Advisory Bulletins • Original Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs – Issued September 1999 • Updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs – Issued May 2013 • This comprehensive 19-page document replaces and supersedes the original bulletin.

9. What is the effect of exclusion? • No Federal health care program payments may be made for any items or services furnished (directly or indirectly), ordered or prescribed by an excluded individual or entity. • This prohibition extends to payment for administrative and management services not directly related to patient care. • No Federal program payment may be made to cover an excluded individual’s salary, expenses, or fringe benefits, regardless of whether they provide direct patient care.

10. Payment prohibition applies: • to the excluded person, anyone who employs or contracts with him or her, any hospital or other provider where the excluded person provides services, regardless of who submits the claims • to ANY or ALL administrative and management services furnished by the excluded person • e.g., IT services, strategic planning, billing and accounting, staff training, and human resources • continues to apply even if the person changes from one health care profession to another

11. May only employ an excluded individual in limited situations: • The provider pays the individual’s salary, expenses, and fringe benefits exclusively with private funds or from other non-federal funding sources • The services furnished by the excluded individual are rendered only to non-federal program patients

12. May request a waiver if… • Provider is the sole source of specialized services in the community.

13. Conditional Stay of Exclusion • Sometimes considered for 1128(b)(4) cases; • Lost license, usually due to substance abuse; • Individual was working, and wants to continue to work, in a capacity that does not require a license; • Duties typically involve no patient care or highly supervised patient care; • Poses little or no risk to patients or programs.

14. Conditional Stay of Exclusion • Employer wants to continue to employ the individual; • Conditional stay does not terminate the exclusion; • Sets out terms and conditions that the excluded individual agrees to meet; • Individual has no intent to have license reinstated; • Provides employer with assurances that it will not be subject to a CMP for employing the individual.

15. Mandatory Exclusions • Conviction of program-related crime • Conviction relating to patient abuse or neglect • Felony conviction relating to health care fraud • Felony conviction relating to controlled substance THE MINIMUM PERIOD FOR A MANDATORY EXCLUSION IS A PERIOD OF FIVE YEARS. A “no contest” plea and deferred adjudication have the same effect under the law as a guilty plea.

16. Mandatory Exclusions • Conviction of two mandatory exclusion offenses Minimum Period: 10 years • Conviction on 3 or more occasions of mandatory exclusion offenses results in permanent exclusion

17. Permissive Exclusions • Sixteen (16) different types of events could form the basis of a permissive exclusion. Examples include: • Lying on a Federal health care program enrollment application • Certain misdemeanors • Loss of a state license to practice • The period of exclusion is indefinite if based on licensure actions • At least the period imposed by the state licensing authority • Failure to repay health education loans (HEAL loans) • Failure to provide quality care

18. How must employers screen prospective and current employees and contractors? • The OIG maintains the “List of Excluded Individuals and Entities” (LEIE) on its website, and it is updated monthly. • LEIE provides identifying information about excluded persons: • Name • Provider type • State where person resided at time of exclusion • EIN/SSN • The OIG recommends verifying the search results by matching the person’s Employment Identification Number or Social Security Number with the information in LEIE.

19. Screening is required! • Providers and contracting entities have an affirmative duty to check the program exclusion status of individuals and entities prior to entering into employment or contractual relationships. OIG website: www.oig.hhs.gov • Health care providers should also check the LEIE on a regular (monthly) basis to check the exclusion status of current employees and contractors. • Available in both on-line searchable and downloadable formats, this information is updated on a monthly basis.

20. Employers may check the GSA website • In July 2012, GSA migrated its Excluded Parties List System (EPLS) and other systems to the new SAM. SAM is a comprehensive database that Federal agencies can use to determine the eligibility of individuals or entities to participate in their programs. • SAM identifies individuals and entities that have been excluded throughout the U.S. Government from receiving Federal contracts or certain subcontracts and from certain types of Federal financial and non-financial assistance and benefits. (Checking this database, in addition to LEIE, required under CIAs.)

21. Excluded provider employed • Voluntary self-disclosure • *Seek advice of counsel. • Repay any overpayment(s); • Implement corrective actions; • Evaluate policy pertaining to excluded providers, revise if necessary, and provide training as required.

22. Civil Monetary Penalties • The OIG has the authority to impose Civil Money Penalties for violations of the payment prohibition. • Civil Money Penalties up to $10,000 may be imposed for each service or item furnished by an excluded person.

23. Assessments • The OIG has the authority to assess a provider for a violation of the payment prohibition. • Assessments may be up to three times the amount of the claim(s) submitted in violation of the payment prohibition.

24. The Appeal Process • All exclusions implemented by the OIG may be appealed to an HHS Administrative Law Judge (ALJ). • Any adverse decision may be appealed to the Civil Remedies Division (CRD) of the HHS Departmental Appeals Board (DAB). • Judicial review in Federal court is also available after a final decision by the DAB.

25. The Appeal Process • CRD cases are docketed upon receipt of a request for an administrative law judge hearing accompanied by a copy of the notification of adverse action which gave rise to the request. • The party requesting the hearing has the right to appear and participate in a hearing in a suitable location, as determined by the judge.

26. The Appeal Process • Parties may be heard with or without representation. • If a party is represented, the representative should file a written notice of appearance. • A request for hearing filed by a representative will suffice for a notice of appearance.

27. The Appeal Process • The regulations governing appeals of exclusions are found at 42 CFR 1001.2007. • The regulations governing procedures for appeals are found at 42 CFR 1005. • The administrative law judge may add to or modify these procedures.

28. Applying for Reinstatement • Reinstatement is not automatic. • Individual/entity must apply in writing. • Must receive authorized notice from the OIG that reinstatement has been granted.

29. To apply for reinstatement: • Submit a written request to the OIG. • HHS, OIG, OIAttn: ExclusionsP.O. Box 23871Washington, DC 20026(202) 691-2298 (Fax) • Excluded parties may write to the OIG within 120 days of the expiration of the minimum period of exclusion to request reinstatement. • Premature requests will not be considered.

30. Reinstatement Process: • OIG provides Statement and Authorization forms; • Forms must be completed, notarized and returned; • The information will be evaluated and a written notification will be sent indicating the final decision of the OIG.

31. How long does the reinstatement process take? • Generally, this process requires up to 120 days to complete. • However, it can take longer if circumstances warrant.

32. If reinstatement is granted, the OIG will provide: • Written notice to the excluded party specifying the date of reinstatement; • Notice to CMS of date of reinstatement; • Notice to appropriate federal and state agencies that administer health care programs; and • Notice to others originally notified.

33. Denial of Reinstatement • If reinstatement is denied, the excluded party is eligible to reapply after one year. • Violation of an exclusion is grounds for the OIG to deny reinstatement to Federal health care programs.

34. To obtain a copy of an exclusion notice – • Submit a written request to the OIG at this address: HHS, OIG, OI Attn: Exclusions P.O. Box 23871 Washington, DC 20026 • Include a printout from the LEIE identifying the individual or entity. (Requests without a printout from the LEIE will be returned.)

35. Contacting Exclusion Program Staff: • E-mail Address:sanction@oig.hhs.gov • Telephone:(202) 691-2311 • Fax:(202) 691-2298 • Mailing Address: HHS, OIG, OI Attn: ExclusionsP.O. Box 23871Washington, DC 20026

36. The National Practitioner Data Bank • The National Practitioner Data Bank (NPDB), or "the Data Bank," is a confidential info clearinghouse created by Congress with the primary goals of improving health care quality, protecting the public, and reducing health care fraud and abuse in the U.S. • Specific procedures that must be followed to query the Data Bank are set forth in the NPDB regulations. • The OIG can impose civil money penalties of up to $11,000 for each offense on those who violate the confidentiality provisions of NPDB information.

37. The National Practitioner Data Bank • Originally established by Title IV of the Health Care Quality Improvement Act of 1986, Public Law 99-660. • Intent was to improve the quality of health care by encouraging State Licensing Boards, professional societies, hospitals, and other health care entities to restrict the ability of incompetent health care practitioners to move from state to state without disclosure or discovery of previous medical malpractice payments and adverse action history.

38. NPDB – a clearinghouse of information: • Medical malpractice payments • Adverse actions related to licensure, clinical privileges and professional society membership • DEA registration actions • Exclusions • NPDB regulations implementing the three laws that govern operations are codified at 45 CFR Part 60.

39. HIPDB consolidated with NPDB • Prior to May 6, 2013, "the Data Bank" referred to two separately operated Data Banks: the NPDB and the Healthcare Integrity and Protection Data Bank (HIPDB). • While the NPDB and the HIPDB were established for different purposes (improve quality v. combat F&A), overlap existed in some reporting and querying requirements. • As a result of ACA (2010), NPDB operations were consolidated with those of the former HIPDB. Information previously collected and disclosed by the HIPDB is now collected and disclosed by the NPDB.

40. Why are there providers on the LEIE who are not included in the NPDB? • The LEIE is a complete list of all currently excluded individuals and entities that have been excluded by the OIG pursuant to sections 1128, 1128A, and 1156 of the Social Security Act. The NPDB's Public Use File contains NPDB data specified under Titles IV of Public Law 99 660 and Section 1921 of the Social Security Act.

41. Why are there providers on the LEIE who are not included in the NPDB? • The criteria for inclusion in the NPDB are different than the criteria for inclusion in the LEIE. As a result, the records of many individuals and entities excluded by the OIG are not contained in the NPDB Public Use File. For example, a DME business owner that has been excluded by the OIG and included in the LEIE will not be found on the NPDB Public Use File.

42. Why are there providers in the NPDB who are not listed on the LEIE? • The LEIE contains all individuals and entities that are currently excluded. Once an individual or entity has been reinstated, they are removed from the LEIE. In contrast, the NPDB contains information on both exclusions and reinstatement actions taken by the OIG. Further, the NPDB contains records on additional providers who have not been excluded by OIG and therefore would not appear in the LEIE.

43. Proposed Rule to Expand Exclusion Authorities • OIG published in Federal Registeron May 9, 2014: • Proposed revisions in definitions • Three new grounds for exclusion • Clarifications to existing regulations to add mitigating and aggravating factors • Proposed early reinstatement procedures • No statute of limitations for exclusion • Amendment to CMP rules

44. Questions?