January 26,2011. Presented by Richard P. Kusserow, former DHHS IG Jillian Bower, MPA

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1 January 26,2011 Presented by Richard P. Kusserow, former DHHS IG Jillian Bower, MPA

2 } Overview of sanction screenings } Sources for sanction data } State screening obligations } Compliance expectations } Risks associated with failing to screen Copyright 2012 Compliance Resource Center, LLC 2

3 } Screen individuals/entities prior to engagement } Screen periodically thereafter } Have applicants agree to background verification } Check federal/state monthly exclusion updates } Consider checking GSA EPLS, DEA, and FDA } Put written guidance is in place } Ensure exclusion service vendors or applications include sanction attestations Copyright 2012 Compliance Resource Center, LLC 3

4 } Must screen as a Condition of Participation } Includes employees, physicians given staff privileges, vendors, and contractors } Differs from credential verification } Can be properly credentialed and yet excluded Copyright 2012 Compliance Resource Center, LLC 4

5 } Credential verification is not sanction screening } Education/occupation license qualifications review } Required by hospital & managed care accreditation bodies } Conducted periodically to avoid malpractice liability } Must do as a Condition of Participation Copyright 2012 Compliance Resource Center, LLC 5

6 } OIG List of Excluded Individuals and Entities** } General Services Administration Excluded Parties List System ** } State Medicaid exclusion databases **/* } Also, consider: } Drug Enforcement Administration } Food and Drug Administration Disqualified List and Debarment List; } State Sex Offender Registries } **Mandatory *Recommended Copyright 20112Compliance Resource Center, LLC 6

7 } 17 separate prosecution and sanction authorities to exclude individuals/entities from participation in federal health care programs, including Medicare, Medicaid, CHIP and TriCare } Maintains a List of Excluded Individuals and Entities (LEIE) } Sections 1128 and 1156 Social Security Act Copyright 2012 Compliance Resource Center, LLC 7

} Exclusion of an individual who: Has ownership or control interest in a sanctioned entity and who knew or should have known ( deliberate ignorance or reckless disregard ) about the underlying

8 } Exclusion of an individual who: Has ownership or control interest in a sanctioned entity and who knew or should have known ( deliberate ignorance or reckless disregard ) about the underlying actions that were the basis for the entity s sanction, or Is an officer or managing employee in a sanctioned entity. } (42 USC 1320a-7(b)(15); section 1128(b)(15) of the SSA) Copyright 2012 Compliance Resource Center, LLC 8

9 } Government-wide debarment and suspension system for parties debarred, suspended or excluded from any federal procurement and non-procurement programs } Debarred individuals or entities are excluded from contracts with and grants from all executive branch agencies } OIG/CMS encourage screening against EPLS Copyright 2012 Compliance Resource Center, LLC 9

10 } To obtain/maintain active enrollment status, providers may not employ or contract with individuals/entities excluded from participation in any federal health care program or debarred by the GSA from any other executive branch program or activity. } (42 CFR ) Copyright 20112Compliance Resource Center, LLC 10

11 } Maintains a list of Cases Against Doctors } DEA Registrant Practitioners, Pharmacies, Hospitals/Clinics, Researchers } A listing of investigations of physician in which DEA was involved that resulted in the arrest and prosecution of the registrant. Copyright 2012 Compliance Resource Center, LLC 11

12 } Debarment List: Those firms or persons debarred due to a felony conviction related to the development or approval of any drug product or related to the regulation of any drug product. } Disqualified List: Debarred clinical investigators failing to comply with applicable regulatory requirements or submitted false information to the FDA. Copyright 2012 Compliance Resource Center, LLC 12

13 } Incorporates state registries (no federal one) } Many organizations are expressing concerns about engaging individuals who are convicted sex abusers } Fear of litigation if such a person commits a violation against a patient or staff member } Failing to search for this information may be grounds for negligent hiring cause of action } In some cases there are concerns in LTC facilities about residents who may have sex offender histories Copyright 2012 Compliance Resource Center, LLC 13

15 } Effective January 2011, under Section 6501 PPACA } State Medicaid agencies are to exclude individuals or entities from participation in the State Medicaid program when the individual or entity has been terminated from participation in Medicare or any other State Medicaid plan. Copyright 2012 Compliance Resource Center, LLC 15

16 } State Medicaid agencies must notify OIG whenever they take action related to participation in the Medicaid program. } OIG reported in Aug 2008 that about 2/3 of providers with final actions imposed by state agencies in 2004 and 2005 were not found in the OIG exclusions data base. } State Medicaid Agency Referrals to Inspector General Exclusions Program, OEI Copyright 2012 Compliance Resource Center, LLC 16

17 } Review Medicaid payments to providers and suppliers to determine how much were for services provided by excluded parties. } Beginning in 2011 OIG issuing reports finding states have inadequate controls to prevent Medicaid payments for services or items furnished by excluded providers or entities (e.g. Iowa and Missouri) Copyright 2012 Compliance Resource Center, LLC 17

18 } June 12, 2008: Should check monthly for exclusions. } January 16, 2009: Should advise providers upon enrollment and reenrollment of their obligation to screen all employees and contractors against the OIG LEIE monthly. Should explicitly require providers to agree to comply with this obligation as a condition of enrollment. Medicaid payments are prohibited for all items/services furnished by excluded persons and entities Copyright 2012 Compliance Resource Center, LLC 18

19 } Many states maintain their own Medicaid sanction and exclusion lists. Alabama Idaho Mississippi Ohio Arkansas Illinois Nebraska Pennsylvania California Kentucky Nevada South Carolina Connecticut Maine New Jersey Texas Florida Maryland New York West Virginia Hawaii Michigan Copyright 2012 Compliance Resource Center, LLC 19

20 } December 2006 Medi-Cal : Providers can t submit claims for services rendered by a suspended provider or excluded by HHS OIG. } Providers can be suspended for submitting a claim to Medi-Cal stemming from a suspended, excluded, or otherwise ineligible individual or entity. } Examples of violating the law that can lead to a provider being suspended include: Billing services for suspended providers; Pharmacies that fill prescriptions and bill for services prescribed by a suspended provider; Providers who bill for services under referral or prescription of a suspended provider; Providers who employ and submit claims for the services of a suspended provider; Physician groups, clinics and institutions that employ and submit claims for the services of a suspended provider; and Any individuals or entities that enter into a business arrangement and submit claims for or in conjunction with a suspended individual or entity. W&I Code Section (a) Copyright 2011 Compliance Resource Center, LLC 20

21 } Department of Health Care Services has the authority to suspend for: Felony conviction Misdemeanor conviction involving fraud, abuse of the Medi-Cal program or any patient, or otherwise substantially related to the qualifications, functions, or duties of a provider of service Suspension from the Federal healthcare programs for any reason Surrender/lost of license, certificate, or approval to provide health care Breach of a contractual agreement with the DHCS that explicitly specifies inclusion on this list as a consequence of the breach } Exclusion list updated monthly Providers are also recommended cross-reference the OIG LEIE to help identify providers who have already been suspended or sanctioned. } Reinstatement is not automatic. Copyright 2011 Compliance Resource Center, LLC 21

22 } No payment for claims associated with excluded or sanctioned providers An excluded person cannot be involved in any activity relating to the furnishing of medical care, services or supplies to recipients of medical assistance for which claims are submitted to Medicare or Medicaid. This prohibition extends to group affiliations and to employers (hospitals, nursing homes, pharmacies etc.) who cannot be associated with, or employ, an excluded individual. } Providers who fail to meet prescribed statutory and regulatory obligations can be sanctioned by the OMIG Sanctions include exclusion from the program for a period of time, censure, or conditional or limited participation 18 NYCRR Copyright 2011 Compliance Resource Center, LLC 22

23 } NY provides a state sanctioned and excluded provider list for providers to screen in addition to the OIG LEIE They do not mandate the frequency of screenings. } Any claims submitted for medical care, services or supplies ordered or prescribed by any providers appearing on this list may be denied Therefore the list should be checked regularly. The list is updated monthly } NY recommends that Web searches should be performed for each individual upon hire and all employees, vendors, and referral sources should be rescreened on a monthly basis at a minimum. Copyright 2011 Compliance Resource Center, LLC 23

24 } } } The Nebraska DHHS issued a bulletin in Sept that Medicaid providers have a responsibility to screen ordering/referring/ prescribing providers for Federal and State suspension or termination status. Won t reimburse for services, items, or drugs that are provided, referred, furnished or prescribed by the suspended or terminated provider or caused to be provided, referred, furnished, ordered or prescribed for a Medicaid client. No provider entity shall submit claims for payment to the DHHS for any services or supplies provided by a person which has been excluded from participation in NMAP except for those services or supplies provided before the suspension or termination. Those entities violating this can be suspended or terminated. 471 NAC Copyright 2011 Compliance Resource Center, LLC 24

25 } NDHHS maintains the Nebraska Medicaid Excluded Providers online database Includes terminations and suspensions } Providers are also required to check the GSA EPLS and the OIG LEIE In a Provider Bulletin in Sept. 2009, providers are required to screen employees and contractors to determine whether any of them have been excluded and are required to search the OIG website monthly to capture exclusions and reinstatements that have occurred since the last search. Civil monetary penalties may be imposed and/or providers who fail to comply with exclusion screening may jeopardize their status as an enrolled Medicaid provider. Copyright 2011 Compliance Resource Center, LLC 25

26 } The Pennsylvania Dept. of Public Welfare states that it is necessary for providers to examine the Medicheck list to assure that an order for a service or a prescription is not initiated by individuals who are no longer permitted to participate. } DPW will not pay for any services prescribed, ordered, or rendered by the providers or individuals listed on the Medicheck List, including services performed in an inpatient hospital or long-term care setting 55 Pa. Code (c) and (c) Copyright 2011 Compliance Resource Center, LLC 26

27 } Providers must check Medicheck at time of hire or contracting and thereafter on a monthly basis. } DPW includes federally excluded individuals and entities who practice in Pennsylvania Providers are advised to also screen LEIE to ensure that the individual/entity is eligible to participate. } Individuals are not automatically reinstated at the end of the preclusion period Similar to OIG LEIE } DPW recommends developing policies and procedures for screening of all employees and contractors. Copyright 2011 Compliance Resource Center, LLC 27

28 } The South Carolina Department of Health and Human Services maintains a list of excluded individuals and entities that have been excluded by the federal government and/or S.C. } No specific state regulation mandates providers to check the exclusion list. However, in a June 2009 letter, SCDHHS states that all South Carolina hospitals, pharmacies, home health agencies, medical or dental practices, nursing facilities, State agencies, managed care organizations, or any other entities or individuals that accept Medicaid funding or that are involved in administering the Medicaid program, should screen all employees and contractors to determine whether any of them have been excluded. Copyright 2011 Compliance Resource Center, LLC 28

29 } Providers included on the list should not submit claims for Medicaid reimbursement and should not be affiliated with any organization or facility that participates in the Medicaid program. } The list is updated monthly. } Most exclusions are for a period of three to five years but can be a permanent exclusion Individuals are not automatically reinstated at the end of the preclusion period Copyright 2011 Compliance Resource Center, LLC 29

30 } } } The Texas Health & Human Services Commissions Office of Inspector General maintains the Medicaid Exclusion Database. Each provider or person is responsible for ensuring that items or services furnished personally by, at the medical direction of, or on the prescription or order of an excluded person are not billed to the Titles V, XIX, XX, and CHIP programs. Failure to ensure excluded providers are not participating in the activities above and/or billing for services rendered by an excluded person will result in: Exclusion of the currently active providers and persons allowing the forbidden activity Recoupment of all funds paid to the currently active provider or person for those activities, and imposition of damages and penalties against both the currently active provider or person and the excluded person. TAC (a) Copyright 2011 Compliance Resource Center, LLC 30

31 } Bases for exclusion include: Convictions for program-related fraud and patient abuse Licensing board actions OIG exclusion actions Permissive exclusions as allowed by various legal authorities } The database is updated monthly. } Reinstatement of excluded entities and individuals is not automatic, they must reapply. TAC Copyright 2011 Compliance Resource Center, LLC 31

33 } Who should check? HR or Compliance Officer, also contractors should check their employees and contractors } Who should be screened? Employees, medial staff, and independent contractors } When? Prior to hiring/contracting and regularly thereafter (see OIG, CMS and State guidance) } Which one? OIG, GSA and State(s) } How? Manually vs. automated Single vs. batch search Direct vs. fuzzy match Copyright 2012 Compliance Resource Center, LLC 33

34 } Has not been definitively defined } Frequency an important resource/financial issue } At time of engagement; periodically thereafter } CIAs and elsewhere OIG calls for quarterly screening } CMS promotes monthly screening } Many states mandate monthly screening Copyright 2012 Compliance Resource Center, LLC 34

35 } Consider: Expense of using in house resources. Monthly uploading and maintaining a database Dedicating staff to the screening process Screening frequency can multiply the costs/ resource Price/fee for using vendors: per click verses fixed price Copyright 2012 Compliance Resource Center, LLC 35

36 } Advantages Using employees only Can be done anytime No outside knowledge of results } Disadvantages Costly to build/maintain search engine/database Expensive to update monthly the data Difficulty in resolving potential hits Copyright 2012 Compliance Resource Center, LLC 36

37 } Advantages Vendor maintains and keeps the data up to date Vendor assumes costs of building/maintaining search engine and database of sanctioned parties Vendor assumes liability for any errors } Disadvantages May be very costly if fees based upon volume of use Copyright 2012 Compliance Resource Center, LLC 37

38 } Individual name searches one at a time } Vendor take batch, runs it, and sends report } Web-based service, immediate report of results } Charges on per click basis v. fixed fee } Assisting in hit resolution } Outsourcing entire process } Limited to LEIE and EPLS } All federal (LEIE, EPLS, DEA, FDA) } All federal plus state Medicaid } All federal, Medicaid, plus others (watch list/sex offenders) Copyright 2012 Compliance Resource Center, LLC 38

40 } One of the biggest sanction screening problems } OIG LEIE is pretty good at providing means to resolve hits } Other data sites, especially EPLS is very bad in providing the kind of information to determine with a hit is false or real } In many cases UPIN/NPI data can be used to do this Copyright 2012 Compliance Resource Center, LLC 40

41 } If on excluded list: Verify (DOB, Address, SSN, etc.) Potential employee/contractor: Do not contract or hire Current employee/contractor: Take remedial steps Identify potential overpayments Repay overpayments within 60 days of identification } Keep records to evidence screening efforts as part of an effective Compliance Program Indicate when screening conducted Indicate source data and last date updated Copyright 2011 Compliance Resource Center, LLC 41

42 } Need written guidance (policies/procedures) } Clearly describe how this is to be done, how often, and by whom } Ensure that applications for employment, staff privileges, etc. call for declarations about past history of problems (convictions, sanctioning, etc.) } Applicants should acknowledge and give permission to check accuracy of information being provided. } All this should be done as a condition of engagement or privileges Copyright 2012 Compliance Resource Center, LLC 42

44 } No payment will be made by any Federal health care program for any items or services: furnished by an excluded individual or entity; at the medical direction; or on the prescription of an excluded individual } } See: OIG Special Advisory Bulletin: The Effect of Exclusion From Participation in Federal Health Care Programs. } (42 CFR ) Copyright 2012 Compliance Resource Center, LLC 44

45 } Failure to screen runs the risk of CMP liability } Screening is related to conditions of participation } Any claims including sanctioned parties is fraud } OIG enforcement actions increasing for violators } Frequency of screening obligations increasing } Cost of screening more often is increasing } Staff time to address results of screening is expensive Copyright 2012 Compliance Resource Center, LLC 45

46 } Mandatory Exclusions: i.e. felonies; patient abuse } Discretionary Exclusions: i.e. misdemeanors; civil violations; abuse } 1983: 230 exclusions imposed } 1990: 900 exclusions imposed } 2010: 3340 exclusions imposed } First half of FY 2011: 1,779 exclusions imposed } Over 58,000 exclusions imposed and 48,890 currently active. Copyright 2011 Compliance Resource Center, LLC 46

47 } 60+ cases in last 3 years } $10 million in settlements } Most involved a single excluded party } >$300,000 per excluded party } Number of cases growing every year Copyright 2012 Compliance Resource Center, LLC 47

48 } Conestoga View Nursing, L.P. Pennsylvania nursing home } Employed an excluded person as a unit clerk for three years Resulted in a $265,000 civil monetary settlement } Individual provided a name on the employment application different from the name she was excluded under. During employment, Conestoga began also screening the employee s alias/married name. } Conestoga did not find either name on the list. However they didn t keep a record of their screening efforts. Copyright 2011 Compliance Resource Center, LLC 48

49 } The take home message is that you need to document your screening efforts! Evidence all names that were screen and the results (i.e. match, no match) } This is a reminder that stiff penalties are enforced even when excluded employees do not provide medical services. Copyright 2011 Compliance Resource Center, LLC 49

50 } CMPs of up to $10,000 for each item or service furnished by an excluded individual or entity and listed on a claim submitted for Federal program payment, AND an assessment of up to three times the amount claimed may be imposed } FCA, up to three times the value of the false claim, plus $5,500 to $11,000 fines per claim } May also be excluded from program participation } Liable for actions of excluded party acting within the scope of agency relationship Copyright 2012 Compliance Resource Center, LLC 50

51 } CMP liability when the provider or other person submits, or causes a claim to be submitted for items/services furnished by an excluded individual or entity and knows or should know that the person was excluded from participation in Federal health care programs. } Should know means: Acts in deliberate ignorance of the truth or falsity of the information; or; Acts in reckless disregard of the truth or falsity of the information. Copyright 20112Compliance Resource Center, LLC 51

52 } Sanction screening is critical for an effective CP } Failure to properly screen = legal/financial liability } More frequent screenings is the trend } Need cost-effective solution to ensure compliance } Conduct Checks Frequently! Copyright Compliance Resource Center, LLC 52

53 } Participant today can receive a Sanction Screening policy template w/o charge } a request and it will be sent to you } Provide size of workforce and type of organization in the request to ensure the best template for your needs. } Copyright 2011 Compliance Resource Center, LLC 53

MEETING THE SANCTION SCREENING CHALLENGE: RULES, REQUIREMENTS, AND METHODS.

MEETING THE SANCTION SCREENING CHALLENGE: RULES, REQUIREMENTS, AND METHODS. Richard P. Kusserow, former DHHS IG Jillian Bower, MPA OVERVIEW OF PROGRAM Why sanction screening is a must Credentialing vs.