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

Transcription

1 MEETING THE SANCTION SCREENING CHALLENGE: RULES, REQUIREMENTS, AND METHODS. Richard P. Kusserow, former DHHS IG Jillian Bower, MPA

2 OVERVIEW OF PROGRAM Why sanction screening is a must Credentialing vs. Sanction Screening Major sources for sanction data Risks associated with exclusions Federal/State exclusion, processes and implications New Federal and State initiatives Compliance expectations 2

3 BACKGROUND: ALL PROVIDERS NEED TO 1. Screen individuals/entities prior to engagement 2. Screen periodically thereafter 3. Check the monthly LEIE updates 4. Check separately Medicaid sanctions in some states 5. Consider checking GSA EPLS, DEA, and FDA 6. Ensure written guidance in place (policy/procedures) 7. Make sure applications include sanction attestations 8. Have applicants agree to background verification 3

4 CONSEQUENCES OF SCREEN OBLIGATIONS 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 4

5 CREDENTIAL VERIFICATION Credential verification is not sanction screening Education or occupation license qualifications review Required by hospital & managed care accreditation bodies Conducted periodically to avoid malpractice liability Must do as a Condition of Participation 5

6 SANCTION SCREENING Differs from credential verification Can be properly credentialed and yet excluded Must screen as a Condition of Participation Includes employees, physicians given staff privileges, vendors, and contractors 6

7 MAJOR SANCTION DATA SOURCES OIG LEIE** EPLS* DEA FDA MEDICAID STATE SANCTIONS* TERRORIST WATCH LIST SEX ABUSE REGISTRIES 7 **Mandatory *Recommended

8 OIG EXCLUSION AUTHORITY 17 separate prosecution and sanction authorities to exclude individuals/entities from participation in federal health care programs, including Medicare, Medicaid, CHIP and TriCare 8 Maintains a List of Excluded Individuals and Entities (LEIE) Sections 1128 and 1156 Social Security Act

9 OIG ENFORCEMENT FOR USING SANCTIONED PARTIES 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 9

10 RECENT OIG ENFORCEMENT ACTIONS CVS, $1M for using one excluded Pharmacist Elder Service Plan, $308,709 for contracted Dentist AdCare Hospital, $254,820 for one excluded person Catholic HealthCare West, $243,819 for 5 persons NY Downtown Hospital, $220,000 for one person U of Arkansas,$201,689 for one person E. Boston Neighborhood Health Center, $200,962 for one person 10

11 OIG EXCLUSIONS 1983: 230 exclusions imposed 1990: 900 exclusions imposed 2010: 3340 exclusions imposed 11 Exclusions Imposed to date: 57,071 Currently active in LEIE: 48,890

12 CONVICTIONS = MANDATORY EXCLUSION Criminal offense of Medicare or Medicaid Patient abuse or neglect criminal offense Felony offense of health care fraud Felony offense re controlled substances 12 (42 USC 1320a-7(a), Section 1128(a) of Social Security Act)

13 MANDATORY EXCLUSIONS 1554 mandatory exclusions in 2010 Minimum period of exclusion 5 years. May be more if aggravating factors. No automatic reinstatement 13

14 DISCRETIONARY OIG EXCLUSIONS Numerous but not as high profile 14 Mostly for abuse and civil violations criminal 2010: 1786

15 DISCRETIONARY OIG EXCLUSIONS (Derivative) Misdemeanor conviction of health care fraud Conviction of criminal obstruction Misdemeanor relating to controlled substances License revocation or suspension Failure to supply payment information or grant immediate access Failure to repay health education assistance loan obligations 15 (42 USC 1320a-7(b), section 1128(b) of the SSA)

16 DISCRETIONARY EXCLUSIONS (Affirmative) 16 Fraud False Claims Kickbacks Quality of Care Violations Failing to meet professionally recognized standards of care Furnishing services/items substantially in excess of patient needs

17 EFFECT OF PROGRAM EXCLUSION 17 No payment will be made by any Federal health care program for any items or services: o furnished by an excluded individual or entity; o at the medical direction; or o 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 )

18 FINANCIAL EXPOSURE TO THOSE WHO EMPLOY EXCLUDED PARTIES 18 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 False Claims Act 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

19 KNOWLEDGE STANDARD FOR CMP LIABILITY 19 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.

20 REINSTATEMENT OF EXCLUDED PARTIES 20 Must file an application with OIG OIG Discretion to grant/deny No appeal rights if denied

21 NEW OIG RESPONSIBLE CORPORATE OFFICER DOCTRINE 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. 21 (42 USC 1320a-7(b)(15); section 1128(b)(15) of the SSA)

22 GSA EXCLUDED PARTIES LIST SYSTEM (EPLS) Government-wide debarment and suspension system for parties debarred, suspended or excluded from any federal procurement and nonprocurement programs 22 Debarred individuals or entities are excluded from contracts with and grants from all executive branch agencies OIG/CMS encourage screening against EPLS

23 CMS REGULATIONS 23 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 )

24 CMS STATE MEDICAID DIRECTOR LETTERS June 12, 2008: Should check monthly for exclusions January 16, 2009: 24 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

25 DRUG ENFORCEMENT ADMINISTRATION Office of Diversion Control maintains a list of Cases Against Doctors DEA Registrant Practitioners, Pharmaciers, Hospitals/Clinics, Researchers A listing of investigations of physician in which DEA was involved that resulted in the arrest and prosecution of the registrant. As a result the DEA registration is revoked, surrendered, or retired, 25

26 FOOD AND DRUG ADMINISTRATION Debarment List 26 A listing of 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 A clinical investigator can be debarred if repeatedly or deliberately failed to comply with applicable regulatory requirements or submitted false information to the sponsor or to FDA. A disqualified or totally restricted clinical investigator is not eligible to receive investigational drugs, biologics, or devices.

27 SEX OFFENDER REGISTRIES 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 27

28 STATES MUST NOTIFY OIG OF SANCTIONS 28 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

29 STATE EXCLUSION LISTS Many States have their own Medicaid Exclusion Lists 29 Alabama Kentucky New York Arkansas Maine Ohio California Maryland Pennsylvania Connecticut Michigan South Carolina Florida Mississippi Texas Idaho Illinois Nebraska New Jersey

30 RESOLVING POSSIBLE FALSE HITS One of the biggest problems with sanction screening OIG LEIE is pretty good at providing the means to resolve this problem 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 30

31 AFFORDABLE CARE ACT Effective January 2011, under Section 6501 PPACA 31 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.

32 OIG REVIEW OF MEDICAID EXCLUSIONS Review Medicaid payments to providers and suppliers to determine how much were for services provided by excluded parties 32 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)

33 PROVIDER SANCTION SCREENING OBLIGATIONS Who should check? HR or Compliance Officer, also contractors should check their employees and contractors Who? Employees, medial staff, and independent contractors When? Prior to hiring/contracting and regularly thereafter (see OIG, CMS and State guidance) Which one? OIG LEIE, GSA and State(s) How? Manually vs. automated Single vs. batch search Direct vs. fuzzy match 33

34 SANCTION SCREENING POLICIES 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 34

35 SANCTION SCREENING FREQUENCY Has not been definitively defined Frequency is 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 35

36 COST AND RESOURCES ISSUES In house is expensive use of resources Monthly uploading and maintaining a database Screening process Screening frequency can multiply costs/resource use Using vendors can be expensive Avoid being charged on the number of searches Look for fixed price vendors to budget the costs 36

37 SCREENING IN HOUSE Advantages Using employees only Can be done anytime No outside knowledge of results 37 Disadvantages Costly to build, upload, and maintain internal sanction screening database and search engine

38 USING A VENDOR FOR SCREENING 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 38 Disadvantages May be very costly if fees based upon volume of use

39 SCREENING COST BENEFIT ANALYSIS Compare the cost and resources of doing it in house versus using a vendor 39 Normally using in house staff and resources far more expensive in time and effort Vendors can amortize their costs over many clients

40 IN HOUSE COST ANALYSIS Determine the following time and effort levels: Developing a database of sanction information Building the search engine to screen Maintenance/updating monthly the data For screening entire workforce/contractors Frequency of sanction screening 40 To resolve possible hits

41 TYPES OF VENDOR SERVICES Individual name searches one at a time Batch searches (if so how big a batch) Vendor take batch, runs it, and sends report Web-based online 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/sex offenders) 41

42 VENDOR USE COST ANALYSIS Ask the following questions How many names can be searched at one time? How fast is the turnaround on results of searches? What they charge (per individual search, fixed batch fee, fixed fee unlimited, etc.)? What other services do they provide (resolution of possible hits)? Can you outsource the entire process to them and if so at what cost? How is the data maintained and secured? How many Federal and State Databases are available? Can we self-manage our screenings? 42

43 43

44 PROVIDER VERIFICATION OBLIGATIONS 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 44 Keep records to evidence screening efforts as part of an effective Compliance Program Indicate when screening conducted Indicate source data and last date updated

45 CONCLUSION NOTE Sanction screening is a critical part of an effective CP and a lack of such screening can lead to legal and financial liability CMP, treble damages, extension of existing exclusion or new exclusion, False Claims Act More frequent screenings of more lists required Need cost-effective solution to ensure compliance 45 Conduct Checks Frequently!

46 POLICY TEMPLATES 46 Any participant today that would like Sanction Screening policy template can a request and it will be sent to you without charge.

47 Questions? 47 Richard P. Kusserow, former IG (703) Jillian M. Bower, MPA (703)