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Federal Register / Vol. 63, No. 210 / Friday, October 30, 1998 / Notices 58399

RespondentNumber of

respondents

Responsesper

respondent

Hours perresponse(minutes)

Total Burdenhours

3,600 .............. .......... .............. .......... 560

Send comm ents to Susan G. Queen,Ph.D., HRSA Reports Clearance Officer,

Room 1433, Parklawn Building, 5600Fisher s Lane, Rockville, MD 20857.Written comments sh ould be receivedwithin 60 days of this notice.

Dated: October 23, 1998.

Jane Harrison,

Director, Division of Policy Review andCoordination.

[FR Doc. 9829111 Filed 102998; 8:45 am ]

BILLING CODE 416015P

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Health Resources and ServicesAdministration

Agency Information CollectionActivities: Submission for OMBReview; Comment Request

Periodically, the Health Resourcesand Services Administration (HRSA)

pu blishes abstracts of informationcollection requests und er review by the

Office of Management an d Bud get, incompliance with the PaperworkReduction Act of 1995 (44 U.S.C.Chapter 35). To request a copy of theclearance requests submitted to OMB forreview, call th e HRSA ReportsClearance Office on (301) 4431129.

The following request has beensubmitted to the Office of Managementand Budget for review und er thePaperwork Reduction Act of 1995:

Proposed Project: Appl ication for NHSCRecruitment and Retention Ass istance(in Use Without Approval)

The National Health Service Corps(NHSC) of the HRSAs Bureau ofPrimary Health Care assists und erservedcommunities through the development,recruitment, and retention of primaryhealth care clinicians dedicated toserving people in h ealth professionalshortage areas.

The App lication for NHSC

Recruitment and Retention Assistance

submitted by sites or clinicians requestsinformation on the practice site,

sponsoring agency, recruitment contact,staffing levels, service users, sites 5

year infant mortality or low birth rate

averages, and next nearest site. Theinformation on the application is used

for determining eligibility of sites and to

verify the need for NHSC providers.Sites must submit applications annually

or when they need a provider.

Estimates of annualized rep orting

burden are as follows:

Type of reportNumber of

respondents

Responsesper

respondent

Hours perresponse

Total burdenhour

Application ............... ................ ............... ............... ................ ............... ............ 1,000 1 .75 750

Written comm ents andrecommend ations concerning theproposed in formation collection shouldbe sent within 30 days of this notice to:Wendy A. Taylor, Human Resourcesand Housing Branch, Office ofManagement and Budget, NewExecutive Office Build ing, Room 10235,Washin gton, DC 20503.

Dated: October 23, 1998.

Jane Harrison,

Director, Division of Policy Review andCoordination.

[FR Doc. 9829112 Filed 102998; 8:45 am ]



Office of Inspector General

Publication of the OIGs Provider Self-Disclosure Protocol

AGENCY: Office of Inspector General(OIG), HHS.

ACTION: Notice.

SUMMARY: This Federal Register noticesets forth th e OIGs recen tly-issuedProvider Self-Disclosure Protocol. ThisSelf-Disclosur e Protocol offers healthcare providers specific steps, includin ga detailed aud it methodology, that maybe und ertaken if they wish to workopenly and cooperatively with the OIGto efficiently quantify a particularproblem and , ultimately, promote ahigher level of ethical and lawfulcondu ct throughout the health careindustry.

FOR FURTHER INFORMATION CONTACT: TedAcosta, Office of Counsel to the

Inspector General, (202) 6192078.

SUPPLEMENTARY INFORMATION: The OIGhas long stressed the role of the h ealthcare indu stry in combating health carefraud, and believes that health careproviders can play a cooperative role inidentifying and voluntarily disclosingprogram abuses. Th e OIGs use ofvoluntary self-disclosure programs, forexample, is premised on a belief thathealth care providers m ust be willing topolice themselves, correct underlyingproblems and work with the

Government to resolve these matters.Based on insights gained from a pilotprogram und ertaken as part ofOperation Restore Trust, d iscussionswith the provider community and thegrowing need for an effective disclosuremechanism , the OIG has now developeda more open-ended process, or protocol,for making a disclosure and allowing ahealth care provider to cooperative workwith th e OIG. Unlike the previousvoluntary disclosure pilot programs,this self-disclosure protocol givesdetailed guidance to the provider onwhat information is appropriate to

include as part of an in vestigative reportand h ow to conduct an audit of thematter, while setting no limitations onthe conditions und er which a healthcare provider may d isclose informationto th e OIG.

A reprin t of the OIGs Provide r Self-Disclosure Protocol follows.

Provider Self-disclosure Protocol

I. Introdu ction

The Office of Insp ector General (OIG)of the United States Department of


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58400 Federal Register / Vol. 63, No. 210 / Friday, October 30, 1998 / Notices

Health and Human Services (HHS)relies heavily upon the health careindu stry to help identify and resolvematters that adversely affect the Federalhealth care programs (as defined in 42U.S.C. 1320a7b(f)). The OIG believesthat, as participants in the Fed eralhealth care p rograms, health careproviders have an ethical and legal duty

to ensure the in tegrity of their dealingswith these programs. This du ty includesan obligation to take measures, such asinstituting a compliance p rogram, todetect and prevent fraudu lent, abusiveand wasteful activities. It alsoencompasses the need to implementspecific procedures and m echanisms toexamine and resolve instances of noncompliance with p rogram requirements.Whether as a result of voluntary selfassessment or in respon se to externalforces, health care providers m ust beprepared to investigate such instan ces,assess the potential losses suffered by

the Federal health care programs, andmake full disclosure to the approp riateauthorities. To encourage providers tomake voluntary d isclosures, the OIGissues this Provider Self-DisclosureProtocol (Protocol).

The concep t of voluntary selfdisclosure is not n ew to the OIG. Formany years, the OIG has w orkedinformally with providers and sup pliersthat came forward to cooperate w ithOIG to resolve billin g, marketing orquality of care problem s. In 1995, aspart of the Operation Restore Trust(ORT) initiative, HHS and th eDepartmen t of Justice (DOJ) annou nced

a pilot voluntary d isclosure program,which embraced OIGs longstandingpolicy favoring voluntary selfdisclosure. The dem onstration programwas developed in coordination withrepre sentatives of the OIG, DOJ, variousUnited States Attorneys Offices, theFederal Bureau of Investigation and theHealth Care Financing Adm inistration(HCFA). The pilot program was limitedto five States (New York, Florida ,Illinois, Texas and California) and fourdifferent types of p roviders (homehealth agencies, skilled nu rsingfacilities, durable m edical equipm ent

supp liers, and hospice providers). Itgave those qualifying entities a formalmechan ism for disclosing and seekingthe resolution of matters relating to theMedicare and Med icaid programs. In1997, the p ilot voluntary disclosureprogram was concluded. While therewas limited participation in the p ilot,the OIG gained valuable insight into thevariables influencing the decision tomake a disclosure to the Government.

The OIG believes it must continu eencouraging the health care ind ustry tocondu ct voluntary self-evaluations and

providing viable opportu nities for selfdisclosure. By establishing this Protocol,the OIG renews its comm itment topromote an environment of openn essand cooperation. The Protocol has norigid requirem ents or limitations.Rather, it provid es the OIGs views onwhat are the app ropriate elements of aneffective investigative and audit

working plan to address instances ofnon-compliance. Providers th at followthe Pr otocol exped ite the OIGsverification process and thus d iminishthe time it takes before the m atter canbe formally resolved. Failure to conformto each element of the Protocol is notnecessarily fatal to the providersdisclosure, but will likely delay theresolution of the matter.

The OIGs prin cipal pu rpose inprodu cing the Protocol is to provideguidance to health care providers thatdecide volun tarily to discloseirregularities in their d ealings with the

Federal health care programs. Because aproviders disclosure can involveanything from a simp le error to outrightfraud, the OIG cannot reasonably makefirm commitments as to how aparticular disclosure w ill be resolved orthe specific benefit that w ill enure to th edisclosing entity. In ou r experience,however, opening lines ofcommu nication with, and making fulldisclosure to, the investigative agency atan early stage generally benefits theindividu al or company. In short, theProtocol can help a health care providerinitiate with the OIG a dialogue d irectedat resolving its potential liabilities.

The d ecision to follow th e OIGssuggested Protocol rests exclusivelywith the provider. While the OIG canoffer only limited guidance on w hat isinherently a case-specific judgement,there are several considerations thatshould influence the decision. First, aprovider that u ncovers an ongoing fraudscheme w ithin its organizationimmed iately should contact the OIG,but sh ould not follow the Protocolssuggested steps to in vestigate orquantify the scope of the p roblem. If theprovider follows the Protocol in thistype of situation w ithout prior

consultation with the OIG, there is asubstantial risk that the Governmentssubsequent in vestigation will becompromised.

Second, the OIG anticipates that aprovider w ill apply th e Protocolssuggested steps only after an initialassessment substantiates there is aproblem with non-compliance withprogram requirements. The initialidentification of p otential risk areasshould be less intensive and need notconform to the Protocols suggestedprocedures. Similarly, when th e OIG

conducts a n ational review of aparticular billing practice, providersshould consid er the option ofconducting a limited assessment of thepractice und er OIG review, rather thanincur the expen se of a comprehen siveaudit. In such cases, an audit thatconforms to the Protocols guidelinesmay be appropriate only in instances

where a preliminary assessmentsuggests the p rovider has in factengaged in the practices un der OIGscrutiny.

II. The Provider Self-Disclosure Protocol

Unlike the earlier pilot p rogram, thereare no pre-disclosure requirements,applications for admission orpreliminary qualifying characteristicsthat mu st be met. The Provider Self-Disclosure Protocol is open to all healthcare providers, whether individu als orentities, and is not limited to anyparticular indu stry, medical specialty ortype of service. While no writtenagreement setting out the term s of theself-assessment w ill be required, theOIG expects the comm itment of thehealth care p rovider to disclose specificinformation and engage in specific selfevaluative steps relating to the disclosedmatter. In contrast to the pilotdisclosure program, the fact that adisclosing health care provider isalready subject to Government inquiry(including investigations, aud its orroutine oversight activities) will notautomatically preclude a disclosure.The disclosure, however, must be madein good faith. The OIG will not continu e

to work with a provider that attempts tocircumvent an ongoing inquiry or failsto fully cooperate in the self-disclosureprocess. In short, the OIG will continueits practice of working with providersthat are th e subject of an investigationor audit, provided that the collaborationdoes not in terfere with the efficient andeffective resolution of the inquiry.

The Provider Self-Disclosure Protocolis intended to facilitate the resolution ofonly matters that, in th e providersreasonable assessment, are potentiallyviolative of Federal criminal, civil oradmin istrative laws. Matters exclusivelyinvolving overpayments or errors thatdo n ot suggest that violations of lawhave occurred should be broughtdirectly to the attention of the entity(e.g., a contractor such as a carrier or anintermediary) that processes claims andissues payment on behalf of theGovernment agency respon sible for theparticular Federal health care program(e.g., HCFA for matters involvin gMedicare). The program contractors areresponsible for processing the refundand will review the circumstancessurround ing the initial overpayment. If


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the contractor concludes that theoverpayment raises concerns about theintegrity of the provider, the m atter maybe referred to th e OIG. Accordin gly, theproviders initial d ecision of where torefer a matter involving non-compliancewith program requirements should bemade carefully.

The OIG is not boun d by an y findings

made by the disclosing provider und erthe Provider Self-Disclosure Protocoland is not obligated to resolve thematter in any particular mann er.Nevertheless , the OIG will w ork closelywith providers that structure theirdisclosures in accordance with theProvider Self-Disclosure Protocol in aneffort to coordinate any investigatorysteps or other activities necessary toreach an effective and prom ptresolution. It is imp ortant to note that,upon review of the providers disclosuresubmission and /or reports, the OIG mayconclude that the d isclosed m atter

warran ts a referral to DOJ forconsideration und er its civil and/orcriminal authorities. Alternatively, theprovider may request the p articipationof a represe ntative of DOJ or a localUnited States Attorn eys Office insettlement discussions in order toresolve potential liability under theFalse Claims Act or other laws. In eithercase, the OIG will report on theproviders involvement an d level ofcooperation throughout the disclosureprocess to any other Governmen tagencies affected by the disclosedmatter.

III. Volun tary Disclosure Subm issionThe d isclosing provider will be

expected to make a submission asfollows.

A. Effective Disclosure

The disclosure must be made inwriting and must be submitted to theAssistant Inspector General forInvestigative Operation s, Office ofInspector General, Department of Healthand Hum an Services, 330 Indep enden ceAvenu e, SW, Cohen Buildin g, Room5409, Washin gton, DC 20201.Submissions by telecopier, facsimile or

other electronic media will not beaccepted.

B. Basic Inform ation

The submission should include thefollowing

1. The name, address, provideridentification nu mber(s) and taxidentification n um ber(s) of thedisclosing health care provider. If theprovider is an entity that is owned,controlled or is otherwise p art of asystem or network, include adescription or d iagram d escribing the

pertinent relationships and the namesand addresses of any related entities, aswell as an y affected corporate divisions,departm ents or branches. Additionally,provide the name and address of thedisclosing entitys designatedrepresentative for pu rposes of thevoluntary disclosure.

2. Indicate wh ether the provider has

knowledge that the matter is undercurrent in quiry by a Governm ent agencyor contractor. If the p rovider hasknowledge of a pending inquiry,identify any such Government entity orindividu al representatives involved.The provider mu st also disclosewheth er it is und er investigation orother inquiry for any other mattersrelating to a Federal health care programand p rovide similar information relatingto those other m atters.

3. A full description of the nature ofthe matter being disclosed, includingthe type of claim, transaction or other

condu ct giving rise to the matter, thenames of entities and ind ividualsbelieved to be imp licated and anexplanation of their roles in the matter,and th e relevant periods involved.

4. The type of health care p roviderimplicated and an y provider billingnu mbers associated with the matterdisclosed. Includ e the Federal healthcare programs affected, includ ingGovernment con tractors such ascarriers, intermediaries and oth er thirdparty payers.

5. The reasons wh y the disclosingprovider believes that a violation of

Federal criminal, civil or admin istrativelaw may have occurred.

6. A certification by the health careprovider or, in th e case of an entity, anauthorized rep resentative on behalf ofthe d isclosing entity stating that, to thebest of the ind ividuals knowled ge, thesubmission contains truthfulinformation and is based on a good faitheffort to bring the m atter to theGovernments attention for the pu rposeof resolving any potential liabilities tothe Governmen t.

C. Substantive Information

As part of its participation in th edisclosure process, the disclosing healthcare provider will be expected tocondu ct an internal investigation and aself-assessment, and then report itsfindings to the OIG. The internal reviewmay occur after the initial disclosure ofthe m atter. The OIG will generally agree,for a reasonable p eriod of time , to foregoan investigation of the matter if theprovider agrees that it will condu ct thereview in accordance with the InternalInvestigation Guidelines an d the Self-Assessment Guidelines set forth below.

IV. Internal Investigation Guidelin es

All disclosures to the OIG under theProvider Self-Disclosure Protocolshould in clude a report based on aninternal investigation conducted by thehealth care provider. While a provideris free to discuss its preliminaryfindings with the OIG prior to

completion of its investigation, thematter cannot be resolved until acomprehen sive assessment has beencompleted pu rsuant to the followingguidelines:

A. Nature and Extent of the Improper orIllegal Pr actice

A voluntary disclosure report shoulddemon strate that a full examination ofthe practice has been conducted. Thereport should contain a w rittennarrative that

1. Identifies the p otential causes ofthe in cident or practice (e.g., intentionalconduct, lack of internal con trols,

circumvention of corporate proceduresor Government regulations);

2. Describes the inciden t or p racticein detail, includ ing how the incident orpractice arose and continued ;

3. Identifies the division,departmen ts, branches or relatedentities involved and /or affected;

4. Identifies the imp act on, and risksto, health , safety, or quality of careposed by the m atter disclosed, withsufficient information to allow the OIGto assess the immediacy of the impactand risks, the steps that sh ould be takento address them, as well as the measures

taken by the disclosing entity;5. Delineates the period du ring which

the incident or practice occurred;6. Identifies the corp orate officials,

employees or agents who kn ew of,encouraged, or participated in, th eincident or practice and any individu alswho m ay have been involved indetecting the matter;

7. Identifies the corp orate officials,employees or agents wh o should h aveknown of, but failed to detect, theincident or p ractice based on th eir jobresponsibilities; an d

8. Estimates the m onetary impact ofthe incident or practice upon theFederal health care programs, pursu antto the Self-Assessment Guidelinesbelow.

B. Discovery and Respon se to theMatter

The in ternal investigation reportshould relate the circumstances und erwhich th e disclosed matter wasdiscovered and fully document themeasures taken up on discovery toaddress the problem and prevent futureabuses. In this regard, the rep ortshould


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1. Describe how the in cident orpractice was iden tified, and the origin ofthe information that led to its discovery.

2. Describe the entitys efforts toinvestigate and docum ent the incidentor prac tice (e.g., use of intern al orexternal legal, audit or consultativeresources).

3. Describe in detail the chronology of

the in vestigative steps taken inconnection with the entitys internalinquiry into the disclosed matterincludin g the following

(a) A list of all ind ividu alsinterviewed, includin g eachindividu als business address andtelephone num ber, and their positionsand titles in the relevant entities duringboth the relevant period and at the timethe d isclosure is being made. For allindividu als interviewed, provide thedates of those interviews and the subjectmatter of each interview, as well assumm aries of the interview. The health

care provider w ill be responsible foradvising the individual to beinterviewed that the information theindividu al provides may, in turn, beprovided to the OIG. Additionally,include a list of those individu als whorefused to be interviewed and providethe reasons cited;

(b) A description of files, documents,and records reviewed w ith sufficientparticularity to allow th eir retrieval, ifnecessary; and

(c) A summary of auditing activityund ertaken and a summary of thedocum ents relied upon in supp ort of the

estimation of losses. These docum entsand information must accompany thereport, unless th e calculation of losses isund ertaken pursuant to the Self-Assessment Guidelines, which containspecific reporting requirements.

4. Describe the actions by the healthcare provider to stop the inap propriateconduct.

5. Describe any related health carebusinesses affected by the inap propriatecondu ct in which the health careprovider is involved, all efforts by thehealth care provider to prevent arecurrence of the incident or p ractice inthe affected division as w ell as in an yrelated health care entities (e.g., newaccounting or internal controlprocedures, increased internal auditefforts, increased sup ervision by highermanagement or th rough training).

6. Describe any disciplinary actiontaken against corporate officials,employees and agents as a result of thedisclosed matter.

7. Describe appropriate notices, ifapplicable, provided to otherGovernmen t agencies, (e.g., Securitiesand Exchange Commission an d Internal

Revenue Service) in connection with th edisclosed matter.

C. The internal investigation reportmu st include a certification by thehealth care p rovider, or in the case of anentity an auth orized representative onbehalf of the disclosing health careprovider, indicating that, to the best ofthe ind ividuals knowledge, the internal

investigation report contains truthfulinformation and is based on a good faitheffort to assist the OIG in its inquir y andverification of the disclosed matter.

V. Self-Assessmen t Guidelines

To estimate the monetary impact ofthe disclosed m atter, the health careprovider also should condu ct aninternal financial assessment andprepare a report of its findin gs. Thisself-assessment m ay be performed at th esame time as the intern al investigation,or commen ced after the scope of thenon-compliance with p rogramrequirements h as been established. Ineither c ase, the OIG will verify aproviders calculation of Federal h ealthcare program losses and it is stronglyrecommend ed that, at a minimum, thereview conform to the followingguidelines.

A. ApproachThe self-assessment should consist of

a review of eith er(1) all of the claimsaffected by the disclosed matter for therelevant p eriod; or (2) a statisticallyvalid sample of the claims that can beprojected to th e popu lation of claimsaffected by the matter for the relevantperiod. This determination should be

based on the size of the popu lationbelieved to be im plicated, the varianceof characteristics to be reviewed, thecost of the self-assessment, the availableresources, the estimated duration of thereview, and other factors as approp riate.

B. Basic Information

Regardless of which of these twoapproaches is used, the d isclosingprovider shou ld subm it to the OIG awork plan describing the selfassessment p rocess. The OIG willreview the proposal and, whereapprop riate, provide comments on theplan in a timely manner. At its option,the OIG may choose to carry out anynecessa ry activities at any stage of thereview to verify that the process isun dertaken correctly and to validate thereview findings. While the OIG is notobligated to accept the results of aproviders self-assessment, findingsbased upon procedu res which conformto the Protocol will be given substantialweight in determin ing any programoverpayments. In add ition, the OIG willuse the validated p rovider selfassessment report in prep aring a

recommendation to DOJ for resolutionof the provid ers False Claims Act orother liability. Among the issues thatshould be addressed in th e plan are thefollowing

1. Review ObjectiveThere shou ld bea statement clearly articulating theobjective of the review and the reviewprocedure or combination of procedures

applied to achieve the objective.2. Review PopulationThe p lan

should id entify the popu lation, which isthe group about which in formation isneeded. In addition, there should be anexplanation of the methodology used todevelop the popu lation and the basis forthis determination.

3. Sou rces of DataThe plan shouldprovide a full description of the sourceof the information upon wh ich thereview will be based, includ ing the legalor other standards to be applied, thesources of payment d ata and thedocum ents that will be relied up on (e.g.,

employmen t contracts, rentalagreements, etc.).4. Personnel QualificationsThe plan

should id entify the nam es and titles ofthose individuals involved in an y aspectof the self-assessment, includ ingstatisticians, accountants, auditors,consultants and m edical reviewers, anddescribe their qualifications.

C. Sample Elements

If the p rovider, in consultation withthe OIG, determines that the financialreview will be based up on a sample, thework plan should also include thesampling plan as follows

1. Sam pling UnitThe plan shoulddefine the sampling unit, which is anyof the designated elements thatcomprise the p opulation of interest.

2. Sam pling FrameThe plan shouldidentify the sampling frame, which isthe totality of the samplin g units fromwhich the samp le will be selected. Inaddition, the plan should documenthow th e audit p opulation differs fromthe samp ling frame and what effect thisdifference has on conclusions reachedas a result of the audit.

3. Samp le SizeThe size of thesample mu st be determined throu gh the

use of a p robe sample. Accordingly, theplan should in clude a description ofboth the probe sample and the fullsample. At a minim um, the full samplemust be designed to generate anestimate with a ninety (90) percent levelof confidence and a precision of twentyfive (25) percent. The probe samp lemust contain at least thirty (30) sampleunits and cannot be used as part of thefull sample.

4. Random Num bers Both the probesample and th e sample mu st be selectedthrough random n um bers. The source of


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the random num bers used mu st beshown in the samp ling plans. The OIGstrongly recommend s the use of itsOffice of Aud it Services StatisticalSampling Software, also known asRAT-STATS, wh ich is curre ntlyavailable free of charge throu gh theinternet at www.hhs.gov/progorg/oas/ratstat.html.

5. Sample DesignUnless th edisclosing provider demonstrates theneed to u se a different sample d esign,the self-assessment should u se simplerandom sampling. If necessitated, theprovider m ay use stratified or m ultistagesamp ling. Details about th e strata, stagesand clusters should be included in thedescription of the audit plan.

6. Estimate of Review Tim e perSam ple Item The plan sh ould estimatethe time expend ed to locate the samp leitems and th e staff hours expended toreview a sample item.

7. Characteristics Measure by th eSampleThe sampling plan shouldidentify the characteristics used fortesting each sam ple item. For example,in a sample d rawn to estimate the valueof overpayments du e to duplicatepayments, the characteristics underconsideration are the conditions thatmu st exist for a sample item to be adup licate. The amount of the duplicatepayment is the measurem ent of theoverpayment. The samp ling plan mu stalso contain the d ecision rules fordeterminin g wheth er a sample itementirely meets the criterion for havingcharacteristics or on ly partially meetsthe criterion.

8. Missing Samp le Items Thesampling plan m ust include adiscussion of how missing sample itemswere handled an d the rationale.

9. Other EvidenceAlthough samp leresults should stand on th eir own interms of validity, sample results may becombined with other evidence inarriving at specific conclusions. Ifapprop riate, indicate what othersubstantiating or corroborating evidencewas developed.

10.Estimation MethodologyBecausethe general purpose of the review is toestimate the mon etary losses to the

Federal health care p rograms, themethodology to be used mu st bevariables samp ling using the differenceestimator. To estimate the amoun timplicated in the d isclosed matter, theprovider must u se the mean pointestimate. The statistical estimates mu stbe reported u sing a ninety (90) percentconfiden ce level. The use of RAT-STATS to calculate the estimates isstrongly recomm ended .

11.Reporting ResultsThe samplin gplan should in dicate how the resultswill be reported at the conclusion of the

review. In p reparing the report, enoughdetails must be provided to clearlyindicate what estimates are reported.

D. Certification

Upon com pletion of the selfassessment, the disclosing health careprovider, or in th e case of an entity itsauthorized representative, must submit

to the OIG a certification stating that, tothe best of the in dividuals knowledge,the report contains truth ful informationand is based on a good faith effort toassist OIG in its inquiry and verificationof the disclosed matter.

VI. OIGs Verification

Upon receipt of a health careproviders disclosure su bmission, theOIG will begin its verification of th edisclosure information. The extent ofthe OIGs verification effort will depen d,in large part, upon the qu ality andthoroughness of the internalinvestigative and self-assessmentreports. Matters uncovered du ring theverification process, which are outsideof the scope of the matter disclosed tothe OIG, may be treated as n ew m attersoutside the Provider Self-DisclosureProtocol.

To facilitate the OIGs verification an dvalidation processes, the OIG mu st haveaccess to all audit w ork papers andother supporting documents without theassertion of privileges or limitations onthe information produced. In the normalcourse of verification, the OIG will n otrequest produ ction of writtencommu nications subject to the attorney

client privilege. There may bedocum ents or other materials, however,that may be covered by the workprodu ct doctrine, but which the OIGbelieves are critical to resolving thedisclosure. The OIG is prepared todiscuss with providers counsel ways togain access to the und erlyinginformation without the need to waivethe protections provided by anappropriately asserted claim ofprivilege.

VII. Payments

Because of the need to verify theinformation provided by a disclosinghealth p rovider, the OIG will not acceptpayments of presumed overpaymentsdetermined by the health care providerprior to th e comp letion of the OIGsinquiry. However, the provider isencouraged to place the overpaymentamoun t in an interest-bearing escrowaccount to minim ize further losses.While the matter is un der OIG inquiry,the disclosing provider mu st refrainfrom m aking payment relating to thedisclosed matter to the Federal healthcare programs or their con tractors

with out th e OIGs prior con sent. If theOIG consents, the disclosing providerwill be required to agree in writing thatthe acceptance of the paymen t does notconstitute the Governments agreementas to the am ount of losses suffered bythe programs as a resu lt of the disclosedmatter, and d oes not affect in anymann er the Governments ability to

pursu e criminal, civil or administrativeremedies or to obtain ad ditional fines,damages or penalties for the mattersdisclosed.

VIII. Cooperation and Removal from theProvider Self-Disclosure Protocol

The disclosing entitys diligent andgood faith cooperation throughout th eentire p rocess is essential. Accordingly,the OIG expects to receive docum entsand in formation from the entity thatrelate to the disclosed m atter withoutthe need to resort to compulsorymethods. If a provider fails to work in

good faith with th e OIG to resolve thedisclosed matter, that lack ofcooperation w ill be considered anaggravating factor wh en th e OIGassesses the appropriate resolution ofthe m atter. Similarly, the intentionalsubmission of false or otherwiseuntru thful information, as well as theintentional omission of relevantinformati on, will be r eferred to DOJ orother Federal agencies and could , initself, result in crimin al and/ or civilsanctions, as well as exclusion fromparticipation in the Federal health careprograms.

Dated: October 21, 1998.June Gibbs Brown,

Insp ector General.

[FR Doc. 9829064 Filed 102998; 8:45 am ]



National Institutes of Health

National Cancer Institute:Opportunities for CooperativeResearch and DevelopmentAgreements (CRADAs) for the JointEvaluation and Development ofMethods to Generate and Expand In-Vitro Modified Dendritic CellPopulations in Order to ElicitPhenotype Specific ImmuneResponses

The NCI is looking for CRADACollaborators to jointly develop thisdend ritic cell immun ology technology.

AGENCY: National Cancer Institute,National Institutes of Health, PHS,DHHS.

Documents

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