Clinical Trials ComplianceJudy L. Harris, Director of ComplianceDavid J. Leffell, M.D., Director, Yale Medical Group Hotline 1-800-351-2831 I Volume I, Issue I November 2002

Penrhyn Cook, Executive Director, Grants and Contracts http://info.med.yale.edu/ymg/comply

This issue inaugurates a new publication designed to provide you with up-to-date information on clinical trials compliance.Please contact Judy Harris bye-mail at judy.harris@yale.edu or at 785~3868 with questions.

Yale Medical GroupITHE PHYSICIANS OF VALE UNIVERSITY

WHY FOCUS ON CLINICAL TRIALS?

When asked why he robbedbanks, career criminal WillieSutton replied "because that's

where the money is". The OIG is adopt-ing a similar strategy by focusing on thearea of clinical trials. Hundreds of mil-lions of federal dollars are involved in clin-ical trials each year.

"because that's where themoney is.

( 'The OIG is seeking to ensure thatservices are billed to the appropriate enti-ty, the financial accounting of the workeffort is correct, conflict of interest issuesare addressed, and the informed consentprocess and the Institutional ReviewBoard guidelines are fulfilled. Clinicalresearch is one of three priorities on theOIG's work plan.

Are The Costs of Experimental Devices &Their Related Services Covered byMedicare?

s of November 1,1995, Medicare

A may pay for services associatedwith an investigational device ifthe device is classified as a

Category B device by the FDA and beingused in the context of a FDA approvedclinical trial. CategoryB devices aretypically those devices that are a newergeneration of a proven technology.Category A devices are never covered byMedicare. The sponsor should provide thePrincipal Investigator (PI) with the

I~ification of the device. It is critical that,I

'(elK. PI obtain this information if he or sheintends to bill for the services associatedwith the device. Claims must be billedwith modifier QA and the IDE numbershould be indicated in block 23 of theHCFA 1500 form.

Some other factors that have placed thespotlight on clinical trials include:

A healthy volunteer diedin anasthma related clinical trial at JohnsHopkins

• .j'

procedures for FDA approval andoversight of a sponsor's monitoringof clinical trials.

• An 18-yearcold volunteer with a taiege.qetic disease at the University ofPennsylvania died after receivioga liver inj~~ti()n.··'This sparkedConcern for..patient safety and properapplication/of the informed consent

•process and .resulted.,in new

• The Center for Medicare andMedicaid Services (CMS formerlyHCFA) issued a NationalCoverage Decision which states ,thatMedicare will,pay for routine costsof qualifying clinical trials arid~omplications from clinical trialseffective September 19, 2000.(*seebackpage)

• A 2.6 million dollar settlement at theThomas Jefferson University resultedwhen a poSt~doctoral fellow.blewthe whistle. The whisrlebloweralleged'that false research dat: wasreported 'and the extent of the .'Principal Investigator's work effortwas inflated:

The federal False Claim Act (FCA)may be invoked if the information report-ed by researchers to the federal govern-ment for the purpose of seeking or sup-porting payment is inaccurate. Sinceresearch information is filed on federalforms such as the PHS Form 398, the FCAmay be applied. Violations of the FCAcan lead to serious penalties for the indi-vidual and the institution conducting theclinical trial,

Because of the increased focus onclinical trials, this publication has beenprepared to keep clinical researchers andtheir research staff informed about med-ical billing requirements of both Medicareand other payers who cover services thatmay overlap with the clinical care provid-ed in sponsored trials.

RESOURCES:The Compliance Department Web-Site(www.info.med.yale.edu/ymg/complyl contains a Research linkthat has information about clinical trials and the billing ofservices related to a clinical trial. The site has a checklist onhow to determine if a clinical trial is a qualifying trial accordingto the CMS standards, the coverage policies of many privateinsurance companies and many other items of interest.

www.info.med.yale.edu/ymg/cOmlllY

Page 2 Clincal Trial Compliance

I_W_hO_'S_W_h_O?_" ----'<\"-_ JThe YMG Compliance Department now monitors clinical trial compliance in response to the increased focus by thefederal government. The team currently consists of judy Harris, c.P.c, Director of Compliance, Jennie Oddy, R.N.,c.P.C and Theresa Griffith, R.N., c.P.C both of who are Senior Compliance Auditors. The Compliance Departmentis working to become a resource for all clinical departments for clinical trial billing information. Through training andauditing, the Compliance Department's goal is to increase awareness and knowledge of the requirements for billing forservices rendered to patients in clinical trials.

Billing Compliance Pitfalls

Some of the pitfalls to avoid when billing for services in a clinical trial include:

Double Billing - if the research sponsor is paying for the costs of some or all of theservices for patients in a clinical trial, billing Medicare or another insurer can be viewed as fraudDevices - make sure thatthe services you are billing that involve medical devices areCategory B devices and not Category A devices. Category A devices are not covered by MedicareWaiving co-payments and offering free services to volunteers in clinical trials is a violation ofgovernment regulationsMonitor the amount of research account balance dollars to avoid large amounts of residual dollars

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To avoid risky pitfalls:

• Identify studies where Medicare beneficiaries are enrolled to ensure the NCD requirements forbilling are metReview the coverage guidelines by private insurers for privately insured patientsWhen requesting ancillary services for your clinical trial patients, inform the performing provider that thepatient is in a clinical trial and who is responsible for payment of the services and, most importantly,the study contract, informed consent and/or protocol should clearly indicate what services the sponsor ispaying for versus what the patient or their insurance may be responsible for.

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Where Do the Private Insurers Stand on Clinical Trial Coverage?

Many of our private insurers were contacted by the YMG and asked to provide their coveragepolicies for clinical trial services. The results of this telephone survey can be found athttp://info.med.yale.edu/yfp/ comply/ alert/Research.htm!. The Compliance Department is in theprocess of verifying this information in writing with each insurer.

Two pieces of recent legislation impact private insurers and their policies for clinical trial coverage.Under the Managed Care Accountability Act, each insurer is required to define their clinical trialcoverage guidelines for policies renewed, altered or distributed as of ililco. The Act also requiresinsurers to offer an expedited appeals process for denials for experimental procedures for thosepatients with less than two years life expectancy. In addition, insurers may not deny as experimen-tal any service that has successfully completed a Phase III clinical tria!' (continued on page 3)

I Volume I, Number I November 2002 Page 3

Continued from page 2

fond piece of legislation, Senate Bill 325, outlines specific coverage criteria related to cancer clinical trials effective January I,

2.,-,02.This bill states that each individual health insurance policy shall provide coverage for routine patient care services in a can-cer clinical trial if the trial is conducted under the auspices of the NIH, FDA, VA, DOD or an affiliate of the National CancerInstitute.

Under this bill, a cancer clinical trial for the prevention of cancer is eligible for coverage if such a trial involves therapeutic inter-vention and is a phase III clinical trial of the FDA. Patients may go to an out of network provider to receive clinical trial servicesand insurers are required to reimburse these services using special payment rules.

Senate Bill 325 does not require insurersto pay:

the cost of the investigationalnew drug or devicecosts paid by a grant or otherfunding in the clinical trial

• services which are deemedunacceptable standards of careservices furnished only to meetthe research process

• travel, lodging, ete.• an investigational new drug

not approved for marketing bythe FDA

1 \

Research CoordinatorsAre Invited To Join

The Yale Clinical ResearchNurse Group

DATE: The second Thursday of everymonth

TIME: 12:30 PM to 1:30 PM (LunchProvided)

PLACE: LMP 3108- Old TraskRoom - 3rd Floor

PURPOSE: Networking andProfessional Development

For more information please come to ameeting or call:

I~ Carole Holmf bepartment of Internal Medicine"",:.:.. LCI!05

Telephone: 203737-4263

Penny Cook,Executive DirectorGrants and Contracts

Clinical Research:A Joint Endeavor

In the face of an increasingly restrictive environment, the Office ofGrant and Contract Administration continues to strive to improve itssupport for clinical research. We have strengthened the basic researchinfrastructure by improving the process of contract negotiation andbudgeting phases by implementing master agreements, standardcontracts and budget templates. We continue to seek better budgetingstrategies to keep us competitive in the market place.

How can you help us do our job better?• If you are considering conducting a clinical research project involve Grant

and Contract Administration (G&CA) early in the process so that contractnegotiations may be initiated as soon as possible. Provide G&CA with aSponsor contact.

• The Sponsor usually presents or has in mind a per patient budget thatwould be fair and reasonable for this project. Consult with your businessoffice or clinical trial office prior to agreeing to a per patient amount. Oncethe per patient amount is accepted contract negotiation can proceed. Notethat it is the University, rather than the PI, that will make the decision onthe acceptabiliry of a contract agreement.

• Follow our new budgeting guidelines that request that you clearly delineatebetween services being provided for research purposes as opposed to thosethat may be considered part of a subject's standard care and thus may bebillable to a third parry payor.

• Submit your HIC protocol early. It may take up to 6 weeks to gain approvalif revisions are required.

• Continue to talk to us about your frustrations, concerns and ideas for newinitiatives that would enhance our infrastructure to support clinical research.

In future articles, we look forward to providing you information on best practices inclinical research. Topics will include Conflict of Interest, Yale's Clinical ResearchCenter's, and Certificates of Confidentiality. If there are specific issues that youwould like to see highlighted E-mail me at penny.cook@yale.edu

NOTE: Grant and Contract Administration Office will be giving a workshop on theadministration of clinical trials on Monday November nth from 12:00 - 1:00 inConference Room 205, 47 College Street.

What is Medicare's National Coverage Decision?_-\5of September 19, 2000, Medicare announced in a "National Coverage Decision" (NCD) that it will cover the routine costs for items 3

services furnished in a qualifYing trial. It is important to determine if your clinical trial is a qualifying trial so that you can inform your_ Iedicare patients of their financial liability for certain services provided in the trial.

A clinical trial is a qualifying trial ifit is one which:

receives support by theNIH, CDC, AHRQ, CMS,DOD, or VA, orinvolves an InvestigationalNew Drug (IND) trialreviewed by the FDA, orinvolves an IND-exemptdrug trial,

andthe purpose of the trial is todetermine if the interventionimproves the patients healthoutcomeit is a study supported byscientific and medical datait does not unjustifiablyduplicate an existing studyit is in compliance withFederal regulation relating tothe protection of HumanSubjects: andit is conducted in accor-dance with appropriate stan-dards of scientific integrity

Judy L. HarrisDirector ofCompliance

Penrhyn CookExecutive DirectorGrants & Contracts

Terri Grif!i,hSenior ComplianceAuditor

Yale Medical GroupITHE PHYSICIANS OF YALE UNIVERSITY

David J. Leffell, M.D., DirectorPO Box 9805

ew Haven, CT 06536-0805Hotline 1-800-351-2831http://info.med. yale.edu/ymg/ comply

What costs are NOT covered in a qualifyingtrial? The costs of:

• The investigational item or service itself• Services provided solely to satisfy data

collection needs and not used in thedirect clinical management of thepatientItems or services provided by thesponsor free of chargeScreening services to see if the patient iseligible for the clinical trial

What costs ARE covered in a qualifying trial?The cost of items or services that are:

• typically provided absent a clinical trialrequired solely for the provision of theinvestigational item of service, theclinically appropriate monitoring of theeffects of the item or service or theprevention of complicationsneeded for reasonable and necessarycare arising from the provision of aninvestigational item or service, inparticular for the diagnosis or treatmentof complications

Services in a qualifying clinicaltrial should be billed to Medicarewith modifier QV. Modifier QVattests to the fact that the clinicaltrial is a qualifying trial.

Ancillary services required inconjunction with the clinical trialmust also contain modifier QV,therefore, it is important tocommunicate to the ancillarydepartments through therequisition or other form ofdocumentation that the patient isin a clinical trial.

Clinical Trials Compliance

Jennie OddySenior ComplianceAuditor