I have to do a Coverage Analysis before I complete my Clinical Trial Budget? David Whaley, J.D. Clinical Trials & Contract Coordinator LSU Health Sciences Center – Stanley S. Scott Cancer Center

Research Billing Rules There is not one place to go for all rules that cover clinical research billing: Statutes Regulations CMS National Coverage Determinations NCD) CMS Manuals Local Coverage Determinations (LCD)

What is a Coverage Analysis? Based on Medicare’s Clinical Trial Policy, National Coverage Decision (NCD 310.1) the Medicare Coverage Analysis (MCA) is one of the most useful documents for building a clinical trial budget and clinical trial billing compliance.

Why do we care about billing compliance? FALSE CLAIMS ACT: No proof of specific intent to defraud is required in order to violate the act. PENALTIES $5,500 to $11,000 for each claim, Possible treble charges (re-pay three times the amount of the claim), Possible criminal charges, Possible exclusion from Federal Healthcare Programs

Rush University Medical Center- $1 million settlement in 2005 for improperly billing services as routine costs under the Medicare Clinical Trial Policy. USC Norris Cancer Center- $1.9 million dollar settlement, billed for services paid by sponsor and billed for services in non- qualifying trial. University of Alabama- $3.39 million settlement for falsely billing Medicare for procedures also billed to the sponsor Emory University- $1.5 million settlement for falsely billing Medicare and Medicaid for clinical trial services that were not permitted. Examples

National Coverage Decision Indications and Limitations of Coverage Effective for items and services furnished on or after July 9, 2007, Medicare covers the routine costs of qualifying clinical trials, as such costs are defined below, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply.

National Coverage Decision Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms of a clinical trial except: The investigational item or service, itself unless otherwise covered outside of the clinical trial; Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan); and Items and services customarily provided by the research sponsors free-of-charge for any enrollee in the trial.

National Coverage Decision Routine costs in clinical trials include: Items or services that are typically provided absent a clinical trial (e.g., conventional care); Items or services required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service in particular, for the diagnosis or treatment of complications.

Routine Costs Any clinical trial receiving Medicare coverage of routine costs must meet the following three requirements: The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category (e.g., physicians' service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids). The trial must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent. Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers. Trials of diagnostic interventions may enroll healthy patients in order to have a proper control group.

Desirable Characteristics The three requirements above are insufficient by themselves to qualify a clinical trial for Medicare coverage of routine costs. Clinical trials also should have the following desirable characteristics; however, some trials, as described below, are presumed to meet these characteristics and are automatically qualified to receive Medicare coverage:

Desirable Characteristics The principal purpose of the trial is to test whether the intervention potentially improves the participants' health outcomes; The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use; The trial does not unjustifiably duplicate existing studies; The trial design is appropriate to answer the research question being asked in the trial;

Desirable Characteristics The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully; The trial is in compliance with Federal regulations relating to the protection of human subjects; and All aspects of the trial are conducted according to the appropriate standards of scientific integrity.

Qualifying Trials Effective September 19, 2000, clinical trials that are deemed to be automatically qualified are: Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA; Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and VA; Trials conducted under an investigational new drug application (IND) reviewed by the FDA; and Drug trials that are exempt from having an IND under 21 CFR 312.2(b)(1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place.

Really? What does all this mean, and how do we know if we are billing correctly? Let’s summarize, look at some examples and tools to help with the process.

Clinical Trial Policy Established criteria under which Medicare would provide coverage for beneficiaries enrolled in a clinical trial Medicare will pay for “routine cost” of “qualifying clinical trials”

What is a Qualifying Trial? Medicare Benefit Category The subject or purpose of the trial must be for the evaluation of a Medicare Benefit Category.

Medicare Benefit Category Generally does it fall into one of these: 1. Drugs, biologics and therapeutics; 2. Laboratory and diagnostic services 3. Medical and surgical procedures 4. Diagnostic imaging 5. Medical devices and prosthetics 6. Durablr medical equipment

What is a Qualifying Trial Must fall into a Medicare Benefit Category plus it must have therapeutic intent. Generally must have therapeutic intent; it cannot exclusively test toxicity or disease pathophysiology.

Therapeutic Intent Sounds easy enough. BUT: The American Society of Clinical Oncology and other cancer organizations have released position statements that Phase I oncology trials do have therapeutic intent. Medicare has not made a determination.

What is a Qualifying Trial? Medicare Benefit Category + Therapeutic Intent + Diagnosed Disease The study must enroll patients with a diagnosed disease.

What is a Qualifying Trial? Medicare Benefit Category + Therapeutic Intent + Diagnosed disease + Deemed The trial must be “Deemed”?

What makes a Trial Deemed? Trial must have the seven desirable characteristics as defined by Medicare: 1. Principal purpose is to test whether the intervention potentially improves participants’ outcomes 2. Trial is well supported by scientific and medical information or is intended to clarify or establish the health outcomes of interventions already in common use. 3. Trial does not unjustifiably duplicate existing studies;

What makes a Trial Deemed? 4. The trial design is appropriate to answer the research question 5. Trial is sponsored by a credible organization or individual capable of successfully executing the trial; 6. Trial is in compliance with Federal Regulation relating to the protection of human subjects; 7. Trial is conducted according to the appropriate standards of scientific integrity.

Studies that are Deemed 1. Studies funded by NIH, CDC, AHRQ, CMS, DOD or VA; 2. Studies supported by centers or cooperative groups funded by NIH, CDC, AHRQ, CMS, DOD or VA; 3. Studies conducted under an IND application; 4. IND exempt studies

Deemed If your study is funded or sponsored by one of those groups or falls into one of the categories it is deemed to have the seven desirable characteristics.

Deemed and Necessary If the study falls within one of the 4 types of trials deemed to meet 7 desirable characteristics, AND the study meets all 3 necessary requirements: 1. Medicare Benefit Category + 2. Have therapeutic intent + 3. Enroll patients with a diagnosed disease = Qualifying Trial

Form in question format

APPENDIX A: Schedule of Treatment and Evaluations Screening -21 DaysCycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6 End of Study or Early Termination Follow-up 12 Comments Signed informed consentS Paid for by sponsor as part of the clinical trial Review inclusion/exclusionS2 Paid for by sponsor funding Medical history 1 NB Part of an office visit, not separately billable Physical examinationNBMMMMMMM First exam is not billable, appears to be only to determine eligibility for the clinical trial, other office visit billable, routine care, would be required for the monitoring of the effects of the investigational item. Height (cm)NB Part of an office visit, not separately billable Weight (kg)NB Part of an office visit, not separately billable BSA calculation M2 Necessary for the administration of the drug, not separately billable, necessary for the calculation of the dose, administration of the study drug is billable Vital signs 3 NB Part of an office visit, not separately billable Karnofsky PSSSSSSSSS Paid for by sponsor as part of the clinical trial Tumor measurements 4 M M M NCCN guidelines do not specifically address KS; however, soft tissue sarcoma guidelines support CT/MRI at workup. CT/MRI should both be done depending on where lesions are locatedl Journal of Clinical Oncology, Vol 16, No7 (July) 1998: pp / HIV Medicine (2008) 9, / NCCN guidelines EXTSARC-1, ECGMM M M M required to monitor the effects of the investigational drug to check for cardiotoxicity ECHO (with ejection fraction)M M M required to monitor the effects of the drug to check for cardiotoxicity CBC w/differential & plts 5 MMMMMMMM required to monitor the effects of the drug, routine care would be done absent a clinical trial Serum chemistries 5,6 MMMMMMMM required to monitor the effects of the drug, routine care would be done absent a clinical trial Urinalysis 7 M M Routine care (same as above) Serum/urine pregnancy testS Strictly for inclusion/exclusion for the clinical trial ALDOXORUBICIN administration 14 MMMMMM Billable as routine under Concomitant medications 9 S2 Paid for through sponsor funding Biopsy of tumor S S S Paid for through sponsor funding Adverse events 10 SSSSSSSS Paid for by sponsor as part of the clinical trial Telephone follow-up 12 SPaid for by sponsor as part of the clinical trial

Routine Costs Routine costs can be billed to Medicare for patients enrolled in this clinical trial.

What are Routine Cost? You can bill more than you think! This is not billing for “Standard of Care” You can bill for any item or service needed for the reasonable and necessary care arising from the provision of the investigational item or service AND for the diagnosis or treatment of complications AND clinically appropriate monitoring of the effects of the item or service or prevention of complications.

Examples A patient is enrolled in a clinical trial and receives the study drug in combination with standard chemotherapy. Is the intravenous infusion of the study drug considered routine cost?

YES You may bill for the infusion of the standard drug AND the investigational drug. REMEMBER: Medicare Clinical Trials Policy covers items or services required solely for the provision of the investigational item or service.

Example Patient is enrolled in a clinical trial for breast cancer, the investigational drug can cause heart arrhythmias. The protocol requires a ECG before enrolling the patient, after the third dose and at end of study. Can you bill Medicare for these ECG’s?

YES It is allowable to bill for tests to detect and treat complications related to the use of the study drug.

Just Routine Care Also remember routine care can be billed to Medicare. For example the protocol requires CT of the chest abdomen and pelvis every three months, NCCN guidelines state a CT of the Chest abdomen and pelvis should be done every 90 days. This is billable, would do this whether the patient is on study or not.

Abbreviated version of Routine 1. Conventional care 2. Administration of Investigational item 3. Detection or prevention of complications

Conventional Care Items or services typically provided absent a clinical trial, do not use the tern “standard of care” Conventional care is broader and more objective. It more accurately equates to the “national standard of billable items or services”

Conventional Care The MCA should identify the objective guidelines to support the designation of “conventional care” –professional association guidelines –Peer-reviewed literature –Disease associations –NIH recommendations ASK THE P.I. FOR GUIDELINES

Coding Clinical Trial Number (value must be used on UB-04) Revenue Codes for Devices and supplies (0624 & 0278) Condition Code 30- qualifying clinical trial Diagnosis Code V70.7- examination of participant in a clinical trial

Coding HCPCS Modifier Q0- Investigational clinical service provided in a clinical research study that is an approved clinical research study HCPCS Modifier Q1- Routine clinical service provided in a clinical research study that is an approved clinical research study

Caveat This has been a very introductory session. Hopefully I have pointed out issues that are important, and everyone understands the extreme importance of completing an MCA.

Bibliography Phases of Clinical Trials: www. cancer. gov/ clinicaltrials/understanding/what-is-a-clinical-trial) Common Per Patient Costs: University of Utah Health Sciences Center; “Budget Development & Negotiations” negotiate.html (10 November 2004) negotiate.html Screen Failures and Early Termination: Office of Clinical Trials: handbook, part2: “Evaluating Budgets” (5 November 2004) Phase IV Trials: ( www. cancer. gov/ clinicaltrials/understanding/what-is-a-clinical-trial)

Contact David Whaley, J.D. Clinical Trials Coordinator LSU Health Sciences Center - Stanley S. Scott Cancer Center