1. 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

2. 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)

3. What is a Coverage Analysis? Based on Medicare’s Clinical Trial Policy, National Coverage Decision 310.1 (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.

4. 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

5. 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

6. 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.

7. 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.

8. 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.

9. 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.

10. 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:

11. 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;

12. 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.

13. 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.

14. 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.

15. Clinical Trial Policy 310.1 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”

16. 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.

17. 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

18. 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.

19. 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.

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

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

22. 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;

23. 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.

24. 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

25. 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.

26. 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

27. Form in question format

30. ServiceCPT Code Pre- Study Evaluati on Cycle 1 Day 1 Cycle 1 Day 2 Cycle 1 Day 8 Cycle 1 Day 15 cycle 2 Day 1 cycle 2 Day 2 cycle 2 Day 8 cycle 2 Day 15 Cycle 3+ Day 1 Cycle 3+ Day 8 Cycle 3+ Day 15 Follow- Up Visit (15-30 days after last BBI503 dose) 0Comment Physical Exam / Vital Signs (E&M Visit) 99201-99205, 99211-99215, G0463 MMM-NCCN Breast Cancer Guidelines (v.1.2016) support H&P at workup (BINV-1,17) -Evaluations at Day 1 of Cycle 2 and beyond, and shortly after drug discontinuation (follow- up) appears performed to monitor toxicities of therapy and disease response/progression -Medical records must document medical necessity and support level of E&M performed. BBI503 (oral) - Once daily N/A MMMMMMMMMMM- Supplied by sponsor Paclitaxel (IV) J9267 MMMMMMMMM- Analysis assumes paclitaxel therapy will be used within FDA label or NCCN compendial listing Paclitaxel has an FDA labeled indication in Breast Cancer: 1)Adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy 2)Treatment of metastatic breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy Paclitaxel has an NCCN Compendial listing in Invasive Breast Cancer: 1)Preoperative systemic therapy 2)Adjuvant systemic therapy 3)May be considered in combination with trastuzumab for low-risk stage I, human epidermal growth factor receptor 2-positive disease 4)Preferred single agent or in combination with gemcitabine or bevacizumab for recurrent or metastatic human epidermal growth factor receptor 2-negative disease 5)Used for recurrent or metastatic human epidermal growth factor receptor 2 (HER2)-positive disease that is either hormone receptor-negative, hormone receptor-positive and endocrine therapy refractory, for symptomatic visceral disease, or visceral crisis 6)Weekly paclitaxel can be used in pregnant women with confirmed breast cancer and no distant metastases if clinically indicated by disease status CT - Abdomen / Pelvis - Baseline, Every 8wks 74176-74178 MM -Per protocol, imaging consists of CT with intravenous contrast of the chest, abdomen, and pelvis or Magnetic resonance imaging (MRI) of the abdomen and pelvis plus a non-contrast CT of the chest (Page 24) -NCCN Breast Cancer Guidelines (v.1.2016) support Chest CT and Abdomen and Pelvic CT or MRI of the abdomen and Pelvic at workup for stage IIIA, and recurrent stage IV disease (BINV- 1,17) -Imaging every 8 weeks appears reasonable and necessary to monitor response to therapy -NCD 220.1 generally support CT use -Medical record must justify use CT - Abdomen - Baseline, Every 8wks 74150-74170 MM - NCCN Breast Cancer Guidelines (v.1.2016) support Chest CT and Abdomen and Pelvic CT or MRI at workup for stage IIIA, and recurrent stage IV disease (BINV-1, 17) CT - Chest - Baseline, Every 8wks 71250-71270 MM -Per protocol, imaging consists of CT with intravenous contrast of the chest, abdomen, and pelvis or Magnetic resonance imaging (MRI) of the abdomen and pelvis plus a non-contrast CT of the chest (Page 24) -NCCN Breast Cancer Guidelines (v.1.2016) support Chest CT and Abdomen and Pelvic CT or MRI of the abdomen and Pelvic at workup for stage IIIA, and recurrent stage IV disease (BINV- 1, 17) -Imaging every 8 weeks appears reasonable and necessary to monitor response to therapy -NCD 220.1 generally support CT use -Medical record must justify use

31. ServiceCPT Code Pre- Study Evaluati on Cycle 1 Day 1 Cycle 1 Day 2 Cycle 1 Day 8 Cycle 1 Day 15 cycle 2 Day 1 cycle 2 Day 2 cycle 2 Day 8 cycle 2 Day 15 Cycle 3+ Day 1 Cycle 3+ Day 8 Cycle 3+ Day 15 Follow- Up Visit (15-30 days after last BBI503 dose) 0Comment CT - Pelvis - Baseline, Every 8wks 72192-72194 MM -Per protocol, imaging consists of CT with intravenous contrast of the chest, abdomen, and pelvis or Magnetic resonance imaging (MRI) of the abdomen and pelvis plus a non-contrast CT of the chest (Page 24) -NCCN Breast Cancer Guidelines (v.1.2016) support Chest CT and Abdomen and Pelvic CT or MRI of the abdomen and Pelvic at workup for stage IIIA, and recurrent stage IV disease (BINV- 1,17) -Imaging every 8 weeks appears reasonable and necessary to monitor response to therapy -NCD 220.1 generally support CT use -Medical record must justify use MRI - Abdomen - Baseline, Every 8wks 74181-74183 MM -Per protocol, imaging consists of CT with intravenous contrast of the chest, abdomen, and pelvis or Magnetic resonance imaging (MRI) of the abdomen and pelvis plus a non-contrast CT of the chest (Page 24) -NCCN Breast Cancer Guidelines (v.1.2016) support Chest CT and Abdomen and Pelvic CT or MRI of the abdomen and Pelvic at workup for stage IIIA, and recurrent stage IV disease (BINV- 1,17) -Imaging every 8 weeks appears reasonable and necessary to monitor response to therapy -NCD 220.2 generally support MRI use -Medical record must justify use MRI - Pelvis - Baseline, Every 8wks 72195-72197 MM -Per protocol, imaging consists of CT with intravenous contrast of the chest, abdomen, and pelvis or Magnetic resonance imaging (MRI) of the abdomen and pelvis plus a non-contrast CT of the chest (Page 24) -NCCN Breast Cancer Guidelines (v.1.2016) support Chest CT and Abdomen and Pelvic CT or MRI of the abdomen and Pelvic at workup for stage IIIA, and recurrent stage IV disease (BINV- 1,17) -Imaging every 8 weeks appears reasonable and necessary to monitor response to therapy -NCD 220.2 generally support MRI use -Medical record must justify use Paclitaxel - Administration once weekly on days 1, 8, and 15 of each 28- day cycle 96413-96417 MMMMMMMMM- Analysis assumes paclitaxel therapy will be used within FDA label or NCCN compendial listing Paclitaxel has an FDA labeled indication in Breast Cancer: 1)Adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy 2)Treatment of metastatic breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy Paclitaxel has an NCCN Compendial listing in Invasive Breast Cancer: 1)Preoperative systemic therapy 2)Adjuvant systemic therapy 3)May be considered in combination with trastuzumab for low-risk stage I, human epidermal growth factor receptor 2-positive disease 4)Preferred single agent or in combination with gemcitabine or bevacizumab for recurrent or metastatic human epidermal growth factor receptor 2-negative disease 5)Used for recurrent or metastatic human epidermal growth factor receptor 2 (HER2)-positive disease that is either hormone receptor-negative, hormone receptor-positive and endocrine therapy refractory, for symptomatic visceral disease, or visceral crisis 6)Weekly paclitaxel can be used in pregnant women with confirmed breast cancer and no distant metastases if clinically indicated by disease status - 0 0 Venipuncture - Conventional Care Draw 36415 MMMMM- Performed to acquire conventional care blood sample aPTT - If clinically indicated 85730 MMMMMPer protocol, "Coagulation indices may be required (PT/INR, PTT) -Analysis assumes testing only preformed if clinically indicated / medically necessary -Medical record must justify use

32. ServiceCPT Code Pre- Study Evaluati on Cycle 1 Day 1 Cycle 1 Day 2 Cycle 1 Day 8 Cycle 1 Day 15 cycle 2 Day 1 cycle 2 Day 2 cycle 2 Day 8 cycle 2 Day 15 Cycle 3+ Day 1 Cycle 3+ Day 8 Cycle 3+ Day 15 Follow- Up Visit (15-30 days after last BBI503 dose) 0Comment CBC w/diff 81025 MMMMMMMMM -Qualifying Clinical trial, NCD 310.1 allows for the coverage of routine cost of conventional care. -Paclitaxel is known to cause hematologic toxicities including Neutropenia, leukopenia, anemia, and thrombocytopenia -Testing at workup, Frequently during therapy, and shortly after drug discontinuation (follow- up) appears performed to establish baseline and monitor toxicities of conventional therapy -Coverage also generally supported by NCD 190.15 -Medical record must justify use CMP 80053 MMMMM -Qualifying Clinical trial, NCD 310.1 allows for the coverage of routine cost of conventional care. -Paclitaxel is known to cause Hepatic (Alkaline phosphatase increased, AST increased) and Renal toxicities (Creatinine increases) - Lexicomp -Testing at workup, Cycle 1 Day 8 and Day 1 of Cycle 2 and beyond, and shortly after drug discontinuation (follow-up) appears performed to establish baseline and monitor toxicities of conventional therapy -Medical record must justify use Direct bilirubin 82248 MMMMM -Qualifying Clinical trial, NCD 310.1 allows for the coverage of routine cost of conventional care. -Paclitaxel is known to cause bilirubin increases - Lexicomp -Testing at workup, Cycle 1 Day 8 and Day 1 of Cycle 2 and beyond, and shortly after drug discontinuation (follow-up) appears performed to establish baseline and monitor toxicities of conventional therapy -Medical record must justify use LDH 83615 MMMMM -Qualifying Clinical trial, NCD 310.1 allows for the coverage of routine cost of conventional care. -An LD level may be ordered, along with other tests such as a comprehensive metabolic panel (CMP), when cellular or tissue damage is suspected. -DH is also used to help stage, determine prognosis, and/or monitor treatment (i.e., chemotherapy) of cancers. -Medical records must document medical necessity. PT/INR - If clinically indicated 85610 MMMMMPer protocol, "Coagulation indices may be required (PT/INR, PTT) -Analysis assumes testing only preformed if clinically indicated / medically necessary -Medical record must justify use Serum Pregnancy 84702-84703 M -While Medicare may not reimburse for pregnancy testing under NCD 190.27 some other payers will reimburse. -Paclitaxel is pregnancy risk category D (There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective) Tumor Markers - If clinically indicated xxxxx MMMM-Protocol does not indicate specific tumor maker -Analysis assumes specific tumor marker testing only preformed if clinically indicated / medically necessary -Medical record must justify use Archival Tissue - Processing 83999, 99000, 99001 S- Per protocol, "Archival tissue samples will be obtained from all enrolled patients." Page 70 Breast Biopsy - optional - Tissue to central lab 83999, 99000, 99001 SS -Optional tumor biopsy component to this study. Patients with tumors which are easil accessible through a minimally invasive procedure as assessed by the investigator will be eligible to participate. -Baseline biopsy obtained prior to the first dose of protocol therapy, and/or an on-study biopsy, obtained on Cycle 2, Day 1. -Performed for research purposes; invoiced to sponso Breast Biopsy - w/imaging - optional 19081, 19083, 19085 SS -Optional tumor biopsy component to this study. Patients with tumors which are easil accessible through a minimally invasive procedure as assessed by the investigator will be eligible to participate. -Baseline biopsy obtained prior to the first dose of protocol therapy, and/or an on-study biopsy, obtained on Cycle 2, Day 1. -Performed for research purposes; invoiced to sponso

33. ServiceCPT Code Pre- Study Evaluati on Cycle 1 Day 1 Cycle 1 Day 2 Cycle 1 Day 8 Cycle 1 Day 15 cycle 2 Day 1 cycle 2 Day 2 cycle 2 Day 8 cycle 2 Day 15 Cycle 3+ Day 1 Cycle 3+ Day 8 Cycle 3+ Day 15 Follow- Up Visit (15-30 days after last BBI503 dose) 0Comment CT - Abdomen / Pelvis - Confirmation Scan 74176-74178 S -Per protocol, "Patients with an imaging assessment which meets criteria for either complete response (CR) or partial response (PR) according to RECIST should have a repeat, confirmatory, radiologic assessment approximately 4 weeks after the assessment in which CR or PR criteria were met." -RECICT 1.1 guidelines support confirmation scans in non-randomized trials where response is the primary endpoint -The BBI503-201 trial prior endpoint does not meet RECIST 1.1 confirmation criteria; sponsor to pay if confirmation imaging performed CT - Abdomen - Confirmation Scan 74150-74170 S -Per protocol, "Patients with an imaging assessment which meets criteria for either complete response (CR) or partial response (PR) according to RECIST should have a repeat, confirmatory, radiologic assessment approximately 4 weeks after the assessment in which CR or PR criteria were met." -RECICT 1.1 guidelines support confirmation scans in non-randomized trials where response is the primary endpoint -The BBI503-201 trial prior endpoint does not meet RECIST 1.1 confirmation criteria; sponsor to pay if confirmation imaging performed CT - Chest - Confirmation Scan 71250-71270 S -Per protocol, "Patients with an imaging assessment which meets criteria for either complete response (CR) or partial response (PR) according to RECIST should have a repeat, confirmatory, radiologic assessment approximately 4 weeks after the assessment in which CR or PR criteria were met." -RECICT 1.1 guidelines support confirmation scans in non-randomized trials where response is the primary endpoint -The BBI503-201 trial prior endpoint does not meet RECIST 1.1 confirmation criteria; sponsor to pay if confirmation imaging performed CT - Pelvis - Confirmation Scan 72192-72194 S -Per protocol, "Patients with an imaging assessment which meets criteria for either complete response (CR) or partial response (PR) according to RECIST should have a repeat, confirmatory, radiologic assessment approximately 4 weeks after the assessment in which CR or PR criteria were met." -RECICT 1.1 guidelines support confirmation scans in non-randomized trials where response is the primary endpoint -The BBI503-201 trial prior endpoint does not meet RECIST 1.1 confirmation criteria; sponsor to pay if confirmation imaging performed ECG 93000/93005-93010 SSSS -12-lead ECG obtained 4 hours after BBI503 dose and 2 hours after comparator therapy (sunitinib, nivolumab, paclitaxel, doxorubicin, pembrolizumab, capecitabine) dose -BBI503 investigational drug brochure does not indicate cardiotoxicity -Testing appears performed for research purposes MRI - Abdomen - Confirmation Scan 74181-74183 S -Per protocol, "Patients with an imaging assessment which meets criteria for either complete response (CR) or partial response (PR) according to RECIST should have a repeat, confirmatory, radiologic assessment approximately 4 weeks after the assessment in which CR or PR criteria were met." -RECICT 1.1 guidelines support confirmation scans in non-randomized trials where response is the primary endpoint -The BBI503-201 trial prior endpoint does not meet RECIST 1.1 confirmation criteria; sponsor to pay if confirmation imaging performed MRI - Pelvis - Confirmation Scan 72195-72197 S -Per protocol, "Patients with an imaging assessment which meets criteria for either complete response (CR) or partial response (PR) according to RECIST should have a repeat, confirmatory, radiologic assessment approximately 4 weeks after the assessment in which CR or PR criteria were met." -RECICT 1.1 guidelines support confirmation scans in non-randomized trials where response is the primary endpoint -The BBI503-201 trial prior endpoint does not meet RECIST 1.1 confirmation criteria; sponsor to pay if confirmation imaging performed Shipping/Handling - Central Lab Sample (PK) 99000-99001 SSSSSSS- Performed for research purposes - 0 0 Venipuncture - research draw - Local lab sample 36415 SSSSS- Performed for research purposes

34. Dat e: M = Potentially Billable to Third Party Payer S = Paid for by Sponsor O = Paid for by Other APPROVAL : Principal Investigator: Institutio n: ServiceCPT Code Pre- Study Evaluati on Cycle 1 Day 1 Cycle 1 Day 2 Cycle 1 Day 8 Cycle 1 Day 15 cycle 2 Day 1 cycle 2 Day 2 cycle 2 Day 8 cycle 2 Day 15 Cycle 3+ Day 1 Cycle 3+ Day 8 Cycle 3+ Day 15 Follow- Up Visit (15-30 days after last BBI503 dose) 0Comment Venipuncture - Research Draw - Central Lab Sample (PK) 36415 SSSSSSS- Performed for research purposes Phosphorus 84100 SSSSS-Testing is not supported in BBI503 Investigational Drug Brochure -Testing is not supported in paclitaxel prescribing information -Test appears performed for research purposes Urinalysis 81000-81015 SSSS-Testing is not supported in BBI503 Investigational Drug Brochure -Testing is not supported in paclitaxel prescribing information -Test appears performed for research purposes Magnesium 83735 SSSSS-Testing is not supported in BBI503 Investigational Drug Brochure -Testing is not supported in paclitaxel prescribing information -Test appears performed for research purposes Uric acid 84550 SSSSS-Testing is not supported in BBI503 Investigational Drug Brochure -Testing is not supported in paclitaxel prescribing information -Test appears performed for research purposes

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

36. 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.

37. 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?

38. 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.

39. 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?

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

41. 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.

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

43. 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”

44. 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

45. 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

46. 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

47. 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.

48. Bibliography Phases of Clinical Trials: http:// www. cancer. gov/ clinicaltrials/understanding/what-is-a-clinical-trial) Common Per Patient Costs: University of Utah Health Sciences Center; “Budget Development & Negotiations” http://uuhsc.utah.edu/clinicalTrials/finanAdmin/budget- negotiate.html (10 November 2004) http://uuhsc.utah.edu/clinicalTrials/finanAdmin/budget- negotiate.html Screen Failures and Early Termination: Office of Clinical Trials: handbook, part2: “Evaluating Budgets” http://research.unc.edu/oct/handbook_part_2.html (5 November 2004) http://research.unc.edu/oct/handbook_part_2.html Phase IV Trials: ( http:// www. cancer. gov/ clinicaltrials/understanding/what-is-a-clinical-trial)

49. Contact David Whaley, J.D. Clinical Trials Coordinator LSU Health Sciences Center - Stanley S. Scott Cancer Center 504-210-2825 dwhal1@lsuhsc.edu