Clinical Trials: Cost Coverage and Implications for the Clinical Trials Nurse

1. Clinical Trials: Cost Coverage and Implications for the Clinical Trials Nurse

2. Objectives • Discuss the costs and health care plan coverage issues associated with clinical trial participation. • Identify the key components of the Medicare 2000 National Coverage Decision. • Properly identify standard of care costs from research costs per regulations and link it to the budgeting, negotiation and payment process. • Describe systems for accurate research billing and common pitfalls

3. The Ties that Bind • Clinical Research is important to cancer treatment • Improved cancer care with new therapies • Defined standards for optimal cancer treatment • Provides options when there are no known treatments for a disease • Provides a potentially more effective and less toxic treatment (American Society of Clinical Oncology, 2003; Association of Academic Health Centers, 2009)

4. Understanding the landscape • Complex infrastructure • Little noted and rarely studied • Rapidly changing environment in recent years as a result of • Increased research activity • Mounting regulatory requirements • Escalating costs (American Society of Clinical Oncology, 2003; Association of Academic Health Centers, 2009)

5. Costs & Coverage • Cancer patients who enroll in clinical trials may face the critical issue of how to cover the costs of care • Health insurance coverage may not include some or all of the costs associated with participation in a clinical trial • Some plans may define clinical trials as “experimental” or “investigational” (Association of Academic Health Centers, 2009; National Cancer Institute, U.S. National Institutes of Health, 2009)

6. What is the Legislation? • Federal • National Coverage Decision on Clinical Research (Clinical Research Policy) • Billing for Clinical Services in a Clinical Trial • Notification to Subjects regarding Costs • Local • Local Medicare Review Policies (LMRP’s) (CMS Medicare National Coverage Determinations Manual, 2009)

7. The Era of Managed Care • Managed Care Organizations and Health Insurance companies determine the services they will pay for by developing a coverage policy that is applied to all members • Established Service • Investigational Service (Emanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003, National Cancer Institute, U.S. National Institutes of Health, 2009)

8. Established: A service is designated “established” if there is sufficient scientific data to support that it is safe and effective. Investigational: A service for which the health plan declares insufficient scientific data to support safety and efficacy. Leads to payment denial Lengthy and often unsuccessful appeal process Established Versus Investigational (Emanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003, National Cancer Institute, U.S. National Institutes of Health, 2009)

9. Clinical Trial Criteria for Coverage • Sponsorship • Some plans may cover costs of trials sponsored by organizations that provide rigorous scientific review and regulatory oversight such as the NCI, according to standards set by the health plan. (National Cancer Institute, U.S. National Institutes of Health, 2009)

10. Clinical Trial Criteria for Coverage • Trial phase and type • Some plans may cover patient care costs only for the clinical trials they judge to be "medically necessary" on a case-by-case basis. The phase of the trial may also affect coverage; for example, while a plan may be willing to cover costs associated with phase III, which include treatments that have already been successful with a certain number of people, the plan may require some documentation of effectiveness before covering a phase I or phase II trial. (National Cancer Institute, U.S. National Institutes of Health, 2009)

11. Clinical Trial Criteria for Coverage • Cost "neutrality“ • Some health plans may provide limited coverage for trials they consider cost-neutral (i.e., not significantly more expensive than the treatments considered standard). (National Cancer Institute, U.S. National Institutes of Health, 2009)

12. Rose Ermete RN, BSN, OCN, CCRP Oncology Research Nurse St. Mary Mercy Hospital Clinical Trials Billing

13. Clinical Trials Billing Overview • The Importance of Compliance • Billing Rules • Systems to ensure appropriate billing

14. Note: Image courtesy of CartoonStock.com. Used with permission.

15. Why is this Important (Meade , 2009; Pitler & Bloom 2006; Barnes & Korn 2005) • Data Mining by CMS • Evaluation of all Claims with Modifiers • Assessment across the institution • The Cost of Non-Compliance • Criminal & Civil Penalties • Ability to conduct Federally Funded Research • Exclusions from Medicare/Medicaid • Adverse Public Relations • Qui Tam: Whistle blowers

16. False Claims Settlements Compliance Rules = Fraud Rules The False Claims Act :Civil Penalties for persons who knowingly make or cause to be made, false claims to the government. Services paid for by sponsor Services promised for free in the Informed Consent Services that are for research purposes only Services that are part of a non-qualifying clinical Trial Fraudulent Claims : Liable to the US Government for civil penalty of not less than $5,000 and not more than $10,000 plus 3 X the amount of damages. ( Beach & Strehlow, 2006; Meade, 2006; FCA, 2007)

17. Partial List of OIG/DOJ Investigations • Rush University 1.0 million settlement • New Jersey Medical 2.0 million settlement • Johns Hopkins 2.6 million settlement • Beth Israel Deaconess 3.2 million settlement • University of Alabama 3.4 million settlement • Cornell University 4.3 million settlement • UCSD 4.7 million settlement • Northwestern University 5.5 million settlement • Medical College of Georgia 6.1 million settlement • Mayo Clinic 6.5 million settlement • Yale University 7.6 million settlement (Based on information from: Schwab, 2009 & TAF, 2008)

18. Lessons from Rush Inspection Findings: Billed third parties for sponsor paid services Billed for services promised for free in the informed consent Billed for services that did not meet the definition of routine costs Coordination & Communication No Centralization of billing process Lack of Coordination between research and billing department The settlement indicates what the government is looking for from providers who conduct clinical trials. Centralization & documentation Oversight throughout institution Monthly account/reconciliation (Schwab, 2009; Boyd & Meade, 2007; Pfadenhauer, 2006)

19. Note: Image courtesy of CartoonStock.com. Used with permission

20. Billing Rules Basic Rules: No double dipping If the service if provided free, you cannot bill for it (Secondary-payer rule) Must be an already covered service The National Coverage Decision (NCD) Covers routine costs of qualifying clinical trials Coverage discretion is up to local Medicare contractors Medicaid is different – does not address research Insurance Companies: 29 states require commercial insurance cover clinical trials. (Barnes & Korn, 2005 ;CMS Medicare National Coverage Determinations Manual, 2009; Meade 2006)

21. States Requiring Health Plans to Cover Patient Care Costs in Clinical Trials (National Cancer Institute, 2009)

22. The Patient Protection & Affordable Care Act of 2010 Signed into law March 23, 2010; Public Law No: 111-148 In General – If a group health plan or a health insurance issuer offering group or individual health insurance coverage provides coverage to a qualified individual, then such plan or issuer: May not deny the individual participation in a clinical trial referred to in subsection (b)(2) Subject to subsection (c), may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and May not discriminate against the individual on the basis of the individual’s participation in such trial. Limitations – subsection (c) HR 3590 Sec.10103 & 2709 retrieved from: http://frwebgate.access.gpo.gov

23. Pending Legislation Improving Access to Clinical Trials Act (S.1674) Introduced by Senator Ron Wyden (D-Oregon), Exempt the first $2,000 a year in compensation for clinical trial participation from determining Social Security Insurance or Medicaid benefits Currently pending before the Senate Finance Committee

24. Note: Image courtesy of CartoonStock.com. Used with permission.

25. What is a Qualifying Trial? 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 and is not statutorily excluded from coverage 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 Deemed Studies Trials funded by NIH, CDC, AHRQ, CMS, DOD and VA Supported by centers or cooperative groups that are funded by the above Conducted under an IND reviewed by the FDA IND exempt studies (Pitler & Bonomi, 2006; CMS National Coverage Determination Manual, 2009; Barnes & Korn, 2005)

26. What is a Qualifying Trial? Seven Desirable Characteristics Principal purpose has to test if the intervention potentially improves the subjects health outcomes Well-supported by available scientific and medical information or intended to clarify or establish the health outcomes of interventions already in common clinical use Does not unjustifiably duplicate existing studies Design is appropriate to answer the research question being asked Sponsored by a credible organization or individual capable of executing the proposed trial successfully Compliance with Federal regulations relating to the protection of human subjects Conducted according to the appropriate standards of scientific integrity Deemed Clinical Trials are deemed by CMS as inherently having these characteristics (Boyd & Meade, 2007; CMS Medicare National Coverage Determinations Manual, 2009; Lanter, 2008)

27. Coverage under the NCD (CTP) What is Covered Items and services provided absent of a clinical trial Required solely for the provision of the investigational item Reasonable and necessary care for the diagnosis or treatment of an illness or injury What is not Covered Data Collection and analysis Items and services customarily provided by the research sponsors free of charge Items and services provided solely to determine trial eligibility The investigational item or service itself, unless otherwise covered outside the clinical trial A Medicare benefit category does not exist for the service (Barnes & Korn, 2005; CMS National Coverage Determination Manual, 2009)

28. Routine vs. Standard of Care Routine Care: Services that would take place as a result of a regular course of treatment for cancer care, However: Consistency doesn’t always exist, just because it is routine in one practice, does not mean it will be covered. National Therapeutic Standards NCCN Guidelines ACOS Guidelines Peer Reviewed Journal Not all routine care is covered Routine Costs also include: Reasonable & necessary to diagnose or treat Services required for the clinically appropriate monitoring or diagnosis of the effects of the item or service, or prevention of complications. (Barnes & Korn, 2005, Meade, 2009; MLN Matters MM6431, 2009; Pitler & Ponomi, 2006; Seiner & Murtha, 2006; Turgon & Welter, 2008)

29. Gratuitous services Items provided gratuitously without regard to beneficiaries ability to pay Anti- Kickback Statute 42 U.S.C. § 1320a-7b Provides for penalties against anyone who knowingly and willfully receives, gives, solicits or offer any payment or other form of remuneration with the intent to induce or influence the purchase, order, or referral of drugs, devices, products, services or other items reimbursable under a federal health care program Penalties for violations of the statue include a fine of not more than $25,000 or imprisonment for up to five years, or both. (AKS, 2007; CMS Medicare Benefit Policy Manual, 2009; MLN Matters SE0822., 2009)

30. Coding Rules Secondary diagnosis code: V70.7 Examination of participant in a clinical trial Used for inpatient & outpatient Healthcare Common Procedure Coding System (HCPCS) modifier: Q0: Investigational clinical services defined as those items and services that are being investigated as an objective within the study. Q1: Constitute medically necessary routine patient care or treatment of complications arising from a Medicare beneficiary's participation in a Medicare-covered clinical trial. HCPCS modifiers are only used in the outpatient setting 8 Digit clinical trial number is optional Inpatient or outpatient (CMS Medicare Claims Processing Manual, 2009; Creighton University, Use of the Q0 & Q1 Modifiers)

31. Strategies for Compliance Challenges Billing systems Decentralization Identifying the research patient Budgets Part of Institutional Compliance Program Communication and Coordination are essential! Identify Team members: everyone needs to know their role Centralization Institution wide process Research Billing Effects all phases of a research project Centralized around the institution’s core values of integrity, accountability and quality DOCUMENTATION (Lester, 2009;Nelson, 2009; Pfadenhauer, 2006; Steiner & Murtha, 2006)

32. Developing a Process Mapping the Process – Flowchart Step by step process Who pays for what, and how are charges routed to the appropriate payer Patient identification Specify payment procedures Coverage Analysis A systematic review of study related documents to determine which items are billable to Medicare (Billing Plan) Standardized throughout institution, all team members should have access to. (Barnes & Korns, 2005; Kulko, 2009; Nelson, 2009; Pitler & Bonomi, 2006; Steiner & Murtha, 2006)

33. Coverage Analysis con’t Maintain a current list of hospital charges for frequent tests and procedures Identify sources of funding for each item/service Protocol Contract Informed Consent Budget Identify costs not covered Non-routine costs Costs with no Medicare benefit category Data Management costs

34. Hypothetical MCA: Manage the Information M=Medicare S=Sponsor ICF=Free in Informed Consent NB=Not billable to Medicare Note: Figure courtesy of Meade, 2009. Used with Permission. 34 34

35. Billing Grid Example Note: Figure courtesy of Lanter, 2008. Used with permission

36. Note: Figure courtesy of Lanter, 2008. Used with permission

37. Charge Identification Models Front-end Process Identifies patient upfront Study specific order forms / charts Coverage Analysis in chart with central repository Back-end Process Review charges after service rendered Hold on patient’s account for review against coverage analysis Designated reviewers (Boyd & Meade, 2007; Kulko, 2009; Nelson, 2009)

38. Evaluation Audit Mechanisms Include a sample of active and past years accounts and protocols Compare accrual information and protocol documents to funds billed and received. Review invoice details to confirm that services were not billed to Medicare or other third party payers in error Document findings, and implement procedures to correct problems Self- Report errors (Meade, 2006; Turgon & Welter, 2008)

39. Clinical Trial Budgeting & Negotiations Denise Friesema, MS, RN, OCN Director, Clinical Research Operations University of Chicago Medical Center

40. Types Drug Studies Device Studies Registry Studies Observational Studies Sponsorship Cooperative Agreements (eg CALGB, SWOG, GOG, RTOG) Industry Sponsored Investigator Initiated Federal Grants & Subcontracts Types of Trials & Sponsorship

41. Three Main Types of Support Provided by a Sponsor • $$$ • Drug • Device Support = Contract (Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

42. What is a Clinical Trial Agreement? “The Contract” • A legally binding formal agreement between the “Sponsor” and the “Institution” • Sponsor may provide • Study drug or device • Financial Support • Proprietary Information • Institution may provide • Data • Publication/Input into Publication • Intellectual Property (Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

43. Why do we need a contract? • Define the scope of work • Parties, performance period, Responsibilities • Protect rights of all parties • Publication, Patents/Inventions/Intellectual Property • Secure Confidential Information • HIPAA, Confidentiality (Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

44. Why do we need a Contract? • Payment for work completed • Budget/Staff support • Compliance • Indemnification, Best efforts/Protocol compliance • Preparation for the Unexpected • Subject Injury, Termination Bottom Line = Reconcile Institutional policies with the needs of the Sponsor (Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

45. Acknowledgments & Responsibility Terms & Termination Clause Payment/ Reimbursement of Costs HIPAA Publication Intellectual Property Confidentiality/ Proprietary Information Indemnification Insurance Subject Injury Sections of the Agreement (Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

46. Important Questions Are the scientific value and ethical quality of the study acceptable? Do I have an adequate pool of potential subjects? Does the proposed budget support the work described in the protocol? If the answer to any of these questions is no, decline the trial. Clinical Trial Budget Basics (Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

47. Clinical Trial Budget Basics • Important to remember: the budget should reflect the proposed work in the protocol not the sponsor’s proposed budget • Review the schedule of visits in the protocol and begin drafting a budget (note: perform this step regardless of whether or not you have received the sponsor’s budget) (Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

48. Study Initiation / Start Up Fees a) IRB b) CCTO c) Pharmacy d) CRC e) Other… 2) Clinical Care Expenses Items deemed research related on the schema by PI 3) Study Implementation & Oversight Expenses a) Staff time b) Supplies c) Parking stickers d) Other…. 4) Indirect Costs 25% Non-Federally Funded 53.5% Federally Funded 4 Components of a Budget

49. Administrative Costs Patient Care Costs Trial Costs Identify the Costs

50. Clinical Trial Office Fees Additional regulatory submissions (amendments, SAEs) Institutional Fees IRB Pharmacy Fees Indirects Non-refundable! Administrative Costs (Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)