1. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress James D. Cross, M.D. National Head Medical Policy and Program Administration Aetna, Inc. Clinical Policy Process

2. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 2 Overview We will discuss the following issues: The purposes and goals of clinical policy at Aetna The criteria Aetna uses to evaluate medical technologies and treatments Aetna’s clinical policy development process Process for assessing cost impact of clinical policies Examples of clinical policy issues Contractual impact

3. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 3 Clinical Policy Unit Function Aetna’s Clinical Policy Unit is responsible for evaluating medical technologies to determine whether they are “experimental and investigational” and “medically necessary” as defined in applicable coverage documents. Aetna has developed more than 600 Clinical Policy Bulletins (CPBs). The goal is to develop objective, clinically supported and defensible determinations.

4. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 4 Clinical Coverage Criteria The following criteria are considered in evaluating a medical technology: The technology must have final approval from the appropriate governmental regulatory bodies, when required The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes The technology must improve net health outcome The technology must be as beneficial as any established alternatives The improvement must be attainable outside investigational settings

5. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 5 Medical Necessity Medically necessary is defined as: In accordance with generally accepted standards of medical practice Clinically appropriate and effective Not primarily for convenience Not more costly than an equivalent alternative service

6. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 6 Experimental and Investigational A technology is deemed experimental and investigational if: There are insufficient outcomes data in the peer-reviewed medical literature; or FDA approval (if required) has not been obtained; or A medical society or regulatory agency deems it experimental.

7. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 7 Exceptions to Experimental Exclusion The following are exceptions to Aetna’s exclusion of coverage of experimental and investigational technologies: Promising experimental inventions for cancer and other terminal illnesses for persons enrolled in certain clinical trials Routine care costs of persons enrolled in clinical trials Category B investigational devices Treatment of unexpected adverse events from experimental clinical interventions

8. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 8 Relationship of Clinical Policy to FDA Approval FDA approval, where applicable, is necessary but not sufficient to meet Aetna’s coverage criteria. FDA does not take into account all of Aetna’s clinical evaluation criteria – Effectiveness outside of the investigational setting – Comparative effectiveness with other alternatives – Comparative costs of equally effective alternatives FDA’s requirements for approval of new devices are less stringent than its requirements for new drugs.

9. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 9 Role of Medicare Policy For its Medicare risk members, Aetna is required to follow either Aetna’s policy or Medicare’s policy -- whichever is most liberal Aetna is not obligated to follow Medicare policy for its commercial members. Medicare’s policy is considered, however, in formulating Aetna’s clinical policies for its commercial plans. In developing clinical policies for Aetna’s commercial plans, national Medicare decisions, developed by CMS, are afforded more weight than individual Medicare local medical review policies.

10. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 10 Prioritizing CPB Requests These factors are considered in prioritizing requests for developing CPBs: The quantity and importance of questions that have arisen regarding the medical technology New evidence, guidelines, consensus statements, changes in regulatory status or other information that is material to the status of the medical technology The potential impact of the technology on Aetna and its members

11. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 11 Drafting Clinical Policy Bulletins The Clinical Policy Unit conducts a comprehensive search of the peer-reviewed published medical literature: Search National Library of Medicine’s PubMed database of peer- reviewed medical literature Assess regulatory status of technology Review evidence-based clinical practice guidelines in AHRQ’s National Guideline Clearinghouse database For drugs, Aetna considers the indications accepted by the U.S. Pharmacopeial Convention (USP DI) and the American Society of Health-System Pharmacists (AHFS Drug Information) Review technology assessments indexed in NLM’s Health Services/Technology Assessment Text (HSTAT) database Opinions of relevant experts may be solicited where necessary

12. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 12 CPB Obtains Final Approval The draft CPB is reviewed and approved by the Clinical Policy Council Review by head of Aetna’s Medical Policy and Program Administration Department Review by Aetna’s Legal Department Review and approval by Aetna’s Chief Medical Officer or his designee Members of the Clinical Policy Unit work with persons from coding and reimbursement areas (Medical Policy and Program Administration) regarding implementation of clinical policies in Aetna systems

13. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 13 Annual Review of CPBs Clinical Policy Unit conducts comprehensive review of peer- reviewed published medical literature to determine if new information has emerged that may warrant a revision in policy. All CPBs are reviewed annually by Aetna’s Clinical Policy Council. CPB review schedule is posted on the internet.

14. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 14 Role of Cost in Clinical Policy Determinations Aetna considers the comparative effectiveness of new medical technologies. Aetna considers the relative costs of equally effective established alternative medical technologies. Cost-effectiveness is not considered.

15. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 15 Cost Analysis of Clinical Policies Each new CPB and CPB revision is reviewed for potential cost impact: Meetings are held monthly to review new and revised CPBs Each new and revised CPB is reviewed to determine whether it is likely to have a material financial impact For those CPBs that are thought to have a material financial impact, a decision is made regarding: 1) priority for analysis (high, medium, low); and 2) whether CPB publication can be held for completion of the analysis Draft cost analyses are drafted by the Medical Policy and Program Administration’s financial analysis group and reviewed at the meeting

16. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 16 Evaluating Future Healthcare Trends Aetna’s Regional Medical Economic Units (MEUs) are responsible for forecasting the long-term business impact of healthcare trends and emerging medical technologies. Regional teams of MEU analysts, business managers, and medical directors have joined to assess the impact of trends in medical technology, demographics, healthcare delivery, and healthcare financing. To assist in this effort, Aetna has contracted for research from SG2, a consulting firm that forecasts these impacts. Each team will be responsible for sharing their findings with Medical Cost Management and with other appropriate functional areas within Aetna.

17. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 17 Specialty Society Policy Liaison Group Aetna’s Specialty Society Policy Liaison Group meets monthly to identify issues for medical specialty society input Issues involving clinical policy and coding are discussed and the relevant specialty society is identified Aetna medical directors have been assigned to be liaison’s for leading medical specialty societies; these medical directors are responsible for soliciting feedback from their designated specialty society Specialty society feedback is tracked and the input is considered by Aetna’s clinical policy and reimbursement areas

18. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 18 Other Sources of Clinical Policy Input Aetna Regional Quality Advisory Committees – composed of external participating physicians Aetna Solid Organ Transplant and Stem Cell Transplant Advisory Committees – provide input to Aetna’s Clinical Policy Unit and National Medical Excellence Unit regarding transplant policy External Review Organization Committee – quarterly meeting to review decisions that have been appealed to external review organizations Physician Advisory Board Mailbox – the Clinical Policy Unit is responsible for responding to inquiries on clinical policy issues from the Physician Advisory Board Mailbox The Clinical Policy Unit is responsible for responding to inquiries from vendors, providers, members and others regarding clinical policy issues

19. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 19 Medical Devices We take all of these processes into consideration as we review new technologies and equipment Here are examples of medical devices that have been considered by Aetna’s Clinical Policy Council Continuous glucose monitoring devices Mobile cardiovascular telemetry

20. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 20 Contractual Impact on Billing Methodologies Aetna contracts affect the way in which providers are reimbursed for durable medical equipment – Individual Physicians New technologies are billed separately per provider Submission of individual codes are easily identified These claims can be more readily related to clinical policy bulletins – Hospitals and other Facilities New contracts usually include new technologies Submission of much less detailed claims that are usually grouped into revenue codes These claims are usually paid as part of a group

21. The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress 21 Aetna’s Commitment to Transparency in Health Care Aetna believes that cost transparency leads to better consumers and providers of health care. To that end, Aetna launched an industry-leading initiative to provide our members, physicians and facilities with price transparency tools for their health care services We provide a wide array of information for our members, physicians and network facilities that include: – Clinical Policy Bulletins Available on aetna.com – DocFind Available on aetna.com and Aetna Navigator – Medical Procedure by Facility Cost Tool Available on Aetna Navigator – Hospital Comparison Tool Available on Aetna Navigator – Provider Website Secure requires registration