Since When Am I Eligible for That The TRICARE Benefit-Development Process

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3. 3 TRICARE (purchased care) is an entitlement program, governed by: Statute: Title 10, Chapter 55 32 Code of Federal Regulations (CFR), Part 199 Policy, Operations, Reimbursement, and Systems Manuals Safety, efficacy, and standard of care All treatments/devices/drugs comparable to or superior to conventional therapy Consistent TRICARE benefit Contrast to regional variation in CMS Some discretion for use of DHP dollars in direct care system Background Insurance plans have additional considerations since they must consider market factors: Demand for technology by patients and physicians Publicity about a new technology State insurance mandates Competition with other health plans Threat of litigation May consider convenience (insulin pump when not medically necessary) or quality of lifeInsurance plans have additional considerations since they must consider market factors: Demand for technology by patients and physicians Publicity about a new technology State insurance mandates Competition with other health plans Threat of litigation May consider convenience (insulin pump when not medically necessary) or quality of life

4. 4 TRICARE covers: Medically necessary and appropriate treatment/procedures/ devices/drugs Some preventive services Well child care TRICARE does not cover: Unproven treatment/procedures/devices/drugs Treatment/procedures/devices/drugs specifically excluded from coverage by statute, regulation, or policy Background TRICARE Standard covers preventive services only as stipulated in the CFR. Prime may have additional preventive services (e.g., AAA screening recently added). Not all FDA-approved devices are part of the TRICARE benefit � they can be covered only when there is reliable evidence that they are safe and effective. Additionally, devices are part of the TRICARE benefit only when used for their FDA-approved indication. At present there is no provision in the CFR for off-label use of devices. Care specifically excluded by statute/regulation/policy includes: Care for obesity (although surgery for morbid obesity is covered if patient meets criteria outlined in CFR and has one of the three procedures listed) Non-coital reproductive technology (including artificial insemination) Smoking cessation therapy Cosmetic surgery Etc, etc.TRICARE Standard covers preventive services only as stipulated in the CFR. Prime may have additional preventive services (e.g., AAA screening recently added). Not all FDA-approved devices are part of the TRICARE benefit � they can be covered only when there is reliable evidence that they are safe and effective. Additionally, devices are part of the TRICARE benefit only when used for their FDA-approved indication. At present there is no provision in the CFR for off-label use of devices. Care specifically excluded by statute/regulation/policy includes: Care for obesity (although surgery for morbid obesity is covered if patient meets criteria outlined in CFR and has one of the three procedures listed) Non-coital reproductive technology (including artificial insemination) Smoking cessation therapy Cosmetic surgery Etc, etc.

5. 5 Background Unproven therapy excluded With exception of explicitly approved clinical trials An advance in medical practice may become a benefit once proven This may differ from the emerging standard of care Actual incorporation into the purchased care program takes time May require revision of statutes or regulations, allocation of funds, changes to the manuals, etc. Implementation may take 1-2 years

6. Orlistat Assisted Weight Loss Program Patient Contract What is my responsibility to be able to continue with Orlistat? You should understand that you may be withdrawn from the drug assisted weight loss program if: A. You fail to lose four (4) pounds within four (4) weeks of starting drug therapy B. You fail to lose > 10% of your initial body weight after being in the program for one (1) year C. You fail to maintain your initial weight loss D. You have significant drug side effects E. Failure to keep scheduled appointments Example of MTF discretionary use of DHP dollars for a service excluded from the TRICARE benefitExample of MTF discretionary use of DHP dollars for a service excluded from the TRICARE benefit

7. Orlistat Assisted Weight Loss Program Patient Contract, cont. You are expected to keep your appointments at the Wellness Center as follows: A. Every week for the first four (4) weeks B. Every two (2) weeks for two (2) to six (6) months C. Every month after six (6) months You will see your healthcare provider: A. At your initial appointment to discuss Orlistat B. Every three (3) months thereafter C. When referred by the Wellness Center staff Example of MTF discretionary use of DHP dollars for a service excluded from the TRICARE benefitExample of MTF discretionary use of DHP dollars for a service excluded from the TRICARE benefit

8. The Wilford Hall Medical Center In Vitro Fertilization (IVF) Program offers full diagnostic testing and all therapies for state-of-the-art infertility treatment. The WHMC IVF program delivers advanced care with a personal touch. We emphasize quality of treatment combined with human warmth. As fellowship-trained specialists, we can quickly arrive at a diagnosis and formulate an efficient, effective therapy. Advanced reproductive techniques such as in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI) and sperm aspiration are performed at Wilford Hall Medical Center. We are offering freezing and transferring of cryopreserved embryos through our affiliated embryology program at the Fertility Center of San Antonio Example of MTF discretionary use of DHP dollars for a service excluded from the TRICARE benefit Example of MTF discretionary use of DHP dollars for a service excluded from the TRICARE benefit

9. Our physicians are Reproductive Endocrinologists who provide full evaluation and treatment of all forms of infertility, polycystic ovarian disease, premature ovarian failure, hirsutism, recurrent pregnancy loss, endometriosis, premenstrual syndrome and complicated menopausal problems. Our staff is aware of the stressful and emotional difficulties, which affect couples dealing with the issue of having a family. We attempt to offer services at WHMC in a warm and friendly atmosphere. Our patients are our priority and supporting their physical and emotional needs is our primary goal. Example of MTF discretionary use of DHP dollars for a service excluded from the TRICARE benefit Example of MTF discretionary use of DHP dollars for a service excluded from the TRICARE benefit

10. Example of MTF discretionary use of DHP dollars for a service excluded from the TRICARE benefit Example of MTF discretionary use of DHP dollars for a service excluded from the TRICARE benefit

11. 11 Types of New Benefit Advances in medical practice New treatment modalities, previously considered unproven Programmatic changes Established treatment modalities, previously considered entities TRICARE could not or should not cover Legislative change, e.g., active duty chiropractic care

12. 12 Advances in  Medical Practice Evolving medical technology Innovative procedures New pharmaceuticals Miniaturization of medical devices Expansion of treatments and imaging techniques to new clinical scenarios Examples: Minimally-invasive surgical procedures Robotic surgery Fetal surgery Non-vital organ transplantation Genetic screening related to Human Genome Project

13. 13 Programmatic Changes Expansion of the benefit Addition to the benefit of services, providers, pharmaceuticals, DME, etc. excluded from coverage by statute, regulation, or policy Examples: Pharmaceutical therapy for weight loss Tobacco cessation treatment Routine genetic testing Non-coital reproductive technology Marriage counseling Phase I clinical trials Visual training (orthoptics) Chiropractic care SNF care outside U.S.

14. 14 How Do We Identify Them? TMA Monitoring advances in medical science Monitoring changes in healthcare coverage/reimbursement Requests from within/outside TMA Factual appeals process Quarterly reports from MCSC MCSCs Requests from physicians/beneficiaries Congressional interest Changes in federal law Hierarchy of reliable evidence does NOT include: anecdotal reports abstracts the fact that a provider or number of providers have elected to adopt a device, treatment, procedure as their procedure of choice or standard of practiceHierarchy of reliable evidence does NOT include: anecdotal reports abstracts the fact that a provider or number of providers have elected to adopt a device, treatment, procedure as their procedure of choice or standard of practice

15. 15 How Do They become  Part of the Benefit? Specifically not included in the meaning of reliable evidence are reports, articles, or statements by providers or groups of providers containing only abstracts, anecdotal evidence, or personal professional opinions.� Also not included in the meaning of reliable evidence is the fact that a provider or number of providers have elected to adopt a drug, device, or medical treatment or procedures as their personal treatment or procedure of choice or standard of practice.� Specifically not included in the meaning of reliable evidence are reports, articles, or statements by providers or groups of providers containing only abstracts, anecdotal evidence, or personal professional opinions.� Also not included in the meaning of reliable evidence is the fact that a provider or number of providers have elected to adopt a drug, device, or medical treatment or procedures as their personal treatment or procedure of choice or standard of practice.�

16. 16 Purchased Care Benefits Development Process for newly proven services: TMA analysis Coordinated by Medical Benefits & Reimbursement Systems Office and Office of Chief Medical Officer OGC review Chief Medical Officer concludes that service is proven Notification of coverage IGCE Program Requirements Board (information brief) Funding Change to TRICARE manuals Contract modification Negotiation with MCSC How Do They become  Part of the Benefit?

17. 17 Purchased Care Benefits Development Process for benefit expansion: TMA analysis and draft proposal Coordinated by Medical Benefits & Reimbursement Systems Office and Office of Chief Medical Officer IGCE TMA review (OGC, RM, etc.) Program Requirements Board (decision brief) Rule publication, if necessary Funding Change to TRICARE manuals Contract modification Negotiation with MCSC How Do They become  Part of the Benefit?

18. 18 Rulemaking process Requires Federal Register publications and OMB approval Subject to interagency and public review, with comment period Two routes to a Final Rule Interim Final Rule ? Final Rule Implements statutory language explicitly Proposed Rule ? Final Rule Implements discretionary aspect of legislation and internally-generated programs How Do They become  Part of the Benefit? Rule making defined in 32 CFR, Part 199 Rule making defined in 32 CFR, Part 199

19. 19 Change Process: Proposed New Benefit Rule-making includes: Draft rule Determine cost (IGCE) Review rule within/outside DoD Allocate funding Publish in Federal Register Once regulatory change is completed, or if no regulatory change is needed: Draft changes to relevant TRICARE manuals: define the benefit, provider categories, reimbursement methodologies Consolidate changes into change package Send package for review and comment Obtain IGCE Earmark funding Finalize package Negotiate price with MCSC Modify contracts Modify TRICARE manualsRule-making includes: Draft rule Determine cost (IGCE) Review rule within/outside DoD Allocate funding Publish in Federal Register Once regulatory change is completed, or if no regulatory change is needed: Draft changes to relevant TRICARE manuals: define the benefit, provider categories, reimbursement methodologies Consolidate changes into change package Send package for review and comment Obtain IGCE Earmark funding Finalize package Negotiate price with MCSC Modify contracts Modify TRICARE manuals

20. 20 When Do They become Part of the Benefit? Established as �proven� Approved by TMA Necessary changes completed Exact effective date of coverage may be dictated by a �sentinel event� Drug approved by FDA for a covered condition Immunization recommended by CDC�s Advisory Panel on Immunization Practices (ACIP) Landmark article Date specified by statute or Final Rule

21. 21 Examples Termination of pregnancy Current benefit: excluded from coverage unless the life of the mother is endangered if fetus carried to term (statute) Smoking cessation Current benefit: excluded from coverage (regulation) DOC band (cranial orthotic for plagiocephaly) Current benefit: excluded from coverage (cosmetic care and unproven) Screening colonoscopy for normal risk beneficiaries Benefit in Jan 2006: excluded from coverage (unproven) Current benefit: TRICARE coverage effective March 15, 2006

22. 22 More Examples Human papillomavirus screening in conjunction with pap test �DNA with Pap� FDA-approved � Mar 2003 Current benefit: excluded from coverage (statute) Botulinum toxin (Botox) for migraine headaches Current benefit: excluded from coverage (unproven�06) Laparoscopic adjustable gastric banding (Lap Band) Current benefit: excluded from coverage (unproven�06) Vagus nerve stimulation for refractory depression Current benefit: excluded from coverage (unproven�06) Home uterine activity monitoring and long term-terbutaline pump for pre-term labor Current benefit: excluded from coverage (unproven�06) Charit� artificial disc Current benefit: excluded from coverage (unproven�05)

23. 23 Rare Diseases Provision Diseases affecting ? 200,000 Americans Slightly less rigorous threshold for �proven� Supplemental Health Care Program General requirement that TRICARE coverage rules apply to SHCP �Proven� care Clinical trials Authority for waiver of policy by Director, TMA to assure adequate availability of health care services to active duty members Other Considerations There is a general requirement under 32 C.F.R. 199.16(c) that the payment rules concerning services for which TRICARE may pay for all other categories of beneficiaries also apply to the SHCP. However, there is authority under 32 C.F.R. 199.16(f) for the Director, TMA, to waive these payment rules if, at the request of an authorized official of the uniformed service concerned, it is determined that such waiver is necessary to assure adequate availability of health care services to active duty members. A waiver can be granted only by the Director, TRICARE Management Activity, and not by an MTF commander or even Service Surgeon General. A few examples of recent determinations related to rare diseases: Liver transplantation for Maple Syrup Urine Disease � unproven Cryotherapy of renal cell carcinoma � proven Rapid-sequence tandem bone marrow transplants for children with high-risk neuroblastoma - proven There is a general requirement under 32 C.F.R. 199.16(c) that the payment rules concerning services for which TRICARE may pay for all other categories of beneficiaries also apply to the SHCP. However, there is authority under 32 C.F.R. 199.16(f) for the Director, TMA, to waive these payment rules if, at the request of an authorized official of the uniformed service concerned, it is determined that such waiver is necessary to assure adequate availability of health care services to active duty members. A waiver can be granted only by the Director, TRICARE Management Activity, and not by an MTF commander or even Service Surgeon General. A few examples of recent determinations related to rare diseases: Liver transplantation for Maple Syrup Urine Disease � unproven Cryotherapy of renal cell carcinoma � proven Rapid-sequence tandem bone marrow transplants for children with high-risk neuroblastoma - proven

24. 24 Experimental therapy and clinical trials: TRICARE DoD/NCI phase II and III trials covered A proposed rule currently in coordination would make �routine care� in other federally-funded phase II and phase III trials a TRICARE benefit Other NIH trials at ASD discretion: TRICARE Clinical Research Review Board Experimental therapy and clinical trials: MTFs IRB-approved clinical trials No current prohibition against unproven or off-label care in MTFs Protection of Human Subjects Statute: Title 10, Section 980 � limits human research 32 Code of Federal Regulations (CFR), Part 219 DoD Directive 3216.2 Other Considerations

25. 25 Summary Only �proven� care can become a TRICARE benefit Exception for clinical trials as allowed under CFR Hierarchy of reliable evidence Benefit change process Newly proven TRICARE benefit when Chief Medical Officer determines that service is proven Expansion of benefit TRICARE benefit after TMA Program Requirements Board approves service as addition to program