21 st Century Infertility Treatment & Access to Care: Fertility Preservation Coverage

Transcription

1 21 st Century Infertility Treatment & Access to Care: Fertility Preservation Coverage Joyce Reinecke, JD Executive Director, Alliance for Fertility Preservation

2 My Story Diagnosed at 29 Treatment plan: Surgery and chemotherapy Informed of Risk of Infertility Married; IVF, froze embryos Path to Parenthood Self advocate to patient advocate

3 Alliance for Fertility Preservation 501c3 charitable organization Professionals in oncology, reproductive endocrinology, research, bioethics, research, reproductive law Leaders in sub specialty of fertility preservation Our Mission: To Increase information, resources and access to fertility preservation for cancer patients and the healthcare professionals who treat them.

4 Defining the Issue Fertility Preservation The process of saving or protecting eggs, sperm, or reproductive tissue so that a person can use them to have biological children in the future. I at ro gen ic [īˌatrəˈjenik] relating to illness caused by medical examination or treatment. Iatrogenic Infertility An impairment of fertility by surgery, radiation, chemotherapy or other medical treatment affecting reproductive organs or processes.

5 Who needs fertility preservation? Cancer Patients 150,000+ diagnosed every year, 45 yrs or under At risk due to treatment Approx. 25% of breast cancer patients 12,000 pediatric patients Emerging Populations Autoimmune diseases, sickle cell, genetic conditions Screening for hereditary diseases, e.g., BRCA Prior to prophylactic surgery, e.g., oophorectomy; hysterectomy Transgender patients

6 What are the options? Men Sperm banking (standard) Sperm extraction, electroejaculation Women Egg & embryo freezing (standard) Ovarian tissue freezing (experimental) Ovarian shielding, ovarian transposition, hormonal suppression Pediatrics Ovarian or testicular tissue banking (experimental)

7 Why is the need for coverage growing? Demographics Technology Clinical Medicine Social/Cultural Improved cancer survival Delayed childbearing Medically effective More reproductive options, std & experimental Egg freezing = standard in 2012 Changes in Oncology: AYA, survivorship, QofL Patient centered care Acceptance of repro technology Other groups seeking biologic parenthood

8 What are the barriers to fertility preservation? Information Disclosure of risks & discussion of options Timely referrals Decision making support Access Geographic, availability of services Cultural, religious; values about reproductive choice FINANCIAL: high cost + lack of insurance coverage

9 What are the costs?

10 Coverage Denial Patient J.H., breast cancer, 34 yrs. old Illinois Plan, IVF coverage included You asked for coverage of retrieving and freezing your eggs. You asked for this because you have cancer and will start chemotherapy. You may want to get pregnant in the future.... This... treatment is not covered unless you have been trying to get pregnant for 12 months without any form of birth control. It would also be covered if you are infertile after your chemotherapy.... You do not meet the definition of infertility. The service is therefore not covered.

11 Private Approaches Meetings with insurers; employers Nonprofit patient groups, Individual patient appeals How can coverage be achieved? Professional Orgs Administrative Medical societies, guidelines, leaders calling for coverage Published research, articles Regulatory change, enforcement actions Depts of Insurance Legislative Introduce bills, pass laws requiring coverage

12 Structuring Coverage Amending infertility coverage to include FP Adding FP as part of cancer coverage 15 states have infertility mandates Employers/self insureds with infertility coverage Federal legislation = WHCRA model NBGH/NCCN Recs on cancer coverage

13 Amending cancer care coverage REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES. The Women s Health and Cancer Rights Act (1998) Deemed breast reconstruction as medically necessary part of treatment for breast cancer Amended ERISA (a) In General.--A group health plan, and a health insurance issuer providing health insurance coverage in connection with a group health plan, that provides medical and surgical benefits with respect to a mastectomy shall provide, in a case of a participant or beneficiary who is receiving benefits in connection with a mastectomy and who elects breast reconstruction in connection with such mastectomy, coverage for-- (1) all stages of reconstruction of the breast on which the mastectomy has been performed; (2) surgery and reconstruction of the other breast to produce a symmetrical appearance; and (3) prostheses and physical complications all stages of mastectomy, including lymphedemas; in a manner determined in consultation with the attending physician and the patient.

14 Amending existing infertility coverage Health insurance contracts -- Infertility. 2 nd state, July 5, 2017 Existing IVF mandate Added in coverage in cases of medical necessity (a) Any health insurance contract, plan, or policy delivered or issued for delivery or renewed in this state, except contracts providing supplemental coverage to Medicare or other governmental programs, which includes pregnancy related benefits, shall provide coverage for medically necessary expenses of diagnosis and treatment of infertility for women between the ages of twenty-five (25) and forty-two (42) years and for standard fertility preservation services when a medically necessary medical treatment may directly or indirectly cause iatrogenic infertility to a covered person.

15 State Structure Proposed Outcome CT Medically necessary Amended statutory definition of infertility to include medical necessity ; existing IVF mandate Signed into law 6/20/17 RI FP iatrogenic Standard FP services if necessary medical treatment may cause iatrogenic infertility; existing IVF mandate Signed into law 7/05/17 MD FP iatrogenic Standard FP services if necessary medical treatment may cause iatrogenic infertility; Signed into law 5/18/18 large groups DE IVF+FP New Infertility mandate, includes IVF and FP Passed; to be signed after 7/15/18 IL FP iatrogenic Standard FP services if necessary medical treatment may cause iatrogenic infertility; broad coverage inc. medicaid NJ FP iatrogenic IVF mandated update 2017; FP to be added Pending NY IVF+FP and FPiatrogenic bills 1. IVF mandate w/ clause for fertility preservation services for iatrogenic infertility; 2. FP cancer only bill CA FP iatrogenic Standard FP services if necessary medical treatment may cause iatrogenic infertility Failed KY Gametes only Ooctye & sperm only; includes one year of storage Failed Passed House & Senate insurance cmte; Pending 1. Passed Assembly 2017 & 2018; Passed Senate, 6/20/18; Failed HI FP cancer Embryo, oocyte, and sperm cryo for adult patients dx w/cancer; have not started Failed; study launched treatment. Limit: one cycle AZ IVF+FP iatrogenic IVF mandate; specific procedures listed; includes FP Failed MS IVF+FP iatrogenic IVF mandate; specific procedures listed; includes FP Failed MO, LA, VT FP cancer Embryo, oocyte, and sperm cryopreservation; 18 yrs old; diagnosed w/cancer; not started treatment Failed

16 2018 FP Legislation Current Status

17 Policy Arguments Supporting Coverage 1. Fertility Preservation is Medical Necessity 2. Treatments are Standard of Care 3. Promotes Better Medical Outcomes 4. Low Cost & Potential Cost Offsets 5. Ethical Bases for Coverage

18 1. FP is Medically Necessary Required for coverage FP not elective patients are facing sterility Only means to safeguard ability to have genetic children In the United States, the concept of medical necessity continues to serve as the primary gatekeeper for the utilization of health care services. [It is used] to distinguish not only necessary from unnecessary care but also medical from cosmetic, experimental, elective...[to] ensur[e] that patients receive treatment that is appropriate and medically indicated while also controlling costs. At the same time, the concept s meaning remains elusive.

19 Recent findings of coverage Cryopreservation. Gamete cryopreservation (sperm or oocytes) is allowable when it is determined by appropriate health care professionals that the care is needed to promote, preserve, or restore the health of the individual and is in accord with generally accepted standards of medical practice (e.g., for oncofertility with cryopreservation of gametes to preserve fertility prior to cancer treatment which would ordinarily render the patient permanently sterile).

20 2. FP is the Standard of Care

21 3. Better Outcomes Patient Provider Discussions Sub par levels of fertility discussions persist Wallet biopsy Improved Survivorship Reduced depression, distress & regret Report higher Quality of Life Medical Outcomes Some patients don t initiate/adhere to treatment due to fertility concerns Better medical decisionmaking

22 4. Relative Costs Provider Cost (Low) Pennies! 2017 CHBRP report: ($.01 $.06 PMPM) 2018 MHCC: ($.14 $.24) FP costs are miniscule % of total cancer care cost Patient Cost (High) Extremely expensive for an individual patient, esp. females Urgency exacerbates costs Patients facing additional costs of cancer care Cost Offsets Reduced distress High costs incurred if less effective treatment leads to more disease Value of future lives/parenthood?

23 5. Ethics Arguments Therefore, females are facing costs for preserving fertility that are more than times that faced by males. [CA Bill] is expected to decrease the gender disparity by reducing females financial burden of fertility preservation services. Remedy iatrogenic harm Status quo (non-coverage) has a disparate impact on certain groups: Women Lower socio-economic population Procreation as a fundamental right Other groups asserting right to this technology Same-sex couples, transgender, single women, those w/ genetic disease

24 Victoria, Hodgkin Lymphoma, 25 My 28 yr old sister received her cancer diagnosis 6 months before I received mine. I was just 25. For anyone who has been dealt the crushing blow of being told you have cancer, I do not need to emphasize the resilience it requires to remain hopeful, to keep your eyes on the future. When I was diagnosed, I was given less than a week to discuss my options with my husband, a newly arrived immigrant from West Africa, whose culture marks marriage with the ability to expand the family tree. We met with a fertility specialist who told us that we would need to begin immediately and come up with $15,000 in cash by the next day. We were told that fertility preservation was not part of my health care plan s coverage. The process was disorganized and left me feeling that I did not have a choice. I now have to watch as chemotherapy drugs are pumped into my body, knowing that they are killing my cancer, but could be destroying my chances of having a child. I can say with all sincerity that is what keeps me up at night.

25 Thank you!