BILL ANALYSIS                                                                                                                                                                                                    �






                             SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:       AB 912
          AUTHOR:        Quirk-Silva
          INTRODUCED:    February 22, 2013
          HEARING DATE:  June 26, 2013
          CONSULTANT:    Robinson-Taylor

           SUBJECT  :  Health care coverage: fertility preservation.
           
          SUMMARY  :  Requires every group or individual health care service  
          plan contract and health insurance policy that is issued,  
          amended, or renewed, on and after January 1, 2014, to provide  
          coverage for medically necessary expenses for standard fertility  
          preservation services when a necessary medical treatment may  
          cause iatrogenic infertility to an enrollee or insured.

          Existing federal law 
          1.Establishes the Affordable Care Act (ACA) to make, among other  
            provisions, statutory changes affecting the regulation of, and  
            payment for, certain types of private health insurance and  
            includes coverage for prescription drugs in the categories of  
            10 essential health benefits (EHBs) that all qualified health  
            plans must cover.
          
          Existing state law:
          1.Establishes the Knox-Keene Health Care Service Plan Act of  
            1975 to regulate and license health plans and specialized  
            health plans by the Department of Managed Health Care (DMHC)  
            and provides for the regulation of health insurers by the  
            California Department of Insurance (CDI).

          2.Requires health plan contracts and health insurance policies  
            to offer group coverage for the treatment of infertility, as  
            defined.

          3.Establishes as California's EHBs the Kaiser Small Group Health  
            Maintenance Organization plan along with the following 10 ACA  
            mandated benefits:

             a.   Ambulatory patient services;
             b.   Emergency services;
             c.   Hospitalization;
             d.   Maternity and newborn care;
             e.   Mental health and substance use disorder services,  
                                                         Continued---



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               including behavioral health treatment;
             f.   Prescription drugs;
             g.   Rehabilitative and habilitative services and devices;
             h.   Laboratory services;
             i.   Preventive and wellness services and chronic disease  
               management; and,
             j.   Pediatric services, including oral and vision care.
          
           FISCAL EFFECT  :  According to the Assembly Appropriations  
          Committee analysis, this bill will result in the following  
          costs:

             1.   Approximately $69,000 to CalPERS for additional  
               premiums.

             2.   Unknown costs, potentially greater than $100,000, to  
               Covered California, to the extent the fertility treatment  
               preservation services exceed the EHBs requirement under the  
               ACA.
          PRIOR VOTES  :  
          Assembly Health:    13- 6
          Assembly Appropriations:12- 5
          Assembly Floor:     52- 26
           
          COMMENTS  :  
                  
          1.Author's statement.  AB 912 ensures that patients with severe  
            diseases don't have to make the wrenching choice between  
            receiving life-saving medical help and starting a family. In  
            the United States, there are approximately 140,000 persons 45  
            and under who are diagnosed with cancer each year.  A  
            diagnosis of cancer or other disease may bring with it an  
            unexpected consequence: the potential loss of fertility. 

          Chemotherapy and radiation may stop the cancer and save lives,  
            but there is a risk of reproductive damage that partially  
            depends on the age and sex of the patient, as well as the type  
            and duration of treatment. Treatments that preserve fertility  
            in men and women can often be performed before therapy starts,  
            and utilized after the patient is given a clean bill of  
            health. However, the cost to preserve fertility is not a  
            covered option for the majority of cancer patients, even  
            though fertility loss occurs as a direct consequence of their  
            treatment.  This bill will provide sperm, embryo and egg  
            preservation insurance coverage for patients undergoing  
            treatments known to compromise fertility. This is a sensible,  




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            humane, and cost-effective solution to a foreseeable harm from  
            medically necessary treatment.

          2.Iatrogenic infertility.  Iatrogenic infertility is medically  
            induced infertility caused by a medical intervention used to  
            treat a primary disease or condition.  According to the  
            California Health Benefits Review Program (CHBRP), iatrogenic  
            infertility is typically caused by cancer treatments, such as  
            radiation and chemotherapy or surgical removal of reproductive  
            organs.  Less frequently, fertility is compromised by  
            treatments for autoimmune disorders such as systemic lupus,  
            rheumatoid arthritis, or Crohn's disease.  Patients at risk  
            for iatrogenic infertility differ from patients being treated  
            for infertility in that they need to undergo fertility  
            preservation services before they undergo treatments that may  
            put them at risk for becoming infertile.  For example, a  
            patient undergoing treatment for cancer would need to freeze  
            his sperm prior to starting treatment for his cancer.  While  
            at the time of the procedure, his fertility may be intact, if  
            he does not take part in fertility preserving treatment, his  
            future ability to father a child may be at risk. 
               
          3.Fertility preservation.  A patient may have coverage for  
            infertility treatment but may not have coverage for fertility  
            preservation treatment.  Current California law mandates  
            health plans and health insurers to offer group purchasers the  
            option of buying coverage of infertility treatment (except in  
            vitro fertilization) but they are not required to cover the  
            service.  Even if patients have coverage for infertility  
            treatment and do not have coverage for fertility preservation  
            treatment, they would be ineligible for coverage of those  
            treatments because they do not meet the definition of being  
            infertile prior to undergoing cancer treatment.

          Fertility preservation services fall into three general  
            categories encompassing seven standard procedures: 1)  
            cryopreservation (freezing reproductive tissue) includes sperm  
            cryopreservation, oocyte cryopreservation, and embryo  
            cryopreservation; 2) harm reduction includes ovarian  
            transposition (oophoropexy), ovarian shielding during  
            radiation therapy, and testicular shielding during radiation  
            therapy; and 3) conservative surgery (cancer therapy modified  
            to preserve reproductive tissue) including the two most common  
            procedures, trachelectomy (i.e., surgical removal of the  
            cervix) and conservative surgery for ovarian cancer. 




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          4.EHBs.  Effective 2014, the ACA requires non-grandfathered  
            small-group and individual market health insurance, including  
            those qualified health plans (QHPs) that will be sold in  
            Covered California, to cover 10 specified categories of EHBs.   
            The federal Department of Health and Human Services has  
            allowed each state to define its own EHBs for 2014 and 2015 by  
            selecting one of a set of specified benchmark plan options.   
            SBX1 2 (Hernandez), Chapter 2, Statutes of 2013-14, first  
            extraordinary session, and ABX1 2 (Pan), Chapter 1, Statutes  
            of 2013-14, first extraordinary session selected the Kaiser  
            Foundation Health Plan Small Group Health Maintenance  
            Organization 30 Plan (Kaiser HMO 30 plan) as its benchmark  
            plan.  According to CHBRP, the ACA allows a state to "require  
            that a qualified health plan offered in an exchange to offer  
            benefits in addition to the EHBs."  If the state does so, the  
            state must make payments to defray the cost of those  
            additionally mandated benefits.  

          According to CHBRP, coverage for medically necessary fertility  
            preservation services are not a covered benefit in the Kaiser  
            HMO 30 plan, and thus are not included in the EHB benchmark  
            benefit package.  According to CHBRP, this triggers the  
            requirement that the state defray the costs of coverage for  
            enrollees in QHPs in Covered California.

          5.CHBRP.  CHBRP was created in response to AB 1996 (Thomson),  
            Chapter 795, Statutes of 2002, which requests the University  
            of California assess legislation proposing a mandated benefit  
            or service, and prepare a written analysis with relevant data  
            on the public health, medical, and economic impact of proposed  
            health plan and health insurance benefit mandate legislation.   
            In its review of this bill, CHBRP focuses on fertility  
            preservation among cancer patients because approximately 90  
            percent of iatrogenic infertility is caused by cancer  
            treatment.  Among CHBRP's findings are the following:
                
                a.     Medical Effectiveness.  According to CHBRP,  
                 fertility preservation services for patients at risk for  
                 iatrogenic fertility vary by age and gender of the  
                 patient, the patient's marital status, cultural and  
                 religious beliefs, and the type of treatment the patient  
                 is undergoing. CHBRP's medical effectiveness review  
                 focused on the three major categories of fertility  
                 preservation services available to male and female  
                 patients undergoing cancer treatments that could  




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                 compromise their fertility.  One involves freezing  
                 reproductive material (sperm, eggs, embryos, testicular  
                 tissue, or ovarian tissue) prior to treatment.  A second  
                 type uses specific methods to try to reduce the harms of  
                 cancer treatment on fertility (ovarian transposition,  
                 gonadal shielding during radiation, and gonadal  
                 suppression with hormone therapies).  The third is to  
                 pick the cancer treatment with the lowest likelihood of  
                 causing infertility, such as selection of a more  
                 conservative surgery, to minimize the amount of  
                 reproductive tissue lost.  CHBRP provides the following  
                 standard fertility preservation services and its  
                 conclusions regarding their overall medical  
                 effectiveness: 

                     i.          Sperm cryopreservation is the collection  
                      and freezing of sperm.  This is the standard  
                      fertility preservation service offered to males at  
                      risk for iatrogenic infertility.  There is a  
                      preponderance of evidence that sperm  
                      cryopreservation with sperm collected through  
                      ejaculate is an effective method of fertility  
                      preservation.

                     ii.         Embryo cryopreservation involves  
                      harvesting eggs followed by in vitro fertilization  
                      and freezing of resulting embryos for later  
                      implantation.  Embryo cryopreservation is the  
                      standard fertility preservation service available  
                      for females.  There is a preponderance of evidence  
                      that embryo cryopreservation is an effective method  
                      of fertility preservation.

                     iii.        Oocyte (egg) cryopreservation, the  
                      collection and freezing of eggs, is an effective  
                      method of fertility preservation and is the standard  
                      offered to females at risk for iatrogenic  
                      infertility who do not have a male partner or who do  
                      not want to use donor sperm. 

                     iv.         Trachelectomy is the treatment for  
                      cervical cancer where the cervix is surgically  
                      removed while the uterus is preserved and ovarian  
                      cancer surgery where the uterus with one ovary can  
                      be preserved are effective methods of conservative  




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                      gynecologic surgeries for fertility preservations.

                     v.          Ovarian transposition, also called  
                      oophoropexy, is a surgical repositioning of ovaries  
                      to another location in the body away from the  
                      radiation field.  There is insufficient evidence to  
                      conclude that ovarian transposition is an effective  
                      method of fertility preservation.  

                     vi.         During cancer treatment with radiation  
                      therapy, special shields can be placed over the  
                      gonads (ovaries in females and testicles in males)  
                      to reduce the dose of radiation delivered to these  
                      reproductive organs.  There is insufficient evidence  
                      that testicular shielding is an effective method of  
                      fertility preservation in males.  There is also  
                      insufficient evidence that ovarian shielding during  
                      radiation therapy is an effective method of  
                      fertility preservation in females.  Despite this, it  
                      stands to reason that patients undergoing pelvic  
                      radiation where there is a high risk of damage to  
                      the reproductive organs may want to consider gonadal  
                      shielding to protect their fertility.

               b.     Utilization, Cost, and Coverage Impacts.   
                 California's existing mandate as it relates to fertility  
                 treatment is a mandate to offer, and it applies for most  
                 group insurance coverage.  As such, some enrollees have  
                 coverage for fertility treatment, and some enrollees  
                 already have coverage for fertility preservation which is  
                 the subject of this bill.  According to CHBRP, 19.4  
                 million enrollees are in DMHC-regulated plans and  
                 CDI-regulated policies that are subject to this bill.   
                 CHBRP reports that approximately 8.3 percent of the 19.4  
                 million enrollees currently have coverage for fertility  
                 preservation services.  Under this bill, 100 percent of  
                 enrollees would be covered.  CHBRP also states that no  
                 publicly funded DMHC-regulated plans currently include  
                 coverage for fertility preservation services, but if  
                 enacted, California Public Employees' Retirement System  
                 HMOs would be subject to this bill. 

               CHBRP's population analysis was restricted to those of  
                 reproductive age (ages 14-40 for females and ages 12-50  
                 for males).  CHBRP estimates that currently in a one year  
                 period, 1,051 male enrollees use sperm cryopreservation  




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                 (with 947 paying for the uncovered benefit directly) and  
                 72 female enrollees use embryo or oocyte cryopreservation  
                 (with 56 paying for the uncovered benefit directly).   
                 CHBRP reports that if this bill in enacted, utilization  
                 for male enrollees will increase by 19 percent (or 198  
                 males) and for female enrollees by 175 percent (or 126  
                 females).  In total a 29 percent increase in the use of  
                 fertility preservation services.

               According to CHBRP, the per-unit costs for fertility  
                 preservation vary depending on whether the procurement  
                 and storage services are for men or for women.  Both face  
                 initial charges for the procurement procedure, along with  
                 annual fees for storage.   CHBRP estimated that the  
                 average per unit cost for the initial procedure of sperm  
                 cryopreservation is $400.  Embryo procurement is a  
                 surgical procedure and requires a month of prescription  
                 drug treatment prior to the actual procedure itself.   
                 Taken together, the average cost of the procurement  
                 surgery and the fertility drugs is approximately $14,700  
                 for embryo cryopreservation.  The annual storage costs  
                 beyond 2014 are estimated to be $100 for sperm and $300  
                 for embryos and oocytes.

               According to CHBRP, increases in per member per month  
                 premiums for newly mandated benefit coverage vary  
                 slightly by market segment but are estimated to range  
                 from 0.0017 percent to 0.031 percent.  CHBRP reports that  
                 the net health expenditures are projected to increase by  
                 $2.1 million due to an $2.9 million increase in premiums  
                 plus a 0.3 million increase in enrollee out-of-pocket  
                 expenses for newly covered benefits, partially offset by  
                 a net reduction in enrollee out-of-pocket expenditures  
                 for uncovered benefits ($1.1 million).

               c.     Public Health Impact.  CHBRP reports that the loss  
                 of fertility can negatively impact the quality of life  
                 for cancer survivors of reproductive age and as a result  
                 of this bill, it is expected that the quality of life  
                 could improve for some of the 7,650 cancer patients at  
                 risk for iatrogenic infertility each year who would gain  
                 coverage.  According to CHBRP it is estimated this bill  
                 would reduce the net financial burden by almost $750,000  
                 across enrollees who would have paid for previously  
                 uncovered services.  According to CHBRP, there is a great  




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                 disparity in the degree to which males and females face  
                 direct expenses and associated financial burden in paying  
                 for fertility preservation services.  As previously  
                 stated, sperm cryopreservation for males is estimated to  
                 cost $400 while embryo cryopreservation for females is  
                 estimated to cost $14,700 and $11,200 for oocyte  
                 cryopreservation.  This bill, according to CHBRP, is  
                 expected to decrease the disparity in the financial  
                 burden of expenses related to fertility preservation  
                 services borne by females.  CHBRP did not find any  
                 disparities in the use of fertility preservation  
                 treatments by race/ethnicity.  CHBRP determined that  
                 although cancer is a substantial cause of iatrogenic  
                 infertility, premature mortality, and economic loss in  
                 California, this bill is not expected to result in a  
                 reduction in premature death or associated economic loss.  
                  And lastly, according to CHBRP, this bill is expected to  
                 increase utilization of sperm cryopreservation and embryo  
                 cryopreservation services and annual long-term benefits  
                 could include an estimated five additional males and four  
                 additional female cancer patients having a biological  
                 child each year as a result of this bill.

          6.Related legislation.  AB 460 (Ammiano) requires coverage for  
            the treatment of infertility to be offered and provided  
            without discrimination on the basis of age, ancestry, color,  
            disability, domestic partner status, gender, gender  
            expression, gender identity, genetic information, marital  
            status, national origin, race, religion, sex, or sexual  
            orientation.
               
          7.Prior legislation.  
               
               a.     AB 428 (Portantino) of 2011, was substantially  
                 similar to this bill.  AB 428 was held in Assembly  
                 Appropriations on suspense.

               b.     AB 2356 (Skinner), Chapter 699, Statutes of 2012,  
                 authorizes a recipient of sperm donated by a sexually  
                 intimate partner (SIP) of the recipient for reproductive  
                 use to waive a second or repeat testing of that donor if  
                 the recipient is informed of the donor testing  
                 requirements, as specified, and signs a written waiver.   
                 Defines SIP to include a known or designated donor to  
                 whose sperm the recipient has previously been exposed in  
                 a nonmedical setting in an attempt to conceive.  Excludes  




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                 physicians and surgeons from liability and disciplinary  
                 action, as specified.
               
               c.     AB 1586 (Koretz), Chapter 421, Statutes of 2005,  
                 defines the term "sex" to include, but not be limited to,  
                 a person's gender, as specified, under existing law that   
                 prohibits health plans and insurers from specified  
                 discriminatory acts.

          8.Support.  The American Society For Reproductive Medicine and  
            the Society for Reproductive Technology (SART), sponsors of  
            this legislation, and the American Congress of Obstetricians  
            and Gynecologists (ACOG) write in support that with advances  
            in medical treatment, many diseases once thought to be fatal  
            or chronic can now be treated and cured but the very treatment  
            that could give a person a good chance for a long life, could  
            also deprive them the potential of biological children.  ACOG  
            maintains that surveys and anecdotal information from treating  
            physicians suggest that patients, if not able to obtain  
            fertility preservation services, choose less effective medical  
            care in an attempt to preserve fertility.  Supporters argue  
            that to choose therapy to try to balance these needs instead  
            of being able to focus on the most effective cure means these  
            patients could have worse outcomes, resulting in more  
            expensive treatment.  Planned Parenthood writes that they  
            believe that the costs of enacting this measure will be  
            modest, due to the relatively small number of people in their  
            reproductive years who will need this care especially when  
            spreading the cost among all insured persons.
            
          9. Opposition.  The California Chamber of Commerce and America's  
            Health Insurance Plans both write in opposition that, while  
            well intentioned, this bill would further exacerbate the  
            problem of rising health care costs.  The opposition maintains  
            that this bill cannot be viewed in isolation. With the state  
            already required to meet requirements designated by the ACA,  
            the opposition believes California should focus its attention  
            on meeting the EHBs required by the ACA rather than adding  
            additional mandated benefits. These mandates, according to the  
            opposition, have already reduced flexibility in benefit  
            design, increased health care costs and premium rates, leading  
            to reduced employers' and individuals' choice of benefit  
            packages from health insurers and HMOs. The opposition asserts  
            that benefit mandates that do not promote evidence-based  
            medicine may lead to lower quality of care, over-utilization,  




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            and high costs for possible non-effective treatments.






           SUPPORT AND OPPOSITION  :
          Support:  American Society for Reproductive Medicine  
                    (co-sponsor)
                    American Congress of Obstetricians and Gynecologists,  
                              District IX
                    Association of Northern California Oncologists
                                                     American Cancer Society Cancer Action Network
                    California Affiliates of Susan G. Komen Race for the  
                              Cure
                    California Chronic Care Coalition
                    Cancer Legal Resource Center
                    CHOC Children's

                    National Center for Lesbian Rights

                    Oncofertility Consortium 

                    Planned Parenthood 

                    Resolve

                    Southern California Institute for Reproductive  
               Sciences



          Oppose:   America's Health Insurance Plans
                    California Association of Health Plans
                    California Association of Health Underwriters
                    California Chamber of Commerce





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