BILL ANALYSIS                                                                                                                                                                                                    �



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          Date of Hearing:  April 30, 2013

                            ASSEMBLY COMMITTEE ON HEALTH
                                 Richard Pan, Chair
               AB 912 (Quirk-Silva) - As Introduced:  February 22, 2013
           
          SUBJECT  :   Health care coverage: fertility preservation.

           SUMMARY :   Mandates that 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,  
          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)Enacts, in federal law, the Patient Protection and Affordable  
            Care Act (ACA) to, among other things, make statutory changes  
            affecting the regulation of, and payment for, certain types of  
            private health insurance.  Includes the definition of  
            essential health benefits (EHBs) that all qualified health  
            plans must cover, at a minimum, with some exceptions.

          2)Provides that the EHB package in 1) above will be determined  
            by the federal Department of Health and Human Services  
            Secretary and must include, at a minimum, ambulatory patient  
            services; emergency services; hospitalizations; mental health  
            and substance abuse disorder services, including behavioral  
            health; prescription drugs; and, rehabilitative and  
            habilitative services and devices, among other things.   
            Through regulations gives states option to choose a benchmark  
            plan to serve as the basis for EHBs in 2014 and 2015.   
            Requires states to defray costs associated with state mandated  
            benefits that exceed EHBs.

           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),  
            mandates coverage for basic health care services, and provides  
            for the regulation of health insurers by the California  
            Department of Insurance (CDI).








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          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 EHB benchmark plan the Kaiser  
            Small Group Health Maintenance Organization (HMO) 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,  
               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  :  This bill has not yet been analyzed by a fiscal  
          committee.

           COMMENTS  :  

           1)PURPOSE OF THIS BILL  .  According to the author of this bill, a  
            diagnosis of cancer may bring with it an unexpected  
            consequence: the potential loss of fertility.  The author  
            maintains that treatments that accompany this diagnosis may  
            have long-term implications for the ability of a survivor to  
            build a family and develop the kind of legacy many people take  
            for granted.  The author asserts that treatments to preserve  
            fertility in men and women can be performed before  
            chemotherapy and radiation starts and used after the patient  
            is given a clean bill of health.  However, the author argues,  
            the cost to preserve fertility is not a covered option for the  
            majority of cancer patients, even though fertility loss occurs  
            as a consequence of their treatment.  The author further  
            argues that as reconstructive coverage for breast cancer  
            patients is required, similarly, the option of fertility  
            preservation for patients undergoing chemotherapy and  
            radiation should also be covered.  The author states that  
            while the cost to preserve fertility is relatively modest,  
            most patients are unable to afford this unexpected  








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            out-of-pocket expense, especially at a time when they are  
            facing other significant cost pressures surrounding treatment.  
             The author argues that the situation is further complicated  
            by a short time frame between diagnosis and treatment that  
            does not allow time to seek appeal when insurance companies  
            deny fertility preservation coverage.  According to the  
            author, this bill seeks to make this coverage available and  
            accessible as soon as the decision is made to undergo  
            fertility preservation.
               
           2)IATROGENIC INFERTILITY  .  Infertility is the diminished ability  
            or the inability to conceive or contribute to conception.   
            Infertility may also be defined in specific terms as the  
            failure to conceive after a year of sexual intercourse without  
            conception.  Iatrogenic infertility is medically induced  
            infertility caused by a medical intervention used to treat a  
            primary disease or condition.  The medical intervention is  
            often gonadotoxic (radiation, chemotherapy, and prescription  
            drugs) or surgical treatment. Iatrogenic infertility is  
            typically caused by cancer treatments such as radiation,  
            chemotherapy, or surgical removal of reproductive organs.   
            Less frequently, fertility is compromised by treatments for  
            autoimmune disorders such as systemic lupus erythematosus,  
            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 male 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, but if he does not take part in fertility  
            preserving treatment, his future ability to father a child may  
            be at risk.  

            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 the patient described above does have coverage for  
            infertility treatment and does not have coverage for fertility  
            preservation treatment, he would be ineligible for coverage of  








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            those treatments because he does not meet the definition of  
            being infertile prior to undergoing cancer treatment.
           3)ETHICS REPORT  .  A June 2005 report published in the American  
            Society for Reproductive Medicine, titled "Fertility  
            Preservation and Reproduction in Cancer Patients," concludes  
            that when damage to reproductive organs due to cancer  
            treatment is unavoidable, cancer specialists should inform  
            patients of options for storing gametes, embryos, or gonadal  
            tissue and refer them to fertility specialists who can  
            provide counseling about such services.  Counseling should  
            include risks of cancer treatment on fertility and the  
            options for and risks of preserving fertility and reproducing  
            after cure or remission.  Parents may act to preserve  
            reproductive options of minor children as long as the minor  
            assents, the intervention does not pose undue risk, and the  
            intervention offers reasonable chance of net benefit to the  
            child.  Programs storing gametes, embryos, or gonadal tissue  
            for cancer patients should request clear instructions  
            including what should be done in the event of the patient's  
            death.  Physicians should assess the likely impact on  
            offspring of cancer treatments and fertility preservation and  
            assisted reproduction procedures and inform patients  
            accordingly.  

           4)CALIFORNIA HEALTH BENEFITS REVIEW PROGRAM  .  The California's  
            Health Benefits Review Program (CHBRP) was created in  
            response to AB 1996 (Thomson), Chapter 795, Statutes of 2002,  
            which requests the University of California to 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% 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  








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               treatments that could 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 is 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 gynecologic surgeries for fertility  
                 preservations.

               v)     Ovarian transposition, also called oophoropexy, is  
                 a surgical repositioning of ovaries to another location  








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                 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% of the 19.4 million enrollees currently  
               have coverage for fertility preservation services.  Under  
               this bill, 100% 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  
               (with 947 paying for the uncovered benefit directly) and  
               72 female enrollees use embryo or oocyte cryopreservation  
               (with 56 paying for the noncovered benefit directly).   
               CHBRP reports that if this bill in enacted, utilization  
               for male enrollees will increase by 19% (or 198 males) and  








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               for female enrollees by 175% (or 126 females).  In total a  
               29% 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%  
               to 0.031%.  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 .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 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  








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               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.

           5)EHBs  .  The Kaiser Small Group HMO 30 EHB benchmark plan for  
            California excludes coverage for the treatment of  
            infertility, therefore health insurance subject to EHB  
            coverage requirements is not required to cover treatment for  
            infertility.  This state benefit mandate meets the definition  
            of a benefit mandate that could exceed EHBs as established by  
            federal regulations on EHBs, which states it must be specific  
            to care, treatment and/or services.  Therefore, according to  
            CHBRP, this mandate could trigger the requirement that the  
            state defray the costs of coverage for enrollees in QHPs in  
            Covered California.  QHP issuers are responsible for  
            calculating the marginal cost that must be defrayed based on  
            "either a statewide average or each issuer's actual cost."   
            California has not yet identified which option it will use.   
            CHBRP is not able to estimate the total number of enrollees  
            in QHPs in 2014, but is able to estimate the marginal change  
            in the PMPM premium that would result from requiring coverage  
            for fertility preservation services in 2014. These estimates  
            reflect a statewide average and not an issuer's actual cost.  
            The marginal change in the PMPM premium that CHBRP estimates  
            would result from this bill and that the state would be  
            responsible for defraying for each enrollee in a QHP in  
            Covered California is $0.01 in nongrandfathered small-group  
            and individual market DMHC-regulated plans; and $0.01 in  
            nongrandfathered small-group and individual market  
            CDI-regulated policies.  So if there were 3 million QHP  
            enrollees, the state would be responsible for $360,000  
            associated with this mandate (.01 x 3 million x 12 months).  








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           6)SUPPORT  . The American Society for Reproductive Medicine, a  
            cosponsor of this bill, writes in support that with advances  
            in medical treatment, many diseases once thought fatal or  
            chronic, can now be treated and cured.  However, the very  
            treatment that saves lives could also cost both men and women  
            the potential of biological children.  Along with their  
            affiliated organization, the Society for Assisted  
            Reproductive Technology, supporters maintain that losing the  
            chance to have children in the future is a major fear for  
            cancer patients.  Supporters cite surveys and anecdotal  
            information from treating physicians which suggests that  
            one-third of patients, if not able to obtain fertility  
            preservation services, choose less effective medical care in  
            an attempt to preserve their fertility.  Supporters argue  
            that this could result in worse outcomes, resulting in more  
            expensive treatment.  Based on the 2011 CHBRP analysis,  
            supporters argue that the cost effect of this coverage is  
            projected to range from zero increase to $0.0373 per member  
            per month, with current efforts aimed at bringing this  
            estimate down to the point of near cost neutrality.   
            Supporters argue that this bill will potentially address  
            certain issues of gender, racial, and ethnic disparities in  
            care and will bring other untold benefits by providing cancer  
            patients and others the opportunity for a long life by  
            allowing them to focus on the best medical care for a cure  
            and to maintain their dream of a biological family after  
            treatment while also lowering the cost of care.

           7)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,  
            and high costs for possible non-effective treatments.








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           8)RELATED LEGISLATION  .  

             a)   AB 219 (Perea) requires health plan contracts and health  
               insurance policies that cover prescribed, orally  
               administered anticancer medications to limit an enrollee or  
               insured's total cost share to no more than $100 per filled  
               prescription.  AB 219 passed the Assembly and is currently  
               in Senate Rules Committee pending referral.

             b)   AB 460 (Ammiano), also pending in the Assembly Health  
               Committee, 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.
             c)   AB 889 (Frazier), currently in the Assembly Health  
               Committee, prohibits a health plan that provides coverage  
               for medications pursuant to step therapy or fail first  
               protocol from requiring a patient to try and fail more than  
               two medications before allowing the patient access to the  
               medication originally prescribed by their provider.   
               Requires health plans to have an expeditious process in  
               place for step therapy exceptions and that the duration of  
               step therapy be consistent with up-to-date evidence-based  
               outcomes and current published peer-reviewed medical and  
               pharmaceutical literature.

             d)   SB 126 (Steinberg), currently in the Senate Health  
               Committee, extends the sunset of the requirement for every  
               health plan contract that provides hospital, medical, or  
               surgical coverage and health insurance policy issued,  
               amended, or renewed on or after July 1, 2012, pursuant to  
               California's mental health parity law, to provide coverage  
               for behavioral health therapy for pervasive developmental  
               disorder or autism from July 1, 2014 to July 1, 2019.

             e)   SB 189 (Monning), also in the Senate Health Committee,  
               prohibits a health care service plan or health insurer from  
               offering a wellness program in connection with a group  
               health plan contract or group health insurance policy, or  
               offering an incentive or reward based on adherence to a  
               wellness program, as specified.








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             f)   SB 320 (Beall) prohibits a health care service plan  
               contract or a health insurance policy issued, amended,  
               renewed, or delivered on or after January 1, 2014, from  
               denying coverage for medically necessary medical or  
               rehabilitation treatment for an acquired brain injury, as  
               specified.

             g)   SB 799 (Ron Calderon) requires a health care service  
               plan contract or a health insurance policy, except as  
               specified, that is issued, amended, or renewed on or after  
               January 1, 2014, to provide coverage for genetic testing  
               for hereditary nonpolyposis colorectal cancer and screening  
               for colorectal cancer under specified circumstances.
              
          9)PREVIOUS LEGISLATION  .
           
              a)   AB 428, substantially similar to this bill, 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  
               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.  
           
           

          REGISTERED SUPPORT / OPPOSITION  :   

           Support 
           
          American Cancer Society Cancer Action Network








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          American Society for Reproductive Medicine
          California Affiliates of Susan G. Komen
          California Chronic Care Coalition
          National Center for Lesbian Rights

           Opposition 
           
          America's Health Insurance Plans
          California Association of Health Plans
          California Chamber of Commerce
           
          Analysis Prepared by  :    Hammad Khan / HEALTH / (916) 319-2097