BILL ANALYSIS                                                                                                                                                                                                    



                                                                  AB 428
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          Date of Hearing:   May 3, 2011

                            ASSEMBLY COMMITTEE ON HEALTH
                              William W. Monning, Chair
                  AB 428 (Portantino) - As Amended:  April 27, 2011
           
          SUBJECT  :  Health care coverage: fertility preservation.

           SUMMARY  :  Requires health care service plan (health plan) 
          contracts and health insurance policies that are issued, 
          amended, delivered, or renewed, on or after July 1, 2012, to 
          provide coverage for medically necessary expenses for standard 
          fertility preservation services when medical treatment may 
          directly or indirectly cause iatrogenic infertility to an 
          enrollee or insured.  

           EXISTING FEDERAL LAW  :

          1)Enacts, in federal law, the Patient Protection and Affordable 
            Care Act (PPACA) 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 (HHS) 
            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.

           EXISTING STATE LAW  :

          1)Establishes the Knox-Keene Health Care Service Plan Act of 
            1975 (Knox-Keene) 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.









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           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 that 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 
            out-of-pocket expense, especially at a time when they are 
            facing significant other 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 infertility caused by a 
            medical intervention, including reactions from prescribed 
            drugs or from medical and surgical procedures.  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 








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            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 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 
            those treatments because he does not meet the definition of 
            being infertile prior to undergoing cancer treatment.  
           
           3)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 
            analysis of this bill, CHBRP reports that its review will not 
            examine other causes of infertility such as underlying 
            medical conditions, genetic defects, or general health and 
            lifestyle status since those causes of infertility are not 
            considered iatrogenic.  CHBRP states that its review will 
            focus on fertility preservation among cancer patients since 
            the majority of iatrogenic infertility occurs in cancer 
            patients and the research on iatrogenic infertility has 
            focused almost exclusively on this group.  Among CHBRP's 
            findings are the following:

              a)   Medical Effectiveness  .  According to CHBRP, fertility 
               preservation services for patients at risk for iatrogenic 








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               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 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)   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.  Despite this, it stands to reason that 
                 under specific circumstances, females undergoing pelvic 
                 radiation, where there is a high risk of ovarian 








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                 failure, may want to consider ovarian transposition as a 
                 method of fertility preservation.

               iv)    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.

               v)     Treatment for gynecological cancers can include 
                 surgery to remove the diseased part of the reproductive 
                 organs.  In cases where fertility preservation is a 
                 priority, conservative gynecologic surgery may be used 
                 to minimize the amount of tissue removed.  Trachelectomy 
                 is a treatment for cervical cancer where the cervix is 
                 surgically removed while the uterus is preserved.  
                 Another conservative surgery for ovarian cancer 
                 preserves the uterus with one ovary.  There is a 
                 preponderance of evidence that conservative gynecologic 
                 surgery is an effective method of fertility preservation 
                 measured by pregnancy rates and live births and there is 
                 a preponderance of evidence that this surgery has no 
                 apparent increase in cancer recurrence or mortality in 
                 selected cases.

              b)   Utilization, Cost, and Coverage Impacts  .  According to 
               CHBRP, this bill would apply to 21.9 million enrollees in 
               all DMHC-regulated, privately funded plans and 
               DMHC-regulated, publicly funded plans, as well as all 
               CDI-regulated policies.  CHBRP reports that approximately 
               5.4% of the 21.9 million enrollees currently have coverage 
               for fertility preservation services.  If this bill is 
               enacted, 100% of enrollees would be covered.  CHBRP also 
               states that no publicly funded DMHC-regulated plans 
               currently include coverage for fertility preservation 
               services.









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             CHBRP's analysis used population estimates based on those 
               who face one of the top 10 cancers associated with 
               treatments that could cause iatrogenic infertility.  
               Additionally, the population analysis was restricted to 
               those of reproductive age (ages 14-40 for females and ages 
               12-50 for males).  CHBRP estimates that currently, 1,057 
               male enrollees use sperm cryopreservation (with 986 paying 
               for the uncovered benefit directly) and 222 female 
               enrollees use embryo cryopreservation (with 188 paying for 
               the noncovered benefit directly).  CHBRP reports that if 
               this bill in enacted, utilization for male enrollees will 
               increase by 19% (or 205 males) and by female enrollees by 
               161% (or 357 females).

             Currently, 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 estimates 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.  

             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 $0.00 to 
               $0.0373.  CHBRP reports that the net health expenditures 
               are projected to increase by $6.5 million due to an $8.5 
               million increase in premiums partially offset by a net 
               reduction in enrollee out-of-pocket expenditures of $2 
               million, comprised of a reduction in enrollee expenses for 
               uncovered benefits ($3.2 million) and an increase in 
               enrollee out-of-pocket expenses for the newly covered 
               benefits ($1.2 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 6,346 cancer patients at risk for 
               iatrogenic infertility each year who would gain coverage.  








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               According to CHBRP research shows that the financial 
               burden faced by cancer patients can be substantial.  CHBRP 
               indicates that one study found that 45% of cancer patients 
               with substantial care needs report a sense of financial 
               burden.  CHBRP also reports that cancer treatment can also 
               have significant long-term economic consequences; one 
               study found that one-third of families lose all or most of 
               their savings after a cancer diagnosis.  Nonmedical costs 
               due to cancer treatment, such as transportation costs and 
               lost wages, can also result in a substantial burden for 
               cancer patients and their families.  Cancer patients who 
               have concerns about maintaining their fertility have an 
               additional burden - not only do they have the burden of 
               their cancer treatments, but they have the burden of 
               paying for their fertility preserving services, CHBRP 
               reports.

             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 cost 
               $14,700.  Therefore, according to CHBRP, females are 
               facing costs for preserving fertility that are more than 
               35 times that faced by males.  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 estimated five additional males and 15 
               additional female cancer patients having a biological 
               child as a result of this bill.
           
          4)EHBs .  The PPACA requires qualified health plans to cover 
            specified categories of EHBs, including behavioral health 
            treatment and rehabilitative services, by 2014.  The HHS 








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            Secretary is tasked with defining these benefit categories 
            through regulation so that they mirror those benefits offered 
            by a "typical" employer plan.  Qualified plans are required to 
            cover EHBs by 2014.  Federal guidance with respect to EHBs is 
            expected later this year and in 2012.

          In a January 2011 issue brief by CHBRP focusing on the federal 
            requirement to cover EHBs, CHBRP notes that there is 
            considerable legal ambiguity over how state mandates requiring 
            the coverage of the treatment for a specific condition or 
            disease will interact with federal law.  CHBRP states that 
            these mandates often extend across multiple benefit 
            categories.  CHBRP cites, as an example, California's mandate 
            to cover breast cancer treatment, which implicitly requires 
            coverage for screening and testing, medically necessary 
            physician services, ambulatory services, prescription drugs, 
            hospitalization, and surgery.  CHBRP writes that it is unclear 
            how California benefit mandates that overlap across several 
            EHB categories would be evaluated in relation to the EHB 
            package.
           
          5)SUPPORT  .  The American Society for Reproductive Medicine, 
            RESOLVE: The National Infertility Association, and Fertility 
            Action all write in support of this bill 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.  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.  Fertile Action further states that 
            fertility preservation should not be a human write just for 
            the wealthy but is very much a part of the cancer continuum 
            for young adults and should be covered as such by insurance 
            companies.  The California Medical Association writes in 
            support that the job of insurance is to cover the necessary 
            costs of care to make someone whole again after an illness or 
            injury.  This bill ensures that promise is kept.  Given the 
            very small number of individuals impacted by this bill, the 
            tiny up-front cost is an investment in the future health and 








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            quality of life for these individuals and their families.

           6)OPPOSITION  .  The California Association of Health Plans, the 
            California Chamber of Commerce, and America's Health Insurance 
            Plans all 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 
            may only minimally increase health insurance premiums, but 
            this increase cannot be viewed in isolation.  The opposition 
            argues that this year alone the Legislature will be 
            considering at least a dozen new mandates along with the many 
            currently imposed benefit mandates.  These mandates, according 
            to the opposition, have reduced flexibility in benefit design, 
            increased health care costs, and premium rates leading to 
            reduced employers' and individuals choice of benefit packages, 
            ultimately contributing to the need for health care reform 
            today.  The opposition asserts that benefit mandates make 
            insurance less affordable, resulting in an increased number of 
            uninsured.

           7)POLICY COMMENT  .  This bill is one of several health mandates 
            introduced for legislative consideration this year.  The 
            author may wish to address the extent to which the need for 
            this bill and others similar to it is premature, given that 
            federal regulations to define the parameters of the EHB 
            package have yet to be promulgated.


           REGISTERED SUPPORT / OPPOSITION  :   

           Support 
           
          American Society of Reproductive Medicine 
          California Medical Association
          California National Organization for Women
          Fertile Action
          Medical Oncology Association of Southern California
          RESOLVE: The National Infertility Association
          Numerous Individuals

           Opposition 
           
          America's Health Insurance Plans
          Association of California Life and Health Insurance Companies
          California Association of Health Plans
  







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          California Association of Health Underwriters
          California Chamber of Commerce

           Analysis Prepared by  :    Tanya Robinson-Taylor / HEALTH / (916) 
          319-2097