Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of the act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. Existing law requires a health care service plan contract to provide subscribers and enrollees all of the basic health care services, and defines basic health care services to include, among other things, physician services, hospital inpatient services and ambulatory care services, and preventive health services. Existing law requires an individual or small group health care service plan contract and health insurance policy issued, amended, or renewed on or after January 1, 2017, to include, at a minimum, coverage for essential health benefits, and defines essential health benefits to include, among other things, medically necessary basic health care services, as defined. Existing law requires every group health care service plan contract and health insurance policy that covers hospital, medical, or surgical expenses to offer coverage for the treatment of infertility, as defined, except in vitro fertilization.

This bill would expand the definition of basic health care services to include standard fertility preservation services when a medically necessary treatment may directly or indirectly cause iatrogenic infertility. The bill would require an individual or group health care service plan contract or health insurance policy issued, amended, or renewed on and after January 1, 2018, that covers hospital, medical, surgical, and other iatrogenic expenses for diagnoses with medical interventions that may directly or indirectly cause iatrogenic infertility, or surgical expenses to include coverage for evaluation and treatment of iatrogenic infertility, as specified. standard fertility preservation services when a medically necessary medical treatment may directly or indirectly cause iatrogenic infertility. The bill would specify that it does not apply to a specialized health care service plan or a specialized health insurance policy. The bill would define terms for these purposes.

Because a willful violation of these provisions by a health care service plan would be a crime, this bill would impose state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of the act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. Existing law requires every group health care service plan contract and health insurance policy that covers hospital, medical, or surgical expenses to offer coverage for the treatment of infertility, as defined, except in vitro fertilization.

This bill would require an individual or group health care service plan contract or health insurance policy issued, amended, or renewed on and after January 1, 2018, that covers hospital, medical, or surgical expenses surgical, and other iatrogenic expenses for diagnoses with medical interventions that may directly or indirectly cause iatrogenic infertility, to include coverage for medically necessary expenses for standard fertility preservation services when a necessary medical treatment may directly or indirectly cause iatrogenic infertility to an enrollee or insured. evaluation and treatment of iatrogenic infertility, as specified. The bill would specify that it does not apply to a specialized health care service plan or a specialized health insurance policy.

Because a willful violation of these provisions by a health care service plan would be a crime, this bill would impose state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of the act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. Existing law requires every group health care service plan contract and health insurance policy that covers hospital, medical, or surgical expenses to offer coverage for the treatment of infertility, as defined, except in vitro fertilization.

This bill would require an individual or group health care service plan contract or health insurance policy issued, amended, or renewed on and after January 1, 2018, that covers hospital, medical, or surgical expenses to include coverage for medically necessary expenses for standard fertility preservation services when a necessary medical treatment may directly or indirectly cause iatrogenic infertility to an enrollee or insured.

Because a willful violation of these provisions by a health care service plan would be a crime, this bill would impose state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

SENATE COMMITTEE ON

Senator Ricardo Lara, Chair

2017 - 2018 Regular Session

SB 172 (Portantino) - Health care coverage: fertility preservation

This bill meets the criteria for referral to the Suspense File.

Bill Summary:

SB 172 would require individual and small group health care coverage to include coverage for standard fertility preservation services, when a medically necessary treatment may cause infertility.

Fiscal Impact:

• Ongoing costs of about $60,000 per year to CalPERS to cover the increased costs of the benefit mandate for its health care plans (various funds).
• No increased cost to the Medi-Cal program, since the benefit mandate in the bill does not apply to Medi-Cal managed care plans, because Medi-Cal managed care plans are not considered group health plans.
• No costs to the state to subsidize the cost of providing the benefit in this bill through Covered California is anticipated. See below.
• One-time costs of about $205,000 over two years for the adoption of regulations by the Department of Managed Health Care (Managed Care Fund).
• Likely one-time costs in the low hundreds of thousands for the adoption of regulations by the Department of Insurance (Insurance Fund).

Background:

Under current law, health insurers are regulated by the Department of Insurance and health plans are regulated by the Department of Managed Health Care.

Under the federal Affordable Care Act, health coverage provided in the small group or individual market (including through health exchanges) must provide essential health benefits. The Affordable Care Act specifies the general categories of benefits that must be provided. Under federal guidance, states can select an essential health benefits benchmark plan. After 2014, all coverage provided in the small group and individual markets must provide coverage equal to or greater than the coverage provided by the benchmark plan. The state has selected the Kaiser Small Group HMO as the state’s essential health benefits benchmark plan.

Under federal law, individuals purchasing coverage through health benefit exchanges are eligible for subsidies, based on income, paid by the federal government. Under federal law, if a state imposes a benefit mandate after January 1, 2012 that exceeds the benefits provided by the essential health benefits benchmark plan, the state is responsible for providing the subsidies for coverage of that mandated benefit.

Certain medical interventions may lead to infertility in the patient (this is referred to as “iatrogenic infertility”). Most commonly, anti-cancer treatments such as surgical removal of reproductive organs, radiation therapy, or chemotherapy can render a patient infertile. In such cases, some patients elect to receive fertility preservation treatments before undergoing treatment for their illness. For example, a male patient may elect to have sperm frozen or a female patient may elect to have either unfertilized eggs or a fertilized embryo frozen. These services are not typically covered by health insurance policies or health plans. Even if the patient’s health insurance policy or health plan provides coverage for infertility, the patient may not qualify for that coverage because the patient is not infertile before medical treatment has begun.

Proposed Law:

SB 172 would require individual and small group health care coverage to include coverage for standard fertility preservation services, when a medically necessary treatment may cause infertility.

Related Legislation:

• AB 912 (Quirk-Silva, 2013) was similar to this bill, but would have only applied to the large group market. That bill was vetoed by Governor Brown.
• AB 428 (Portantino, 2011) was substantially similar to this bill. That bill was held on the Assembly Appropriations Committee’s Suspense File.

Staff Comments:

Under the Affordable Care Act, individuals purchasing health care coverage in health benefit exchanges (such as Covered California) are eligible for premium subsidies based on their household income. Federal law and guidance requires states to assume the additional costs to subsidize any new health benefit mandate adopted after 2012.

If this bill were interpreted by the federal government as exceeding the state’s essential health benefits benchmark, the state would be responsible for paying the cost to subsidize this benefit. About 90% of individuals purchasing coverage through Covered California receive subsidized coverage. Subsidies are generally based on household income, and thus most of the cost for rising premiums are generally paid for by subsidies. To the extent that the federal government determines that the state is liable for the subsidy cost to provide the new benefits of this bill, the state would pay most of the cost for this benefit.

It does not appear that this bill mandates a new benefit that exceeds the benefits in the state’s benchmark plan. Both the Department of Managed Health Care and the California Health Benefits Review Program indicate that medically necessary fertility preservation service, when part of a medically necessary treatment for an underlying condition, are already considered basic health care services. Therefore, the requirements of this bill do not appear to exceed the essential health benefits benchmark requirements. It is not anticipated that the state would be obligated to pay for the cost to subsidize this benefit for subsidized Covered California plans.

The only costs that may be incurred by a local agency relate to crimes and infractions. Under the California Constitution, such costs are not reimbursable by the state.

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SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: SB 172

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 January 1, 2018, 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: 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 (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.
3. Establishes as California's EHBs the Kaiser Small Group Health Maintenance Organization plan along with the following 10 ACA mandated benefits:
4. Ambulatory patient services;
5. Emergency services;
6. Hospitalization;
7. Maternity and newborn care;
8. Mental health and substance use disorder services, including behavioral health treatment;
9. Prescription drugs;
10. Rehabilitative and habilitative services and devices;
11. Laboratory services;
12. Preventive and wellness services and chronic disease management; and,
13. Pediatric services, including oral and vision care.

This bill:

1. Requires health plan contract and health insurance policies issued, amended, renewed, on or after January 1, 2018 to cover evaluation and treatment of iatrogenic infertility, including but not limited to standard fertility preservation.
2. Defines the following terms:
3. Iatrogenic as illness caused by medical examination or treatment;
4. Iatrogenic infertility as infertility caused by a medical intervention, including, but not limited to, reactions from prescribed drugs or from medical and surgical procedures;
5. Infertility as the result of a disease, an interruption, cessation, or disorder of body functions, systems, or organs, of the male or female reproductive tract that prevents the conception of a child or the ability to carry a pregnancy to delivery;
6. “May directly or indirectly cause” as treatment with a likely side effect of infertility as established by the American Society for Reproductive Medicine, the American Society of Clinical Oncology, or other reputable professional organization; and,
7. “Standard fertility preservation services” as procedures consistent with established medical practices and professional guidelines published by the American Society for Reproductive Medicine, the American Society of Clinical Oncology, or other reputable professional medical organization.

FISCAL EFFECT:

This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. Author’s statement. According to the author, it just doesn’t seem right that anyone should have to choose between fighting cancer and his or her ability to have children. While most insurance policies and plans cover a wide variety of cancer treatments and follow-up procedures due to consequences and effects of treatment, such as reconstructive surgery, fertility preservations unfortunately is not included in those plans. This omission forces many patients to forego or delay treatment as they grapple with these decisions. Many get sicker as a result of these delays. SB 172 is an effort to take one decision from their burden so patients can focus on getting better.
   
2. Iatrogenic infertility. According to the National Institute of Health (NIH), 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. According to a study published in the Cancer Treatment and Research Journal, an iatrogenic condition is a side effect or adverse condition caused by medically necessary treatments and activities. It is typically caused by the side effects of chemotherapy, radiation therapy, and/or the removal of reproductive organs. Chemotherapeutic drugs consist of a wide range of ingredients that have known to interfere with fertility by damaging sperm or egg cells. Many of them are dose dependent, meaning that the more and longer the drug is taken, the more damage can occur. 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.
3. Standard fertility preservation. According to the NIH, fertility preservation is 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. People with certain disease, disorders, or life events that may affect fertility can utilize fertility preservation in order to attempt having a child later in life. A range of options is available for both male and female patients. For males, these include sperm cryopreservation, where semen is frozen and stored for future use, and gonadal shielding, which protect the pelvic area of harmful radiation during cancer treatment. For females, the most successful fertility preservation option is embryo cryopreservation. First, eggs are removed from the ovaries and are then fertilized with sperm via in vitro fertilization. The resulting embryos are frozen and stored for future use. Other fertility preservation methods include oocyte cryopreservation, where an unfertilized egg is stored; gonadal shieling to protect the ovaries from radiation; and, ovarian transposition, where a small surgery is used to relocate ovaries to an area of the abdomen that will not receive harmful radiation. The American Society of Clinical Oncology has also recommended conservation gynecology by performing conservation surgeries. These can include a trachelectomy for cervical cancers, which remove the cervix while preserving the uterus. For treatment of ovarian cancer, the removal of the uterus (hysterectomy) and removal of both ovaries is recommended. If the cancer is confined to only ovary, conservation surgery can save one ovary and/or the uterus
4. Current health insurance coverage. 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.
   
5. California Health Benefit Review Program (CHBRP) analysis.  AB 1996 (Thomson, Chapter 795, Statutes of 2002) requests the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996, and reviewed this bill.  Key findings include:
   1. Coverage impacts and enrollees covered. Using estimates of females aged 12 to 44 and males aged 12 to 49 who could be at risk of iatrogenic infertility, CHBRP approximates that currently 85%, (13.7 million) of enrollees with health insurance that would be subject to SB 172 already have coverage that is compliant with covering at least one fertility preservation services for each gender. Of those 13.7 million enrollees, an estimated 7,589 are cancer patients at the risk of iatrogenic infertility.
   2. Essential health benefits. SB 172 could be interpreted to trigger financial costs to the state for exceeding EHBs. The amended bill language of SB 172 requires coverage of the “evaluation and treatment of iatrogenic infertility,” which could include a large range of services beyond just fertility preservation services, but could mean to include infertility treatment, therefore exceeding the EHBs.
   3. Medical effectiveness. CHBRP measured effectiveness of the five most common fertility preservation techniques for females (i-iv below) and for males (v-vi below) based on the following outcomes: clinical pregnancy rate, pregnancy rate, cumulative pregnancy rate, birth rate, live birth rate, and the cumulative birth rate. Techniques were rated on a scale ranging from Not Effective to Effective, measured by data that was considered either clear and convincing, preponderance, limited, or conflicting.

CHBRP found that there is limited evidence that embryo cryopreservation is an effective method of fertility perseveration based on three outcomes, such as successful thawing of embryos, successful implementation of embryos, and resulting live births.

• • 1. There is limited evidence that oocyte cryopreservation is an effective method based on the success of thawing oocytes, success of implantation of embryos, and the number of resulting live births.
    2. There is limited evidence that ovarian transposition is an effective method of maintaining ovarian function among women undergoing radiation as part of their cancer treatment.
    3. The practice of ovarian shielding during radiation therapy had insufficient evidence to determine its effectiveness, which does not indicate that the treatment is not effective, but that not enough data is available to make any determinations.
    4. CHBRP concluded that there is limited evidence that trachelectomy and conservation ovary surgeries are effective conservative gynecologic surgeries based on the pregnancy rates and live births that resulted.
    5. There is limited evidence that sperm cryopreservation is an effective method of fertility preservation as measured by pregnancy rates and live births.
    6. Similar to the ovarian shielding methodology, testicular shielding did not have sufficient evidence to determine if it is an effective method of fertility preservation in males.
  1. Utilization. Using data on enrollees with the top ten cancer diagnoses, CHBRP determined utilization for a current status quo level as well as post-mandate scenarios provided by the introduced bill language and the amended bill. Currently, prior to the implantation of SB 172, based on the total number of insured enrollees in California, the number of enrollees who would be impacted by SB 172, the number of enrollees who may have iatrogenic infertility due to cancer, a total of 186 enrollees would use fertility preservation techniques but not be covered under the health plans, compared to 1,452 enrollees whose plans already provide coverage.

CHBRP expects utilization of fertility preservation to increase with an additional 219 males and 216 females if SB 172, as introduced, were to be implemented; and, to consider the amended bill language, currently 9.5% (31) of males and 33% (108) of females who undergo fertility preservation due to iatrogenic infertility may return later for infertility treatment. These attempts will result in 66 live births and 33 miscarriages. This additional inclusion in covered services, based on the amended bill language, would add an additional 59 males and 21 females post-mandate who may utilize infertility treatment services, resulting in 123 more live births (189 total) and 62 more miscarriages (95 total).

• 1. Per patient cost. CHBRP utilized claims data to determine the per-unit cost of fertility preservation services. Currently, male preservation services cost an average of $600 and services for females cost $13,500. These costs are not expected to change post-mandate based on the introduced language. However, if the amended language is mandated, the cost of infertility treatment would cost an average of $1,750 per procedure for males and $9,800 per procedure per females.
  2. Impact on expenditures. The introduced language of SB 172 would result in a net change of $2,197,000 (0.0015%) in expenditure, due to an increase in total health insurance premiums paid by employers and enrollees for the new benefits, which is counterbalanced by the amount saved by enrollees now covered under the new benefits. Similarly, if the amended bill language is passed, there would be a $6,001,000 net change in expenditure. SB 172 would not impact Medi-Cal as it does not apply. CalPERS managed care plans have estimated an increase in $0.0068 in premiums based on the introduced version and $0.03 increased premiums based on the amended bill.
  3. Public health. CHBRP determined that SB 172 would likely improve the quality of life by reducing regret about fertility outcomes, dissatisfaction, and distress for the additional estimated 435 enrollees utilizing fertility preservation service during the first year post-mandate. Additionally, females experience cancer at twice the rate as males, and pay 12 times more in uncovered fertility preservation services than men. Therefore, SB 172 could greatly decrease the cost disparity by providing benefit coverage for both. Long term studies showed that fertility preservation does not pose any higher risk to the health outcome of children conceived with cryopreserved eggs, sperm, or embryos from patients with iatrogenic infertility than those risks associated with infertility treatment services used to treat non-iatrogenic infertility.

1. Prior legislation. AB 428 (Portantino of 2011) was substantially similar to the introduced version of the bill. AB 428 was held on suspense in the Senate Appropriations Committee.
   
   AB 912 (Quirk-Silva of 2013) was similar to the introduced version of the bill but applied to large group insurance plans. AB 912 was vetoed by the Governor, who stated in part:

“Large group employers already have the ability to negotiate richer benefit packages that meet the needs of their employees. While I understand the desire to preserve fertility where possible, such coverage was not included in the essential health benefits that the Legislature passed just last year for individual and small group coverage. Coverage that goes beyond the essential health benefits is no doubt useful and desirable for many, but we should not consider mandating additional benefits until we implement the comprehensive package of reforms that are required by the [ACA].”

1. Support. Supporters of this bill state that it will clarify fertility preservation coverage as medically necessary in health insurance and health service plan policies for patients who will undergo lifesaving treatment for cancer or other diseases that will compromise the patient’s future fertility. Fertility preservation is most commonly needed by cancer patients, who undergo treatments such as chemotherapy, radiation, and certain surgeries. Steps taken to preserve their fertility will avoid the delay or omission in cancer treatment. Supporters also argue that coverage is typically provided for other side effects of cancer treatment, such as chemotherapy-induced anemia, wigs, and prostheses. Therefore, the extension of coverage to protect fertility and reproduction is logical. Similarly, breast re-construction surgery is an integral part of breast cancer treatment and is therefore covered under health insurance plans. Fertility preservation should be equally recognized as a reproductive function for cancer patients.
2. Opposition. The California Association of Health Plans (CAHP) states that the uncertain future of the health insurance market, increased consumer price sensitivity, and an overreach of essential health benefits make it a particularly bad time to pass additional benefit mandates. The Association of California Life and Health Insurance Companies (ACLHIC), and the America’s Health Insurance Plans (AHIP) oppose this bill because health insurance mandates threaten the efforts of all health care stakeholders to provide consumers with meaningful health care choices and affordable coverage options. Specifically, with the proposed mandate exceeding the EHB, increased premiums and costs for California’s businesses, taxpayers, and families will create additional fiscal burdens. Lastly, the adoption of benefit mandates that do not promote evidence-based medicine may lead to lower quality of care, over- or mis-utilization of services, and higher costs for treatments that may be ineffective, less safe, or higher cost than other benefits and services. The California Chamber of Commerce opposes this bill, citing the rising health care costs and premiums employers and employees continue to face. It also references the limited or insufficient evidence that fertility preservations methods would be effective, as reported by the CHBRP analysis.
   
3. Policy Comment. Fertility preservation for iatrogenic infertility is distinct from infertility treatment and may already be covered as a medically necessary treatment. As such the author may wish to amend this bill to instead of mandating new coverage, clarify the existing statute consistent with this understanding.
   

SUPPORT AND OPPOSITION:

Support: American Society for Reproductive Medicine (co-sponsor)

American Cancer Society Cancer Action Network

American Congress of Obstetricians and Gynecologists

California Cryobank
Fertile Action
National Health Law Program
RESOLVE: The National Infertility Association

Susan G. Komen California Collaborative

Oppose: America’s Health Insurance Plans

Association of California Life and Health Insurance Companies

California Association of Health Plans
California Chamber of Commerce

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