BILL ANALYSIS Ó
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