BILL ANALYSIS �
AB 912
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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