BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 999
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|AUTHOR: |Pavley |
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|VERSION: |March 29, 2016 |
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|HEARING DATE: |April 13, 2016 | | |
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|CONSULTANT: |Teri Boughton |
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SUBJECT : Health insurance: contraceptives: annual supply
SUMMARY : Requires health plans and health insurers to cover a 12-month
supply of self-administered hormonal contraceptives approved by
the Food and Drug Administration, and permits pharmacists who
furnish self-administered hormonal contraceptives under protocol
developed by the Board of Pharmacy to dispense up to a 12-month
supply at one time.
Existing law:
1)Establishes the Department of Managed Health Care (DMHC) to
regulate health care service plans (health plans), the
California Department of Insurance (CDI) to regulate insurers,
including health insurers, the Board of Pharmacy (BOP) to
administer the Pharmacy Law, and the Department of Health Care
Services (DHCS) to administer the Medi-Cal program.
2)Requires a health plan contract, or a group or individual
policy of disability insurance, except for a specialized
health plan contract or a specialized health insurance policy,
that is issued, amended, renewed, or delivered on or after
January 1, 2016, to provide coverage for all of the following
services and contraceptive methods for women:
a) All Food and Drug Administration
(FDA)-approved contraceptive drugs, devices, and other
products for women, including all FDA-approved
contraceptive drugs, devices, and products available
over the counter, as prescribed by the enrollee's or
insured's provider;
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b) Voluntary sterilization procedures;
c) Patient education and counseling on
contraception; and,
d) Follow-up services related to the drugs,
devices, products, and procedures, including, but not
limited to, management of side effects, counseling for
continued adherence, and device insertion and removal.
3)Prohibits a health plan or disability insurer from imposing a
deductible, coinsurance, copayment, or any other cost-sharing
requirement on the coverage provided pursuant to 2) above,
except in the case of a grandfathered health plan. Prohibits
cost sharing from being imposed on any Medi-Cal beneficiary.
4)Permits a religious employer to request a health plan contract
or disability insurance policy without coverage for
FDA-approved contraceptive methods that are contrary to the
religious employer's religious tenets, and requires a health
plan contract or disability insurance policy to be provided
without coverage for contraceptive methods, if requested.
5)Establishes as California's essential health benefits (EHBs)
the Kaiser Small Group HMO plan along with the following 10
federally mandated benefits under the Patient Protection and
Affordable Care Act (ACA) as well as other existing state
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
SB 999 (Pavley) Page 3 of ?
care.
6)Permits a pharmacist to dispense not more than a 90-day supply
of a dangerous drug other than a controlled substance pursuant
to a valid prescription that specifies an initial quantity of
less than a 90-day supply followed by periodic refills of that
amount if specified requirements are satisfied, such as the
patient has completed an initial 30-day supply of the
dangerous drug. Prohibits a pharmacist from dispensing a
greater supply of a dangerous drug if the prescriber
personally indicates, either orally or in his or her own
handwriting, "No change to quantity," or words of similar
meaning.
7)Permits a pharmacist to furnish self-administered hormonal
contraceptives in accordance with standardized procedures or
protocols developed and approved by both the BOP and the
Medical Board of California in consultation with the American
Congress of Obstetricians and Gynecologists, the California
Pharmacists Association, and other appropriate entities.
8)Requires the standardized procedure or protocol in 7) above to
require that the patient use a self-screening tool that will
identify patient risk factors for use of self-administered
hormonal contraceptives, based on the current United States
Medical Eligibility Criteria for Contraceptive Use developed
by the federal Centers for Disease Control and Prevention, and
that the pharmacist refer the patient to the patient's primary
care provider or, if the patient does not have a primary care
provider, to nearby clinics, upon furnishing a
self-administered hormonal contraceptive, or if it is
determined that use of a self-administered hormonal
contraceptive is not recommended.
9)Requires the pharmacist to provide the recipient a
standardized factsheet that includes, but is not limited to,
the indications and contraindications for use of the drug, the
appropriate method for using the drug, the need for medical
follow-up, and other appropriate information, developed, as
specified.
This bill:
1)Requires every health plan contract, group or individual
policy of disability insurance that is issued, amended,
renewed, or delivered on or after January 1, 2017, to cover a
SB 999 (Pavley) Page 4 of ?
12-month supply of FDA-approved, self-administered hormonal
contraceptives dispensed by a prescriber or pharmacy at one
time to an enrollee.
2)Requires the health plan or insurer to cover the 12-month
supply if a 12-month supply of FDA-approved, self-administered
hormonal contraceptives is dispensed onsite at a location
licensed or otherwise authorized to dispense drugs or
supplies.
3)Exempts FDA-approved, self-administered hormonal
contraceptives from the 90-day dispensing supply limitation in
existing BOP law, except when the prescriber indicates "no
change to quantity," as specified.
4)Requires a prescription for FDA-approved, self-administered
hormonal contraceptives to be dispensed as provided on the
prescription, including, but not limited to, a prescription
for a 12-month supply.
5)Permits a pharmacist who furnishes self-administered hormonal
contraception pursuant to protocols developed by the BOP to
dispense, at the patient's request, up to a 12-month supply at
one time.
FISCAL
EFFECT : This bill has not been analyzed by a fiscal committee.
COMMENTS :
1)Author's statement. According to the author, SB 999 addresses
a leading barrier to obtaining consistent, uninterrupted
contraception. Under current law, health insurance companies
and plans must limit their coverage of birth control to a
one-or- three- month supply. This practice can lead to
unwanted gaps in use and increase unintended pregnancies.
Inconsistent supplies of birth control are problematic for
many women who have unpredictable work hours, difficulty
accessing transportation, or other barriers preventing them
from accessing a provider, pharmacy or clinic, in a timely
manner. By allowing women to receive up to a 12 month supply
of birth control at one time, women can better control their
birth control use. The California Health Benefits Review Panel
(CHBRP) estimates that under this bill, costs to employers and
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consumers would be reduced by over $42 million annually, with
15,000 fewer unintended pregnancies, and 7000 fewer abortions
each year. The report cited that the program found no
difference in medical health risks in three, six, or 12 month
dispensation. Given that California has a continued access to
care crisis, a provider shortage and high rates of unintended
pregnancy, California must continue to find inventive ways to
remove barriers to providing consistent contraception.
2)Contraception. According to the CHBRP analysis of this bill,
the FDA categorizes contraceptives into five methods -
permanent sterilization, long-acting reversible
contraceptives, short-acting hormonal methods, barrier
methods, and emergency contraception. This bill only impacts
self-administered hormonal contraceptives, which includes oral
contraceptives (pill, mini-pill, and extended/continuous use
pill), and the contraceptive ring (NuvaRing) or patch
(OrthoEvra). In the United States, 68% of women at risk of
unintended pregnancy use contraception correctly and
consistently throughout any given year and account for only
five percent of unintended pregnancies. In California, nearly
half of the over 818,700 pregnancies per year are unintended.
3)CA Family Planning Program. Family Planning, Access, Care,
and Treatment (PACT) is a reproductive health program for
clinical family planning services. Family PACT provides
comprehensive family planning services to women and men
including all FDA approved forms of contraception, emergency
contraception, pregnancy testing with counseling,
preconception counseling, male and female sterilization,
limited infertility services, sexually transmitted infection
testing and treatment, cancer screening, and HIV screening.
Individual client reproductive health education and counseling
is an ongoing component of all services. Family PACT clients
are female and male residents of California with a family
income at or below 200% of the federal poverty level with no
other source of family planning coverage. Clients are
individuals with a medical necessity for family planning
services who do not have Medi-Cal and do not have access to
health insurance. Medi-Cal clients with an unmet share of cost
may also be eligible. Eligibility determination and enrollment
are conducted at the provider's office with point of service
activation of a client membership card.
4)Medi-Cal requirements. According to a recently revised All
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Plan Letter (APL) issued by DHCS, effective May 1, 2016,
Medi-Cal managed care plans must pay for up to thirteen cycles
of oral contraceptives, up to twelve patches in a 90 day
period, and up to four vaginal rings in a 90 day period if
such quantity is dispensed in an onsite clinic and billed by a
qualified family planning provider, including out-of-plan
providers. A qualified provider is a provider who is licensed
to furnish family planning services within their scope of
practice, is an enrolled Medi-Cal provider, and is willing to
furnish family planning services to an enrollee, as specified
in regulation. A physician, physician assistant (under the
supervision of a physician), certified nurse midwife, and
nurse practitioner are authorized to dispense medications.
Pursuant to California law, if these contraceptives are
dispensed by a registered nurse (RN), the RN must have
completed required training, and the contraceptives must be
billed with Evaluation and Management procedure codes, as
specified.
The APL also states that under federal law, a primary care case
management system, a health maintenance organization, or a
similar entity shall not restrict the choice of the qualified
person from whom the individual may receive such services
under 1396d(a)(4)(C) of Title 42. Therefore Medi-Cal managed
care plan beneficiaries must be allowed freedom of choice of
family planning providers, and may receive such services from
any qualified family planning provider, including out-of-plan
providers, without prior authorization.
5)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:
a) Coverage impacts and enrollees covered . In 2016,
25.2 million Californians have state-regulated coverage
that would be subject to this bill. Medi-Cal already has
a policy in place that allows enrollees to receive a
12-month supply at one time of oral contraceptives (but
not the ring or patch). CHBRP estimates that 744,000
women aged 15 to 44 currently have active prescriptions
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for self-administered hormonal contraceptives. Of the
744,000, 67% currently receive a one month supply per
prescription refill, 32% currently receive a three month
supply at a time, and six percent receive 12 months at
one time. In the insured population under the current
distribution of self-administered hormonal contraceptives
there are 67,000 unintended pregnancies, which CHBRP
estimates results in 28,000 live births, 9,000
miscarriages, and 30,000 abortions. Coverage for an
annual supply of self-administered hormonal
contraceptives (including oral contraceptive pill, patch,
and ring) is estimated to increase from zero percent to
100% of enrollees of DMHC-regulated plans and
CDI-regulated policies;
b) Essential Health Benefits . This bill does not
constitute a new benefit but rather, alters the terms and
conditions (i.e., supply dispensed) of an existing
benefit (coverage for self-administered hormonal
contraceptives), therefor this bill does not exceed
essential health benefits;
c) Medical effectiveness . According to CHBRP, one study
conducted in California found that among a group of
28,000 women receiving oral contraceptives from clinics
that can dispense a 12-month supply at no cost to the
patient, 11% were dispensed pills in a one month supply,
27% were dispensed in a three month supply, seven percent
were dispensed in a six month supply, four percent were
dispensed in a ten month supply, 34% were dispensed in a
12-month supply, and 17% were dispensed in other
quantities (Foster et al., 2011). As there was only one
study identified that looked at this topic, CHBRP
concludes that there is insufficient evidence to
determine the impact of policies allowing for dispensing
of 12-month supply of self-administered oral
contraceptives on dispensing patterns. However, CHBRP
states that there is a preponderance of evidence from
studies with moderate research designs that conclude that
dispensing oral contraceptives in larger quantities leads
to a reduction in unintended pregnancy and related
outcomes. There was no known literature on the impact of
dispensing patterns for vaginal ring and contraceptive
patch;
d) Utilization . Postmandate, the number of active
self-administered hormonal contraceptive prescriptions is
estimated to remain the same, but more women will receive
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a 12-month supply at once. Office visits are expected to
decrease;
e) Impact on expenditures . Total net annual
expenditures are estimated to decrease by $42,799,000 or
0.03% for enrollees with DMHC-regulated plans and
CDI-regulated policies. Savings are attributed to
prevented unintended pregnancies as a result of access to
a longer supply of self-administered hormonal
contraceptives and fewer office visits; and,
f) Public Health . A decrease in unintended pregnancies
of 15,000 (which includes 6,000 fewer live births, 2,000
fewer miscarriages, and 7,000 fewer abortions) are
estimated to result from this bill.
6)Oregon. In 2015, Oregon passed legislation to require a
prescription drug benefit program, a prescription drug benefit
offered under a health benefit plan, as defined, or under a
student health insurance policy, to reimburse a health care
provider or dispensing entity for dispensing contraceptives
intended to last for a three-month period for the first
dispensing of the contraceptive to an insured; and twelve
month period for subsequent dispensing of the same
contraceptive to the insured regardless of whether the insured
was enrolled in the program, plan or policy at the time of the
first dispensing.
7)Double referral. This bill was heard in the Senate Business,
Professions and Economic Development Committee on April 4,
2016 and was approved with a vote of 7-2.
8)Related legislation. AB 1954 (Burke) would require every
health plan contract or health insurance policy issued,
amended, renewed, or delivered on or after January 1, 2017, to
provide coverage for reproductive and sexual health care
services, as defined, through out-of-network providers under
specified circumstances, and prohibits those plan contracts or
insurance policies from requiring an enrollee or insured to
receive a referral in order to receive reproductive or sexual
health care services. AB 1954 is scheduled for a hearing in
the Assembly Health Committee on April 19, 2016.
9)Prior legislation. SB 493 (Hernandez, Chapter 469, Statutes of
2013), updates Pharmacy Law to authorize pharmacists to
perform certain functions according to specified requirements;
including permitting a pharmacist to furnish self-administered
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hormonal contraceptives, nicotine replacement products, and
prescription medications not requiring a diagnosis that are
recommended by the federal Centers for Disease Control and
Prevention for individuals traveling outside of the U.S., in
addition to emergency contraception drug therapy.
SB 1053 (Mitchell, Chapter 576, Statutes of 2014), requires,
effective January 1, 2016, most health plans and insurers to
cover a variety of FDA-approved contraceptive drugs, devices,
and products for women, as well as related counseling and
follow-up services and voluntary sterilization procedures.
Prohibits cost-sharing, restrictions, or delays in the
provision of covered services, but allows cost-sharing and
utilization management procedures if a therapeutic equivalent
drug or device is offered by the plan with no cost-sharing.
10)Support. The American Civil Liberties Union of California
states that this bill aligns with California's historic
leadership in establishing public policies that increase
access to contraceptives. Planned Parenthood Action Fund of
the Pacific Southwest writes for birth control to be
effective, consistency is essential. For many women,
particularly those who live in low income rural areas,
receiving only short supply of contraception can impede their
ability to use birth control on a consistent basis. Planned
Parenthood Mar Monte and Planned Parenthood Affiliates of
California write that studies show that dispensing a 12-month
supply of birth control at one time reduces a woman's odds of
having an unintended pregnancy by 30%. Health Access
California writes providing women with annual supplies instead
of making them visit a clinic or refill their scripts every
month means they will be less likely to run out of birth
control, less likely to get pregnant, and less likely to have
an abortion. This means health plans and public programs such
as Medi-Cal will avoid paying for more costly unintended
pregnancies. SB 999 is particularly beneficial to women living
in low-income communities where there are fewer pharmacies.
11)Support if amended. Kaiser Permanente is generally
supportive of this policy as it removes access barriers to
contraception and believes the bill represents good public
policy for all women and families. Kaiser requests that the
bill be amended to clarify that the health plan coverage up to
an annual supply of birth control only applies to a product
that is prescribed/furnished by in-network providers and
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dispensed at in-network pharmacies.
12)Opposition. According to the California Association of
Health Plans (CAHP), the bill will lead to multiple
unnecessary prescriptions and there is concern with filling a
12-month supply without the prior use of the contraceptive by
the enrollee. If the patient needs to change prescriptions for
any reason, the health plans will have to purchase an
additional 12-month supply. CAHP writes that the bill does not
specify that the prescriptions must be picked up at an
in-network pharmacy, and it exceeds the parameters for
Medi-Cal managed care. CAHP also states that the inclusion of
the non-oral contraceptive that has a shelf life of less than
a year is problematic because it will expire prior to being
used, resulting in product waste. In a joint letter, CAHP,
the Association of California Life and Health Insurance
Companies, and America's Health Insurance Plans write that
when a state passes a benefit mandate, the mandate remains
static and often does not reflect changes in the practice of
medicine, new medical technology, or other medical advances or
knowledge that may make the mandate obsolete, or even harmful,
to patients. The adoption of benefit mandates that do not
promote evidence-based medicine may lead to lower quality of
care, over-utilization, and high costs for possibly
non-effective treatments. The California Catholic Conference
writes that this bill would reduce the standard of care for
women seeking help and information regarding the variety of
proven contraception methods available. The Conference
suggests to reduce the number of pregnancies women ought to be
made aware of other safe and effective pregnancy-prevention
methods, such as natural family planning, which is medically
endorsed tool for couples to making parenting decisions,
especially those struggling with contraceptive-infertility
issues.
13)Policy Comments.
a) Initial Use Period. Some have raised concerns
that dispensing a 12-month supply upon first time use
by the enrollee or insured could result in waste if the
enrollee or insured finds that she is not proficient or
comfortable using of the type of contraceptive after a
period of initial use. Existing California law requires
use of an initial 30-day supply prior to the dispensing
of a 90-day supply. Oregon requires coverage for
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12-month supply after an initial use period of three
months. Should this bill require an initial use period
prior to a requirement for dispensing a 12-month
supply?
b) In network only. A tenet of closed network
managed care is a requirement that enrollees use
network providers for non-emergency services. This
bill appears to require coverage of a 12-month supply
of self-administered hormonal contraceptives dispensed
by a prescriber or pharmacy, or if dispensed onsite at
a location licensed or otherwise authorized to dispense
drugs or supplies, whether or not these prescribers,
providers, locations are in the health plan network.
Medi-Cal is required under federal law to allow freedom
of choice of family planning providers, including
out-of-plan providers, without prior authorization. Is
there a reason to extend freedom of choice to
commercially covered enrollees?
c) Dispensing requirements. The manufacturer's
guidance indicates that prior to dispensing to the user
NuvaRing should be stored at 2-8C (36-46F). After
dispensing to the user NuvaRing can be stored for up to
four months at 25C (77F). The manufacturer indicates
that when NuvaRing is dispensed to the user, the
dispenser must place a date on the label. The date
should not exceed either four months from the date of
dispensing or the expiration, whichever comes first.
The manufacturer indicates it must provide guidance in
accordance with their label. Do pharmacists have
discretion to dispense in a manner that is inconsistent
with the manufacturer labeling requirements?
1) Amendments. The author has agreed to take amendments in
response to Kaiser's request. The amendments would revise
sections 3 and 4. Parallel changes as seen below would be
amended into the Insurance Code section.
(d)(1) Every health care service plan contract that is issued,
amended, renewed, or delivered on or after January 1, 2017,
shall cover up to a 12-month supply of FDA-approved,
self-administered hormonal contraceptives when dispensed at one
time for an enrollee by a provider, pharmacist, or at a location
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licensed or otherwise authorized to dispense drugs or supplies.
(2) If a 12-month supply of FDA-approved, self-administered
hormonal contraceptives is dispensed onsite at a location
licensed or otherwise authorized to dispense drugs or supplies,
the health care service plan shall cover the 12-month supply.
(2) Nothing in this subdivision shall be construed to require a
health care service plan contract to cover contraceptives
provided by an out-of-network provider, pharmacy, or location
licensed or otherwise authorized to dispense drugs or supplies
except as may be otherwise authorized by state or federal law or
by the plan's policies governing out-of-network coverage.
(3) Nothing in this subdivision shall be construed to require
providers to prescribe, furnish or dispense 12 months of
self-administered hormonal contraceptives at one time.
SUPPORT AND OPPOSITION :
Support: Planned Parenthood Affiliates of California
(cosponsor)
California Family Health Council (cosponsor)
NARAL Pro Choice California (cosponsor)
American Civil Liberties Union
American Congress of Obstetricians and Gynecologists
District IX
American Medical Women's Association
Asian Law Alliance
Bayer
Black Women for Wellness
California Academy of PAs
California Family Health Council
California Medical Association
California Pan-Ethnic Health Network
California Primary Care Association
California Religious Coalition for Reproductive Choice
California Women's Law Center
Citizens for Choice
Community Action Fund of Planned Parenthood of Orange
and San Bernardino Counties
Forward Together
Health Access California
National Association of Social Workers - California
Chapter
Maternal and Child Health Access
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Physicians for Reproductive Health
Planned Parenthood Action Fund of Santa Barbara,
Ventura, & San Luis Obispo Counties
Planned Parenthood Action Fund of the Pacific
Southwest
Planned Parenthood Advocacy Project Los Angeles County
Planned Parenthood Advocates Pasadena and San Gabriel
Valley
Planned Parenthood Mar Monte
Planned Parenthood Northern California Action Fund
Oppose: America's Health Insurance Plans
Association of California Life and Health Insurance
Companies
California Association of Health Plans
California Catholic Conference
California Right to Life Committee
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