BILL ANALYSIS �
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 255
AUTHOR: Pavley
AMENDED: April 25, 2011
HEARING DATE: January 11, 2012
CONSULTANT: Tadeo
SUBJECT : Health care coverage: breast cancer.
SUMMARY : For purposes of health care coverage of mastectomy
procedures, revises the definition of mastectomy to specify
that the partial removal of a breast includes lumpectomy,
which includes surgical removal of a tumor with clear
margins. Allows the length of a hospital stay associated
with mastectomy procedures to be determined post-surgery.
Existing law:
1.Federal law defines, under the Patient Protection and
Affordable Care Act (PPACA) (Public Law 111-148), as
amended by the Health Care Education and Reconciliation
Act of 2010 (Public Law 111-152), a list of essential
health benefits which health insurance coverage and group
health plans must provide beginning in 2014.
Provides protections to patients who choose to have
breast reconstruction in connection with a mastectomy
under the Women's Health and Cancer Rights Act of 1998
(WHCRA). Requires health care service plans (health
plans) and group health insurers (insurers) that provide
mastectomy coverage benefits to cover reconstruction of
the breast removed, surgery and reconstruction of the
other breast to achieve symmetry, any external breast
prostheses needed before or during the reconstruction and
any physical complications at all stages of mastectomy,
including lymphedema.
2.State law provides for the regulation of health plans by
the Department of Managed Health Care (DMHC) and
individual or insurers by the California Department of
Insurance (CDI).
Requires every health plan contract and health insurance
policy to provide coverage for screening for, diagnosis
of, and treatment for breast cancer, including coverage
Continued---
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for prosthetic devices or reconstructive surgery to
restore and achieve symmetry for the patient incidental
to a mastectomy.
Requires every health plan and health insurance policy
that provides coverage for mastectomies and lymph node
dissections to allow the length of stay to be determined
by the attending physician and surgeon in consultation
with the patient, cover prosthetic devices or
reconstructive surgery and cover all complications from a
mastectomy, as specified. Prohibits a health plan or
insurer from requiring a treating physician and surgeon
to receive prior approval in determining length of
hospital stay following those procedures.
Defines mastectomy as the removal of all or part of the
breast for medically necessary reasons, as determined by
a licensed physician and surgeon.
This bill:
1.Revises the definition of mastectomy to specify that the
partial removal of a breast includes, but is not limited
to, lumpectomy, which includes surgical removal of the
tumor with clear margins.
2.Requires the length of a hospital stay associated with
those procedures be determined post-surgery by the
attending physician and surgeon in consultation with the
patient, consistent with sound clinical principles and
processes.
3.Contains findings and declarations related to breast
cancer and breast cancer surgical treatment.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1.Author's statement. All breast cancer surgery is surgery.
It should be taken seriously whether it is a mastectomy
or a lumpectomy. Either type of surgery can have
complications, such as staph infections, bleeding, need
for fluid drains, post-operative pain, and adverse
reactions to anesthesia. In addition, breast cancer
patients may be unable to understand discharge
instructions or they may not have a responsible adult to
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take care of them at home. There is no one-size-fits-all
solution for treatment, but it is important to recognize
that these surgeries are forms of amputation and can have
potentially serious consequences.
SB 255 simply clarifies that the original hospital
safeguards placed in law 14 years ago, apply to both
mastectomies and lumpectomies. The law was intended to
cover both types of surgeries by using the definition
"removal of all or part of the breast." This bill
simply updates the law with the medical name for removing
"part of the breast." This is the same terminology that
is included in the California Department of Public Health
brochure that is required to be given to all breast
cancer patients. SB 255 puts the correct medical term
in statute so that doctors, patients and payers are clear
about appropriate treatment when it is medically
necessary for breast cancer surgeries. The California
Health Benefits Review Program (CHBRP) report correctly
cites that while lumpectomy does not routinely require an
overnight stay, some lumpectomies are not without risk.
Patients should be provided adequate medical assistance
that will prevent costly or long-term adverse health
effects.
2.Background. Breast cancer is an abnormal growth in cells
that line the lobules (milk-producing glands) or the
ducts (vessels that carry milk). According to the
California Cancer Registry (CCR), breast cancer is the
most common cancer diagnosed in California, with nearly
24,000 new cases and more than 4,200 deaths expected for
2011. An average newborn girl's chance of eventually
being diagnosed with invasive breast cancer in California
is approximately twelve percent, or one in eight. There
are nearly 300,000 women currently living with breast
cancer in California.
CCR reports that, although breast cancer is the most
common cancer found among women in California, when
diagnosed early, survival rates are high. In California,
71 percent of breast cancer is diagnosed in the early
stages. Among California women, the five-year relative
survival rate for breast cancer is 91 percent. This rate
varies with the stage at diagnosis with a 99 percent
five-year relative survival rate for localized breast
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cancer, which means the cancer is confined within the
breast, 85 percent for regional breast cancer, which
means the cancer has spread to the lymph nodes, and 25
percent for distant breast cancer, which means the cancer
has spread to other organs of the body (metastasized).
Breast cancer is typically treated through a combination
of surgery and/or radiation, and may include chemotherapy
and hormone therapy. Initial treatment usually consists
of surgery to remove the tumor from the breast, although
some women receive chemotherapy prior to surgery to
reduce the size of the tumor. Women with early-stage
breast cancer are often given two options for surgery:
mastectomy or lumpectomy plus radiation.
Mastectomy is performed under general anesthesia. Most
women treated with mastectomy are hospitalized for at
least one night following surgery. The entire affected
breast plus some lymph nodes are removed. (The lymph
nodes are removed to determine whether the cancer has
spread to them.) Women who have a mastectomy may choose
to have breast reconstruction at the same time or at a
later date.
Lumpectomy is performed under either local or general
anesthesia and is typically provided on an outpatient
basis in a hospital or outpatient surgical center. The
area of the breast in which the tumor is located plus a
border of healthy tissue around the tumor are removed. A
second incision is often made under the arm to remove
some lymph nodes. The border of healthy tissue around
the tumor is referred to as the surgical margin. If the
surgical margin is not free of cancer, a second surgery
is performed to obtain cancer-free margins.
3.The California Health Benefits Review Program (CHBRP).
Pursuant to AB 1996 (Thomson), Chapter 795, Statutes of
2002, and SB 1704 (Kuehl), Chapter 684, Statutes of 2006,
the University of California is requested to assess
legislation proposing a mandated benefit or service, or
the repeal of a mandated benefit or service, through
CHBRP. CHBRP prepares a written analysis of the public
health, medical, and economic impacts of such measures.
The following are highlights from the CHBRP analysis of
SB 255:
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Assumptions of the analysis. Due to existing law, CHBRP
does not expect SB 255 to have any measurable cost
impact.
This bill is intended as a clarification to help ensure
that safe minimum standards are followed, and to reduce
the number of complications for women following
lumpectomy procedures.
Medical effectiveness. There is clear and convincing
evidence from multiple randomized controlled trials
(RCTs) that rates of overall survival and local/regional
recurrence of breast cancer are equivalent for women with
stage I or II breast cancer who are treated with
mastectomy or lumpectomy plus radiation.
There is clear and convincing evidence from multiple RCTs
that women with stage I or II breast cancer who receive
lumpectomy with radiation have a lower rate of in-breast
recurrence of breast cancer than women with stage I or II
cancer who receive lumpectomy alone (i.e., without
radiation). There is also a preponderance of evidence
that they also have a lower rate of death from all
causes.
There is clear and convincing evidence that women with
ductal carcinoma in situ (DCIS) who receive lumpectomy
with radiation have lower rates of in-breast recurrence
of DCIS and invasive breast cancer than women with DCIS
who receive lumpectomy alone.
Impact on coverage. DHMC-regulated plans and
CDI-regulated policies are estimated to be currently
compliant with the provision in SB 255 of medically
necessary lumpectomy upon provider referral. Therefore,
no measurable change in coverage for these services is
expected.
DHMC-regulated plans and CDI-regulated policies are
estimated to be currently compliant with the provision in
SB 255 requiring coverage of post-surgery consultation
regarding the length of any hospital stay.
Impact on utilization. As no measurable change in
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benefit coverage is expected (100 percent of female
enrollees in DMHC-regulated plans and CDI-regulated
policies are estimated to be in compliant plans), no
measurable change in utilization is projected.
Impact on total health care costs. As no measurable
change in benefit coverage is expected, no measurable
changes in total premiums and total health care
expenditures are expected.
Public health impact. Although lumpectomy procedures are
medically effective treatments for DCIS, stage I, and
some stage II cancers, CHBRP finds that no change in
enrollee coverage or utilization of this treatment would
occur through SB 255. Therefore, CHBRP anticipates no
public health impact on short- and long-term health
outcomes, possible disparities, premature death, or
economic loss related to breast cancer or its treatment
through lumpectomy procedures.
4.Essential health benefits and state benefit mandates.
Effective January 1, 2014, federal law requires Medicaid
benchmark and benchmark equivalent plans, plans sold
through the Exchange and the Basic Health Program (if
enacted), and health plans and health insurers providing
coverage to individuals and small employers to ensure
coverage of "essential health benefits," (EHB) as defined
by the Secretary of the Department of Health and Human
Services (HHS). HHS is required to ensure that the scope
of EHBs is equal to the scope of benefits provided under
a typical employer plan, as determined by the Secretary.
Under federal law, EHBs must include 10 general
categories and the items and services covered within the
categories:
� Ambulatory patient services.
� Emergency services.
� Hospitalization.
� Maternity and newborn care.
� Mental health and substance use disorder
services, including behavioral health treatment.
� Prescription drugs.
� Rehabilitative and habilitative services and
devices.
� Laboratory services.
� Preventive and wellness services and chronic
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disease management.
� Pediatric services, including oral and vision
care.
The federal EHBs are broader than what is required under
California law for health plans, with the exception of
two requirements placed on DMHC-regulated health plans to
cover home health services and hospice care. Examples of
the federal benefit requirements that are more expansive
than California law include coverage of prescription
drugs, substance use disorder services, and wellness
services. Health plans and insurers can voluntarily
cover benefits above the essential health benefits.
Additionally, states can require that health plans offer
benefits in addition to EHBs. However, if a state
requires additional benefits, it is also required to
defray the cost of any required additional benefits for
people receiving coverage in the Exchange.
On December 16, 2011, the HHS Center for Consumer
Information and Insurance Oversight (CCIIO) released an
EHB Bulletin outlining a regulatory approach that HHS
plans to propose to define EHBs. In the Bulletin, HHS
proposed that EHBs be defined using a benchmark approach.
States would have the flexibility to select a benchmark
plan that reflects the scope of services offered by a
"typical employer plan." EHBs would include coverage of
services and items in all 10 statutory categories above,
but states would choose one of the following benchmark
health insurance plans:
� One of the three largest small group plans in
the state by enrollment;
� One of the three largest state employee health
plans by enrollment;
� One of the three largest federal employee
health plan options by enrollment; or,
� The largest HMO plan offered in the state's
commercial market by enrollment.
� If a state chose not to select a benchmark, HHS
proposed that the default benchmark will be the
small group plan with the largest enrollment in the
state. HHS is accepting comments on the Bulletin
until January 31, 2012.
Department of Labor National Compensation Survey (NCS).
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PPACA instructs the Secretary of Labor to conduct a
survey of employer-sponsored coverage to determine the
benefits typically covered by employers and to report the
results of the survey to the Secretary of Health and
Human Services. The survey on selected medical benefits,
released on April 15, 2011, consists of 12 selected
benefits for which sufficient data was available.
Mastectomy procedures were not among the services
included in the study. The services include maternity
care, emergency room visits, ambulance services, diabetes
care management, kidney dialysis, physical therapy,
durable medical equipment, prosthetics, infertility
treatment, sterilization, gynecological exams and
services, and organ and tissue transplantation.
1.Prior legislation. AB 7 (Brown), Chapter 789, Statutes
of 1998, requires every health care service plan contract
and every policy of disability insurance that is issued,
amended, renewed, or delivered on and after January 1,
1999, that provides coverage for mastectomies and lymph
node dissections, to allow the length of a hospital stay
associated with these procedures to be determined by the
attending physician and surgeon in consultation with the
patient and consistent with sound clinical principles and
processes. Requires health plans and insurers to cover
prosthetic devices or reconstructive surgery, and to
cover all complications from a mastectomy.
2.Support. Susan G. Komen for the Cure - the California
Affiliates, the sponsor of SB 255, state that this bill
will improve health care coverage options for many
patients undergoing mastectomies and lumpectomies.
The Breast Cancer Fund states that placing the definition
of mastectomy and lumpectomy directly in statute will
help ensure that all breast cancer patients have the same
safeguards to help improve their lives and save them from
preventable serious and costly complications.
The California Medical Association (CMA) states that
premature discharge of breast cancer patients from the
hospital can lead to adverse outcomes, including
infection and inadequately controlled pain. CMA contends
that SB 255 ensures that the length of hospital stay is a
decision made by the physician and patient taking
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individual needs into account.
3.Opposition. America's Health Insurance Plans states that
health insurance mandates threaten efforts to provide
consumers with meaningful health care choices and
affordable coverage options. The California Association
of Health Plans (CAHP) argues that the mandate component
of SB 255 is unnecessary because health plans are already
required to cover mastectomies under existing law and
that this is defined as the removal of all or part of the
breast for medically necessary reasons. CAHP also states
that due to health care reform at the federal level, more
time is needed before the Legislature considers enacting
new benefit mandates or changing the laws governing
existing mandates.
SUPPORT AND OPPOSITION :
Support: Susan G. Komen for the Cure - California
Affiliates (sponsor)
American Congress of Obstetricians and
Gynecologists
Breast Cancer Fund
California Communities United Institute
California Medical Association
CommuniCare Health Centers
Michelle's Place, Breast Cancer Resource Center
Junior League of California
Medical Oncology Association of Southern
California, Inc.
Planned Parenthood Affiliates of California
Surgical Oncologists, University of California,
Davis Cancer Center
Oppose: America's Health Insurance Plans
Association of California Life and Health
Insurance Companies
California Association of Health Plans
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