BILL ANALYSIS Ó
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 255
S
AUTHOR: Pavley
B
AMENDED: April 25, 2011
HEARING DATE: April 27, 2011
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CONSULTANT:
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Tadeo
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SUBJECT
Health care coverage: breast cancer
SUMMARY
For purposes of insurance 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 postsurgery,
consistent with sound clinical principles and processes.
CHANGES TO EXISTING LAW
Existing 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 plans and insurers that provide mastectomy
Continued---
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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.
Existing state law:
Provides for the regulation of health care service plans
(health plans) by the Department of Managed Health Care
(DMHC) and individual or group health insurers (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 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:
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.
Clarifies that the length of a hospital stay associated
with those procedures shall be determined by the attending
physician and surgeon in consultation with the patient,
postsurgery, consistent with sound clinical principles and
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processes.
Contains findings and declarations related to breast cancer
and breast cancer surgical treatment.
FISCAL IMPACT
This bill has not been analyzed by a fiscal committee.
BACKGROUND AND DISCUSSION
The author points out that current law has long allowed the
length of hospital stay associated with mastectomies,
partial removal of the breast, and lymph node dissections,
to be determined by the physician and patient, and that,
while many mastectomies are still performed, because of
advances in medical science, a majority of women currently
choose to have a lumpectomy. The author states that
lumpectomies and mastectomies are two standard treatment
options for breast cancer that are widely recognized by
medical authorities and the state, and points to the
Department of Public Health booklet, "A Woman's Guide to
Breast Cancer Diagnosis and Treatment," which has been
distributed to patients and providers since 1995, which
recognizes this terminology and explains that both
surgeries can have similar medical complications.
The author argues that SB 255 will ensure that medical
terms in the law are compatible with medical terms provided
to breast cancer patients and providers. The author
further states that SB 255 will also ensure that health
plans and insurers follow safe minimum standards for
medically necessary hospital stays for all breast cancer
surgeries. While most lumpectomy patients will not need a
longer hospital stay, some patients undergoing these
surgeries may experience unexpected complications, have no
support at home, or may require a longer stay to manage
pain, bleeding drains and the risk of infection. These
situations may not be evident until after the surgery.
Breast cancer, mastectomy and lumpectomy
Breast cancer is an abnormal growth in cells that line the
lobules (milk-producing glands) or the ducts (vessels that
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carry milk). Clinicians classify the cancer according to
the location of its origin. Those cancers that are confined
to a duct or lobule are known as carcinoma in situ or
noninvasive cancer cells that are still encapsulated in the
duct or lobule.
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 in 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 cancer, 85 percent for
regional breast cancer, and 25 percent for distant breast
cancer.
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
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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.
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 173:
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.
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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 postsurgery
consultation regarding the length of any hospital
stay.
Impact on utilization
As no measurable change in 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.
As no measurable change in benefit coverage or cost is
expected, no measurable change in the number of
uninsured persons is expected.
Public health impact
Although lumpectomy procedures are medically effective
treatments for ductal carcinoma in situ, 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,
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premature death, or economic loss related to breast
cancer or its treatment through lumpectomy procedures.
Potential impact of federal health care reform
Essential health benefits (EHBs) are defined to
include ambulatory patient services, hospitalization,
and preventive and wellness services and chronic
disease management. In addition, HHS when
promulgating regulations on EHBs is to ensure that the
EHB floor "is equal to the scope of benefits provided
under a typical employer plan." Virtually all
employers provide coverage for lumpectomy services.
Therefore, it is highly unlikely that there would be
any impacts resulting from SB 255 in the longer term,
beyond 2014.
Department of Labor National Compensation Survey (NCS)
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.
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.
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Arguments in support
The California affiliates of Susan G. Komen for the Cure,
the sponsor of SB 255, states 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 individual needs into
account.
Arguments in opposition
America's Health Insurance Plans states that the 18 health
insurance mandates proposed during the 2011 session
threaten efforts to provide consumers with meaningful
health care choices and affordable coverage options.
The California Association of Health Plans argues that
mandates put the state general fund at risk, pointing to
federal law that states the subsidy of any additional
benefits required by state law that exceeds EHBs must be
borne by the state.
POSITIONS
Support: Susan G. Komen for the Cure - California
Affiliates (sponsor)
Breast Cancer Fund
California Communities United Institute
California Medical Association
CommuniCare Health Centers
Oppose: America's Health Insurance Plans
Association of California Life and Health
Insurance Companies
California Association of Health Plans
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