BILL ANALYSIS Ó
AB 1763
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Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 1763
(Gipson) - As Introduced February 3, 2016
SUBJECT: Health care coverage: colorectal cancer: screening
and testing.
SUMMARY: Requires health care service plan (health plan)
contracts and health insurance policies to cover all colorectal
cancer (CRC) screening examinations and laboratory tests
assigned either an "A" or "B" grade by the United States
Preventive Services Task Force (USPSTF) for individuals at
average risk. Requires coverage for high risk individuals to
include additional tests as recommended by the treating
physician. Prohibits cost sharing for individuals 50 years of
age or older. Specifically, this bill:
1)Requires a health plan contract or health insurance policy
renewed on or after January 1, 2018, to provide coverage for
all CRC screening examinations and laboratory tests assigned
either a grade of A or B by USPSTF for individuals at average
risk. Requires the coverage to include, at a minimum, all of
the following:
a) High sensitivity fecal occult blood tests (FOBT);
b) Flexible sigmoidoscopy with high sensitivity FOBT; and,
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c) Colonoscopies, including the removal of polyps during a
screening procedure.
2)States that if an enrollee or insured is at high risk for CRC,
the coverage required by 1) above must include additional CRC
screening examinations and laboratory tests as recommended by
the treating physician. States that an individual is at high
risk for CRC if the individual has any of the following:
a) A family medical history of CRC;
b) A prior occurrence of cancer or precursor neoplastic
polyp;
c) A prior occurrence of a chronic digestive disease
condition, including, but not limited to, inflammatory
bowel disease, Crohn's disease, or ulcerative colitis; or,
d) Other predisposing factors.
3)Prohibits a health plan or health insurer from imposing cost
sharing on an enrollee who is 50 years of age or older, for
either of the following:
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a) The coverage required by this bill; or,
b) Colonoscopies, including the removal of polyps during a
screening procedure, if the enrollee has a positive result
on any fecal test assigned either a grade of A or a grade
of B by the USPSTF.
4)Excludes from the requirement in 1) c) above high deductible
health plans.
EXISTING LAW:
1)Requires health plans to be regulated by the Department of
Managed Health Care (DMHC) and health insurers to be regulated
by the California Department of Insurance (CDI).
2)Requires health plans and insurers providing health coverage
in the individual and small group markets to cover, at a
minimum, essential health benefits (EHBs), including the 10
EHB benefit categories in the Patient Protection and
Affordable Care Act (ACA), and consistent with California's
EHB benchmark plan, the Kaiser Foundation Health Plan Small
Group HMO 30 plan (Kaiser benchmark), as specified in state
law.
3)Requires issuers of individual and small group coverage to, at
a minimum, cover EHBs in the following 10 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
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wellness services and chronic disease management, and
pediatric services, including oral and vision care.
4)Requires health plans to provide basic health care services,
including physician services; hospital inpatient and
ambulatory care services; diagnostic laboratory and diagnostic
and therapeutic radiologic services; home health services;
preventive health services; emergency health care services;
and, hospice care.
5)Requires, under the federal ACA, all non-grandfathered group
health plans and health insurance coverage offered in the
individual or group market to cover without cost sharing all
evidenced-based items or services that have in effect a rating
of "A" or "B" in the current recommendations of the USPSTF.
FISCAL EFFECT: This bill has not yet been heard by a fiscal
committee.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, this bill is
needed to remove cost barriers to colonoscopies for adults 50
to 75 years of age, helping to catch cases of CRC sooner and
save the lives of many. The author notes that the ACA
requires coverage of CRC screening tests by health plans with
no cost sharing for persons age 50 to 75 years. This is
important because cost had been a barrier to more people
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getting life-saving early detection tests for CRC. There are
different types of CRC screenings; among the tests recommended
by the USPSTF are stool blood tests such as the fecal
immunochemical test (FIT) and the colonoscopy. Either test
can be performed without copayments or cost sharing. The FIT
test is a noninvasive, cost-effective stool blood test that is
more acceptable than a colonoscopy to many people. Some
individuals, including those from low income communities and
communities of color may not have initial access to screening
colonoscopy or may prefer a stool blood test because the
procedure is simpler, has lower risk of complications, and is
less invasive. If a FIT test is positive, follow up
colonoscopy is needed to examine the entire colon and remove
any polyps found during the procedure. This process is still
part of the "screening" and completes the continuum of care in
CRC screening. However, some plans impose cost sharing for
the follow up colonoscopy and/or the polyp removal. Some
patients, because of cost, will forgo the follow up
colonoscopy leaving them at higher risk for CRC and death. As
with all cancers, the sooner it is detected and treated, the
more likely the patient is to survive.
2)BACKGROUND. Colon cancer is cancer of the large intestine
(colon), the lower part of the digestive system. Rectal
cancer is cancer of the last several inches of the colon.
Together, they're often referred to as CRC. Most cases of CRC
begin as small, noncancerous (benign) clumps of cells called
adenomatous polyps. Over time some of these polyps become
CRCs. Polyps may be small and produce few, if any, symptoms.
For this reason, doctors recommend regular screening tests to
help prevent CRC by identifying and removing polyps before
they become CRC. In most cases, it is not clear what causes
CRC. Inherited gene mutations that significantly increase the
risk of CRC can be passed through families, but these are
linked to only a small percentage of CRCs. According to the
Mayo Clinic, factors that may increase risk of CRC include:
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a) Older age. The great majority of people diagnosed
with CRC are older than 50. CRC can occur in younger
people, but it occurs much less frequently;
b) African-American. African-Americans have a greater
risk of CRC than do people of other races;
c) A personal history of CRC or polyps. People who have
already had CRC or adenomatous polyps, have a greater risk
of CRC in the future;
d) Inflammatory intestinal conditions. Chronic
inflammatory diseases of the colon, such as ulcerative
colitis and Crohn's disease, can increase your risk of
CRC;
e) Inherited syndromes that increase CRC risk. Genetic
syndromes passed through generations of your family can
increase your risk of CRC. These syndromes include
familial adenomatous polyposis and hereditary nonpolyposis
CRC, which is also known as Lynch syndrome;
f) Family history of CRC. People are more likely to
develop CRC if they have a parent, sibling or child with
the disease. If more than one family member has CRC or
rectal cancer, the risk is even greater;
g) Low-fiber, high-fat diet. CRC and rectal cancer may
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be associated with a diet low in fiber and high in fat and
calories. Research in this area has had mixed results.
Some studies have also found an increased risk of CRC in
people who eat diets high in red meat and processed meat;
h) A sedentary lifestyle. People who are inactive are
more likely to develop CRC. Getting regular physical
activity may reduce the risk of CRC;
i) Diabetes. People with diabetes and insulin resistance
may have an increased risk of CRC;
j) Obesity. People who are obese have an increased risk
of CRC and an increased risk of dying of CRC when compared
with people considered normal weight;
aa) Smoking. People who smoke may have an increased risk
of CRC;
bb) Alcohol. Heavy use of alcohol may increase your risk
of CRC; and,
cc) Radiation therapy for cancer. Radiation therapy
directed at the abdomen to treat previous cancers may
increase the risk of CRC.
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3)California Health Benefits Review Program (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. SB 125 (Hernandez), Chapter 9, Statutes of 2015, adds
an impact assessment on EHBs, and legislation that impacts
health insurance benefit designs, cost sharing, premiums, and
other health insurance topics. Highlights of the CHBRP
analysis on this bill as follows:
a) Enrollees covered. CHBRP estimates that as of 2016,
25.2 million Californians have state-regulated coverage
that would be subject to this bill. If enacted, CHBRP
estimates the percentage of enrollees with coverage for
CRC screening exams and lab tests assigned a grade of A or
B by the USPSTF and additional screening and tests
recommended by a physician would remain to be 100%.
However, this bill would eliminate cost sharing on CRC
screenings and lab tests for enrollees aged 50 and older
including colonoscopies with the removal of polyps if the
enrollee has a positive result on any fecal test. Since
this bill does not apply to high-deductible plans, CHBRP
estimates that 5% of enrollees aged 50 and older would be
exempted from waving cost sharing. Accordingly, CHBRP
estimates that the percent of enrollees aged 50 and older
with coverage for CRC screening services listed in this
bill without cost sharing would increase from 78% to 95%.
b) Impact on expenditures. CHBRP estimates this bill
would increase total net annual expenditures by $5.63
million or 0.004% for enrollees with DMHC regulated plans
and CDI-regulated policies. This is due to a 25.92
million increase in total health insurance premiums paid
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by employers and enrollees for newly covered benefits,
partially offset by a decrease in enrollee expenditures
for previously noncovered benefits ($20.29 million). On a
per member per month basis, CHBRP estimates that premiums
on various plans and policies would increase by $0.003 to
$0.21.
c) EHBs. This bill impacts the terms and conditions of
coverage for CRC screenings and tests, but does not change
coverage itself. This bill does not exceed EHBs.
d) Medical effectiveness. There is a preponderance of
evidence that USPSTF-recommended CRC screening modalities
are medically effective for the detection and prevention
of CRC among average and high-risk individuals.
e) Utilization. CHBRP assumes that the overall
utilization of CRC screening and lab tests is going to
increase by 0.3% (1,764 users), which is mainly due to the
increase in use among enrollees aged 50 and older after
the removal of cost-sharing requirements for CRC screening
and lab tests.
f) Public Health. CHBRP projects no measurable public
health impact on the diagnosis or prevention of CRC at the
population level due to the small number (1,764) of
additional enrollees who would avail themselves of CRC
screening. At the individual level, this bill would
likely yield health and quality of life improvements, such
as reduced screening-related financial burden and
identification of CRC at earlier, and therefore more
treatable, stages.
g) Long-term impacts. To the extent that this bill would
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eliminate cost sharing for medically necessary additional
CRC screenings and all events along the stepwise
"continuum of screening," including follow-up
colonoscopies to positive fecal tests and polyp removal
during colonoscopies, it would be reasonable to assume
that this reduction in financial burden would promote
greater adherence to physician-recommended screenings
beyond those projected for the first 12 months following
implementation of the mandate
4)ACA Frequently Asked Questions (FAQs) RELATED TO THIS BILL.
The federal Departments of Labor, Health and Human Services,
and Treasury has published FAQs with answers related to
provisions of the ACA. Set 12 of these FAQs include the
following two that are relevant to this bill:
a) Questions 5: If a colonoscopy is scheduled and
performed as a screening procedure pursuant to the USPSTF
recommendation, is it permissible for a plan or issuer to
impose cost-sharing for the cost of a polyp removal during
the colonoscopy?
No. Based on clinical practice and comments received from
the American College of Gastroenterology, American
Gastroenterological Association, American Society of
Gastrointestinal Endoscopy, and the Society for
Gastroenterology Nurses and Associates, polyp removal is
an integral part of a colonoscopy. Accordingly, the plan
or issuer may not impose cost-sharing with respect to a
polyp removal during a colonoscopy performed as a
screening procedure. On the other hand, a plan or issuer
may impose cost-sharing for a treatment that is not a
recommended preventive service, even if the treatment
results from a recommended preventive service.
b) Question 7: Some USPSTF recommendations apply to
certain populations identified as high-risk. Some
individuals, for example, are at increased risk for
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certain diseases because they have a family or personal
history of the disease. It is not clear, however, how a
plan or issuer would identify individuals who belong to a
high-risk population. How can a plan or issuer determine
when a service should or should not be covered without
cost-sharing?
Identification of "high-risk" individuals is determined by
clinical expertise. Decisions regarding whether an
individual is part of a high-risk population, and should
therefore receive a specific preventive item or service
identified for those at high-risk, should be made by the
attending provider. Therefore, if the attending provider
determines that a patient belongs to a high-risk
population and a USPSTF recommendation applies to that
high-risk population, that service is required to be
covered in accordance with the requirements of the interim
final regulations (that is, without cost-sharing, subject
to reasonable medical management).
5)SUPPORT. The American Cancer Society Cancer Acton Network
(ACS CAN), a cosponsor of this bill, states that CRC is the
second leading cause of cancer deaths in the US but is the
most preventable with screening and early detection. Timely
and appropriate screening can decrease CRC incidence and
mortality by 30% to 60%. ACS CAN argues that the overall
reduction of CRC incidence and mortality rates in the U.S.
over the last few years has largely been attributed to
increased preventative screening. Eliminating out-of-pocket
cost? sharing for follow-up colonoscopy after a positive stool
test will remove a significant barrier to CRC screening and it
will greatly contribute to the goal of increasing the nation's
CRC screening rate to 80% by 2018. The California Black
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Health Network supports this bill because of the devastating
incidence of CRC in the African-American community. CRC is
the third most common cancer in both black men and women with
incidence rates higher in black males and females compared to
whites (27% and 22% respectively). Research has shown that
limiting CRC screening choices to only colonoscopy can result
in a lower CRC screening completion rate compared to providing
an initial choice between colonoscopy and a stool-based test,
particularly among communities of color.
6)OPPOSITION. The California Association of Health Plans argues
that this bill will increase costs for employers and
individuals by creating a new benefit mandate that expands CRC
screening while prohibiting cost-sharing. Blue Shield of
California (BSC) argues that new USPSTF screening
recommendations expected later in 2016 are likely to be
different than current ones, making this bill premature. BSC
is also concerned with this bill's requirement to cover, at no
share of cost, a broad array of additional screenings and
tests recommended by a physician if a person is considered
"high risk." Lastly, this bill is unclear in its intent to
include secondary prevention. The Association of California
Health Insurance Companies and America's Health Insurance
Plans oppose all mandate bills introduced this year because of
possible state financial exposure, the need for a robust
health insurance marketplace offering competition and choice,
and the fact that mandates stifle the use of innovative,
evidence-based medicine.
7)OPPOSE UNLESS AMENDED. The California Chamber of Commerce has
a number of concerns, including: a) this bill specifies
coverage of certain screening tests that in the future may not
meet USPSTF guidelines; b) this bill's definition of high risk
differs from the Medicare definition; and, c) the cost impact
of this bill falls on all enrollees, not only those in the
50-75 year age range.
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8)PROPOSED AMENDMENTS. Amendments are proposed to clarify and
narrow the scope of this bill, including:
a) Delete the following language related to screening
test coverage:
The coverage shall include, at a minimum, all of the
following:
(1) High sensitivity fecal occult blood tests (FOBT).
(2) Flexible sigmoidoscopy with high sensitivity FOBT.
(3) Colonoscopies, including the removal of polyps during
a screening procedure.
b) Delete the following language related to high risk
criteria:
For purposes of this subdivision, an individual is at high
risk for colorectal cancer if the individual has any of
the following:
(A) A family medical history of colorectal cancer.
(B) A prior occurrence of cancer or precursor neoplastic
polyps.
(C) A prior occurrence of a chronic digestive disease
condition, including, but not limited to, inflammatory
bowel disease, Crohn's disease, or ulcerative colitis.
(D) Other predisposing factors.
c) Clarify provisions regarding colonoscopy and polyp
removal without cost sharing; and,
d) Other technical changes.
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REGISTERED SUPPORT / OPPOSITION:
Support
American Cancer Society Cancer Acton Network (cosponsor)
California Colorectal Cancer Coalition (cosponsor)
American College of Gastroenterology
American College of Physicians
American College of Surgeons
American Gastrological Association
American Society for Gastrointestinal Endoscopy
California Primary Care Association
California Black Health Network
Opposition
America's Health Insurance Plans
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Association of California Health Insurance Companies
California Association of Health Plans
Analysis Prepared by:John Gilman / HEALTH / (916) 319-2097