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[Senate Report 107-245]
[From the U.S. Government Publishing Office]

                                                       Calendar No. 555
107th Congress                                                   Report
                                 SENATE
 2d Session                                                     107-245

======================================================================

 
                ELIMINATE COLORECTAL CANCER ACT OF 2001

                                _______
                                

                August 28, 2002.--Ordered to be printed

   Filed under authority of the order of the Senate of July 29, 2002

                                _______
                                

   Mr. Kennedy, from the Committee on Health, Education, Labor, and 
                   Pensions, submitted the following

                              R E P O R T

                             together with

                             MINORITY VIEWS

                         [To accompany S. 710]

    The Committee on Health, Education, Labor, and Pensions, to 
which was referred the bill (S. 710) to require coverage for 
colorectal cancer screenings, having considered the same, 
reports favorably thereon with an amendment and recommends that 
the bill (as amended) do pass.

                                CONTENTS

  I. Purpose and summary of bill......................................1
 II. Background and need for legislation..............................2
III. Legislative history and committee action.........................8
 IV. Committee views..................................................9
  V. Cost estimate...................................................11
 VI. Application of law to the legislative branch....................14
VII. Regulatory impact statement.....................................15
VIII.Section-by-section analysis.....................................15

 IX. Minority views..................................................16
  X. Changes in existing law.........................................22

                     I. Purpose and Summary of Bill

    As reported by the Committee on Health, Education, Labor, 
and Pensions, S. 710 increases access to colorectal screening 
tests for insured Americans. This legislation requires issuers 
of group health plans and individual health plans to cover 
screening tests for colorectal cancer. In doing so, the 
committee is acting to increase public access to screening 
services for colorectal cancer in order to prevent premature 
deaths from this disease.

                II. Background and Need for Legislation

The value of effective screening for colorectal cancer

    As the second leading cause of cancer deaths, colorectal 
cancer takes a tremendous toll on the American public with 
about 148,300 new cases diagnosed annually. This year alone, 
approximately 56,600 Americans will die from this disease. An 
overwhelming body of medical evidence shows the value of 
screening in detecting--and thus providing the opportunity to 
treat--colorectal cancer at an early stage. When colorectal 
cancer is diagnosed early, more than 90 percent of patients 
survive for five years or more. Once the desease has 
metastasized, only 8 percent of patients survive for that 
period. As Secretary of Health and Human Services, Tommy 
Thompson, has so rightly stated, ``Colorectal cancer is the 
second leading cancer killer in the United States and screening 
can save lives. If Americans age 50 or older had regular 
screening tests, our nation would see a substantial reduction 
in colorectal cancer deaths.''
    The value of early screening for colorectal cancer is also 
recognized by numerous scientific and professional societies 
with expertise in cancer. For example, the American 
Gastroenterology Association, the American Cancer Society, the 
American Medical Association, the American Academy of Family 
Physicians, the American College of Obstetricians & 
Gynecologists and an interdisciplinary task force originally 
convened by the U.S. Agency for Health Care Policy and Research 
in 1997 have all adopted similar guidelines recommending 
regular colorectal cancer screening for individuals over 50 and 
for younger persons at high risk for colorectal cancer. 
Specifically, these organizations recommend a range of 
screening options--fecal occult blood test (FOBT), flexible 
sigmoidoscopy, colonoscopy, and double contrast barium enema 
(DCBE)--because it is important that patients and physicians 
choose the most medically appropriate test.
    In its most recent report updating its 1996 colorectal 
cancer screening guidelines, the United States Preventive 
Service Task Force (USPSTF) also strongly recommends regular 
colorectal cancer screening as an effective way to reduce the 
mortality and morbidity associated with this disease. According 
to the report, ``The USPSTF strongly recommends that clinicians 
screen men and women 50 years of age or older for colorectal 
cancer.'' The Task Force deems this a Grade A recommendation 
which, under the Task Force's grading scheme, means that the 
Task Force ``found good evidence that [the service] improves 
important health outcomes and concludes that benefits 
substantially outweight harms.'' A Grade A recommendation also 
indicates that the Task Force ``strongly recommends that 
clinicians routinely provide [the service] to eligible 
patients.'' There is no doubt that colorectal cancer screening 
is effective and is critical to reducing colorectal cancer 
mortality in this country.
    In addition to upgrading the overall recommendation for 
colorectal cancer screening, the Task Force also recommended 
the same full range of screening tests--FOBT, flexible 
sigmoidoscopy, colonoscopy, and DCBE--as the scientific and 
professional organizations mentioned above. The Task Force did 
not recommend one test for all individuals. Rather, it outlined 
the range of options and advised that patients should discuss 
each option with their physician before selecting the test that 
is best for them. As the Task Force noted, ``Each option has 
advantages and disadvantages that may vary for individual 
patients and practice settings. The choice of specific 
screening strategy should be based on patient preferences, 
medical contraindications, patient adherence, and available 
resources for testing and follow up. Clincians should talk to 
patients about the benefits and potential harm associated with 
each option before selecting a screening strategy.'' Thus, the 
recommendations of the Task Force and the intent of the 
legislation approved by the committee are consistent; both 
recognize the value of colorectalcancer screening while 
allowing patients and physicians to choose the most appropriate 
screening methodology.

The effectiveness of different colorectal cancer screening tests

    Much research has been conducted recently on the relative 
sensitivity of various colorectal cancer screening tests. A 
substantial and increasing body of evidence shows that 
colonoscopy is by far the most sensitive of the tests, since 
only colonoscopy can clearly visualize lesions in the proximal 
colon. By contrast, flexible sigmoidoscopy provides physicians 
with a view only of the distal colon, which consists of about 
one-third to one-half of the colon. FOBT detects the presence 
of blood in the stool, but is highly subject to false readings 
and has a low patient compliance rate. DCBE provides an image 
of the entire colon, as does colonoscopy, but its level of 
resolution is far lower than that of colonoscopy. During the 
committee's executive session on the legislation, it was noted 
that colonoscopy has been the test of choice for many committee 
members and that President Bush also recently had a 
colonoscopy. As Dr. Richard Tubb, the President's physician, 
stated, ``The beauty of the colonoscopy is that it is able to 
examine an entire colon from start to finish. There are other 
colorectal screening procedures, but colonoscopy is the one and 
only that can look in detail at the entire colon . . . this is 
preventive medicine at it finest.''
    Several large scale studies reported in leading medical 
journals have demonstrated the value of colonoscopy. A study by 
Lieberman and colleagues in the New England Journal of Medicine 
in 2000 found that colonoscopy detected neoplasms in the 
proximal colon which would have gone undetected by less 
sensitive techniques. The study found that 52 percent of 
patients with advanced proximal neoplasms had no distal 
neoplasms. Thus, their colorectal cancer would have gone 
undiagnosed with flexible sigmoidoscopy. A study by Imperiale 
and colleagues in the same issue of the Journal found similar 
results. In that study, 46 percent of patents with advanced 
proximal neoplasms had no distal polyps. Again, the presence of 
polyps in these patients was revealed only through colonoscopy.
    Because colonoscopy allows both for visualization and 
removal of cancerous polyps, it allows for detection and 
prevention of colorectal cancer in the same procedure. For this 
reason, colonoscopy can markedly reduce the incidence of 
colorectal cancer. After conducting a six year study involving 
1,418 patients, Winawer and colleagues reported in the New 
England Journal of Medicine in 1993 that there was a 76 to 90 
percent decrease in the incidence of colorectal cancer among 
patients who had previously had a polyp removed during 
colonscopy.
    The safety of colonoscopy has also been well-studied. While 
there is a risk associated with colonoscopy, primarily due to 
bleeding or perforation of the colon, the risk is very low. In 
an extensive study of colonoscopy performed at Veterans' 
Affairs hospitals, Nelson and colleagues found that 
approximately 3 persons out of every 1000 examined by 
colonoscopy experienced complications requiring medical 
intervention. Pignone and colleagues found that complication 
rates for colonoscopy ranged from 0.03 to 0.62 percent. Tran 
and colleagues, reporting in the September 2001 edition of 
American Surgery, found that perforation occurred in 21 out of 
26,162 colonoscopies analyzed. Only one death occurred among 
the 16,948 screening colonoscopies analyzed. Analyses of 
colonoscopy performed in Germany and in Sweden have reported 
similar low frequencies of complication.
    Clinical trials using randomly assigned controls 
prospectively are often used to prove the effectiveness of new 
treatments or technologies, but these types of studies are not 
feasible or necessary to show the effectiveness of colonoscopy 
in reducing cancer mortality. Prospectively controlled trials 
rely on randomly assigning a population to either an 
experimental or control group. In a hypothetical randomized 
prospectively controlled trial of the effectiveness of 
colonoscopy, one group would receive a colonoscopy and the 
other would receive some other form of colorectal cancer 
screening or no screening at all. A trial structured in this 
manner would require some patients to give up their opportunity 
to have a colonoscopy and instead settle for a test that is 
commonly known to be less accurate. Furthermore, such a trial 
would require experimenters not to intervene medically as 
patients in the control population developed colorectal cancer 
so as not to bias the outcome of the study. Needless to say, an 
experiment of this type would likely fail to recruit 
participants and would violate basic ethical requirements for 
the protection of research subjects.
    Extensive studies to examine the effectiveness of 
colonoscopy in reducing mortality have been performed that used 
age- and sex-matched controls as well as clinically matched 
controls from retrospective analysis of medical records. A 
study of exactly this design was reported by Winawer and 
colleagues in the New England Journal of Medicine (NEJM 329: 
1977-1981). Patients were randomly assigned to one of two study 
cohorts in which they received different protocols of 
colorectal screening using colonoscopy followed by polyp 
removal. The cancer incidence and death rates of each cohort 
were followed and compared to three reference groups. The first 
reference group was derived from the general population and was 
age- and sex-matched to the experimental population. The second 
and third reference groups were controls who had similar 
clinical histories to the experimental group, but did not 
receive colonoscopy. Rather than subjecting a control 
population to an ethically unacceptable elevated risk of 
cancer, the experimenters derived these two control populations 
from a retrospective analysis of medical records. In this well-
controlled clinical trial, the experimenters found that 
patients undergoing colonoscopy had mortality rates that were 
significantly lower than either of the three control 
populations. Evidence from this and similarly well-controlled 
clinical trials was persuasive for a wide range of expert 
medical organizations as well as the USPSTF to include 
colonoscopy in their current screening guidelines.

Barriers to widespread screening

    Although screening can save lives, screening rates are low. 
In fact, a mere 44% of adults over 50 have had any type of 
recent screening test for colorectal cancer. As a result, only 
about 37% of colorectal cancers are actually diagnosed at an 
early stage, when the cancer is most treatable. The remaining 
63% of colorectal cancer patients--more than 90,000 Americans 
every year--do not receive treatment for colorectal cancer when 
it is most effective because the disease is not detected in its 
early stages. Early detection would thus spare thousands of 
Americans from needless suffering and premature death from this 
deadly form of cancer.
    An important element in raising screening rates are 
campaigns to inform the public about colorectal cancer, such as 
the ``Screening for Life'' campaign conducted by the Department 
of Health and Human Services (HHS) and the ``Polyp Man'' 
campaign designed by the American Cancer Society and the Ad 
Council. Yet such campaigns will have little value if patients 
cannot obtain coverage for colorectal cancer screening through 
their health insurance plans.
    Recognizing that colorectal cancer screening rates among 
Medicare beneficiaries were extremely low, Congress took action 
to make the benefits of regular colorectal cancer screening 
available through Medicare. In 1997, Congress enacted the 
Balanced Budget Act, which provided coverage of FOBT and 
flexible sigmoidoscopy to Medicare beneficiaries 50 or older at 
average risk for the disease. Colonoscopy was also covered, but 
only for high-risk individuals. In regulatory guidance adopted 
in 1997 prior to the coverage effective date, the Department of 
Health and Human Services also provided coverage under Medicare 
for DCBE. In 2000, Congress enhanced this basic coverage by 
expanding colonoscopy coverage to average risk individuals. 
Thus, every Medicare beneficiary now has access to the full 
range of scientifically accepted tests that provide screening 
for colorectal cancer: colonscopy, FOBT, flexible sigmoidoscopy 
and DCBE. However, Medicare coverage of colonoscopy generally 
becomes available to individuals at age 65, which is 15 years 
after the age at which screening is first recommended.
    Americans below the age of 65 face a far more uncertain 
terrain when trying to obtain health insurance coverage for 
colorectal cancer screening. While many insurers indicate that 
they provide coverage for some types of colorectal cancer 
screening, few provide comprehensive coverage that includes 
colonoscopy, the most sensitive colorectal cancer screening 
test. Commercial health plan coverage data is generally held 
proprietary by the health plans. However, a recent study by the 
Lewin Group, a respected health care consulting firm, analyzed 
the range of colorectal screening tests that were included in 
the plan brochures of insurance plans participating in the 
Federal Employee Health Benefit Plan (FEHBP), which posts its 
plan brochures publicly. While plans may at their own option 
provide services not specifically enumerated in the plan 
brochure, the plan is required to cover only those specific 
services spelled out in the brochure or contract of coverage. 
Thus, a beneficiary has no certainty of receiving coverage for 
any service unless it is specified in the brochure.
    The study found that fewer than 5 percent of these plan 
brochures stated that they cover colonoscopies as a method to 
screen for colorectal cancer, although all provided coverage 
for flexible sigmoidoscopy and/or FOBT. In a letter submitted 
for the record during committee consideration of this 
legislation, the Office of Personnel Management (OPM) agreed 
that FEHBP plans are currently providing coverage for 
colonoscopy for diagnosis. However, OM's most recent guidance 
encourages plans to expand their current limited coverage to 
include screening colonoscopy.
    The fact that plans are covering FOBT and flexible 
sigmoidoscopy but not colonoscopy is significant from a fiscal 
perspective. A cost analysis, also prepared by The Lewin Group, 
showed that colonoscopy was no more expensive than the FOBT/
flexible sigmoidoscopy combination in terms of per member per 
month (PMPM) costs. The analysis found that for plans already 
covering FOBT and flexible sigmoidoscopy, adding coverage for 
colonoscopy could actually reduce PMPM costs by 11 cents. 
Therefore, if insurers already cover FOBT combined with 
flexible sigmoidoscopy, there is no financial reason not to 
cover colonoscopy as well. Colonoscopy can be covered for 
little or no additional costs, and the savings in human terms 
are immeasurable.
    A survey conducted by the American Association of Health 
Plans (AAHP) claims that most plans cover the full range of 
screening tools, including colonoscopy. However, the AAHP study 
methodology made available to the committee does not define 
``screening coverage.'' This term often means plans allow 
patients to get a colonoscopy once they have exhibited symptoms 
or as a follow up to another test. Because colorectal cancer is 
highly metastatic, waiting until other signs or symptoms 
indicate its presence before performing a colonoscopy 
unnecessarily raises the morbidity and mortality associated 
with this disease. Thus, the finding that many pans cover 
colonoscopy after initial tests indicate the likelihood of 
cancer does not reduce the need for the legislation. The intent 
of this legislation is to assure that patients receive the 
benefits of colorectal cancer screening before they develop the 
disease, rather than as a method to confirm diagnosis.
    Several lines of evidence, however, contradict the 
assertion that insurance companies routinely cover the costs of 
the full range of medically recommended screening tests. First, 
a report prepared for the Health Insurance Association of 
America (HIAA) on new medical technologies acknowledges that 
health plans are currently not providing coverage for the full 
range of screening tests, noting that ``most private insurers 
will only cover colonoscopies for high risk populations'' 
(``The Impact of Medical Technology on Future Health Care 
Costs'', a report prepared for HIAA and Blue Cross/Blue Shield 
in February of 2001).
    Second, information provided directly from health insurance 
companies indicates that coverage for colorectal screening is 
incomplete. Legislation to require coverage of colorectal 
cancer screening has been enacted in sixteen states and 
considered in several others. Two bills have been introduced in 
the Pennsylvania legislature dealing with coverage for 
colorectal cancer screening; one dealt solely with colorectal 
cancer screening, while the other encompassed both colorectal 
cancer screening and prostate cancer screening. In its analysis 
of the latter, the Pennsylvania Health Care Cost Containment 
Council examined the degree to which insurance companies in 
Pennsylvania provided coverage for colorectal cancer screening. 
To that end, the Council requested data from leading insurers 
on their coverage of colorectal cancer screening tests. In its 
submission to the Council, Blue Cross of Northeastern 
Pennsylvania stated that ``under traditional coverage * * * for 
the asymptomatic patient, there would be no coverage for 
periodic screening examinations.'' Another leading insurer, 
Highmark, notified the Council that ``under Highmark's 
traditional group and individual coverage and preferred 
provider organization (PPOs) benefit plans, routine `screening' 
tests are not considered eligible for reimbursement'' 
(Pennsylvania Health Care Cost Containment Council; Review of 
Senate Bill 39).
    Finally, documents from the widely respected HHS ``Screen 
for Life'' campaign support the conclusion that insurance 
coverage for the full range of medically recommended colorectal 
cancer tests is sporadic. According to the HHS fact sheet on 
screening options used in thiscampaign, ``coverage is variable 
when colonoscopy is used for screening. If it's needed for a follow-up 
test or diagnosing a problem, most plans cover'' (``Colorectal Cancer: 
Facts on Screening,''; CDC publication #099-6486; CMS publication 
#11012).
    Thus, evidence from national surveys of insurance plans, 
data from individual insurance companies and HHS' own flagship 
screening program for colorectal cancer all support the 
conclusion that while most insurance companies do provide 
coverage for colorectal cancer detection procedures as a 
diagnostic test for colorectal cancer, coverage of the full 
range of medically recommended tests for screening purposes is 
sporadic.
    However, even if one were to accept the argument advanced 
by opponents of the legislation that the vast majority of 
insurance companies already provide adequate coverage for 
screening, the need for the legislation would be undiminished. 
If indeed the bulk of insurance companies are already providing 
the coverage required by the legislation, then complying with 
the requirements of the bill would have no impact on the vast 
majority of insurance plans. It is hard to reconcile opponents' 
arguments that insurance companies are already providing 
coverage for colorectal screening with their simultaneous 
assertion that the legislation is an undue burden on insurance 
issuers.
     A second inconsistency is found in opponents' arguments 
that providing insurance coverage for colorectal cancer 
screening will have little impact on utilization rates. This 
argument is based in part on a GAO report analyzing rates of 
colorectal cancer screening among Medicare beneficiaries. This 
report was issued in March of 2000 and examined utilization 
rates in 1999, only two years after enactment of the initial 
legislation establishing coverage for colorectal cancer 
screening. GAO found that screening rates among beneficiaries 
were low--an unsurprising finding, given the short interval 
between enactment of the authorizing legislation and the time 
the data were collected. However, some opponents of the 
legislation have used this report to argue that requiring 
insurance companies to cover colorectal cancer screening will 
have little effect on screening rates. Yet at the same time, 
they assert that enacting S. 710 will drive up the costs of 
insurance. Both of these assertions cannot simultaneously be 
valid. If the legislation will have little effect on 
utilization rates, it will similarly have little effect on 
costs. Whereas if the legislation does affect costs, it will do 
so through increasing the utilization rate for the covered 
service and thus saving lives.

Screening requirements save lives

    The benefits of screening requirements such as that 
provided by S. 710 are shown by the experience of States that 
have enacted requirements for insurance plans to provide 
coverage for breast cancer screening. The first state law 
requiring coverage for breast cancer screening was enacted in 
1981, and now 49 States have enacted such requirements. The 
increase in breast cancer screening during the period since 
1981 has been dramatic. Fifteen years ago, fewer than a third 
of women between the ages of 50 and 64 received mammograms. Now 
almost three quarters of women in this age bracket receive 
these needed tests. Increased screening has resulted in reduced 
death rates from breast cancer. Breast cancer rates have 
dropped by 2 percent a year since 1990 and are dropping almost 
4 percent a year now. It is the committee's belief that the 
legislation approved by the committee could result in similar 
dramatic increases in the rate of screening for colorectal 
cancer and concomitant decreases in the death rate from this 
painful disease.
    Some have argued that enacting requirements for insurance 
companies to cover colorectal cancer screening is best left to 
the states. Indeed, 16 states and the District of Columbia have 
already enacted laws assuring coverage of colorectal cancer 
coverage screening. However, Federal legislation can assure 
that the benefits of colorectal cancer screening are realized 
in all states, not simply the few that have already taken 
action.
    Even in states that have enacted requirements for insurance 
companies to cover colorectal cancer screening tests, state law 
does not have jurisdiction over ERISA plans. Thus, residents of 
those states who receive health insurance through ERISA plans 
are not assured coverage of the full range of colorectal cancer 
screening tests despite state laws to the contrary. Only 
Federal legislation can ensure that all plans cover these 
lifesaving screening tests.

             III. Legislative History and Committee Action

    S. 710 was introduced on April 5, 2001 by Senator Kennedy 
for himself and Senator Helms was cosponsored by Senators 
Brownback, Cantwell, Cochran, Daschle, Jeffords, Johnson, 
Kerry, Landrieu, Miller, Murray, Reid, Roberts and Snowe. S. 
710 was referred to the Committee on Health, Education, Labor, 
and Pensions. On July 10, 2002, the Senate Committee on Health, 
Education, Labor, and Pensions held an executive session to 
consider S. 710. The committee approved by voice vote an 
amendment offered by Senator Kennedy and Senator Roberts to 
make technical improvements in the legislation.
    The committee rejected by roll call vote 11 to 10 an 
amendment proposed by Senator Gregg that it was the Sense of 
the Senate that there be established an expert Standing 
Commission that shall be required to study and make 
recommendations to Congress regarding the costs and benefits of 
mandated health insurance benefits. Voting in the negative were 
Senators Kennedy, Dodd, Harkin, Jeffords, Mikulski, Bingaman, 
Wellstone, Murray, Reed, Edwards, and Clinton. Voting in the 
affirmative were Senators Gregg, Frist, Enzi, Hutchinson, 
Warner, Bond, Roberts, Collins, Sessions and DeWine.
    The committee rejected by roll call vote 15 to 6 an 
amendment offered by Senator Frist to strike all provisions of 
the bill after the enacting clause and replace them with (1) a 
survey to be conducted by the Comptroller General and (2) a 
study by the Institute of Medicine. The survey by the 
Comptroller General would examine the extent to which health 
insurance issuers and group health plans provide coverage for 
colorectal cancer screening, including colonoscopy. The study 
by the Institute of Medicine would analyze the available 
medical evidence regarding the safety and effectiveness and 
cost of various colorectal cancer screening methods. The study 
would also identify factors that may affect patient access to, 
and use of, colorectal cancer screening and the extent to which 
each of these factors contributes to screening frequency among 
patients. Voting in the negative were Senators Kennedy, Dodd, 
Harkin, Jeffords, Mikulski, Bingaman, Wellstone, Murray, Reed, 
Edwards, Clinton, Warner, Roberts, Collins and DeWine.Voting in 
the affirmative were Senators Gregg, Frist, Enzi, Hutchinson, Bond and 
Sessions.
    The committee accepted by voice vote an amendment proposed 
by Senator Enzi to assure that the provisions of the Act apply 
to insurance plans that are the subject of collective 
bargaining agreements with the same effective date (January 1, 
2003) applicable to other plans.
    S. 710 was ordered reported, as amended, favorably by a 
roll call vote in which Senators Bingaman, Clinton, Collins, 
DeWine, Dodd, Edwards, Harkin, Hutchinson, Jeffords, Kennedy, 
Mikulski, Murray, Reed, Roberts, Warner, and Wellstone voted in 
the affirmative and Senators Bond, Enzi, Frist, Gregg, and 
Sessions voted in the negative.

                          IV. Committee Views

    The Committee recognizes the need for access to colorectal 
cancer screening as part of a comprehensive strategy in the war 
against cancer. Congress has played a crucial role in the 
nation's war against cancer. The committee intends for this 
legislation to build on this Congressional effort and to 
increase access to and use of colorectal cancer screening.
    In adopting the Kennedy-Roberts substitute amendment, the 
committee intended to clarify the provisions of the legislation 
in several areas.
    First, the amendment clarifies the scope of tests that 
insurance plans are required to cover under the terms of the 
legislation. The amendment specifies that insurance providers 
and plans must cover tests that are (1) deemed appropriate by a 
physician treating the participant or beneficiary, in 
consultation with the participant or beneficiary and (2) one of 
the four tests covered under Medicare (FOBT, flexible 
sigmoidoscopy, colonoscopy or double contrast barium enema) or 
are otherwise specified by the Secretary of HHS ``based upon 
the recommendations of appropriate organizations with special 
expertise in the field of colorectal cancer.''
    Through this provision, the committee intends to ensure 
that the decision regarding whether or not a patient receives a 
colorectal cancer screen and the choice of the screening method 
used remains a decision made by the patient and treating 
physician--rather than being determined by the coverage 
policies of an insurance plan. The choice of screening method 
used is customarily based upon the preferences and health 
status of the patient as well as the accessibility of health 
professionals with the training and expertise to provide 
accurate and safe endoscopic tests. This policy is consistent 
with the recommendations and guidelines of leading medical and 
scientific organizations.
    In adopting the provision allowing the Secretary of HHS to 
update the range of tests required to be covered, it was the 
committee's intent to allow the requirements of the legislation 
to be flexible enough to respond to evolving scientific and 
medical knowledge. For example, the efficacy of ``virtual 
colonoscopy'' in providing reliable screening for colorectal 
cancer has not yet been definitively established. However, 
ongoing research in this area may in the future show that 
virtual colonoscopy is an effective means to provide for early 
detection of precancerous polyps. If the efficacy of virtual 
colonoscopy is indeed established and recognized by the medical 
expert community, it is the committee's intent to allow the 
Secretary of HHS to add this procedure or other effective 
screening methods to the range of tests required to be covered 
by insurance plans under the legislation.
    Second, the amendment clarifies the frequency of screening 
required to be covered under the legislation. Under Medicare, 
no coverage is provided for tests conducted at intervals more 
frequent than those specified under Section 1834(d) of the 
Social Security Act. In adopting the Kennedy-Roberts amendment, 
it was the intent of the committee to mirror this provision of 
Medicare, but also to allow the Secretary of HHS the 
flexibility to modify the required coverage frequencies where 
such modifications are ``based upon new scientific knowledge 
and consistent with the recommendations of appropriate 
organizations with special expertise in the field of colorectal 
cancer.''
    It is the committee's intent to allow such modifications to 
the required frequencies of coverage only if new scientific 
findings clearly indicate that such modifications are warranted 
and only if such modifications receive the approval of the 
scientific and medical communities with expertise in this 
field. Finally, any modified frequency must be no less 
effective in providing colorectal cancer screening than the 
frequency of coverage provided under Medicare as of the date of 
enactment of this Act.
    Third, the Kennedy-Roberts amendment also specifies the 
characteristics of patients for whom insurance plans must 
provide coverage. Specifically, the legislation requires 
coverage for (1) any participant or beneficiary age 50 or over 
and (2) any participant or beneficiary under the age of 50 who 
is at a high risk for colorectal cancer. The amendment 
incorporates the definition of ``high-risk'' from the 
requirements of Medicare (as specified in section 1861(pp)(2) 
of the Social Security Act), under which a high risk individual 
is defined as ``an individual who, because of family history, 
prior experience of cancer or precursor neoplastic polyps, a 
history of chronic digestive disease condition (including 
inflammatory bowel disease, Crohn's Disease, or ulcerative 
colitis), the presence of any appropriate recognized gene 
markers for colorectal cancer, or other predisposing factors, 
faces a high risk for colorectal cancer.''
    Fourth, the Kennedy-Roberts amendment clarifies that the 
health care provider who recommends that patient receive a 
colorectal cancer screening must be a physician under the 
meaning of that term as defined in the Social Security Act (42 
U.S.C. 1395x(r)). It is the committee's intent to ensure that 
patients receive a recommendation to receive a colorectal 
cancer screening test from a physician familiar with their 
medical condition.

                            V. Cost Estimate

               CONGRESSIONAL BUDGET OFFICE COST ESTIMATE

S. 710--Eliminate Colorectal Cancer Act of 2002

    Summary: S. 710 would require group health plans and health 
insurance issuers to cover colorectal cancer screening at 
regular intervals for all plan enrollees over the age of 50 and 
for certain enrollees under the age of 50 who are at high risk 
of developing colorectal cancer. The bill would require 
insurers to adopt guidelines used in the Medicare program that 
specify the types and frequency of screening procedures that 
must be covered. The bill would not preempt state laws that 
require plans to provide more comprehensive benefits for 
colorectal cancer screening than the requirements of the bill.
    Enacting S. 710 would affect the federal budget because it 
would result in higher premiums for employer-sponsored health 
benefits. Higher premiums, in turn, would result in more of an 
employee's compensation being received in the form of 
nontaxable employer-paid premiums, and less in the form of 
taxable wages. As a result of this shift, federal income and 
payroll tax revenues would decline. CBO estimates that enacting 
the bill would reduce federal tax revenues by $10 million in 
2003, by $125 million over the 2003-2007 period, and by $375 
million over the 2003-2012 period. Because the bill would 
affect revenues, pay-as-you-go procedures would apply.
    Enacting S. 710 would not affect spending in the Federal 
Employees' Health Benefits program because participating health 
plans already meet the requirements of the bill under current 
law.
    The bill's requirements for colorectal cancer screening 
would apply to health plans operated by state, local, and 
tribal governments for the benefit of their employees. It also 
would preempt some state laws that establish requirements for 
colorectal cancer screening. These provisions of the bill would 
be intergovernmental mandates as defined in the Unfunded 
Mandates Reform Act (UMRA), but the costs would not exceed the 
threshold established in UMRA ($58 million in 2002, adjusted 
annually for inflation).
    The bill would impose a private-sector mandate, as defined 
in UMRA, on group health plans and health insurance issuers by 
requiring them to provide coverage of colorectal cancer 
screening for certain plan enrollees. CBO estimates that the 
direct cost of this mandate would equal about $110 million in 
2003, about $240 million in 2004, and more in later years. 
Those amounts would not exceed the annual threshold established 
in UMRA ($115 million in 2002, adjusted annually for inflation) 
in the first year that the mandate would be effective, but 
would exceed the annual threshold in each of the subsequent 
four years.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of S. 710 is shown in the following table.

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                                                                      By fiscal year, in millions of dollars--
                                                                  ----------------------------------------------
                                                                    2002   2003    2004    2005    2006    2007
----------------------------------------------------------------------------------------------------------------
                                               CHANGES IN REVENUES

Income and HI Payroll Taxes (on-budget)..........................      0      -5     -10     -20     -20     -30
Social Security Payroll Taxes (off-budget).......................      0      -5      -5     -10     -10     -10
                                                                  ----------------------------------------------
      Total changes..............................................      0     -10     -15     -30     -30     -40
----------------------------------------------------------------------------------------------------------------
Note.--HI = Hospital Insurance.

    Basis of estimate: The bill would require group health 
plans and health insurance issuers to provide coverage for 
colorectal cancer screening to all plan enrollees aged 50 and 
over, and to provide that coverage to certain high-risk 
enrollees under age 50. Plans would be required to cover the 
screening procedures specified in Medicare guidelines, 
including fecal-occult blood test, flexible sigmoidoscopy, 
colonoscopy, and double-contrast barium enema. The frequency 
with which those procedures would be covered would also have to 
be consistent with Medicare's guidelines. For example, plans 
would be required to cover one screening colonoscopy every 10 
years for individuals who are not at high risk of colorectal 
cancer, and one colonoscopy every two years for individuals who 
are at high risk of colorectal cancer. High-risk enrollees 
would be defined using rules established for the Medicare 
program and would include those individuals with a family 
history of colorectal cancer, a prior diagnosis of colorectal 
cancer or precursor neoplastic polyps, a history of chronic 
digestive disease, or genetic markers for colorectal cancer.
    The bill's requirements would apply to both self-insured 
and fully insured group health plans as well as plans sold in 
the individual market. In states with laws that require 
coverage of more comprehensive benefits for colorectal cancer 
screening, fully insured plans would be required to comply with 
the state law, while self-insured plans would be required to 
comply with the provisions of S. 710.
    CBO's estimate of the cost of this bill is based on data 
about the use of colorectal cancer screening procedures among 
the privately insured population, the extent of current 
coverage of colorectal cancer screening in private health 
insurance plans, and the cost of performing each procedure that 
the bill would cover. CBO assumed that under the bill, 
utilization of colorectal cancer screening procedures among 
enrollees in plans that do not currently cover those procedures 
would grow to match the utilization rates of those procedures 
among enrollees in plans that do cover them. CBO estimates that 
among enrollees between the ages of 50 and 64, about 210,000 
additional insured colonoscopies and 67,000 additional insured 
flexible sigmoidoscopies would be performed in 2003. Among 
enrollees at high risk of colorectal cancer, about 4,600 
additional insured colonoscopies would be performed in 2003. 
The numbers of additional procedures performed as a result of 
the bill's enactment would grow in subsequent years.
    CBO's estimate also takes into account the costs of follow-
up care for individuals who receive newly covered screening 
procedures. Those costs include the cost of removing polyps 
identified by the screening, the cost of treating perforations 
of the colon (a side effect of both the screening procedure and 
polyp removal), and the cost of more frequent colonoscopies for 
individuals who were identified as being at high risk through a 
screening procedure.
    Because some individuals who would have developed 
colorectal cancer will be identified through screening and have 
polyps removed prior to their becoming cancerous, our estimate 
includes the savings from treating those averted cancer cases.
    CBO estimates that enacting S. 710 would increase premiums 
for private health insurance by an average of less than 0.1 
percent, before accounting for the responses of health plans, 
employers, and workers to the higher premiums. Those responses 
would include reductions in the number of employers offering 
insurance to their employees and in the number of employees 
enrolling in employer-sponsored insurance, changes in the types 
of health plans that are offered, and reductions in the scope 
or generosity of health insurance benefits, such as increased 
deductibles or higher copayments. CBO assumes that these 
behavioral responses would offset 60 percent of the potential 
impact of the bill on total health plan costs.
    The remaining 40 percent of the potential increase in 
costs, or about 0.03 percent of group health insurance 
premiums, would occur in the form of increased outlays for 
health insurance. Those costs would be passed through to 
workers, reducing both their taxable compensation and other 
fringe benefit. For employees of private firms, CBO assumes 
that all of that increase would ultimately be passed through to 
workers. We assume that state, local, and tribal governments 
would absorb 75 percent of the increase and would reduce their 
workers' taxable income and other fringe benefits to offset the 
remaining one-quarter of the increase. CBO estimates that the 
resulting reduction in taxable income would grow from $21 
million in calendar year 2003 to $185 million in 2012.
    Those reductions in workers' taxable compensation would 
lead to lower federal tax revenues. The estimate assumes an 
average marginal rate of about 20 percent for income taxes and 
the current-law rates for the Hospital Insurance and Social 
Security payroll taxes (2.9 percent and 12.4 percent, 
respectively). CBO further assumes that 15 percent of the 
change in taxable compensation would not be subject to the 
Social Security payroll tax. As a result, we estimate that 
federal tax revenues would fall by $10 million in 2003 and by a 
total of $375 million over the 2003-2012 period if S. 710 were 
enacted. Social Security payroll taxes, which are off-budget, 
account for about 30 percent of those totals.
    Pay-as-you-go considerations: The Balanced Budget and 
Emergency Deficit Control Act sets up pay-as-you-go procedures 
for legislation affecting direct spending or receipts. The net 
changes in governmental receipts that are subject to pay-as-
you-go procedures are shown in the following table. Changes in 
Social Security receipts are not subject to pay-as-you-go 
procedures. (Hence, the following table shows only the 
estimated changes in Income and Hospital Insurance Payroll 
taxes.) For the purposes of enforcing pay-as-you-go procedures, 
only the effects through 2006 are counted.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          By fiscal year, in millions of dollars--
                                                                   -------------------------------------------------------------------------------------
                                                                     2002   2003   2004    2005    2006    2007    2008    2009    2010    2011    2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
Changes in receipts...............................................      0     -5     -10     -20     -20     -30     -30     -30     -30     -40     -40
Changes in outlays................................................                                     Not applicable
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated impact on state, local, and tribal government: 
The requirements in S. 710 would apply to health plans that 
state, local, and tribal governments operate for the benefit of 
their employees, specifically those that self-insure their 
benefit programs. Those requirements would be intergovernmental 
mandates as defined in UMRA. State, local, and tribal 
governments that do not self-insure their benefit programs, but 
rather contract with private health insurers, also would face 
increased premium costs, but the requirements (and hence the 
mandates) included in the bill would fall on the private plans. 
However, significant costs would be passed on to the state and 
local governments that purchase the health care coverage.
    CBO estimates that state and local governments that self-
insure would be directly responsible for providing regular 
screenings for colorectal cancer and would face increased costs 
as a result of the mandate of between $40 million in 2003 and 
$50 million in 2007. In no year would those costs exceed the 
threshold for intergovernmental mandates established in UMRA 
($58 million in 2002, adjusted annual for inflation).
    The bill also would preempt state laws that do not provide 
greater protection for colorectal cancer screening than the 
bill. This preemption would be an intergovernmental mandate as 
defined in UMRA because it would limit the application of state 
law. It would not, however, impose additional costs on state, 
local, or tribal governments.
    Estimated impact on the private sector: The bill would 
impose a mandate on private-sector group health plans and 
health insurance issuers by requiring them to provide coverage 
of colorectal cancer screening for certain plan enrollees. CBO 
estimates that premiums for private health insurance would 
increase by less than 0.1 percent if the bill were enacted. The 
direct cost of the mandate in the bill would equal about $110 
million in 2003, rising to about $450 million in 2007. That 
amount would not exceed the annual threshold established by 
UMRA ($115 million in 2002, adjusted annually for inflation) in 
the first year that the mandate would be effective, but would 
exceed the annual threshold in each of the subsequent four 
years.
    Estimate prepared by: Federal Receipts: Alexis Ahlstrom; 
Federal Outlays: Chuck Betley; Impact on State, Local, and 
Tribal Governments: Leo Lex; and Impact on the Private Sector: 
Jennifer Bowman and Judy Wagner.
    Estimate approved by: Peter H. Fontaine, Deputy Assistant 
Director for Budget Analysis.

            VI. Application of Law to the Legislative Branch

    The Eliminate Colorectal Cancer Act amends the Public 
Health Services Act and the Employee Retirement Income Security 
Act to ensure health insurance coverage of colorectal cancer 
screening tests and, as such, has no application to the 
legislative branch.

                    VII. Regulatory Impact Statement

    The committee has determined that there will be no 
increases in the regulatory burden of paperwork as a result of 
this bill.

                   VIII. Section-by-Section Analysis

Section 1. Short title; findings

    Section 1 provides that this Act may be cited as the 
``Eliminate Colorectal Cancer Act of 2001''. Section 1 provides 
information that attests to the importance and need for 
screening for colorectal cancer. The findings are facts about 
the frequency of colorectal cancer and the importance of public 
access to screening in decreasing the number of deaths due to 
colorectal cancer each year.

Section 2. Coverage for colorectal cancer screening

    Section 2 requires group health plans referred to in the 
PHSA and ERISA to cover colorectal cancer screening for 
colorectal cancer. This section also requires individual health 
insurance issuers to provide coverage for screening tests for 
colorectal cancer. These programs are meant to provide access 
to a full-range of screening tests for colorectal cancer for 
Americans who are individuals age 50 or over or at high risk 
and covered by private insurance plans.

 IX. MINORITY VIEWS OF SENATORS GREGG, FRIST, ENZI, BOND, AND SESSIONS

    Colorectal cancer is the second leading cause of cancer-
related deaths in the United Stats for men and women combined. 
As a public health matter, colorectal cancer is a serious 
concern. The good news is that screening can detect colorectal 
cancer early, when treatment can be very effective. There is no 
dispute about the value of colorectal cancer screening, and the 
Minority is committed to finding meaningful ways to increase 
awareness and screening rates, and ultimately finding a cure 
for the disease.
    The legislation mandates that all private health plans 
cover the full range of screening methods recommended by the 
American Cancer Society and covered under the Medicare program. 
However, there is not sufficient evidence to support the 
Majority's claim that S. 710 would improve colorectal cancer 
screening rates. Instead, it is an attempt to mandate that all 
private-sector health plans cover a particular screening test, 
colonoscopy, as a first screen for all asymptomatic persons, 
even those at low risk. At no time in the debate on this bill 
was there discussion of any other form of colorectal cancer 
screening, nor was there any claim made that private insurers 
are not covering these other forms of screening. The debate and 
this bill are aimed at colonoscopy. Advocates for this 
legislation believe that colonoscopy is a superior form of 
screening, that there is a significant lack of coverage in the 
private market, and therefore an insurance mandate is 
justified.
    While there is no debate about the value of screening, the 
scientific evidence currently available simply does not support 
the superiority of any one method. Moreover, there is no 
credible evidence that private health plans routinely deny 
coverage for scientifically proven screening methods. Given the 
degree of scientific uncertainty in this area and the lack of 
evidence to support claims that private insurance coverage is 
lacking, the Minority believes that, while well-intentioned, 
this legislation misses the mark with respect to reducing 
colorectal cancer mortality. Moreover, the Minority is 
concerned that this legislation potentially puts patients in 
harm's way by ignoring the scientific evidence on colorectal 
cancer screening.
Scientific evidence
    The United States Preventive Services Task Force (Task 
Force) is the official advisory group to the U.S. Government on 
the current status of scientific evidence related to preventive 
services, including screening tests. It consists of a panel of 
independent, multi-disciplinary experts who have no 
professional, personal, or financial interest attached to their 
recommendations. On July 16, 2002, just 6 days after the 
committee approved S. 710, the Task Force released its new 
guidelines for colorectal cancer screening.
    Based on its comprehensive analysis, the Task Force found 
that ``the quality of evidence, magnitude of benefit, and 
potential harms vary with each method,'' and that ``there is 
insufficient evidence to determine which strategy is best in 
terms of the balance of benefits and potential harms or cost-
effectiveness.'' S. 710, however, makes just such a 
determination by mandating coverage of all screening methods, 
regardless of their potential risks,and in spite of lack of 
proof of efficacy, as a first screen for asymptomatic persons. 
The entire Task Force report can be found on the website of the 
Department of Health and Human Services, under the Agency for 
Health Care Policy and Research (AHRQ), U.S. Preventive 
Services Task Force (www.ahcpr.gov/clinic/3rduspstf/colorectal/
colorr.htm).
    The Majority references to particular studies regarding the 
advantages of colonoscopy over other procedures are a 
misleading attempt to justify a government mandate of a 
specific medical procedure. For instance, the Majority fails to 
highlight the Task Force warning that studies regarding 
effectiveness of colonoscopy ``should be interpreted with 
caution, because they are based on historical controls.'' The 
public should bear in mind that the Task Force considered all 
the studies and evidence regarding the different types of 
colorectal cancer screening and sensitivity of tests and still 
it ``did not find direct evidence that screen colonoscopy is 
effective in reducing colorectal cancer mortality.'' The bottom 
line on colonoscopy is that there has not been one single 
randomized clinical trial to date that demonstrates that 
colonoscopy reduces colorectal cancer mortality.\1\
---------------------------------------------------------------------------
    \1\ Notice that the evidence on using colonoscopy as a diagnostic 
tool is stronger than using it as a screening tool. However, the 
legislation only deals with a screening mandate.
---------------------------------------------------------------------------
    This is not to say that colonoscopy may not turn out to be 
a superior screening methodology after further scientific 
review. Many health professionals believe that colonoscopy is 
superior. Rather, it is to say that Congress should not mandate 
coverage of specific screening methods, particularly when the 
scientific evidence is lacking.
    The Majority also fails to provide all the relevant 
findings on the safety of colonoscopy. While it is true that 
the risks of colonoscopy are fairly low, the Task Force notes 
that ``screening colonoscopy poses higher risks than fecal 
occult blood tests (FOBT) or sigmoidoscopy, both because it is 
a more invasive procedure and because generally it is used with 
conscious sedation, which may lead to complications.'' Even low 
rates of complications are a significant public health concern 
when a test is being advocated for universal use and when most 
of those receiving it are asymptomatic, well people. It is 
precisely to such populations that a higher standard of safety 
in screening tests is typically applied. Regarding safety, the 
Task Force concludes that ``it is unclear whether the increased 
accuracy of colonoscopy compared with alternative screening 
methods offsets the procedure's additional complications, 
inconvenience, and costs.''
State of insurance coverage
    In addition to being inconsistent with the scientific 
evidence, the legislation appears to be based on a 
misunderstanding about the state of insurance coverage. 
According to data presented at the committee markup of S. 710, 
health plans provide comprehensive coverage of colorectal 
cancer screening. On its website, the Centers for Disease 
Control notes that ``many insurance plans, including Medicare, 
help pay for colorectal cancer screening'' (CDC's Screen For 
Life Program; www.cdc.gov). The American Association of Health 
plan's (AAHP) 2001 Annual Industry Survey revealed that many 
health plans rely on the Task Force recommendations as the 
authoritative guide to clinical preventive services. The survey 
revealed that 93 percent of allhealth plans cover colonoscopy 
for colorectal cancer screening.\2\
---------------------------------------------------------------------------
    \2\ The 2001 AAHP Annual Industry Survey represents a profile of 
the industry and provides information on 64.3 million covered lives, or 
approximately 68 percent of total U.S. managed care enrollment.
---------------------------------------------------------------------------
    Not only are health plans covering screening, but many 
plans actively promote colorectal cancer screening services. 
For instance, GIGNA HealthCare sends out annual birthday 
reminder cards to their enrollees that recommends colorectal 
cancer screening, including screening colonoscopy, for all 
enrollees beginning at age 50. Physicians also report that they 
have no problems getting insurance companies to cover 
colonoscopy.
    The Majority assertion that insurance coverage is a barrier 
to screening, and therefore ``a major factor contributing to 
this unacceptable number of preventable deaths from colon 
cancer,'' is baseless. The Majority references an unpublished 
Lewin study of the Federal Employees Health Benefits Program 
(FEHBP) that was based on a review of a public website. 
However, the Majority has refused to provide the actual study 
to the Minority or submit it for the record. Moreover, the 
Office of Personnel Management, the agency that administers 
FEHBP, dismisses the Lewin conclusions as inaccurate and 
uninformed. The truth is the Majority failed to provide a 
single shred of evidence at the markup or since that time that 
supports their erroneous claim about insurance coverage.
    Given these data, it is unlikely that an insurance mandate 
would improve colon cancer screening rates. This is supported 
by Medicare's experience. Several years after mandating 
colorectal cancer screening for Medicare beneficiaries, the 
U.S. General Accounting Office found that screening rates 
remain very low for that population. Specifically, GAO found 
that:

        various factors contribute to the low use of screening 
        and diagnostic services, some of which are beginning to 
        be addressed by public health agencies and private 
        organizations. Key among these is poor patient 
        awareness of recommendations and coverage for 
        screening, physician reluctance to perform the 
        procedures because of the time and complexity involved, 
        and lack of monitoring systems to encourage greater 
        use. (Medicare: Few Beneficiaries Use Colorectal Cancer 
        Screening and Diagnostic Services; GAO/T-HEHS-00-68)

    The Majority also erroneously asserts, based on a Lewin 
study, that insurance coverage of colonoscopy will reduce costs 
for plans that cover other screening procedures. However, 
screening tests do not reduce costs. If they are effective, 
they save lives at a cost of $20,000-$30,000 per year of life 
saved. The true costs of colonoscopy will depend, in part, on 
the frequency of complications that will require medical 
treatment. The true frequency of these complications is unknown 
since colonoscopy has not been studied in community-based 
studies, in conditions that will exist if it is a universally 
used, first-line, screening test.

Understanding screening rates

    There are many reasons unrelated to insurance coverage for 
low rates of colorectal cancer screening, including lack of 
awareness about the prevalence of colon cancer and the 
importance screening, as well as the distasteful nature of the 
screening methods. Instead of creating a costly and ineffective 
insurance mandate, the Minority believes the committee should 
focus its efforts on finding and addressing real reasons behind 
low screening rates.
    For instance, many members of this committee supported a 
Senate commitment to finding lifesaving cures for all cancers 
by doubling the National Institutes of Health research funding 
over 5 years. In addition, the committee has supported CDC's 
Chronic Disease Prevention and Health Promotion Program, which 
houses CDC's ``Screen for Life'' Campaign. That Campaign is a 
multi-year, multimedia, national campaign to inform men and 
women age 50 years and older about the importance of having 
regular colorectal cancer screening tests. Many are familiar 
with the CDC's public service announcements on television 
featuring the ``Polyp Man.''

Appropriate government role

    Even if this bill were based on a reasonable degree of 
scientific certainty, the Minority would find it difficult to 
support a precedential new Federal mandate of this nature, 
particularly during this time of skyrocketing insurance 
premiums and large numbers of uninsured. Congress rarely passes 
insurance mandates (states are the traditional regulators of 
insurance), and has never passed legislation that mandates a 
particular screening benefit for private health insurance. This 
is due, in part, to the fact that private employers and health 
insurers have actually led the market in offering and promoting 
preventive health benefits. In contrast, government programs, 
such as Medicare, provide less generous benefits than private 
insurance and are totally reliant on Congress to add new 
benefits like prescription drugs and preventive screening.
    The Majority correctly states that S. 710 allows 
physicians, in consultation with their patients, to make the 
ultimate decision regarding which screening method to use. 
However, it is well documented that insurance coverage drives 
physician utilization patterns, and it is logical that a 
government mandate of coverage would augment that effect. 
Moreover, an insurance mandate that is out of sync with the 
scientific evidence will send a conflicting and confusing 
message to physicians and patients.
    The Majority asks the rhetorical question why not go ahead 
and mandate insurance coverage if most plans are already 
providing these benefits? This is the wrong question to ask. 
The better question in this context is whether the Federal 
Government should dictate insurance coverage, and, therefore, 
medical practice in the area of colorectal cancer screening? In 
general, the Minority is concerned that piecemeal mandates 
will, overtime, translate into higher health insurance costs, 
and lock in outdated medical practice. This is particularly 
true when there is scientific uncertainty and a lack of solid 
information on private health coverage.
    Sometimes the practice of medicine, when pushed by advocacy 
rather than science, has had to reverse its course. For 
example, during the 1980s, endometrial biopsy at menopause was 
recommended for all high risk women. Likewise, during the early 
1990s, autologous bone marrow transplant and high dose 
chemotherapy were considered the cutting edge treatment for 
certain types of breast cancer. Breast cancer advocates 
intensely pursued insurance coverage of this treatment and were 
successful in getting many states to mandate such coverage. 
Most private health plans decided to implement coverage, in 
part, to avoid a public backlash, even though they were 
concerned about the lack of scientific evidence. When the 
research on these treatments was finally concluded, it showed 
that, not only is the treatment ineffective, but it is actually 
harmful to some women. Even now, the breast cancer community is 
embroiled in recently-released questions about the relative 
benefits and risks of mammography among asymptomatic women.
    Based on this experience, the Minority strongly believes 
that it is not the appropriate role for the Federal Government 
to micro-manage medical practice and insurance coverage in the 
private market. Imagine if, given the recent recommendations by 
NIH, Congress had enacted Federal insurance mandate to cover 
Hormone Replacement Therapy? The current state of confusion and 
fear brought on by recent events concerning HRT would only be 
exacerbated if the government had mandated coverage of such 
therapy.
    There are numerous screening tests, including colorectal 
cancer screening, pap smear, mammography, prostate screening, 
amniocentesis and other maternity screenings, that are offered 
by insurers without a Congressional mandate. There has been no 
evidence offered that the private sector insurance market is 
not keeping up with scientific evidence. If S. 710 were 
enacted, there would likely be a great deal of increasing 
pressure for Congress to add similar mandates for a wide range 
of screening techniques and other medical procedures. Over 
time, this would result in Congressional micro-management of 
private health insurance, which would probably mean fewer 
benefits and more expensive health insurance for everyone.

State experience

    Finally, State experience with insurance mandates, 
including colorectal cancer screening, does not offer 
convincing evidence that the Federal Government should get 
involved in this area. Only eleven States have passed a 
colorectal cancer screening mandate to date. After years of 
over-regulation, most States are now seeking ways to reduce 
insurance costs and improve access, rather than add new 
mandates. Twenty-five States have enacted some sort of process 
or commission for evaluating the benefits and costs of a 
particular mandate before they decide to enact it. Pennsylvania 
specifically examined a colorectal cancer screening proposal, 
similar to S. 710, and concluded that ``while there is a 
general consensus about the medical efficacy of screening for 
colorectal cancer, there is disagreement about the need to 
mandate coverage and whether mandated coverage would bring a 
desired increase in screening utilization.'' (``Mandated 
Benefits Review by the Pennsylvania Health Care Cost 
Containment Council,'' S. 636, Colorectal Cancer Screening 
Mandate, May 2002).
    At present, there is insufficient and sometimes conflicting 
information about the state of insurance coverage for 
colorectal cancer screening using specific screening methods. 
There is also a lack of scientific consensus about the relative 
efficacy of different screening methods. Finally, the Minority 
has very serious concerns regarding the appropriate role of the 
Federal Government in mandating coverage of specific medical 
procedures. These are the types of issues typically clarified 
during hearings, but unfortunately, the committee never held a 
hearing on this legislation or even on the issue of colorectal 
cancer. In conclusion, the Minority believes that there are 
simply too many unknown factors and unanswered questions about 
this legislation to warrant support of S. 710. If and when the 
legislation is considered by the full Senate, the Minority 
intends to pursue full debate and bring light to these 
important issues while simultaneously focusing on meaningful 
solutions to promote screening and reduce the incidence and 
burden of colon cancer.

                                   Judd Gregg.
                                   Bill Frist.
                                   Michael B. Enzi.
                                   Christopher S. Bond.
                                   Jeff Sessions.

                       X. CHANGES IN EXISTING LAW

    In compliance with rule XXVI paragraph 12 of the Standing 
Rules of the Senate, the following provides a print of the 
statute or the part or section thereof to be amended or 
replaced (existing law proposed to be omitted is enclosed in 
black brackets, new matter is printed in italic, existing law 
in which no change is proposed is shown in roman):

PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *

               TITLE XXIX--MISCELLANEOUS HEALTH COVERAGE

SEC. 2901. COVERAGE FOR COLORECTAL CANCER SCREENING.

    (a) Coverage for Colorectal Cancer Screening.--
          (1) In general.--A group health plan, and a health 
        insurance issuer offering group health insurance 
        coverage, shall provide coverage for colorectal cancer 
        screening at regular intervals to--
                  (A) any participant or beneficiary age 50 or 
                over; and
                  (B) any participant or beneficiary under the 
                age of 50 who is at a high risk for colorectal 
                cancer.
          (2) Definition of high risk.--For purposes of 
        subsection (a)(1)(B), the term ``high risk for 
        colorectal cancer'' has the meaning given such term in 
        section 1861(pp)(2) of the Social Security Act (42 
        U.S.C. 1395x(pp)(2)).
          (3) Requirement for screening.--The group health plan 
        or health insurance issuer shall cover methods of 
        colorectal cancer screening that--
                  (A) are deemed appropriate by a physician (as 
                defined in section 1861(r) of the Social 
                Security Act (42 U.S.C. 1395x(r))) treating the 
                participant or beneficiary, in consultation 
                with the participant or beneficiary;
                  (B) are--
                          (i) described in section 1861(pp)(1) 
                        of the Social Security Act (42 U.S.C. 
                        1395x(pp)(1)) or section 410.37 of 
                        title 42, Code of Federal Regulations; 
                        or
                          (ii) specified by the Secretary, 
                        based upon the recommendations of 
                        appropriate organizations with special 
                        expertise in the field of colorectal 
                        cancer; and
                  (C) are performed at a frequency not greater 
                than that--
                          (i) described for such method in 
                        section 1834(d) of the Social Security 
                        Act (42 U.S.C. 1395m(d)) or section 
                        410.37 of title 42, Code of Federal 
                        Regulations; or
                          (ii) specified by the Secretary for 
                        such method, if the Secretary finds, 
                        based upon new scientific knowledge and 
                        consistent with the recommendations of 
                        appropriate organizations with special 
                        expertise in the field of colorectal 
                        cancer, that a different frequency 
                        would not adversely affect the 
                        effectiveness of such screening.
    (b) Notice.--A group health plan under this section shall 
comply with the notice requirement under section 714(d) of the 
Employee Retirement Income Security Act of 1974 with respect to 
the requirements of this section as if such section applied to 
such plan.
    (c) Non-Preemption of More Protective State Law With 
Respect to Health Insurance Issuers.--This section shall not be 
construed to supersede any provision of State law which 
establishes, implements, or continues in effect any standard or 
requirement solely relating to health insurance issuers in 
connection with group health insurance coverage that provides 
greater protections to participants and beneficiaries than the 
protection provided under this section.
    (d) Definitions and Enforcement.--The definitions and 
enforcement provisions of title XXVII shall apply for purposes 
of this section.

           *       *       *       *       *       *       *

    TITLE XXVII--REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE

                      PART A--GROUP MARKET REFORMS

Subpart 1--* * *

           *       *       *       *       *       *       *

                    PART B--INDIVIDUAL MARKET RULES

     Subpart 1--Portability, Access, and Renewability Requirements

SEC. 2741. GUARANTEED AVAILABILITY OF INDIVIDUAL HEALTH INSURANCE 
                    COVERAGE TO CERTAIN INDIVIDUALS WITH PRIOR GROUP 
                    COVERAGE.

    (a) Guaranteed Availability.--* * *

           *       *       *       *       *       *       *

SEC. 2752. [300GG-52] REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY 
                    FOLLOWING MASTECTOMIES.

    The provisions of section 2706 shall apply to health 
insurance coverage offered by a health insurance issuer in the 
individual market in the same manner as they apply to health 
insurance coverage offered by a health insurance issuer in 
connection with a group health plan in the small or large group 
market.

SEC. 2753. COVERAGE FOR COLORECTAL CANCER SCREENING.

    (a) In General.--The provisions of section 2901(a) shall 
apply to health insurance coverage offered by a health 
insurance issuer in the individual market in the same manner as 
it applies to health insurance coverage offered by a health 
insurance issuer in connection with a group health plan in the 
small or large group market.
    (b) Notice.--A health insurance issuer under this part 
shall comply with the notice requirement under section 714(b) 
of the Employee Retirement Income Security Act of 1974 with 
respect to the requirements referred to in subsection (a) as if 
such section applied to such issuer and such issuer were a 
group health plan.

           *       *       *       *       *       *       *

SEC. 2762. PREEMPTION.

    (a) In General.--Subject to subsection (b), nothing in this 
part (or part C insofar as it applies to this part) shall be 
construed to prevent a State from establishing, implementing, 
or continuing in effect standards and requirements unless such 
standards and requirements prevent the application of a 
requirement of this part.
    (b) Rules of Construction.--(1) Nothing in this part (or 
part C insofar as it applies to this part) shall be construed 
to affect or modify the provisions of section 514 of the 
Employee Retirement Income Security Act of 1974 (29 U.S.C. 
1144).
    (2) Nothing in this part (other than [section 2751] 
sections 2751 and 2753 shall be construed as requiring health 
insurance coverage offered in the individual market to provide 
specific benefits under the terms of such coverage.

           *       *       *       *       *       *       *

            EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974

                             TABLE OF CONTENTS

      * * * * * * *

             TITLE I--PROTECTION OF EMPLOYEE BENEFIT RIGHTS

      * * * * * * *

                    Subtitle B--Regulatory Provisions

      * * * * * * *

                 PART 7--GROUP HEALTH PLAN REQUIREMENTS

      * * * * * * *

                      Subpart B--Other Requirements

      * * * * * * *
Sec. 714. Coverage for colorectal cancer screening.
      * * * * * * *

TITLE I--PROTECTION OF EMPLOYEE BENEFIT RIGHTS

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SEC. 714. COVERAGE FOR COLORECTAL CANCER SCREENING.

    (a) Coverage for Colorectal Cancer Screening.--
          (1) In general.--A group health plan, and a health 
        insurance issuer offering group health insurance 
        coverage, shall provide coverage for colorectal cancer 
        screening at regular intervals to--
                  (A) any participant or beneficiary age 50 or 
                over; and
                  (B) any participant or beneficiary under the 
                age of 50 who is at a high risk for colorectal 
                cancer.
          (2) Definition of high risk.--For purposes of 
        subsection (a)(1)(B), the term ``high risk for 
        colorectal cancer has the meaning given such term in 
        section 1861(pp)(2) of the Social Security Act (42 
        U.S.C. 1395x(pp)(2)).
          (3) Requirement for screening.--The group health plan 
        or health insurance issuer shall cover methods of 
        colorectal cancer screening that--
                  (A) are deemed appropriate by a physician (as 
                defined in section 1861(r) of the Social 
                Security Act (42 U.S.C. 1395x(r))) treating the 
                participant or beneficiary, in consultation 
                with the participant or beneficiary;
                  (B) are--
                          (i) described in section 1861(pp)(1) 
                        of the Social Security Act (42 U.S.C. 
                        1395(pp)(1)) or section 410.37 of title 
                        42, Code of Federal Regulations; or
                          (ii) specified by the Secretary, 
                        based upon the recommendations of 
                        appropriate organizations with special 
                        expertise in the field of colorectal 
                        cancer; and
                  (C) are performed at a frequency not greater 
                than that--
                          (i) described for such method in 
                        section 1834(d) of the Social Security 
                        Act (42 U.S.C. 1395m(d)) or section 
                        410.37 of title 42, Code of Federal 
                        Regulations; or
                          (ii) specified by the Secretary for 
                        such method, if the Secretary finds, 
                        based upon new scientific knowledge and 
                        consistent with the recommendations of 
                        appropriate organizations with special 
                        expertise in the field of colorectal 
                        cancer, that a different frequency 
                        would not adversely affect the 
                        effectiveness of such screening.
    (b) Notice Under Group Health Plan.--The imposition of the 
requirements of this section shall be treated as a material 
modification in the terms of the plan described in section 
102(a), for purposes of assuring notice of such requirements 
under the plan; except that the summary description required to 
be provided under the third to last sentence of section 
104(b)(1) with respect to such modification shall be provided 
by not later than 60 days after the first day of the first plan 
year in which such requirements apply.

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                     Subpart C--General Provisions

SEC. 731. PREEMPTION; STATE FLEXIBILITY; CONSTRUCTION.

    (a) * * *

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    (c) Rules of Construction.--Except as provided in section 
[711] sections 711 and 714, nothing in this part shall be 
construed as requiring a group health plan or health insurance 
coverage to provide specific benefits under the terms of such 
plan or coverage.

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SEC. 732. SPECIAL RULES RELATING TO GROUP HEALTH PLANS.

    (a) General Exception for Certain Small Group Health 
Plans.--The requirements of this part (other than [section 711] 
sections 711 and 714) shall not apply to any group health plan 
(and group health insurance coverage offered in connection with 
a group health plan) for any plan year if, on the first day of 
such plan year, such plan has less than 2 participants who are 
current employees.

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