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Illinois Department of Insurance
Investigational Cancer Treatments Coverage Report

May 14, 2003
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State of Illinois Seal

STATE OF ILLINOIS

DEPARTMENT OF INSURANCE

320 WEST WASHINGTON STREET

SPRINGFIELD, ILLINOIS 62767-0001

     

ROD R. BLAGOJEVICH

 

J. ANTHONY CLARK

GOVERNOR

 

DIRECTOR

May 14, 2003
To: Rod R. Blagojevich, Governor
  Members of the General Assembly
From: J. Anthony Clark, Director of Insurance
Re: Investigational Cancer Treatments Coverage Report

To comply with 20 ILCS 1405/56.3, the Department is pleased to submit the Investigational Cancer Treatments Coverage Report.

The report was mandated by P.A. 91-0406 (effective January 1, 2000). The intent of the Act was to express the determination of the General Assembly that cancer clinical trials could be cost neutral in comparison to standard therapy. The legislation sunset effective January 1, 2003.

The Department of Insurance was required to conduct a three-year report, covering the years 2000 through 2002. The report was to include an analysis of the effect of the coverage requirements on the cost of insurance and health care, the results of the treatment to patients, the mortality rate among cancer patients, any improvements in care of patients, and any improvements in the quality of life of patients.

The attached report contains the Department's analysis of existing literature and results of a survey of affected insurers and HMOs.


TABLE OF CONTENTS

  1. EXECUTIVE SUMMARY
  2. SECTION I: STATUTORY REQUIREMENTS
  3. SECTION II: REVIEW OF PUBLICATIONS AND OTHER PERTINENT MATERIAL
  4. SECTION III: METHODOLOGY
  5. SECTION IV: ANALYSIS
  6. SECTION V: CONCLUSION
  7. NOTES
  8. SELECTED BIBLIOGRAPHY

Table of Contents

EXECUTIVE SUMMARY

This report is the Department of Insurance's response to the directive from P. A. 91-0406 from the 91st General Assembly to report to the Governor and the General Assembly a study and analysis of investigational cancer treatments.

The first section of the report contains a statement of the statutory requirements with which the Department was charged. It also describes the "must offer" requirement for coverage of investigational cancer treatment for the three-year study period on which the Department was to report.

The second section provides a description of existing studies, research and reference material the Department reviewed in an effort to assess results of prior clinical trials. Although the report required by this legislation is for cancer only, clinical trials in general are receiving an ever-increasing focus. Therefore, some of what the Department reviewed examined the topic in broader terms, as opposed to focusing solely on cancer.

The review enabled the Department to identify existing barriers impeding progress in cancer clinical trials including low patient participation, lack of funding, poor public awareness or understanding of clinical trials, and perceived competition between industry and federally funded cancer research programs.

The third section explains the Department's methodology in conducting a survey of insurers effected by the Illinois law. Based on the statutory requirements, the Department designed its questionnaire for 1,313 insurers to obtain the following information:

  1. The number of policies issued that included the coverage;
  2. The cost of a policy without the coverage;
  3. The cost of a policy with the coverage;
  4. The additional cost of the coverage;
  5. Claims made against the coverage;
  6. Whether there was a change in mortality rates; and,
  7. Whether there was an improvement in care and the quality of life.

The fourth section is the Department's analysis of the feedback it received from the 1,018 responses for the three-year period.

The final section contains the Department's conclusion and assessment of the information gleaned from all sources. Despite the Department's attempt to assess the costs and effects of coverage as mandated in Public Act 91-0406, the information obtained from insurers and other resources does not add enough significant data to reach conclusions on the cost or benefits derived by enactment of this legislation.


Table of Contents

SECTION I: STATUTORY REQUIREMENTS

P. A. 91-0406, effective January 1, 2000, required all insurers and Health Maintenance Organizations (HMOs) with authority to issue accident and health insurance, to offer coverage for certain cancer clinical trials (215 ILCS 5/356y). Coverage for routine patient care costs was to be provided to applicants and policyholders on a "must offer" basis. Purchased coverage would be available to insureds when medically appropriate and when the insured or member had a terminal condition related to cancer that was considered life threatening. The patient must also participate in an approved cancer research trial. Coverage applied to both group and individual products and was limited to $10,000 annually.

Routine patient care costs were not to include the cost of any clinical therapies, regimens or combinations thereof or any drugs or pharmaceuticals associated with the clinical trial. The intent of the legislation was not to relieve the sponsor of the clinical trial program from the financial responsibility for accepted costs of a program, but to cover auxiliary expenses which otherwise would have been covered under the policy for standard cancer treatment.

The legislation provided specific standards for expenses of trials to be covered. Those standards included requirements that the effectiveness of the treatment had not been determined relative to established therapies, the treatment was under clinical investigation as an approved cancer research trial in Phase II, III or IV of the investigation and that it had been approved by:

  1. The U.S. Secretary of Health and Human Services;
  2. The Director of the National Institutes of Health;
  3. The Commissioner of the Food and Drug Administration;
  4. A qualified non-governmental cancer research entity; or,
  5. A peer reviewed and approved cancer research program.

In order for expenses to qualify for coverage the legislation also required trials to be conducted at multiple sites across the state and include the patient's primary care physician (PCP), if applicable, in the coordination of care. The results of the investigational trial must be submitted for publication under specified guidelines.

The Act required the Department of Insurance to conduct an analysis and report of the costs and any benefits that may be derived from the implementation of the requirements for investigational cancer treatment as required by the Act.

The report was to include the years 2000, 2001 and 2002 and additionally required, "an analysis of the effect of the coverage requirements on the cost of insurance and health care, the results of the treatments to patients, the mortality rate among cancer patients, any improvements in care of patients, and any improvements in the quality of life of patients."

THE CLINICAL TRIAL PROCESS

Clinical trials are a necessary part to the development and approval process of a drug or device. The Food and Drug Administration (FDA) observes the clinical trial process. The FDA is a consumer protection agency of the U. S. Department of Health and Human Services. The FDA is required by law to review all test results for new drugs to ensure they are safe and effective.

The first step in the clinical trial process is to file an Investigational New Drug application with the FDA. Once this application is approved, the sponsor may begin testing with clinical trials.

Most clinical research is conducted in a series of steps, called phases. By researching in phases, reliable information can be obtained by answering questions within each phase. Clinical trials are usually classified in one of three phases. There is a fourth phase, which is addressed after the FDA approves the drug.

Phase I trials determine the safety and appropriate dosage of the drug for humans.

Phase II trials evaluate the effectiveness of the new drug and look for side effects.

Phase III trials evaluate the effectiveness of the new treatment, compared to standard treatment.

Phase IV trials are used to further evaluate the long-term safety and effectiveness of the treatment. Phase IV usually takes place after the new treatment has been approved for standard use.


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SECTION II: REVIEW OF PUBLICATIONS AND OTHER PERTINENT MATERIAL

Prior to preparing the report on the data provided, the Department reviewed a sampling of other pertinent material. This was to provide a foundation from which to analyze and review the material gathered from its survey of insurance companies selling products in Illinois. The following summaries represent the Department's research on these materials.

PARTICIPATION RATES

Several sources identified by the Department brought into question the ability to fairly assess the cost or effectiveness of the cancer clinical trials under current circumstances given the overall lack of participation by possible cancer trial candidates.

"Executive Summary Report from the Summit on Clinical Trials"

The "Executive Summary Report from the Summit on Clinical Trials," part of an effort to help draw attention to the condition of the United States' national cancer research program, reported that participation of adult cancer patients in clinical trials needed to increase between 10-15% of the total cancer patients.1 Today, only about 3-5% of adult cancer patients are enrolled in clinical trials. In contrast, about 60% of pediatric cancer patients are trial participants, and the cure rate for children has increased from close to 30% to more than 75% in the last several decades.2

The task of increasing adult participation might be made easier by simplifying trial design and including more minorities and elderly patients. The report additionally recommended patients and doctors be provided incentives to take part in trials and existing financial barriers be reduced to ensure greater participation.3

Medicare

Senator Connie Mack (R-Fla), in addressing this issue at the federal level in 1999, stated that for all but the wealthiest Medicare beneficiaries, it is too cost prohibitive to participate in cancer clinical trials.4 The statistics the Department reviewed, provided by the Lewin Group, a healthcare policy and management consulting firm, indicated that of the 38,000,000 Medicare enrollees in 1997 less than .05 % of those individuals (161,000) had been enrolled in medical clinical trials.5

Additionally, because a substantial proportion of patient care provided in clinical trials is routine, involving care that would be covered even if it were outside the scope of a clinical trial, it may be that claims for many clinical trial billings are submitted to the Center for Medicare & Medicaid Services (CMS) without any indication that the charges are for a clinical trial. CMS likely would forward those billings to its contractors without ever knowing the charges relate to a clinical trial.

Conclusion

Increased participation in cancer clinical trials could have a number of beneficial effects. On an individual level, trial specific improvements could lead to quicker recovery times for affected patients. Unfortunately, trials also by definition could result in less than optimum results. Additionally, increased participation would likely result in faster determinations of effectiveness of overall treatments leading to additional known methods for cancer treatment. Finally, greater participation rates would allow a more scientific understanding of costs associated with such treatments. Without greater participation rates, any conclusions must be viewed as preliminary at best.

ADDITIONAL COSTS OF COVERING CLINICAL TRIALS

Several of the studies the Department reviewed dealt more universally with the costs of covering ancillary treatments to cancer clinical trials. These studies are summarized below.

Institute of Medicine: "Extending Medicare Reimbursement in Clinical Trials"

CMS commissioned the Institute of Medicine to study routine patient care costs for beneficiaries enrolled in covered clinical trial programs. The Committee that studied the issue produced a report, "Extending Medicare Reimbursement in Clinical Trials," recommending, among other things, that Medicare reimburse routine care for patients in clinical trials in the same manner it reimburses routine care for patients not in clinical trials.6 The recommendation applied to clinical trials for any condition, not just cancer, and further advised coverage be provided for treatments as long as reimbursement would be available if the patient were not in a clinical trial. The report also recommended that Medicare not reimburse the costs of experimental intervention.

This report and its conclusions address the fact that many of the associated costs of clinical trials could currently be allowable charges under Medicare. The report went on to comment that, while there could be added administrative costs with covering additional enrollees for clinical trial costs, overall cost increases would be minimal 1) because such costs would be generally equivalent to standard care costs for similar individuals not in a trial, and any increase would be minimal compared to other costs incurred by Medicare, 2) ineffective interventions could be eliminated, saving money in the long term, and 3) because the number of individuals applying for clinical trial coverage would be insignificant in terms of existing costs for the universe of Medicare enrollees. Unfortunately, while anticipating some cost increase for this coverage, the report was not able to quantify this cost.

National Cancer Institute Pilot Studies

The National Cancer Institute (NCI) sponsored three pilot studies that addressed the issue of the cost of patient care for individuals participating in an NCI sponsored clinical trial relative to the cost of patient care for comparable individuals receiving "standard" care for cancer treatment. The three studies were conducted at the Mayo Clinic, Group Health Cooperative of Puget Sound (GHC) and Kaiser Permanente of Northern California (KPNC). The patients analyzed participated in NCI-sponsored phase II and III clinical trials.

The Mayo Clinic study was conducted from 1988-1994 and included sixty-one matched pairs of clinical trial participants and patients receiving standard cancer care. After one year, trial enrollee costs were $24,645 compared to $23,964 for control patients. With data available on some patients for as long as five years, coverage for trial enrollees cost as much as 10% more than for control subjects depending on the follow-up period, which in no case exceeded five years. The mean cumulative five-year cost in 1995 inflation-adjusted U.S. dollars among trial enrollees was $46,424 compared to $44,133 for control patients, which is less than a 5% difference.7

A May, 1999 article, "Incremental Costs of Enrolling Cancer Patients in Clinical Trials: A Population-Based Study" which appeared in the Journal of the National Cancer Institute concluded that the Mayo Clinic study suggested that cancer chemotherapy trials do not necessarily involve "budget-breaking" costs particularly considering that cancer is a high-cost illness.8

The KPNC study took place from 1994-1996 and involved 135 patients enrolled in NCI-sponsored clinical trials with 135 matched control patients. Their goal was to assess the direct cost of medical care for a one-year period. The 135 trial enrollees were enrolled in twenty-two clinical trials for treatments of breast cancer, melanoma, lymphoma and cancers of the colon, lung, kidney, ovary, stomach and brain.9

Ninety percent of the matched pairs were female, including 44% of pairs with enrollees in trials for cancers other than breast cancer. The mean of total medical care costs during the one year period for the patients enrolled in the clinical trial was $17,003, which was 10% more than the $15,516 mean cost for the matched control subjects during the comparable year. The chemotherapy costs for the control patients were 40% higher than for those of the matched patients. Most of the cost difference between the two were attributed to a higher number of chemotherapy visits, although the drug cost differences were reduced due to many of the trial enrollees receiving donated drugs.10

The GHC study involved patients from Southwest Oncology Group for breast and colorectal cancer from 1990-1996. It examined the costs for forty patients in breast cancer clinical trials and twenty-eight patients in colon cancer trials with adjusted comparisons to unmatched control subjects as well as matched analyses of the trial patients for whom well-matched control subjects could be found.11

The forty patients in the breast cancer trials had mean costs equal to or less than the costs for 1100 unmatched control subjects two years following diagnosis. However, the costs for trial patients were 26% higher than those for control subjects in the twenty-six available matched pairs. Matched controls were chosen on the basis of additional automated and chart data on age, date of diagnosis, stage, comorbidity and trial eligibility. Patient cost in the colon cancer trials at the GHC study were slightly more than the unmatched control subjects, but the difference was not statistically significant.12

Association of American Cancer Institutes

The Association of American Cancer Institutes (AACI) conducted a study of costs and charges of NCI-sponsored phase I, II and III clinical trials at fourteen different centers in twelve states and the District of Columbia.

A pilot study matched and evaluated thirty-five pairs of patients from five cancer institutes. The different types and numbers of patients treated were:

twelve for breast cancer;
nine for lung cancer;
eight for colon cancer;
four for lymphoma; and,
two for prostate cancer.

Approximately 56% were treated by only chemotherapy; 19% were treated by high-dose therapy with stem cell rescue and 19% were treated with chemotherapy and radiation. The study groups were evenly matched on the basis of clinical factors. About 25% of the patients had stage III disease at the time of treatment and more than 50% had stage IV disease.13

The total mean charges of treatment (based on 1998 US dollars) for six months of treatment were $57,542 for the clinical trial patients and $63,721 for the control patients. The difference of $6,180, or a 10.7% decrease, while arguably important in terms of coverage cost, was not considered to be statistically significant in terms of statistical analysis.14

AACI is also conducting a larger study of 2,100 patients at fourteen different cancer centers for phase I, II and III clinical trials. Information on that study is not available at this time.

Conclusion

While nowhere near exhaustive (entering "cancer clinical trials" on a Web search engine produced over 70,000 results), the information summarized above gives a fair indication that covering ancillary costs for cancer clinical trials would likely result in an increase in costs and thus an increase in premiums. Whether this increase would be cost prohibitive is difficult to conclude, however, due to the small volume of persons enrolled in such trials.

STATE STUDIES

Of particular interest to the Department was whether other states had produced studies similar to those required by P.A. 91-0406. Specifically two states had similar required studies.

Maryland

Maryland enacted legislation on medical clinical trials in 1998. It required insurers, non-profits and HMOs that provide group or individual accident and health benefits to provide coverage for patient costs to a member in a medical clinical trial. It did not require those entities to include the cost of the investigational drug in the coverage.

The legislation also required the Maryland Insurance Administration (the Insurance Administration) to convene a working group to study and develop a methodology for assessing the economic and clinical impacts of coverage for patient costs in clinical trials.15 It was also to assess any differences in patient care costs and clinical outcomes between patients treated in clinical trials and those not treated in clinical trials. Additionally, it had the flexibility to look at any other issues it chose to review that it considered appropriate.

Significantly, only a few carriers were able to identify any claims that were paid relating to medical clinical trials; nor were carriers able to provide any breakdown between cost of cancer clinical trials and other medical clinical trials. The Insurance Administration concluded carriers were not able to provide adequate proof that adding coverage for medical clinical trials would add substantial cost.16

In Maryland's report for the year 2000 only eleven of ninety-one carriers who reported to the Insurance Administration were able to identify claims being paid for medical clinical trials. For the year 2001 only seven of fifty-four carriers were able to identify such claims. For the years 1999 and 2000 combined, carriers were only able to identify a total of 117 patients involved in medical clinical trials.17

In an effort to be certain insurers were not inappropriately denying claims for medical clinical trials the Insurance Administration reviewed its record of complaints for 1999 and 2000 and only could find one complaint filed regarding a medical clinical trial that had been denied.18

The Insurance Administration concluded the annual medical clinical trial report required by the legislation should be repealed since carriers were not able to adequately identify insureds participating in clinical trials, thus making future reports meaningless.19

Virginia

Virginia, in the1999 legislative session, implemented a mandate of coverage for patient costs incurred during participation in cancer clinical trials. The scope of the legislation, in terms of applicability to insurers, was identical to Maryland. It also excluded coverage for the cost of the investigational drug in the clinical trial.

The Virginia State Corporation Commission (the Commission) is statutorily required to annually issue a report to the Governor and General Assembly on the financial impact of insurance mandates. The Commission's report for the year 2000 was the first report including statistics on cancer clinical trials. Of the 885 companies licensed to issue accident and health, subscription (non-profit) or HMO coverage only fifty-seven were required to file full reports; but only fifty-five provided credible data. Their findings indicated that the premium on group accident and health contracts as a percent of the overall average cost of premium was .41% for single coverage and .47% for family coverage. For individual accident and health those same figures were .85% for single coverage and .78% for family coverage.20

The claims experience statistics the Commission gathered provided the average claim cost per contract. For both individual and group accident and health contracts the figure was .01%. The average percent of total claims statistics for cancer clinical trials was .00% for both group and individual.21 The Commission also reported utilization of services figures, but only included the group insurance statistics. They considered group insurance significantly more reliable than individual for utilization reporting purposes. Their reported statistics for both the average visits and days of confinement per certificate were .00%.22 The report additionally provided statistics on the premium impact as a percent of overall average premium. The impact for individual HMO members was .00% for both single and family coverage. The impact on group HMO members was .20% for single coverage and .21% for family.23 The claims experience, as an average percent of total claims for HMO members, was .00% for individual members and .01% for group.24

Taken as a whole, although these statistics are only for the first year, the Virginia Commission's report does not seem to indicate a significant cost impact for the inclusion of cancer clinical trials in an insurance contract.

Conclusion

The experience reported by Maryland and Virginia suggests that mandatory coverage for treatments associated with cancer clinical trials does not seem to be cost prohibitive.


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SECTION III: METHODOLOGY

In order to obtain the Illinois specific data for the years and information required by P.A. 91-0406, the Department surveyed affected insurers to ascertain their experience with the new mandated offer.

As provided by the Act, (215 ILCS 5/356y), the requirement to offer coverage for investigational cancer treatment applied to: "An insurer that issues, delivers, amends, or renews an individual or group policy of accident and health insurance in this State..." Therefore, every insurer, regardless of whether writing accident and health insurance or property and casualty insurance, having authority to issue accident and health policies in Illinois, was contacted for the Department's survey.

The Department designed the survey to conform to the requirements of 20 ILCS 1405/56.3(a) that stated the survey is to include "...an analysis of the effect of the coverage requirements on the cost of insurance and health care, the results of the treatments to patients, the mortality rate among cancer patients, any improvements in care of patients, and any improvements in the quality of life of patients." Therefore, based on those requirements, the Department asked insurers to provide the following information for the years 2000, 2001 and 2002 in the survey:

  1. The number of policies issued that included the coverage;
  2. The cost of a policy without the coverage;
  3. The cost of a policy with the coverage;
  4. Additional cost of the coverage;
  5. Claims made against the coverage;
  6. Whether there was a change in the mortality rates; and,
  7. Whether there was an improvement in care and the quality of life.

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SECTION IV: ANALYSIS

Over the three-year period from 2000 to 2002, the Department received a total of 1,018 responses. There were generally three types of responses received for the survey. The first type was from companies indicating that the mandate was not applicable due to the type of policies the company sold (usually property and casualty or reinsurance only). The second type of response was from companies indicating they had incorporated the requirements of the statute as a standard benefit in its policies and, therefore, the company was not able to provide specific data to respond to the survey. Finally, responses were received from companies containing data for the survey.

The table below shows the response rate for the survey. It includes the three types of responses the Department received.


2000 2001 2002
TOTAL SURVEYS SENT 1313 1313 1313
TOTAL RESPONSES 1012 1012 989
TOTAL NA* RESPONSES 934 935 1152
TOTAL NR* RESPONSES 33 33 24
TOTAL RESPONSES WITH DATA 45 44 30

*NA-Not applicable responses
*NR-Clinical Trial added as standard benefit

With the information gleaned from insurers in terms of how they incorporated this mandate into their policies, it soon became obvious that there was little commonality in how insurers were able to assess the effect of the mandate in response to Department inquiries.

As noted earlier, a significant percentage of responding insurers affected by the mandate already covered costs for treatment associated with cancer clinical trials prior to the Act going into effect (42.3% in 2000, 42.9% in 2001 and 44.4% in 2002). As such, these insurers had no way to distinguish what affect the Act had on covered persons. Also, as is generally the case, once insurers establish rates, they do not necessarily track specific claims categories to differentiate the costs of specific mandates.

For a large number of the remaining respondents who did not cover the mandate prior to the Act, they too decided to cover costs associated with cancer clinical trials by automatically providing such coverage within all their policies. As with the insurers that covered this benefit prior to the Act, because the benefit was included as a standard benefit, there generally was no way to distinguish specific information for cancer clinical trial claims submissions.

For those companies that covered cancer clinical trials as a standard benefit, the vast majority included the coverage in the existing cost of the policy. Given the overall increasing costs of health care and premiums, along with the historically infrequent use of clinical trials, such a decision is not totally surprising.

For companies that did supplement the coverage by adding additional costs to the premium, the standard premium increase was calculated to be less than 2%. Several companies reported increases of 5%. In two reported instances, companies actually charged less for policies with coverage for treatment associated with cancer clinical trials. In at least one instance however the company offered the coverage as required by the mandate, but the offer was not accepted. As such, the insurer did not proceed with a calculation of costs. Importantly, some companies reported that baseline costs of coverage would also be effected by other demographics such as age, geographic location and actual experience. Costs, in these instances, were usually reported as a range between 1% and 5%.

A few companies were able to provide some information on actual claims experience, but the limited experience provides little on which to base an assessment. One company reported that the few claims it could identify to cover the trial costs were denied as the other requirements of the Act, which set the parameters of covered services, were not met. The company admitted, however that it generally approved coverage for any drug approved by the FDA for chemotherapy. Therefore, the company admitted that it might have covered some investigational treatments without being aware of it because it does not match diagnoses with the types or dosages of drugs. This trend was also previously noted in studies done on such coverage under Medicare. Similarly, one company reported that it had 479 diagnoses for cancer, but that its coding system did not allow it to specifically break out the smaller number of cancer clinical trials from this larger universe of cancer claims.

Two companies were able to specifically identify claims submitted for cancer clinical trials, but even here that information is useful more for anecdotal assessments of why a limited study might not be the best venue for a cost/benefit analysis of mandating such coverage. One company reported one claim paid. One company reported 24 claims paid, but for one person over a one-year period. Again, basing universal conclusions on such a limited survey population could be misleading.

No company was able to provide a response to the questions on change in mortality rates or on any improvement in the care and qualify of life. (One company did estimate that there may have been an improvement in the quality of life of one patient for a short period of time.) Companies' current tracking systems are not programmed to retrieve that type of information and it would be extremely difficult and perhaps subjective to try to determine improvements in care and quality of life. In addition, given the limited time frame and limited number of policies sold, mortality improvements would be nearly impossible to measure.


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SECTION V: CONCLUSION

The literature the Department reviewed does not provide any solid conclusions and it is difficult to assess the costs and affects of such trials given the small percentage of cancer patients involved in such trials. Of course, increasing participation may also entail additional costs that will continue to act as a barrier to participation.

The Department's review of the information as provided in this report, which included a review of each response provided for the survey as well as review of pertinent literature, is unable to add a great deal to the overall body of knowledge on the topic.

Based on the results of our survey it is difficult to estimate the added cost of the coverage given the small number of policies to which the coverage was added. Additionally, given the imbalance of the reporting which skewed the total report based on data provided by only a small percent of companies, and the lack of standardized or defined terms between companies, data submitted provided little basis from which to extract meaningful conclusions.

One could argue that even a 1% increase in premium is significant in terms of contributing to the added cost of coverage. Due to the lack of enough statistical information it is impossible to say that in the long run any premium increase charge would be offset by more effective, cost-efficient cancer treatment regimens that would save lives and reduce the cost of coverage.

Regardless, nothing the Department reviewed indicated the coverage would be cost prohibitive. But the Department's information was limited to the three-year survey period. As such, the Department is unable to make an argument that the cost increase is significant enough to dissuade employer groups and individuals from purchasing coverage or that the cost increase is minimal and therefore would not have a noticeable impact on the overall coverage in the market place.

Overall, the Department believes that for a report to provide conclusive evidence of the benefits derived from and the need to cover standard costs associated with cancer clinical trials, any report should be based on multi-state or national population base and that health assessments resulting from such trials would be more reliable if provided by clinical trial or health professionals or specialists.


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NOTES

1"Executive Summary Report from the Summit on Clinical Trials," in preparation for "The March: Coming Together to Conquer Cancer, September 26, 1998," National Coalition for Cancer Survivorship.

2 "Cancer Clinical Trials: Are They Right for You?" Newsweek, May 2001.

3 "Executive Summary Report from the Summit on Clinical Trials."

4Nathan D. Childs, "Bills Push for Insurers to Cover Cancer Trials," Internal Medicine News, July 1999.

5Henry J. Aaron and Helen Gelband, ed. "Extending Medicare Reimbursement in Clinical Trials," Institute of Medicine, April 2000, p. 63.

6Ibid., p. 55.

7Steven R. Alberts and Steven Cha, "Incremental Costs of Enrolling Cancer Patients in Clinical Trials: a Population-Based Study," Journal of the National Cancer Institute, May 1999, p. 847.

8Ibid.

9Louis Fehrenbacher, Bruce H. Fireman, Elizabeth P. Gruskin and Thomas Ray, "Cost of Care for Patients in Cancer Clinical Trials," Journal of the National Cancer Institute, January 2000, p. 138.

10Ibid., pp. 136, 138.

11Ibid., p. 140.

12Ibid.

13Charles L. Bennett, Thomas N. Chirikos, Jane Hobbs, Donald Leedy, Patrick O'Brien, Marguerite M. Ramsey, et al., "Evaluating the Financial Impact of Clinical Trials in Oncology: Results From a Pilot Study From the Association of American Cancer Institutes/Northwestern University Clinical Trials Costs and Charges Project," Journal of Clinical Oncology, August 2000, p. 2807.

14Ibid.

15Maryland Insurance Administration, "Report on Medical Clinical Trials," July 2001, p. 4.

16Ibid.

17Ibid., p. 22.

18Ibid., p. 23.

19Ibid.

20Annual Report of the Commonwealth of Virginia State Corporation Commission, "The Financial Impact of Mandated Health Insurance Benefits and Providers Pursuant to Section 38.2-3419.1 of the Code of Virginia: 2000 Reporting Period," House Document No.10, 2002, pp. 16,18-20.

21Ibid., pp. 24-25.

22Ibid., p. 27.

23Ibid., p. 35.

24Ibid.


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SELECTED BIBLIOGRAPHY

Aaron, Henry T. and Helen Gelband, ed. "Extending Medicare Reimbursement in Clinical Trials." Institute of Medicine, 3 April 2000.

Alberts, Steven R., Steven Cha, Christopher G. Chute, Priscilla Van Grevenhof, Jill Killian, Jeff Killian, et al. "Incremental Costs of Enrolling Cancer Patients in Clinical Trials: a Population-Based Study." Journal of the National Cancer Institute, Vol. 91, No. 10, 19 May 1999.

Annual Report of the Commonwealth of Virginia State Corporation Commission. "The Financial Impact of Mandated Health Insurance Benefits and Providers Pursuant to Section 38.2-3419.1 of the Code of Virginia. 2000 Reporting Period." House Document No. 10, 2002.

Bennett, Charles L., Thomas N. Chirikos, Jane Hobbs, Donald Leedy, Patrick O'Brien, Marguerite M. Ramsey, et al. "Evaluating the Financial Impact of Clinical Trials in Oncology: Results From a Pilot Study From the Association of American Cancer Institutes/Northwestern University Clinical Trials Costs and Charges Project." Journal of Clinical Oncology, Vol. 18, No 15. August 2000, pp. 2805-2810.

Brown, Martin L., "Cancer Patient Care in Clinical Trials Sponsored by the National Cancer Institute: What Does It Cost?" Journal of the National Cancer Institute. Vol. 91, No. 10. 19 May 1999.

Charles, David M. MD. "Protecting Human Subjects in Research: Are Current Safeguards Adequate?" Written Testimony For: U.S. Senate Commission on Health Education, Labor and Pensions. 23 April 2002.

Childs, Nathan D. "Bills Push for Insurers to Cover Cancer Clinical Trials." Internal Medicine News.1 July 1999.

Coalition of National Cancer Cooperative Groups. "Cancer Clinical Trials: Are They Right for You?" Newsweek. 7 May 2001.

"Executive Summary Report From the Summit on Clinical Trials," in preparation for "The March: Coming Together to Conquer Cancer, September 26, 1998." National Coalition for Cancer Survivorship.

Fehrenbacher, Louis, Fireman, Bruce H., Elizabeth P. Gruskin and G. Thomas Ray, "Cost of Care for Patients in Cancer Clinical Trials." Journal of the National Cancer Institute. Vol. 92, No. 2. 19 January 2000.

"Increasing Participation in Research Trials." Artemis Feature Article. April 2001.

Maryland Insurance Administration. "Report on Medical Clinical Trials." July 2001.

National Cancer Institute. "Clinical Trials Not Costly." Electronic Version, Posted February 9, 2002.]

National Cancer Institute. "Evidence Mounts that Clinical Trials Are Not Costly." Electronic Version, Posted May 20, 2000.

New Jersey Commission on Cancer Research. "What is a Clinical Trial? Excerpts from: What are Clinical Trials All About, National Institutes of Health and National Cancer Institute. " Electronic Version (http://www.nj.gov/health/ccr/clinical.htm) Last Updated 31 March 2003.

"Patients Unaware of Clinical Trials." Artemis Feature Article. March 2001.

Speers, Marjorie A. Written Testimony Before the Committee on Health, Education, Labor, and Pensions Subcommittee on Public Health. U.S. Senate Hearing on Human Subjects Protection. 23 April 2002.