Proponents of the mandates under Senate Bill 39 cite statistics on the prevalence and incidence of prostate and colorectal cancer in Pennsylvania and nationwide to illustrate a need for the benefit. For example, in their submission, "The American Cancer Society estimates that 131,600 cases of colon and rectum cancer will be diagnosed [nationally] in 1998." The Cancer Society further writes that, "[National] Incident rates have declined in recent years from a high of 53 per 100,000 in 1985 to 45 per 100,000 in 1993. Research suggests that the recent decline may be due to increased sigmoidoscopic screening and polyp removal, preventing the progression of polyps to invasive cancers."
Although the submission by the American Cancer Society did not address the number of cases in Pennsylvania, an attachment to their submission estimates that 7,900 cases of colorectal cancer will be diagnosed in Pennsylvania in 1998. Furthermore, it is estimated that colorectal cancer will account for 3,400 deaths in Pennsylvania this year.
According to the submission from Fox Chase Cancer Center, "In 1997, prostate cancer was the leading cancer diagnosed in the Commonwealth of Pennsylvania." The Fox Chase submission also states, "In 1998, [prostate cancer] is estimated to be the leading cancer to be diagnosed among the men of the State with over 10,000 new cases and 2,200 deaths expected this year alone (ACS [American Cancer Society], 1998)."
While it is clear from these statistics that Pennsylvanians suffer from these diseases, proponents provided insufficient information to fully understand the issue of whether the proposed benefits are available to and utilized by the population of the Commonwealth.
In independent research, Council staff found that in the "Behavioral Risk Factor Surveillance Report - 1995" published by the Pennsylvania Department of Health, the percentage of men (age 40 and over) who reported receiving a digital rectal examination in the previous year was 43%. Additionally, 38% of men aged 40 and older reported ever receiving a prostate specific antigen test. The Department of Health also reported that 30% of Pennsylvania's population aged 40 and over reported ever having received a sigmoidoscopy. In evaluating these figures, one should keep in mind that recommendations for screening procedures suggest that they apply to people aged 50 and over, whereas the Department of Health reported on the prevalence of testing in people aged 40 and over.
As the Insurance Federation points out, the issue may not be the lack of insurance coverage, but rather the under utilization of the screening tests. On this issue, the Foundation states that, "Attempts to induce preventive health habits through insurance mandates are ineffective public policy." In a discussion of this issue, the Federation further states, "There is no empirical evidence of which we are aware that mandating commercial health insurance coverage for preventative tests actually induces citizens to take them."
The Federation submission continues, "Further, with respect to detecting the specific conditions which this bill addresses, there is direct evidence of the difficulty of inducing voluntary tests. Every year Aetna U.S. Healthcare sends out a fecal occult blood test kit to policyholders over 50 with directions on sending in a self testing sample for a free analysis. Only 25% of those contacted bother to take the sample and return it for analysis."
According to the Federation, "Reducing cost barriers only does so much, if anything, toward getting men to undergo tests which many would prefer not to take in the first place ... Were there such evidence of changed behavior, it might go far toward convincing insurers that testing coverage mandates can be beneficial."
According to the Highmark submission, "Mandating these benefits does not necessarily mean that more people will seek out the services. Many people elect not to have a sigmoidoscopy, due to their reluctance to have the test performed. In this case, whether or not a benefit is mandated does not necessarily mean that individuals will seek out the testing."
As noted by the Insurance Federation and Highmark, even when these tests are available, utilization may be less than expected. To improve compliance with standards set by groups such as the U.S. Preventive Services Task Force and the Centers for Disease Control and Prevention, education on the benefits of testing and the risks of cancer may be more effective.
The Fox Chase submission states that, "lacking a statewide survey of insurers, it is impossible to determine existing coverage for prostate cancer screening." Additionally, no proponent of the proposed benefits demonstrated that citizens of the Commonwealth were receiving inadequate health care or experiencing financial hardship due to a lack of coverage.
According to the insurance industry, coverage for both prostate cancer screening and colorectal cancer screening is already widespread. The Insurance Federation writes, "Many types of health insurers, particularly health maintenance organizations, already cover these tests so the coverage is to some degree already available." The Insurance Federation continues, "The issue with this prostate and colon cancer testing mandate is not whether health care is inadequate without this mandate or whether most citizens can afford these tests. The primary issue is whether this bill is a very effective approach to induce Pennsylvanians to undergo the tests as part of their regular checkup, etc."
The Insurance Federation's claim of widespread coverage is supported by the submission from the Managed Care Association. The Managed Care Association states that, "HMOs, which provide coverage to approximately 40 percent of the State's population or 4.9 million Pennsylvanians, generally adhere to a set of standard preventive health guidelines issued by organizations such as the American Academy of Family Physicians, the U.S. Preventive Services Task Force or the American Cancer Society. The standards include all the preventive screenings listed in Senate Bill 39." The Association further states, "The preventive measures outlined in the bill are also part of the benefit requirements for HMOs participating in the State's Medical Assistance (MA) program." Council staff notes it is the stated intention of the Department of Public Welfare to move the entire Medical Assistance Program to managed care in the coming years.
Additionally, the Managed Care Association notes that, "For those Medicare beneficiaries enrolled in a traditional Medigap program, the Federal Balanced Budget Act of 1997 incorporated several important changes to Medicare's preventive health coverage:
The Highmark submission states that, "Coverage for the other benefits outlined in Senate Bill 39 - prostate specific antigen (PSA) test, the fecal occult blood test and sigmoidoscopy varies, depending on the Highmark benefit plan. Under Highmark's traditional group and individual coverage and preferred provider organization (PPOs) benefit plans, routine 'diagnostic' exam may be indicated. Diagnostic tests are considered to be an eligible covered service." Highmark also states that, "Highmark health maintenance organizations (HMOs) and point of service (POS) plans provide coverage for certain screening tests, such as the fecal occult blood test and or sigmoidoscopy, if done in accordance with recommended guidelines as outlined by Highmark."
The submission from Blue Cross of Northeastern Pennsylvania demonstrates coverage similar to that of Highmark. Blue Cross of Northeastern Pennsylvania states, "The cancer treatment provisions listed in this bill: ... digital rectal exam, prostate specific antigen (PSA), fecal occult test, are all covered benefits under our health maintenance organization." Their submission also states, "Under traditional coverage ... for the asymptomatic patient, there would be no coverage for periodic screening examinations ... However, our experience rated groups can purchase preventive testing on an optional basis."
Overall, we found that many Pennsylvanians currently have access to screening through private insurance and government sponsored programs, such as Medicare and Medical Assistance. It should be noted, however, that the Council received insufficient information to determine the precise percentage of Pennsylvanians who already have coverage. We also recognize that, for a variety of reasons, compliance with suggested screening procedures is not fully utilized when available.
The Council recognizes the number of people with prostate cancer and colorectal cancer in Pennsylvania and the burden of suffering which these people and their families experience. In the submissions received, however, we cannot be certain that mandating these benefits would have brought about different results; nor did we receive sufficient information to determine whether those Pennsylvanians with these diseases experience undue financial burden because of coverage issues.
The number of submissions supporting the benefits in Senate Bill 39 were minimal, which may suggest that public demand for these benefits is limited.
Fox Chase, however, claimed that, "there is public outcry for screening benefits." While Fox Chase provides information on the number of men affected by prostate cancer, their submission does not document specific support from the general population of Pennsylvania.
The American Cancer Society submitted information in support of colorectal cancer screening. This group did not address the issue of prostate cancer screening. The Council finds the American Cancer Society's lack of information on prostate cancer screening coverage in its submission to be significant in light of the many recommendations against widespread screening of asymptotic men.
Among the recommendations against universal screening for prostate cancer are those of the U.S. Preventive Services Task Force, the Centers for Disease Control and Prevention (which support the recommendation of the U.S. Preventive Services Task Force), and the American College of Physicians. In addition, the Council notes that the National Cancer Institute issued a report which stated, "There is insufficient evidence to establish whether a decrease in mortality from prostate cancer occurs with screening by digital rectal examination, transrectal ultrasound, or serum markers including prostate-specific antigen."
The Insurance Federation writes, "There does not appear to be any specific public focus of mandating the coverage of these particular tests." This statement appears to be supported by the minimal information the Council received in support of the screening benefits.
At the same time, the opposition to Senate Bill 39 appears to be limited. Although not endorsing the bill, the Insurance Federation of Pennsylvania writes that it "does not object to the Health Care Cost Containment Council approving the captioned bill [Senate Bill 39]." Furthermore, while opponents discussed the impact of cumulative mandates, they only briefly discussed the specific mandates proposed under Senate Bill 39.
According to the Managed Care Association, health maintenance organizations encourage preventive screening and services. "The Managed Care Association thereby supports the intent of Senate Bill 39. The Association has three general concerns, however, with legislating medical practice:
The Managed Care Association further identifies the following concerns specific to Senate Bill 39.
Highmark also discusses the opposition to mandates. "Insurers and employers who pay health insurance premiums are generally opposed to mandated benefits because they have a tendency to increase health insurance costs. A recent study conducted by the U.S. Department of Health and Human Services' Agency for Health Care Policy and Research indicates that even when employers offer health insurance to their employees, an increasing number of employees decline the coverage (Cooper, 1997). Between 1987 and 1996, the number of workers declining coverage jumped by 140 percent. One of the reasons given is that state mandates increase insurance costs." An article submitted by Highmark further states, "The past ten years also have been a time of profound change in health insurance markets. Many states have adopted legislation that mandated specific types of insurance benefits, allowed for purchasing alliances designed to spread risk across larger populations, and enacted small-group market reforms to increase the availability (and, in some states, control the cost) of health insurance for persons working in small firms. Much of this legislation was designed to enhance insurance coverage and improve health plan generosity, but it may have contributed to the rise in health insurance costs."
Highmark also writes, "Another study conducted by Milliman and Robertson ... estimates that the cost of 12 of the most common mandates can increase the cost of health insurance by as much as 30 percent. (National Center for Policy Analysis, 1997) This represents an increase in costs of between $525 to $1,050 [per year]. Although cancer screening is not one of the 12 most common mandates, it would further increase costs for employers and ultimately employees. The Pennsylvania General Assembly has already enacted six of the 12 most common mandates and the two most expensive mandates have also been referred to the Pennsylvania Health Care Cost Containment Council for review."
Highmark also cites a report by the Pennsylvania Economy League and states, "Another point to be made about limiting the number of mandated benefits is the fact that the Commonwealth of Pennsylvania, compared with surrounding states, stacks up well in the relative cost of health care. According to a recent study conducted by the Pennsylvania Economy League for the Pennsylvania Coalition for Quality Health Care, the 'cost of health care is comparatively low for Pennsylvania employers.' The study goes further by stating, 'Added costs through legislative regulation will erode Pennsylvania's comparative position in competition for new jobs and retaining existing employment. Increased health care costs could turn one of Pennsylvania's competitive advantages into one more negative factor in Pennsylvania's business climate, a climate many people feel is noncompetitive in many aspects.' Mandated benefits such as those contained in Senate Bill 39 may add to this dilemma."
The general opposition to mandates is also apparent in the submission by the Insurance Federation. They note, "The further away insurance gets from spreading the risk of truly random events and the closer it gets to being a funding vehicle, the less efficient it is. Consequently, the mandated coverage of nonrandom, individually scheduled health tests is of questionable efficiency."
According to the Federation, "One simply cannot gauge the impact of these bills without taking into account a variety of economic factors. The tradeoffs of the dollars committed to covering these tests, even if they succeed in their object to some degree, are nevertheless difficult. As an example, the Pennsylvania Chamber of Business and Industry notes that 'Pennsylvania employers pay more than $10 billion in health care premiums annually. Any 1% increase in the cost of health care translates to a $100 million increase in the cost of business in the commonwealth.' Chamber, The Sentinel, May 15, 1998, page one."
Some opponents note that the medical community has conflicting opinions on the effectiveness of screening for prostate cancer. The submission from the Managed Care Association notes that, "the medical community has differing opinions as to the appropriateness and timing of PSA [prostate specific antigen] screening and digital rectal exams as illustrated by the following from nationally recognized organizations:
The Council notes the above recommendations of the American Cancer Society were not included in their submission to the Council.
Highmark also notes the differing opinions in the medical community and states that, "There appear to be several discrepancies within the medical community on the need and frequency of screening."
Although the Council received submissions supporting the benefit, the information did not identify the specific demand for the proposed benefit from the public.
While there was no strong opposition to Senate Bill 39 in particular, the Council found opposition to mandated benefits in general.
In their submission, Fox Chase states, "Multiple studies have documented the fact that African American males have the highest incidence of prostate cancer in the world. The National Cancer Institutes Surveillance, Epidemiology, and End Results (SEER) study indicates that the age-adjusted prostate cancer mortality rate for black men has been approximately twice that of white men, and that black men had a lower 5-year survival rate (62%) when compared to white men (75%). These findings were attributed to limited health care access among black men resulting in the detection of prostate cancer at a later (more costly to treat) stage (NIH Publication, 1990)."
Other submissions, however, suggest that access to screening procedures may be adequate, but simply underutilized. As previously mentioned, the Insurance Federation writes that, "attempts to induce preventative health habits through insurance mandates are ineffective public policy."
The Highmark submission recognizes that, "The types of cancer referenced in Senate Bill 39 account for over 146,000 deaths per year [nationally]." The Highmark submission further states, "However, screening for these types of cancer is not a panacea and will not eradicate the disease or decrease the number of people getting the disease. The most important factor that can be stressed is lifestyle change." "Although screening may detect cancers earlier, lifestyle changes may decrease the incidence of cancer being found at all."
While the social impact of cancer is relatively clear, the impact of a lack of a mandate for cancer screening coverage is not as clear. Many insurers, in particular health maintenance organizations and Medicare, already provide coverage for screening procedures in asymptomatic men. Other insurers, including traditional indemnity plans such as Highmark and Blue Cross of Northeastern Pennsylvania, currently provide coverage for diagnostic procedures when symptoms or risk factors are present. Even without a mandate, coverage appears to be widespread. Therefore, the lack of a mandate for prostate and colorectal cancer screening does not appear to have a negative social impact.
The Council does not consider the screening procedures proposed under Senate Bill 39 to be a type of therapy. Submissions received by the Council, however, noted the following information in response to this requirement.
In their submission, Fox Chase states, "Preliminary results of a Canadian study on prostate cancer screening made international news on May 18, 1998, when researchers at the American Society of Clinical Oncology annual meeting announced that screening for prostate cancer specific antigen can reduce the death rate due to prostate cancer by 69%. In the long-term study that began in 1988, researchers invited half of 46,289 men aged 45 to 80 years living in the Quebec City area to be screened for prostate specific antigen (PSA), a blood protein that increases with benign conditions, such as enlarged prostate, and with prostate cancer. A total of 8,137 men came in for screening, and if their PSA result was 3.0 nanograms per milliliter of blood, or there was an increase of more than 20% in their PSA in one year, the men had digital rectal examinations and transrectal ultrasound to look for cancer. In the group of 38,056 unscreened men, there were 137 deaths due to prostate cancer, compared with just 5 prostate cancer deaths among the men who were screened."
There are two concerns with the study cited by Fox Chase. The first is the design of the study. In a submission from the Managed Care Association, "urologists now tend to call this [type of study] case finding. It certainly isn't screening. The test is not being given at random because the men have selected themselves." Council staff located an article from the Wall Street Journal discussing the same Canadian study. The Journal article states, "Other researchers criticized the study because about 23,000 of those invited [for screening] decided not to participate, leaving behind a group that could have been skewed toward more health conscious men, less likely to be at risk from factors such as smoking or bad diet."
Fox Chase further writes, "Clinical trials assessing the impact of prostate cancer screening on morbidity and mortality are underway." The Council believes Fox Chase is referring to the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial, organized by the National Cancer Institute. This trial is a two-armed randomized clinical trial of 16 years duration involving 74,000 females and 74,000 males aged 55-74 at entry; the trial began in 1992, suggesting the data will not be available until after the year 2000.
This requirement is not relevant to the discussion of the mandates proposed under Senate Bill 39.
The submission from Highmark contains the recommendations of the U.S. Preventive Services Task Force for both colorectal cancer screening and prostate cancer screening. For everyone age 50 and above, the [U.S. Preventive Services] Task Force recommends colorectal cancer screening with sigmoidoscopy, annual fecal occult blood testing, or both. The best interval between sigmoidoscopic exams is not established; a 10-year interval may be adequate." The Preventive Services Task Force notes that, "Colorectal cancer causes 55,000 deaths each year and is the second most common form of cancer in the United States. Routine screening with fecal occult blood tests or sigmoidoscopy could reduce mortality by more than one-third."
In terms of prostate cancer screening, "The 1995 Guide [of the U.S. Preventive Services Task Force] does not recommend routine screening of asymptomatic men for prostate cancer by measurement of prostate-specific antigen (PSA) or performance of digital rectal examination (DRE). If clinicians choose to offer screening to individual patients, they should target men with a life expectancy of at least 10 years, explain the potential risks and benefits of screening and treatment, and let patients decide whether or not to undergo screening."
Highmark also submitted several articles which addressed the medical consequences of prostate cancer screening. One article states, "The essential reason that [prostate cancer] screening cannot be justified at present is because ... there is currently no information about the impact of screening on prostate cancer mortality. This does not mean that screening for prostate cancer will not ultimately prove to reduce mortality. It means instead that the information is not yet available, and without it, recommendations in favor of [prostate cancer] screening would be inappropriate."
The article continues, "The debate over screening is not new. Over the past several years, the controversy has been evaluated in consensus conferences in Sweden, Canada, France, by a U.S. Task Force, and by the International Union Against Cancer. In each case, the conclusion was that routine screening should not be recommended because there is insufficient data to prove a benefit. This conclusion is not uniform, however. Both the American Cancer Society and the American Urological Society have recommended screening. This apparent paradox is not based on scientific information but rather on the belief and hope that screening is the best thing to do to reduce mortality from the disease. Although this may prove to be true, it does present a practical dilemma for physicians and for their male population who want to follow medical recommendations." "In summary, screening for prostate cancer is a complex problem. Unfortunately, the debate will not be readily resolved until proper studies have been completed. Until that time, unbalanced recommendations to screen which are based on personal biases rather than scientific fact are not in the public's best interest, and it is the medical community rather than the male population that is deriving the greatest benefit. Sending a more balanced message that includes the risks as well as the benefits of screening and treatment is in everyone's best interest."
Another article submitted by Highmark addresses the aspect of prostate cancer screening from a public health perspective. It states, "The appropriateness of adopting a new screening policy depends on the burden of suffering from the disease, and on the effectiveness, potential harms and cost of screening. Prostate cancer clearly satisfies the first requirement, but the relationship among its benefits, harms and costs is uncertain due to lack of data. Available screening tests (for example prostate specific antigen) can detect early stage disease but there is no evidence that clinical outcomes are improved by early detection." The author contends that while the burden of suffering may be great, it is "insufficient grounds for screening. There must also be evidence that the intervention is effective in lessening the burden of suffering."
The author continues, "Physicians and medical groups that advocate screening tests or any other form of costly technology can no longer do so simply because they 'think it is a good idea.' They must be prepared to defend their recommendations with an explicit analytical rationale that addresses the potential benefits and harms, and a clear accounting of the evidence on which those assumptions are based." "There is another reason for adhering to the science. Recommendations for screening in the absence of an explicit rationale raise concerns about conflicts of interest, especially when the downstream effects of the recommendations include increased income for the group promoting screening. It is a common paradox in the development of practice guidelines that the experts who know the most about a topic are often in specialties or enterprises that benefit from the recommended procedure. It is essential that this concern be kept in mind with prostate cancer screening, which in the recent past has been the subject of news reports about conflicts of interest (Wall Street Journal, February 16, 1993, page B1, and New York Times, June 23, 1993, page C12). These reports have focussed attention on the role of specific speculates, clinical laboratories, pharmaceutical companies and product manufacturers in promoting prostate cancer screening. The best way to counter speculation that such guidelines are self-serving is to build the argument for screening on sound public health arguments and an explicit scientific rationale."
The article concludes by stating, "Measured against the [four] criteria outlined in this article, the case for prostate cancer screening seems weak: 1) the burden of suffering is great, 2) the screening tests may be sensitive but there is no evidence that early detection improves health outcomes, 3) possible harms to the screened population are potentially great, leaving the question unresolved whether screening results in more good than harm and 4) the effort would be costly at a time when available resources are increasingly limited. Groups that use explicit criteria to develop evidence based practice guidelines (for example United State Preventive Services Task Force, American College of Physicians, and Canadian Task Force on the Periodic Health Examination) have, therefore, recommended against routine PSA [prostate specific antigen] screening for prostate cancer. The National Cancer Institute also does not recommend PSA [prostate specific antigen] screening."
In the Highmark submission, a document from the American Cancer Society states, "There is not yet conclusive evidence that early detection can reduce prostate cancer mortality, an issue being studied in an ongoing trial sponsored by the National Cancer Institute. At the same time, the potential adverse consequences of widespread screening are important, especially in men over age 70: frequent false-positive results, unnecessary prostate biopsies, and harms from aggressive treatments for indolent cancer that may never have caused symptoms in a patient's lifetime."
Highmark's submission also addressed the issue of colorectal cancer screening. Attached to their submission was a study performed by the U.S. Office of Technology Assessment entitled, "Cost-Effectiveness of Colorectal Cancer Screening in Average-Risk Adults." This study states that, "A lifetime schedule of colorectal cancer screening beginning at age 50 requires a net lifetime investment whose present [1995] value is roughly $400 to $1300 per person entering the screening program, depending on both the polyp dwell time and the specific screening strategy adopted. Strategies involving either FSIG [flexible sigmoidoscopy] or DCBE [double contrast barium enema] alone require a lifetime investment whose present [1995] value is between $400 and $700 per person screened. For that investment, the population would reap gains in life expectancy on the order of roughly [one] week to [one] month per person screened. Although this gain in statistical life expectancy appears small, in the real world, the benefits would be concentrated in the roughly 6 percent of 50-year-old Americans who, in the absence of screening, are destined to suffer from colorectal cancer at some time in their life." "Thus, if OTA's [Office of Technology Assessment's] model is a reasonable approximation of the natural history of CRC [colorectal cancer] and the accuracy and costs of the screening interventions, the implication for CRC [colorectal cancer] screening guidelines are clear: CRC [colorectal cancer] screening in average-risk adults beginning at age 50 is a relatively good investment for society."
Colorectal cancer screening was also addressed by the Managed Care Association. As an attachment to their submission, the Managed Care Association included a summary of colorectal cancer screening provided by the U.S. Department of Health and Human Services' Agency for Health Care Policy and Research. This article states, "There is a lack of consensus concerning the choice of screening and surveillance tests, the appropriate screening and surveillance intervals ... " The Agency continues, "the significant findings set forth in this evidence report can be summarized as follows:
Council staff research found that the National Cancer Institute cites several studies demonstrating the effectiveness of colorectal cancer screening. The success of fecal occult blood testing is demonstrated in the following trials which involved over 250,000 people in three countries. A Minnesota trial demonstrated decreased mortality from colorectal cancer of 33% through annual fecal occult blood testing. A British trial demonstrated an 18% drop in the colorectal cancer mortality rate using biennial fecal occult blood testing. Another trial in Denmark demonstrated an 18% reduction in colorectal cancer mortality using biennial fecal occult blood testing.
The National Cancer Institute also cites two case-control studies evaluating the efficacy of sigmoidoscopy screening for colorectal cancer. Both studies were conducted by health plans and both suggested a significantly decreased risk (60% to 80%) of fatal colorectal cancer among people with a history of one or more sigmoidoscopic examinations over those with no history of such an exam. However, neither study addressed the issue of frequency of sigmoidoscopic exams.
The Council recognizes that several international studies have demonstrated a connection between screening for colorectal cancer through the use of the fecal occult blood test. Furthermore, there is a wide consensus in the medical community that screening for colorectal cancer is medically effective and generally considered to be a good thing. The Council is concerned, however, about the possibility of mandating insurers to cover procedures for prostate cancer screening which have not been definitively shown to have an impact on morbidity or mortality.
Submissions did not provide sufficient information addressing this issue. The only two submissions which addressed this issue were those from the Managed Care Association and Highmark.
Although failing to discuss the issue specifically, the Managed Care Association submission states, "Mandating that all men in a particular age range receive the screenings would have cost impacts. Examples of the costs for specific screening tests include:
According to the Highmark submission, "Highmark actuaries estimate that the cost of providing this benefit would increase our annual claims expense by approximately $800,000 to $1.5 million. While this may not appear to be a significant increase to some, when you consider the cost of Pennsylvania mandated benefits in cumulative terms, Highmark customers have had to absorb millions of dollars in additional premiums that they otherwise would not have to pay if they were given the opportunity to select only those benefit options of their choosing." While this information was helpful, it was specific only to Highmark's costs, not on costs throughout the Commonwealth.
It should also be noted that although the Fox Chase submission did not deal directly with this issue, their submission states, "Prostate cancer testing is cost effective. A study comparing costs of prostate cancer testing (DRE & PSA) with Medicare costs for breast cancer screening tests (mammography) found that the combined costs of a DRE and PSA were $35 whereas breast cancer testing was $58."
According to the American Foundation for Urologic Disease and Highmark, there are 14 states and the District of Columbia which mandate coverage for prostate cancer screening. These states are: Alaska, Colorado, Delaware, Georgia, Illinois, Louisiana, Maryland, Minnesota, New Jersey, North Carolina, North Dakota, Tennessee, Texas, and West Virginia. Additionally, a similar proposal is pending in Virginia.
The only information submitted concerning the financial impact of similar legislation in other states was a fiscal note for Maryland House Bill 1040. This fiscal note was written before the benefit was mandated and discussed only the expected impact on state expenditures as part of the employee benefit health plan. According to the Maryland Department of Fiscal Services, the estimated cost for covering state employees enrolled in the State employee benefit health plans for FY 1998 was $314,000. Under the proposition, Medicaid would not be affected because the Medicaid program reimburses providers only for medically necessary tests, not diagnostic tests such as these. There is no analysis of the cost impact to small businesses. The fiscal note mentions that less than 36% of Maryland residents will be affected by the mandate. The financial analysis also noted that due to a state tax on insurance premiums, general fund revenues in Maryland were expected to increase by an indeterminate minimal amount due to an increase in the cost of insurance resulting from enactment of the prostate cancer screening mandate.
When Council staff contacted the Maryland Insurance Administration requesting additional information about the cost impact of the prostate cancer mandate, they were told no such information was available.
No information was submitted concerning other states which mandate coverage for colorectal cancer screening. In conducting independent research, Council staff was unable to learn of any states which mandate coverage for colorectal cancer screening. In addition, the National Conference of State Legislatures does not know of any states with a similar mandate.
The issue of increased utilization is really at the center of debate for Senate Bill 39. According to the Insurance Federation, "There is no empirical evidence of which we are aware that mandating commercial health insurance coverage for preventative tests actually induces citizens to take them."
The Federation continues, "Further, with respect to detecting the specific conditions which this bill addresses, there is direct evidence of the difficulty of inducing voluntary tests. Every year Aetna U.S. Healthcare sends out a fecal occult blood test kit to policyholders over 50 with directions on sending in a self testing sample for a free analysis. Only 25% of those contacts bother to take the sample and return it for analysis."
According to the Federation, "Reducing cost barriers only does so much, if anything, toward getting men to undergo tests which many would prefer not to take in the first place ... Were there such evidence of changed behavior, it might go far toward convincing insurers that testing coverage mandates can be beneficial."
Council suggests that utilization of these tests might improve with increased education about the risks of colorectal cancer and the risks and benefits of screening for prostate cancer.
The only submission addressing this issue was that of Highmark which states, "Highmark Inc. actuaries estimate that the increase in administrative expenses as a result of enactment of Senate Bill 39 will be minimal, based on the estimated annual increase of $800,000 to $1.5 million."
According to the Highmark submission, "Whenever a benefit is added to an insurance product, the cost will increase in part due to increased utilization. These costs are then passed onto customers, primarily employers, labor groups, and individuals." The Council notes, however, that both Highmark and the Insurance Federation propose that mandating coverage of benefits does not in itself increase utilization. If one believes that mandating coverage for the proposed screening procedures does not induce people to use the services, (i.e., that utilization will not increase significantly with a mandate) then one must assume that costs will not increase significantly with enactment of such a mandate. Ultimately, if the incremental increase in utilization is relatively small, the resulting incremental increase in costs should also be small.
The Insurance Federation states that, "however important these tests are, they may not be appropriate for a given purchasing group or they may not be among the essential benefits which are all that the purchasers can afford."
The Insurance Federation supports this point by citing an article from the Pennsylvania Chamber of Business and Industry which notes that, "Pennsylvania employers pay more than $10 billion in health care premiums annually. Any 1% increase in the cost of health care translates to a $100 million increase in the cost of business in the Commonwealth" (Chamber, The Sentinel, May 15, 1998). Therefore, even though the costs may appear to be minimal, they may still have a profound impact on the cost of business and the number of people with health insurance.
The Fox Chase submission addressed the possible cost to purchasers of the prostate cancer segment of the benefits. The Fox Chase submission states, "We have no direct data for the analysis of cost increase to purchasers on a mandated prostate cancer screening benefit." Fox Chase, however, extrapolates the data on mandated coverage for mammography screening and concludes, "it stands to reason that the insurance cost increase from a prostate cancer screening mandate would also be less than 1% or less than $35." Supporters did not discuss the impact which benefits for colorectal cancer screening would have on the cost to purchasers.
Combining the above statements from the Insurance Federation and Fox Chase illustrates the impact that even a small increase in health care costs could have for Pennsylvanians. As suggested by Fox Chase, the insurance cost increase from enactment of a prostate cancer screening mandate is less than 1%, which to the outside observer seems insignificant. If, however, as the Insurance Federation suggests, a 1% increase in the cost of health care translates into a $100 million increase in the cost of business in Pennsylvania, the enactment of the prostate cancer screening mandate could raise the cost of business by $100 million. One should keep in mind that this increase is only for the proposed prostate cancer screening benefits.
In their submission, Highmark writes, "Another study conducted by Milliman and Robertson ... estimates that the cost of 12 of the most common mandates can increase the cost of health insurance by as much as 30 percent. (National Center for Policy Analysis, 1997) This represents an increase in costs of between $525 to $1,050 [per year]. Although cancer screening is not one of the 12 most common mandates, it would further increase costs for employers and ultimately employees. The Pennsylvania General Assembly has already enacted six of the 12 most common mandates and the two most expensive mandates have also been referred to the Pennsylvania Health Care Cost Containment Council for review."
Highmark also references an article stating the impact mandates have on business (The Record of the Society of Actuaries):
It is again important to note a study referenced in the Highmark submission. Highmark states, "Another point to be made about limiting the number of mandated benefits is the fact that the Commonwealth of Pennsylvania, compared with surrounding states, stacks up well in the relative cost of health care. According to a recent study conducted by the Pennsylvania Economy League for the Pennsylvania Coalition for Quality Health Care, the 'cost of health care is comparatively low for Pennsylvania employers.' The study goes further by stating 'Added costs through legislative regulation will erode Pennsylvania's comparative position in competition for new jobs and retaining existing employment. Increase health care costs could turn one of Pennsylvania's competitive advantages into one more negative factor in Pennsylvania's business climate, a climate many people feel is noncompetitive in many aspects.' Mandated benefits such as those contained in Senate Bill 39 may add to this dilemma."
The American Cancer Society states in their submission, "According to research published in Gastroenterology [1997], screening for colorectal cancer in average-risk people (starting at age 50; stopping at age 85) is within the range of cost-effectiveness commonly accepted for other screening tests. All strategies they analyzed cost less than $20,000 per year of life saved. Years of life saved by screening a population of 100,000 varies from approximately 8,000 to 14,000 years, depending on the screening strategy."
Fox Chase writes in their submission that, "the cost of treating early stage prostate cancer is approximately $20,000 vs. $50,000 for late stage disease (Benoit & Naslund, 1994)." Further they contend that, "the cost per life year saved by screening with both DRE and PSA was $2,339 to $3,005 for men age 50 to 69; $3,822 to $4,956 when only the PSA was used for men age 50 to 70." They compare these ranges to other accepted screening programs including mammography ($27,273 to $55,887). Although referencing these figures, neither Fox Chase nor the American Cancer Society sufficiently addressed the impact on the total cost of health care.
In their submission, "The Insurance Federation believes that the overall financial impact of the bill will be de mimimis. This is an admittedly speculative conclusion, but one inferred from the fact that many insurers cover these procedures currently." The Federation also writes, "The net economic benefit to the overall system is probably nil because the cost of additional procedures should be offset by savings drawn from early detection."
Cost estimates calculated by Council staff support this statement by the Insurance Federation. Based on assumptions about current coverage, expected utilization rates, the cost of procedures, etc., Council staff estimated that the proposed coverage for colorectal cancer screening may cost between $7.2 million and $10.9 million annually. Proponents hope that with an increase in early detection, a higher percentage of cancers will be found at an early stage, which is less expensive to treat than later stage cancers. If the percentage of colorectal cancer diagnosed at an early stage increased from 37 percent to 50 percent, the total cost of treating colorectal may be reduced by $10 million, thereby offsetting the possible increase in costs due to additional screening.
The Council once again notes that if the expected increase in utilization is minimal, the associated costs will also be minimal. If there is only a small increase in utilization, the increase in costs should also be relatively small.
Insurers do not appear to be as concerned about the cost of this particular mandate as they are about the cumulative cost of all mandates imposed. As previously stated, state-mandated benefits have been linked to the rising costs of health care and likelihood that purchasers of health insurance may be adversely affected. The Insurance Federation states, "One simply cannot gauge the impact of these bills without taking into account a variety of economic factors. The tradeoffs of the dollars committed to covering these tests, even if they succeed in their object to some degree, are nevertheless difficult."
In closing, it is relevant to reference the submission by the Insurance Federation which states, "Since we do not know the exact cost of this bill, we cannot quantify the effect of it on health care costs and hence judge its effect of the competitiveness of Pennsylvania. More to the point, how many small groups and individuals get priced out of the health insurance market for every 1% increase in the cost of policies? This is the problem with mandated benefits: they are also mandated cost increase. The legislators who sponsor them never propose to pay for the costs of the new benefits by dropping required coverage of services of equivalent cost. Consequently, the tradeoffs get determined, not by the market forces of supply and demand and product design, but rather by legislative fiat."
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