HEALTH VALUE = Quality/cost

Quality , in this context, reflects the Institute of Medicine’s 6 Aims for health care, which focus on safety, timeliness, effectiveness, efficacy, and equitable patient-centered care. Cost can be defined at a patient (episode cost) or population level.

In 1998, colonoscopy became a covered benefit for Medicare patients when used for colorectal cancer (CRC) screening. Medicare coverage spurred commercial health plans to implement a similar benefit and by now colonoscopy has become the community standard for CRC screening and is most frequently advocated in both scientific and lay press.

A screening test, by definition, is recommended for a large segment of the population that shows no signs or symptoms of the condition in question. As such, the test must be effective, safe, resource efficient, and widely available. Of all tests included in the US Preventative Services Task Force (USPSTF) Guide to Adult Clinical Preventive Services , colonoscopy is the most invasive, expensive, and dangerous. When gastroenterologists led the effort to have screening colonoscopy covered, collectively we made an implicit promise to maximize its health value and build infrastructure needed to provide it.

As of 2010, between 10 and 12 million patients undergo colonoscopy annually in the United States and the 10,000 board-certified, community-based gastroenterologists currently practicing perform most of the examinations. Therefore, it is essential that we try and determine if the value of these examinations has been pushed to their maximal extent. This article discusses the value of community-based colonoscopy, a term that includes both quality and cost.

Historical considerations of screening colonoscopy

Scientific evidence supporting the effectiveness of colonoscopy to reduce CRC came from the National Polyp Study (NPS) published in 1993. The authors concluded that a high-quality colonoscopy that cleared the colon of all neoplastic lesions would reduce risk of CRC by 76% to 90%, with subsequent analysis suggesting an effect sustained for at least 10 years. Based on these findings and several smaller, feasibility studies, the Health Care Financing Administration (HCFA, subsequently known as the Center for Medicare and Medicaid [CMS]) elected to cover colonoscopy for average-risk beneficiaries. Subsequently, USPSTF gave CRC screening (including colonoscopy) a Grade A recommendation.

Once scientific evidence exists to support a population-based screening test, a cost-benefit ratio is calculated and compared with other interventions that are covered benefits. Screening tests were often compared with the cost (per year of life saved) of renal dialysis, which the government had agreed to cover under Public Law 92-603 in 1972. In 1998, the cost per year of life saved by colonoscopy screening was estimated to be about $15,000, less than that of dialysis and breast cancer screening, for example. In 2000, Sonnenberg and colleagues concluded, “Colonoscopy represents a cost-effective means of screening for colorectal cancer because it reduces mortality at relatively low incremental costs.” Recently, Zauber and colleagues published a decision analysis of multiple CRC screening strategies for the USPSTF and an updated cost-effectiveness analysis for the Agency for Health care Research and Quality.

It is important to review the underlying assumptions of these publications because they reflect the generally accepted cost benefit for colonoscopy. Sonnenberg’s cost-effectiveness analysis assumed a 75% reduction in CRC risk with colonoscopy at a per-procedure cost of $681 for a screening examination (45,378) and $1000 for a colonoscopy that included polypectomy (45,385). Sensitivity analysis revealed that a reduction in efficacy of colonoscopy to 60% doubled the overall cost. Zauber’s analyses concluded that colonoscopy was the most effective screening test based on a 95% sensitivity of colonoscopy for advanced polyps and cancer with a per-procedure cost of $800 for 45,378 and $1000 for 45,385.

Historical considerations of screening colonoscopy

Scientific evidence supporting the effectiveness of colonoscopy to reduce CRC came from the National Polyp Study (NPS) published in 1993. The authors concluded that a high-quality colonoscopy that cleared the colon of all neoplastic lesions would reduce risk of CRC by 76% to 90%, with subsequent analysis suggesting an effect sustained for at least 10 years. Based on these findings and several smaller, feasibility studies, the Health Care Financing Administration (HCFA, subsequently known as the Center for Medicare and Medicaid [CMS]) elected to cover colonoscopy for average-risk beneficiaries. Subsequently, USPSTF gave CRC screening (including colonoscopy) a Grade A recommendation.

Once scientific evidence exists to support a population-based screening test, a cost-benefit ratio is calculated and compared with other interventions that are covered benefits. Screening tests were often compared with the cost (per year of life saved) of renal dialysis, which the government had agreed to cover under Public Law 92-603 in 1972. In 1998, the cost per year of life saved by colonoscopy screening was estimated to be about $15,000, less than that of dialysis and breast cancer screening, for example. In 2000, Sonnenberg and colleagues concluded, “Colonoscopy represents a cost-effective means of screening for colorectal cancer because it reduces mortality at relatively low incremental costs.” Recently, Zauber and colleagues published a decision analysis of multiple CRC screening strategies for the USPSTF and an updated cost-effectiveness analysis for the Agency for Health care Research and Quality.

It is important to review the underlying assumptions of these publications because they reflect the generally accepted cost benefit for colonoscopy. Sonnenberg’s cost-effectiveness analysis assumed a 75% reduction in CRC risk with colonoscopy at a per-procedure cost of $681 for a screening examination (45,378) and $1000 for a colonoscopy that included polypectomy (45,385). Sensitivity analysis revealed that a reduction in efficacy of colonoscopy to 60% doubled the overall cost. Zauber’s analyses concluded that colonoscopy was the most effective screening test based on a 95% sensitivity of colonoscopy for advanced polyps and cancer with a per-procedure cost of $800 for 45,378 and $1000 for 45,385.

Quality issues for colonoscopy in 2010

Since these original estimates, several changes have occurred that affect the value of colonoscopy. There is clear evidence that the quality of colonoscopy examinations in the general community is variable, many practices (both primary care and specialists) do not follow evidence-based screening and surveillance guidelines (leading to both overuse and underuse), colonoscopy’s CRC risk reduction appears to be less than originally thought, and the total cost of CRC screening has increased substantially. Each of these points are discussed further.

Recent publications have brought into question the effectiveness of community-based colonoscopy as a CRC prevention modality likely because training and credentialing of community endoscopists varies and quality is generally not monitored. One large, retrospective outcome study suggested that colonoscopy provides a risk reduction of approximately 65% and most (if not all) of the effect applies to left-sided cancers. Although this study has methodological weaknesses, findings suggest that NPS conclusions were either overly optimistic or that community-based physicians do not generate results that match NPS investigators. Factors known to compromise efficacy include missed prevalent cancers (incomplete examinations or true visual misses), missed proximal precancerous polyps (which tend to grow in a sessile or flat configuration), underestimation of the cancer potential of proximal serrated lesions (usually by the pathologist), microsatellite instable polyps that are difficult to resect fully and tend to grow rapidly, small flat adenomas, rapid examination times, and a variety of other factors.

Miss rates for CRC among endoscopists vary 10-fold from 0.5% to 5.0% and from 6% to 18% for adenomas greater than 5 mm. Barclay and colleagues studied the relation between an endoscopist’s withdrawal time (time from cecum to examination end) and their adenoma find rate (AFR), which is defined as the percentage of average risk patients in whom at least 1 adenoma was discovered during a screening examination. They demonstrated significant differences in AFR between endoscopists with a withdrawal time less than 6 minutes compared with those whose withdrawal times exceeded 6 minutes. They then demonstrated an increase in AFR among experienced colonoscopists by using an audible timer to slow examiners.

Others have emphasized the relationship between adenoma detection at colonoscopy and factors, such as preparation quality, level of sedation, and total procedure time. Withdrawal time measurement has become a common surrogate measure for colonoscopy quality, but 2 subsequent studies demonstrated that factors other than increasing withdrawal time will be needed to improve adenoma detection among those endoscopists who have low baseline detection rates.

Variation in colonoscopy quality and outcomes exists and will likely continue until process and outcome measures for all colonoscopy examinations are either mandated (see later discussion) or become a routine part of practice for both gastroenterologists and nongastroenterologists who perform screening colonoscopy. The current system of fee-for-service reimbursement, which is disconnected from health outcomes, and credentialing of endoscopists at the facility level (a situation with inherent economic conflicts of interest) both suggest that factors other than quality and patient-centered health outcomes will continue to be powerful influences in community settings.

Cost issues in colonoscopy in 2010

In the last decade, the cost for CRC prevention has exploded in the United States, a factor that by itself has the potential to diminish the value of colonoscopy to society. Careful analysis of factors driving this cost increase help us understand if this trend can be slowed.

Before 1998, the percentage of Medicare recipients who underwent any type of CRC screening was estimated to be approximately 25% and most were screened using fecal occult blood tests. Screening rates are now approximately 50% and most people undergo colonoscopy. This trend has paralleled a 2% annual decrease in CRC incidence over 2 decades, a change thought to be attributable in large part to screening and polyp removal. Annually, there are 10 to 12 million colonoscopy examinations in the United States with approximately 75% performed for CRC screening or surveillance. It is estimated that if screening rates were to increase to 70% of eligible Americans, an additional 10 million colonoscopy examinations would be needed. Ten million examinations at an average cost of $800 would translate to a national cost of $8 billion annually. As demonstrated in the following discussion, this is certainly an underestimate.

In 1980, Medicare reimbursed colonoscopy at a rate of approximately $500 for the professional fee (with regional variation) and $2000 for the facility fee (colonoscopy was universally performed in a hospital setting). In 1983, the first Medicare Certified Ambulatory Endoscopy Center (AEC) opened in Tennessee, followed 2 months later by one in Minnesota. Shortly thereafter, for-profit companies emerged offering to partner with physicians in building AECs. The subsequent increase in AECs is well documented and there are now more than 5100 Medicare-certified centers in the United States. These centers, for the most part, were built by community-based gastroenterologists and provide the major infrastructure needed to deliver on our CRC prevention commitment.

Profitability from managing an AEC is still acceptable, although stringent regulations and increasing fixed costs are leading many physicians to sell AECs to hospitals in a joint-venture arrangement. Despite financial and managerial obstacles over the last decade, the proliferation of accessible, cost-effective AECs led to the vast expansion of CRC screening capability in the United States and hastened the widespread use of colonoscopy as the primary CRC screening test.

In addition to overall increases in the volume of colonoscopy, per-procedure costs have escalated dramatically despite moving most examinations from hospitals to AECs. Colonoscopy, as practiced today, can be delivered in a hospital outpatient department (HOPD), an AEC, or an office. Both HOPD and AECs receive a facility fee (CMS AEC facility fees are now tied to HOPD at approximately 65%). Office endoscopy does not generate a separate facility fee but the professional fee paid by CMS is augmented to cover increased office expense of the service (site of service differential). In addition, sedation might be administered by the endoscopy team (no additional payment) or an anesthesia professional (separate charge). Entire costs for a screening colonoscopy might include some or all of the following: (1) preprocedure evaluation (not covered by CMS for screening examinations), (2) endoscopist professional fee, (3) facility fee (hospital or AEC), (4) pathology facility charge (if biopsies are sent), (5) pathology professional charge, (6) anesthesia professional fee, (8) costs of complications, (9) cost of ancillary examinations (imaging for incomplete procedures), and (10) indirect costs (lost work for both patients and their ride). Widespread practice changes that add to any portion of the per-unit cost will lead to a substantial escalation of the nation’s total cost of CRC prevention and diminish overall value unless there is a demonstrable increase in quality or health outcomes.

Patients undergoing colonoscopy in HOPD are subjected to an unbundled facility charge where equipment costs are passed along as line items. In AECs, all equipment is bundled into the facility fee, thus making future predictions of costs more accurate. HOPD charges are frequently 2 to 10 times more than the charges from an AEC.

The actual per-procedure cost of colonoscopy is not generally known or publicized. On the Minnesota Gastroenterology Web site, the cost of a screening colonoscopy is listed as $1568 (professional and facility fee only). Atlanta Gastroenterology (Atlanta, Georgia) charges a bundled fee of $1500 for cash-pay (or high deductible) patients, which includes the endoscopist’s professional fee, facility, pathology, and anesthesia. It should be noted that the listed fee at the author’s organization (and likely that of the Atlanta group) represents a financial target that is based on regional reimbursement and the estimated impact of the fee on the small proportion of cash-based patients. In reality, insurance-based reimbursement unbundles the charges and depends on negotiated rates for each component of service. Thus, facility fees can range from $346 (Medicare) to more than $5000. The upper end reflects commercial payers that must negotiate HOPD rates as part of a total health delivery contract, often with hospitals that enjoy enhanced bargaining power because of geographic imperatives or a reputation as a must-have facility. Similarly, anesthesia professionals might cost less than $200 per case (Medicare) or more than $1000 for anesthesiologists that do not participate in a particular patient’s health plan (non-par). Less dramatic fluctuations in price occur for endoscopy professional fees and pathology.

In 2009, Minnesota Gastroenterology performed 36,031 colonoscopy procedures in their AECs ( Table 1 ), for a total annual cost to Minnesota payers of approximately $60,000,000 (including all of the direct medical costs listed previously). The increase in pathology rates (see Table 1 ) alone, compared with 2006, increased cost by $1.8 million. If they were to close all AECs and perform colonoscopy within the regional HOPDs, where average facility fees would add approximately $850 per procedure, the annual increased cost for this change alone would be $30,626,350. If anesthesia professionals administered sedation in their AECs, it would add approximately $350 (conservatively) to each procedure for an annual increase of $12,610,850 (colonoscopy alone, not including upper endoscopy). If they made both changes, and used HOPD anesthesia, the increase in cost for the same physicians performing colonoscopy on the same patients would be approximately $57,000,000 annually, which is about double the current cost (see previous discussion). Remember, 10 to 12 million colonoscopy examinations are performed annually and we are advocating for 10 million more (increased screening rates).

Table 1

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