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Reimbursement and Managed Care News: July/August 2007

OBTN, July/August 2007, Volume 1, Issue 6

In this issue we highlight topics presented at the 43rd annual meeting of the American Society of Clinical Oncology: 1) Focus Groups and Advisory Boards: To What Extent Do They Supplement Oncologists' Income? 2) The High Overhead Cost of Complying With National Guidelines Other topics covered include: 1) Research Budgets Not Keeping Pace With Inflation, Cancer Advances May Suffer 2) New National Cancer Network Seeks to Improve Care Quality 3) Non-Hodgkin�s Lymphoma Guidelines Updated 4) Genetic Test May Be Unnecessary if Children Receive Lower Dose 5) Alternative to Colonoscopy Studied for Colon Cancer Screening

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â–º ASCO Spotlight: Focus Groups and Advisory Boards: To What Extent Do They Supplement Oncologists’ Income?

The implementation of the average sales price reimbursement formula for chemotherapeutic agents administered in oncology has had a significant effect on the income of a typical oncology practice. A researcher from Totowa, New Jersey, sought to find out if oncologists were taking advantage of the many advisory board or focus group invitations they received for conducting market research.

Based on surveys of oncologists in private practice and academic hematologists and oncologists, Dr. Kenneth Hoffman found that private practitioners received each week on average six invitations to participate in Web-based market research boards and one phone teleconference. He noted that most of the respondents received two or three invitations each month for ad boards for which they would have to appear and travel; they attended the majority of them.

The greatest predictive factor of whether the oncologist would participate in the market research activity was the amount of money offered, not the topic. It seemed that $150/hr was the minimum amount offered that would help ensure participation. However, Dr. Hoffman revealed that academicians were less likely to participate in Web-based conferences in any case; 55% said they did not even open the invitation.

Dr. Hoffman concluded that “market research is playing an increasing important role in the financial health of many physicians.”

Hoffman KR: Evaluating a new income source for medical oncologists: Market research. Presented at the annual ASCO meeting, Chicago, June 4, 2007.

â–º ASCO Spotlight:

The High Overhead Cost of Complying With National Guidelines

Implementing electronic medical records (EMRs) and reporting of data on quality of care are important activities, but they are not inexpensive from the oncology practice‘s perspective. Health insurance plans and payers for care want contracted physicians in their networks to be of optimal quality, and they want the means to measure meaningful differences among practices.

One multisite oncology practice, based in West Covina, California, utilized an EMR to evaluate compliance with practice guidelines, and then sought to quantify the overhead costs associated with maintaining this quality of care. Applying its assumptions to an HMO patient population of 75,000 covered lives, the investigators included EMR developmental costs, operational costs, personnel time, and training.

Direct costs for computer hardware cost $25,000, personnel training was $10,900, and EMR licensing was $12,500. Annualized costs were estimated at $184,900 (see Table for breakdown). Direct costs per covered lifewere $0.645. Overhead costs per covered lifewere $2.704 per year.

The investigators conclude that the costs to maintain quality oncology care and ensure compliance with treatment guidelines “are substantial and must be reimbursed by health insurance plans and HMOs.” A better understanding of these costs may assist oncology practices in negotiating care contracts with health insurers that seek to monitor quality of care.

Annualized Costs of Maintaining and Collating Data from Electronic Medical Records in an Oncology Practice

EMR Maintenance Fees $1,000

IT Consultants $4,500

Physician Time to Enter Patient Data $58,000

Nursing Time to Enter Treatment Data $7,650

Physician Training $11,250

Senior Administrator Coordination $30,000

Administrative Supervision $17,900

Clerical Data Analysis $22,500

Senior Physician Supervision $50,000

_____________________________________________

Total Annualized Costs $184,900

EMR = Electronic medical record IT = information technology

Vakil R, Bosserman LD, Presant C, et al: Overhead costs (OCs) associated with quality oncology care (QOC) monitoring to ensure compliance with national treatment guidelines. Presented at the annual ASCO meeting, Chicago, June 4, 2007

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Research Budgets Not Keeping Pace With Inflation, Cancer Advances May Suffer

Pointing out that the research budget of the National Cancer Institute has remained fixed since 2003, the American Society of Clinical Oncologists complained that “The pace of progress is at risk, just when knowledge about the genetic basis of cancer is exploding,” according to ASCO Chief Executive Allen Lichter.

The plateaued spending rate means that there has been an effective 12% decline in spending, when adjusted for inflation, and the Society has urged Congress to jumpstart federal spending on cancer research by hiking spending by 7%.

This call to action comes on the heels of warnings from the National Cancer Institute (NCI) that hospital networks involved in clinical trials to assume that research budgets would be cut by 10% this year. Although the warning was later rescinded, the message is clear: funding for cancer trials will not be increased, without intervention.

This problem was well illustrated when the NCI announced in late June that it cancelled a 12,800-patient study that was to compare letrozole versus raloxifene for the prevention of breast cancer. The study would have recruited patients from 500 North American sites and followed them for up to five years. Cost was cited as one of the main reasons for the cancellation.

Cancer Advances Hurt by Funding Slump, Doctors Say. www.Bloomberg.com, June 3, 2007.

Stein R: Breast Cancer Drug Study Canceled.

June 21, 2007.

Washington Post

New National Cancer Network Seeks to Improve Care Quality

In an attempt to better control the high costs of care and to provide high quality care, a new network of 21 oncology practices in more than a dozen states has been launched. The self-titled Cancer Clinics of Excellence includes 224 oncologists. The organization claims that it will establish evidence-based treatment protocols, based on existing guidelines from the American Society of Clinical Oncology and the National Comprehensive Cancer Network, in an effort to then measure the quality of care provided.

The network will use a singular technology platform, supplied by OTN of Nashville, to enable its member practices to collect data, conduct analyses, and monitor quality of care provided by its oncologists.

Cancer Clinics of Excellence, New National Network of Oncologists, Launches With Goal of Improving Quality of Cancer Care (press release). Nashville, OTN, May 31, 2007.

Non-Hodgkin’s Lymphoma Guidelines Updated

Announcing updates to its non-Hodgkin’s lymphoma guidelines, the National Comprehensive Cancer Network (NCCN) highlighted several areas that have changed specifically.

As part of the update, new guidelines were added for peripheral T-cell lymphomas and cutaneous T-cell lymphoma, in which T lymphocytes become malignant. The Guidelines for cutaneous T-cell Lymphoma advocate the use of vorinostat (Zolinza), which was recently approved by the Food and Drug Administration.

For the B-cell lymphoma portion of the guidelines, NCCN characterized testing for hepatitis B as “essential” to the work-up, because of rituximab’s (Rituxan) warning against use in those with hepatitis B.

Drug therapy changes were added for some patients with chronic lymphocytic leukemia and small lymphocytic lymphoma. For example, alemtuzumab (Campath) is now listed as a first-line option and for those with diffuse large B-cell lymphoma, a second-line therapeutic combination of gemcitabine (Gemzar), dexamethasone, cisplatin, and/or rituximab.

NCCN Updates Non-Hodgkin’s Lymphoma Guidelines (press release). Jenkintown, PA, National Comprehensive Cancer Network, June 20, 2007.

Genetic Test May Be Unnecessary if Children Receive Lower Dose

Managed care organizations are watching warily as the world of pharmacogenomics evolves, in which gene testing can determine whether some patients would benefit more from one type of therapy than another (or may be less prone to side effects of a particular medication). Although genetic testing may make treatment more efficient, and possibly reduce the cost of treating adverse events, the genetic tests are not inexpensive.

Standard administration of irinotecan involves one large dose given once each month, to treat neuroblastoma, sarcomas and kidney tumors. The Food and Drug Administration mandates that adults receiving irinotecan undergo genetic testing to help predict whom might benefit from alternative therapeutic options.

Investigators from St. Jude Children’s Research Hospital, Denver revealed that when the cancer drug irinotecan (Camptosar) is given in 10 low doses over two weeks of treatment to children, genetic testing to determine the risk of neutropenia may be unnecessary. The specific gene variant sought is from the UGT1A1 family (UGT1A1*28), which fails to eliminate the drug from the body, enabling it to remain in the circulation and cause side effects, like neutropenia and severe diarrhea.

This study of 74 children included 27 with the normal UGT1A1 gene, 36 with one copy of the gene variant, and nine with two copies of the variant gene. The researchers found no association between genetic status and the incidence of side effects if the low dose of irinotecan was used. The researchers concluded that it was not useful to test patients to determine if they had UGT1A1*28.

Stewart CF, Panetta JC, O’Shaughnessy MA, et al: UGT1A1 promoter genotype correlates with SN-38 pharmacokinetics, but not severe toxicity in patients receiving low-dose irinotecan

2007;25:2594-2600.

. J Clin Oncol

Alternative to Colonoscopy Studied for Colon Cancer Screening

Patients and insurers have long sought a noninvasive screening test for colon cancer. For decades, the colonoscopy has been the gold standard, but not only is the procedure costly, patients bristle against the bowel preparations and anesthesia, and physicians have varied somewhat in their ability to detect precancerous polyps. Scientists from Johns Hopkins and the University of Pittsburgh Cancer Institute think a new blood test may help blaze a different path to screening.

The research is focused on two blood proteins, colon cancer—specific antigen (CCSA)-3 and CCSA-4. These two proteins may be debris from dead cancer cells. However, the actual role of the proteins is unknown at this time. It is speculated that these proteins play a role in supportive nuclear structures within the tumor cell.

The researchers tested their theory by obtaining blood samples from 107 individuals just before their routine colonoscopies and 28 patients with colorectal cancer. The investigators were blinded to the patients’ status, but correctly identified the patients with colorectal cancer, by setting 2 μg/mL for CCSA-3 and 0.3 μg/mL for CCSA-4 as the threshold markers. Using the same protein markers, the investigators were able to identify 51 of 53 individuals (96.2%) with healthy colons and 14 of 18 (77.8%) with advanced precancerous polyps people undergoing routine colonoscopy. The specificity for the combined endpoint of cancer and advanced adenoma was 89% CCSA-3 and 84% for CCSA-4.

It should also be pointed out that this test was performed using an enzyme-linked immunosorbent assay, this test should be easily reproduced. The investigators believe that it could result in a practical alternative to routine colonoscopy and help identify patients who require the procedure for polyp removal or further evaluation.

Leman ES, Schoen RE, Weissfeld JL, et al: Initial analyses of colon cancer-specific antigen (CCSA)- 3 and CCSA-4 as colorectal cancer-associated serum Markers

2007;67:5600-5605.

. Cancer Res