Neil Osterweil

ORLANDO – The investigational oral anticoagulant rivaroxaban was not inferior to a combination of the low-molecular-weight heparin enoxaparin and a vitamin K antagonist for reducing risk of recurrent deep venous thromboembolism for up to 1 year, reported investigators with the EINSTEIN Acute DVT study.

In an open-label study, venous thromboembolism (VTE) or pulmonary embolism recurred in 2.1% of 1,731 patients randomized to rivaroxaban and in 3.0% of 1,718 patients randomized to enoxaparin (Lovenox) followed by either warfarin or acenocoumarol. The data were reported by Harry R. Büller, M.D., Ph.D., at the annual meeting of the American Society of Hematology and online in the New England Journal of Medicine (Dec. 4, 2010 [10.1056/NEJMoa1007903]).

Incidence of major bleeding or clinically relevant nonmajor bleeding was identical in the two groups, at 8.1%. Additionally, rivaroxaban, a factor Xa inhibitor in late-stage clinical development, was superior in efficacy to placebo in a randomized double-blind extension study in patients who had completed 6-12 months of thromboprophylaxis.

"This regimen of 15 mg [rivaroxaban] twice a day for the first 3 weeks followed by 20 mg for the remainder period provides clinicians and patients, I think, with an attractive and simple treatment option for venous thrombosis, not only in the acute phase, but also when prolonged treatment is indicated," Dr. Büller of the Academic Medical Center in Amsterdam, the Netherlands, said in a media briefing.

The EINSTEIN Acute-DVT trial compared oral rivaroxaban alone with enoxaparin followed by a vitamin K antagonist for prophylaxis of recurrent VTE or pulmonary embolism in 3,449 patients. Rivaroxaban was delivered orally 15 mg twice daily for 3 weeks, followed by 20 mg orally once daily for 3, 6, or 12 months. Duration of treatment was at the discretion of the treating physician at the time of randomization.

The EINSTEIN-extension study compared rivaroxaban with placebo in 1,197 patients who had completed 6-12 months of rivaroxaban in the EINSTEIN studies or 6-12 months of a vitamin K antagonist, either in the EINSTEIN studies or in routine care.

The primary efficacy end point for both studies was the incidence of recurrent VTE. The primary safety outcome for the acute DVT trial was major bleeding or clinically relevant minor bleeding. The major safety outcome in the extension trial was major bleeding.

In the acute trial, there were 36 VTE events in the rivaroxaban group, compared with 51 in the enoxaparin/vitamin K antagonist group (hazard ratio, 0.68; P less than .001). A total of 8.1% of patients in each group experienced a recurrent VTE.

In the continuation trial, there were 8 events among 602 patients (1.3%) treated with rivaroxaban, compared with 42 of 594 patients (7.1%) treated with the enoxaparin/vitamin K antagonist regimen (hazard ratio, 0.18; P less than .001). There were four nonfatal major bleeding events among patients treated with rivaroxaban, versus none in those who received placebo.

Both trials were sponsored by Bayer Schering Pharma and Ortho-McNeil.

ORLANDO – The investigational oral anticoagulant rivaroxaban was not inferior to a combination of the low-molecular-weight heparin enoxaparin and a vitamin K antagonist for reducing risk of recurrent deep venous thromboembolism for up to 1 year, reported investigators with the EINSTEIN Acute DVT study.

In an open-label study, venous thromboembolism (VTE) or pulmonary embolism recurred in 2.1% of 1,731 patients randomized to rivaroxaban and in 3.0% of 1,718 patients randomized to enoxaparin (Lovenox) followed by either warfarin or acenocoumarol. The data were reported by Harry R. Büller, M.D., Ph.D., at the annual meeting of the American Society of Hematology and online in the New England Journal of Medicine (Dec. 4, 2010 [10.1056/NEJMoa1007903]).

Incidence of major bleeding or clinically relevant nonmajor bleeding was identical in the two groups, at 8.1%. Additionally, rivaroxaban, a factor Xa inhibitor in late-stage clinical development, was superior in efficacy to placebo in a randomized double-blind extension study in patients who had completed 6-12 months of thromboprophylaxis.

"This regimen of 15 mg [rivaroxaban] twice a day for the first 3 weeks followed by 20 mg for the remainder period provides clinicians and patients, I think, with an attractive and simple treatment option for venous thrombosis, not only in the acute phase, but also when prolonged treatment is indicated," Dr. Büller of the Academic Medical Center in Amsterdam, the Netherlands, said in a media briefing.

The EINSTEIN Acute-DVT trial compared oral rivaroxaban alone with enoxaparin followed by a vitamin K antagonist for prophylaxis of recurrent VTE or pulmonary embolism in 3,449 patients. Rivaroxaban was delivered orally 15 mg twice daily for 3 weeks, followed by 20 mg orally once daily for 3, 6, or 12 months. Duration of treatment was at the discretion of the treating physician at the time of randomization.

The EINSTEIN-extension study compared rivaroxaban with placebo in 1,197 patients who had completed 6-12 months of rivaroxaban in the EINSTEIN studies or 6-12 months of a vitamin K antagonist, either in the EINSTEIN studies or in routine care.

The primary efficacy end point for both studies was the incidence of recurrent VTE. The primary safety outcome for the acute DVT trial was major bleeding or clinically relevant minor bleeding. The major safety outcome in the extension trial was major bleeding.

In the acute trial, there were 36 VTE events in the rivaroxaban group, compared with 51 in the enoxaparin/vitamin K antagonist group (hazard ratio, 0.68; P less than .001). A total of 8.1% of patients in each group experienced a recurrent VTE.

In the continuation trial, there were 8 events among 602 patients (1.3%) treated with rivaroxaban, compared with 42 of 594 patients (7.1%) treated with the enoxaparin/vitamin K antagonist regimen (hazard ratio, 0.18; P less than .001). There were four nonfatal major bleeding events among patients treated with rivaroxaban, versus none in those who received placebo.

Both trials were sponsored by Bayer Schering Pharma and Ortho-McNeil.

ORLANDO – The investigational oral anticoagulant rivaroxaban was not inferior to a combination of the low-molecular-weight heparin enoxaparin and a vitamin K antagonist for reducing risk of recurrent deep venous thromboembolism for up to 1 year, reported investigators with the EINSTEIN Acute DVT study.

In an open-label study, venous thromboembolism (VTE) or pulmonary embolism recurred in 2.1% of 1,731 patients randomized to rivaroxaban and in 3.0% of 1,718 patients randomized to enoxaparin (Lovenox) followed by either warfarin or acenocoumarol. The data were reported by Harry R. Büller, M.D., Ph.D., at the annual meeting of the American Society of Hematology and online in the New England Journal of Medicine (Dec. 4, 2010 [10.1056/NEJMoa1007903]).

Incidence of major bleeding or clinically relevant nonmajor bleeding was identical in the two groups, at 8.1%. Additionally, rivaroxaban, a factor Xa inhibitor in late-stage clinical development, was superior in efficacy to placebo in a randomized double-blind extension study in patients who had completed 6-12 months of thromboprophylaxis.

"This regimen of 15 mg [rivaroxaban] twice a day for the first 3 weeks followed by 20 mg for the remainder period provides clinicians and patients, I think, with an attractive and simple treatment option for venous thrombosis, not only in the acute phase, but also when prolonged treatment is indicated," Dr. Büller of the Academic Medical Center in Amsterdam, the Netherlands, said in a media briefing.

The EINSTEIN Acute-DVT trial compared oral rivaroxaban alone with enoxaparin followed by a vitamin K antagonist for prophylaxis of recurrent VTE or pulmonary embolism in 3,449 patients. Rivaroxaban was delivered orally 15 mg twice daily for 3 weeks, followed by 20 mg orally once daily for 3, 6, or 12 months. Duration of treatment was at the discretion of the treating physician at the time of randomization.

The EINSTEIN-extension study compared rivaroxaban with placebo in 1,197 patients who had completed 6-12 months of rivaroxaban in the EINSTEIN studies or 6-12 months of a vitamin K antagonist, either in the EINSTEIN studies or in routine care.

The primary efficacy end point for both studies was the incidence of recurrent VTE. The primary safety outcome for the acute DVT trial was major bleeding or clinically relevant minor bleeding. The major safety outcome in the extension trial was major bleeding.

In the acute trial, there were 36 VTE events in the rivaroxaban group, compared with 51 in the enoxaparin/vitamin K antagonist group (hazard ratio, 0.68; P less than .001). A total of 8.1% of patients in each group experienced a recurrent VTE.

In the continuation trial, there were 8 events among 602 patients (1.3%) treated with rivaroxaban, compared with 42 of 594 patients (7.1%) treated with the enoxaparin/vitamin K antagonist regimen (hazard ratio, 0.18; P less than .001). There were four nonfatal major bleeding events among patients treated with rivaroxaban, versus none in those who received placebo.

Both trials were sponsored by Bayer Schering Pharma and Ortho-McNeil.

ORLANDO – The investigational oral anticoagulant rivaroxaban was not inferior to a combination of the low-molecular-weight heparin enoxaparin and a vitamin K antagonist for reducing risk of recurrent deep venous thromboembolism for up to 1 year, reported investigators with the EINSTEIN Acute DVT study.

In an open-label study, venous thromboembolism (VTE) or pulmonary embolism recurred in 2.1% of 1,731 patients randomized to rivaroxaban and in 3.0% of 1,718 patients randomized to enoxaparin (Lovenox) followed by either warfarin or acenocoumarol. The data were reported by Harry R. Büller, M.D., Ph.D., at the annual meeting of the American Society of Hematology and online in the New England Journal of Medicine (Dec. 4, 2010 [10.1056/NEJMoa1007903]).

Incidence of major bleeding or clinically relevant nonmajor bleeding was identical in the two groups, at 8.1%. Additionally, rivaroxaban, a factor Xa inhibitor in late-stage clinical development, was superior in efficacy to placebo in a randomized double-blind extension study in patients who had completed 6-12 months of thromboprophylaxis.

"This regimen of 15 mg [rivaroxaban] twice a day for the first 3 weeks followed by 20 mg for the remainder period provides clinicians and patients, I think, with an attractive and simple treatment option for venous thrombosis, not only in the acute phase, but also when prolonged treatment is indicated," Dr. Büller of the Academic Medical Center in Amsterdam, the Netherlands, said in a media briefing.

The EINSTEIN Acute-DVT trial compared oral rivaroxaban alone with enoxaparin followed by a vitamin K antagonist for prophylaxis of recurrent VTE or pulmonary embolism in 3,449 patients. Rivaroxaban was delivered orally 15 mg twice daily for 3 weeks, followed by 20 mg orally once daily for 3, 6, or 12 months. Duration of treatment was at the discretion of the treating physician at the time of randomization.

The EINSTEIN-extension study compared rivaroxaban with placebo in 1,197 patients who had completed 6-12 months of rivaroxaban in the EINSTEIN studies or 6-12 months of a vitamin K antagonist, either in the EINSTEIN studies or in routine care.

The primary efficacy end point for both studies was the incidence of recurrent VTE. The primary safety outcome for the acute DVT trial was major bleeding or clinically relevant minor bleeding. The major safety outcome in the extension trial was major bleeding.

In the acute trial, there were 36 VTE events in the rivaroxaban group, compared with 51 in the enoxaparin/vitamin K antagonist group (hazard ratio, 0.68; P less than .001). A total of 8.1% of patients in each group experienced a recurrent VTE.

In the continuation trial, there were 8 events among 602 patients (1.3%) treated with rivaroxaban, compared with 42 of 594 patients (7.1%) treated with the enoxaparin/vitamin K antagonist regimen (hazard ratio, 0.18; P less than .001). There were four nonfatal major bleeding events among patients treated with rivaroxaban, versus none in those who received placebo.

Both trials were sponsored by Bayer Schering Pharma and Ortho-McNeil.

ORLANDO – The investigational oral anticoagulant rivaroxaban was not inferior to a combination of the low-molecular-weight heparin enoxaparin and a vitamin K antagonist for reducing risk of recurrent deep venous thromboembolism for up to 1 year, reported investigators with the EINSTEIN Acute DVT study.

In an open-label study, venous thromboembolism (VTE) or pulmonary embolism recurred in 2.1% of 1,731 patients randomized to rivaroxaban and in 3.0% of 1,718 patients randomized to enoxaparin (Lovenox) followed by either warfarin or acenocoumarol. The data were reported by Harry R. Büller, M.D., Ph.D., at the annual meeting of the American Society of Hematology and online in the New England Journal of Medicine (Dec. 4, 2010 [10.1056/NEJMoa1007903]).

Incidence of major bleeding or clinically relevant nonmajor bleeding was identical in the two groups, at 8.1%. Additionally, rivaroxaban, a factor Xa inhibitor in late-stage clinical development, was superior in efficacy to placebo in a randomized double-blind extension study in patients who had completed 6-12 months of thromboprophylaxis.

"This regimen of 15 mg [rivaroxaban] twice a day for the first 3 weeks followed by 20 mg for the remainder period provides clinicians and patients, I think, with an attractive and simple treatment option for venous thrombosis, not only in the acute phase, but also when prolonged treatment is indicated," Dr. Büller of the Academic Medical Center in Amsterdam, the Netherlands, said in a media briefing.

The EINSTEIN Acute-DVT trial compared oral rivaroxaban alone with enoxaparin followed by a vitamin K antagonist for prophylaxis of recurrent VTE or pulmonary embolism in 3,449 patients. Rivaroxaban was delivered orally 15 mg twice daily for 3 weeks, followed by 20 mg orally once daily for 3, 6, or 12 months. Duration of treatment was at the discretion of the treating physician at the time of randomization.

The EINSTEIN-extension study compared rivaroxaban with placebo in 1,197 patients who had completed 6-12 months of rivaroxaban in the EINSTEIN studies or 6-12 months of a vitamin K antagonist, either in the EINSTEIN studies or in routine care.

The primary efficacy end point for both studies was the incidence of recurrent VTE. The primary safety outcome for the acute DVT trial was major bleeding or clinically relevant minor bleeding. The major safety outcome in the extension trial was major bleeding.

In the acute trial, there were 36 VTE events in the rivaroxaban group, compared with 51 in the enoxaparin/vitamin K antagonist group (hazard ratio, 0.68; P less than .001). A total of 8.1% of patients in each group experienced a recurrent VTE.

In the continuation trial, there were 8 events among 602 patients (1.3%) treated with rivaroxaban, compared with 42 of 594 patients (7.1%) treated with the enoxaparin/vitamin K antagonist regimen (hazard ratio, 0.18; P less than .001). There were four nonfatal major bleeding events among patients treated with rivaroxaban, versus none in those who received placebo.

Both trials were sponsored by Bayer Schering Pharma and Ortho-McNeil.

ORLANDO – The investigational oral anticoagulant rivaroxaban was not inferior to a combination of the low-molecular-weight heparin enoxaparin and a vitamin K antagonist for reducing risk of recurrent deep venous thromboembolism for up to 1 year, reported investigators with the EINSTEIN Acute DVT study.

In an open-label study, venous thromboembolism (VTE) or pulmonary embolism recurred in 2.1% of 1,731 patients randomized to rivaroxaban and in 3.0% of 1,718 patients randomized to enoxaparin (Lovenox) followed by either warfarin or acenocoumarol. The data were reported by Harry R. Büller, M.D., Ph.D., at the annual meeting of the American Society of Hematology and online in the New England Journal of Medicine (Dec. 4, 2010 [10.1056/NEJMoa1007903]).

Incidence of major bleeding or clinically relevant nonmajor bleeding was identical in the two groups, at 8.1%. Additionally, rivaroxaban, a factor Xa inhibitor in late-stage clinical development, was superior in efficacy to placebo in a randomized double-blind extension study in patients who had completed 6-12 months of thromboprophylaxis.

"This regimen of 15 mg [rivaroxaban] twice a day for the first 3 weeks followed by 20 mg for the remainder period provides clinicians and patients, I think, with an attractive and simple treatment option for venous thrombosis, not only in the acute phase, but also when prolonged treatment is indicated," Dr. Büller of the Academic Medical Center in Amsterdam, the Netherlands, said in a media briefing.

The EINSTEIN Acute-DVT trial compared oral rivaroxaban alone with enoxaparin followed by a vitamin K antagonist for prophylaxis of recurrent VTE or pulmonary embolism in 3,449 patients. Rivaroxaban was delivered orally 15 mg twice daily for 3 weeks, followed by 20 mg orally once daily for 3, 6, or 12 months. Duration of treatment was at the discretion of the treating physician at the time of randomization.

The EINSTEIN-extension study compared rivaroxaban with placebo in 1,197 patients who had completed 6-12 months of rivaroxaban in the EINSTEIN studies or 6-12 months of a vitamin K antagonist, either in the EINSTEIN studies or in routine care.

The primary efficacy end point for both studies was the incidence of recurrent VTE. The primary safety outcome for the acute DVT trial was major bleeding or clinically relevant minor bleeding. The major safety outcome in the extension trial was major bleeding.

In the acute trial, there were 36 VTE events in the rivaroxaban group, compared with 51 in the enoxaparin/vitamin K antagonist group (hazard ratio, 0.68; P less than .001). A total of 8.1% of patients in each group experienced a recurrent VTE.

In the continuation trial, there were 8 events among 602 patients (1.3%) treated with rivaroxaban, compared with 42 of 594 patients (7.1%) treated with the enoxaparin/vitamin K antagonist regimen (hazard ratio, 0.18; P less than .001). There were four nonfatal major bleeding events among patients treated with rivaroxaban, versus none in those who received placebo.

Both trials were sponsored by Bayer Schering Pharma and Ortho-McNeil.

More than a decade after receiving autologous chondrocyte implants for treatment of full-thickness chondral lesions of the knee, nearly 75% of patients reported continued improvement or stability at their last follow-up, and 90% said they would have the procedure again.

Patients had significant improvement over baseline by objective clinical measures, although there was a slight but significant decline in function from the first to second follow-up period, according to Dr. Haris S. Vasiliadis and colleagues from the University of Gothenburg (Sweden) and the University of Ioannina (Greece).

Neither concomitant injuries to the knee nor prior bone marrow–stimulating surgeries appeared to decrease the overall benefit of chondrocyte implantation at long-term follow-up, the investigators wrote (Osteoarthritis Cartilage 2010 May 5 [doi:10.1016/j.joca.2010.04.003]).

They assessed responses from 224 patients who were treated with ACI in 1988–1998. At intermediate follow-up, the Lysholm scores (on a 0- to 95-point scale, with higher scores equating with better function) had improved by a mean of 14.8 points, compared with baseline (P = .0003). The mean change over baseline at 10 years was a 10-point improvement (P = .0016). Brittberg-Peterson scores (on a 0- to 130-point scale, with 0 being no pain and best function) were significantly lower at final follow-up than at baseline (mean decrease, 14 points; P = .004).

The investigators said no financial support was provided for the study, and they had no conflicts of interest.

More than a decade after receiving autologous chondrocyte implants for treatment of full-thickness chondral lesions of the knee, nearly 75% of patients reported continued improvement or stability at their last follow-up, and 90% said they would have the procedure again.

Patients had significant improvement over baseline by objective clinical measures, although there was a slight but significant decline in function from the first to second follow-up period, according to Dr. Haris S. Vasiliadis and colleagues from the University of Gothenburg (Sweden) and the University of Ioannina (Greece).

Neither concomitant injuries to the knee nor prior bone marrow–stimulating surgeries appeared to decrease the overall benefit of chondrocyte implantation at long-term follow-up, the investigators wrote (Osteoarthritis Cartilage 2010 May 5 [doi:10.1016/j.joca.2010.04.003]).

They assessed responses from 224 patients who were treated with ACI in 1988–1998. At intermediate follow-up, the Lysholm scores (on a 0- to 95-point scale, with higher scores equating with better function) had improved by a mean of 14.8 points, compared with baseline (P = .0003). The mean change over baseline at 10 years was a 10-point improvement (P = .0016). Brittberg-Peterson scores (on a 0- to 130-point scale, with 0 being no pain and best function) were significantly lower at final follow-up than at baseline (mean decrease, 14 points; P = .004).

The investigators said no financial support was provided for the study, and they had no conflicts of interest.

More than a decade after receiving autologous chondrocyte implants for treatment of full-thickness chondral lesions of the knee, nearly 75% of patients reported continued improvement or stability at their last follow-up, and 90% said they would have the procedure again.

Patients had significant improvement over baseline by objective clinical measures, although there was a slight but significant decline in function from the first to second follow-up period, according to Dr. Haris S. Vasiliadis and colleagues from the University of Gothenburg (Sweden) and the University of Ioannina (Greece).

Neither concomitant injuries to the knee nor prior bone marrow–stimulating surgeries appeared to decrease the overall benefit of chondrocyte implantation at long-term follow-up, the investigators wrote (Osteoarthritis Cartilage 2010 May 5 [doi:10.1016/j.joca.2010.04.003]).

They assessed responses from 224 patients who were treated with ACI in 1988–1998. At intermediate follow-up, the Lysholm scores (on a 0- to 95-point scale, with higher scores equating with better function) had improved by a mean of 14.8 points, compared with baseline (P = .0003). The mean change over baseline at 10 years was a 10-point improvement (P = .0016). Brittberg-Peterson scores (on a 0- to 130-point scale, with 0 being no pain and best function) were significantly lower at final follow-up than at baseline (mean decrease, 14 points; P = .004).

The investigators said no financial support was provided for the study, and they had no conflicts of interest.

A major insurance company is betting that oncology practices can handle cancer-care payments as if they were like the household grocery budget or a weekly allowance: Be frugal and you’ll have some left over for next time. Spend too much, and you’ll have to borrow from the future.

Photo credit: National Cancer Institute

The idea of its pilot study, says UnitedHealthcare, based in Minnetonka, Minn., is to separate drug costs from treatment costs by paying oncologists an up-front, per-patient fee. (In insurance-speak, this is called a "bundled" or "episode" payment.) The payments will be based on best medical practices for three common malignancies: breast cancer, colon cancer, and lung cancer. Decisions about optimal treatment for each disease state will be determined by consensus among clinicians, and not by the insurer, the company said in a press release.

"By paying medical oncologists for a patient’s total cycle of treatment, rather than the number of visits and the amount of chemotherapy drugs given, this program promotes better, more patient-centric, evidence-based care with no loss of revenue for the physician," said Dr. Lee N. Newcomer, UnitedHealthcare’s senior vice president for oncology. "Everyone wins. As oncologists share best practices from the program about which treatment regimens are most effective, we expect to see consistently improved patient outcomes."

The company is working with five small- to mid-size oncology practices based in Dayton, Ohio; Fort Worth, Tex.; Kansas City, Mo; Marietta, Ga.; and Memphis. Analysis is to begin after a year’s data are collected.

"Over the course of the pilot, the various treatment regimens selected by the medical groups will be evaluated to identify which are the most effective for a range of clinical presentations [such as physical signs and symptoms and diagnoses]. UnitedHealthcare will play no role in determining which treatment plan the oncologists choose, but the intent of the pilot is to identify and reduce unnecessary drug administration that does not improve the patient’s health outcomes," the company stated.

Under this payment system, the insurer will determine its cancer-care payments based on the difference between drug costs and the current fee schedule of the oncology group, with payments made on the first day on which an insured patient receives care from that practice. The payments will include case-management fees to cover patient management costs.

Thus, if during the course of an individual patient’s care clinicians decide to switch to a more expensive drug, there would be no additional payments to compensate for the difference.

Each of the agreed-upon regimens in the pilot will be evaluated based on health outcomes and the frequency of adverse events, emergency department visits, and other consequences that can drive up costs without additional treatment benefit, the insurer says.

Worth a Look

The proposed payment model is an interesting approach to the goal of containing medical costs while fairly compensating clinicians and protecting high-quality patient care. But it also raises many questions about its applicability across a broad range of clinical and financial situations, say medical economists and oncologists who were interviewed for this article.

"We are pleased to see experimentation taking place around how oncology care is paid for," said Dr. Allen S. Lichter, CEO of the American Society of Clinical Oncology. "The oncology community needs to do these pilot projects, and understand whether moving away from the current models based on fee-for-service and some percentage of margin off the chemotherapy agents can be replaced by something else – and if so, what should that something else look like and how does it work?"

"I think it’s an interesting experiment and an important one, one that Dr. Newcomer and United can run because of their large claims-based database, and we’re all interested to see how it works," agreed Dr. Samuel M. Silver, chair of the subcommittee on reimbursement for the American Society of Hematology and a professor of internal medicine at the University of Michigan in Ann Arbor.

Jack Hoadley, Ph.D., a health policy analyst and research professor at the Health Policy Institute at Georgetown University in Washington, D.C., noted that "Medicare has tried a number of experiments with various types of bundled payments, and it seems [as if] Medicare could either watch what’s going on in this private-sector pilot and use that as a way to learn, or – sooner than that – try bundled-payment structures to see how they work."

Outliers Could Be a Problem

One of the many questions that remain to be answered about the pilot project, however, is the problem of outliers (patients whose care doesn’t fit neatly within the prescribed protocol, such as those with significant comorbidities or adverse drug reactions that require a change in the treatment regimen).

"When one starts to deal with individual practices who have just a couple of these patients, one outlier can make it financially very difficult, so the question is, how often is that going to happen?" Dr. Silver said.

Dr. Hoadley said that the system needs to have flexibility to account for differences in the patient population. "Obviously, you’ve got to get that bundled amount right and appropriately adjusted for the average, across the kind of patients the practice is going to see, with some particular adjustments for patient severity," and other factors, he commented.

Where there are outliers, there are also inliers (patients who, for medical or other reasons, don’t undergo a full course of prescribed therapy), and in these cases, bundled payments would result in additional income for a practice, Dr. Lichter said. Over time, the outliers and inliers tend to balance out, and in the case of the extraordinary outlier – the patient who is admitted for a planned 2-day stay but ends up being hospitalized for 6 months – some sort of contingency payment would be made, he added.

"In talking to United Healthcare, while they didn’t sit down and write rules for every possible situation, I know that if a case is so far beyond the norm, they will sit down and look at it and agree to some type of remedial payment for it," he said.

Rare Cancers and Cherry Picking

A related issue of concern is how bundled payment systems would handle rare cancers, or clinical situations for which there is little or no consensus on optimal therapies, such as the use of chemotherapy for some soft-tissue sarcomas.

As vice-chair of the board of the National Comprehensive Cancer Network, Dr. Silver is an advocate of evidence-based guidelines, but said he’s aware that many patients have variations that don’t fit neatly into the standard chemotherapy guidelines that are acceptable under a bundled-payment system.

"Which brings us to another issue: Would there be cherry picking?" he asked. "Because it would be the patients who are young and healthy and can go through those therapies, and [who] don’t have comorbidities and variations on their disease that would best fit into these bundled programs. So what happens to the others?"

In such cases, the burden of care for the more severely ill patients would fall on teaching hospitals, and it’s unclear whether they would be adequately compensated under a bundled-payment system, he said.

Stifle Drug Development?

Matt Farber, director of provider economics and public policy for the Association of Community Cancer Centers, said that bundled-payment systems could have a dampening effect on drug development. He points to sipuleucel-T (Provenge), the recently approved autologous immunotherapy vaccine for advanced prostate cancer that uses antigen-presenting cells unique to each patient.

"Would payment systems like this stop those drugs from being developed? Because if it’s a personalized treatment, would it therefore not be included in whatever benchmark is deemed the most appropriate or most effective care for most people?" Mr. Farber asked.

And what happens when novel drugs or new versions of conventional chemotherapeutic agents (such as palifosfamide, an active metabolite of ifosfamide) come on the market?

"They’re working right now with these five practices to determine what are the best courses of treatment currently for the disease states that they’re looking at. So when a new drug comes down the line, what’s the process and how quickly do they update?" Mr. Farber said.

Similarly, said Dr. Silver, if patients are being treated and oncologists are being paid according to best medical practice, there would be fewer incentives for patients to enroll in clinical trials, which are the principal means whereby the science of medicine advances.

Define ‘Costs’

It’s also unclear just how drug costs would be defined under the proposed system, Georgetown’s Dr. Hoadley said.

"The company says, ‘Chemotherapy drugs will be reimbursed at manufacturer’s cost.’ But as Medicare has learned, that’s an ambiguous term. Medicare has gone from reimbursing based on average wholesale price to now the average sales price, and has come up with new mechanisms to define fairly what the price is for the practices that are paying to get those drugs. So the details need to be filled in about how they’re going to go about doing that," he said.

"The good news, potentially, is that you can get away from this old system that has existed for much of the past, where the practices could make money on drug reimbursements (which is how they made money to finance other things), but it would create potentially distorted incentives. You’ve still got to get it right, though," he added.

Although it’s still early, the pilot program is a good place to start, according to Dr. Lichter.

"One wants to start a pilot project in situations where there’s a lot of grounding in the types of therapies that are appropriate, so the choices are relatively limited and you can draw a box around the universe of care. If you find out that this works – if the patients are satisfied, the payers are satisfied, the system seems to be working well, and you’ve done the appropriate tweaks and nips and tucks to make it better – then you have to begin to expand it," he said.

A major insurance company is betting that oncology practices can handle cancer-care payments as if they were like the household grocery budget or a weekly allowance: Be frugal and you’ll have some left over for next time. Spend too much, and you’ll have to borrow from the future.

Photo credit: National Cancer Institute

The idea of its pilot study, says UnitedHealthcare, based in Minnetonka, Minn., is to separate drug costs from treatment costs by paying oncologists an up-front, per-patient fee. (In insurance-speak, this is called a "bundled" or "episode" payment.) The payments will be based on best medical practices for three common malignancies: breast cancer, colon cancer, and lung cancer. Decisions about optimal treatment for each disease state will be determined by consensus among clinicians, and not by the insurer, the company said in a press release.

"By paying medical oncologists for a patient’s total cycle of treatment, rather than the number of visits and the amount of chemotherapy drugs given, this program promotes better, more patient-centric, evidence-based care with no loss of revenue for the physician," said Dr. Lee N. Newcomer, UnitedHealthcare’s senior vice president for oncology. "Everyone wins. As oncologists share best practices from the program about which treatment regimens are most effective, we expect to see consistently improved patient outcomes."

The company is working with five small- to mid-size oncology practices based in Dayton, Ohio; Fort Worth, Tex.; Kansas City, Mo; Marietta, Ga.; and Memphis. Analysis is to begin after a year’s data are collected.

"Over the course of the pilot, the various treatment regimens selected by the medical groups will be evaluated to identify which are the most effective for a range of clinical presentations [such as physical signs and symptoms and diagnoses]. UnitedHealthcare will play no role in determining which treatment plan the oncologists choose, but the intent of the pilot is to identify and reduce unnecessary drug administration that does not improve the patient’s health outcomes," the company stated.

Under this payment system, the insurer will determine its cancer-care payments based on the difference between drug costs and the current fee schedule of the oncology group, with payments made on the first day on which an insured patient receives care from that practice. The payments will include case-management fees to cover patient management costs.

Thus, if during the course of an individual patient’s care clinicians decide to switch to a more expensive drug, there would be no additional payments to compensate for the difference.

Each of the agreed-upon regimens in the pilot will be evaluated based on health outcomes and the frequency of adverse events, emergency department visits, and other consequences that can drive up costs without additional treatment benefit, the insurer says.

Worth a Look

The proposed payment model is an interesting approach to the goal of containing medical costs while fairly compensating clinicians and protecting high-quality patient care. But it also raises many questions about its applicability across a broad range of clinical and financial situations, say medical economists and oncologists who were interviewed for this article.

"We are pleased to see experimentation taking place around how oncology care is paid for," said Dr. Allen S. Lichter, CEO of the American Society of Clinical Oncology. "The oncology community needs to do these pilot projects, and understand whether moving away from the current models based on fee-for-service and some percentage of margin off the chemotherapy agents can be replaced by something else – and if so, what should that something else look like and how does it work?"

"I think it’s an interesting experiment and an important one, one that Dr. Newcomer and United can run because of their large claims-based database, and we’re all interested to see how it works," agreed Dr. Samuel M. Silver, chair of the subcommittee on reimbursement for the American Society of Hematology and a professor of internal medicine at the University of Michigan in Ann Arbor.

Jack Hoadley, Ph.D., a health policy analyst and research professor at the Health Policy Institute at Georgetown University in Washington, D.C., noted that "Medicare has tried a number of experiments with various types of bundled payments, and it seems [as if] Medicare could either watch what’s going on in this private-sector pilot and use that as a way to learn, or – sooner than that – try bundled-payment structures to see how they work."

Outliers Could Be a Problem

One of the many questions that remain to be answered about the pilot project, however, is the problem of outliers (patients whose care doesn’t fit neatly within the prescribed protocol, such as those with significant comorbidities or adverse drug reactions that require a change in the treatment regimen).

"When one starts to deal with individual practices who have just a couple of these patients, one outlier can make it financially very difficult, so the question is, how often is that going to happen?" Dr. Silver said.

Dr. Hoadley said that the system needs to have flexibility to account for differences in the patient population. "Obviously, you’ve got to get that bundled amount right and appropriately adjusted for the average, across the kind of patients the practice is going to see, with some particular adjustments for patient severity," and other factors, he commented.

Where there are outliers, there are also inliers (patients who, for medical or other reasons, don’t undergo a full course of prescribed therapy), and in these cases, bundled payments would result in additional income for a practice, Dr. Lichter said. Over time, the outliers and inliers tend to balance out, and in the case of the extraordinary outlier – the patient who is admitted for a planned 2-day stay but ends up being hospitalized for 6 months – some sort of contingency payment would be made, he added.

"In talking to United Healthcare, while they didn’t sit down and write rules for every possible situation, I know that if a case is so far beyond the norm, they will sit down and look at it and agree to some type of remedial payment for it," he said.

Rare Cancers and Cherry Picking

A related issue of concern is how bundled payment systems would handle rare cancers, or clinical situations for which there is little or no consensus on optimal therapies, such as the use of chemotherapy for some soft-tissue sarcomas.

As vice-chair of the board of the National Comprehensive Cancer Network, Dr. Silver is an advocate of evidence-based guidelines, but said he’s aware that many patients have variations that don’t fit neatly into the standard chemotherapy guidelines that are acceptable under a bundled-payment system.

"Which brings us to another issue: Would there be cherry picking?" he asked. "Because it would be the patients who are young and healthy and can go through those therapies, and [who] don’t have comorbidities and variations on their disease that would best fit into these bundled programs. So what happens to the others?"

In such cases, the burden of care for the more severely ill patients would fall on teaching hospitals, and it’s unclear whether they would be adequately compensated under a bundled-payment system, he said.

Stifle Drug Development?

Matt Farber, director of provider economics and public policy for the Association of Community Cancer Centers, said that bundled-payment systems could have a dampening effect on drug development. He points to sipuleucel-T (Provenge), the recently approved autologous immunotherapy vaccine for advanced prostate cancer that uses antigen-presenting cells unique to each patient.

"Would payment systems like this stop those drugs from being developed? Because if it’s a personalized treatment, would it therefore not be included in whatever benchmark is deemed the most appropriate or most effective care for most people?" Mr. Farber asked.

And what happens when novel drugs or new versions of conventional chemotherapeutic agents (such as palifosfamide, an active metabolite of ifosfamide) come on the market?

"They’re working right now with these five practices to determine what are the best courses of treatment currently for the disease states that they’re looking at. So when a new drug comes down the line, what’s the process and how quickly do they update?" Mr. Farber said.

Similarly, said Dr. Silver, if patients are being treated and oncologists are being paid according to best medical practice, there would be fewer incentives for patients to enroll in clinical trials, which are the principal means whereby the science of medicine advances.

Define ‘Costs’

It’s also unclear just how drug costs would be defined under the proposed system, Georgetown’s Dr. Hoadley said.

"The company says, ‘Chemotherapy drugs will be reimbursed at manufacturer’s cost.’ But as Medicare has learned, that’s an ambiguous term. Medicare has gone from reimbursing based on average wholesale price to now the average sales price, and has come up with new mechanisms to define fairly what the price is for the practices that are paying to get those drugs. So the details need to be filled in about how they’re going to go about doing that," he said.

"The good news, potentially, is that you can get away from this old system that has existed for much of the past, where the practices could make money on drug reimbursements (which is how they made money to finance other things), but it would create potentially distorted incentives. You’ve still got to get it right, though," he added.

Although it’s still early, the pilot program is a good place to start, according to Dr. Lichter.

"One wants to start a pilot project in situations where there’s a lot of grounding in the types of therapies that are appropriate, so the choices are relatively limited and you can draw a box around the universe of care. If you find out that this works – if the patients are satisfied, the payers are satisfied, the system seems to be working well, and you’ve done the appropriate tweaks and nips and tucks to make it better – then you have to begin to expand it," he said.

A major insurance company is betting that oncology practices can handle cancer-care payments as if they were like the household grocery budget or a weekly allowance: Be frugal and you’ll have some left over for next time. Spend too much, and you’ll have to borrow from the future.

Photo credit: National Cancer Institute

The idea of its pilot study, says UnitedHealthcare, based in Minnetonka, Minn., is to separate drug costs from treatment costs by paying oncologists an up-front, per-patient fee. (In insurance-speak, this is called a "bundled" or "episode" payment.) The payments will be based on best medical practices for three common malignancies: breast cancer, colon cancer, and lung cancer. Decisions about optimal treatment for each disease state will be determined by consensus among clinicians, and not by the insurer, the company said in a press release.

"By paying medical oncologists for a patient’s total cycle of treatment, rather than the number of visits and the amount of chemotherapy drugs given, this program promotes better, more patient-centric, evidence-based care with no loss of revenue for the physician," said Dr. Lee N. Newcomer, UnitedHealthcare’s senior vice president for oncology. "Everyone wins. As oncologists share best practices from the program about which treatment regimens are most effective, we expect to see consistently improved patient outcomes."

The company is working with five small- to mid-size oncology practices based in Dayton, Ohio; Fort Worth, Tex.; Kansas City, Mo; Marietta, Ga.; and Memphis. Analysis is to begin after a year’s data are collected.

"Over the course of the pilot, the various treatment regimens selected by the medical groups will be evaluated to identify which are the most effective for a range of clinical presentations [such as physical signs and symptoms and diagnoses]. UnitedHealthcare will play no role in determining which treatment plan the oncologists choose, but the intent of the pilot is to identify and reduce unnecessary drug administration that does not improve the patient’s health outcomes," the company stated.

Under this payment system, the insurer will determine its cancer-care payments based on the difference between drug costs and the current fee schedule of the oncology group, with payments made on the first day on which an insured patient receives care from that practice. The payments will include case-management fees to cover patient management costs.

Thus, if during the course of an individual patient’s care clinicians decide to switch to a more expensive drug, there would be no additional payments to compensate for the difference.

Each of the agreed-upon regimens in the pilot will be evaluated based on health outcomes and the frequency of adverse events, emergency department visits, and other consequences that can drive up costs without additional treatment benefit, the insurer says.

Worth a Look

The proposed payment model is an interesting approach to the goal of containing medical costs while fairly compensating clinicians and protecting high-quality patient care. But it also raises many questions about its applicability across a broad range of clinical and financial situations, say medical economists and oncologists who were interviewed for this article.

"We are pleased to see experimentation taking place around how oncology care is paid for," said Dr. Allen S. Lichter, CEO of the American Society of Clinical Oncology. "The oncology community needs to do these pilot projects, and understand whether moving away from the current models based on fee-for-service and some percentage of margin off the chemotherapy agents can be replaced by something else – and if so, what should that something else look like and how does it work?"

"I think it’s an interesting experiment and an important one, one that Dr. Newcomer and United can run because of their large claims-based database, and we’re all interested to see how it works," agreed Dr. Samuel M. Silver, chair of the subcommittee on reimbursement for the American Society of Hematology and a professor of internal medicine at the University of Michigan in Ann Arbor.

Jack Hoadley, Ph.D., a health policy analyst and research professor at the Health Policy Institute at Georgetown University in Washington, D.C., noted that "Medicare has tried a number of experiments with various types of bundled payments, and it seems [as if] Medicare could either watch what’s going on in this private-sector pilot and use that as a way to learn, or – sooner than that – try bundled-payment structures to see how they work."

Outliers Could Be a Problem

One of the many questions that remain to be answered about the pilot project, however, is the problem of outliers (patients whose care doesn’t fit neatly within the prescribed protocol, such as those with significant comorbidities or adverse drug reactions that require a change in the treatment regimen).

"When one starts to deal with individual practices who have just a couple of these patients, one outlier can make it financially very difficult, so the question is, how often is that going to happen?" Dr. Silver said.

Dr. Hoadley said that the system needs to have flexibility to account for differences in the patient population. "Obviously, you’ve got to get that bundled amount right and appropriately adjusted for the average, across the kind of patients the practice is going to see, with some particular adjustments for patient severity," and other factors, he commented.

Where there are outliers, there are also inliers (patients who, for medical or other reasons, don’t undergo a full course of prescribed therapy), and in these cases, bundled payments would result in additional income for a practice, Dr. Lichter said. Over time, the outliers and inliers tend to balance out, and in the case of the extraordinary outlier – the patient who is admitted for a planned 2-day stay but ends up being hospitalized for 6 months – some sort of contingency payment would be made, he added.

"In talking to United Healthcare, while they didn’t sit down and write rules for every possible situation, I know that if a case is so far beyond the norm, they will sit down and look at it and agree to some type of remedial payment for it," he said.

Rare Cancers and Cherry Picking

A related issue of concern is how bundled payment systems would handle rare cancers, or clinical situations for which there is little or no consensus on optimal therapies, such as the use of chemotherapy for some soft-tissue sarcomas.

As vice-chair of the board of the National Comprehensive Cancer Network, Dr. Silver is an advocate of evidence-based guidelines, but said he’s aware that many patients have variations that don’t fit neatly into the standard chemotherapy guidelines that are acceptable under a bundled-payment system.

"Which brings us to another issue: Would there be cherry picking?" he asked. "Because it would be the patients who are young and healthy and can go through those therapies, and [who] don’t have comorbidities and variations on their disease that would best fit into these bundled programs. So what happens to the others?"

In such cases, the burden of care for the more severely ill patients would fall on teaching hospitals, and it’s unclear whether they would be adequately compensated under a bundled-payment system, he said.

Stifle Drug Development?

Matt Farber, director of provider economics and public policy for the Association of Community Cancer Centers, said that bundled-payment systems could have a dampening effect on drug development. He points to sipuleucel-T (Provenge), the recently approved autologous immunotherapy vaccine for advanced prostate cancer that uses antigen-presenting cells unique to each patient.

"Would payment systems like this stop those drugs from being developed? Because if it’s a personalized treatment, would it therefore not be included in whatever benchmark is deemed the most appropriate or most effective care for most people?" Mr. Farber asked.

And what happens when novel drugs or new versions of conventional chemotherapeutic agents (such as palifosfamide, an active metabolite of ifosfamide) come on the market?

"They’re working right now with these five practices to determine what are the best courses of treatment currently for the disease states that they’re looking at. So when a new drug comes down the line, what’s the process and how quickly do they update?" Mr. Farber said.

Similarly, said Dr. Silver, if patients are being treated and oncologists are being paid according to best medical practice, there would be fewer incentives for patients to enroll in clinical trials, which are the principal means whereby the science of medicine advances.

Define ‘Costs’

It’s also unclear just how drug costs would be defined under the proposed system, Georgetown’s Dr. Hoadley said.

"The company says, ‘Chemotherapy drugs will be reimbursed at manufacturer’s cost.’ But as Medicare has learned, that’s an ambiguous term. Medicare has gone from reimbursing based on average wholesale price to now the average sales price, and has come up with new mechanisms to define fairly what the price is for the practices that are paying to get those drugs. So the details need to be filled in about how they’re going to go about doing that," he said.

"The good news, potentially, is that you can get away from this old system that has existed for much of the past, where the practices could make money on drug reimbursements (which is how they made money to finance other things), but it would create potentially distorted incentives. You’ve still got to get it right, though," he added.

Although it’s still early, the pilot program is a good place to start, according to Dr. Lichter.

"One wants to start a pilot project in situations where there’s a lot of grounding in the types of therapies that are appropriate, so the choices are relatively limited and you can draw a box around the universe of care. If you find out that this works – if the patients are satisfied, the payers are satisfied, the system seems to be working well, and you’ve done the appropriate tweaks and nips and tucks to make it better – then you have to begin to expand it," he said.

A major insurance company is betting that oncology practices can handle cancer-care payments as if they were like the household grocery budget or a weekly allowance: Be frugal and you’ll have some left over for next time. Spend too much, and you’ll have to borrow from the future.

The idea of its pilot study, says UnitedHealthcare, based in Minnetonka, Minn., is to separate drug costs from treatment costs by paying oncologists an up-front, per-patient fee. (In insurance-speak, this is called a "bundled" or "episode" payment.) The payments will be based on best medical practices for three common malignancies: breast cancer, colon cancer, and lung cancer. Decisions about optimal treatment for each disease state will be determined by consensus among clinicians, and not by the insurer, the company said in a press release.

Photo courtesy National Cancer Institute

"By paying medical oncologists for a patient’s total cycle of treatment, rather than the number of visits and the amount of chemotherapy drugs given, this program promotes better, more patient-centric, evidence-based care with no loss of revenue for the physician," said Dr. Lee N. Newcomer, UnitedHealthcare’s senior vice president for oncology. "Everyone wins. As oncologists share best practices from the program about which treatment regimens are most effective, we expect to see consistently improved patient outcomes."

The company is working with five small- to mid-size oncology practices based in Dayton, Ohio; Fort Worth, Tex.; Kansas City, Mo; Marietta, Ga.; and Memphis. Analysis is to begin after a year’s data are collected.

"Over the course of the pilot, the various treatment regimens selected by the medical groups will be evaluated to identify which are the most effective for a range of clinical presentations [such as physical signs and symptoms and diagnoses]. UnitedHealthcare will play no role in determining which treatment plan the oncologists choose, but the intent of the pilot is to identify and reduce unnecessary drug administration that does not improve the patient’s health outcomes," the company stated.

Under this payment system, the insurer will determine its cancer-care payments based on the difference between drug costs and the current fee schedule of the oncology group, with payments made on the first day on which an insured patient receives care from that practice. The payments will include case-management fees to cover patient management costs.

Thus, if during the course of an individual patient’s care clinicians decide to switch to a more expensive drug, there would be no additional payments to compensate for the difference.

Each of the agreed-upon regimens in the pilot will be evaluated based on health outcomes and the frequency of adverse events, emergency department visits, and other consequences that can drive up costs without additional treatment benefit, the insurer says.

Worth a Look

The proposed payment model is an interesting approach to the goal of containing medical costs while fairly compensating clinicians and protecting high-quality patient care. But it also raises many questions about its applicability across a broad range of clinical and financial situations, say medical economists and oncologists who were interviewed for this article.

"We are pleased to see experimentation taking place around how oncology care is paid for," said Dr. Allen S. Lichter, CEO of the American Society of Clinical Oncology. "The oncology community needs to do these pilot projects, and understand whether moving away from the current models based on fee-for-service and some percentage of margin off the chemotherapy agents can be replaced by something else – and if so, what should that something else look like and how does it work?"

"I think it's an interesting experiment and an important one, one that Dr. Newcomer and United can run because of their large claims-based database, and we’re all interested to see how it works," agreed Dr. Samuel M. Silver, chair of the subcommittee on reimbursement for the American Society of Hematology and a professor of internal medicine at the University of Michigan in Ann Arbor.

Jack Hoadley, Ph.D., a health policy analyst and research professor at the Health Policy Institute at Georgetown University in Washington, D.C., noted that "Medicare has tried a number of experiments with various types of bundled payments, and it seems [as if] Medicare could either watch what’s going on in this private-sector pilot and use that as a way to learn, or – sooner than that – try bundled-payment structures to see how they work."

Outliers Could Be a Problem

One of the many questions that remain to be answered about the pilot project, however, is the problem of outliers (patients whose care doesn’t fit neatly within the prescribed protocol, such as those with significant comorbidities or adverse drug reactions that require a change in the treatment regimen).

"When one starts to deal with individual practices who have just a couple of these patients, one outlier can make it financially very difficult, so the question is, how often is that going to happen?" Dr. Silver said.

Dr. Hoadley said that the system needs to have flexibility to account for differences in the patient population. "Obviously, you’ve got to get that bundled amount right and appropriately adjusted for the average, across the kind of patients the practice is going to see, with some particular adjustments for patient severity," and other factors, he commented.

Where there are outliers, there are also inliers (patients who, for medical or other reasons, don’t undergo a full course of prescribed therapy), and in these cases, bundled payments would result in additional income for a practice, Dr. Lichter said. Over time, the outliers and inliers tend to balance out, and in the case of the extraordinary outlier – the patient who is admitted for a planned 2-day stay but ends up being hospitalized for 6 months – some sort of contingency payment would be made, he added.

"In talking to United Healthcare, while they didn’t sit down and write rules for every possible situation, I know that if a case is so far beyond the norm, they will sit down and look at it and agree to some type of remedial payment for it," he said.

Rare Cancers and Cherry Picking

A related issue of concern is how bundled payment systems would handle rare cancers, or clinical situations for which there is little or no consensus on optimal therapies, such as the use of chemotherapy for some soft-tissue sarcomas.

As vice-chair of the board of the National Comprehensive Cancer Network, Dr. Silver is an advocate of evidence-based guidelines, but said he’s aware that many patients have variations that don’t fit neatly into the standard chemotherapy guidelines that are acceptable under a bundled-payment system.

"Which brings us to another issue: Would there be cherry picking?" he asked. "Because it would be the patients who are young and healthy and can go through those therapies, and [who] don't have comorbidities and variations on their disease that would best fit into these bundled programs. So what happens to the others?"

In such cases, the burden of care for the more severely ill patients would fall on teaching hospitals, and it’s unclear whether they would be adequately compensated under a bundled-payment system, he said.

Stifle Drug Development?

Matt Farber, director of provider economics and public policy for the Association of Community Cancer Centers, said that bundled-payment systems could have a dampening effect on drug development. He points to sipuleucel-T (Provenge), the recently approved autologous immunotherapy vaccine for advanced prostate cancer that uses antigen-presenting cells unique to each patient.

"Would payment systems like this stop those drugs from being developed? Because if it’s a personalized treatment, would it therefore not be included in whatever benchmark is deemed the most appropriate or most effective care for most people?" Mr. Farber asked.

And what happens when novel drugs or new versions of conventional chemotherapeutic agents (such as palifosfamide, an active metabolite of ifosfamide) come on the market?

"They’re working right now with these five practices to determine what are the best courses of treatment currently for the disease states that they’re looking at. So when a new drug comes down the line, what’s the process and how quickly do they update?" Mr. Farber said.

Similarly, said Dr. Silver, if patients are being treated and oncologists are being paid according to best medical practice, there would be fewer incentives for patients to enroll in clinical trials, which are the principal means whereby the science of medicine advances.

Define 'Costs'

It’s also unclear just how drug costs would be defined under the proposed system, Georgetown’s, Dr. Hoadley said.

"The company says, 'Chemotherapy drugs will be reimbursed at manufacturer’s cost.' But as Medicare has learned, that’s an ambiguous term. Medicare has gone from reimbursing based on average wholesale price to now the average sales price, and has come up with new mechanisms to define fairly what the price is for the practices that are paying to get those drugs. So the details need to be filled in about how they’re going to go about doing that," he said.

"The good news, potentially, is that you can get away from this old system that has existed for much of the past, where the practices could make money on drug reimbursements (which is how they made money to finance other things), but it would create potentially distorted incentives. You've still got to get it right, though," he added.

Although it’s still early, the pilot program is a good place to start, according to Dr. Lichter.

"One wants to start a pilot project in situations where there’s a lot of grounding in the types of therapies that are appropriate, so the choices are relatively limited and you can draw a box around the universe of care. If you find out that this works – if the patients are satisfied, the payers are satisfied, the system seems to be working well, and you’ve done the appropriate tweaks and nips and tucks to make it better – then you have to begin to expand it," he said.

A major insurance company is betting that oncology practices can handle cancer-care payments as if they were like the household grocery budget or a weekly allowance: Be frugal and you’ll have some left over for next time. Spend too much, and you’ll have to borrow from the future.

The idea of its pilot study, says UnitedHealthcare, based in Minnetonka, Minn., is to separate drug costs from treatment costs by paying oncologists an up-front, per-patient fee. (In insurance-speak, this is called a "bundled" or "episode" payment.) The payments will be based on best medical practices for three common malignancies: breast cancer, colon cancer, and lung cancer. Decisions about optimal treatment for each disease state will be determined by consensus among clinicians, and not by the insurer, the company said in a press release.

Photo courtesy National Cancer Institute

"By paying medical oncologists for a patient’s total cycle of treatment, rather than the number of visits and the amount of chemotherapy drugs given, this program promotes better, more patient-centric, evidence-based care with no loss of revenue for the physician," said Dr. Lee N. Newcomer, UnitedHealthcare’s senior vice president for oncology. "Everyone wins. As oncologists share best practices from the program about which treatment regimens are most effective, we expect to see consistently improved patient outcomes."

The company is working with five small- to mid-size oncology practices based in Dayton, Ohio; Fort Worth, Tex.; Kansas City, Mo; Marietta, Ga.; and Memphis. Analysis is to begin after a year’s data are collected.

"Over the course of the pilot, the various treatment regimens selected by the medical groups will be evaluated to identify which are the most effective for a range of clinical presentations [such as physical signs and symptoms and diagnoses]. UnitedHealthcare will play no role in determining which treatment plan the oncologists choose, but the intent of the pilot is to identify and reduce unnecessary drug administration that does not improve the patient’s health outcomes," the company stated.

Under this payment system, the insurer will determine its cancer-care payments based on the difference between drug costs and the current fee schedule of the oncology group, with payments made on the first day on which an insured patient receives care from that practice. The payments will include case-management fees to cover patient management costs.

Thus, if during the course of an individual patient’s care clinicians decide to switch to a more expensive drug, there would be no additional payments to compensate for the difference.

Each of the agreed-upon regimens in the pilot will be evaluated based on health outcomes and the frequency of adverse events, emergency department visits, and other consequences that can drive up costs without additional treatment benefit, the insurer says.

Worth a Look

The proposed payment model is an interesting approach to the goal of containing medical costs while fairly compensating clinicians and protecting high-quality patient care. But it also raises many questions about its applicability across a broad range of clinical and financial situations, say medical economists and oncologists who were interviewed for this article.

"We are pleased to see experimentation taking place around how oncology care is paid for," said Dr. Allen S. Lichter, CEO of the American Society of Clinical Oncology. "The oncology community needs to do these pilot projects, and understand whether moving away from the current models based on fee-for-service and some percentage of margin off the chemotherapy agents can be replaced by something else – and if so, what should that something else look like and how does it work?"

"I think it's an interesting experiment and an important one, one that Dr. Newcomer and United can run because of their large claims-based database, and we’re all interested to see how it works," agreed Dr. Samuel M. Silver, chair of the subcommittee on reimbursement for the American Society of Hematology and a professor of internal medicine at the University of Michigan in Ann Arbor.

Jack Hoadley, Ph.D., a health policy analyst and research professor at the Health Policy Institute at Georgetown University in Washington, D.C., noted that "Medicare has tried a number of experiments with various types of bundled payments, and it seems [as if] Medicare could either watch what’s going on in this private-sector pilot and use that as a way to learn, or – sooner than that – try bundled-payment structures to see how they work."

Outliers Could Be a Problem

One of the many questions that remain to be answered about the pilot project, however, is the problem of outliers (patients whose care doesn’t fit neatly within the prescribed protocol, such as those with significant comorbidities or adverse drug reactions that require a change in the treatment regimen).

"When one starts to deal with individual practices who have just a couple of these patients, one outlier can make it financially very difficult, so the question is, how often is that going to happen?" Dr. Silver said.

Dr. Hoadley said that the system needs to have flexibility to account for differences in the patient population. "Obviously, you’ve got to get that bundled amount right and appropriately adjusted for the average, across the kind of patients the practice is going to see, with some particular adjustments for patient severity," and other factors, he commented.

Where there are outliers, there are also inliers (patients who, for medical or other reasons, don’t undergo a full course of prescribed therapy), and in these cases, bundled payments would result in additional income for a practice, Dr. Lichter said. Over time, the outliers and inliers tend to balance out, and in the case of the extraordinary outlier – the patient who is admitted for a planned 2-day stay but ends up being hospitalized for 6 months – some sort of contingency payment would be made, he added.

"In talking to United Healthcare, while they didn’t sit down and write rules for every possible situation, I know that if a case is so far beyond the norm, they will sit down and look at it and agree to some type of remedial payment for it," he said.

Rare Cancers and Cherry Picking

A related issue of concern is how bundled payment systems would handle rare cancers, or clinical situations for which there is little or no consensus on optimal therapies, such as the use of chemotherapy for some soft-tissue sarcomas.

As vice-chair of the board of the National Comprehensive Cancer Network, Dr. Silver is an advocate of evidence-based guidelines, but said he’s aware that many patients have variations that don’t fit neatly into the standard chemotherapy guidelines that are acceptable under a bundled-payment system.

"Which brings us to another issue: Would there be cherry picking?" he asked. "Because it would be the patients who are young and healthy and can go through those therapies, and [who] don't have comorbidities and variations on their disease that would best fit into these bundled programs. So what happens to the others?"

In such cases, the burden of care for the more severely ill patients would fall on teaching hospitals, and it’s unclear whether they would be adequately compensated under a bundled-payment system, he said.

Stifle Drug Development?

Matt Farber, director of provider economics and public policy for the Association of Community Cancer Centers, said that bundled-payment systems could have a dampening effect on drug development. He points to sipuleucel-T (Provenge), the recently approved autologous immunotherapy vaccine for advanced prostate cancer that uses antigen-presenting cells unique to each patient.

"Would payment systems like this stop those drugs from being developed? Because if it’s a personalized treatment, would it therefore not be included in whatever benchmark is deemed the most appropriate or most effective care for most people?" Mr. Farber asked.

And what happens when novel drugs or new versions of conventional chemotherapeutic agents (such as palifosfamide, an active metabolite of ifosfamide) come on the market?

"They’re working right now with these five practices to determine what are the best courses of treatment currently for the disease states that they’re looking at. So when a new drug comes down the line, what’s the process and how quickly do they update?" Mr. Farber said.

Similarly, said Dr. Silver, if patients are being treated and oncologists are being paid according to best medical practice, there would be fewer incentives for patients to enroll in clinical trials, which are the principal means whereby the science of medicine advances.

Define 'Costs'

It’s also unclear just how drug costs would be defined under the proposed system, Georgetown’s, Dr. Hoadley said.

"The company says, 'Chemotherapy drugs will be reimbursed at manufacturer’s cost.' But as Medicare has learned, that’s an ambiguous term. Medicare has gone from reimbursing based on average wholesale price to now the average sales price, and has come up with new mechanisms to define fairly what the price is for the practices that are paying to get those drugs. So the details need to be filled in about how they’re going to go about doing that," he said.

"The good news, potentially, is that you can get away from this old system that has existed for much of the past, where the practices could make money on drug reimbursements (which is how they made money to finance other things), but it would create potentially distorted incentives. You've still got to get it right, though," he added.

Although it’s still early, the pilot program is a good place to start, according to Dr. Lichter.

"One wants to start a pilot project in situations where there’s a lot of grounding in the types of therapies that are appropriate, so the choices are relatively limited and you can draw a box around the universe of care. If you find out that this works – if the patients are satisfied, the payers are satisfied, the system seems to be working well, and you’ve done the appropriate tweaks and nips and tucks to make it better – then you have to begin to expand it," he said.

A major insurance company is betting that oncology practices can handle cancer-care payments as if they were like the household grocery budget or a weekly allowance: Be frugal and you’ll have some left over for next time. Spend too much, and you’ll have to borrow from the future.

The idea of its pilot study, says UnitedHealthcare, based in Minnetonka, Minn., is to separate drug costs from treatment costs by paying oncologists an up-front, per-patient fee. (In insurance-speak, this is called a "bundled" or "episode" payment.) The payments will be based on best medical practices for three common malignancies: breast cancer, colon cancer, and lung cancer. Decisions about optimal treatment for each disease state will be determined by consensus among clinicians, and not by the insurer, the company said in a press release.

Photo courtesy National Cancer Institute

"By paying medical oncologists for a patient’s total cycle of treatment, rather than the number of visits and the amount of chemotherapy drugs given, this program promotes better, more patient-centric, evidence-based care with no loss of revenue for the physician," said Dr. Lee N. Newcomer, UnitedHealthcare’s senior vice president for oncology. "Everyone wins. As oncologists share best practices from the program about which treatment regimens are most effective, we expect to see consistently improved patient outcomes."

The company is working with five small- to mid-size oncology practices based in Dayton, Ohio; Fort Worth, Tex.; Kansas City, Mo; Marietta, Ga.; and Memphis. Analysis is to begin after a year’s data are collected.

"Over the course of the pilot, the various treatment regimens selected by the medical groups will be evaluated to identify which are the most effective for a range of clinical presentations [such as physical signs and symptoms and diagnoses]. UnitedHealthcare will play no role in determining which treatment plan the oncologists choose, but the intent of the pilot is to identify and reduce unnecessary drug administration that does not improve the patient’s health outcomes," the company stated.

Under this payment system, the insurer will determine its cancer-care payments based on the difference between drug costs and the current fee schedule of the oncology group, with payments made on the first day on which an insured patient receives care from that practice. The payments will include case-management fees to cover patient management costs.

Thus, if during the course of an individual patient’s care clinicians decide to switch to a more expensive drug, there would be no additional payments to compensate for the difference.

Each of the agreed-upon regimens in the pilot will be evaluated based on health outcomes and the frequency of adverse events, emergency department visits, and other consequences that can drive up costs without additional treatment benefit, the insurer says.

Worth a Look

The proposed payment model is an interesting approach to the goal of containing medical costs while fairly compensating clinicians and protecting high-quality patient care. But it also raises many questions about its applicability across a broad range of clinical and financial situations, say medical economists and oncologists who were interviewed for this article.

"We are pleased to see experimentation taking place around how oncology care is paid for," said Dr. Allen S. Lichter, CEO of the American Society of Clinical Oncology. "The oncology community needs to do these pilot projects, and understand whether moving away from the current models based on fee-for-service and some percentage of margin off the chemotherapy agents can be replaced by something else – and if so, what should that something else look like and how does it work?"

"I think it's an interesting experiment and an important one, one that Dr. Newcomer and United can run because of their large claims-based database, and we’re all interested to see how it works," agreed Dr. Samuel M. Silver, chair of the subcommittee on reimbursement for the American Society of Hematology and a professor of internal medicine at the University of Michigan in Ann Arbor.

Jack Hoadley, Ph.D., a health policy analyst and research professor at the Health Policy Institute at Georgetown University in Washington, D.C., noted that "Medicare has tried a number of experiments with various types of bundled payments, and it seems [as if] Medicare could either watch what’s going on in this private-sector pilot and use that as a way to learn, or – sooner than that – try bundled-payment structures to see how they work."

Outliers Could Be a Problem

One of the many questions that remain to be answered about the pilot project, however, is the problem of outliers (patients whose care doesn’t fit neatly within the prescribed protocol, such as those with significant comorbidities or adverse drug reactions that require a change in the treatment regimen).

"When one starts to deal with individual practices who have just a couple of these patients, one outlier can make it financially very difficult, so the question is, how often is that going to happen?" Dr. Silver said.

Dr. Hoadley said that the system needs to have flexibility to account for differences in the patient population. "Obviously, you’ve got to get that bundled amount right and appropriately adjusted for the average, across the kind of patients the practice is going to see, with some particular adjustments for patient severity," and other factors, he commented.

Where there are outliers, there are also inliers (patients who, for medical or other reasons, don’t undergo a full course of prescribed therapy), and in these cases, bundled payments would result in additional income for a practice, Dr. Lichter said. Over time, the outliers and inliers tend to balance out, and in the case of the extraordinary outlier – the patient who is admitted for a planned 2-day stay but ends up being hospitalized for 6 months – some sort of contingency payment would be made, he added.

"In talking to United Healthcare, while they didn’t sit down and write rules for every possible situation, I know that if a case is so far beyond the norm, they will sit down and look at it and agree to some type of remedial payment for it," he said.

Rare Cancers and Cherry Picking

A related issue of concern is how bundled payment systems would handle rare cancers, or clinical situations for which there is little or no consensus on optimal therapies, such as the use of chemotherapy for some soft-tissue sarcomas.

As vice-chair of the board of the National Comprehensive Cancer Network, Dr. Silver is an advocate of evidence-based guidelines, but said he’s aware that many patients have variations that don’t fit neatly into the standard chemotherapy guidelines that are acceptable under a bundled-payment system.

"Which brings us to another issue: Would there be cherry picking?" he asked. "Because it would be the patients who are young and healthy and can go through those therapies, and [who] don't have comorbidities and variations on their disease that would best fit into these bundled programs. So what happens to the others?"

In such cases, the burden of care for the more severely ill patients would fall on teaching hospitals, and it’s unclear whether they would be adequately compensated under a bundled-payment system, he said.

Stifle Drug Development?

Matt Farber, director of provider economics and public policy for the Association of Community Cancer Centers, said that bundled-payment systems could have a dampening effect on drug development. He points to sipuleucel-T (Provenge), the recently approved autologous immunotherapy vaccine for advanced prostate cancer that uses antigen-presenting cells unique to each patient.

"Would payment systems like this stop those drugs from being developed? Because if it’s a personalized treatment, would it therefore not be included in whatever benchmark is deemed the most appropriate or most effective care for most people?" Mr. Farber asked.

And what happens when novel drugs or new versions of conventional chemotherapeutic agents (such as palifosfamide, an active metabolite of ifosfamide) come on the market?

"They’re working right now with these five practices to determine what are the best courses of treatment currently for the disease states that they’re looking at. So when a new drug comes down the line, what’s the process and how quickly do they update?" Mr. Farber said.

Similarly, said Dr. Silver, if patients are being treated and oncologists are being paid according to best medical practice, there would be fewer incentives for patients to enroll in clinical trials, which are the principal means whereby the science of medicine advances.

Define 'Costs'

It’s also unclear just how drug costs would be defined under the proposed system, Georgetown’s, Dr. Hoadley said.

"The company says, 'Chemotherapy drugs will be reimbursed at manufacturer’s cost.' But as Medicare has learned, that’s an ambiguous term. Medicare has gone from reimbursing based on average wholesale price to now the average sales price, and has come up with new mechanisms to define fairly what the price is for the practices that are paying to get those drugs. So the details need to be filled in about how they’re going to go about doing that," he said.

"The good news, potentially, is that you can get away from this old system that has existed for much of the past, where the practices could make money on drug reimbursements (which is how they made money to finance other things), but it would create potentially distorted incentives. You've still got to get it right, though," he added.

Although it’s still early, the pilot program is a good place to start, according to Dr. Lichter.

"One wants to start a pilot project in situations where there’s a lot of grounding in the types of therapies that are appropriate, so the choices are relatively limited and you can draw a box around the universe of care. If you find out that this works – if the patients are satisfied, the payers are satisfied, the system seems to be working well, and you’ve done the appropriate tweaks and nips and tucks to make it better – then you have to begin to expand it," he said.

A major insurance company is betting that oncology practices can handle cancer-care payments as if they were like the household grocery budget or a weekly allowance: Be frugal and you’ll have some left over for next time. Spend too much, and you’ll have to borrow from the future.

Photo credit: National Cancer Institute

The idea of its pilot study, says UnitedHealthcare, based in Minnetonka, Minn., is to separate drug costs from treatment costs by paying oncologists an up-front, per-patient fee. (In insurance-speak, this is called a "bundled" or "episode" payment.) The payments will be based on best medical practices for three common malignancies: breast cancer, colon cancer, and lung cancer. Decisions about optimal treatment for each disease state will be determined by consensus among clinicians, and not by the insurer, the company said in a press release.

"By paying medical oncologists for a patient’s total cycle of treatment, rather than the number of visits and the amount of chemotherapy drugs given, this program promotes better, more patient-centric, evidence-based care with no loss of revenue for the physician," said Dr. Lee N. Newcomer, UnitedHealthcare’s senior vice president for oncology. "Everyone wins. As oncologists share best practices from the program about which treatment regimens are most effective, we expect to see consistently improved patient outcomes."

The company is working with five small- to mid-size oncology practices based in Dayton, Ohio; Fort Worth, Tex.; Kansas City, Mo; Marietta, Ga.; and Memphis. Analysis is to begin after a year’s data are collected.

"Over the course of the pilot, the various treatment regimens selected by the medical groups will be evaluated to identify which are the most effective for a range of clinical presentations [such as physical signs and symptoms and diagnoses]. UnitedHealthcare will play no role in determining which treatment plan the oncologists choose, but the intent of the pilot is to identify and reduce unnecessary drug administration that does not improve the patient’s health outcomes," the company stated.

Under this payment system, the insurer will determine its cancer-care payments based on the difference between drug costs and the current fee schedule of the oncology group, with payments made on the first day on which an insured patient receives care from that practice. The payments will include case-management fees to cover patient management costs.

Thus, if during the course of an individual patient’s care clinicians decide to switch to a more expensive drug, there would be no additional payments to compensate for the difference.

Each of the agreed-upon regimens in the pilot will be evaluated based on health outcomes and the frequency of adverse events, emergency department visits, and other consequences that can drive up costs without additional treatment benefit, the insurer says.

Worth a Look

The proposed payment model is an interesting approach to the goal of containing medical costs while fairly compensating clinicians and protecting high-quality patient care. But it also raises many questions about its applicability across a broad range of clinical and financial situations, say medical economists and oncologists who were interviewed for this article.

"We are pleased to see experimentation taking place around how oncology care is paid for," said Dr. Allen S. Lichter, CEO of the American Society of Clinical Oncology. "The oncology community needs to do these pilot projects, and understand whether moving away from the current models based on fee-for-service and some percentage of margin off the chemotherapy agents can be replaced by something else – and if so, what should that something else look like and how does it work?"

"I think it’s an interesting experiment and an important one, one that Dr. Newcomer and United can run because of their large claims-based database, and we’re all interested to see how it works," agreed Dr. Samuel M. Silver, chair of the subcommittee on reimbursement for the American Society of Hematology and a professor of internal medicine at the University of Michigan in Ann Arbor.

Jack Hoadley, Ph.D., a health policy analyst and research professor at the Health Policy Institute at Georgetown University in Washington, D.C., noted that "Medicare has tried a number of experiments with various types of bundled payments, and it seems [as if] Medicare could either watch what’s going on in this private-sector pilot and use that as a way to learn, or – sooner than that – try bundled-payment structures to see how they work."

Outliers Could Be a Problem

One of the many questions that remain to be answered about the pilot project, however, is the problem of outliers (patients whose care doesn’t fit neatly within the prescribed protocol, such as those with significant comorbidities or adverse drug reactions that require a change in the treatment regimen).

"When one starts to deal with individual practices who have just a couple of these patients, one outlier can make it financially very difficult, so the question is, how often is that going to happen?" Dr. Silver said.

Dr. Hoadley said that the system needs to have flexibility to account for differences in the patient population. "Obviously, you’ve got to get that bundled amount right and appropriately adjusted for the average, across the kind of patients the practice is going to see, with some particular adjustments for patient severity," and other factors, he commented.

Where there are outliers, there are also inliers (patients who, for medical or other reasons, don’t undergo a full course of prescribed therapy), and in these cases, bundled payments would result in additional income for a practice, Dr. Lichter said. Over time, the outliers and inliers tend to balance out, and in the case of the extraordinary outlier – the patient who is admitted for a planned 2-day stay but ends up being hospitalized for 6 months – some sort of contingency payment would be made, he added.

"In talking to United Healthcare, while they didn’t sit down and write rules for every possible situation, I know that if a case is so far beyond the norm, they will sit down and look at it and agree to some type of remedial payment for it," he said.

Rare Cancers and Cherry Picking

A related issue of concern is how bundled payment systems would handle rare cancers, or clinical situations for which there is little or no consensus on optimal therapies, such as the use of chemotherapy for some soft-tissue sarcomas.

As vice-chair of the board of the National Comprehensive Cancer Network, Dr. Silver is an advocate of evidence-based guidelines, but said he’s aware that many patients have variations that don’t fit neatly into the standard chemotherapy guidelines that are acceptable under a bundled-payment system.

"Which brings us to another issue: Would there be cherry picking?" he asked. "Because it would be the patients who are young and healthy and can go through those therapies, and [who] don’t have comorbidities and variations on their disease that would best fit into these bundled programs. So what happens to the others?"

In such cases, the burden of care for the more severely ill patients would fall on teaching hospitals, and it’s unclear whether they would be adequately compensated under a bundled-payment system, he said.

Stifle Drug Development?

Matt Farber, director of provider economics and public policy for the Association of Community Cancer Centers, said that bundled-payment systems could have a dampening effect on drug development. He points to sipuleucel-T (Provenge), the recently approved autologous immunotherapy vaccine for advanced prostate cancer that uses antigen-presenting cells unique to each patient.

"Would payment systems like this stop those drugs from being developed? Because if it’s a personalized treatment, would it therefore not be included in whatever benchmark is deemed the most appropriate or most effective care for most people?" Mr. Farber asked.

And what happens when novel drugs or new versions of conventional chemotherapeutic agents (such as palifosfamide, an active metabolite of ifosfamide) come on the market?

"They’re working right now with these five practices to determine what are the best courses of treatment currently for the disease states that they’re looking at. So when a new drug comes down the line, what’s the process and how quickly do they update?" Mr. Farber said.

Similarly, said Dr. Silver, if patients are being treated and oncologists are being paid according to best medical practice, there would be fewer incentives for patients to enroll in clinical trials, which are the principal means whereby the science of medicine advances.

Define ‘Costs’

It’s also unclear just how drug costs would be defined under the proposed system, Georgetown’s Dr. Hoadley said.

"The company says, ‘Chemotherapy drugs will be reimbursed at manufacturer’s cost.’ But as Medicare has learned, that’s an ambiguous term. Medicare has gone from reimbursing based on average wholesale price to now the average sales price, and has come up with new mechanisms to define fairly what the price is for the practices that are paying to get those drugs. So the details need to be filled in about how they’re going to go about doing that," he said.

"The good news, potentially, is that you can get away from this old system that has existed for much of the past, where the practices could make money on drug reimbursements (which is how they made money to finance other things), but it would create potentially distorted incentives. You’ve still got to get it right, though," he added.

Although it’s still early, the pilot program is a good place to start, according to Dr. Lichter.

"One wants to start a pilot project in situations where there’s a lot of grounding in the types of therapies that are appropriate, so the choices are relatively limited and you can draw a box around the universe of care. If you find out that this works – if the patients are satisfied, the payers are satisfied, the system seems to be working well, and you’ve done the appropriate tweaks and nips and tucks to make it better – then you have to begin to expand it," he said.

A major insurance company is betting that oncology practices can handle cancer-care payments as if they were like the household grocery budget or a weekly allowance: Be frugal and you’ll have some left over for next time. Spend too much, and you’ll have to borrow from the future.

Photo credit: National Cancer Institute

The idea of its pilot study, says UnitedHealthcare, based in Minnetonka, Minn., is to separate drug costs from treatment costs by paying oncologists an up-front, per-patient fee. (In insurance-speak, this is called a "bundled" or "episode" payment.) The payments will be based on best medical practices for three common malignancies: breast cancer, colon cancer, and lung cancer. Decisions about optimal treatment for each disease state will be determined by consensus among clinicians, and not by the insurer, the company said in a press release.

"By paying medical oncologists for a patient’s total cycle of treatment, rather than the number of visits and the amount of chemotherapy drugs given, this program promotes better, more patient-centric, evidence-based care with no loss of revenue for the physician," said Dr. Lee N. Newcomer, UnitedHealthcare’s senior vice president for oncology. "Everyone wins. As oncologists share best practices from the program about which treatment regimens are most effective, we expect to see consistently improved patient outcomes."

The company is working with five small- to mid-size oncology practices based in Dayton, Ohio; Fort Worth, Tex.; Kansas City, Mo; Marietta, Ga.; and Memphis. Analysis is to begin after a year’s data are collected.

"Over the course of the pilot, the various treatment regimens selected by the medical groups will be evaluated to identify which are the most effective for a range of clinical presentations [such as physical signs and symptoms and diagnoses]. UnitedHealthcare will play no role in determining which treatment plan the oncologists choose, but the intent of the pilot is to identify and reduce unnecessary drug administration that does not improve the patient’s health outcomes," the company stated.

Under this payment system, the insurer will determine its cancer-care payments based on the difference between drug costs and the current fee schedule of the oncology group, with payments made on the first day on which an insured patient receives care from that practice. The payments will include case-management fees to cover patient management costs.

Thus, if during the course of an individual patient’s care clinicians decide to switch to a more expensive drug, there would be no additional payments to compensate for the difference.

Each of the agreed-upon regimens in the pilot will be evaluated based on health outcomes and the frequency of adverse events, emergency department visits, and other consequences that can drive up costs without additional treatment benefit, the insurer says.

Worth a Look

The proposed payment model is an interesting approach to the goal of containing medical costs while fairly compensating clinicians and protecting high-quality patient care. But it also raises many questions about its applicability across a broad range of clinical and financial situations, say medical economists and oncologists who were interviewed for this article.

"We are pleased to see experimentation taking place around how oncology care is paid for," said Dr. Allen S. Lichter, CEO of the American Society of Clinical Oncology. "The oncology community needs to do these pilot projects, and understand whether moving away from the current models based on fee-for-service and some percentage of margin off the chemotherapy agents can be replaced by something else – and if so, what should that something else look like and how does it work?"

"I think it’s an interesting experiment and an important one, one that Dr. Newcomer and United can run because of their large claims-based database, and we’re all interested to see how it works," agreed Dr. Samuel M. Silver, chair of the subcommittee on reimbursement for the American Society of Hematology and a professor of internal medicine at the University of Michigan in Ann Arbor.

Jack Hoadley, Ph.D., a health policy analyst and research professor at the Health Policy Institute at Georgetown University in Washington, D.C., noted that "Medicare has tried a number of experiments with various types of bundled payments, and it seems [as if] Medicare could either watch what’s going on in this private-sector pilot and use that as a way to learn, or – sooner than that – try bundled-payment structures to see how they work."

Outliers Could Be a Problem

One of the many questions that remain to be answered about the pilot project, however, is the problem of outliers (patients whose care doesn’t fit neatly within the prescribed protocol, such as those with significant comorbidities or adverse drug reactions that require a change in the treatment regimen).

"When one starts to deal with individual practices who have just a couple of these patients, one outlier can make it financially very difficult, so the question is, how often is that going to happen?" Dr. Silver said.

Dr. Hoadley said that the system needs to have flexibility to account for differences in the patient population. "Obviously, you’ve got to get that bundled amount right and appropriately adjusted for the average, across the kind of patients the practice is going to see, with some particular adjustments for patient severity," and other factors, he commented.

Where there are outliers, there are also inliers (patients who, for medical or other reasons, don’t undergo a full course of prescribed therapy), and in these cases, bundled payments would result in additional income for a practice, Dr. Lichter said. Over time, the outliers and inliers tend to balance out, and in the case of the extraordinary outlier – the patient who is admitted for a planned 2-day stay but ends up being hospitalized for 6 months – some sort of contingency payment would be made, he added.

"In talking to United Healthcare, while they didn’t sit down and write rules for every possible situation, I know that if a case is so far beyond the norm, they will sit down and look at it and agree to some type of remedial payment for it," he said.

Rare Cancers and Cherry Picking

A related issue of concern is how bundled payment systems would handle rare cancers, or clinical situations for which there is little or no consensus on optimal therapies, such as the use of chemotherapy for some soft-tissue sarcomas.

As vice-chair of the board of the National Comprehensive Cancer Network, Dr. Silver is an advocate of evidence-based guidelines, but said he’s aware that many patients have variations that don’t fit neatly into the standard chemotherapy guidelines that are acceptable under a bundled-payment system.

"Which brings us to another issue: Would there be cherry picking?" he asked. "Because it would be the patients who are young and healthy and can go through those therapies, and [who] don’t have comorbidities and variations on their disease that would best fit into these bundled programs. So what happens to the others?"

In such cases, the burden of care for the more severely ill patients would fall on teaching hospitals, and it’s unclear whether they would be adequately compensated under a bundled-payment system, he said.

Stifle Drug Development?

Matt Farber, director of provider economics and public policy for the Association of Community Cancer Centers, said that bundled-payment systems could have a dampening effect on drug development. He points to sipuleucel-T (Provenge), the recently approved autologous immunotherapy vaccine for advanced prostate cancer that uses antigen-presenting cells unique to each patient.

"Would payment systems like this stop those drugs from being developed? Because if it’s a personalized treatment, would it therefore not be included in whatever benchmark is deemed the most appropriate or most effective care for most people?" Mr. Farber asked.

And what happens when novel drugs or new versions of conventional chemotherapeutic agents (such as palifosfamide, an active metabolite of ifosfamide) come on the market?

"They’re working right now with these five practices to determine what are the best courses of treatment currently for the disease states that they’re looking at. So when a new drug comes down the line, what’s the process and how quickly do they update?" Mr. Farber said.

Similarly, said Dr. Silver, if patients are being treated and oncologists are being paid according to best medical practice, there would be fewer incentives for patients to enroll in clinical trials, which are the principal means whereby the science of medicine advances.

Define ‘Costs’

It’s also unclear just how drug costs would be defined under the proposed system, Georgetown’s Dr. Hoadley said.

"The company says, ‘Chemotherapy drugs will be reimbursed at manufacturer’s cost.’ But as Medicare has learned, that’s an ambiguous term. Medicare has gone from reimbursing based on average wholesale price to now the average sales price, and has come up with new mechanisms to define fairly what the price is for the practices that are paying to get those drugs. So the details need to be filled in about how they’re going to go about doing that," he said.

"The good news, potentially, is that you can get away from this old system that has existed for much of the past, where the practices could make money on drug reimbursements (which is how they made money to finance other things), but it would create potentially distorted incentives. You’ve still got to get it right, though," he added.

Although it’s still early, the pilot program is a good place to start, according to Dr. Lichter.

"One wants to start a pilot project in situations where there’s a lot of grounding in the types of therapies that are appropriate, so the choices are relatively limited and you can draw a box around the universe of care. If you find out that this works – if the patients are satisfied, the payers are satisfied, the system seems to be working well, and you’ve done the appropriate tweaks and nips and tucks to make it better – then you have to begin to expand it," he said.

A major insurance company is betting that oncology practices can handle cancer-care payments as if they were like the household grocery budget or a weekly allowance: Be frugal and you’ll have some left over for next time. Spend too much, and you’ll have to borrow from the future.

Photo credit: National Cancer Institute

The idea of its pilot study, says UnitedHealthcare, based in Minnetonka, Minn., is to separate drug costs from treatment costs by paying oncologists an up-front, per-patient fee. (In insurance-speak, this is called a "bundled" or "episode" payment.) The payments will be based on best medical practices for three common malignancies: breast cancer, colon cancer, and lung cancer. Decisions about optimal treatment for each disease state will be determined by consensus among clinicians, and not by the insurer, the company said in a press release.

"By paying medical oncologists for a patient’s total cycle of treatment, rather than the number of visits and the amount of chemotherapy drugs given, this program promotes better, more patient-centric, evidence-based care with no loss of revenue for the physician," said Dr. Lee N. Newcomer, UnitedHealthcare’s senior vice president for oncology. "Everyone wins. As oncologists share best practices from the program about which treatment regimens are most effective, we expect to see consistently improved patient outcomes."

The company is working with five small- to mid-size oncology practices based in Dayton, Ohio; Fort Worth, Tex.; Kansas City, Mo; Marietta, Ga.; and Memphis. Analysis is to begin after a year’s data are collected.

"Over the course of the pilot, the various treatment regimens selected by the medical groups will be evaluated to identify which are the most effective for a range of clinical presentations [such as physical signs and symptoms and diagnoses]. UnitedHealthcare will play no role in determining which treatment plan the oncologists choose, but the intent of the pilot is to identify and reduce unnecessary drug administration that does not improve the patient’s health outcomes," the company stated.

Under this payment system, the insurer will determine its cancer-care payments based on the difference between drug costs and the current fee schedule of the oncology group, with payments made on the first day on which an insured patient receives care from that practice. The payments will include case-management fees to cover patient management costs.

Thus, if during the course of an individual patient’s care clinicians decide to switch to a more expensive drug, there would be no additional payments to compensate for the difference.

Each of the agreed-upon regimens in the pilot will be evaluated based on health outcomes and the frequency of adverse events, emergency department visits, and other consequences that can drive up costs without additional treatment benefit, the insurer says.

Worth a Look

The proposed payment model is an interesting approach to the goal of containing medical costs while fairly compensating clinicians and protecting high-quality patient care. But it also raises many questions about its applicability across a broad range of clinical and financial situations, say medical economists and oncologists who were interviewed for this article.

"We are pleased to see experimentation taking place around how oncology care is paid for," said Dr. Allen S. Lichter, CEO of the American Society of Clinical Oncology. "The oncology community needs to do these pilot projects, and understand whether moving away from the current models based on fee-for-service and some percentage of margin off the chemotherapy agents can be replaced by something else – and if so, what should that something else look like and how does it work?"

"I think it’s an interesting experiment and an important one, one that Dr. Newcomer and United can run because of their large claims-based database, and we’re all interested to see how it works," agreed Dr. Samuel M. Silver, chair of the subcommittee on reimbursement for the American Society of Hematology and a professor of internal medicine at the University of Michigan in Ann Arbor.

Jack Hoadley, Ph.D., a health policy analyst and research professor at the Health Policy Institute at Georgetown University in Washington, D.C., noted that "Medicare has tried a number of experiments with various types of bundled payments, and it seems [as if] Medicare could either watch what’s going on in this private-sector pilot and use that as a way to learn, or – sooner than that – try bundled-payment structures to see how they work."

Outliers Could Be a Problem

One of the many questions that remain to be answered about the pilot project, however, is the problem of outliers (patients whose care doesn’t fit neatly within the prescribed protocol, such as those with significant comorbidities or adverse drug reactions that require a change in the treatment regimen).

"When one starts to deal with individual practices who have just a couple of these patients, one outlier can make it financially very difficult, so the question is, how often is that going to happen?" Dr. Silver said.

Dr. Hoadley said that the system needs to have flexibility to account for differences in the patient population. "Obviously, you’ve got to get that bundled amount right and appropriately adjusted for the average, across the kind of patients the practice is going to see, with some particular adjustments for patient severity," and other factors, he commented.

Where there are outliers, there are also inliers (patients who, for medical or other reasons, don’t undergo a full course of prescribed therapy), and in these cases, bundled payments would result in additional income for a practice, Dr. Lichter said. Over time, the outliers and inliers tend to balance out, and in the case of the extraordinary outlier – the patient who is admitted for a planned 2-day stay but ends up being hospitalized for 6 months – some sort of contingency payment would be made, he added.

"In talking to United Healthcare, while they didn’t sit down and write rules for every possible situation, I know that if a case is so far beyond the norm, they will sit down and look at it and agree to some type of remedial payment for it," he said.

Rare Cancers and Cherry Picking

A related issue of concern is how bundled payment systems would handle rare cancers, or clinical situations for which there is little or no consensus on optimal therapies, such as the use of chemotherapy for some soft-tissue sarcomas.

As vice-chair of the board of the National Comprehensive Cancer Network, Dr. Silver is an advocate of evidence-based guidelines, but said he’s aware that many patients have variations that don’t fit neatly into the standard chemotherapy guidelines that are acceptable under a bundled-payment system.

"Which brings us to another issue: Would there be cherry picking?" he asked. "Because it would be the patients who are young and healthy and can go through those therapies, and [who] don’t have comorbidities and variations on their disease that would best fit into these bundled programs. So what happens to the others?"

In such cases, the burden of care for the more severely ill patients would fall on teaching hospitals, and it’s unclear whether they would be adequately compensated under a bundled-payment system, he said.

Stifle Drug Development?

Matt Farber, director of provider economics and public policy for the Association of Community Cancer Centers, said that bundled-payment systems could have a dampening effect on drug development. He points to sipuleucel-T (Provenge), the recently approved autologous immunotherapy vaccine for advanced prostate cancer that uses antigen-presenting cells unique to each patient.

"Would payment systems like this stop those drugs from being developed? Because if it’s a personalized treatment, would it therefore not be included in whatever benchmark is deemed the most appropriate or most effective care for most people?" Mr. Farber asked.

And what happens when novel drugs or new versions of conventional chemotherapeutic agents (such as palifosfamide, an active metabolite of ifosfamide) come on the market?

"They’re working right now with these five practices to determine what are the best courses of treatment currently for the disease states that they’re looking at. So when a new drug comes down the line, what’s the process and how quickly do they update?" Mr. Farber said.

Similarly, said Dr. Silver, if patients are being treated and oncologists are being paid according to best medical practice, there would be fewer incentives for patients to enroll in clinical trials, which are the principal means whereby the science of medicine advances.

Define ‘Costs’

It’s also unclear just how drug costs would be defined under the proposed system, Georgetown’s Dr. Hoadley said.

"The company says, ‘Chemotherapy drugs will be reimbursed at manufacturer’s cost.’ But as Medicare has learned, that’s an ambiguous term. Medicare has gone from reimbursing based on average wholesale price to now the average sales price, and has come up with new mechanisms to define fairly what the price is for the practices that are paying to get those drugs. So the details need to be filled in about how they’re going to go about doing that," he said.

"The good news, potentially, is that you can get away from this old system that has existed for much of the past, where the practices could make money on drug reimbursements (which is how they made money to finance other things), but it would create potentially distorted incentives. You’ve still got to get it right, though," he added.

Although it’s still early, the pilot program is a good place to start, according to Dr. Lichter.

"One wants to start a pilot project in situations where there’s a lot of grounding in the types of therapies that are appropriate, so the choices are relatively limited and you can draw a box around the universe of care. If you find out that this works – if the patients are satisfied, the payers are satisfied, the system seems to be working well, and you’ve done the appropriate tweaks and nips and tucks to make it better – then you have to begin to expand it," he said.

Major Finding: A total of 34% of available lungs and 45% of hearts were successfully procured from donors managed for more than 20 hours, compared with only 7% of lungs and 12% of hearts from donors managed for 20 hours or less.

Data Source: Prospective study of 100 consecutive donors in a regional organ procurement program.

Disclosures: The study was internally funded. Dr. Christmas disclosed no conflicts of interest.

BOSTON – It seems counterintuitive, but when management times of potential heart and lung donors stretched beyond 20 hours, successful organ procurement rates at one center actually went up rather than down, investigators reported.

Among 42 donors managed for 20 hours or less, only six lungs (7% of possible total) and five hearts (12%) could be procured. In contrast, among 58 donors managed for more than 20 hours, 40 lungs (34%) and 26 hearts (45%) could be procured.

The surprising findings, from a prospective analysis of 100 consecutive organ donors, occurred despite the fact that there were no significant differences in attainment of preprocurement donor-management goals, said Dr. A. Britton Christmas of the surgery department at the Carolinas Medical Center, Charlotte, N.C.

A total of 133 organs, mean 3.2/donor, were obtained from donors managed 20 hours or less, and 243, mean 4.2/donor, from those managed for more than 20 hours (P less than .01). There was a mean of 2.6 organs transplanted for each donor managed 20 hours or less, and 3.7 for each managed for more than 20 hours (P less than .01).

“The general consensus is that early procurement removes the transplant organ from a hostile environment, but we believe that this study provides evidence to the contrary. Perhaps the reward really is worth the wait,” Dr. Christmas said.

Their original hypothesis was that shorter management times would yield higher organ procurement and transplant rates in general and heart and lung transplants in particular.

The investigators collaborated with the organ procurement organization LifeShare of the Carolinas, which covers 40 hospitals in a 20-county region. The analysis consisted of data on 100 consecutive donors from 2007 through 2008 that included age, ethnicity, blood type, mechanisms of death, management teams, organs procured, organs transplanted, donor type, donor management, reasons for nonuse of organs, and donor management goals.

Causes of death were traumatic brain injury in 44 donors, cerebrovascular accidents or stroke in 38, anoxic brain injury in 13, and other in 5.

The management goals included mean arterial pressure (60–100 mm Hg), central venous pressure (4–10 mm Hg), pH (7.30–7.45), PaO₂ (greater than 100 mm Hg), serum sodium (155 mEq/L or less), serum glucose (less than 150 mg/dL), and urine output (0.5–0.3 mL/kg per hour).

Although heart and lung procurement rates were significantly higher for donors managed for longer times, there were no significant differences between less than 20 hours vs. more than 20 hours in terms of the percentage of kidneys (85% and 91%, respectively) or livers (90% in each group) successfully harvested.

There were also no significant differences between the time groups in any of the preprocurement management goals.

The study was limited by the use of data from a single organ procurement organization, small sample size, and lack of data on the exact time of brain death, Dr. Christmas acknowledged.

The investigators speculated that the longer interval between brain death and organ procurement might permit the improvement of in situ graft function and might promote the procurement of some organs initially deemed unsuitable.

Major Finding: A total of 34% of available lungs and 45% of hearts were successfully procured from donors managed for more than 20 hours, compared with only 7% of lungs and 12% of hearts from donors managed for 20 hours or less.

Data Source: Prospective study of 100 consecutive donors in a regional organ procurement program.

Disclosures: The study was internally funded. Dr. Christmas disclosed no conflicts of interest.

BOSTON – It seems counterintuitive, but when management times of potential heart and lung donors stretched beyond 20 hours, successful organ procurement rates at one center actually went up rather than down, investigators reported.

Among 42 donors managed for 20 hours or less, only six lungs (7% of possible total) and five hearts (12%) could be procured. In contrast, among 58 donors managed for more than 20 hours, 40 lungs (34%) and 26 hearts (45%) could be procured.

The surprising findings, from a prospective analysis of 100 consecutive organ donors, occurred despite the fact that there were no significant differences in attainment of preprocurement donor-management goals, said Dr. A. Britton Christmas of the surgery department at the Carolinas Medical Center, Charlotte, N.C.

A total of 133 organs, mean 3.2/donor, were obtained from donors managed 20 hours or less, and 243, mean 4.2/donor, from those managed for more than 20 hours (P less than .01). There was a mean of 2.6 organs transplanted for each donor managed 20 hours or less, and 3.7 for each managed for more than 20 hours (P less than .01).

“The general consensus is that early procurement removes the transplant organ from a hostile environment, but we believe that this study provides evidence to the contrary. Perhaps the reward really is worth the wait,” Dr. Christmas said.

Their original hypothesis was that shorter management times would yield higher organ procurement and transplant rates in general and heart and lung transplants in particular.

The investigators collaborated with the organ procurement organization LifeShare of the Carolinas, which covers 40 hospitals in a 20-county region. The analysis consisted of data on 100 consecutive donors from 2007 through 2008 that included age, ethnicity, blood type, mechanisms of death, management teams, organs procured, organs transplanted, donor type, donor management, reasons for nonuse of organs, and donor management goals.

Causes of death were traumatic brain injury in 44 donors, cerebrovascular accidents or stroke in 38, anoxic brain injury in 13, and other in 5.

The management goals included mean arterial pressure (60–100 mm Hg), central venous pressure (4–10 mm Hg), pH (7.30–7.45), PaO₂ (greater than 100 mm Hg), serum sodium (155 mEq/L or less), serum glucose (less than 150 mg/dL), and urine output (0.5–0.3 mL/kg per hour).

Although heart and lung procurement rates were significantly higher for donors managed for longer times, there were no significant differences between less than 20 hours vs. more than 20 hours in terms of the percentage of kidneys (85% and 91%, respectively) or livers (90% in each group) successfully harvested.

There were also no significant differences between the time groups in any of the preprocurement management goals.

The study was limited by the use of data from a single organ procurement organization, small sample size, and lack of data on the exact time of brain death, Dr. Christmas acknowledged.

The investigators speculated that the longer interval between brain death and organ procurement might permit the improvement of in situ graft function and might promote the procurement of some organs initially deemed unsuitable.

Major Finding: A total of 34% of available lungs and 45% of hearts were successfully procured from donors managed for more than 20 hours, compared with only 7% of lungs and 12% of hearts from donors managed for 20 hours or less.

Data Source: Prospective study of 100 consecutive donors in a regional organ procurement program.

Disclosures: The study was internally funded. Dr. Christmas disclosed no conflicts of interest.

BOSTON – It seems counterintuitive, but when management times of potential heart and lung donors stretched beyond 20 hours, successful organ procurement rates at one center actually went up rather than down, investigators reported.

Among 42 donors managed for 20 hours or less, only six lungs (7% of possible total) and five hearts (12%) could be procured. In contrast, among 58 donors managed for more than 20 hours, 40 lungs (34%) and 26 hearts (45%) could be procured.

The surprising findings, from a prospective analysis of 100 consecutive organ donors, occurred despite the fact that there were no significant differences in attainment of preprocurement donor-management goals, said Dr. A. Britton Christmas of the surgery department at the Carolinas Medical Center, Charlotte, N.C.

A total of 133 organs, mean 3.2/donor, were obtained from donors managed 20 hours or less, and 243, mean 4.2/donor, from those managed for more than 20 hours (P less than .01). There was a mean of 2.6 organs transplanted for each donor managed 20 hours or less, and 3.7 for each managed for more than 20 hours (P less than .01).

“The general consensus is that early procurement removes the transplant organ from a hostile environment, but we believe that this study provides evidence to the contrary. Perhaps the reward really is worth the wait,” Dr. Christmas said.

Their original hypothesis was that shorter management times would yield higher organ procurement and transplant rates in general and heart and lung transplants in particular.

The investigators collaborated with the organ procurement organization LifeShare of the Carolinas, which covers 40 hospitals in a 20-county region. The analysis consisted of data on 100 consecutive donors from 2007 through 2008 that included age, ethnicity, blood type, mechanisms of death, management teams, organs procured, organs transplanted, donor type, donor management, reasons for nonuse of organs, and donor management goals.

Causes of death were traumatic brain injury in 44 donors, cerebrovascular accidents or stroke in 38, anoxic brain injury in 13, and other in 5.

The management goals included mean arterial pressure (60–100 mm Hg), central venous pressure (4–10 mm Hg), pH (7.30–7.45), PaO₂ (greater than 100 mm Hg), serum sodium (155 mEq/L or less), serum glucose (less than 150 mg/dL), and urine output (0.5–0.3 mL/kg per hour).

Although heart and lung procurement rates were significantly higher for donors managed for longer times, there were no significant differences between less than 20 hours vs. more than 20 hours in terms of the percentage of kidneys (85% and 91%, respectively) or livers (90% in each group) successfully harvested.

There were also no significant differences between the time groups in any of the preprocurement management goals.

The study was limited by the use of data from a single organ procurement organization, small sample size, and lack of data on the exact time of brain death, Dr. Christmas acknowledged.

The investigators speculated that the longer interval between brain death and organ procurement might permit the improvement of in situ graft function and might promote the procurement of some organs initially deemed unsuitable.

BOSTON – A point-of-care assay that assesses platelet inhibition levels may be helpful for rapidly identifying trauma patients who might not respond to platelet reversal therapies or antiplatelet management, reported Dr. Vishal Bansal.

In a prospective study of 46 trauma patients who reported taking the platelet inhibitor clopidogrel (Plavix), nearly 30% had no platelet inhibition, and another 30% had minimal or low platelet inhibition, said Dr. Bansal of the department of surgery at the University of California at San Diego.

“Unlike warfarin, which has been well established to increase morbidity and mortality from trauma, typically in TBI [traumatic brain injury], and where INR [international normalized ratio] can help guide management, in Plavix that is not the case,” said Dr. Bansal at the annual meeting of the American Association for the Surgery of Trauma. “The effects in the trauma patient are less well known, managing platelet inhibition is difficult and often not standardized, and managing these patients is often based solely on history.”

Nearly 30% of patients on clopidogrel are thought to have some degree of resistance to the drug, and the Food and Drug Administration in March 2010 required the manufacturer to include a boxed warning about the drug’s reduced efficacy in poor metabolizers. Patients with genetic variations in the cytochrome P450 system, particularly in cytochrome P2C19 (CYP2C19), may be unable to metabolize the drug into its active metabolite.

The investigators sought to determine the degree of platelet inhibition in trauma patients on clopidogrel, employing a point-of-care assay developed for detecting platelet inhibition levels in cardiovascular patients (VerifyNow P2Y12).

All trauma patients seen at their center in 2009 were asked by prehospital personnel and trauma team members whether they took clopidogrel. Blood samples were obtained by arterial or venous puncture from patients who reported taking the drug, and the samples were assayed. The assay results are expressed in P2Y12 reaction units and in the percentage of platelet inhibition within 30 minutes.

Of 2,520 patients admitted directly to the trauma unit, 84 were identified as using clopidogrel, and of these, 46 had their blood assayed. The mean patient age was 75.9 years, mean injury severity score was 7.0, and mean Glasgow Coma Scale score was 14.2.

The primary mechanism of injury was falling in 40 patients (86.9%), a car crash in 4 (8.7%), and being struck by a car in 2 (4.3%). The mean INR on admission was 1.1, and the mean systolic blood pressure was 146.8 mm Hg. Fourteen patients (30.4%) used aspirin concomitantly with clopidogrel.

Thirteen patients (28.2%) were found to have no platelet inhibition, and 10 (21.7%) had low levels of inhibition (between 0% and 20% inhibition). Four patients (8.7%) had inhibition levels between 20% and 30%, and 19 (41.3%) had inhibition levels greater than 30%.

In all, 17 patients (36.9%) had platelet inhibition from 0% to 10%, levels considered by the American College of Cardiology to be subtherapeutic, Dr. Bansal said.

Two patients had subdural hemorrhage – one in the 0% inhibition group, and one in the greater than 30% group.

“We concluded that the P2Y12 point-of-care platelet inhibition assay determined that a significant number of patients had no measurable platelet inhibition. These patients may be nonresponders, noncompliant, or simply not being treated with clopidogrel. It is unlikely that platelet reversal therapies or antiplatelet management algorithms will be beneficial in this group of patients,” Dr. Bansal said.

He acknowledged that the study was limited by the small sample size and by a lack of information about the correlation between percentage of platelet inhibition and risks of increased hemorrhagic complications.

“If we can correlate this, similar to INR, I think we can effectively manage these patients. And finally, we need to assess whether platelet transfusion or DDAVP [desmopressin] administration can be monitored and optimized by measuring posttherapy percentage of platelet inhibition,” he added.

However, invited discussant Dr. C. Clay Cothren, trauma surgeon and chief of surgical oncology at Denver Health Medical Center, cautioned that assay results don’t always correlate with clinical findings.

“One of the clear points in reading the cardiology literature on this topic is the difficulty in applying platelet-function testing in a clinical setting. There is no agreement on the optimal test, much less the optimal test value which correlates with an optimal clinical response. In fact, none of the available assays have an established range for clopidogrel responsiveness,” she said.

A finding of clopidogrel nonresponsiveness is therefore test-dependent, and there are currently no clinical guidelines to support the use of platelet function testing to clinically manage patients and their antiplatelet therapy, she added.

The study had no industry support, and neither the authors nor Dr. Cothren reported any conflicts of interest.

BOSTON – A point-of-care assay that assesses platelet inhibition levels may be helpful for rapidly identifying trauma patients who might not respond to platelet reversal therapies or antiplatelet management, reported Dr. Vishal Bansal.

In a prospective study of 46 trauma patients who reported taking the platelet inhibitor clopidogrel (Plavix), nearly 30% had no platelet inhibition, and another 30% had minimal or low platelet inhibition, said Dr. Bansal of the department of surgery at the University of California at San Diego.

“Unlike warfarin, which has been well established to increase morbidity and mortality from trauma, typically in TBI [traumatic brain injury], and where INR [international normalized ratio] can help guide management, in Plavix that is not the case,” said Dr. Bansal at the annual meeting of the American Association for the Surgery of Trauma. “The effects in the trauma patient are less well known, managing platelet inhibition is difficult and often not standardized, and managing these patients is often based solely on history.”

Nearly 30% of patients on clopidogrel are thought to have some degree of resistance to the drug, and the Food and Drug Administration in March 2010 required the manufacturer to include a boxed warning about the drug’s reduced efficacy in poor metabolizers. Patients with genetic variations in the cytochrome P450 system, particularly in cytochrome P2C19 (CYP2C19), may be unable to metabolize the drug into its active metabolite.

The investigators sought to determine the degree of platelet inhibition in trauma patients on clopidogrel, employing a point-of-care assay developed for detecting platelet inhibition levels in cardiovascular patients (VerifyNow P2Y12).

All trauma patients seen at their center in 2009 were asked by prehospital personnel and trauma team members whether they took clopidogrel. Blood samples were obtained by arterial or venous puncture from patients who reported taking the drug, and the samples were assayed. The assay results are expressed in P2Y12 reaction units and in the percentage of platelet inhibition within 30 minutes.

Of 2,520 patients admitted directly to the trauma unit, 84 were identified as using clopidogrel, and of these, 46 had their blood assayed. The mean patient age was 75.9 years, mean injury severity score was 7.0, and mean Glasgow Coma Scale score was 14.2.

The primary mechanism of injury was falling in 40 patients (86.9%), a car crash in 4 (8.7%), and being struck by a car in 2 (4.3%). The mean INR on admission was 1.1, and the mean systolic blood pressure was 146.8 mm Hg. Fourteen patients (30.4%) used aspirin concomitantly with clopidogrel.

Thirteen patients (28.2%) were found to have no platelet inhibition, and 10 (21.7%) had low levels of inhibition (between 0% and 20% inhibition). Four patients (8.7%) had inhibition levels between 20% and 30%, and 19 (41.3%) had inhibition levels greater than 30%.

In all, 17 patients (36.9%) had platelet inhibition from 0% to 10%, levels considered by the American College of Cardiology to be subtherapeutic, Dr. Bansal said.

Two patients had subdural hemorrhage – one in the 0% inhibition group, and one in the greater than 30% group.

“We concluded that the P2Y12 point-of-care platelet inhibition assay determined that a significant number of patients had no measurable platelet inhibition. These patients may be nonresponders, noncompliant, or simply not being treated with clopidogrel. It is unlikely that platelet reversal therapies or antiplatelet management algorithms will be beneficial in this group of patients,” Dr. Bansal said.

He acknowledged that the study was limited by the small sample size and by a lack of information about the correlation between percentage of platelet inhibition and risks of increased hemorrhagic complications.

“If we can correlate this, similar to INR, I think we can effectively manage these patients. And finally, we need to assess whether platelet transfusion or DDAVP [desmopressin] administration can be monitored and optimized by measuring posttherapy percentage of platelet inhibition,” he added.

However, invited discussant Dr. C. Clay Cothren, trauma surgeon and chief of surgical oncology at Denver Health Medical Center, cautioned that assay results don’t always correlate with clinical findings.

“One of the clear points in reading the cardiology literature on this topic is the difficulty in applying platelet-function testing in a clinical setting. There is no agreement on the optimal test, much less the optimal test value which correlates with an optimal clinical response. In fact, none of the available assays have an established range for clopidogrel responsiveness,” she said.

A finding of clopidogrel nonresponsiveness is therefore test-dependent, and there are currently no clinical guidelines to support the use of platelet function testing to clinically manage patients and their antiplatelet therapy, she added.

The study had no industry support, and neither the authors nor Dr. Cothren reported any conflicts of interest.

BOSTON – A point-of-care assay that assesses platelet inhibition levels may be helpful for rapidly identifying trauma patients who might not respond to platelet reversal therapies or antiplatelet management, reported Dr. Vishal Bansal.

In a prospective study of 46 trauma patients who reported taking the platelet inhibitor clopidogrel (Plavix), nearly 30% had no platelet inhibition, and another 30% had minimal or low platelet inhibition, said Dr. Bansal of the department of surgery at the University of California at San Diego.

“Unlike warfarin, which has been well established to increase morbidity and mortality from trauma, typically in TBI [traumatic brain injury], and where INR [international normalized ratio] can help guide management, in Plavix that is not the case,” said Dr. Bansal at the annual meeting of the American Association for the Surgery of Trauma. “The effects in the trauma patient are less well known, managing platelet inhibition is difficult and often not standardized, and managing these patients is often based solely on history.”

Nearly 30% of patients on clopidogrel are thought to have some degree of resistance to the drug, and the Food and Drug Administration in March 2010 required the manufacturer to include a boxed warning about the drug’s reduced efficacy in poor metabolizers. Patients with genetic variations in the cytochrome P450 system, particularly in cytochrome P2C19 (CYP2C19), may be unable to metabolize the drug into its active metabolite.

The investigators sought to determine the degree of platelet inhibition in trauma patients on clopidogrel, employing a point-of-care assay developed for detecting platelet inhibition levels in cardiovascular patients (VerifyNow P2Y12).

All trauma patients seen at their center in 2009 were asked by prehospital personnel and trauma team members whether they took clopidogrel. Blood samples were obtained by arterial or venous puncture from patients who reported taking the drug, and the samples were assayed. The assay results are expressed in P2Y12 reaction units and in the percentage of platelet inhibition within 30 minutes.

Of 2,520 patients admitted directly to the trauma unit, 84 were identified as using clopidogrel, and of these, 46 had their blood assayed. The mean patient age was 75.9 years, mean injury severity score was 7.0, and mean Glasgow Coma Scale score was 14.2.

The primary mechanism of injury was falling in 40 patients (86.9%), a car crash in 4 (8.7%), and being struck by a car in 2 (4.3%). The mean INR on admission was 1.1, and the mean systolic blood pressure was 146.8 mm Hg. Fourteen patients (30.4%) used aspirin concomitantly with clopidogrel.

Thirteen patients (28.2%) were found to have no platelet inhibition, and 10 (21.7%) had low levels of inhibition (between 0% and 20% inhibition). Four patients (8.7%) had inhibition levels between 20% and 30%, and 19 (41.3%) had inhibition levels greater than 30%.

In all, 17 patients (36.9%) had platelet inhibition from 0% to 10%, levels considered by the American College of Cardiology to be subtherapeutic, Dr. Bansal said.

Two patients had subdural hemorrhage – one in the 0% inhibition group, and one in the greater than 30% group.

“We concluded that the P2Y12 point-of-care platelet inhibition assay determined that a significant number of patients had no measurable platelet inhibition. These patients may be nonresponders, noncompliant, or simply not being treated with clopidogrel. It is unlikely that platelet reversal therapies or antiplatelet management algorithms will be beneficial in this group of patients,” Dr. Bansal said.

He acknowledged that the study was limited by the small sample size and by a lack of information about the correlation between percentage of platelet inhibition and risks of increased hemorrhagic complications.

“If we can correlate this, similar to INR, I think we can effectively manage these patients. And finally, we need to assess whether platelet transfusion or DDAVP [desmopressin] administration can be monitored and optimized by measuring posttherapy percentage of platelet inhibition,” he added.

However, invited discussant Dr. C. Clay Cothren, trauma surgeon and chief of surgical oncology at Denver Health Medical Center, cautioned that assay results don’t always correlate with clinical findings.

“One of the clear points in reading the cardiology literature on this topic is the difficulty in applying platelet-function testing in a clinical setting. There is no agreement on the optimal test, much less the optimal test value which correlates with an optimal clinical response. In fact, none of the available assays have an established range for clopidogrel responsiveness,” she said.

A finding of clopidogrel nonresponsiveness is therefore test-dependent, and there are currently no clinical guidelines to support the use of platelet function testing to clinically manage patients and their antiplatelet therapy, she added.

The study had no industry support, and neither the authors nor Dr. Cothren reported any conflicts of interest.

BOSTON – A point-of-care assay that assesses platelet inhibition levels may be helpful for rapidly identifying trauma patients who might not respond to platelet reversal therapies or antiplatelet management, reported Dr. Vishal Bansal.

In a prospective study of 46 trauma patients who reported taking the platelet inhibitor clopidogrel (Plavix), nearly 30% had no platelet inhibition, and another 30% had minimal or low platelet inhibition, said Dr. Bansal of the department of surgery at the University of California at San Diego.

“Unlike warfarin, which has been well established to increase morbidity and mortality from trauma, typically in TBI [traumatic brain injury], and where INR [international normalized ratio] can help guide management, in Plavix that is not the case,” said Dr. Bansal at the annual meeting of the American Association for the Surgery of Trauma. “The effects in the trauma patient are less well known, managing platelet inhibition is difficult and often not standardized, and managing these patients is often based solely on history.”

Nearly 30% of patients on clopidogrel are thought to have some degree of resistance to the drug, and the Food and Drug Administration in March 2010 required the manufacturer to include a boxed warning about the drug’s reduced efficacy in poor metabolizers. Patients with genetic variations in the cytochrome P450 system, particularly in cytochrome P2C19 (CYP2C19), may be unable to metabolize the drug into its active metabolite.

The investigators sought to determine the degree of platelet inhibition in trauma patients on clopidogrel, employing a point-of-care assay developed for detecting platelet inhibition levels in cardiovascular patients (VerifyNow P2Y12).

All trauma patients seen at their center in 2009 were asked by prehospital personnel and trauma team members whether they took clopidogrel. Blood samples were obtained by arterial or venous puncture from patients who reported taking the drug, and the samples were assayed. The assay results are expressed in P2Y12 reaction units and in the percentage of platelet inhibition within 30 minutes.

Of 2,520 patients admitted directly to the trauma unit, 84 were identified as using clopidogrel, and of these, 46 had their blood assayed. The mean patient age was 75.9 years, mean injury severity score was 7.0, and mean Glasgow Coma Scale score was 14.2.

The primary mechanism of injury was falling in 40 patients (86.9%), a car crash in 4 (8.7%), and being struck by a car in 2 (4.3%). The mean INR on admission was 1.1, and the mean systolic blood pressure was 146.8 mm Hg. Fourteen patients (30.4%) used aspirin concomitantly with clopidogrel.

Thirteen patients (28.2%) were found to have no platelet inhibition, and 10 (21.7%) had low levels of inhibition (between 0% and 20% inhibition). Four patients (8.7%) had inhibition levels between 20% and 30%, and 19 (41.3%) had inhibition levels greater than 30%.

In all, 17 patients (36.9%) had platelet inhibition from 0% to 10%, levels considered by the American College of Cardiology to be subtherapeutic, Dr. Bansal said.

Two patients had subdural hemorrhage – one in the 0% inhibition group, and one in the greater than 30% group.

“We concluded that the P2Y12 point-of-care platelet inhibition assay determined that a significant number of patients had no measurable platelet inhibition. These patients may be nonresponders, noncompliant, or simply not being treated with clopidogrel. It is unlikely that platelet reversal therapies or antiplatelet management algorithms will be beneficial in this group of patients,” Dr. Bansal said.

He acknowledged that the study was limited by the small sample size and by a lack of information about the correlation between percentage of platelet inhibition and risks of increased hemorrhagic complications.

“If we can correlate this, similar to INR, I think we can effectively manage these patients. And finally, we need to assess whether platelet transfusion or DDAVP [desmopressin] administration can be monitored and optimized by measuring posttherapy percentage of platelet inhibition,” he added.

However, invited discussant Dr. C. Clay Cothren, trauma surgeon and chief of surgical oncology at Denver Health Medical Center, cautioned that assay results don’t always correlate with clinical findings.

“One of the clear points in reading the cardiology literature on this topic is the difficulty in applying platelet-function testing in a clinical setting. There is no agreement on the optimal test, much less the optimal test value which correlates with an optimal clinical response. In fact, none of the available assays have an established range for clopidogrel responsiveness,” she said.

A finding of clopidogrel nonresponsiveness is therefore test-dependent, and there are currently no clinical guidelines to support the use of platelet function testing to clinically manage patients and their antiplatelet therapy, she added.

The study had no industry support, and neither the authors nor Dr. Cothren reported any conflicts of interest.

BOSTON – A point-of-care assay that assesses platelet inhibition levels may be helpful for rapidly identifying trauma patients who might not respond to platelet reversal therapies or antiplatelet management, reported Dr. Vishal Bansal.

In a prospective study of 46 trauma patients who reported taking the platelet inhibitor clopidogrel (Plavix), nearly 30% had no platelet inhibition, and another 30% had minimal or low platelet inhibition, said Dr. Bansal of the department of surgery at the University of California at San Diego.

“Unlike warfarin, which has been well established to increase morbidity and mortality from trauma, typically in TBI [traumatic brain injury], and where INR [international normalized ratio] can help guide management, in Plavix that is not the case,” said Dr. Bansal at the annual meeting of the American Association for the Surgery of Trauma. “The effects in the trauma patient are less well known, managing platelet inhibition is difficult and often not standardized, and managing these patients is often based solely on history.”

Nearly 30% of patients on clopidogrel are thought to have some degree of resistance to the drug, and the Food and Drug Administration in March 2010 required the manufacturer to include a boxed warning about the drug’s reduced efficacy in poor metabolizers. Patients with genetic variations in the cytochrome P450 system, particularly in cytochrome P2C19 (CYP2C19), may be unable to metabolize the drug into its active metabolite.

The investigators sought to determine the degree of platelet inhibition in trauma patients on clopidogrel, employing a point-of-care assay developed for detecting platelet inhibition levels in cardiovascular patients (VerifyNow P2Y12).

All trauma patients seen at their center in 2009 were asked by prehospital personnel and trauma team members whether they took clopidogrel. Blood samples were obtained by arterial or venous puncture from patients who reported taking the drug, and the samples were assayed. The assay results are expressed in P2Y12 reaction units and in the percentage of platelet inhibition within 30 minutes.

Of 2,520 patients admitted directly to the trauma unit, 84 were identified as using clopidogrel, and of these, 46 had their blood assayed. The mean patient age was 75.9 years, mean injury severity score was 7.0, and mean Glasgow Coma Scale score was 14.2.

The primary mechanism of injury was falling in 40 patients (86.9%), a car crash in 4 (8.7%), and being struck by a car in 2 (4.3%). The mean INR on admission was 1.1, and the mean systolic blood pressure was 146.8 mm Hg. Fourteen patients (30.4%) used aspirin concomitantly with clopidogrel.

Thirteen patients (28.2%) were found to have no platelet inhibition, and 10 (21.7%) had low levels of inhibition (between 0% and 20% inhibition). Four patients (8.7%) had inhibition levels between 20% and 30%, and 19 (41.3%) had inhibition levels greater than 30%.

In all, 17 patients (36.9%) had platelet inhibition from 0% to 10%, levels considered by the American College of Cardiology to be subtherapeutic, Dr. Bansal said.

Two patients had subdural hemorrhage – one in the 0% inhibition group, and one in the greater than 30% group.

“We concluded that the P2Y12 point-of-care platelet inhibition assay determined that a significant number of patients had no measurable platelet inhibition. These patients may be nonresponders, noncompliant, or simply not being treated with clopidogrel. It is unlikely that platelet reversal therapies or antiplatelet management algorithms will be beneficial in this group of patients,” Dr. Bansal said.

He acknowledged that the study was limited by the small sample size and by a lack of information about the correlation between percentage of platelet inhibition and risks of increased hemorrhagic complications.

“If we can correlate this, similar to INR, I think we can effectively manage these patients. And finally, we need to assess whether platelet transfusion or DDAVP [desmopressin] administration can be monitored and optimized by measuring posttherapy percentage of platelet inhibition,” he added.

However, invited discussant Dr. C. Clay Cothren, trauma surgeon and chief of surgical oncology at Denver Health Medical Center, cautioned that assay results don’t always correlate with clinical findings.

“One of the clear points in reading the cardiology literature on this topic is the difficulty in applying platelet-function testing in a clinical setting. There is no agreement on the optimal test, much less the optimal test value which correlates with an optimal clinical response. In fact, none of the available assays have an established range for clopidogrel responsiveness,” she said.

A finding of clopidogrel nonresponsiveness is therefore test-dependent, and there are currently no clinical guidelines to support the use of platelet function testing to clinically manage patients and their antiplatelet therapy, she added.

The study had no industry support, and neither the authors nor Dr. Cothren reported any conflicts of interest.

BOSTON – A point-of-care assay that assesses platelet inhibition levels may be helpful for rapidly identifying trauma patients who might not respond to platelet reversal therapies or antiplatelet management, reported Dr. Vishal Bansal.

In a prospective study of 46 trauma patients who reported taking the platelet inhibitor clopidogrel (Plavix), nearly 30% had no platelet inhibition, and another 30% had minimal or low platelet inhibition, said Dr. Bansal of the department of surgery at the University of California at San Diego.

“Unlike warfarin, which has been well established to increase morbidity and mortality from trauma, typically in TBI [traumatic brain injury], and where INR [international normalized ratio] can help guide management, in Plavix that is not the case,” said Dr. Bansal at the annual meeting of the American Association for the Surgery of Trauma. “The effects in the trauma patient are less well known, managing platelet inhibition is difficult and often not standardized, and managing these patients is often based solely on history.”

Nearly 30% of patients on clopidogrel are thought to have some degree of resistance to the drug, and the Food and Drug Administration in March 2010 required the manufacturer to include a boxed warning about the drug’s reduced efficacy in poor metabolizers. Patients with genetic variations in the cytochrome P450 system, particularly in cytochrome P2C19 (CYP2C19), may be unable to metabolize the drug into its active metabolite.

The investigators sought to determine the degree of platelet inhibition in trauma patients on clopidogrel, employing a point-of-care assay developed for detecting platelet inhibition levels in cardiovascular patients (VerifyNow P2Y12).

All trauma patients seen at their center in 2009 were asked by prehospital personnel and trauma team members whether they took clopidogrel. Blood samples were obtained by arterial or venous puncture from patients who reported taking the drug, and the samples were assayed. The assay results are expressed in P2Y12 reaction units and in the percentage of platelet inhibition within 30 minutes.

Of 2,520 patients admitted directly to the trauma unit, 84 were identified as using clopidogrel, and of these, 46 had their blood assayed. The mean patient age was 75.9 years, mean injury severity score was 7.0, and mean Glasgow Coma Scale score was 14.2.

The primary mechanism of injury was falling in 40 patients (86.9%), a car crash in 4 (8.7%), and being struck by a car in 2 (4.3%). The mean INR on admission was 1.1, and the mean systolic blood pressure was 146.8 mm Hg. Fourteen patients (30.4%) used aspirin concomitantly with clopidogrel.

Thirteen patients (28.2%) were found to have no platelet inhibition, and 10 (21.7%) had low levels of inhibition (between 0% and 20% inhibition). Four patients (8.7%) had inhibition levels between 20% and 30%, and 19 (41.3%) had inhibition levels greater than 30%.

In all, 17 patients (36.9%) had platelet inhibition from 0% to 10%, levels considered by the American College of Cardiology to be subtherapeutic, Dr. Bansal said.

Two patients had subdural hemorrhage – one in the 0% inhibition group, and one in the greater than 30% group.

“We concluded that the P2Y12 point-of-care platelet inhibition assay determined that a significant number of patients had no measurable platelet inhibition. These patients may be nonresponders, noncompliant, or simply not being treated with clopidogrel. It is unlikely that platelet reversal therapies or antiplatelet management algorithms will be beneficial in this group of patients,” Dr. Bansal said.

He acknowledged that the study was limited by the small sample size and by a lack of information about the correlation between percentage of platelet inhibition and risks of increased hemorrhagic complications.

“If we can correlate this, similar to INR, I think we can effectively manage these patients. And finally, we need to assess whether platelet transfusion or DDAVP [desmopressin] administration can be monitored and optimized by measuring posttherapy percentage of platelet inhibition,” he added.

However, invited discussant Dr. C. Clay Cothren, trauma surgeon and chief of surgical oncology at Denver Health Medical Center, cautioned that assay results don’t always correlate with clinical findings.

“One of the clear points in reading the cardiology literature on this topic is the difficulty in applying platelet-function testing in a clinical setting. There is no agreement on the optimal test, much less the optimal test value which correlates with an optimal clinical response. In fact, none of the available assays have an established range for clopidogrel responsiveness,” she said.

A finding of clopidogrel nonresponsiveness is therefore test-dependent, and there are currently no clinical guidelines to support the use of platelet function testing to clinically manage patients and their antiplatelet therapy, she added.

The study had no industry support, and neither the authors nor Dr. Cothren reported any conflicts of interest.

BOSTON – Physical examination is still the gold standard for patients with vascular injury of the extremities, and can reduce unnecessary imaging in the majority of patients. But when imaging is called for, multidetector CT angiography is a highly sensitive and specific noninvasive option, said Dr. Kenji Inaba.

In a prospective study involving 73 patients with extremity trauma but uncertain signs of vascular injury, multidetector CT angiography (MCTA) flagged 24 injuries, all but 1 of which were confirmed in the operating room, Dr. Inaba said at the annual meeting of the American Association for the Surgery of Trauma.

“There are a lot of potential advantages to using CT angio: It’s widely available everywhere using preexisting hardware and software, it’s fast and becoming faster, and it’s available 24 hours a day without any delay from calling the interventional radiology team in,” said Dr. Inaba from the division of trauma and surgical critical care at the Los Angeles County Hospital/University of Southern California Medical Center.

Because the technique is not performed under a sterile field, it simplifies patient monitoring, and it produces “surgeon-friendly,” three-dimensional multiplanar images.

“Not only does it let us look at the vasculature, it also lets us look at soft tissues and all the bone structures as well. Unlike conventional angio, it doesn’t need a central arterial catheterization – all the contrast is given through peripheral venous access,” Dr. Inaba said.

He and his colleagues took a prospective look at the ability of MCTA to detect arterial injuries in the arms and legs. They studied patients aged 16 and older treated from January 2009 to August 2010 who presented with either penetrating injury, blunt crush, or long bone fracture or dislocation. Arm injuries could be anywhere down to the wrist, and leg injuries were anywhere down to the ankle.

A total of 635 patients were assigned to one of three treatment groups based on findings at physical examination. Those with hard signs of vascular injury (35 patients) were sent into surgery. Hard signs were defined as absent pulses, active hemorrhage, expanding/pulsatile hematoma, bruit or thrill, or shock unresponsive to resuscitation.

Those with no signs (527 patients) were put on observation for a minimum of 24 hours. Patients were considered to have no vascular injury signs if they had asymptomatic limbs and an ankle-brachial index (ABI) or a brachial-brachial index (BBI) of 0.9 or greater.

The remaining 73 patients had “soft” signs, such as venous oozing, nonexpanding or nonpulsatile hematoma, diminished pulses, or an abnormal ankle-brachial/brachial-brachial index. These patients underwent MCTA.

The patients underwent a total of 89 MCTA studies. The mean age was 30.3 years (range, 16-77); 88% were male; and 70% had penetrating injuries. The mean injury severity score was 10 plus or minus 8.1, and 38% of the patients had an abbreviated injury score of 3 or higher. Nearly half of all injuries were to the thigh. Other sites were the upper arm, knee, groin, shoulder/axilla, forearm, elbow, and calf.

Indications for MCTA included nonexpanding or nonpulsatile hematoma or an abnormal ABI or BBI (in 35.6% each), venous oozing in 21.9%, diminished pulses in 19.2%, and proximity of injury to a major vessel in 15.1%; some patients had more than one indication. Imaging for proximity was not one of the study indications, Dr. Inaba noted. The investigators classified the MCTA findings as either nondiagnostic, negative, or positive. Seven of the 89 studies were deemed to be nondiagnostic: 5 because of retained shotgun pellets or bullets causing artifacts that obscured potential injuries, and 2 because of technical problems that occurred with unfamiliar equipment in the new Los Angeles County facility during the early months of the study. These patients underwent conventional angiography, and there were no missed diagnoses, Dr. Inaba said.

Most of the MCTA studies (58) were negative. The patients were followed for a minimum of 24 hours (range, 1-41 days), and none had clinically significant missed injuries.

The remaining 24 studies were positive, and all but 1, a posterior tibular injury, were confirmed in the operating room.

“CT angio was not only able to locate the site of the injury, but it was also able to well characterize the injury itself,” Dr. Inaba said.

Limitations of the study included a lack of confirmatory imaging in the patients with negative studies because of the cost, time, and unjustifiable extra radiation exposure. In addition, 21% of these patients were sent home after 24 hours of observation, and it’s possible that CT angiography missed injuries that were later picked up at another hospital. The investigators also relied on final radiology reports rather than de novo blinded readings.

“These CT scanners are improving on a daily basis, and there’s true concern that we may be detecting clinically nonsignificant injuries,” he added.

Although Dr. Inaba said that the study showed MCTA sensitivity and specificity for vascular injury to be 100% each, the inconclusive study results indicate that neither could be 100%, said Dr. David Spain of the division of trauma/critical care at Stanford (Calif.) University Hospital. He was the invited discussant.

“The sensitivity and specificity analysis isn’t just for CTA. It’s actually for a structured physical exam followed by a CTA,” Dr. Spain commented.

The study was internally funded. The authors said they had no conflicts of interest.

BOSTON – Physical examination is still the gold standard for patients with vascular injury of the extremities, and can reduce unnecessary imaging in the majority of patients. But when imaging is called for, multidetector CT angiography is a highly sensitive and specific noninvasive option, said Dr. Kenji Inaba.

In a prospective study involving 73 patients with extremity trauma but uncertain signs of vascular injury, multidetector CT angiography (MCTA) flagged 24 injuries, all but 1 of which were confirmed in the operating room, Dr. Inaba said at the annual meeting of the American Association for the Surgery of Trauma.

“There are a lot of potential advantages to using CT angio: It’s widely available everywhere using preexisting hardware and software, it’s fast and becoming faster, and it’s available 24 hours a day without any delay from calling the interventional radiology team in,” said Dr. Inaba from the division of trauma and surgical critical care at the Los Angeles County Hospital/University of Southern California Medical Center.

Because the technique is not performed under a sterile field, it simplifies patient monitoring, and it produces “surgeon-friendly,” three-dimensional multiplanar images.

“Not only does it let us look at the vasculature, it also lets us look at soft tissues and all the bone structures as well. Unlike conventional angio, it doesn’t need a central arterial catheterization – all the contrast is given through peripheral venous access,” Dr. Inaba said.

He and his colleagues took a prospective look at the ability of MCTA to detect arterial injuries in the arms and legs. They studied patients aged 16 and older treated from January 2009 to August 2010 who presented with either penetrating injury, blunt crush, or long bone fracture or dislocation. Arm injuries could be anywhere down to the wrist, and leg injuries were anywhere down to the ankle.

A total of 635 patients were assigned to one of three treatment groups based on findings at physical examination. Those with hard signs of vascular injury (35 patients) were sent into surgery. Hard signs were defined as absent pulses, active hemorrhage, expanding/pulsatile hematoma, bruit or thrill, or shock unresponsive to resuscitation.

Those with no signs (527 patients) were put on observation for a minimum of 24 hours. Patients were considered to have no vascular injury signs if they had asymptomatic limbs and an ankle-brachial index (ABI) or a brachial-brachial index (BBI) of 0.9 or greater.

The remaining 73 patients had “soft” signs, such as venous oozing, nonexpanding or nonpulsatile hematoma, diminished pulses, or an abnormal ankle-brachial/brachial-brachial index. These patients underwent MCTA.

The patients underwent a total of 89 MCTA studies. The mean age was 30.3 years (range, 16-77); 88% were male; and 70% had penetrating injuries. The mean injury severity score was 10 plus or minus 8.1, and 38% of the patients had an abbreviated injury score of 3 or higher. Nearly half of all injuries were to the thigh. Other sites were the upper arm, knee, groin, shoulder/axilla, forearm, elbow, and calf.

Indications for MCTA included nonexpanding or nonpulsatile hematoma or an abnormal ABI or BBI (in 35.6% each), venous oozing in 21.9%, diminished pulses in 19.2%, and proximity of injury to a major vessel in 15.1%; some patients had more than one indication. Imaging for proximity was not one of the study indications, Dr. Inaba noted. The investigators classified the MCTA findings as either nondiagnostic, negative, or positive. Seven of the 89 studies were deemed to be nondiagnostic: 5 because of retained shotgun pellets or bullets causing artifacts that obscured potential injuries, and 2 because of technical problems that occurred with unfamiliar equipment in the new Los Angeles County facility during the early months of the study. These patients underwent conventional angiography, and there were no missed diagnoses, Dr. Inaba said.

Most of the MCTA studies (58) were negative. The patients were followed for a minimum of 24 hours (range, 1-41 days), and none had clinically significant missed injuries.

The remaining 24 studies were positive, and all but 1, a posterior tibular injury, were confirmed in the operating room.

“CT angio was not only able to locate the site of the injury, but it was also able to well characterize the injury itself,” Dr. Inaba said.

Limitations of the study included a lack of confirmatory imaging in the patients with negative studies because of the cost, time, and unjustifiable extra radiation exposure. In addition, 21% of these patients were sent home after 24 hours of observation, and it’s possible that CT angiography missed injuries that were later picked up at another hospital. The investigators also relied on final radiology reports rather than de novo blinded readings.

“These CT scanners are improving on a daily basis, and there’s true concern that we may be detecting clinically nonsignificant injuries,” he added.

Although Dr. Inaba said that the study showed MCTA sensitivity and specificity for vascular injury to be 100% each, the inconclusive study results indicate that neither could be 100%, said Dr. David Spain of the division of trauma/critical care at Stanford (Calif.) University Hospital. He was the invited discussant.

“The sensitivity and specificity analysis isn’t just for CTA. It’s actually for a structured physical exam followed by a CTA,” Dr. Spain commented.

The study was internally funded. The authors said they had no conflicts of interest.

BOSTON – Physical examination is still the gold standard for patients with vascular injury of the extremities, and can reduce unnecessary imaging in the majority of patients. But when imaging is called for, multidetector CT angiography is a highly sensitive and specific noninvasive option, said Dr. Kenji Inaba.

In a prospective study involving 73 patients with extremity trauma but uncertain signs of vascular injury, multidetector CT angiography (MCTA) flagged 24 injuries, all but 1 of which were confirmed in the operating room, Dr. Inaba said at the annual meeting of the American Association for the Surgery of Trauma.

“There are a lot of potential advantages to using CT angio: It’s widely available everywhere using preexisting hardware and software, it’s fast and becoming faster, and it’s available 24 hours a day without any delay from calling the interventional radiology team in,” said Dr. Inaba from the division of trauma and surgical critical care at the Los Angeles County Hospital/University of Southern California Medical Center.

Because the technique is not performed under a sterile field, it simplifies patient monitoring, and it produces “surgeon-friendly,” three-dimensional multiplanar images.

“Not only does it let us look at the vasculature, it also lets us look at soft tissues and all the bone structures as well. Unlike conventional angio, it doesn’t need a central arterial catheterization – all the contrast is given through peripheral venous access,” Dr. Inaba said.

He and his colleagues took a prospective look at the ability of MCTA to detect arterial injuries in the arms and legs. They studied patients aged 16 and older treated from January 2009 to August 2010 who presented with either penetrating injury, blunt crush, or long bone fracture or dislocation. Arm injuries could be anywhere down to the wrist, and leg injuries were anywhere down to the ankle.

A total of 635 patients were assigned to one of three treatment groups based on findings at physical examination. Those with hard signs of vascular injury (35 patients) were sent into surgery. Hard signs were defined as absent pulses, active hemorrhage, expanding/pulsatile hematoma, bruit or thrill, or shock unresponsive to resuscitation.

Those with no signs (527 patients) were put on observation for a minimum of 24 hours. Patients were considered to have no vascular injury signs if they had asymptomatic limbs and an ankle-brachial index (ABI) or a brachial-brachial index (BBI) of 0.9 or greater.

The remaining 73 patients had “soft” signs, such as venous oozing, nonexpanding or nonpulsatile hematoma, diminished pulses, or an abnormal ankle-brachial/brachial-brachial index. These patients underwent MCTA.

The patients underwent a total of 89 MCTA studies. The mean age was 30.3 years (range, 16-77); 88% were male; and 70% had penetrating injuries. The mean injury severity score was 10 plus or minus 8.1, and 38% of the patients had an abbreviated injury score of 3 or higher. Nearly half of all injuries were to the thigh. Other sites were the upper arm, knee, groin, shoulder/axilla, forearm, elbow, and calf.

Indications for MCTA included nonexpanding or nonpulsatile hematoma or an abnormal ABI or BBI (in 35.6% each), venous oozing in 21.9%, diminished pulses in 19.2%, and proximity of injury to a major vessel in 15.1%; some patients had more than one indication. Imaging for proximity was not one of the study indications, Dr. Inaba noted. The investigators classified the MCTA findings as either nondiagnostic, negative, or positive. Seven of the 89 studies were deemed to be nondiagnostic: 5 because of retained shotgun pellets or bullets causing artifacts that obscured potential injuries, and 2 because of technical problems that occurred with unfamiliar equipment in the new Los Angeles County facility during the early months of the study. These patients underwent conventional angiography, and there were no missed diagnoses, Dr. Inaba said.

Most of the MCTA studies (58) were negative. The patients were followed for a minimum of 24 hours (range, 1-41 days), and none had clinically significant missed injuries.

The remaining 24 studies were positive, and all but 1, a posterior tibular injury, were confirmed in the operating room.

“CT angio was not only able to locate the site of the injury, but it was also able to well characterize the injury itself,” Dr. Inaba said.

Limitations of the study included a lack of confirmatory imaging in the patients with negative studies because of the cost, time, and unjustifiable extra radiation exposure. In addition, 21% of these patients were sent home after 24 hours of observation, and it’s possible that CT angiography missed injuries that were later picked up at another hospital. The investigators also relied on final radiology reports rather than de novo blinded readings.

“These CT scanners are improving on a daily basis, and there’s true concern that we may be detecting clinically nonsignificant injuries,” he added.

Although Dr. Inaba said that the study showed MCTA sensitivity and specificity for vascular injury to be 100% each, the inconclusive study results indicate that neither could be 100%, said Dr. David Spain of the division of trauma/critical care at Stanford (Calif.) University Hospital. He was the invited discussant.

“The sensitivity and specificity analysis isn’t just for CTA. It’s actually for a structured physical exam followed by a CTA,” Dr. Spain commented.

The study was internally funded. The authors said they had no conflicts of interest.