Susan London

SAN FRANCISCO – In women with term pregnancies and an unfavorable cervix, different methods of labor induction have their pros and cons, according to the results of a pair of randomized trials reported at the annual meeting of the Society for Maternal-Fetal Medicine.

A trial conducted in the Netherlands found that roughly one-fifth of women eventually had a cesarean section whether labor was induced with a Foley catheter or with vaginal prostaglandin gel. But there was less maternal and neonatal morbidity with the former.

And a trial conducted in Canada found that a Foley catheter plus oxytocin or misoprostol was associated with a higher rate of delivery within 24 hours than misoprostol alone. However, the misoprostol methods were associated with a lower cesarean rate.

Dutch trial. U.S. and Dutch guidelines indicate that both prostaglandin E analogues and Foley catheters are options for inducing labor, said Dr. Marta JóŸwiak, an obstetrician at the Groene Hart Hospital in Gouda, the Netherlands.

As a result, clinical practice varies. Although these methods have been compared, questions remain about their relative benefits and drawbacks, including complications and their costs.

Dr. JóŸwiak and her coinvestigators conducted a trial called PROBAAT (Prostaglandins or Balloon for Induction of Labor at Term) in 819 women with a term pregnancy who had a vital singleton fetus in cephalic presentation, intact membranes, and an unfavorable cervix, defined as a Bishop score of less than 6.

The women were 31 years old, on average, and 81% were white. The median gestational age was 40 weeks. Two-thirds were nulliparous, and most (83%) had a Bishop score of 3 or less. The leading indications for labor induction were postterm pregnancy (36%) and hypertensive disorders (34%). Patients were excluded from the study if they had had a cesarean delivery, or had placenta previa, a fetus with congenital anomalies, or hypersensitivity to either of the products used for labor induction.

The investigators randomized the women in equal numbers to nonblinded treatment with a transcervical Foley catheter or vaginal prostaglandin E2 gel. Analyses were based on 411 women in the former group and 408 in the latter group.

Trial results showed that the rate of cesarean section, the primary outcome, was 23% in the Foley catheter group and 20% in the prostaglandin gel group, a difference that was not significant, Dr. JóŸwiak reported.

The rate of vaginal instrumental delivery did not differ, but the combined rate of cesarean and vaginal instrumental deliveries specifically for fetal distress was significantly lower in the Foley group (12% vs. 18%). The rate of maternal infection during labor also was lower in that group (2% vs. 4%).

The groups were similar with respect to rates of other maternal outcomes (hyperstimulation, postpartum hemorrhage, and blood transfusion). There were two cases of uterine rupture, both in the prostaglandin group.

In terms of neonatal outcomes, neonates in the Foley group were significantly less likely than their counterparts in the prostaglandin group to be admitted to the ward (12% vs. 19%), while rates of intensive care unit admission were identical.

The groups were similar with respect to rates of other neonatal outcomes, such as Apgar scores, umbilical cord blood pH, reasons for admission, and length of admission.

Subgroup analyses are still ongoing, according to Dr. JóŸwiak, but preliminary results suggest that the Foley catheter was the more successful of the two methods in nulliparous women, who are more likely to have trouble with labor induction.

"Induction with a Foley catheter is, in terms of cesarean section, as effective as induction with prostaglandin E2 gel, with less neonatal and maternal morbidity," she concluded. "We recommend considering the Foley catheter as a first choice for induction of labor at term in women with an unfavorable cervix."

Canadian trial. Elective induction of labor now occurs in 21%-30% of all births, noted Dr. Marie-Danielle Dionne, a fetal-maternal medicine specialist at the University of Montreal. "An improved Bishop score before induction increases the rate of vaginal birth."

She and her coinvestigators enrolled women with a normal singleton pregnancy at term who had intact membranes and an unfavorable cervix, with a Bishop score of 5 or less. Women were ineligible if they had prostaglandin hypersensitivity, previous uterine surgery, a noncephalic fetal presentation, or nonreassuring fetal cardiac monitoring.

The women were randomized in equal numbers to nonblinded treatment with a Foley catheter plus intravenous oxytocin infusion, a Foley catheter plus intravaginal misoprostol, or intravaginal misoprostol alone.

The trial was stopped early because of an elevated rate of cesarean deliveries in the first group, according to Dr. Dionne.

Intention-to-treat analyses were based on 92 women in the Foley plus oxytocin group, 85 women in the Foley plus misoprostol group, and 88 women in the misoprostol-only group.

On average, the women were 30 years old, and the median gestational age was 40.5 weeks. About three-fourths of the women were nulliparous. The mean Bishop score was 3. The leading indications for induction were a postdate pregnancy (54%) and diabetes (27%).

Trial results showed that the rate of delivery within 24 hours, the primary outcome, was highest in the Foley plus oxytocin group at 94%, Dr. Dionne reported. It was statistically similar in the Foley plus misoprostol group at 87%, but significantly lower in the misoprostol-only group at 74%.

However, the rate of cesarean delivery was 44% in the Foley plus oxytocin group. It was significantly lower in both the Foley plus misoprostol group at 24%, and in the misoprostol-only group at 28%.

The three groups did not differ with respect to rates of maternal complications (postpartum hemorrhage, hyperstimulation, receipt of antibiotics, and placental retention) and fetal and neonatal outcomes (Apgar scores, cord blood arterial pH, admission to the neonatal intensive care unit, meconium in amniotic fluid, receipt of antibiotics, and nonreassuring fetal monitoring).

"We can say that in our institutions, the use of a Foley catheter is associated with more deliveries within 24 hours," said Dr. Dionne. "This is mostly due to a smaller delay from induction to labor."

"Misoprostol use significantly reduced the rate of c-section, with or without a Foley catheter," she further noted.

Dr. Dionne speculated that the higher rate of cesareans with the Foley catheter plus oxytocin, despite the more rapid delivery, was due to inadequate cervical ripening in the face of contractions. "There is a small change in the cervix and there are regular contractions, but it is probably not as physiological as with the misoprostol," she said.

"So we have to decide which is best: more deliveries within 24 hours or more vaginal births," Dr. Dionne concluded. "The answer is easy for me: We think more vaginal births is better."

Dr. JóŸwiak and Dr. Dionne did not report any relevant financial disclosures.

SAN FRANCISCO – In women with term pregnancies and an unfavorable cervix, different methods of labor induction have their pros and cons, according to the results of a pair of randomized trials reported at the annual meeting of the Society for Maternal-Fetal Medicine.

A trial conducted in the Netherlands found that roughly one-fifth of women eventually had a cesarean section whether labor was induced with a Foley catheter or with vaginal prostaglandin gel. But there was less maternal and neonatal morbidity with the former.

And a trial conducted in Canada found that a Foley catheter plus oxytocin or misoprostol was associated with a higher rate of delivery within 24 hours than misoprostol alone. However, the misoprostol methods were associated with a lower cesarean rate.

Dutch trial. U.S. and Dutch guidelines indicate that both prostaglandin E analogues and Foley catheters are options for inducing labor, said Dr. Marta JóŸwiak, an obstetrician at the Groene Hart Hospital in Gouda, the Netherlands.

As a result, clinical practice varies. Although these methods have been compared, questions remain about their relative benefits and drawbacks, including complications and their costs.

Dr. JóŸwiak and her coinvestigators conducted a trial called PROBAAT (Prostaglandins or Balloon for Induction of Labor at Term) in 819 women with a term pregnancy who had a vital singleton fetus in cephalic presentation, intact membranes, and an unfavorable cervix, defined as a Bishop score of less than 6.

The women were 31 years old, on average, and 81% were white. The median gestational age was 40 weeks. Two-thirds were nulliparous, and most (83%) had a Bishop score of 3 or less. The leading indications for labor induction were postterm pregnancy (36%) and hypertensive disorders (34%). Patients were excluded from the study if they had had a cesarean delivery, or had placenta previa, a fetus with congenital anomalies, or hypersensitivity to either of the products used for labor induction.

The investigators randomized the women in equal numbers to nonblinded treatment with a transcervical Foley catheter or vaginal prostaglandin E2 gel. Analyses were based on 411 women in the former group and 408 in the latter group.

Trial results showed that the rate of cesarean section, the primary outcome, was 23% in the Foley catheter group and 20% in the prostaglandin gel group, a difference that was not significant, Dr. JóŸwiak reported.

The rate of vaginal instrumental delivery did not differ, but the combined rate of cesarean and vaginal instrumental deliveries specifically for fetal distress was significantly lower in the Foley group (12% vs. 18%). The rate of maternal infection during labor also was lower in that group (2% vs. 4%).

The groups were similar with respect to rates of other maternal outcomes (hyperstimulation, postpartum hemorrhage, and blood transfusion). There were two cases of uterine rupture, both in the prostaglandin group.

In terms of neonatal outcomes, neonates in the Foley group were significantly less likely than their counterparts in the prostaglandin group to be admitted to the ward (12% vs. 19%), while rates of intensive care unit admission were identical.

The groups were similar with respect to rates of other neonatal outcomes, such as Apgar scores, umbilical cord blood pH, reasons for admission, and length of admission.

Subgroup analyses are still ongoing, according to Dr. JóŸwiak, but preliminary results suggest that the Foley catheter was the more successful of the two methods in nulliparous women, who are more likely to have trouble with labor induction.

"Induction with a Foley catheter is, in terms of cesarean section, as effective as induction with prostaglandin E2 gel, with less neonatal and maternal morbidity," she concluded. "We recommend considering the Foley catheter as a first choice for induction of labor at term in women with an unfavorable cervix."

Canadian trial. Elective induction of labor now occurs in 21%-30% of all births, noted Dr. Marie-Danielle Dionne, a fetal-maternal medicine specialist at the University of Montreal. "An improved Bishop score before induction increases the rate of vaginal birth."

She and her coinvestigators enrolled women with a normal singleton pregnancy at term who had intact membranes and an unfavorable cervix, with a Bishop score of 5 or less. Women were ineligible if they had prostaglandin hypersensitivity, previous uterine surgery, a noncephalic fetal presentation, or nonreassuring fetal cardiac monitoring.

The women were randomized in equal numbers to nonblinded treatment with a Foley catheter plus intravenous oxytocin infusion, a Foley catheter plus intravaginal misoprostol, or intravaginal misoprostol alone.

The trial was stopped early because of an elevated rate of cesarean deliveries in the first group, according to Dr. Dionne.

Intention-to-treat analyses were based on 92 women in the Foley plus oxytocin group, 85 women in the Foley plus misoprostol group, and 88 women in the misoprostol-only group.

On average, the women were 30 years old, and the median gestational age was 40.5 weeks. About three-fourths of the women were nulliparous. The mean Bishop score was 3. The leading indications for induction were a postdate pregnancy (54%) and diabetes (27%).

Trial results showed that the rate of delivery within 24 hours, the primary outcome, was highest in the Foley plus oxytocin group at 94%, Dr. Dionne reported. It was statistically similar in the Foley plus misoprostol group at 87%, but significantly lower in the misoprostol-only group at 74%.

However, the rate of cesarean delivery was 44% in the Foley plus oxytocin group. It was significantly lower in both the Foley plus misoprostol group at 24%, and in the misoprostol-only group at 28%.

The three groups did not differ with respect to rates of maternal complications (postpartum hemorrhage, hyperstimulation, receipt of antibiotics, and placental retention) and fetal and neonatal outcomes (Apgar scores, cord blood arterial pH, admission to the neonatal intensive care unit, meconium in amniotic fluid, receipt of antibiotics, and nonreassuring fetal monitoring).

"We can say that in our institutions, the use of a Foley catheter is associated with more deliveries within 24 hours," said Dr. Dionne. "This is mostly due to a smaller delay from induction to labor."

"Misoprostol use significantly reduced the rate of c-section, with or without a Foley catheter," she further noted.

Dr. Dionne speculated that the higher rate of cesareans with the Foley catheter plus oxytocin, despite the more rapid delivery, was due to inadequate cervical ripening in the face of contractions. "There is a small change in the cervix and there are regular contractions, but it is probably not as physiological as with the misoprostol," she said.

"So we have to decide which is best: more deliveries within 24 hours or more vaginal births," Dr. Dionne concluded. "The answer is easy for me: We think more vaginal births is better."

Dr. JóŸwiak and Dr. Dionne did not report any relevant financial disclosures.

SAN FRANCISCO – In women with term pregnancies and an unfavorable cervix, different methods of labor induction have their pros and cons, according to the results of a pair of randomized trials reported at the annual meeting of the Society for Maternal-Fetal Medicine.

A trial conducted in the Netherlands found that roughly one-fifth of women eventually had a cesarean section whether labor was induced with a Foley catheter or with vaginal prostaglandin gel. But there was less maternal and neonatal morbidity with the former.

And a trial conducted in Canada found that a Foley catheter plus oxytocin or misoprostol was associated with a higher rate of delivery within 24 hours than misoprostol alone. However, the misoprostol methods were associated with a lower cesarean rate.

Dutch trial. U.S. and Dutch guidelines indicate that both prostaglandin E analogues and Foley catheters are options for inducing labor, said Dr. Marta JóŸwiak, an obstetrician at the Groene Hart Hospital in Gouda, the Netherlands.

As a result, clinical practice varies. Although these methods have been compared, questions remain about their relative benefits and drawbacks, including complications and their costs.

Dr. JóŸwiak and her coinvestigators conducted a trial called PROBAAT (Prostaglandins or Balloon for Induction of Labor at Term) in 819 women with a term pregnancy who had a vital singleton fetus in cephalic presentation, intact membranes, and an unfavorable cervix, defined as a Bishop score of less than 6.

The women were 31 years old, on average, and 81% were white. The median gestational age was 40 weeks. Two-thirds were nulliparous, and most (83%) had a Bishop score of 3 or less. The leading indications for labor induction were postterm pregnancy (36%) and hypertensive disorders (34%). Patients were excluded from the study if they had had a cesarean delivery, or had placenta previa, a fetus with congenital anomalies, or hypersensitivity to either of the products used for labor induction.

The investigators randomized the women in equal numbers to nonblinded treatment with a transcervical Foley catheter or vaginal prostaglandin E2 gel. Analyses were based on 411 women in the former group and 408 in the latter group.

Trial results showed that the rate of cesarean section, the primary outcome, was 23% in the Foley catheter group and 20% in the prostaglandin gel group, a difference that was not significant, Dr. JóŸwiak reported.

The rate of vaginal instrumental delivery did not differ, but the combined rate of cesarean and vaginal instrumental deliveries specifically for fetal distress was significantly lower in the Foley group (12% vs. 18%). The rate of maternal infection during labor also was lower in that group (2% vs. 4%).

The groups were similar with respect to rates of other maternal outcomes (hyperstimulation, postpartum hemorrhage, and blood transfusion). There were two cases of uterine rupture, both in the prostaglandin group.

In terms of neonatal outcomes, neonates in the Foley group were significantly less likely than their counterparts in the prostaglandin group to be admitted to the ward (12% vs. 19%), while rates of intensive care unit admission were identical.

The groups were similar with respect to rates of other neonatal outcomes, such as Apgar scores, umbilical cord blood pH, reasons for admission, and length of admission.

Subgroup analyses are still ongoing, according to Dr. JóŸwiak, but preliminary results suggest that the Foley catheter was the more successful of the two methods in nulliparous women, who are more likely to have trouble with labor induction.

"Induction with a Foley catheter is, in terms of cesarean section, as effective as induction with prostaglandin E2 gel, with less neonatal and maternal morbidity," she concluded. "We recommend considering the Foley catheter as a first choice for induction of labor at term in women with an unfavorable cervix."

Canadian trial. Elective induction of labor now occurs in 21%-30% of all births, noted Dr. Marie-Danielle Dionne, a fetal-maternal medicine specialist at the University of Montreal. "An improved Bishop score before induction increases the rate of vaginal birth."

She and her coinvestigators enrolled women with a normal singleton pregnancy at term who had intact membranes and an unfavorable cervix, with a Bishop score of 5 or less. Women were ineligible if they had prostaglandin hypersensitivity, previous uterine surgery, a noncephalic fetal presentation, or nonreassuring fetal cardiac monitoring.

The women were randomized in equal numbers to nonblinded treatment with a Foley catheter plus intravenous oxytocin infusion, a Foley catheter plus intravaginal misoprostol, or intravaginal misoprostol alone.

The trial was stopped early because of an elevated rate of cesarean deliveries in the first group, according to Dr. Dionne.

Intention-to-treat analyses were based on 92 women in the Foley plus oxytocin group, 85 women in the Foley plus misoprostol group, and 88 women in the misoprostol-only group.

On average, the women were 30 years old, and the median gestational age was 40.5 weeks. About three-fourths of the women were nulliparous. The mean Bishop score was 3. The leading indications for induction were a postdate pregnancy (54%) and diabetes (27%).

Trial results showed that the rate of delivery within 24 hours, the primary outcome, was highest in the Foley plus oxytocin group at 94%, Dr. Dionne reported. It was statistically similar in the Foley plus misoprostol group at 87%, but significantly lower in the misoprostol-only group at 74%.

However, the rate of cesarean delivery was 44% in the Foley plus oxytocin group. It was significantly lower in both the Foley plus misoprostol group at 24%, and in the misoprostol-only group at 28%.

The three groups did not differ with respect to rates of maternal complications (postpartum hemorrhage, hyperstimulation, receipt of antibiotics, and placental retention) and fetal and neonatal outcomes (Apgar scores, cord blood arterial pH, admission to the neonatal intensive care unit, meconium in amniotic fluid, receipt of antibiotics, and nonreassuring fetal monitoring).

"We can say that in our institutions, the use of a Foley catheter is associated with more deliveries within 24 hours," said Dr. Dionne. "This is mostly due to a smaller delay from induction to labor."

"Misoprostol use significantly reduced the rate of c-section, with or without a Foley catheter," she further noted.

Dr. Dionne speculated that the higher rate of cesareans with the Foley catheter plus oxytocin, despite the more rapid delivery, was due to inadequate cervical ripening in the face of contractions. "There is a small change in the cervix and there are regular contractions, but it is probably not as physiological as with the misoprostol," she said.

"So we have to decide which is best: more deliveries within 24 hours or more vaginal births," Dr. Dionne concluded. "The answer is easy for me: We think more vaginal births is better."

Dr. JóŸwiak and Dr. Dionne did not report any relevant financial disclosures.

Major Finding: A prior term birth was independently protective among women who had just one previous spontaneous preterm delivery (OR, 0.83), but not among those who had more than one.

Data Source: Retrospective study of 7,319 women with a singleton pregnancy who received 17 alpha-hydroxyprogesterone caproate because they had previously experienced spontaneous preterm delivery.

Disclosures: Dr. Barton reported receiving support from Alere San Diego Inc. for preeclampsia research.

SAN FRANCISCO – Obstetric history may influence how much benefit pregnant women obtain from 17 alpha-hydroxyprogesterone caproate that is taken to prevent a recurrence of preterm delivery, according to results of a retrospective study.

All of the 7,319 pregnant women in the retrospective study were receiving 17 alpha-hydroxyprogesterone caproate (17P) because they had experienced at least one spontaneous preterm delivery (SPTD).

The group who had just a single SPTD was 17% less likely to have a recurrence if they had also experienced a prior term birth. There was a trend toward a benefit of a prior term birth only in the group who had had multiple SPTDs.

These findings raise the possibility that a prior term birth may modify the effectiveness of 17P, according to Dr. John R. Barton.

Still, “current information would suggest that 17P be offered to all women with a history of prior SPTD in a current singleton pregnancy, even if they have experienced a term gestation, especially now with the Food and Drug Administration's approval of 17P,” he said at the meeting. The FDA said that it had approved 17P for the prevention of recurrent preterm birth in women with singleton pregnancies.

Investigators have noted a lack of direct data on the benefit of 17P in women with a prior term birth followed by SPTD, Dr. Barton observed. Additionally, some have expressed concern that this treatment may increase fetal loss.

He and his colleagues studied women with a singleton pregnancy who received weekly 250-mg intramuscular injections of 17P through a home administration program because of previous SPTD. Treatment began before 25 weeks' gestation and continued until 36 completed weeks or preterm delivery.

About 70% of the women had previously experienced just one SPTD, while the other 30% had experienced more than one, reported Dr. Barton, who is director of maternal-fetal medicine at Central Baptist Hospital in Lexington, Ky.

In the group who had just one SPTD, women with a prior term birth were significantly less likely than those without a prior term birth to have a recurrent SPTD before 37 weeks' gestation (odds ratio, 0.83), and also before 35 weeks (OR, 0.73) and before 32 weeks (OR, 0.74).

In a multivariate logistic regression analysis, a prior term birth still significantly protected against recurrent SPTD before 37 weeks (OR, 0.83; P = .01).

In the group who had more than one SPTD, women with a prior term birth were significantly less likely to have a recurrent SPTD before 37 weeks' gestation (OR, 0.79) but not before 35 or 32 weeks. And in a multivariate logistic regression analysis, there was a trend toward a lower risk of recurrent SPTD only before 37 weeks (OR, 0.83; P = .06).

Comparing results across singleton progestin studies, Dr. Barton noted that the rate of fetal death in the study cohort was just 0.37%, or much lower than the 1.3% observed in the placebo arms of two randomized trials (N. Engl. J. Med. 2003;348:2379-85; Ultrasound Obstet. Gynecol. 2007;30:687-96).

Moreover, those two trials were much smaller. Therefore, “I think we can conclude that our stillbirth rate was not increased above those in the placebo cohorts.”

The study had its limitations, acknowledged Dr. Barton. It was retrospective, did not have data on cervical length, and lacked a control group not given 17P.

But there also were some noteworthy strengths. “This is the largest cohort of women with a prior SPTD evaluating 17P therapy in a community setting,” he elaborated.

“It's also the first to evaluate the impact of a prior term delivery as a modifier of the risk of recurrent SPTD at less than 37, less than 35, and less than 32 weeks' gestation,” Dr. Barton said.

Major Finding: A prior term birth was independently protective among women who had just one previous spontaneous preterm delivery (OR, 0.83), but not among those who had more than one.

Data Source: Retrospective study of 7,319 women with a singleton pregnancy who received 17 alpha-hydroxyprogesterone caproate because they had previously experienced spontaneous preterm delivery.

Disclosures: Dr. Barton reported receiving support from Alere San Diego Inc. for preeclampsia research.

SAN FRANCISCO – Obstetric history may influence how much benefit pregnant women obtain from 17 alpha-hydroxyprogesterone caproate that is taken to prevent a recurrence of preterm delivery, according to results of a retrospective study.

All of the 7,319 pregnant women in the retrospective study were receiving 17 alpha-hydroxyprogesterone caproate (17P) because they had experienced at least one spontaneous preterm delivery (SPTD).

The group who had just a single SPTD was 17% less likely to have a recurrence if they had also experienced a prior term birth. There was a trend toward a benefit of a prior term birth only in the group who had had multiple SPTDs.

These findings raise the possibility that a prior term birth may modify the effectiveness of 17P, according to Dr. John R. Barton.

Still, “current information would suggest that 17P be offered to all women with a history of prior SPTD in a current singleton pregnancy, even if they have experienced a term gestation, especially now with the Food and Drug Administration's approval of 17P,” he said at the meeting. The FDA said that it had approved 17P for the prevention of recurrent preterm birth in women with singleton pregnancies.

Investigators have noted a lack of direct data on the benefit of 17P in women with a prior term birth followed by SPTD, Dr. Barton observed. Additionally, some have expressed concern that this treatment may increase fetal loss.

He and his colleagues studied women with a singleton pregnancy who received weekly 250-mg intramuscular injections of 17P through a home administration program because of previous SPTD. Treatment began before 25 weeks' gestation and continued until 36 completed weeks or preterm delivery.

About 70% of the women had previously experienced just one SPTD, while the other 30% had experienced more than one, reported Dr. Barton, who is director of maternal-fetal medicine at Central Baptist Hospital in Lexington, Ky.

In the group who had just one SPTD, women with a prior term birth were significantly less likely than those without a prior term birth to have a recurrent SPTD before 37 weeks' gestation (odds ratio, 0.83), and also before 35 weeks (OR, 0.73) and before 32 weeks (OR, 0.74).

In a multivariate logistic regression analysis, a prior term birth still significantly protected against recurrent SPTD before 37 weeks (OR, 0.83; P = .01).

In the group who had more than one SPTD, women with a prior term birth were significantly less likely to have a recurrent SPTD before 37 weeks' gestation (OR, 0.79) but not before 35 or 32 weeks. And in a multivariate logistic regression analysis, there was a trend toward a lower risk of recurrent SPTD only before 37 weeks (OR, 0.83; P = .06).

Comparing results across singleton progestin studies, Dr. Barton noted that the rate of fetal death in the study cohort was just 0.37%, or much lower than the 1.3% observed in the placebo arms of two randomized trials (N. Engl. J. Med. 2003;348:2379-85; Ultrasound Obstet. Gynecol. 2007;30:687-96).

Moreover, those two trials were much smaller. Therefore, “I think we can conclude that our stillbirth rate was not increased above those in the placebo cohorts.”

The study had its limitations, acknowledged Dr. Barton. It was retrospective, did not have data on cervical length, and lacked a control group not given 17P.

But there also were some noteworthy strengths. “This is the largest cohort of women with a prior SPTD evaluating 17P therapy in a community setting,” he elaborated.

“It's also the first to evaluate the impact of a prior term delivery as a modifier of the risk of recurrent SPTD at less than 37, less than 35, and less than 32 weeks' gestation,” Dr. Barton said.

Major Finding: A prior term birth was independently protective among women who had just one previous spontaneous preterm delivery (OR, 0.83), but not among those who had more than one.

Data Source: Retrospective study of 7,319 women with a singleton pregnancy who received 17 alpha-hydroxyprogesterone caproate because they had previously experienced spontaneous preterm delivery.

Disclosures: Dr. Barton reported receiving support from Alere San Diego Inc. for preeclampsia research.

SAN FRANCISCO – Obstetric history may influence how much benefit pregnant women obtain from 17 alpha-hydroxyprogesterone caproate that is taken to prevent a recurrence of preterm delivery, according to results of a retrospective study.

All of the 7,319 pregnant women in the retrospective study were receiving 17 alpha-hydroxyprogesterone caproate (17P) because they had experienced at least one spontaneous preterm delivery (SPTD).

The group who had just a single SPTD was 17% less likely to have a recurrence if they had also experienced a prior term birth. There was a trend toward a benefit of a prior term birth only in the group who had had multiple SPTDs.

These findings raise the possibility that a prior term birth may modify the effectiveness of 17P, according to Dr. John R. Barton.

Still, “current information would suggest that 17P be offered to all women with a history of prior SPTD in a current singleton pregnancy, even if they have experienced a term gestation, especially now with the Food and Drug Administration's approval of 17P,” he said at the meeting. The FDA said that it had approved 17P for the prevention of recurrent preterm birth in women with singleton pregnancies.

Investigators have noted a lack of direct data on the benefit of 17P in women with a prior term birth followed by SPTD, Dr. Barton observed. Additionally, some have expressed concern that this treatment may increase fetal loss.

He and his colleagues studied women with a singleton pregnancy who received weekly 250-mg intramuscular injections of 17P through a home administration program because of previous SPTD. Treatment began before 25 weeks' gestation and continued until 36 completed weeks or preterm delivery.

About 70% of the women had previously experienced just one SPTD, while the other 30% had experienced more than one, reported Dr. Barton, who is director of maternal-fetal medicine at Central Baptist Hospital in Lexington, Ky.

In the group who had just one SPTD, women with a prior term birth were significantly less likely than those without a prior term birth to have a recurrent SPTD before 37 weeks' gestation (odds ratio, 0.83), and also before 35 weeks (OR, 0.73) and before 32 weeks (OR, 0.74).

In a multivariate logistic regression analysis, a prior term birth still significantly protected against recurrent SPTD before 37 weeks (OR, 0.83; P = .01).

In the group who had more than one SPTD, women with a prior term birth were significantly less likely to have a recurrent SPTD before 37 weeks' gestation (OR, 0.79) but not before 35 or 32 weeks. And in a multivariate logistic regression analysis, there was a trend toward a lower risk of recurrent SPTD only before 37 weeks (OR, 0.83; P = .06).

Comparing results across singleton progestin studies, Dr. Barton noted that the rate of fetal death in the study cohort was just 0.37%, or much lower than the 1.3% observed in the placebo arms of two randomized trials (N. Engl. J. Med. 2003;348:2379-85; Ultrasound Obstet. Gynecol. 2007;30:687-96).

Moreover, those two trials were much smaller. Therefore, “I think we can conclude that our stillbirth rate was not increased above those in the placebo cohorts.”

The study had its limitations, acknowledged Dr. Barton. It was retrospective, did not have data on cervical length, and lacked a control group not given 17P.

But there also were some noteworthy strengths. “This is the largest cohort of women with a prior SPTD evaluating 17P therapy in a community setting,” he elaborated.

“It's also the first to evaluate the impact of a prior term delivery as a modifier of the risk of recurrent SPTD at less than 37, less than 35, and less than 32 weeks' gestation,” Dr. Barton said.

Major Finding: Many women did not know their cancer's ER status (26%), whether they had had lymph nodes removed (16%), and all of the chemotherapy drugs they had received (44%). But most (88%) nonetheless believed they could clearly communicate their treatments to health care providers.

Data Source: A cross-sectional survey of 490 women who had completed primary treatment for stage 0-III breast cancer.

Disclosures: Dr. Mao reported that he had no relevant financial disclosures.

SEATTLE – Many women who have had early breast cancer don't know key treatment facts that may have implications for their long-term follow-up and health, according to a survey of cancer survivors.

Among nearly 500 respondents who had completed primary treatment, one in four didn't know their cancer's estrogen receptor (ER) status, and one in six didn't know whether they had had any lymph nodes removed. In addition, nearly half of those who had undergone chemotherapy were unable to correctly identify all of the agents they had received, according to survey results.

Yet when asked questions about their perceived self-efficacy in navigating survivorship care, most of the women believed that they could clearly communicate their treatments to health care providers outside their oncology clinic, reported Dr. Jun James Mao.

“We need to begin designing interventions to allow the accurate transfer of cancer treatment information, as well as to promote self-efficacy among a diverse group – especially among individuals who are particularly vulnerable to health disparities, such as racial/ethnic minorities and elderly patients,” noted Dr. Mao, director of integrative medicine at the Hospital of the University of Pennsylvania, Philadelphia.

The investigators surveyed women from the university's outpatient breast cancer oncology clinic who were participating in a study of aromatase inhibitors. All had stage 0-III breast cancer, had completed primary treatment, and were taking one of those agents. The women were classified as knowing a given aspect of their cancer or treatment if their response on the questionnaire matched the information in their chart. They were classified as not knowing if they answered that they did not know or if their response did not match the chart information.

The mean age of the 490 participating women was 62 years. In all, 82% of participants were white, 14.5% were black, 1.8% were Asian, 1% were Hispanic, and the rest were of other races/ethnicities. The majority had a college education (43%) or graduate/professional education (36%). About a third each had received their diagnosis less than 2 years, 2-5 years, and more than 5 years in the past.

Study results showed that substantial proportions of women did not know their breast cancer stage (49%), ER status (26%), progesterone receptor status (75%), HER2 status (58%), whether they had had lymph nodes removed (16%), and whether they had any positive lymph nodes (15%). Only 5% did not know if they had received chemotherapy. Among the group of patients who underwent chemotherapy, nearly half (44%) did not know all of the agents they had received, although the value was somewhat lower (21%-29%) for individual agents. That finding is “strongly troubling,” Dr. Mao said, given that “chemotherapy is one of the greatest sources of long-term late effects.”

Of particular note, despite the gaps seen in knowledge about treatment, 88% of the women agreed or strongly agreed that “I can communicate clearly about my cancer treatment(s) to other health care providers.”

“One of the most striking differences we found was the racial/ethnic difference in cancer knowledge and self-efficacy,” Dr. Mao noted. In multivariate analyses, relative to their white counterparts, women who were not white had significantly lower scores for knowledge (14.5 points lower) and self-efficacy (13.5 points lower).

In addition, women had lower levels of knowledge if they were older, had less education, received chemotherapy, or were a longer time out from diagnosis. And they had lower levels of self-efficacy if they were older and less educated.

Major Finding: Many women did not know their cancer's ER status (26%), whether they had had lymph nodes removed (16%), and all of the chemotherapy drugs they had received (44%). But most (88%) nonetheless believed they could clearly communicate their treatments to health care providers.

Data Source: A cross-sectional survey of 490 women who had completed primary treatment for stage 0-III breast cancer.

Disclosures: Dr. Mao reported that he had no relevant financial disclosures.

SEATTLE – Many women who have had early breast cancer don't know key treatment facts that may have implications for their long-term follow-up and health, according to a survey of cancer survivors.

Among nearly 500 respondents who had completed primary treatment, one in four didn't know their cancer's estrogen receptor (ER) status, and one in six didn't know whether they had had any lymph nodes removed. In addition, nearly half of those who had undergone chemotherapy were unable to correctly identify all of the agents they had received, according to survey results.

Yet when asked questions about their perceived self-efficacy in navigating survivorship care, most of the women believed that they could clearly communicate their treatments to health care providers outside their oncology clinic, reported Dr. Jun James Mao.

“We need to begin designing interventions to allow the accurate transfer of cancer treatment information, as well as to promote self-efficacy among a diverse group – especially among individuals who are particularly vulnerable to health disparities, such as racial/ethnic minorities and elderly patients,” noted Dr. Mao, director of integrative medicine at the Hospital of the University of Pennsylvania, Philadelphia.

The investigators surveyed women from the university's outpatient breast cancer oncology clinic who were participating in a study of aromatase inhibitors. All had stage 0-III breast cancer, had completed primary treatment, and were taking one of those agents. The women were classified as knowing a given aspect of their cancer or treatment if their response on the questionnaire matched the information in their chart. They were classified as not knowing if they answered that they did not know or if their response did not match the chart information.

The mean age of the 490 participating women was 62 years. In all, 82% of participants were white, 14.5% were black, 1.8% were Asian, 1% were Hispanic, and the rest were of other races/ethnicities. The majority had a college education (43%) or graduate/professional education (36%). About a third each had received their diagnosis less than 2 years, 2-5 years, and more than 5 years in the past.

Study results showed that substantial proportions of women did not know their breast cancer stage (49%), ER status (26%), progesterone receptor status (75%), HER2 status (58%), whether they had had lymph nodes removed (16%), and whether they had any positive lymph nodes (15%). Only 5% did not know if they had received chemotherapy. Among the group of patients who underwent chemotherapy, nearly half (44%) did not know all of the agents they had received, although the value was somewhat lower (21%-29%) for individual agents. That finding is “strongly troubling,” Dr. Mao said, given that “chemotherapy is one of the greatest sources of long-term late effects.”

Of particular note, despite the gaps seen in knowledge about treatment, 88% of the women agreed or strongly agreed that “I can communicate clearly about my cancer treatment(s) to other health care providers.”

“One of the most striking differences we found was the racial/ethnic difference in cancer knowledge and self-efficacy,” Dr. Mao noted. In multivariate analyses, relative to their white counterparts, women who were not white had significantly lower scores for knowledge (14.5 points lower) and self-efficacy (13.5 points lower).

In addition, women had lower levels of knowledge if they were older, had less education, received chemotherapy, or were a longer time out from diagnosis. And they had lower levels of self-efficacy if they were older and less educated.

Major Finding: Many women did not know their cancer's ER status (26%), whether they had had lymph nodes removed (16%), and all of the chemotherapy drugs they had received (44%). But most (88%) nonetheless believed they could clearly communicate their treatments to health care providers.

Data Source: A cross-sectional survey of 490 women who had completed primary treatment for stage 0-III breast cancer.

Disclosures: Dr. Mao reported that he had no relevant financial disclosures.

SEATTLE – Many women who have had early breast cancer don't know key treatment facts that may have implications for their long-term follow-up and health, according to a survey of cancer survivors.

Among nearly 500 respondents who had completed primary treatment, one in four didn't know their cancer's estrogen receptor (ER) status, and one in six didn't know whether they had had any lymph nodes removed. In addition, nearly half of those who had undergone chemotherapy were unable to correctly identify all of the agents they had received, according to survey results.

Yet when asked questions about their perceived self-efficacy in navigating survivorship care, most of the women believed that they could clearly communicate their treatments to health care providers outside their oncology clinic, reported Dr. Jun James Mao.

“We need to begin designing interventions to allow the accurate transfer of cancer treatment information, as well as to promote self-efficacy among a diverse group – especially among individuals who are particularly vulnerable to health disparities, such as racial/ethnic minorities and elderly patients,” noted Dr. Mao, director of integrative medicine at the Hospital of the University of Pennsylvania, Philadelphia.

The investigators surveyed women from the university's outpatient breast cancer oncology clinic who were participating in a study of aromatase inhibitors. All had stage 0-III breast cancer, had completed primary treatment, and were taking one of those agents. The women were classified as knowing a given aspect of their cancer or treatment if their response on the questionnaire matched the information in their chart. They were classified as not knowing if they answered that they did not know or if their response did not match the chart information.

The mean age of the 490 participating women was 62 years. In all, 82% of participants were white, 14.5% were black, 1.8% were Asian, 1% were Hispanic, and the rest were of other races/ethnicities. The majority had a college education (43%) or graduate/professional education (36%). About a third each had received their diagnosis less than 2 years, 2-5 years, and more than 5 years in the past.

Study results showed that substantial proportions of women did not know their breast cancer stage (49%), ER status (26%), progesterone receptor status (75%), HER2 status (58%), whether they had had lymph nodes removed (16%), and whether they had any positive lymph nodes (15%). Only 5% did not know if they had received chemotherapy. Among the group of patients who underwent chemotherapy, nearly half (44%) did not know all of the agents they had received, although the value was somewhat lower (21%-29%) for individual agents. That finding is “strongly troubling,” Dr. Mao said, given that “chemotherapy is one of the greatest sources of long-term late effects.”

Of particular note, despite the gaps seen in knowledge about treatment, 88% of the women agreed or strongly agreed that “I can communicate clearly about my cancer treatment(s) to other health care providers.”

“One of the most striking differences we found was the racial/ethnic difference in cancer knowledge and self-efficacy,” Dr. Mao noted. In multivariate analyses, relative to their white counterparts, women who were not white had significantly lower scores for knowledge (14.5 points lower) and self-efficacy (13.5 points lower).

In addition, women had lower levels of knowledge if they were older, had less education, received chemotherapy, or were a longer time out from diagnosis. And they had lower levels of self-efficacy if they were older and less educated.

What does an oncologist need to know about OIGs, RACs, and ZPICs? Plenty. They are some of the auditors who can make life difficult if a practice is not in compliance with Medicare and Medicaid billing and utilization procedures, Roberta L. Buell said at this journal’s annual Community Oncology Conference in Las Vegas.

The government is financing health¬care reform in part through audits to recover stolen and misused money, she explained. Thus far, it has recovered impressive sums, suggesting that the auditors are here to stay no matter how reform plays out. Anyone who runs a practice could be audited, cautioned Ms. Buell, a principal and coding and reimbursement specialist at onPoint Oncology in Sausalito, California. She discussed some of the key types of auditors and their roles.

Acronyms with a mission

Office of Inspector General auditors (OIGs) are responsible for ensuring appropriate use of Medicare funds. Their activities range from conducting basic audits to arranging arrests if a practice is deemed to have done something criminal.

OIGs will be scrutinizing a host of issues in 2011 and 2012, according to Ms. Buell. One is “place-of-service” errors, whereby a claim indicates a patient was treated in an office, where reimbursement is higher, but treatment actually took place in a hospital or ambulatory surgical center. This can be tricky for oncologists who sell their practices to a hospital but maintain a separate office. When physicians see patients in the office, “they’re…billing Part B. But if they walk across the hall to the infusion center and they see [patients] over there,…their place of service will be the hospital,” she said.

The OIGs will also be taking a close look at evaluation and management (E/M) codes to assess whether the codes accurately reflect the type, setting, and complexity of services provided as well as patient status—new or established. Also within the E/M category, auditors will be on the look out for identical (boilerplate) documentation across patients, sometimes a result of use of electronic medical records.

Error-prone providers, such as those with high numbers of duplicate claims, will catch the auditors’ attention as well. To avoid this, Ms. Buell recommended following up with a phone call when a claim goes unpaid, rather than resubmitting the claim. Medicare incentive payments for use of electronic medical records will also feature in the auditors’ work plan. “People are going to be randomly audited to make sure that they had 90 days of consecutive meaningful use—and it has to be for all patients, not just for Medicare patients,” Ms. Buell said.

Compliance with the Health Insurance Portability and Accountability Act will also be assessed. Some large fines have already been levied because of data-security breaches, so practices need to be especially vigilant about not leaving records around or losing laptops.

The OIGs will also scrutinize a variety of issues related to the Part D prescription drug program, such as inclusion of Part A and B claims with Part D claims. Ms. Buell cited billing practices for erythropoiesis-stimulating agents and pegfilgrastim (Neulasta) as an example: a practice might bill through Part D for Neulasta because it is “under water” on it, but “that is going to come back to haunt [you], because that’s not supposed to happen.”

A related aspect of Part D billing is the duplication of drug claims for hospice patients. “If somebody is in the hospice and is getting a drug through the hospice, but comes to your practice and gets it again, that’s going to be looked at,” she explained.

Zone Program Integrity Contractors (ZPICs) “are the [auditors] you really have to worry about. These are the folks who are looking for fraud.” Their data-analysis program is intended to identify provider billing practices and services that pose the greatest financial risk to the Medicare program, for example, high-volume and high-cost services that are being widely overused. But they also investigate credible whistle-blower (qui tam) complaints.

ZPICs can send a practice two types of letters. One is a request for records within 30 days, which usually means the practice was flagged by the screening program and the auditors want to take a closer look at the documentation. In this case, an attorney is not necessary. “But you have to have people look very hard at those records…[so] that everything that is done is justified in the record,” she said. The other type of letter usually arrives by fax and states that auditors will be on site within a few days. “That means that they have a complaint, either by a patient or more likely by a disgruntled physician or employee,” Ms. Buell noted. Here, the stakes are criminal penalties, and there should be an attorney on site during the visit.

Recovery Audit Contractors (RACs) “are bounty hunters,” she said. They are focused on recovering misspent Medicare funds and are paid a contingency fee of 9%–12% of the amount recovered. However, they are not active in practices because they have enjoyed such success in hospitals. At present, they do automated screening of practices’ Part B payments. “If you fall out of the screen, they ask for the money back and that’s the end,” Ms. Buell said. She cautioned, however, that RACs might start doing complex reviews later this year. And if they do, drugs are likely to be an early focus “because there is so much money involved and they have seen that [in the hospitals].”

Medicaid Integrity Contractors (MICs) review Medicaid claims for inappropriate payments and fraud, using a data-driven approach to identify aberrant billing practices. Unlike RACs, who receive a contingency fee, MICs are paid for their services and receive a quality-related bonus. Their look-back period for medical records varies by state. At present, they target mainly hospitals and, to a lesser extent, skilled nursing facilities, nursing homes, and hospices. Physicians are low on the list of priorities, “but…if you have a heavy Medicaid load, you do have to worry about [it],” Ms. Buell said.

Medicare Administrative Contractors (MACs) process claims for both Part A and Part B services and therefore can review discrepancies between the two sets of claims, revise payments, and increase denials. Some ongoing MAC activities include audits regarding usage of the 99204 and 99205 procedure codes for new patients.

Minimizing the risks

Given this environment, what can oncology practices do to minimize their risk? “Have a compliance [program] and make it a priority,” Ms. Buell recommended, adding that it is also a requirement of healthcare reform. Be sure to fix anything the program identifies, because auditors will take a much stiffer stance if they discover issues that were known but not resolved.

Practices can refer to a set of components that the OIG has set forth as the foundation of an effective compliance and ethics program (www.oig.hhs.gov/authorities/docs/physician.pdf). For example, there should be standard policies and procedures in the practice for things such as documentation, education and training, and updates on Medicare regulations. The enforcement of these policies is also a key element of an effective compliance program, as is a prevention component that anticipates mistakes and prevents them from occurring whenever possible.

The healthcare reform legislation requires that practices report and return Medicare and Medicaid overpayments. “If you find that you have been overpaid, for any reason, even if it’s their mistake, give the money back,” Ms. Buell said, because there is a good chance that auditors will eventually discover it.

Any practice that is concerned about being at risk for whistle-blower incidents should obtain legal help. “If you think there is…someone out there who can hurt you, you need to have your compliance program administered by an attorney.”

Finally, “educate, educate, educate,” she advised, to keep physicians and other practice members current on compliance issues.

What does an oncologist need to know about OIGs, RACs, and ZPICs? Plenty. They are some of the auditors who can make life difficult if a practice is not in compliance with Medicare and Medicaid billing and utilization procedures, Roberta L. Buell said at this journal’s annual Community Oncology Conference in Las Vegas.

The government is financing health¬care reform in part through audits to recover stolen and misused money, she explained. Thus far, it has recovered impressive sums, suggesting that the auditors are here to stay no matter how reform plays out. Anyone who runs a practice could be audited, cautioned Ms. Buell, a principal and coding and reimbursement specialist at onPoint Oncology in Sausalito, California. She discussed some of the key types of auditors and their roles.

Acronyms with a mission

Office of Inspector General auditors (OIGs) are responsible for ensuring appropriate use of Medicare funds. Their activities range from conducting basic audits to arranging arrests if a practice is deemed to have done something criminal.

OIGs will be scrutinizing a host of issues in 2011 and 2012, according to Ms. Buell. One is “place-of-service” errors, whereby a claim indicates a patient was treated in an office, where reimbursement is higher, but treatment actually took place in a hospital or ambulatory surgical center. This can be tricky for oncologists who sell their practices to a hospital but maintain a separate office. When physicians see patients in the office, “they’re…billing Part B. But if they walk across the hall to the infusion center and they see [patients] over there,…their place of service will be the hospital,” she said.

The OIGs will also be taking a close look at evaluation and management (E/M) codes to assess whether the codes accurately reflect the type, setting, and complexity of services provided as well as patient status—new or established. Also within the E/M category, auditors will be on the look out for identical (boilerplate) documentation across patients, sometimes a result of use of electronic medical records.

Error-prone providers, such as those with high numbers of duplicate claims, will catch the auditors’ attention as well. To avoid this, Ms. Buell recommended following up with a phone call when a claim goes unpaid, rather than resubmitting the claim. Medicare incentive payments for use of electronic medical records will also feature in the auditors’ work plan. “People are going to be randomly audited to make sure that they had 90 days of consecutive meaningful use—and it has to be for all patients, not just for Medicare patients,” Ms. Buell said.

Compliance with the Health Insurance Portability and Accountability Act will also be assessed. Some large fines have already been levied because of data-security breaches, so practices need to be especially vigilant about not leaving records around or losing laptops.

The OIGs will also scrutinize a variety of issues related to the Part D prescription drug program, such as inclusion of Part A and B claims with Part D claims. Ms. Buell cited billing practices for erythropoiesis-stimulating agents and pegfilgrastim (Neulasta) as an example: a practice might bill through Part D for Neulasta because it is “under water” on it, but “that is going to come back to haunt [you], because that’s not supposed to happen.”

A related aspect of Part D billing is the duplication of drug claims for hospice patients. “If somebody is in the hospice and is getting a drug through the hospice, but comes to your practice and gets it again, that’s going to be looked at,” she explained.

Zone Program Integrity Contractors (ZPICs) “are the [auditors] you really have to worry about. These are the folks who are looking for fraud.” Their data-analysis program is intended to identify provider billing practices and services that pose the greatest financial risk to the Medicare program, for example, high-volume and high-cost services that are being widely overused. But they also investigate credible whistle-blower (qui tam) complaints.

ZPICs can send a practice two types of letters. One is a request for records within 30 days, which usually means the practice was flagged by the screening program and the auditors want to take a closer look at the documentation. In this case, an attorney is not necessary. “But you have to have people look very hard at those records…[so] that everything that is done is justified in the record,” she said. The other type of letter usually arrives by fax and states that auditors will be on site within a few days. “That means that they have a complaint, either by a patient or more likely by a disgruntled physician or employee,” Ms. Buell noted. Here, the stakes are criminal penalties, and there should be an attorney on site during the visit.

Recovery Audit Contractors (RACs) “are bounty hunters,” she said. They are focused on recovering misspent Medicare funds and are paid a contingency fee of 9%–12% of the amount recovered. However, they are not active in practices because they have enjoyed such success in hospitals. At present, they do automated screening of practices’ Part B payments. “If you fall out of the screen, they ask for the money back and that’s the end,” Ms. Buell said. She cautioned, however, that RACs might start doing complex reviews later this year. And if they do, drugs are likely to be an early focus “because there is so much money involved and they have seen that [in the hospitals].”

Medicaid Integrity Contractors (MICs) review Medicaid claims for inappropriate payments and fraud, using a data-driven approach to identify aberrant billing practices. Unlike RACs, who receive a contingency fee, MICs are paid for their services and receive a quality-related bonus. Their look-back period for medical records varies by state. At present, they target mainly hospitals and, to a lesser extent, skilled nursing facilities, nursing homes, and hospices. Physicians are low on the list of priorities, “but…if you have a heavy Medicaid load, you do have to worry about [it],” Ms. Buell said.

Medicare Administrative Contractors (MACs) process claims for both Part A and Part B services and therefore can review discrepancies between the two sets of claims, revise payments, and increase denials. Some ongoing MAC activities include audits regarding usage of the 99204 and 99205 procedure codes for new patients.

Minimizing the risks

Given this environment, what can oncology practices do to minimize their risk? “Have a compliance [program] and make it a priority,” Ms. Buell recommended, adding that it is also a requirement of healthcare reform. Be sure to fix anything the program identifies, because auditors will take a much stiffer stance if they discover issues that were known but not resolved.

Practices can refer to a set of components that the OIG has set forth as the foundation of an effective compliance and ethics program (www.oig.hhs.gov/authorities/docs/physician.pdf). For example, there should be standard policies and procedures in the practice for things such as documentation, education and training, and updates on Medicare regulations. The enforcement of these policies is also a key element of an effective compliance program, as is a prevention component that anticipates mistakes and prevents them from occurring whenever possible.

The healthcare reform legislation requires that practices report and return Medicare and Medicaid overpayments. “If you find that you have been overpaid, for any reason, even if it’s their mistake, give the money back,” Ms. Buell said, because there is a good chance that auditors will eventually discover it.

Any practice that is concerned about being at risk for whistle-blower incidents should obtain legal help. “If you think there is…someone out there who can hurt you, you need to have your compliance program administered by an attorney.”

Finally, “educate, educate, educate,” she advised, to keep physicians and other practice members current on compliance issues.

What does an oncologist need to know about OIGs, RACs, and ZPICs? Plenty. They are some of the auditors who can make life difficult if a practice is not in compliance with Medicare and Medicaid billing and utilization procedures, Roberta L. Buell said at this journal’s annual Community Oncology Conference in Las Vegas.

The government is financing health¬care reform in part through audits to recover stolen and misused money, she explained. Thus far, it has recovered impressive sums, suggesting that the auditors are here to stay no matter how reform plays out. Anyone who runs a practice could be audited, cautioned Ms. Buell, a principal and coding and reimbursement specialist at onPoint Oncology in Sausalito, California. She discussed some of the key types of auditors and their roles.

Acronyms with a mission

Office of Inspector General auditors (OIGs) are responsible for ensuring appropriate use of Medicare funds. Their activities range from conducting basic audits to arranging arrests if a practice is deemed to have done something criminal.

OIGs will be scrutinizing a host of issues in 2011 and 2012, according to Ms. Buell. One is “place-of-service” errors, whereby a claim indicates a patient was treated in an office, where reimbursement is higher, but treatment actually took place in a hospital or ambulatory surgical center. This can be tricky for oncologists who sell their practices to a hospital but maintain a separate office. When physicians see patients in the office, “they’re…billing Part B. But if they walk across the hall to the infusion center and they see [patients] over there,…their place of service will be the hospital,” she said.

The OIGs will also be taking a close look at evaluation and management (E/M) codes to assess whether the codes accurately reflect the type, setting, and complexity of services provided as well as patient status—new or established. Also within the E/M category, auditors will be on the look out for identical (boilerplate) documentation across patients, sometimes a result of use of electronic medical records.

Error-prone providers, such as those with high numbers of duplicate claims, will catch the auditors’ attention as well. To avoid this, Ms. Buell recommended following up with a phone call when a claim goes unpaid, rather than resubmitting the claim. Medicare incentive payments for use of electronic medical records will also feature in the auditors’ work plan. “People are going to be randomly audited to make sure that they had 90 days of consecutive meaningful use—and it has to be for all patients, not just for Medicare patients,” Ms. Buell said.

Compliance with the Health Insurance Portability and Accountability Act will also be assessed. Some large fines have already been levied because of data-security breaches, so practices need to be especially vigilant about not leaving records around or losing laptops.

The OIGs will also scrutinize a variety of issues related to the Part D prescription drug program, such as inclusion of Part A and B claims with Part D claims. Ms. Buell cited billing practices for erythropoiesis-stimulating agents and pegfilgrastim (Neulasta) as an example: a practice might bill through Part D for Neulasta because it is “under water” on it, but “that is going to come back to haunt [you], because that’s not supposed to happen.”

A related aspect of Part D billing is the duplication of drug claims for hospice patients. “If somebody is in the hospice and is getting a drug through the hospice, but comes to your practice and gets it again, that’s going to be looked at,” she explained.

Zone Program Integrity Contractors (ZPICs) “are the [auditors] you really have to worry about. These are the folks who are looking for fraud.” Their data-analysis program is intended to identify provider billing practices and services that pose the greatest financial risk to the Medicare program, for example, high-volume and high-cost services that are being widely overused. But they also investigate credible whistle-blower (qui tam) complaints.

ZPICs can send a practice two types of letters. One is a request for records within 30 days, which usually means the practice was flagged by the screening program and the auditors want to take a closer look at the documentation. In this case, an attorney is not necessary. “But you have to have people look very hard at those records…[so] that everything that is done is justified in the record,” she said. The other type of letter usually arrives by fax and states that auditors will be on site within a few days. “That means that they have a complaint, either by a patient or more likely by a disgruntled physician or employee,” Ms. Buell noted. Here, the stakes are criminal penalties, and there should be an attorney on site during the visit.

Recovery Audit Contractors (RACs) “are bounty hunters,” she said. They are focused on recovering misspent Medicare funds and are paid a contingency fee of 9%–12% of the amount recovered. However, they are not active in practices because they have enjoyed such success in hospitals. At present, they do automated screening of practices’ Part B payments. “If you fall out of the screen, they ask for the money back and that’s the end,” Ms. Buell said. She cautioned, however, that RACs might start doing complex reviews later this year. And if they do, drugs are likely to be an early focus “because there is so much money involved and they have seen that [in the hospitals].”

Medicaid Integrity Contractors (MICs) review Medicaid claims for inappropriate payments and fraud, using a data-driven approach to identify aberrant billing practices. Unlike RACs, who receive a contingency fee, MICs are paid for their services and receive a quality-related bonus. Their look-back period for medical records varies by state. At present, they target mainly hospitals and, to a lesser extent, skilled nursing facilities, nursing homes, and hospices. Physicians are low on the list of priorities, “but…if you have a heavy Medicaid load, you do have to worry about [it],” Ms. Buell said.

Medicare Administrative Contractors (MACs) process claims for both Part A and Part B services and therefore can review discrepancies between the two sets of claims, revise payments, and increase denials. Some ongoing MAC activities include audits regarding usage of the 99204 and 99205 procedure codes for new patients.

Minimizing the risks

Given this environment, what can oncology practices do to minimize their risk? “Have a compliance [program] and make it a priority,” Ms. Buell recommended, adding that it is also a requirement of healthcare reform. Be sure to fix anything the program identifies, because auditors will take a much stiffer stance if they discover issues that were known but not resolved.

Practices can refer to a set of components that the OIG has set forth as the foundation of an effective compliance and ethics program (www.oig.hhs.gov/authorities/docs/physician.pdf). For example, there should be standard policies and procedures in the practice for things such as documentation, education and training, and updates on Medicare regulations. The enforcement of these policies is also a key element of an effective compliance program, as is a prevention component that anticipates mistakes and prevents them from occurring whenever possible.

The healthcare reform legislation requires that practices report and return Medicare and Medicaid overpayments. “If you find that you have been overpaid, for any reason, even if it’s their mistake, give the money back,” Ms. Buell said, because there is a good chance that auditors will eventually discover it.

Any practice that is concerned about being at risk for whistle-blower incidents should obtain legal help. “If you think there is…someone out there who can hurt you, you need to have your compliance program administered by an attorney.”

Finally, “educate, educate, educate,” she advised, to keep physicians and other practice members current on compliance issues.

LAS VEGAS – Lean Six Sigma, a method for improving quality and efficiency that originated in automotive and semiconductor manufacturing, can also bring impressive results to community oncology practices, according to a physician who has applied the method in the nation’s largest private cancer care network.

"We have shown – and we are convinced – that continuous improvement with Lean Six Sigma can be successfully applied to an oncology clinic, and we can see real benefits as a result," said Dr. David C. Fryefield, medical director of the Practice Quality and Efficiency (PQE) program created in 2006 that implements Lean Six Sigma at US Oncology’s member practices.

Between 2007 and 2010, those practices that participated in the program added $80 million to their bottom line, Dr. Fryefield said, stressing that the program is comprehensive and includes quality assessments, such as patient surveys, as well as improvements in efficiency.

The initiative began with a study of the day-to-day workings of two practices in Oregon and Texas. Results showed that on average, various processes had some kind of defect or breakdown about 20% of the time, according to Dr. Fryefield, also medical director of the Willamette Valley Cancer Institute in Eugene, Ore. For example, lab reports were available on time for physicians in just 44% of cases, and complete physician orders for admixtures were available when needed in 71% of cases.

This is "the dirty laundry part," Dr. Fryefield told attendees. "But if you are honest, I bet you’ll know that these kinds of things are happening in your practice as well."

Further analyses showed that staff, especially medical assistants, had substantial amounts of what is called "non–value-added time," or time not spent in direct or supportive patient care activities.

"Essentially, these [employees] are work-around bees," Dr. Fryefield said. "We have a defective process, and we hire a medical assistant to work around that process, to make that extra phone call" to track down a missing lab report.

The flawed processes were causing increased wait times in the clinic. For most types of encounters, more than half of a patient’s visit was spent waiting.

Finally, the practices had a distortion in capacity, according to Dr. Fryefield. Their labs’ target capacity was 60%, but the labs were actually operating at 115%. Meanwhile, exam rooms and chemotherapy chairs were well under their target capacity, which wasted resources as patients sat and sat.

Clearly, oncology practices had plenty of room for improvement, and Lean Six Sigma was chosen to bring that about, he said. "Lean" shortens the time required to complete a task by reducing steps and improving handoffs between people, Dr. Fryefield, explained at the annual Community Oncology Conference. "Six Sigma" is a systematic approach to reducing defects in a process by controlling the causative factors.

The method’s steps are summed up by the acronym DMAIC, which stands for define, measure, analyze, improve, and control.

"Define" refers to the establishment of agreed-on expectations for a given process; for example, the steps involved in patient scheduling or drug preparation.

"Measure" can be implemented by simple means, such as having observers use a stopwatch and clipboard to tally performance for each metric.

"Analysis" entails crunching the numbers to find the root cause of problems.

In "Improve," the findings are applied in a focused way that addresses the defective processes.

Finally, "Control" pertains to sustaining the improvement. For example, display results where staff can see them, and periodically remeasure to prevent any backsliding.

Each part of the process – no matter how seemingly small or obvious – is important to the whole, Dr. Fryefield said. He introduced the following four case studies:

• Case 1. Practice leaders thought they had insufficient exam rooms for their physicians, but Lean Six Sigma showed that "the exam rooms were the least of the problems," Dr. Fryefield said. The practice had long wait times to first appointments, whereas its oncologists had as few as 11 patient slots per day. After focused improvements in these areas, including the addition of many fewer rooms than planned, new patient volume rose by 6% and the labor cost per visit fell by 4%.

• Case 2. An oncology practice had excess capacity in its radiation therapy clinic, with relatively poor productivity for the number of radiation therapists employed. Computer modeling indicated that with flexible staff scheduling and other measures, the practice could get by with just two of its three linear accelerators. Therefore, the oldest was mothballed, and staff was reduced, resulting in a cost savings of nearly $500,000.

• Case 3. Again, scheduling, registration, and patient flow were frustrating and inefficient in a clinic. "They found that there were actually too many people in the process," Dr. Fryefield said. After assigning one person to scheduling and then reassigning the rest, productivity improved as the number of patients per FTE (full-time equivalent) staff increased by 17%.

• Case 4. Chaotic procedures resulted in an unhappy staff in this oncology practice. Lean Six Sigma showed inefficiencies in almost every aspect of care delivery, according to Dr. Fryefield. When best practices were implemented and various processes were streamlined, the volume of new patients increased by 22%, and productivity increased by 10%.

Experience with the PQE program using the Lean Six Sigma method has provided some important overall lessons, summarized Dr. Fryefield.

"Clearly, oncology practices are full of inefficiencies. That’s not really surprising," he said. Historically, "when we would try to solve problems in our clinics, we would just do something that seemed like a good idea, but it turned out that it was expensive or inefficient, or sometimes both."

Furthermore, although practice size, composition, and dynamics differ along with local markets, the inefficiencies and process defects are often similar. "For instance, the lab is always a bottleneck," he noted.

Overall, by using Lean Six Sigma, the PQE program has shown some impressive tangible benefits in the four process areas it focuses on, according to Dr. Fryefield. On average, participating practices have seen the following changes:

• A 3%-5% growth in patient volume (referral development).

• A 6%-8% increase in visits per staff full-time equivalent (care delivery).

• A 3%-5% improvement in costs with better cash flow (revenue cycle).

• A $1-$2 million increase in practice earnings (drug management).

"There isn’t anybody who can come in and do this [process] for you. Everybody in the practice has to [buy in], and that really starts with the docs," Dr. Fryefield advised. "They have to be part of this solution. If they think they are separate from this, they are wrong; MD leadership is essential."

Other senior practice members – executive directors, managers, and so on – also must be solidly on board, he said. And staff at all levels should be polled for their input and, ideally, be actively involved. The process also requires a commitment to change. "Change is never popular unless everyone thinks it’s their idea," he noted.

"PQE is a journey, not a destination," Dr. Fryefield concluded. "That’s one of the things that’s a little difficult for doctors to understand because doctors like to fix things and then move on. Some of my docs will say, ‘When is the change going to settle down?’ And the answer, of course, is never."

Community Oncology and this news organization are owned by Elsevier.

LAS VEGAS – Lean Six Sigma, a method for improving quality and efficiency that originated in automotive and semiconductor manufacturing, can also bring impressive results to community oncology practices, according to a physician who has applied the method in the nation’s largest private cancer care network.

"We have shown – and we are convinced – that continuous improvement with Lean Six Sigma can be successfully applied to an oncology clinic, and we can see real benefits as a result," said Dr. David C. Fryefield, medical director of the Practice Quality and Efficiency (PQE) program created in 2006 that implements Lean Six Sigma at US Oncology’s member practices.

Between 2007 and 2010, those practices that participated in the program added $80 million to their bottom line, Dr. Fryefield said, stressing that the program is comprehensive and includes quality assessments, such as patient surveys, as well as improvements in efficiency.

The initiative began with a study of the day-to-day workings of two practices in Oregon and Texas. Results showed that on average, various processes had some kind of defect or breakdown about 20% of the time, according to Dr. Fryefield, also medical director of the Willamette Valley Cancer Institute in Eugene, Ore. For example, lab reports were available on time for physicians in just 44% of cases, and complete physician orders for admixtures were available when needed in 71% of cases.

This is "the dirty laundry part," Dr. Fryefield told attendees. "But if you are honest, I bet you’ll know that these kinds of things are happening in your practice as well."

Further analyses showed that staff, especially medical assistants, had substantial amounts of what is called "non–value-added time," or time not spent in direct or supportive patient care activities.

"Essentially, these [employees] are work-around bees," Dr. Fryefield said. "We have a defective process, and we hire a medical assistant to work around that process, to make that extra phone call" to track down a missing lab report.

The flawed processes were causing increased wait times in the clinic. For most types of encounters, more than half of a patient’s visit was spent waiting.

Finally, the practices had a distortion in capacity, according to Dr. Fryefield. Their labs’ target capacity was 60%, but the labs were actually operating at 115%. Meanwhile, exam rooms and chemotherapy chairs were well under their target capacity, which wasted resources as patients sat and sat.

Clearly, oncology practices had plenty of room for improvement, and Lean Six Sigma was chosen to bring that about, he said. "Lean" shortens the time required to complete a task by reducing steps and improving handoffs between people, Dr. Fryefield, explained at the annual Community Oncology Conference. "Six Sigma" is a systematic approach to reducing defects in a process by controlling the causative factors.

The method’s steps are summed up by the acronym DMAIC, which stands for define, measure, analyze, improve, and control.

"Define" refers to the establishment of agreed-on expectations for a given process; for example, the steps involved in patient scheduling or drug preparation.

"Measure" can be implemented by simple means, such as having observers use a stopwatch and clipboard to tally performance for each metric.

"Analysis" entails crunching the numbers to find the root cause of problems.

In "Improve," the findings are applied in a focused way that addresses the defective processes.

Finally, "Control" pertains to sustaining the improvement. For example, display results where staff can see them, and periodically remeasure to prevent any backsliding.

Each part of the process – no matter how seemingly small or obvious – is important to the whole, Dr. Fryefield said. He introduced the following four case studies:

• Case 1. Practice leaders thought they had insufficient exam rooms for their physicians, but Lean Six Sigma showed that "the exam rooms were the least of the problems," Dr. Fryefield said. The practice had long wait times to first appointments, whereas its oncologists had as few as 11 patient slots per day. After focused improvements in these areas, including the addition of many fewer rooms than planned, new patient volume rose by 6% and the labor cost per visit fell by 4%.

• Case 2. An oncology practice had excess capacity in its radiation therapy clinic, with relatively poor productivity for the number of radiation therapists employed. Computer modeling indicated that with flexible staff scheduling and other measures, the practice could get by with just two of its three linear accelerators. Therefore, the oldest was mothballed, and staff was reduced, resulting in a cost savings of nearly $500,000.

• Case 3. Again, scheduling, registration, and patient flow were frustrating and inefficient in a clinic. "They found that there were actually too many people in the process," Dr. Fryefield said. After assigning one person to scheduling and then reassigning the rest, productivity improved as the number of patients per FTE (full-time equivalent) staff increased by 17%.

• Case 4. Chaotic procedures resulted in an unhappy staff in this oncology practice. Lean Six Sigma showed inefficiencies in almost every aspect of care delivery, according to Dr. Fryefield. When best practices were implemented and various processes were streamlined, the volume of new patients increased by 22%, and productivity increased by 10%.

Experience with the PQE program using the Lean Six Sigma method has provided some important overall lessons, summarized Dr. Fryefield.

"Clearly, oncology practices are full of inefficiencies. That’s not really surprising," he said. Historically, "when we would try to solve problems in our clinics, we would just do something that seemed like a good idea, but it turned out that it was expensive or inefficient, or sometimes both."

Furthermore, although practice size, composition, and dynamics differ along with local markets, the inefficiencies and process defects are often similar. "For instance, the lab is always a bottleneck," he noted.

Overall, by using Lean Six Sigma, the PQE program has shown some impressive tangible benefits in the four process areas it focuses on, according to Dr. Fryefield. On average, participating practices have seen the following changes:

• A 3%-5% growth in patient volume (referral development).

• A 6%-8% increase in visits per staff full-time equivalent (care delivery).

• A 3%-5% improvement in costs with better cash flow (revenue cycle).

• A $1-$2 million increase in practice earnings (drug management).

"There isn’t anybody who can come in and do this [process] for you. Everybody in the practice has to [buy in], and that really starts with the docs," Dr. Fryefield advised. "They have to be part of this solution. If they think they are separate from this, they are wrong; MD leadership is essential."

Other senior practice members – executive directors, managers, and so on – also must be solidly on board, he said. And staff at all levels should be polled for their input and, ideally, be actively involved. The process also requires a commitment to change. "Change is never popular unless everyone thinks it’s their idea," he noted.

"PQE is a journey, not a destination," Dr. Fryefield concluded. "That’s one of the things that’s a little difficult for doctors to understand because doctors like to fix things and then move on. Some of my docs will say, ‘When is the change going to settle down?’ And the answer, of course, is never."

Community Oncology and this news organization are owned by Elsevier.

LAS VEGAS – Lean Six Sigma, a method for improving quality and efficiency that originated in automotive and semiconductor manufacturing, can also bring impressive results to community oncology practices, according to a physician who has applied the method in the nation’s largest private cancer care network.

"We have shown – and we are convinced – that continuous improvement with Lean Six Sigma can be successfully applied to an oncology clinic, and we can see real benefits as a result," said Dr. David C. Fryefield, medical director of the Practice Quality and Efficiency (PQE) program created in 2006 that implements Lean Six Sigma at US Oncology’s member practices.

Between 2007 and 2010, those practices that participated in the program added $80 million to their bottom line, Dr. Fryefield said, stressing that the program is comprehensive and includes quality assessments, such as patient surveys, as well as improvements in efficiency.

The initiative began with a study of the day-to-day workings of two practices in Oregon and Texas. Results showed that on average, various processes had some kind of defect or breakdown about 20% of the time, according to Dr. Fryefield, also medical director of the Willamette Valley Cancer Institute in Eugene, Ore. For example, lab reports were available on time for physicians in just 44% of cases, and complete physician orders for admixtures were available when needed in 71% of cases.

This is "the dirty laundry part," Dr. Fryefield told attendees. "But if you are honest, I bet you’ll know that these kinds of things are happening in your practice as well."

Further analyses showed that staff, especially medical assistants, had substantial amounts of what is called "non–value-added time," or time not spent in direct or supportive patient care activities.

"Essentially, these [employees] are work-around bees," Dr. Fryefield said. "We have a defective process, and we hire a medical assistant to work around that process, to make that extra phone call" to track down a missing lab report.

The flawed processes were causing increased wait times in the clinic. For most types of encounters, more than half of a patient’s visit was spent waiting.

Finally, the practices had a distortion in capacity, according to Dr. Fryefield. Their labs’ target capacity was 60%, but the labs were actually operating at 115%. Meanwhile, exam rooms and chemotherapy chairs were well under their target capacity, which wasted resources as patients sat and sat.

Clearly, oncology practices had plenty of room for improvement, and Lean Six Sigma was chosen to bring that about, he said. "Lean" shortens the time required to complete a task by reducing steps and improving handoffs between people, Dr. Fryefield, explained at the annual Community Oncology Conference. "Six Sigma" is a systematic approach to reducing defects in a process by controlling the causative factors.

The method’s steps are summed up by the acronym DMAIC, which stands for define, measure, analyze, improve, and control.

"Define" refers to the establishment of agreed-on expectations for a given process; for example, the steps involved in patient scheduling or drug preparation.

"Measure" can be implemented by simple means, such as having observers use a stopwatch and clipboard to tally performance for each metric.

"Analysis" entails crunching the numbers to find the root cause of problems.

In "Improve," the findings are applied in a focused way that addresses the defective processes.

Finally, "Control" pertains to sustaining the improvement. For example, display results where staff can see them, and periodically remeasure to prevent any backsliding.

Each part of the process – no matter how seemingly small or obvious – is important to the whole, Dr. Fryefield said. He introduced the following four case studies:

• Case 1. Practice leaders thought they had insufficient exam rooms for their physicians, but Lean Six Sigma showed that "the exam rooms were the least of the problems," Dr. Fryefield said. The practice had long wait times to first appointments, whereas its oncologists had as few as 11 patient slots per day. After focused improvements in these areas, including the addition of many fewer rooms than planned, new patient volume rose by 6% and the labor cost per visit fell by 4%.

• Case 2. An oncology practice had excess capacity in its radiation therapy clinic, with relatively poor productivity for the number of radiation therapists employed. Computer modeling indicated that with flexible staff scheduling and other measures, the practice could get by with just two of its three linear accelerators. Therefore, the oldest was mothballed, and staff was reduced, resulting in a cost savings of nearly $500,000.

• Case 3. Again, scheduling, registration, and patient flow were frustrating and inefficient in a clinic. "They found that there were actually too many people in the process," Dr. Fryefield said. After assigning one person to scheduling and then reassigning the rest, productivity improved as the number of patients per FTE (full-time equivalent) staff increased by 17%.

• Case 4. Chaotic procedures resulted in an unhappy staff in this oncology practice. Lean Six Sigma showed inefficiencies in almost every aspect of care delivery, according to Dr. Fryefield. When best practices were implemented and various processes were streamlined, the volume of new patients increased by 22%, and productivity increased by 10%.

Experience with the PQE program using the Lean Six Sigma method has provided some important overall lessons, summarized Dr. Fryefield.

"Clearly, oncology practices are full of inefficiencies. That’s not really surprising," he said. Historically, "when we would try to solve problems in our clinics, we would just do something that seemed like a good idea, but it turned out that it was expensive or inefficient, or sometimes both."

Furthermore, although practice size, composition, and dynamics differ along with local markets, the inefficiencies and process defects are often similar. "For instance, the lab is always a bottleneck," he noted.

Overall, by using Lean Six Sigma, the PQE program has shown some impressive tangible benefits in the four process areas it focuses on, according to Dr. Fryefield. On average, participating practices have seen the following changes:

• A 3%-5% growth in patient volume (referral development).

• A 6%-8% increase in visits per staff full-time equivalent (care delivery).

• A 3%-5% improvement in costs with better cash flow (revenue cycle).

• A $1-$2 million increase in practice earnings (drug management).

"There isn’t anybody who can come in and do this [process] for you. Everybody in the practice has to [buy in], and that really starts with the docs," Dr. Fryefield advised. "They have to be part of this solution. If they think they are separate from this, they are wrong; MD leadership is essential."

Other senior practice members – executive directors, managers, and so on – also must be solidly on board, he said. And staff at all levels should be polled for their input and, ideally, be actively involved. The process also requires a commitment to change. "Change is never popular unless everyone thinks it’s their idea," he noted.

"PQE is a journey, not a destination," Dr. Fryefield concluded. "That’s one of the things that’s a little difficult for doctors to understand because doctors like to fix things and then move on. Some of my docs will say, ‘When is the change going to settle down?’ And the answer, of course, is never."

Community Oncology and this news organization are owned by Elsevier.

LAS VEGAS – Lean Six Sigma, a method for improving quality and efficiency that originated in automotive and semiconductor manufacturing, can also bring impressive results to community oncology practices, according to a physician who has applied the method in the nation’s largest private cancer care network.

"We have shown – and we are convinced – that continuous improvement with Lean Six Sigma can be successfully applied to an oncology clinic, and we can see real benefits as a result," said Dr. David C. Fryefield, medical director of the Practice Quality and Efficiency (PQE) program created in 2006 that implements Lean Six Sigma at US Oncology’s member practices.

Between 2007 and 2010, those practices that participated in the program added $80 million to their bottom line, Dr. Fryefield said, stressing that the program is comprehensive and includes quality assessments, such as patient surveys, as well as improvements in efficiency.

The initiative began with a study of the day-to-day workings of two practices in Oregon and Texas. Results showed that on average, various processes had some kind of defect or breakdown about 20% of the time, according to Dr. Fryefield, also medical director of the Willamette Valley Cancer Institute in Eugene, Ore. For example, lab reports were available on time for physicians in just 44% of cases, and complete physician orders for admixtures were available when needed in 71% of cases.

This is "the dirty laundry part," Dr. Fryefield told attendees. "But if you are honest, I bet you’ll know that these kinds of things are happening in your practice as well."

Further analyses showed that staff, especially medical assistants, had substantial amounts of what is called "non–value-added time," or time not spent in direct or supportive patient care activities.

"Essentially, these [employees] are work-around bees," Dr. Fryefield said. "We have a defective process, and we hire a medical assistant to work around that process, to make that extra phone call" to track down a missing lab report.

The flawed processes were causing increased wait times in the clinic. For most types of encounters, more than half of a patient’s visit was spent waiting.

Finally, the practices had a distortion in capacity, according to Dr. Fryefield. Their labs’ target capacity was 60%, but the labs were actually operating at 115%. Meanwhile, exam rooms and chemotherapy chairs were well under their target capacity, which wasted resources as patients sat and sat.

Clearly, oncology practices had plenty of room for improvement, and Lean Six Sigma was chosen to bring that about, he said. "Lean" shortens the time required to complete a task by reducing steps and improving handoffs between people, Dr. Fryefield, explained at the annual Community Oncology Conference. "Six Sigma" is a systematic approach to reducing defects in a process by controlling the causative factors.

The method’s steps are summed up by the acronym DMAIC, which stands for define, measure, analyze, improve, and control.

"Define" refers to the establishment of agreed-on expectations for a given process; for example, the steps involved in patient scheduling or drug preparation.

"Measure" can be implemented by simple means, such as having observers use a stopwatch and clipboard to tally performance for each metric.

"Analysis" entails crunching the numbers to find the root cause of problems.

In "Improve," the findings are applied in a focused way that addresses the defective processes.

Finally, "Control" pertains to sustaining the improvement. For example, display results where staff can see them, and periodically remeasure to prevent any backsliding.

Each part of the process – no matter how seemingly small or obvious – is important to the whole, Dr. Fryefield said. He introduced the following four case studies:

• Case 1. Practice leaders thought they had insufficient exam rooms for their physicians, but Lean Six Sigma showed that "the exam rooms were the least of the problems," Dr. Fryefield said. The practice had long wait times to first appointments, whereas its oncologists had as few as 11 patient slots per day. After focused improvements in these areas, including the addition of many fewer rooms than planned, new patient volume rose by 6% and the labor cost per visit fell by 4%.

• Case 2. An oncology practice had excess capacity in its radiation therapy clinic, with relatively poor productivity for the number of radiation therapists employed. Computer modeling indicated that with flexible staff scheduling and other measures, the practice could get by with just two of its three linear accelerators. Therefore, the oldest was mothballed, and staff was reduced, resulting in a cost savings of nearly $500,000.

• Case 3. Again, scheduling, registration, and patient flow were frustrating and inefficient in a clinic. "They found that there were actually too many people in the process," Dr. Fryefield said. After assigning one person to scheduling and then reassigning the rest, productivity improved as the number of patients per FTE (full-time equivalent) staff increased by 17%.

• Case 4. Chaotic procedures resulted in an unhappy staff in this oncology practice. Lean Six Sigma showed inefficiencies in almost every aspect of care delivery, according to Dr. Fryefield. When best practices were implemented and various processes were streamlined, the volume of new patients increased by 22%, and productivity increased by 10%.

Experience with the PQE program using the Lean Six Sigma method has provided some important overall lessons, summarized Dr. Fryefield.

"Clearly, oncology practices are full of inefficiencies. That’s not really surprising," he said. Historically, "when we would try to solve problems in our clinics, we would just do something that seemed like a good idea, but it turned out that it was expensive or inefficient, or sometimes both."

Furthermore, although practice size, composition, and dynamics differ along with local markets, the inefficiencies and process defects are often similar. "For instance, the lab is always a bottleneck," he noted.

Overall, by using Lean Six Sigma, the PQE program has shown some impressive tangible benefits in the four process areas it focuses on, according to Dr. Fryefield. On average, participating practices have seen the following changes:

• A 3%-5% growth in patient volume (referral development).

• A 6%-8% increase in visits per staff full-time equivalent (care delivery).

• A 3%-5% improvement in costs with better cash flow (revenue cycle).

• A $1-$2 million increase in practice earnings (drug management).

"There isn’t anybody who can come in and do this [process] for you. Everybody in the practice has to [buy in], and that really starts with the docs," Dr. Fryefield advised. "They have to be part of this solution. If they think they are separate from this, they are wrong; MD leadership is essential."

Other senior practice members – executive directors, managers, and so on – also must be solidly on board, he said. And staff at all levels should be polled for their input and, ideally, be actively involved. The process also requires a commitment to change. "Change is never popular unless everyone thinks it’s their idea," he noted.

"PQE is a journey, not a destination," Dr. Fryefield concluded. "That’s one of the things that’s a little difficult for doctors to understand because doctors like to fix things and then move on. Some of my docs will say, ‘When is the change going to settle down?’ And the answer, of course, is never."

Community Oncology and this news organization are owned by Elsevier.

LAS VEGAS – Lean Six Sigma, a method for improving quality and efficiency that originated in automotive and semiconductor manufacturing, can also bring impressive results to community oncology practices, according to a physician who has applied the method in the nation’s largest private cancer care network.

"We have shown – and we are convinced – that continuous improvement with Lean Six Sigma can be successfully applied to an oncology clinic, and we can see real benefits as a result," said Dr. David C. Fryefield, medical director of the Practice Quality and Efficiency (PQE) program created in 2006 that implements Lean Six Sigma at US Oncology’s member practices.

Between 2007 and 2010, those practices that participated in the program added $80 million to their bottom line, Dr. Fryefield said, stressing that the program is comprehensive and includes quality assessments, such as patient surveys, as well as improvements in efficiency.

The initiative began with a study of the day-to-day workings of two practices in Oregon and Texas. Results showed that on average, various processes had some kind of defect or breakdown about 20% of the time, according to Dr. Fryefield, also medical director of the Willamette Valley Cancer Institute in Eugene, Ore. For example, lab reports were available on time for physicians in just 44% of cases, and complete physician orders for admixtures were available when needed in 71% of cases.

This is "the dirty laundry part," Dr. Fryefield told attendees. "But if you are honest, I bet you’ll know that these kinds of things are happening in your practice as well."

Further analyses showed that staff, especially medical assistants, had substantial amounts of what is called "non–value-added time," or time not spent in direct or supportive patient care activities.

"Essentially, these [employees] are work-around bees," Dr. Fryefield said. "We have a defective process, and we hire a medical assistant to work around that process, to make that extra phone call" to track down a missing lab report.

The flawed processes were causing increased wait times in the clinic. For most types of encounters, more than half of a patient’s visit was spent waiting.

Finally, the practices had a distortion in capacity, according to Dr. Fryefield. Their labs’ target capacity was 60%, but the labs were actually operating at 115%. Meanwhile, exam rooms and chemotherapy chairs were well under their target capacity, which wasted resources as patients sat and sat.

Clearly, oncology practices had plenty of room for improvement, and Lean Six Sigma was chosen to bring that about, he said. "Lean" shortens the time required to complete a task by reducing steps and improving handoffs between people, Dr. Fryefield, explained at the annual Community Oncology Conference. "Six Sigma" is a systematic approach to reducing defects in a process by controlling the causative factors.

The method’s steps are summed up by the acronym DMAIC, which stands for define, measure, analyze, improve, and control.

"Define" refers to the establishment of agreed-on expectations for a given process; for example, the steps involved in patient scheduling or drug preparation.

"Measure" can be implemented by simple means, such as having observers use a stopwatch and clipboard to tally performance for each metric.

"Analysis" entails crunching the numbers to find the root cause of problems.

In "Improve," the findings are applied in a focused way that addresses the defective processes.

Finally, "Control" pertains to sustaining the improvement. For example, display results where staff can see them, and periodically remeasure to prevent any backsliding.

Each part of the process – no matter how seemingly small or obvious – is important to the whole, Dr. Fryefield said. He introduced the following four case studies:

• Case 1. Practice leaders thought they had insufficient exam rooms for their physicians, but Lean Six Sigma showed that "the exam rooms were the least of the problems," Dr. Fryefield said. The practice had long wait times to first appointments, whereas its oncologists had as few as 11 patient slots per day. After focused improvements in these areas, including the addition of many fewer rooms than planned, new patient volume rose by 6% and the labor cost per visit fell by 4%.

• Case 2. An oncology practice had excess capacity in its radiation therapy clinic, with relatively poor productivity for the number of radiation therapists employed. Computer modeling indicated that with flexible staff scheduling and other measures, the practice could get by with just two of its three linear accelerators. Therefore, the oldest was mothballed, and staff was reduced, resulting in a cost savings of nearly $500,000.

• Case 3. Again, scheduling, registration, and patient flow were frustrating and inefficient in a clinic. "They found that there were actually too many people in the process," Dr. Fryefield said. After assigning one person to scheduling and then reassigning the rest, productivity improved as the number of patients per FTE (full-time equivalent) staff increased by 17%.

• Case 4. Chaotic procedures resulted in an unhappy staff in this oncology practice. Lean Six Sigma showed inefficiencies in almost every aspect of care delivery, according to Dr. Fryefield. When best practices were implemented and various processes were streamlined, the volume of new patients increased by 22%, and productivity increased by 10%.

Experience with the PQE program using the Lean Six Sigma method has provided some important overall lessons, summarized Dr. Fryefield.

"Clearly, oncology practices are full of inefficiencies. That’s not really surprising," he said. Historically, "when we would try to solve problems in our clinics, we would just do something that seemed like a good idea, but it turned out that it was expensive or inefficient, or sometimes both."

Furthermore, although practice size, composition, and dynamics differ along with local markets, the inefficiencies and process defects are often similar. "For instance, the lab is always a bottleneck," he noted.

Overall, by using Lean Six Sigma, the PQE program has shown some impressive tangible benefits in the four process areas it focuses on, according to Dr. Fryefield. On average, participating practices have seen the following changes:

• A 3%-5% growth in patient volume (referral development).

• A 6%-8% increase in visits per staff full-time equivalent (care delivery).

• A 3%-5% improvement in costs with better cash flow (revenue cycle).

• A $1-$2 million increase in practice earnings (drug management).

"There isn’t anybody who can come in and do this [process] for you. Everybody in the practice has to [buy in], and that really starts with the docs," Dr. Fryefield advised. "They have to be part of this solution. If they think they are separate from this, they are wrong; MD leadership is essential."

Other senior practice members – executive directors, managers, and so on – also must be solidly on board, he said. And staff at all levels should be polled for their input and, ideally, be actively involved. The process also requires a commitment to change. "Change is never popular unless everyone thinks it’s their idea," he noted.

"PQE is a journey, not a destination," Dr. Fryefield concluded. "That’s one of the things that’s a little difficult for doctors to understand because doctors like to fix things and then move on. Some of my docs will say, ‘When is the change going to settle down?’ And the answer, of course, is never."

Community Oncology and this news organization are owned by Elsevier.

LAS VEGAS – Lean Six Sigma, a method for improving quality and efficiency that originated in automotive and semiconductor manufacturing, can also bring impressive results to community oncology practices, according to a physician who has applied the method in the nation’s largest private cancer care network.

"We have shown – and we are convinced – that continuous improvement with Lean Six Sigma can be successfully applied to an oncology clinic, and we can see real benefits as a result," said Dr. David C. Fryefield, medical director of the Practice Quality and Efficiency (PQE) program created in 2006 that implements Lean Six Sigma at US Oncology’s member practices.

Between 2007 and 2010, those practices that participated in the program added $80 million to their bottom line, Dr. Fryefield said, stressing that the program is comprehensive and includes quality assessments, such as patient surveys, as well as improvements in efficiency.

The initiative began with a study of the day-to-day workings of two practices in Oregon and Texas. Results showed that on average, various processes had some kind of defect or breakdown about 20% of the time, according to Dr. Fryefield, also medical director of the Willamette Valley Cancer Institute in Eugene, Ore. For example, lab reports were available on time for physicians in just 44% of cases, and complete physician orders for admixtures were available when needed in 71% of cases.

This is "the dirty laundry part," Dr. Fryefield told attendees. "But if you are honest, I bet you’ll know that these kinds of things are happening in your practice as well."

Further analyses showed that staff, especially medical assistants, had substantial amounts of what is called "non–value-added time," or time not spent in direct or supportive patient care activities.

"Essentially, these [employees] are work-around bees," Dr. Fryefield said. "We have a defective process, and we hire a medical assistant to work around that process, to make that extra phone call" to track down a missing lab report.

The flawed processes were causing increased wait times in the clinic. For most types of encounters, more than half of a patient’s visit was spent waiting.

Finally, the practices had a distortion in capacity, according to Dr. Fryefield. Their labs’ target capacity was 60%, but the labs were actually operating at 115%. Meanwhile, exam rooms and chemotherapy chairs were well under their target capacity, which wasted resources as patients sat and sat.

Clearly, oncology practices had plenty of room for improvement, and Lean Six Sigma was chosen to bring that about, he said. "Lean" shortens the time required to complete a task by reducing steps and improving handoffs between people, Dr. Fryefield, explained at the annual Community Oncology Conference. "Six Sigma" is a systematic approach to reducing defects in a process by controlling the causative factors.

The method’s steps are summed up by the acronym DMAIC, which stands for define, measure, analyze, improve, and control.

"Define" refers to the establishment of agreed-on expectations for a given process; for example, the steps involved in patient scheduling or drug preparation.

"Measure" can be implemented by simple means, such as having observers use a stopwatch and clipboard to tally performance for each metric.

"Analysis" entails crunching the numbers to find the root cause of problems.

In "Improve," the findings are applied in a focused way that addresses the defective processes.

Finally, "Control" pertains to sustaining the improvement. For example, display results where staff can see them, and periodically remeasure to prevent any backsliding.

Each part of the process – no matter how seemingly small or obvious – is important to the whole, Dr. Fryefield said. He introduced the following four case studies:

• Case 1. Practice leaders thought they had insufficient exam rooms for their physicians, but Lean Six Sigma showed that "the exam rooms were the least of the problems," Dr. Fryefield said. The practice had long wait times to first appointments, whereas its oncologists had as few as 11 patient slots per day. After focused improvements in these areas, including the addition of many fewer rooms than planned, new patient volume rose by 6% and the labor cost per visit fell by 4%.

• Case 2. An oncology practice had excess capacity in its radiation therapy clinic, with relatively poor productivity for the number of radiation therapists employed. Computer modeling indicated that with flexible staff scheduling and other measures, the practice could get by with just two of its three linear accelerators. Therefore, the oldest was mothballed, and staff was reduced, resulting in a cost savings of nearly $500,000.

• Case 3. Again, scheduling, registration, and patient flow were frustrating and inefficient in a clinic. "They found that there were actually too many people in the process," Dr. Fryefield said. After assigning one person to scheduling and then reassigning the rest, productivity improved as the number of patients per FTE (full-time equivalent) staff increased by 17%.

• Case 4. Chaotic procedures resulted in an unhappy staff in this oncology practice. Lean Six Sigma showed inefficiencies in almost every aspect of care delivery, according to Dr. Fryefield. When best practices were implemented and various processes were streamlined, the volume of new patients increased by 22%, and productivity increased by 10%.

Experience with the PQE program using the Lean Six Sigma method has provided some important overall lessons, summarized Dr. Fryefield.

"Clearly, oncology practices are full of inefficiencies. That’s not really surprising," he said. Historically, "when we would try to solve problems in our clinics, we would just do something that seemed like a good idea, but it turned out that it was expensive or inefficient, or sometimes both."

Furthermore, although practice size, composition, and dynamics differ along with local markets, the inefficiencies and process defects are often similar. "For instance, the lab is always a bottleneck," he noted.

Overall, by using Lean Six Sigma, the PQE program has shown some impressive tangible benefits in the four process areas it focuses on, according to Dr. Fryefield. On average, participating practices have seen the following changes:

• A 3%-5% growth in patient volume (referral development).

• A 6%-8% increase in visits per staff full-time equivalent (care delivery).

• A 3%-5% improvement in costs with better cash flow (revenue cycle).

• A $1-$2 million increase in practice earnings (drug management).

"There isn’t anybody who can come in and do this [process] for you. Everybody in the practice has to [buy in], and that really starts with the docs," Dr. Fryefield advised. "They have to be part of this solution. If they think they are separate from this, they are wrong; MD leadership is essential."

Other senior practice members – executive directors, managers, and so on – also must be solidly on board, he said. And staff at all levels should be polled for their input and, ideally, be actively involved. The process also requires a commitment to change. "Change is never popular unless everyone thinks it’s their idea," he noted.

"PQE is a journey, not a destination," Dr. Fryefield concluded. "That’s one of the things that’s a little difficult for doctors to understand because doctors like to fix things and then move on. Some of my docs will say, ‘When is the change going to settle down?’ And the answer, of course, is never."

Community Oncology and this news organization are owned by Elsevier.

LAS VEGAS – Lean Six Sigma, a method for improving quality and efficiency that originated in automotive and semiconductor manufacturing, can also bring impressive results to community oncology practices, according to a physician who has applied the method in the nation’s largest private cancer care network.

"We have shown – and we are convinced – that continuous improvement with Lean Six Sigma can be successfully applied to an oncology clinic, and we can see real benefits as a result," said Dr. David C. Fryefield, medical director of the Practice Quality and Efficiency (PQE) program created in 2006 that implements Lean Six Sigma at US Oncology’s member practices.

Between 2007 and 2010, those practices that participated in the program added $80 million to their bottom line, Dr. Fryefield said, stressing that the program is comprehensive and includes quality assessments, such as patient surveys, as well as improvements in efficiency.

The initiative began with a study of the day-to-day workings of two practices in Oregon and Texas. Results showed that on average, various processes had some kind of defect or breakdown about 20% of the time, according to Dr. Fryefield, also medical director of the Willamette Valley Cancer Institute in Eugene, Ore. For example, lab reports were available on time for physicians in just 44% of cases, and complete physician orders for admixtures were available when needed in 71% of cases.

This is "the dirty laundry part," Dr. Fryefield told attendees. "But if you are honest, I bet you’ll know that these kinds of things are happening in your practice as well."

Further analyses showed that staff, especially medical assistants, had substantial amounts of what is called "non–value-added time," or time not spent in direct or supportive patient care activities.

"Essentially, these [employees] are work-around bees," Dr. Fryefield said. "We have a defective process, and we hire a medical assistant to work around that process, to make that extra phone call" to track down a missing lab report.

The flawed processes were causing increased wait times in the clinic. For most types of encounters, more than half of a patient’s visit was spent waiting.

Finally, the practices had a distortion in capacity, according to Dr. Fryefield. Their labs’ target capacity was 60%, but the labs were actually operating at 115%. Meanwhile, exam rooms and chemotherapy chairs were well under their target capacity, which wasted resources as patients sat and sat.

Clearly, oncology practices had plenty of room for improvement, and Lean Six Sigma was chosen to bring that about, he said. "Lean" shortens the time required to complete a task by reducing steps and improving handoffs between people, Dr. Fryefield, explained at the annual Community Oncology Conference. "Six Sigma" is a systematic approach to reducing defects in a process by controlling the causative factors.

The method’s steps are summed up by the acronym DMAIC, which stands for define, measure, analyze, improve, and control.

"Define" refers to the establishment of agreed-on expectations for a given process; for example, the steps involved in patient scheduling or drug preparation.

"Measure" can be implemented by simple means, such as having observers use a stopwatch and clipboard to tally performance for each metric.

"Analysis" entails crunching the numbers to find the root cause of problems.

In "Improve," the findings are applied in a focused way that addresses the defective processes.

Finally, "Control" pertains to sustaining the improvement. For example, display results where staff can see them, and periodically remeasure to prevent any backsliding.

Each part of the process – no matter how seemingly small or obvious – is important to the whole, Dr. Fryefield said. He introduced the following four case studies:

• Case 1. Practice leaders thought they had insufficient exam rooms for their physicians, but Lean Six Sigma showed that "the exam rooms were the least of the problems," Dr. Fryefield said. The practice had long wait times to first appointments, whereas its oncologists had as few as 11 patient slots per day. After focused improvements in these areas, including the addition of many fewer rooms than planned, new patient volume rose by 6% and the labor cost per visit fell by 4%.

• Case 2. An oncology practice had excess capacity in its radiation therapy clinic, with relatively poor productivity for the number of radiation therapists employed. Computer modeling indicated that with flexible staff scheduling and other measures, the practice could get by with just two of its three linear accelerators. Therefore, the oldest was mothballed, and staff was reduced, resulting in a cost savings of nearly $500,000.

• Case 3. Again, scheduling, registration, and patient flow were frustrating and inefficient in a clinic. "They found that there were actually too many people in the process," Dr. Fryefield said. After assigning one person to scheduling and then reassigning the rest, productivity improved as the number of patients per FTE (full-time equivalent) staff increased by 17%.

• Case 4. Chaotic procedures resulted in an unhappy staff in this oncology practice. Lean Six Sigma showed inefficiencies in almost every aspect of care delivery, according to Dr. Fryefield. When best practices were implemented and various processes were streamlined, the volume of new patients increased by 22%, and productivity increased by 10%.

Experience with the PQE program using the Lean Six Sigma method has provided some important overall lessons, summarized Dr. Fryefield.

"Clearly, oncology practices are full of inefficiencies. That’s not really surprising," he said. Historically, "when we would try to solve problems in our clinics, we would just do something that seemed like a good idea, but it turned out that it was expensive or inefficient, or sometimes both."

Furthermore, although practice size, composition, and dynamics differ along with local markets, the inefficiencies and process defects are often similar. "For instance, the lab is always a bottleneck," he noted.

Overall, by using Lean Six Sigma, the PQE program has shown some impressive tangible benefits in the four process areas it focuses on, according to Dr. Fryefield. On average, participating practices have seen the following changes:

• A 3%-5% growth in patient volume (referral development).

• A 6%-8% increase in visits per staff full-time equivalent (care delivery).

• A 3%-5% improvement in costs with better cash flow (revenue cycle).

• A $1-$2 million increase in practice earnings (drug management).

"There isn’t anybody who can come in and do this [process] for you. Everybody in the practice has to [buy in], and that really starts with the docs," Dr. Fryefield advised. "They have to be part of this solution. If they think they are separate from this, they are wrong; MD leadership is essential."

Other senior practice members – executive directors, managers, and so on – also must be solidly on board, he said. And staff at all levels should be polled for their input and, ideally, be actively involved. The process also requires a commitment to change. "Change is never popular unless everyone thinks it’s their idea," he noted.

"PQE is a journey, not a destination," Dr. Fryefield concluded. "That’s one of the things that’s a little difficult for doctors to understand because doctors like to fix things and then move on. Some of my docs will say, ‘When is the change going to settle down?’ And the answer, of course, is never."

Community Oncology and this news organization are owned by Elsevier.

LAS VEGAS – Lean Six Sigma, a method for improving quality and efficiency that originated in automotive and semiconductor manufacturing, can also bring impressive results to community oncology practices, according to a physician who has applied the method in the nation’s largest private cancer care network.

"We have shown – and we are convinced – that continuous improvement with Lean Six Sigma can be successfully applied to an oncology clinic, and we can see real benefits as a result," said Dr. David C. Fryefield, medical director of the Practice Quality and Efficiency (PQE) program created in 2006 that implements Lean Six Sigma at US Oncology’s member practices.

Between 2007 and 2010, those practices that participated in the program added $80 million to their bottom line, Dr. Fryefield said, stressing that the program is comprehensive and includes quality assessments, such as patient surveys, as well as improvements in efficiency.

The initiative began with a study of the day-to-day workings of two practices in Oregon and Texas. Results showed that on average, various processes had some kind of defect or breakdown about 20% of the time, according to Dr. Fryefield, also medical director of the Willamette Valley Cancer Institute in Eugene, Ore. For example, lab reports were available on time for physicians in just 44% of cases, and complete physician orders for admixtures were available when needed in 71% of cases.

This is "the dirty laundry part," Dr. Fryefield told attendees. "But if you are honest, I bet you’ll know that these kinds of things are happening in your practice as well."

Further analyses showed that staff, especially medical assistants, had substantial amounts of what is called "non–value-added time," or time not spent in direct or supportive patient care activities.

"Essentially, these [employees] are work-around bees," Dr. Fryefield said. "We have a defective process, and we hire a medical assistant to work around that process, to make that extra phone call" to track down a missing lab report.

The flawed processes were causing increased wait times in the clinic. For most types of encounters, more than half of a patient’s visit was spent waiting.

Finally, the practices had a distortion in capacity, according to Dr. Fryefield. Their labs’ target capacity was 60%, but the labs were actually operating at 115%. Meanwhile, exam rooms and chemotherapy chairs were well under their target capacity, which wasted resources as patients sat and sat.

Clearly, oncology practices had plenty of room for improvement, and Lean Six Sigma was chosen to bring that about, he said. "Lean" shortens the time required to complete a task by reducing steps and improving handoffs between people, Dr. Fryefield, explained at the annual Community Oncology Conference. "Six Sigma" is a systematic approach to reducing defects in a process by controlling the causative factors.

The method’s steps are summed up by the acronym DMAIC, which stands for define, measure, analyze, improve, and control.

"Define" refers to the establishment of agreed-on expectations for a given process; for example, the steps involved in patient scheduling or drug preparation.

"Measure" can be implemented by simple means, such as having observers use a stopwatch and clipboard to tally performance for each metric.

"Analysis" entails crunching the numbers to find the root cause of problems.

In "Improve," the findings are applied in a focused way that addresses the defective processes.

Finally, "Control" pertains to sustaining the improvement. For example, display results where staff can see them, and periodically remeasure to prevent any backsliding.

Each part of the process – no matter how seemingly small or obvious – is important to the whole, Dr. Fryefield said. He introduced the following four case studies:

• Case 1. Practice leaders thought they had insufficient exam rooms for their physicians, but Lean Six Sigma showed that "the exam rooms were the least of the problems," Dr. Fryefield said. The practice had long wait times to first appointments, whereas its oncologists had as few as 11 patient slots per day. After focused improvements in these areas, including the addition of many fewer rooms than planned, new patient volume rose by 6% and the labor cost per visit fell by 4%.

• Case 2. An oncology practice had excess capacity in its radiation therapy clinic, with relatively poor productivity for the number of radiation therapists employed. Computer modeling indicated that with flexible staff scheduling and other measures, the practice could get by with just two of its three linear accelerators. Therefore, the oldest was mothballed, and staff was reduced, resulting in a cost savings of nearly $500,000.

• Case 3. Again, scheduling, registration, and patient flow were frustrating and inefficient in a clinic. "They found that there were actually too many people in the process," Dr. Fryefield said. After assigning one person to scheduling and then reassigning the rest, productivity improved as the number of patients per FTE (full-time equivalent) staff increased by 17%.

• Case 4. Chaotic procedures resulted in an unhappy staff in this oncology practice. Lean Six Sigma showed inefficiencies in almost every aspect of care delivery, according to Dr. Fryefield. When best practices were implemented and various processes were streamlined, the volume of new patients increased by 22%, and productivity increased by 10%.

Experience with the PQE program using the Lean Six Sigma method has provided some important overall lessons, summarized Dr. Fryefield.

"Clearly, oncology practices are full of inefficiencies. That’s not really surprising," he said. Historically, "when we would try to solve problems in our clinics, we would just do something that seemed like a good idea, but it turned out that it was expensive or inefficient, or sometimes both."

Furthermore, although practice size, composition, and dynamics differ along with local markets, the inefficiencies and process defects are often similar. "For instance, the lab is always a bottleneck," he noted.

Overall, by using Lean Six Sigma, the PQE program has shown some impressive tangible benefits in the four process areas it focuses on, according to Dr. Fryefield. On average, participating practices have seen the following changes:

• A 3%-5% growth in patient volume (referral development).

• A 6%-8% increase in visits per staff full-time equivalent (care delivery).

• A 3%-5% improvement in costs with better cash flow (revenue cycle).

• A $1-$2 million increase in practice earnings (drug management).

"There isn’t anybody who can come in and do this [process] for you. Everybody in the practice has to [buy in], and that really starts with the docs," Dr. Fryefield advised. "They have to be part of this solution. If they think they are separate from this, they are wrong; MD leadership is essential."

Other senior practice members – executive directors, managers, and so on – also must be solidly on board, he said. And staff at all levels should be polled for their input and, ideally, be actively involved. The process also requires a commitment to change. "Change is never popular unless everyone thinks it’s their idea," he noted.

"PQE is a journey, not a destination," Dr. Fryefield concluded. "That’s one of the things that’s a little difficult for doctors to understand because doctors like to fix things and then move on. Some of my docs will say, ‘When is the change going to settle down?’ And the answer, of course, is never."

Community Oncology and this news organization are owned by Elsevier.

LAS VEGAS – Lean Six Sigma, a method for improving quality and efficiency that originated in automotive and semiconductor manufacturing, can also bring impressive results to community oncology practices, according to a physician who has applied the method in the nation’s largest private cancer care network.

"We have shown – and we are convinced – that continuous improvement with Lean Six Sigma can be successfully applied to an oncology clinic, and we can see real benefits as a result," said Dr. David C. Fryefield, medical director of the Practice Quality and Efficiency (PQE) program created in 2006 that implements Lean Six Sigma at US Oncology’s member practices.

Between 2007 and 2010, those practices that participated in the program added $80 million to their bottom line, Dr. Fryefield said, stressing that the program is comprehensive and includes quality assessments, such as patient surveys, as well as improvements in efficiency.

The initiative began with a study of the day-to-day workings of two practices in Oregon and Texas. Results showed that on average, various processes had some kind of defect or breakdown about 20% of the time, according to Dr. Fryefield, also medical director of the Willamette Valley Cancer Institute in Eugene, Ore. For example, lab reports were available on time for physicians in just 44% of cases, and complete physician orders for admixtures were available when needed in 71% of cases.

This is "the dirty laundry part," Dr. Fryefield told attendees. "But if you are honest, I bet you’ll know that these kinds of things are happening in your practice as well."

Further analyses showed that staff, especially medical assistants, had substantial amounts of what is called "non–value-added time," or time not spent in direct or supportive patient care activities.

"Essentially, these [employees] are work-around bees," Dr. Fryefield said. "We have a defective process, and we hire a medical assistant to work around that process, to make that extra phone call" to track down a missing lab report.

The flawed processes were causing increased wait times in the clinic. For most types of encounters, more than half of a patient’s visit was spent waiting.

Finally, the practices had a distortion in capacity, according to Dr. Fryefield. Their labs’ target capacity was 60%, but the labs were actually operating at 115%. Meanwhile, exam rooms and chemotherapy chairs were well under their target capacity, which wasted resources as patients sat and sat.

Clearly, oncology practices had plenty of room for improvement, and Lean Six Sigma was chosen to bring that about, he said. "Lean" shortens the time required to complete a task by reducing steps and improving handoffs between people, Dr. Fryefield, explained at the annual Community Oncology Conference. "Six Sigma" is a systematic approach to reducing defects in a process by controlling the causative factors.

The method’s steps are summed up by the acronym DMAIC, which stands for define, measure, analyze, improve, and control.

"Define" refers to the establishment of agreed-on expectations for a given process; for example, the steps involved in patient scheduling or drug preparation.

"Measure" can be implemented by simple means, such as having observers use a stopwatch and clipboard to tally performance for each metric.

"Analysis" entails crunching the numbers to find the root cause of problems.

In "Improve," the findings are applied in a focused way that addresses the defective processes.

Finally, "Control" pertains to sustaining the improvement. For example, display results where staff can see them, and periodically remeasure to prevent any backsliding.

Each part of the process – no matter how seemingly small or obvious – is important to the whole, Dr. Fryefield said. He introduced the following four case studies:

• Case 1. Practice leaders thought they had insufficient exam rooms for their physicians, but Lean Six Sigma showed that "the exam rooms were the least of the problems," Dr. Fryefield said. The practice had long wait times to first appointments, whereas its oncologists had as few as 11 patient slots per day. After focused improvements in these areas, including the addition of many fewer rooms than planned, new patient volume rose by 6% and the labor cost per visit fell by 4%.

• Case 2. An oncology practice had excess capacity in its radiation therapy clinic, with relatively poor productivity for the number of radiation therapists employed. Computer modeling indicated that with flexible staff scheduling and other measures, the practice could get by with just two of its three linear accelerators. Therefore, the oldest was mothballed, and staff was reduced, resulting in a cost savings of nearly $500,000.

• Case 3. Again, scheduling, registration, and patient flow were frustrating and inefficient in a clinic. "They found that there were actually too many people in the process," Dr. Fryefield said. After assigning one person to scheduling and then reassigning the rest, productivity improved as the number of patients per FTE (full-time equivalent) staff increased by 17%.

• Case 4. Chaotic procedures resulted in an unhappy staff in this oncology practice. Lean Six Sigma showed inefficiencies in almost every aspect of care delivery, according to Dr. Fryefield. When best practices were implemented and various processes were streamlined, the volume of new patients increased by 22%, and productivity increased by 10%.

Experience with the PQE program using the Lean Six Sigma method has provided some important overall lessons, summarized Dr. Fryefield.

"Clearly, oncology practices are full of inefficiencies. That’s not really surprising," he said. Historically, "when we would try to solve problems in our clinics, we would just do something that seemed like a good idea, but it turned out that it was expensive or inefficient, or sometimes both."

Furthermore, although practice size, composition, and dynamics differ along with local markets, the inefficiencies and process defects are often similar. "For instance, the lab is always a bottleneck," he noted.

Overall, by using Lean Six Sigma, the PQE program has shown some impressive tangible benefits in the four process areas it focuses on, according to Dr. Fryefield. On average, participating practices have seen the following changes:

• A 3%-5% growth in patient volume (referral development).

• A 6%-8% increase in visits per staff full-time equivalent (care delivery).

• A 3%-5% improvement in costs with better cash flow (revenue cycle).

• A $1-$2 million increase in practice earnings (drug management).

"There isn’t anybody who can come in and do this [process] for you. Everybody in the practice has to [buy in], and that really starts with the docs," Dr. Fryefield advised. "They have to be part of this solution. If they think they are separate from this, they are wrong; MD leadership is essential."

Other senior practice members – executive directors, managers, and so on – also must be solidly on board, he said. And staff at all levels should be polled for their input and, ideally, be actively involved. The process also requires a commitment to change. "Change is never popular unless everyone thinks it’s their idea," he noted.

"PQE is a journey, not a destination," Dr. Fryefield concluded. "That’s one of the things that’s a little difficult for doctors to understand because doctors like to fix things and then move on. Some of my docs will say, ‘When is the change going to settle down?’ And the answer, of course, is never."

Community Oncology and this news organization are owned by Elsevier.