Screening mammography is not a perfect test, but it still plays an important role for women even in their 40s, when the incidence of breast cancer is low but the risk of a tumor being aggressive is especially high.

See related counterpoint

SCREENING DETECTS CANCER EARLY

The goal of screening mammography is to reduce breast cancer deaths by detecting cancers early, when treatment is more effective and less harmful.

Mammography detects tumors when they are smaller: the median size of breast cancers found with high-quality, two-view screening mammography is 1.0 to 1.5 cm, whereas cancers found by palpation are 2.0 to 2.5 cm.¹ In general, tumors found when they are smaller require less treatment, and patients are more likely to survive.

Moreover, about 10% of invasive cancers smaller than 1 cm have spread to lymph nodes at the time of detection, compared with 35% of those 2 cm in size and 60% of those 4 cm or larger. Women who have a positive lymph node at the time of diagnosis usually undergo more intensive treatment with chemotherapy and more radical surgery than those who do not. The 5-year disease-free survival rate is more than 98% for breast cancer with a tumor smaller than 2 cm that has not spread to lymph nodes (stage I), compared with 86% for stage II disease (tumors 2.1–5 cm or one to three positive axillary lymph nodes).²

The median size of breast cancers found by mammography is 1.0–1.5 cm; by palpation, 2.0–2.5 cm

Treating breast cancer early is also less expensive. In a study of women enrolled in a health maintenance organization in Pennsylvania, 14% of those not screened presented with advanced breast cancer (stage III or IV) compared with 2% who had been screened. The cumulative cost of treating advanced breast cancer was two to three times that of treating early breast cancer (stage 0 or I), not accounting for time lost away from work and family, in addition to pain and suffering.³

SCREENING SAVES LIVES

Multiple prospective, randomized controlled trials have been conducted to assess whether inviting women between ages 40 and 74 to undergo screening mammography reduces the rate of death from breast cancer.^4,5 Such trials tend to underestimate the effect of screening because not all women invited to be screened actually are screened, and some in the control group may undergo screening on their own.⁶

The Canadian National Breast Screening Study (NBSS) had additional problems that underestimated the benefits of screening. The quality of mammography came under question, and an issue with randomization became evident after the first round of screening, as  the group invited to be screened had an excess of women presenting with palpable lumps and advanced breast cancer.^6–8 Despite these issues, a meta-analysis of randomized controlled trials of screening mammography, including the NBSS data, found a 15% reduction in deaths.⁹ When the NBSS data were excluded, the reduction was 24%.¹⁰

In 2009, the United States Preventive Services Task Force (USPSTF)¹¹ recommended against mammographic screening for women ages 40 to 49. Using results from trials including the NBSS, they estimated that the number of women needed to be invited to screening to prevent one breast cancer death was:

• 1,904 for ages 39 to 49
• 1,339 for ages 50 to 59
• 377 for ages 60 to 69.

But if the NBSS study were excluded, these results would be 950, 670, and 377, respectively.⁶

In a review on screening mammography, Feig¹² points out that the USPSTF selected the number of women invited to be screened rather than the number that were actually screened to measure the absolute benefit of screening.

Hendrick and Helvie¹³ reported that the number of women who needed to be screened to prevent one cancer death was:

• 746 for ages 40 to 49
• 351 for ages 50 to 59
• 253 for ages 60 to 69.

The benefit of screening, if analyzed by number of life years gained rather than number of deaths prevented, is even more favorable to younger women with longer life expectancy. The number needed to be screened per life year gained is:

• 28 at ages 40 to 49
• 17 at ages 50 to 59
• 16 at ages 60 to 69.¹²

These data provide additional support for screening women starting at age 40.

Observational studies, which provide a better measure of effectiveness because only women who actually undergo routine mammography are compared with those who do not, also support this conclusion. An observational study in Sweden with 20 years of follow-up found that women of all ages who participated in screening had a 44% lower risk of death from breast cancer than with those who were not screened; for women in their 40s, the risk reduction was 48%.¹⁴ Similarly, an observational study conducted in British Columbia¹⁵ found a 40% decrease in deaths in women screened annually between ages 40 and 79, and a 39% decrease in deaths in women first screened between ages 40 and 49.

LOW RATE OF FALSE-POSITIVE RESULTS

Like many screening programs, screening mammography does not benefit all women equally.

Only about 1% of the women screened underwent an unnecessary biopsy

False-positive results occur, for which women need additional imaging or a biopsy for findings that turn out not to be cancer. But the false-positive rate is not high: for every 1,000 women screened in the United States, 80 to 100 (10% or less) are recalled for additional evaluation, 15 (1.5%) undergo biopsy, and 2 to 5 have a cancer, so only about 1% of the women screened underwent an unnecessary biopsy.¹⁶

False-positive test results can provoke unnecessary anxiety, but evidence indicates that this tends to be a temporary effect, and even women who had a false-positive result tend to support mammography. In a report by Lerman et al,¹⁷ when mood was assessed 3 months after mammography, worry was reported by 26% of women who had had a false-positive report, compared with 9% of women who had had a normal mammogram. Another report addressing the consequences of false-positive mammograms found that although short-term anxiety increased, long-term anxiety did not.¹⁸­ In a random telephone survey, 98% of adults who reported having had a false-positive cancer screening result stated that they were nevertheless glad that they had undergone screening.¹⁹

OVERDIAGNOSIS OCCURS BUT IS LIKELY UNCOMMON

Overdiagnosis of breast cancer is a possible drawback of screening mammography. Cancers may be detected that would not have become clinically apparent in a person’s lifetime²⁰ or have affected ultimate prognosis,¹⁸ and so would not have needed to be treated.

Overdiagnosis from screening mammography usually refers to finding ductal carcinoma in situ (DCIS) on breast biopsy. Because no randomized controlled study has been done in which breast cancer was diagnosed and not treated, evidence of the danger from DCIS comes from retrospective reviews of 130 cases in which excised tissue initially interpreted as benign was actually cancerous. Over 10 to 30 years, 11% to 60% of these patients developed invasive breast cancer in the same quadrant from which tissue had been excised.²¹ This rate of cancer development could lead to underestimation of the invasive potential of DCIS because the patients studied all had low-grade DCIS; further, some of the baseline biopsies involved complete removal of the tumor, thereby preventing the development or progression of cancer.

All DCIS is not the same. An ongoing trial²² found a 5-year recurrence rate of 6.1% after surgery for low-grade or intermediate-grade DCIS, and 15% after surgery for high-grade DCIS. Swedish trials²³ have shown that most women who die of “early” breast cancer have high-grade DCIS. These findings suggest that although screening mammography may result in overdiagnosis and overtreatment of low-grade DCIS, high-grade DCIS can be lethal and should be treated. Thus, overdiagnosis likely represents a small fraction of all breast cancers.

Most important, it is not yet possible to accurately predict the biologic behavior of an individual tumor. Current clinical practice is to treat patients with DCIS similar to the way we treat patients with early-stage breast cancer, as we cannot determine which types of DCIS may remain indolent and which ones may become invasive.

HOW FREQUENTLY SHOULD YOUNGER WOMEN BE SCREENED?

The frequency of screening mammography has been another area of controversy, but we believe that annual screening offers the greatest benefit, especially for younger women.

Tumors in younger women tend to grow and spread more quickly

The optimum screening frequency depends on how fast breast cancer grows and spreads. Data suggest that tumors in younger women tend to be biologically aggressive and grow and spread more quickly, making the benefit of yearly mammography more dramatic for younger women. A model­ based on data from Swedish studies^24–26 predicted that the mortality reduction from breast cancer in women ages 40 to 49 would be 36% with annual screening, 18% with screening every 2 years, and 4% with screening every 3 years. For women in their 50s, the model estimated a reduction of 46% for yearly mammography, and 39% and 34% for screening every 2 or 3 years, respectively.⁶

In a prospective cohort study of the Breast Cancer Surveillance Consortium,²⁷ in women ages 40 to 49 with extremely dense breasts, screening every 2 years was associated with a higher risk of advanced-stage disease (IIb or higher) and large tumors (> 2 cm) than with annual screening. For women ages 50 to 74, screening every 2 years vs every year did not increase the odds of advanced-stage or larger tumors.

AN INFORMED DECISION

In agreement with the current recommendations from the American Cancer Society, the American College of Radiology, and the American Congress of Obstetricians and Gynecologists, we support starting breast cancer screening with mammography at age 40.

Not all cancers are visible on mammography (false negatives), as they may be masked by mammographically dense breast tissue. Women should be informed of the importance of seeking medical attention for breast symptoms, even if mammography is normal. We need to inform women of the benefits and risks of screening mammography, including the risk of false-positive results that could lead to additional imaging and anxiety, and the uncertainties related to the potential for overdiagnosis and overtreatment. This information, offered in an easily understandable format, can help the patient make an informed decision regarding screening mammography, based on her values and preferences.

Screening mammography is not a perfect test, but it still plays an important role for women even in their 40s, when the incidence of breast cancer is low but the risk of a tumor being aggressive is especially high.

See related counterpoint

SCREENING DETECTS CANCER EARLY

The goal of screening mammography is to reduce breast cancer deaths by detecting cancers early, when treatment is more effective and less harmful.

Mammography detects tumors when they are smaller: the median size of breast cancers found with high-quality, two-view screening mammography is 1.0 to 1.5 cm, whereas cancers found by palpation are 2.0 to 2.5 cm.¹ In general, tumors found when they are smaller require less treatment, and patients are more likely to survive.

Moreover, about 10% of invasive cancers smaller than 1 cm have spread to lymph nodes at the time of detection, compared with 35% of those 2 cm in size and 60% of those 4 cm or larger. Women who have a positive lymph node at the time of diagnosis usually undergo more intensive treatment with chemotherapy and more radical surgery than those who do not. The 5-year disease-free survival rate is more than 98% for breast cancer with a tumor smaller than 2 cm that has not spread to lymph nodes (stage I), compared with 86% for stage II disease (tumors 2.1–5 cm or one to three positive axillary lymph nodes).²

The median size of breast cancers found by mammography is 1.0–1.5 cm; by palpation, 2.0–2.5 cm

Treating breast cancer early is also less expensive. In a study of women enrolled in a health maintenance organization in Pennsylvania, 14% of those not screened presented with advanced breast cancer (stage III or IV) compared with 2% who had been screened. The cumulative cost of treating advanced breast cancer was two to three times that of treating early breast cancer (stage 0 or I), not accounting for time lost away from work and family, in addition to pain and suffering.³

SCREENING SAVES LIVES

Multiple prospective, randomized controlled trials have been conducted to assess whether inviting women between ages 40 and 74 to undergo screening mammography reduces the rate of death from breast cancer.^4,5 Such trials tend to underestimate the effect of screening because not all women invited to be screened actually are screened, and some in the control group may undergo screening on their own.⁶

The Canadian National Breast Screening Study (NBSS) had additional problems that underestimated the benefits of screening. The quality of mammography came under question, and an issue with randomization became evident after the first round of screening, as  the group invited to be screened had an excess of women presenting with palpable lumps and advanced breast cancer.^6–8 Despite these issues, a meta-analysis of randomized controlled trials of screening mammography, including the NBSS data, found a 15% reduction in deaths.⁹ When the NBSS data were excluded, the reduction was 24%.¹⁰

In 2009, the United States Preventive Services Task Force (USPSTF)¹¹ recommended against mammographic screening for women ages 40 to 49. Using results from trials including the NBSS, they estimated that the number of women needed to be invited to screening to prevent one breast cancer death was:

• 1,904 for ages 39 to 49
• 1,339 for ages 50 to 59
• 377 for ages 60 to 69.

But if the NBSS study were excluded, these results would be 950, 670, and 377, respectively.⁶

In a review on screening mammography, Feig¹² points out that the USPSTF selected the number of women invited to be screened rather than the number that were actually screened to measure the absolute benefit of screening.

Hendrick and Helvie¹³ reported that the number of women who needed to be screened to prevent one cancer death was:

• 746 for ages 40 to 49
• 351 for ages 50 to 59
• 253 for ages 60 to 69.

The benefit of screening, if analyzed by number of life years gained rather than number of deaths prevented, is even more favorable to younger women with longer life expectancy. The number needed to be screened per life year gained is:

• 28 at ages 40 to 49
• 17 at ages 50 to 59
• 16 at ages 60 to 69.¹²

These data provide additional support for screening women starting at age 40.

Observational studies, which provide a better measure of effectiveness because only women who actually undergo routine mammography are compared with those who do not, also support this conclusion. An observational study in Sweden with 20 years of follow-up found that women of all ages who participated in screening had a 44% lower risk of death from breast cancer than with those who were not screened; for women in their 40s, the risk reduction was 48%.¹⁴ Similarly, an observational study conducted in British Columbia¹⁵ found a 40% decrease in deaths in women screened annually between ages 40 and 79, and a 39% decrease in deaths in women first screened between ages 40 and 49.

LOW RATE OF FALSE-POSITIVE RESULTS

Like many screening programs, screening mammography does not benefit all women equally.

Only about 1% of the women screened underwent an unnecessary biopsy

False-positive results occur, for which women need additional imaging or a biopsy for findings that turn out not to be cancer. But the false-positive rate is not high: for every 1,000 women screened in the United States, 80 to 100 (10% or less) are recalled for additional evaluation, 15 (1.5%) undergo biopsy, and 2 to 5 have a cancer, so only about 1% of the women screened underwent an unnecessary biopsy.¹⁶

False-positive test results can provoke unnecessary anxiety, but evidence indicates that this tends to be a temporary effect, and even women who had a false-positive result tend to support mammography. In a report by Lerman et al,¹⁷ when mood was assessed 3 months after mammography, worry was reported by 26% of women who had had a false-positive report, compared with 9% of women who had had a normal mammogram. Another report addressing the consequences of false-positive mammograms found that although short-term anxiety increased, long-term anxiety did not.¹⁸­ In a random telephone survey, 98% of adults who reported having had a false-positive cancer screening result stated that they were nevertheless glad that they had undergone screening.¹⁹

OVERDIAGNOSIS OCCURS BUT IS LIKELY UNCOMMON

Overdiagnosis of breast cancer is a possible drawback of screening mammography. Cancers may be detected that would not have become clinically apparent in a person’s lifetime²⁰ or have affected ultimate prognosis,¹⁸ and so would not have needed to be treated.

Overdiagnosis from screening mammography usually refers to finding ductal carcinoma in situ (DCIS) on breast biopsy. Because no randomized controlled study has been done in which breast cancer was diagnosed and not treated, evidence of the danger from DCIS comes from retrospective reviews of 130 cases in which excised tissue initially interpreted as benign was actually cancerous. Over 10 to 30 years, 11% to 60% of these patients developed invasive breast cancer in the same quadrant from which tissue had been excised.²¹ This rate of cancer development could lead to underestimation of the invasive potential of DCIS because the patients studied all had low-grade DCIS; further, some of the baseline biopsies involved complete removal of the tumor, thereby preventing the development or progression of cancer.

All DCIS is not the same. An ongoing trial²² found a 5-year recurrence rate of 6.1% after surgery for low-grade or intermediate-grade DCIS, and 15% after surgery for high-grade DCIS. Swedish trials²³ have shown that most women who die of “early” breast cancer have high-grade DCIS. These findings suggest that although screening mammography may result in overdiagnosis and overtreatment of low-grade DCIS, high-grade DCIS can be lethal and should be treated. Thus, overdiagnosis likely represents a small fraction of all breast cancers.

Most important, it is not yet possible to accurately predict the biologic behavior of an individual tumor. Current clinical practice is to treat patients with DCIS similar to the way we treat patients with early-stage breast cancer, as we cannot determine which types of DCIS may remain indolent and which ones may become invasive.

HOW FREQUENTLY SHOULD YOUNGER WOMEN BE SCREENED?

The frequency of screening mammography has been another area of controversy, but we believe that annual screening offers the greatest benefit, especially for younger women.

Tumors in younger women tend to grow and spread more quickly

The optimum screening frequency depends on how fast breast cancer grows and spreads. Data suggest that tumors in younger women tend to be biologically aggressive and grow and spread more quickly, making the benefit of yearly mammography more dramatic for younger women. A model­ based on data from Swedish studies^24–26 predicted that the mortality reduction from breast cancer in women ages 40 to 49 would be 36% with annual screening, 18% with screening every 2 years, and 4% with screening every 3 years. For women in their 50s, the model estimated a reduction of 46% for yearly mammography, and 39% and 34% for screening every 2 or 3 years, respectively.⁶

In a prospective cohort study of the Breast Cancer Surveillance Consortium,²⁷ in women ages 40 to 49 with extremely dense breasts, screening every 2 years was associated with a higher risk of advanced-stage disease (IIb or higher) and large tumors (> 2 cm) than with annual screening. For women ages 50 to 74, screening every 2 years vs every year did not increase the odds of advanced-stage or larger tumors.

AN INFORMED DECISION

In agreement with the current recommendations from the American Cancer Society, the American College of Radiology, and the American Congress of Obstetricians and Gynecologists, we support starting breast cancer screening with mammography at age 40.

Not all cancers are visible on mammography (false negatives), as they may be masked by mammographically dense breast tissue. Women should be informed of the importance of seeking medical attention for breast symptoms, even if mammography is normal. We need to inform women of the benefits and risks of screening mammography, including the risk of false-positive results that could lead to additional imaging and anxiety, and the uncertainties related to the potential for overdiagnosis and overtreatment. This information, offered in an easily understandable format, can help the patient make an informed decision regarding screening mammography, based on her values and preferences.

Screening mammography is not a perfect test, but it still plays an important role for women even in their 40s, when the incidence of breast cancer is low but the risk of a tumor being aggressive is especially high.

See related counterpoint

SCREENING DETECTS CANCER EARLY

The goal of screening mammography is to reduce breast cancer deaths by detecting cancers early, when treatment is more effective and less harmful.

Mammography detects tumors when they are smaller: the median size of breast cancers found with high-quality, two-view screening mammography is 1.0 to 1.5 cm, whereas cancers found by palpation are 2.0 to 2.5 cm.¹ In general, tumors found when they are smaller require less treatment, and patients are more likely to survive.

Moreover, about 10% of invasive cancers smaller than 1 cm have spread to lymph nodes at the time of detection, compared with 35% of those 2 cm in size and 60% of those 4 cm or larger. Women who have a positive lymph node at the time of diagnosis usually undergo more intensive treatment with chemotherapy and more radical surgery than those who do not. The 5-year disease-free survival rate is more than 98% for breast cancer with a tumor smaller than 2 cm that has not spread to lymph nodes (stage I), compared with 86% for stage II disease (tumors 2.1–5 cm or one to three positive axillary lymph nodes).²

The median size of breast cancers found by mammography is 1.0–1.5 cm; by palpation, 2.0–2.5 cm

Treating breast cancer early is also less expensive. In a study of women enrolled in a health maintenance organization in Pennsylvania, 14% of those not screened presented with advanced breast cancer (stage III or IV) compared with 2% who had been screened. The cumulative cost of treating advanced breast cancer was two to three times that of treating early breast cancer (stage 0 or I), not accounting for time lost away from work and family, in addition to pain and suffering.³

SCREENING SAVES LIVES

Multiple prospective, randomized controlled trials have been conducted to assess whether inviting women between ages 40 and 74 to undergo screening mammography reduces the rate of death from breast cancer.^4,5 Such trials tend to underestimate the effect of screening because not all women invited to be screened actually are screened, and some in the control group may undergo screening on their own.⁶

The Canadian National Breast Screening Study (NBSS) had additional problems that underestimated the benefits of screening. The quality of mammography came under question, and an issue with randomization became evident after the first round of screening, as  the group invited to be screened had an excess of women presenting with palpable lumps and advanced breast cancer.^6–8 Despite these issues, a meta-analysis of randomized controlled trials of screening mammography, including the NBSS data, found a 15% reduction in deaths.⁹ When the NBSS data were excluded, the reduction was 24%.¹⁰

In 2009, the United States Preventive Services Task Force (USPSTF)¹¹ recommended against mammographic screening for women ages 40 to 49. Using results from trials including the NBSS, they estimated that the number of women needed to be invited to screening to prevent one breast cancer death was:

• 1,904 for ages 39 to 49
• 1,339 for ages 50 to 59
• 377 for ages 60 to 69.

But if the NBSS study were excluded, these results would be 950, 670, and 377, respectively.⁶

In a review on screening mammography, Feig¹² points out that the USPSTF selected the number of women invited to be screened rather than the number that were actually screened to measure the absolute benefit of screening.

Hendrick and Helvie¹³ reported that the number of women who needed to be screened to prevent one cancer death was:

• 746 for ages 40 to 49
• 351 for ages 50 to 59
• 253 for ages 60 to 69.

The benefit of screening, if analyzed by number of life years gained rather than number of deaths prevented, is even more favorable to younger women with longer life expectancy. The number needed to be screened per life year gained is:

• 28 at ages 40 to 49
• 17 at ages 50 to 59
• 16 at ages 60 to 69.¹²

These data provide additional support for screening women starting at age 40.

Observational studies, which provide a better measure of effectiveness because only women who actually undergo routine mammography are compared with those who do not, also support this conclusion. An observational study in Sweden with 20 years of follow-up found that women of all ages who participated in screening had a 44% lower risk of death from breast cancer than with those who were not screened; for women in their 40s, the risk reduction was 48%.¹⁴ Similarly, an observational study conducted in British Columbia¹⁵ found a 40% decrease in deaths in women screened annually between ages 40 and 79, and a 39% decrease in deaths in women first screened between ages 40 and 49.

LOW RATE OF FALSE-POSITIVE RESULTS

Like many screening programs, screening mammography does not benefit all women equally.

Only about 1% of the women screened underwent an unnecessary biopsy

False-positive results occur, for which women need additional imaging or a biopsy for findings that turn out not to be cancer. But the false-positive rate is not high: for every 1,000 women screened in the United States, 80 to 100 (10% or less) are recalled for additional evaluation, 15 (1.5%) undergo biopsy, and 2 to 5 have a cancer, so only about 1% of the women screened underwent an unnecessary biopsy.¹⁶

False-positive test results can provoke unnecessary anxiety, but evidence indicates that this tends to be a temporary effect, and even women who had a false-positive result tend to support mammography. In a report by Lerman et al,¹⁷ when mood was assessed 3 months after mammography, worry was reported by 26% of women who had had a false-positive report, compared with 9% of women who had had a normal mammogram. Another report addressing the consequences of false-positive mammograms found that although short-term anxiety increased, long-term anxiety did not.¹⁸­ In a random telephone survey, 98% of adults who reported having had a false-positive cancer screening result stated that they were nevertheless glad that they had undergone screening.¹⁹

OVERDIAGNOSIS OCCURS BUT IS LIKELY UNCOMMON

Overdiagnosis of breast cancer is a possible drawback of screening mammography. Cancers may be detected that would not have become clinically apparent in a person’s lifetime²⁰ or have affected ultimate prognosis,¹⁸ and so would not have needed to be treated.

Overdiagnosis from screening mammography usually refers to finding ductal carcinoma in situ (DCIS) on breast biopsy. Because no randomized controlled study has been done in which breast cancer was diagnosed and not treated, evidence of the danger from DCIS comes from retrospective reviews of 130 cases in which excised tissue initially interpreted as benign was actually cancerous. Over 10 to 30 years, 11% to 60% of these patients developed invasive breast cancer in the same quadrant from which tissue had been excised.²¹ This rate of cancer development could lead to underestimation of the invasive potential of DCIS because the patients studied all had low-grade DCIS; further, some of the baseline biopsies involved complete removal of the tumor, thereby preventing the development or progression of cancer.

All DCIS is not the same. An ongoing trial²² found a 5-year recurrence rate of 6.1% after surgery for low-grade or intermediate-grade DCIS, and 15% after surgery for high-grade DCIS. Swedish trials²³ have shown that most women who die of “early” breast cancer have high-grade DCIS. These findings suggest that although screening mammography may result in overdiagnosis and overtreatment of low-grade DCIS, high-grade DCIS can be lethal and should be treated. Thus, overdiagnosis likely represents a small fraction of all breast cancers.

Most important, it is not yet possible to accurately predict the biologic behavior of an individual tumor. Current clinical practice is to treat patients with DCIS similar to the way we treat patients with early-stage breast cancer, as we cannot determine which types of DCIS may remain indolent and which ones may become invasive.

HOW FREQUENTLY SHOULD YOUNGER WOMEN BE SCREENED?

The frequency of screening mammography has been another area of controversy, but we believe that annual screening offers the greatest benefit, especially for younger women.

Tumors in younger women tend to grow and spread more quickly

The optimum screening frequency depends on how fast breast cancer grows and spreads. Data suggest that tumors in younger women tend to be biologically aggressive and grow and spread more quickly, making the benefit of yearly mammography more dramatic for younger women. A model­ based on data from Swedish studies^24–26 predicted that the mortality reduction from breast cancer in women ages 40 to 49 would be 36% with annual screening, 18% with screening every 2 years, and 4% with screening every 3 years. For women in their 50s, the model estimated a reduction of 46% for yearly mammography, and 39% and 34% for screening every 2 or 3 years, respectively.⁶

In a prospective cohort study of the Breast Cancer Surveillance Consortium,²⁷ in women ages 40 to 49 with extremely dense breasts, screening every 2 years was associated with a higher risk of advanced-stage disease (IIb or higher) and large tumors (> 2 cm) than with annual screening. For women ages 50 to 74, screening every 2 years vs every year did not increase the odds of advanced-stage or larger tumors.

AN INFORMED DECISION

In agreement with the current recommendations from the American Cancer Society, the American College of Radiology, and the American Congress of Obstetricians and Gynecologists, we support starting breast cancer screening with mammography at age 40.

Not all cancers are visible on mammography (false negatives), as they may be masked by mammographically dense breast tissue. Women should be informed of the importance of seeking medical attention for breast symptoms, even if mammography is normal. We need to inform women of the benefits and risks of screening mammography, including the risk of false-positive results that could lead to additional imaging and anxiety, and the uncertainties related to the potential for overdiagnosis and overtreatment. This information, offered in an easily understandable format, can help the patient make an informed decision regarding screening mammography, based on her values and preferences.

A  60-year-old man presented to the emergency department with abdominal pain. The pain was dull and constant, with no radiation and no aggravating or relieving factors. He also reported decreased appetite, weight loss, and constipation over the past 3 months.

He had no history of significant medical problems and was not taking any medications. He had no fever and no evidence of gastrointestinal bleeding.

Physical examination showed mild tenderness around the umbilicus and a painless, small nodule (15 mm by 6 mm) protruding through the umbilicus with surrounding erythematous discoloration (Figure 1). A digital rectal examination was normal. Laboratory studies showed only mild normocytic anemia.

The patient underwent abdominal ultrasonography, which showed free fluid in the abdominopelvic cavity. This was followed by computed tomography of the abdominopelvic cavity, which revealed ascites and a small mass in the umbilicus. Punch biopsy of the umbilical lesion was performed, and histologic study indicated a diagnosis of adenocarcinoma.

Based on the biopsy results and the patient’s history of gastrointestinal symptoms, colonoscopy was performed, which showed an exophytic tumor of the transverse colon. The tumor was biopsied, and pathologic evaluation confirmed adenocarcinoma. A diagnosis of metastatic colon cancer was made. The patient received chemotherapy and underwent surgery to relieve the bowel obstruction.

SISTER MARY JOSEPH NODULE

A periumbilical nodule representing metastatic cancer, also known as Sister Mary Joseph nodule,¹ is typically associated with intra-abdominal malignancy. An estimated 1% to 3% of patients with abdominopelvic malignancy present with this nodule,² most often from gastrointestinal cancer but also from gynecologic malignancies. In about 15% to 30% of cases, no origin is identified.³

How these cancers spread to the umbilicus is not known. Proposed mechanisms include direct transperitoneal, lymphatic, or hematogenous spread, and even iatrogenic spread during laparotomy.^4,5

The differential diagnosis includes umbilical hernia, cutaneous endometriosis, lymphangioma, melanoma, pilonidal sinus, and pyogenic granuloma. It is usually described as a painful nodule with irregular margins and a mean diameter of 2 to 3 cm.² The condition is always a sign of metastatic cancer. Although it can be useful for diagnosing advanced disease, whether this would lead to earlier diagnosis is doubtful. Palliative treatment is generally most appropriate.

A  60-year-old man presented to the emergency department with abdominal pain. The pain was dull and constant, with no radiation and no aggravating or relieving factors. He also reported decreased appetite, weight loss, and constipation over the past 3 months.

He had no history of significant medical problems and was not taking any medications. He had no fever and no evidence of gastrointestinal bleeding.

Physical examination showed mild tenderness around the umbilicus and a painless, small nodule (15 mm by 6 mm) protruding through the umbilicus with surrounding erythematous discoloration (Figure 1). A digital rectal examination was normal. Laboratory studies showed only mild normocytic anemia.

The patient underwent abdominal ultrasonography, which showed free fluid in the abdominopelvic cavity. This was followed by computed tomography of the abdominopelvic cavity, which revealed ascites and a small mass in the umbilicus. Punch biopsy of the umbilical lesion was performed, and histologic study indicated a diagnosis of adenocarcinoma.

Based on the biopsy results and the patient’s history of gastrointestinal symptoms, colonoscopy was performed, which showed an exophytic tumor of the transverse colon. The tumor was biopsied, and pathologic evaluation confirmed adenocarcinoma. A diagnosis of metastatic colon cancer was made. The patient received chemotherapy and underwent surgery to relieve the bowel obstruction.

SISTER MARY JOSEPH NODULE

A periumbilical nodule representing metastatic cancer, also known as Sister Mary Joseph nodule,¹ is typically associated with intra-abdominal malignancy. An estimated 1% to 3% of patients with abdominopelvic malignancy present with this nodule,² most often from gastrointestinal cancer but also from gynecologic malignancies. In about 15% to 30% of cases, no origin is identified.³

How these cancers spread to the umbilicus is not known. Proposed mechanisms include direct transperitoneal, lymphatic, or hematogenous spread, and even iatrogenic spread during laparotomy.^4,5

The differential diagnosis includes umbilical hernia, cutaneous endometriosis, lymphangioma, melanoma, pilonidal sinus, and pyogenic granuloma. It is usually described as a painful nodule with irregular margins and a mean diameter of 2 to 3 cm.² The condition is always a sign of metastatic cancer. Although it can be useful for diagnosing advanced disease, whether this would lead to earlier diagnosis is doubtful. Palliative treatment is generally most appropriate.

A  60-year-old man presented to the emergency department with abdominal pain. The pain was dull and constant, with no radiation and no aggravating or relieving factors. He also reported decreased appetite, weight loss, and constipation over the past 3 months.

He had no history of significant medical problems and was not taking any medications. He had no fever and no evidence of gastrointestinal bleeding.

Physical examination showed mild tenderness around the umbilicus and a painless, small nodule (15 mm by 6 mm) protruding through the umbilicus with surrounding erythematous discoloration (Figure 1). A digital rectal examination was normal. Laboratory studies showed only mild normocytic anemia.

The patient underwent abdominal ultrasonography, which showed free fluid in the abdominopelvic cavity. This was followed by computed tomography of the abdominopelvic cavity, which revealed ascites and a small mass in the umbilicus. Punch biopsy of the umbilical lesion was performed, and histologic study indicated a diagnosis of adenocarcinoma.

Based on the biopsy results and the patient’s history of gastrointestinal symptoms, colonoscopy was performed, which showed an exophytic tumor of the transverse colon. The tumor was biopsied, and pathologic evaluation confirmed adenocarcinoma. A diagnosis of metastatic colon cancer was made. The patient received chemotherapy and underwent surgery to relieve the bowel obstruction.

SISTER MARY JOSEPH NODULE

A periumbilical nodule representing metastatic cancer, also known as Sister Mary Joseph nodule,¹ is typically associated with intra-abdominal malignancy. An estimated 1% to 3% of patients with abdominopelvic malignancy present with this nodule,² most often from gastrointestinal cancer but also from gynecologic malignancies. In about 15% to 30% of cases, no origin is identified.³

How these cancers spread to the umbilicus is not known. Proposed mechanisms include direct transperitoneal, lymphatic, or hematogenous spread, and even iatrogenic spread during laparotomy.^4,5

The differential diagnosis includes umbilical hernia, cutaneous endometriosis, lymphangioma, melanoma, pilonidal sinus, and pyogenic granuloma. It is usually described as a painful nodule with irregular margins and a mean diameter of 2 to 3 cm.² The condition is always a sign of metastatic cancer. Although it can be useful for diagnosing advanced disease, whether this would lead to earlier diagnosis is doubtful. Palliative treatment is generally most appropriate.

In this issue of the Journal, Alraies et al comment on how extensively we should look for the cause of an initial episode of pericarditis.

The pericardium, like the pleura, peritoneum, and synovium, can be affected in a number of inflammatory and infectious disorders. The mechanisms by which these tissues are affected are not fully understood, nor is the process by which different diseases seem to selectively target the joint or pericardium. Why are the joints only minimally inflamed in systemic lupus erythematosus (SLE), while lupus pericarditis, in the uncommon occurrence of significant effusion, is often quite inflammatory, with a neutrophil predominance in the fluid? Why is pericardial involvement so often demonstrable by imaging in patients with SLE and rheumatoid arthritis, yet an acute pericarditis presentation with audible pericardial rubs is so seldom recognized?

Although nuances like these are not well understood, in medical school we all learned the association between connective tissue disease and pericarditis. The importance of recalling these associations is repeatedly reinforced during residency and in disease-focused review articles. During my training, woe to the resident who presented a patient at rounds who was admitted with unexplained pericarditis and was not evaluated for SLE with at least an antinuclear antibody (ANA) test, even if there were no other features to suggest the disease. Ordering the test reflected that we knew that, occasionally, pericardial disease is the sole presenting manifestation of lupus.

Such is the plight of the internist. Pericarditis can be the initial manifestation of an autoimmune or inflammatory disease, but this is more often relevant on certification examinations and in medical education than in everyday practice. We are now charged with ordering tests in a more cost-effective manner than in the past. This means that we should not order tests simply because of an epidemiologic association, but only when the result is likely to influence decisions about testing or treatment. But that creates the intellectual dissonance of knowing of a potential relationship (which someone, someday, may challenge us about) but not looking for it. There is an inherent conflict between satisfying intellectual curiosity and the need to be thorough while at the same time containing costs and avoiding the potential harm inherent in overtesting.

A partial solution is to try to define the immediate risk of not recognizing a life- or organ-threatening disease process that can be suggested by a positive nonspecific test (eg, ANA), and to refine the pretest likelihood of specific diagnoses by obtaining an accurate and complete history and performing a focused physical examination. For example, if we suspect that SLE may be the cause of an initial episode of symptomatic pericarditis, our initial evaluation should focus on the patient’s clinical picture. Is there bitemporal hair-thinning? New-onset Raynaud symptoms? Mild generalized adenopathy or lymphopenia? A borderline-low platelet count, or any proteinuria or microhematuria (which should warrant a prompt examination of a fresh urine sediment sample by a physician at the point of care to look for cellular casts indicative of glomerulonephritis)?

As internists, we should try to fulfill our need to be thorough and compulsive by using our honed skills as careful observers and historians—taking a careful history from the patient and family, performing a focused physical examination, and appropriately using disease-defining or staging tests before ordering less specific serologic or other tests. Practicing medicine in a conscientious and compulsive manner does not mean that every diagnostic possibility must be tested for at initial presentation.

Reading how experienced clinicians approach the problem of pericarditis in a specialized clinic provides a useful prompt to self-assess how we approach analogous clinical scenarios.

In this issue of the Journal, Alraies et al comment on how extensively we should look for the cause of an initial episode of pericarditis.

The pericardium, like the pleura, peritoneum, and synovium, can be affected in a number of inflammatory and infectious disorders. The mechanisms by which these tissues are affected are not fully understood, nor is the process by which different diseases seem to selectively target the joint or pericardium. Why are the joints only minimally inflamed in systemic lupus erythematosus (SLE), while lupus pericarditis, in the uncommon occurrence of significant effusion, is often quite inflammatory, with a neutrophil predominance in the fluid? Why is pericardial involvement so often demonstrable by imaging in patients with SLE and rheumatoid arthritis, yet an acute pericarditis presentation with audible pericardial rubs is so seldom recognized?

Although nuances like these are not well understood, in medical school we all learned the association between connective tissue disease and pericarditis. The importance of recalling these associations is repeatedly reinforced during residency and in disease-focused review articles. During my training, woe to the resident who presented a patient at rounds who was admitted with unexplained pericarditis and was not evaluated for SLE with at least an antinuclear antibody (ANA) test, even if there were no other features to suggest the disease. Ordering the test reflected that we knew that, occasionally, pericardial disease is the sole presenting manifestation of lupus.

Such is the plight of the internist. Pericarditis can be the initial manifestation of an autoimmune or inflammatory disease, but this is more often relevant on certification examinations and in medical education than in everyday practice. We are now charged with ordering tests in a more cost-effective manner than in the past. This means that we should not order tests simply because of an epidemiologic association, but only when the result is likely to influence decisions about testing or treatment. But that creates the intellectual dissonance of knowing of a potential relationship (which someone, someday, may challenge us about) but not looking for it. There is an inherent conflict between satisfying intellectual curiosity and the need to be thorough while at the same time containing costs and avoiding the potential harm inherent in overtesting.

A partial solution is to try to define the immediate risk of not recognizing a life- or organ-threatening disease process that can be suggested by a positive nonspecific test (eg, ANA), and to refine the pretest likelihood of specific diagnoses by obtaining an accurate and complete history and performing a focused physical examination. For example, if we suspect that SLE may be the cause of an initial episode of symptomatic pericarditis, our initial evaluation should focus on the patient’s clinical picture. Is there bitemporal hair-thinning? New-onset Raynaud symptoms? Mild generalized adenopathy or lymphopenia? A borderline-low platelet count, or any proteinuria or microhematuria (which should warrant a prompt examination of a fresh urine sediment sample by a physician at the point of care to look for cellular casts indicative of glomerulonephritis)?

As internists, we should try to fulfill our need to be thorough and compulsive by using our honed skills as careful observers and historians—taking a careful history from the patient and family, performing a focused physical examination, and appropriately using disease-defining or staging tests before ordering less specific serologic or other tests. Practicing medicine in a conscientious and compulsive manner does not mean that every diagnostic possibility must be tested for at initial presentation.

Reading how experienced clinicians approach the problem of pericarditis in a specialized clinic provides a useful prompt to self-assess how we approach analogous clinical scenarios.

In this issue of the Journal, Alraies et al comment on how extensively we should look for the cause of an initial episode of pericarditis.

The pericardium, like the pleura, peritoneum, and synovium, can be affected in a number of inflammatory and infectious disorders. The mechanisms by which these tissues are affected are not fully understood, nor is the process by which different diseases seem to selectively target the joint or pericardium. Why are the joints only minimally inflamed in systemic lupus erythematosus (SLE), while lupus pericarditis, in the uncommon occurrence of significant effusion, is often quite inflammatory, with a neutrophil predominance in the fluid? Why is pericardial involvement so often demonstrable by imaging in patients with SLE and rheumatoid arthritis, yet an acute pericarditis presentation with audible pericardial rubs is so seldom recognized?

Although nuances like these are not well understood, in medical school we all learned the association between connective tissue disease and pericarditis. The importance of recalling these associations is repeatedly reinforced during residency and in disease-focused review articles. During my training, woe to the resident who presented a patient at rounds who was admitted with unexplained pericarditis and was not evaluated for SLE with at least an antinuclear antibody (ANA) test, even if there were no other features to suggest the disease. Ordering the test reflected that we knew that, occasionally, pericardial disease is the sole presenting manifestation of lupus.

Such is the plight of the internist. Pericarditis can be the initial manifestation of an autoimmune or inflammatory disease, but this is more often relevant on certification examinations and in medical education than in everyday practice. We are now charged with ordering tests in a more cost-effective manner than in the past. This means that we should not order tests simply because of an epidemiologic association, but only when the result is likely to influence decisions about testing or treatment. But that creates the intellectual dissonance of knowing of a potential relationship (which someone, someday, may challenge us about) but not looking for it. There is an inherent conflict between satisfying intellectual curiosity and the need to be thorough while at the same time containing costs and avoiding the potential harm inherent in overtesting.

A partial solution is to try to define the immediate risk of not recognizing a life- or organ-threatening disease process that can be suggested by a positive nonspecific test (eg, ANA), and to refine the pretest likelihood of specific diagnoses by obtaining an accurate and complete history and performing a focused physical examination. For example, if we suspect that SLE may be the cause of an initial episode of symptomatic pericarditis, our initial evaluation should focus on the patient’s clinical picture. Is there bitemporal hair-thinning? New-onset Raynaud symptoms? Mild generalized adenopathy or lymphopenia? A borderline-low platelet count, or any proteinuria or microhematuria (which should warrant a prompt examination of a fresh urine sediment sample by a physician at the point of care to look for cellular casts indicative of glomerulonephritis)?

As internists, we should try to fulfill our need to be thorough and compulsive by using our honed skills as careful observers and historians—taking a careful history from the patient and family, performing a focused physical examination, and appropriately using disease-defining or staging tests before ordering less specific serologic or other tests. Practicing medicine in a conscientious and compulsive manner does not mean that every diagnostic possibility must be tested for at initial presentation.

Reading how experienced clinicians approach the problem of pericarditis in a specialized clinic provides a useful prompt to self-assess how we approach analogous clinical scenarios.

To the Editor: We previously addressed whether VKORC1 and CYP2C9 pharmacogenomic testing should be considered when prescribing warfarin.¹ Our recommendation, based on available evidence at that time, was that physicians should consider pharmacogenomic testing for any patient who is started on warfarin therapy.

Since the publication of this recommendation, two major trials, COAG (Clarification of Optimal Anticoagulation Through Genetics)² and EU-PACT (European Pharmacogenetics of Anticoagulant Therapy-Warfarin),³ were published along with commentaries debating the clinical utility of warfarin pharmacogenomics.^4–15 Based on these publications, we would like to update our recommendations for pharmacogenomic testing for warfarin therapy.

COAG compared the efficacy of a clinical algorithm or a clinical algorithm plus VKORC1 and CYP2C9 genotyping to guide warfarin dosage. At the end of 4 weeks, the mean percentage of time within the therapeutic international normalized ratio (INR) range was 45.4% for those in the clinical algorithm arm and 45.2% for those in the genotyping arm (95% confidence interval [CI] –3.4 to 3.1, P = .91). For both treatment groups, clinical data that included body surface area, age, target INR, concomitantly prescribed drugs, and smoking status were used to predict warfarin dose, with the genotyping arm including VKORC1 and CYP2C9. Although VKORC1 and CYP2C9 genotyping offered no additional benefit, caution should be used when extrapolating this conclusion to clinical settings in which warfarin therapy is initiated using a standardized starting dose (eg, 5 mg daily) instead of a clinical dosing algorithm.

Of interest, in the COAG trial, among black patients, the mean percentage of time in the therapeutic INR range was significantly less for those in the genotype-guided arm than for those in the clinically guided arm—ie, 35.2% vs 43.5% (95% CI –15.0 to –2.0, P = .01). The percentage of time with therapeutic INR has been identified as a surrogate marker for poor outcomes such as death, stroke, or major hemorrhage, with those with a lower percentage of time in therapeutic INR being at greater risk of an adverse event.¹⁶ Wan et al¹⁷ demonstrated that a 6.9% improvement of time in therapeutic INR decreased the risk of major hemorrhage by one event per 100 patient-years.¹⁷ Therefore, black patients in the COAG genotyping arm may have been at greater risk for an adverse event because of a lower observed percentage of time within the therapeutic INR range.

In the COAG trial, genotyping was done for only one VKORC1 variant and for two CYP2C9 alleles (CYP2C9*2, and CYP2C9*3). Other genetic variants are of clinical importance for warfarin dosing in black patients, and the lack of genotyping for these additional variants may explain why black patients in the genotyping arm performed worse.^5,7,11 In particular, CYP2C9*8 may be an important predictor of warfarin dose in black patients.¹⁸

EU-PACT compared the efficacy of standardized warfarin dosing and that of a clinical algorithm.³ Patients in the standardized dosing arm were prescribed warfarin 10 mg on the first day of treatment (5 mg for those over age 75), and 5 mg on days 2 and 3, with subsequent dosing adjustments based on INR. Patients in the genotyping arm were prescribed warfarin based on an algorithm that incorporated clinical data that included body surface area, age, and concomitantly prescribed drugs, as well as VKORC1 and CYP2C9 genotypes. At the end of 12 weeks, the mean percentage of time in the therapeutic INR range was 60.3% for those in the standardized-dosing arm and 67.4% for those in the genotyping arm (95% CI 3.3 to 10.6, P < .001).² The approximate 7% improvement in percentage of time in the therapeutic INR range may predict a lower risk of hemorrhage for those in the genotyping arm.¹⁷ Although patients in the genotyping arm had a higher percentage of time in the therapeutic INR range, it is unclear whether genotyping alone is superior to standardized dosing because the dosing algorithm used both clinical data and genotype data.

There are substantial differences between the COAG and EU-PACT trials, including dosing schemes, racial diversity, and trial length, and these differences could have contributed to the conflicting results. Based on these two trials, a possible conclusion is that genotype-guided warfarin dosing may be superior to standardized dosing, but may be no better than utilizing a clinical algorithm in white patients. For black patients, additional studies are needed to determine which genetic variants are of importance for guiding warfarin dosing.

We would like to update the recommendations we made in our previously published article,¹ to state that genotyping for CYP2C9 and VKORC1 may be of clinical utility in white patients depending on whether standardized dosing or a clinical algorithm is used to initiate warfarin therapy. Routine genotyping in black patients is not recommended until further studies clarify which genetic variants are of importance for guiding warfarin dosing.

The ongoing Genetics Informatics Trial of Warfarin to Prevent Venous Thrombosis may bring much needed clarity to the clinical utility of warfarin pharmacogenomics. We hope to publish a more detailed update of our 2013 article after completion of that trial.

To the Editor: We previously addressed whether VKORC1 and CYP2C9 pharmacogenomic testing should be considered when prescribing warfarin.¹ Our recommendation, based on available evidence at that time, was that physicians should consider pharmacogenomic testing for any patient who is started on warfarin therapy.

Since the publication of this recommendation, two major trials, COAG (Clarification of Optimal Anticoagulation Through Genetics)² and EU-PACT (European Pharmacogenetics of Anticoagulant Therapy-Warfarin),³ were published along with commentaries debating the clinical utility of warfarin pharmacogenomics.^4–15 Based on these publications, we would like to update our recommendations for pharmacogenomic testing for warfarin therapy.

COAG compared the efficacy of a clinical algorithm or a clinical algorithm plus VKORC1 and CYP2C9 genotyping to guide warfarin dosage. At the end of 4 weeks, the mean percentage of time within the therapeutic international normalized ratio (INR) range was 45.4% for those in the clinical algorithm arm and 45.2% for those in the genotyping arm (95% confidence interval [CI] –3.4 to 3.1, P = .91). For both treatment groups, clinical data that included body surface area, age, target INR, concomitantly prescribed drugs, and smoking status were used to predict warfarin dose, with the genotyping arm including VKORC1 and CYP2C9. Although VKORC1 and CYP2C9 genotyping offered no additional benefit, caution should be used when extrapolating this conclusion to clinical settings in which warfarin therapy is initiated using a standardized starting dose (eg, 5 mg daily) instead of a clinical dosing algorithm.

Of interest, in the COAG trial, among black patients, the mean percentage of time in the therapeutic INR range was significantly less for those in the genotype-guided arm than for those in the clinically guided arm—ie, 35.2% vs 43.5% (95% CI –15.0 to –2.0, P = .01). The percentage of time with therapeutic INR has been identified as a surrogate marker for poor outcomes such as death, stroke, or major hemorrhage, with those with a lower percentage of time in therapeutic INR being at greater risk of an adverse event.¹⁶ Wan et al¹⁷ demonstrated that a 6.9% improvement of time in therapeutic INR decreased the risk of major hemorrhage by one event per 100 patient-years.¹⁷ Therefore, black patients in the COAG genotyping arm may have been at greater risk for an adverse event because of a lower observed percentage of time within the therapeutic INR range.

In the COAG trial, genotyping was done for only one VKORC1 variant and for two CYP2C9 alleles (CYP2C9*2, and CYP2C9*3). Other genetic variants are of clinical importance for warfarin dosing in black patients, and the lack of genotyping for these additional variants may explain why black patients in the genotyping arm performed worse.^5,7,11 In particular, CYP2C9*8 may be an important predictor of warfarin dose in black patients.¹⁸

EU-PACT compared the efficacy of standardized warfarin dosing and that of a clinical algorithm.³ Patients in the standardized dosing arm were prescribed warfarin 10 mg on the first day of treatment (5 mg for those over age 75), and 5 mg on days 2 and 3, with subsequent dosing adjustments based on INR. Patients in the genotyping arm were prescribed warfarin based on an algorithm that incorporated clinical data that included body surface area, age, and concomitantly prescribed drugs, as well as VKORC1 and CYP2C9 genotypes. At the end of 12 weeks, the mean percentage of time in the therapeutic INR range was 60.3% for those in the standardized-dosing arm and 67.4% for those in the genotyping arm (95% CI 3.3 to 10.6, P < .001).² The approximate 7% improvement in percentage of time in the therapeutic INR range may predict a lower risk of hemorrhage for those in the genotyping arm.¹⁷ Although patients in the genotyping arm had a higher percentage of time in the therapeutic INR range, it is unclear whether genotyping alone is superior to standardized dosing because the dosing algorithm used both clinical data and genotype data.

There are substantial differences between the COAG and EU-PACT trials, including dosing schemes, racial diversity, and trial length, and these differences could have contributed to the conflicting results. Based on these two trials, a possible conclusion is that genotype-guided warfarin dosing may be superior to standardized dosing, but may be no better than utilizing a clinical algorithm in white patients. For black patients, additional studies are needed to determine which genetic variants are of importance for guiding warfarin dosing.

We would like to update the recommendations we made in our previously published article,¹ to state that genotyping for CYP2C9 and VKORC1 may be of clinical utility in white patients depending on whether standardized dosing or a clinical algorithm is used to initiate warfarin therapy. Routine genotyping in black patients is not recommended until further studies clarify which genetic variants are of importance for guiding warfarin dosing.

The ongoing Genetics Informatics Trial of Warfarin to Prevent Venous Thrombosis may bring much needed clarity to the clinical utility of warfarin pharmacogenomics. We hope to publish a more detailed update of our 2013 article after completion of that trial.

To the Editor: We previously addressed whether VKORC1 and CYP2C9 pharmacogenomic testing should be considered when prescribing warfarin.¹ Our recommendation, based on available evidence at that time, was that physicians should consider pharmacogenomic testing for any patient who is started on warfarin therapy.

Since the publication of this recommendation, two major trials, COAG (Clarification of Optimal Anticoagulation Through Genetics)² and EU-PACT (European Pharmacogenetics of Anticoagulant Therapy-Warfarin),³ were published along with commentaries debating the clinical utility of warfarin pharmacogenomics.^4–15 Based on these publications, we would like to update our recommendations for pharmacogenomic testing for warfarin therapy.

COAG compared the efficacy of a clinical algorithm or a clinical algorithm plus VKORC1 and CYP2C9 genotyping to guide warfarin dosage. At the end of 4 weeks, the mean percentage of time within the therapeutic international normalized ratio (INR) range was 45.4% for those in the clinical algorithm arm and 45.2% for those in the genotyping arm (95% confidence interval [CI] –3.4 to 3.1, P = .91). For both treatment groups, clinical data that included body surface area, age, target INR, concomitantly prescribed drugs, and smoking status were used to predict warfarin dose, with the genotyping arm including VKORC1 and CYP2C9. Although VKORC1 and CYP2C9 genotyping offered no additional benefit, caution should be used when extrapolating this conclusion to clinical settings in which warfarin therapy is initiated using a standardized starting dose (eg, 5 mg daily) instead of a clinical dosing algorithm.

Of interest, in the COAG trial, among black patients, the mean percentage of time in the therapeutic INR range was significantly less for those in the genotype-guided arm than for those in the clinically guided arm—ie, 35.2% vs 43.5% (95% CI –15.0 to –2.0, P = .01). The percentage of time with therapeutic INR has been identified as a surrogate marker for poor outcomes such as death, stroke, or major hemorrhage, with those with a lower percentage of time in therapeutic INR being at greater risk of an adverse event.¹⁶ Wan et al¹⁷ demonstrated that a 6.9% improvement of time in therapeutic INR decreased the risk of major hemorrhage by one event per 100 patient-years.¹⁷ Therefore, black patients in the COAG genotyping arm may have been at greater risk for an adverse event because of a lower observed percentage of time within the therapeutic INR range.

In the COAG trial, genotyping was done for only one VKORC1 variant and for two CYP2C9 alleles (CYP2C9*2, and CYP2C9*3). Other genetic variants are of clinical importance for warfarin dosing in black patients, and the lack of genotyping for these additional variants may explain why black patients in the genotyping arm performed worse.^5,7,11 In particular, CYP2C9*8 may be an important predictor of warfarin dose in black patients.¹⁸

EU-PACT compared the efficacy of standardized warfarin dosing and that of a clinical algorithm.³ Patients in the standardized dosing arm were prescribed warfarin 10 mg on the first day of treatment (5 mg for those over age 75), and 5 mg on days 2 and 3, with subsequent dosing adjustments based on INR. Patients in the genotyping arm were prescribed warfarin based on an algorithm that incorporated clinical data that included body surface area, age, and concomitantly prescribed drugs, as well as VKORC1 and CYP2C9 genotypes. At the end of 12 weeks, the mean percentage of time in the therapeutic INR range was 60.3% for those in the standardized-dosing arm and 67.4% for those in the genotyping arm (95% CI 3.3 to 10.6, P < .001).² The approximate 7% improvement in percentage of time in the therapeutic INR range may predict a lower risk of hemorrhage for those in the genotyping arm.¹⁷ Although patients in the genotyping arm had a higher percentage of time in the therapeutic INR range, it is unclear whether genotyping alone is superior to standardized dosing because the dosing algorithm used both clinical data and genotype data.

There are substantial differences between the COAG and EU-PACT trials, including dosing schemes, racial diversity, and trial length, and these differences could have contributed to the conflicting results. Based on these two trials, a possible conclusion is that genotype-guided warfarin dosing may be superior to standardized dosing, but may be no better than utilizing a clinical algorithm in white patients. For black patients, additional studies are needed to determine which genetic variants are of importance for guiding warfarin dosing.

We would like to update the recommendations we made in our previously published article,¹ to state that genotyping for CYP2C9 and VKORC1 may be of clinical utility in white patients depending on whether standardized dosing or a clinical algorithm is used to initiate warfarin therapy. Routine genotyping in black patients is not recommended until further studies clarify which genetic variants are of importance for guiding warfarin dosing.

The ongoing Genetics Informatics Trial of Warfarin to Prevent Venous Thrombosis may bring much needed clarity to the clinical utility of warfarin pharmacogenomics. We hope to publish a more detailed update of our 2013 article after completion of that trial.

Sometimes it’s difficult to figure out which way is forward. For the past few years, private insurers and the federal government (through the Medicare program) have been experimenting with and putting in place different ways of paying physicians for the care they provide. Many alternatives are designed to increase value for our nation’s health care dollars and improve quality of care, often through care coordination. Most involve different ways of “bundling” care—paying a single sum for a patient’s episode of care rather than separate payments each time a physician encounters a patient.

For more than 20 years, Medicare has bundled most surgeries, paying 1 sum to the physician and requiring only 1 copayment from the beneficiary patient. In this way, when a patient needs surgery, Medicare pays the surgeon 1 payment for preparation the day before surgery, for the surgery itself, and for either 10 or 90 days of follow-up care, depending on the specific procedure involved (TABLE 1). Similarly the patient has had 1 copay for the entire episode of care. This ­bundling is called global surgical codes, and it applies to coding, billing, and reimbursement.

This approach may change soon—and not for the better. In this article, I describe how the federal Centers for Medicare and Medicaid Services (CMS) plan to eliminate global surgery bundling, as well as the efforts under way by the American Congress of Obstetricians and Gynecologists (ACOG) and other organizations to stop the proposed change.

The CMS plan to eliminate surgical bundling
In a significant twist from the trend toward bundling and care coordination, CMS finalized its proposed policy in its 2015 Medicare Physician Fee Schedule final rule to transition all 10- and 90-day global surgical codes to 0-day global surgical codes by 2017 and 2018, respectively. Beginning in 2017 for 10-day global codes and 2018 for 90-day codes, physicians will be paid separately for the day of surgery and for evaluation and management (E&M) provided on the day before and any days after. Patients will have copays for each physician intervention.

CMS has decided to move forward with this change despite overwhelming concern and opposition on the part of both patients and physicians. This change would affect more than 4,200 services on the Medicare Physician Fee Schedule—well over one-third of the 9,900 current procedural terminology (CPT) codes.

The new codes and increased paperwork and billing are daunting, and would result in an estimated 63 million additional claims per year to account for postsurgical E&M services. The cost to CMS alone for this huge new mountain of claims may be as high as $95 million per year. Moreover, under the new system, patients may not return for the full range of follow-up care needed if they get billed for every visit, possibly resulting in poorer outcomes.

CMS’ justification for unbundling
CMS argues that this change is needed because many surgeons are failing to provide as much care (as many E&M follow-up visits) as they’re paid to deliver under the 10- and 90-day codes. As evidence, CMS points to 3 reports published by the Department of Health and Human Services Office of Inspector General:

Based largely on these reports, CMS has determined that it cannot verify the number of visits, level of service, and relative costs of the services included in a global package, in large part because the current valuation methodology relies on survey data estimating the resources used in a typical case, instead of on actual data.

In each of these reports, the Inspector General also found smaller numbers of cases where surgeons provided more E&M care than was covered under the global payment. In each report, the Inspector General suggests that CMS should do more to identify and correctly value misvalued codes. ACOG Vice President for Health Policy Barbara Levy, MD, who is also chair of the Relative Value Scale Update Committee, or RUC, makes a compelling case that the RUC has identified and corrected many global surgical codes since these reports were issued and is in the process of revising more codes. She also argues that the RUC is the appropriate place to address these issues.

Policy analysis finds that total RVUs would decline
CMS has indicated that it intends to use a formula for converting the 10- and 90-day global services into 0-day services by simply reducing the work relative value units (RVUs) for the service by the number of work RVUs in the postoperative visits. The American College of Surgeons asked Health Policy Alternatives (HPA), a consulting firm, to analyze the CMS decision. HPA found that “systematically convert[ing] all global surgical codes to 0-day global codes by backing out of the bundled E&M services reduces the total RVUs and each component (work, practice expense, and malpractice) for surgical codes. Specifically, for surgical specialties, the impact of this transition on all Medicare reimbursed codes results in the following reductions:

This modeling resulted in a total overall payment increase of 0.1% for generalists and a payment increase of 0.3% for medical specialists.”⁴

HPA’s findings related to the malpractice component are especially interesting for the ObGyn specialty. “Model results demonstrate that this policy results in significant redistribution of malpractice away from the main specialty provider of the surgical procedure into the entire group of providers (surgical and nonsurgical),” notes the HPA report.⁴ “Most impacted will be specialties with higher malpractice expenses, such as neurosurgeons and cardiac surgeons.”⁴ We could add ObGyns to that list.

ACOG cites numerous objections
ACOG is deeply involved in opposing this new CMS policy and preventing it from ever going into effect, working on our own, in coalition with our medical organization colleagues and patient organizations, and working closely with the US Congress.

ACOG and 28 other medical organizations, including the American Medical Association (AMA), summarized our opposition in a letter to US House and Senate Democratic and Republican leaders in December 2014, saying that this new policy:

Detracts from quality of care, impedes patient access, and complicates patient copays

Undermines Medicare reform initiatives

Increases administrative burden

Obstructs clinical registry data collection and quality improvement

Additional ACOG concerns
ACOG added these concerns to our opposition to the CMS plan:

We have important allies
The American Association of Retired ­Persons (AARP) joined us in September 2014, when it formally asked CMS to abandon this new policy. In a letter to CMS Administrator Marilyn Tavenner, AARP noted that, “from a beneficiary perspective, we are concerned that this unbundling could produce considerable confusion and cause beneficiaries to receive multiple explanations of Medicare benefits (and incur separate cost-sharing obligations) related to a single surgical procedure….[G]iven the obvious methodological uncertainty and complexity involved in determining appropriate values for a very large number of ‘new’ 0-day global services, and the likely confusion surrounding the resulting increase in Medicare claims, AARP has serious doubts regarding the benefit of this unbundling proposal. We suggest [that] CMS consider other available alternatives, including the re-valuation of global services whose current values are believed to be incorrect.”⁶

Also in September, 27 Republican and Democratic members of Congress wrote a strong letter to CMS echoing the medical community’s concerns. The letter and many months of congressional leadership have been spearheaded by Representatives Larry Bucshon, MD, and Ami Bera, MD—demonstrating the value of having physicians in elective office. Other physician members of Congress who have provided outstanding leadership include ACOG Fellows and Representatives Michael Burgess, MD, and Phil Roe, MD, as well as Representatives Tom Price, MD; Andy Harris, MD; Joe Heck, DO; Charles Boustany, MD; Raul Ruiz, MD; and Dan Benishek, MD.

This important group of physician leaders, ACOG, AARP, and the surgical community are hard at work to derail or significantly delay what most physicians and policy analysts see as a very bad idea.

Congress takes action
In April 2015, Congress passed HR2, the Medicare Access and CHIP Reauthorization Bill, which most notably repealed the Medicare Sustainable Growth Rate formula. Included in this law is an important provision to halt implementation of CMS’ plan to unbundle all 10- and 90-day global codes.

Section 523 of that law requires CMS to periodically collect information on the services that surgeons furnish during these global periods, beginning no later than 2017, and use that information to ensure that the bundled payment amounts for surgical services are accurate. The Secretary of Health and Human Services is given the authority to withhold a portion of payment for services with a 10- or 90-day global period to incentivize the reporting of information. The Secretary can stop collecting this information from surgeons once the needed data can be obtained through other mechanisms, such as clinical data registries and electronic medical records.

Congressmen Bucshon and Bera championed this provision, along with nearly all physician members of the US House of Representatives. This change ensures a thorough, data-driven approach to appropriately valuing surgical services, including those provided by ObGyn subspecialists, such as urogynecologists and gynecologic oncologists.

Acknowledgment
The author thanks Barbara Levy, MD, ACOG Vice President for Health Policy, for her helpful comments.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Sometimes it’s difficult to figure out which way is forward. For the past few years, private insurers and the federal government (through the Medicare program) have been experimenting with and putting in place different ways of paying physicians for the care they provide. Many alternatives are designed to increase value for our nation’s health care dollars and improve quality of care, often through care coordination. Most involve different ways of “bundling” care—paying a single sum for a patient’s episode of care rather than separate payments each time a physician encounters a patient.

For more than 20 years, Medicare has bundled most surgeries, paying 1 sum to the physician and requiring only 1 copayment from the beneficiary patient. In this way, when a patient needs surgery, Medicare pays the surgeon 1 payment for preparation the day before surgery, for the surgery itself, and for either 10 or 90 days of follow-up care, depending on the specific procedure involved (TABLE 1). Similarly the patient has had 1 copay for the entire episode of care. This ­bundling is called global surgical codes, and it applies to coding, billing, and reimbursement.

This approach may change soon—and not for the better. In this article, I describe how the federal Centers for Medicare and Medicaid Services (CMS) plan to eliminate global surgery bundling, as well as the efforts under way by the American Congress of Obstetricians and Gynecologists (ACOG) and other organizations to stop the proposed change.

The CMS plan to eliminate surgical bundling
In a significant twist from the trend toward bundling and care coordination, CMS finalized its proposed policy in its 2015 Medicare Physician Fee Schedule final rule to transition all 10- and 90-day global surgical codes to 0-day global surgical codes by 2017 and 2018, respectively. Beginning in 2017 for 10-day global codes and 2018 for 90-day codes, physicians will be paid separately for the day of surgery and for evaluation and management (E&M) provided on the day before and any days after. Patients will have copays for each physician intervention.

CMS has decided to move forward with this change despite overwhelming concern and opposition on the part of both patients and physicians. This change would affect more than 4,200 services on the Medicare Physician Fee Schedule—well over one-third of the 9,900 current procedural terminology (CPT) codes.

The new codes and increased paperwork and billing are daunting, and would result in an estimated 63 million additional claims per year to account for postsurgical E&M services. The cost to CMS alone for this huge new mountain of claims may be as high as $95 million per year. Moreover, under the new system, patients may not return for the full range of follow-up care needed if they get billed for every visit, possibly resulting in poorer outcomes.

CMS’ justification for unbundling
CMS argues that this change is needed because many surgeons are failing to provide as much care (as many E&M follow-up visits) as they’re paid to deliver under the 10- and 90-day codes. As evidence, CMS points to 3 reports published by the Department of Health and Human Services Office of Inspector General:

Based largely on these reports, CMS has determined that it cannot verify the number of visits, level of service, and relative costs of the services included in a global package, in large part because the current valuation methodology relies on survey data estimating the resources used in a typical case, instead of on actual data.

In each of these reports, the Inspector General also found smaller numbers of cases where surgeons provided more E&M care than was covered under the global payment. In each report, the Inspector General suggests that CMS should do more to identify and correctly value misvalued codes. ACOG Vice President for Health Policy Barbara Levy, MD, who is also chair of the Relative Value Scale Update Committee, or RUC, makes a compelling case that the RUC has identified and corrected many global surgical codes since these reports were issued and is in the process of revising more codes. She also argues that the RUC is the appropriate place to address these issues.

Policy analysis finds that total RVUs would decline
CMS has indicated that it intends to use a formula for converting the 10- and 90-day global services into 0-day services by simply reducing the work relative value units (RVUs) for the service by the number of work RVUs in the postoperative visits. The American College of Surgeons asked Health Policy Alternatives (HPA), a consulting firm, to analyze the CMS decision. HPA found that “systematically convert[ing] all global surgical codes to 0-day global codes by backing out of the bundled E&M services reduces the total RVUs and each component (work, practice expense, and malpractice) for surgical codes. Specifically, for surgical specialties, the impact of this transition on all Medicare reimbursed codes results in the following reductions:

This modeling resulted in a total overall payment increase of 0.1% for generalists and a payment increase of 0.3% for medical specialists.”⁴

HPA’s findings related to the malpractice component are especially interesting for the ObGyn specialty. “Model results demonstrate that this policy results in significant redistribution of malpractice away from the main specialty provider of the surgical procedure into the entire group of providers (surgical and nonsurgical),” notes the HPA report.⁴ “Most impacted will be specialties with higher malpractice expenses, such as neurosurgeons and cardiac surgeons.”⁴ We could add ObGyns to that list.

ACOG cites numerous objections
ACOG is deeply involved in opposing this new CMS policy and preventing it from ever going into effect, working on our own, in coalition with our medical organization colleagues and patient organizations, and working closely with the US Congress.

ACOG and 28 other medical organizations, including the American Medical Association (AMA), summarized our opposition in a letter to US House and Senate Democratic and Republican leaders in December 2014, saying that this new policy:

Detracts from quality of care, impedes patient access, and complicates patient copays

Undermines Medicare reform initiatives

Increases administrative burden

Obstructs clinical registry data collection and quality improvement

Additional ACOG concerns
ACOG added these concerns to our opposition to the CMS plan:

We have important allies
The American Association of Retired ­Persons (AARP) joined us in September 2014, when it formally asked CMS to abandon this new policy. In a letter to CMS Administrator Marilyn Tavenner, AARP noted that, “from a beneficiary perspective, we are concerned that this unbundling could produce considerable confusion and cause beneficiaries to receive multiple explanations of Medicare benefits (and incur separate cost-sharing obligations) related to a single surgical procedure….[G]iven the obvious methodological uncertainty and complexity involved in determining appropriate values for a very large number of ‘new’ 0-day global services, and the likely confusion surrounding the resulting increase in Medicare claims, AARP has serious doubts regarding the benefit of this unbundling proposal. We suggest [that] CMS consider other available alternatives, including the re-valuation of global services whose current values are believed to be incorrect.”⁶

Also in September, 27 Republican and Democratic members of Congress wrote a strong letter to CMS echoing the medical community’s concerns. The letter and many months of congressional leadership have been spearheaded by Representatives Larry Bucshon, MD, and Ami Bera, MD—demonstrating the value of having physicians in elective office. Other physician members of Congress who have provided outstanding leadership include ACOG Fellows and Representatives Michael Burgess, MD, and Phil Roe, MD, as well as Representatives Tom Price, MD; Andy Harris, MD; Joe Heck, DO; Charles Boustany, MD; Raul Ruiz, MD; and Dan Benishek, MD.

This important group of physician leaders, ACOG, AARP, and the surgical community are hard at work to derail or significantly delay what most physicians and policy analysts see as a very bad idea.

Congress takes action
In April 2015, Congress passed HR2, the Medicare Access and CHIP Reauthorization Bill, which most notably repealed the Medicare Sustainable Growth Rate formula. Included in this law is an important provision to halt implementation of CMS’ plan to unbundle all 10- and 90-day global codes.

Section 523 of that law requires CMS to periodically collect information on the services that surgeons furnish during these global periods, beginning no later than 2017, and use that information to ensure that the bundled payment amounts for surgical services are accurate. The Secretary of Health and Human Services is given the authority to withhold a portion of payment for services with a 10- or 90-day global period to incentivize the reporting of information. The Secretary can stop collecting this information from surgeons once the needed data can be obtained through other mechanisms, such as clinical data registries and electronic medical records.

Congressmen Bucshon and Bera championed this provision, along with nearly all physician members of the US House of Representatives. This change ensures a thorough, data-driven approach to appropriately valuing surgical services, including those provided by ObGyn subspecialists, such as urogynecologists and gynecologic oncologists.

Acknowledgment
The author thanks Barbara Levy, MD, ACOG Vice President for Health Policy, for her helpful comments.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Sometimes it’s difficult to figure out which way is forward. For the past few years, private insurers and the federal government (through the Medicare program) have been experimenting with and putting in place different ways of paying physicians for the care they provide. Many alternatives are designed to increase value for our nation’s health care dollars and improve quality of care, often through care coordination. Most involve different ways of “bundling” care—paying a single sum for a patient’s episode of care rather than separate payments each time a physician encounters a patient.

For more than 20 years, Medicare has bundled most surgeries, paying 1 sum to the physician and requiring only 1 copayment from the beneficiary patient. In this way, when a patient needs surgery, Medicare pays the surgeon 1 payment for preparation the day before surgery, for the surgery itself, and for either 10 or 90 days of follow-up care, depending on the specific procedure involved (TABLE 1). Similarly the patient has had 1 copay for the entire episode of care. This ­bundling is called global surgical codes, and it applies to coding, billing, and reimbursement.

This approach may change soon—and not for the better. In this article, I describe how the federal Centers for Medicare and Medicaid Services (CMS) plan to eliminate global surgery bundling, as well as the efforts under way by the American Congress of Obstetricians and Gynecologists (ACOG) and other organizations to stop the proposed change.

The CMS plan to eliminate surgical bundling
In a significant twist from the trend toward bundling and care coordination, CMS finalized its proposed policy in its 2015 Medicare Physician Fee Schedule final rule to transition all 10- and 90-day global surgical codes to 0-day global surgical codes by 2017 and 2018, respectively. Beginning in 2017 for 10-day global codes and 2018 for 90-day codes, physicians will be paid separately for the day of surgery and for evaluation and management (E&M) provided on the day before and any days after. Patients will have copays for each physician intervention.

CMS has decided to move forward with this change despite overwhelming concern and opposition on the part of both patients and physicians. This change would affect more than 4,200 services on the Medicare Physician Fee Schedule—well over one-third of the 9,900 current procedural terminology (CPT) codes.

The new codes and increased paperwork and billing are daunting, and would result in an estimated 63 million additional claims per year to account for postsurgical E&M services. The cost to CMS alone for this huge new mountain of claims may be as high as $95 million per year. Moreover, under the new system, patients may not return for the full range of follow-up care needed if they get billed for every visit, possibly resulting in poorer outcomes.

CMS’ justification for unbundling
CMS argues that this change is needed because many surgeons are failing to provide as much care (as many E&M follow-up visits) as they’re paid to deliver under the 10- and 90-day codes. As evidence, CMS points to 3 reports published by the Department of Health and Human Services Office of Inspector General:

Based largely on these reports, CMS has determined that it cannot verify the number of visits, level of service, and relative costs of the services included in a global package, in large part because the current valuation methodology relies on survey data estimating the resources used in a typical case, instead of on actual data.

In each of these reports, the Inspector General also found smaller numbers of cases where surgeons provided more E&M care than was covered under the global payment. In each report, the Inspector General suggests that CMS should do more to identify and correctly value misvalued codes. ACOG Vice President for Health Policy Barbara Levy, MD, who is also chair of the Relative Value Scale Update Committee, or RUC, makes a compelling case that the RUC has identified and corrected many global surgical codes since these reports were issued and is in the process of revising more codes. She also argues that the RUC is the appropriate place to address these issues.

Policy analysis finds that total RVUs would decline
CMS has indicated that it intends to use a formula for converting the 10- and 90-day global services into 0-day services by simply reducing the work relative value units (RVUs) for the service by the number of work RVUs in the postoperative visits. The American College of Surgeons asked Health Policy Alternatives (HPA), a consulting firm, to analyze the CMS decision. HPA found that “systematically convert[ing] all global surgical codes to 0-day global codes by backing out of the bundled E&M services reduces the total RVUs and each component (work, practice expense, and malpractice) for surgical codes. Specifically, for surgical specialties, the impact of this transition on all Medicare reimbursed codes results in the following reductions:

This modeling resulted in a total overall payment increase of 0.1% for generalists and a payment increase of 0.3% for medical specialists.”⁴

HPA’s findings related to the malpractice component are especially interesting for the ObGyn specialty. “Model results demonstrate that this policy results in significant redistribution of malpractice away from the main specialty provider of the surgical procedure into the entire group of providers (surgical and nonsurgical),” notes the HPA report.⁴ “Most impacted will be specialties with higher malpractice expenses, such as neurosurgeons and cardiac surgeons.”⁴ We could add ObGyns to that list.

ACOG cites numerous objections
ACOG is deeply involved in opposing this new CMS policy and preventing it from ever going into effect, working on our own, in coalition with our medical organization colleagues and patient organizations, and working closely with the US Congress.

ACOG and 28 other medical organizations, including the American Medical Association (AMA), summarized our opposition in a letter to US House and Senate Democratic and Republican leaders in December 2014, saying that this new policy:

Detracts from quality of care, impedes patient access, and complicates patient copays

Undermines Medicare reform initiatives

Increases administrative burden

Obstructs clinical registry data collection and quality improvement

Additional ACOG concerns
ACOG added these concerns to our opposition to the CMS plan:

We have important allies
The American Association of Retired ­Persons (AARP) joined us in September 2014, when it formally asked CMS to abandon this new policy. In a letter to CMS Administrator Marilyn Tavenner, AARP noted that, “from a beneficiary perspective, we are concerned that this unbundling could produce considerable confusion and cause beneficiaries to receive multiple explanations of Medicare benefits (and incur separate cost-sharing obligations) related to a single surgical procedure….[G]iven the obvious methodological uncertainty and complexity involved in determining appropriate values for a very large number of ‘new’ 0-day global services, and the likely confusion surrounding the resulting increase in Medicare claims, AARP has serious doubts regarding the benefit of this unbundling proposal. We suggest [that] CMS consider other available alternatives, including the re-valuation of global services whose current values are believed to be incorrect.”⁶

Also in September, 27 Republican and Democratic members of Congress wrote a strong letter to CMS echoing the medical community’s concerns. The letter and many months of congressional leadership have been spearheaded by Representatives Larry Bucshon, MD, and Ami Bera, MD—demonstrating the value of having physicians in elective office. Other physician members of Congress who have provided outstanding leadership include ACOG Fellows and Representatives Michael Burgess, MD, and Phil Roe, MD, as well as Representatives Tom Price, MD; Andy Harris, MD; Joe Heck, DO; Charles Boustany, MD; Raul Ruiz, MD; and Dan Benishek, MD.

This important group of physician leaders, ACOG, AARP, and the surgical community are hard at work to derail or significantly delay what most physicians and policy analysts see as a very bad idea.

Congress takes action
In April 2015, Congress passed HR2, the Medicare Access and CHIP Reauthorization Bill, which most notably repealed the Medicare Sustainable Growth Rate formula. Included in this law is an important provision to halt implementation of CMS’ plan to unbundle all 10- and 90-day global codes.

Section 523 of that law requires CMS to periodically collect information on the services that surgeons furnish during these global periods, beginning no later than 2017, and use that information to ensure that the bundled payment amounts for surgical services are accurate. The Secretary of Health and Human Services is given the authority to withhold a portion of payment for services with a 10- or 90-day global period to incentivize the reporting of information. The Secretary can stop collecting this information from surgeons once the needed data can be obtained through other mechanisms, such as clinical data registries and electronic medical records.

Congressmen Bucshon and Bera championed this provision, along with nearly all physician members of the US House of Representatives. This change ensures a thorough, data-driven approach to appropriately valuing surgical services, including those provided by ObGyn subspecialists, such as urogynecologists and gynecologic oncologists.

Acknowledgment
The author thanks Barbara Levy, MD, ACOG Vice President for Health Policy, for her helpful comments.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Delayed birth, intubation failure: $10M settlement
Two days shy of her due date, a woman went to an Army hospital to report bloody mucus discharge and sporadic contractions. She was 2 cm dilated and 50% effaced with the baby at –2 station. Fetal heart-rate monitor results were reassuring. She was discharged home but returned 5 hours later with increased pain and contractions. She was 5 cm dilated, 90% effaced; the baby was at –3 station. When contractions ceased, she was discharged. There had been no cervical change for 6 hours with a negative fern test. Fetal monitoring results were reassuring. 

The woman returned 3 hours later with increased pain and contractions. She had a fever and high white blood cell and neutrophil counts. She was 6 cm dilated, 90% effaced, but the baby was still at –3 station. Ampicillin sodium/sulbactam sodium was administered. The ObGyn was called 4 times over the next 2.5 hours, when fetal monitoring results worsened and bradycardia developed. The nurses treated fetal distress by changing the maternal position and performing amnioinfusion. Then the ObGyn came to the bedside and ordered cesarean delivery. The baby was born severely compromised from hypoxic ischemic encephalopathy and metabolic acidosis. The pediatrician responsible for the baby’s resuscitation failed to get a response with bag ventilation after 5 minutes; 2 attempts at intubation failed. When the chief of pediatrics arrived at 15 minutes, the infant was successfully intubated. The baby was transferred to another facility. The child has profound disabilities. 

Parents’ claim The hospital staff and physician did not deliver the baby in a timely manner when fetal distress was first noted. The pediatrician did not properly resuscitate the newborn.

Defendants’ defense Chorioamnionitis and funisitis caused or contributed to the infant’s injuries. Proper care was provided.

Verdict A $10 million Washington settlement was reached.

Did OCs cause this woman’s stroke?
A 40-year-old woman went to a clinic to obtain a prescription for birth control pills. A physician assistant (PA) conducted a complete physical examination. When no contraindications were found, a prescription for oral contraceptives (OCs) was provided. Two months later, the patient suffered a debilitating stroke. After the stroke, the patient was found to have a patent foramen ovale. 

Patient’s claim The risks and benefits of the OC were not fully explained  to the patient by the PA. She was not offered other contraceptive options. OCs are not safe for a woman her age due to a higher risk of stroke.

Defendants’ defense The patient used OCs in the past, and had received information from other physicians about their use. The stroke occurred because of the foramen ovale, not the use of OCs.

Verdict A Washington defense verdict was returned. 

Ureter injury not treated until the next day
During cesarean delivery, the ObGyn identified a small ureteral injury but did not repair it. The next day, the ObGyn consulted a urologist and ordered an intravenous ­pyelogram (IVP). The urologist identified a ureteral obstruction and surgically repaired the injury. The patient was required to use a nephros-tomy bag for 6 months until the nephrostomy was reversed. 

Patient’s claim The ObGyn was negligent in failing to immediately treat the ureter injury. The delay in repair necessitated the use of the nephrostomy bag.

Physician’s defense A ureter injury is a known complication of the procedure. The ObGyn did not cause the obstruction. Failure to perform an immediate repair was due to his concern that the patient might have lost too much blood during cesarean delivery. Bringing in the urologist the next day was appropriate. The patient completely recovered.

Verdict A $484,141 Mississippi verdict was returned.

Patient didn’t want male physician
After a woman experienced sexual assault in college, she did not want a male physician to perform a vaginal examination. When pregnant, she discussed that request with her nurse midwives. While she was in labor, a male ObGyn examined her. 

Patient’s claim The nurse midwives failed to document her request not to be examined by a male clinician. The patient experienced severe emotional distress.

Defendants’ defense The midwives claimed they were never told of the patient’s aversion to having a male physician examine her. The male physician and the birthing center denied knowledge of the request.

Verdict A $270,000 Washington verdict was returned.

Symptoms attributed to anesthesia: $2M
A 62-year-old woman underwent treatment for abnormal uterine bleeding (AUB). Hysteroscopy revealed a retroverted uterus containing a 3-cm polyp. During resection of the polyp, the uterus was perforated and bowel was drawn into the uterus. The injury was not recognized. The patient was discharged home the same day.

The next day, she phoned to report vomiting, abdominal pain, and urinary retention. The gynecologist attributed the symptoms to anesthesia and told the patient to allow more time for resolution.

The patient went to an emergency department (ED) 48 hours later with a distended abdomen and severe pain. She was transferred to a regional hospital with acute sepsis. A small bowel perforation was identified, requiring extensive treatment, including hysterectomy and resection of 27 cm of small bowel. 

Patient’s claim The gynecologist was negligent in failing to recognize the injury intraoperatively. He didn’t examine the patient when she first reported symptoms.

Physician’s defense The injuries are known risks of the procedure. The patient’s complaints could reasonably be associated with post­anesthesia residuals.

Verdict A $5 million Virginia verdict was reduced to $2 million by the statutory cap.

Did nosebleeds cause baby’s disabilities?
After a 33-year-old woman had a nosebleed she noted decreased fetal movement. At the ED, preterm labor was ruled out, fetal monitoring results were normal, and she was discharged. She returned that afternoon with a nosebleed. After 4 hours, when fetal monitoring results were normal, she was again discharged.

The next morning, an otolaryngologist cauterized her right nostril. After another nosebleed, the physician packed the right nasal cavity. She returned with bleeding from the left nostril and remained at the ear, nose, and throat (ENT) clinic for several hours until the bleeding stopped.

The following day, she returned to the ENT clinic asking that the packing be removed, but it needed to remain. She called a covering ObGyn to request anti-anxiety medication because the packing was making her feel claustrophobic.

The next day, after additional nosebleeds, she was taken to the ED with mild contractions. Her hematocrit was 25.6% and her hemoglobin level was 8.8 g/dL. When fetal heart-rate monitoring was nonreassuring, a cesarean delivery was expedited. The child has profound physical and developmental disabilities, uses a feeding tube and ventilator, and needs 24-hour care. 

Parents’ claim The mother and fetus were never properly assessed or treated. 

Defendants’ defense The physicians denied negligence and disputed the severity of most of the nosebleeds. At each ED presentation, hematocrit and hemoglobin levels were normal and the mother was stable at discharge. When fetal monitoring was performed, the results were normal. When the mother left the ENT clinic after the third visit, she was told to go to the ED or call 911 if she had another nosebleed, which she did not do. When she went to the ED with contractions, staff reacted to fetal distress and performed emergency cesarean delivery.

Verdict A Texas defense verdict was returned.

Difficult neonatal resuscitation: $8.4M
A nuchal cord was discovered at delivery. The child has cerebral palsy, a seizure disorder, and developmental delays. He cannot walk or talk, uses a feeding tube, and requires 24-hour care. 

Parents’ claim Monitoring showed fetal distress for 5 hours, but the staff failed to perform a cesarean delivery or have a neonatal resuscitation team ready at delivery. After delivery, the baby was deprived of oxygen for 8 minutes before intubation. A back-up team should have been available.

Medical center’s defense Proper care was given. The resuscitation team was in a surgical suite.

Verdict An $8.4 million Georgia verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements, & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Delayed birth, intubation failure: $10M settlement
Two days shy of her due date, a woman went to an Army hospital to report bloody mucus discharge and sporadic contractions. She was 2 cm dilated and 50% effaced with the baby at –2 station. Fetal heart-rate monitor results were reassuring. She was discharged home but returned 5 hours later with increased pain and contractions. She was 5 cm dilated, 90% effaced; the baby was at –3 station. When contractions ceased, she was discharged. There had been no cervical change for 6 hours with a negative fern test. Fetal monitoring results were reassuring. 

The woman returned 3 hours later with increased pain and contractions. She had a fever and high white blood cell and neutrophil counts. She was 6 cm dilated, 90% effaced, but the baby was still at –3 station. Ampicillin sodium/sulbactam sodium was administered. The ObGyn was called 4 times over the next 2.5 hours, when fetal monitoring results worsened and bradycardia developed. The nurses treated fetal distress by changing the maternal position and performing amnioinfusion. Then the ObGyn came to the bedside and ordered cesarean delivery. The baby was born severely compromised from hypoxic ischemic encephalopathy and metabolic acidosis. The pediatrician responsible for the baby’s resuscitation failed to get a response with bag ventilation after 5 minutes; 2 attempts at intubation failed. When the chief of pediatrics arrived at 15 minutes, the infant was successfully intubated. The baby was transferred to another facility. The child has profound disabilities. 

Parents’ claim The hospital staff and physician did not deliver the baby in a timely manner when fetal distress was first noted. The pediatrician did not properly resuscitate the newborn.

Defendants’ defense Chorioamnionitis and funisitis caused or contributed to the infant’s injuries. Proper care was provided.

Verdict A $10 million Washington settlement was reached.

Did OCs cause this woman’s stroke?
A 40-year-old woman went to a clinic to obtain a prescription for birth control pills. A physician assistant (PA) conducted a complete physical examination. When no contraindications were found, a prescription for oral contraceptives (OCs) was provided. Two months later, the patient suffered a debilitating stroke. After the stroke, the patient was found to have a patent foramen ovale. 

Patient’s claim The risks and benefits of the OC were not fully explained  to the patient by the PA. She was not offered other contraceptive options. OCs are not safe for a woman her age due to a higher risk of stroke.

Defendants’ defense The patient used OCs in the past, and had received information from other physicians about their use. The stroke occurred because of the foramen ovale, not the use of OCs.

Verdict A Washington defense verdict was returned. 

Ureter injury not treated until the next day
During cesarean delivery, the ObGyn identified a small ureteral injury but did not repair it. The next day, the ObGyn consulted a urologist and ordered an intravenous ­pyelogram (IVP). The urologist identified a ureteral obstruction and surgically repaired the injury. The patient was required to use a nephros-tomy bag for 6 months until the nephrostomy was reversed. 

Patient’s claim The ObGyn was negligent in failing to immediately treat the ureter injury. The delay in repair necessitated the use of the nephrostomy bag.

Physician’s defense A ureter injury is a known complication of the procedure. The ObGyn did not cause the obstruction. Failure to perform an immediate repair was due to his concern that the patient might have lost too much blood during cesarean delivery. Bringing in the urologist the next day was appropriate. The patient completely recovered.

Verdict A $484,141 Mississippi verdict was returned.

Patient didn’t want male physician
After a woman experienced sexual assault in college, she did not want a male physician to perform a vaginal examination. When pregnant, she discussed that request with her nurse midwives. While she was in labor, a male ObGyn examined her. 

Patient’s claim The nurse midwives failed to document her request not to be examined by a male clinician. The patient experienced severe emotional distress.

Defendants’ defense The midwives claimed they were never told of the patient’s aversion to having a male physician examine her. The male physician and the birthing center denied knowledge of the request.

Verdict A $270,000 Washington verdict was returned.

Symptoms attributed to anesthesia: $2M
A 62-year-old woman underwent treatment for abnormal uterine bleeding (AUB). Hysteroscopy revealed a retroverted uterus containing a 3-cm polyp. During resection of the polyp, the uterus was perforated and bowel was drawn into the uterus. The injury was not recognized. The patient was discharged home the same day.

The next day, she phoned to report vomiting, abdominal pain, and urinary retention. The gynecologist attributed the symptoms to anesthesia and told the patient to allow more time for resolution.

The patient went to an emergency department (ED) 48 hours later with a distended abdomen and severe pain. She was transferred to a regional hospital with acute sepsis. A small bowel perforation was identified, requiring extensive treatment, including hysterectomy and resection of 27 cm of small bowel. 

Patient’s claim The gynecologist was negligent in failing to recognize the injury intraoperatively. He didn’t examine the patient when she first reported symptoms.

Physician’s defense The injuries are known risks of the procedure. The patient’s complaints could reasonably be associated with post­anesthesia residuals.

Verdict A $5 million Virginia verdict was reduced to $2 million by the statutory cap.

Did nosebleeds cause baby’s disabilities?
After a 33-year-old woman had a nosebleed she noted decreased fetal movement. At the ED, preterm labor was ruled out, fetal monitoring results were normal, and she was discharged. She returned that afternoon with a nosebleed. After 4 hours, when fetal monitoring results were normal, she was again discharged.

The next morning, an otolaryngologist cauterized her right nostril. After another nosebleed, the physician packed the right nasal cavity. She returned with bleeding from the left nostril and remained at the ear, nose, and throat (ENT) clinic for several hours until the bleeding stopped.

The following day, she returned to the ENT clinic asking that the packing be removed, but it needed to remain. She called a covering ObGyn to request anti-anxiety medication because the packing was making her feel claustrophobic.

The next day, after additional nosebleeds, she was taken to the ED with mild contractions. Her hematocrit was 25.6% and her hemoglobin level was 8.8 g/dL. When fetal heart-rate monitoring was nonreassuring, a cesarean delivery was expedited. The child has profound physical and developmental disabilities, uses a feeding tube and ventilator, and needs 24-hour care. 

Parents’ claim The mother and fetus were never properly assessed or treated. 

Defendants’ defense The physicians denied negligence and disputed the severity of most of the nosebleeds. At each ED presentation, hematocrit and hemoglobin levels were normal and the mother was stable at discharge. When fetal monitoring was performed, the results were normal. When the mother left the ENT clinic after the third visit, she was told to go to the ED or call 911 if she had another nosebleed, which she did not do. When she went to the ED with contractions, staff reacted to fetal distress and performed emergency cesarean delivery.

Verdict A Texas defense verdict was returned.

Difficult neonatal resuscitation: $8.4M
A nuchal cord was discovered at delivery. The child has cerebral palsy, a seizure disorder, and developmental delays. He cannot walk or talk, uses a feeding tube, and requires 24-hour care. 

Parents’ claim Monitoring showed fetal distress for 5 hours, but the staff failed to perform a cesarean delivery or have a neonatal resuscitation team ready at delivery. After delivery, the baby was deprived of oxygen for 8 minutes before intubation. A back-up team should have been available.

Medical center’s defense Proper care was given. The resuscitation team was in a surgical suite.

Verdict An $8.4 million Georgia verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements, & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Delayed birth, intubation failure: $10M settlement
Two days shy of her due date, a woman went to an Army hospital to report bloody mucus discharge and sporadic contractions. She was 2 cm dilated and 50% effaced with the baby at –2 station. Fetal heart-rate monitor results were reassuring. She was discharged home but returned 5 hours later with increased pain and contractions. She was 5 cm dilated, 90% effaced; the baby was at –3 station. When contractions ceased, she was discharged. There had been no cervical change for 6 hours with a negative fern test. Fetal monitoring results were reassuring. 

The woman returned 3 hours later with increased pain and contractions. She had a fever and high white blood cell and neutrophil counts. She was 6 cm dilated, 90% effaced, but the baby was still at –3 station. Ampicillin sodium/sulbactam sodium was administered. The ObGyn was called 4 times over the next 2.5 hours, when fetal monitoring results worsened and bradycardia developed. The nurses treated fetal distress by changing the maternal position and performing amnioinfusion. Then the ObGyn came to the bedside and ordered cesarean delivery. The baby was born severely compromised from hypoxic ischemic encephalopathy and metabolic acidosis. The pediatrician responsible for the baby’s resuscitation failed to get a response with bag ventilation after 5 minutes; 2 attempts at intubation failed. When the chief of pediatrics arrived at 15 minutes, the infant was successfully intubated. The baby was transferred to another facility. The child has profound disabilities. 

Parents’ claim The hospital staff and physician did not deliver the baby in a timely manner when fetal distress was first noted. The pediatrician did not properly resuscitate the newborn.

Defendants’ defense Chorioamnionitis and funisitis caused or contributed to the infant’s injuries. Proper care was provided.

Verdict A $10 million Washington settlement was reached.

Did OCs cause this woman’s stroke?
A 40-year-old woman went to a clinic to obtain a prescription for birth control pills. A physician assistant (PA) conducted a complete physical examination. When no contraindications were found, a prescription for oral contraceptives (OCs) was provided. Two months later, the patient suffered a debilitating stroke. After the stroke, the patient was found to have a patent foramen ovale. 

Patient’s claim The risks and benefits of the OC were not fully explained  to the patient by the PA. She was not offered other contraceptive options. OCs are not safe for a woman her age due to a higher risk of stroke.

Defendants’ defense The patient used OCs in the past, and had received information from other physicians about their use. The stroke occurred because of the foramen ovale, not the use of OCs.

Verdict A Washington defense verdict was returned. 

Ureter injury not treated until the next day
During cesarean delivery, the ObGyn identified a small ureteral injury but did not repair it. The next day, the ObGyn consulted a urologist and ordered an intravenous ­pyelogram (IVP). The urologist identified a ureteral obstruction and surgically repaired the injury. The patient was required to use a nephros-tomy bag for 6 months until the nephrostomy was reversed. 

Patient’s claim The ObGyn was negligent in failing to immediately treat the ureter injury. The delay in repair necessitated the use of the nephrostomy bag.

Physician’s defense A ureter injury is a known complication of the procedure. The ObGyn did not cause the obstruction. Failure to perform an immediate repair was due to his concern that the patient might have lost too much blood during cesarean delivery. Bringing in the urologist the next day was appropriate. The patient completely recovered.

Verdict A $484,141 Mississippi verdict was returned.

Patient didn’t want male physician
After a woman experienced sexual assault in college, she did not want a male physician to perform a vaginal examination. When pregnant, she discussed that request with her nurse midwives. While she was in labor, a male ObGyn examined her. 

Patient’s claim The nurse midwives failed to document her request not to be examined by a male clinician. The patient experienced severe emotional distress.

Defendants’ defense The midwives claimed they were never told of the patient’s aversion to having a male physician examine her. The male physician and the birthing center denied knowledge of the request.

Verdict A $270,000 Washington verdict was returned.

Symptoms attributed to anesthesia: $2M
A 62-year-old woman underwent treatment for abnormal uterine bleeding (AUB). Hysteroscopy revealed a retroverted uterus containing a 3-cm polyp. During resection of the polyp, the uterus was perforated and bowel was drawn into the uterus. The injury was not recognized. The patient was discharged home the same day.

The next day, she phoned to report vomiting, abdominal pain, and urinary retention. The gynecologist attributed the symptoms to anesthesia and told the patient to allow more time for resolution.

The patient went to an emergency department (ED) 48 hours later with a distended abdomen and severe pain. She was transferred to a regional hospital with acute sepsis. A small bowel perforation was identified, requiring extensive treatment, including hysterectomy and resection of 27 cm of small bowel. 

Patient’s claim The gynecologist was negligent in failing to recognize the injury intraoperatively. He didn’t examine the patient when she first reported symptoms.

Physician’s defense The injuries are known risks of the procedure. The patient’s complaints could reasonably be associated with post­anesthesia residuals.

Verdict A $5 million Virginia verdict was reduced to $2 million by the statutory cap.

Did nosebleeds cause baby’s disabilities?
After a 33-year-old woman had a nosebleed she noted decreased fetal movement. At the ED, preterm labor was ruled out, fetal monitoring results were normal, and she was discharged. She returned that afternoon with a nosebleed. After 4 hours, when fetal monitoring results were normal, she was again discharged.

The next morning, an otolaryngologist cauterized her right nostril. After another nosebleed, the physician packed the right nasal cavity. She returned with bleeding from the left nostril and remained at the ear, nose, and throat (ENT) clinic for several hours until the bleeding stopped.

The following day, she returned to the ENT clinic asking that the packing be removed, but it needed to remain. She called a covering ObGyn to request anti-anxiety medication because the packing was making her feel claustrophobic.

The next day, after additional nosebleeds, she was taken to the ED with mild contractions. Her hematocrit was 25.6% and her hemoglobin level was 8.8 g/dL. When fetal heart-rate monitoring was nonreassuring, a cesarean delivery was expedited. The child has profound physical and developmental disabilities, uses a feeding tube and ventilator, and needs 24-hour care. 

Parents’ claim The mother and fetus were never properly assessed or treated. 

Defendants’ defense The physicians denied negligence and disputed the severity of most of the nosebleeds. At each ED presentation, hematocrit and hemoglobin levels were normal and the mother was stable at discharge. When fetal monitoring was performed, the results were normal. When the mother left the ENT clinic after the third visit, she was told to go to the ED or call 911 if she had another nosebleed, which she did not do. When she went to the ED with contractions, staff reacted to fetal distress and performed emergency cesarean delivery.

Verdict A Texas defense verdict was returned.

Difficult neonatal resuscitation: $8.4M
A nuchal cord was discovered at delivery. The child has cerebral palsy, a seizure disorder, and developmental delays. He cannot walk or talk, uses a feeding tube, and requires 24-hour care. 

Parents’ claim Monitoring showed fetal distress for 5 hours, but the staff failed to perform a cesarean delivery or have a neonatal resuscitation team ready at delivery. After delivery, the baby was deprived of oxygen for 8 minutes before intubation. A back-up team should have been available.

Medical center’s defense Proper care was given. The resuscitation team was in a surgical suite.

Verdict An $8.4 million Georgia verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements, & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In this month’s podcast for The Journal of Community and Supportive Oncology, Dr David Henry highlights two Original Reports, one on the effectiveness and safety of ipilimumab therapy in advanced melanoma, and another on the feasibility of implementing a community-based randomized trial of yoga for women who are undergoing chemotherapy for breast cancer. Also in the line-up are a Review article on sleep disorders in patients with cancer; a Community Translations examination of palonosetron and netupitant for the prevention of chemotherapy-induced nausea and vomiting in cancer patients; and Case Reports on distant skin metastases as primary presentation of gastric cancer, and sarcoidosis, complete heart block, and warm autoimmune hemolytic anemia in a young woman. The bimonthly New Therapies feature focuses on hard-to-treat tumors, specifically, glioblastoma, bone sarcoma, and liver cancer.

In this month’s podcast for The Journal of Community and Supportive Oncology, Dr David Henry highlights two Original Reports, one on the effectiveness and safety of ipilimumab therapy in advanced melanoma, and another on the feasibility of implementing a community-based randomized trial of yoga for women who are undergoing chemotherapy for breast cancer. Also in the line-up are a Review article on sleep disorders in patients with cancer; a Community Translations examination of palonosetron and netupitant for the prevention of chemotherapy-induced nausea and vomiting in cancer patients; and Case Reports on distant skin metastases as primary presentation of gastric cancer, and sarcoidosis, complete heart block, and warm autoimmune hemolytic anemia in a young woman. The bimonthly New Therapies feature focuses on hard-to-treat tumors, specifically, glioblastoma, bone sarcoma, and liver cancer.

In this month’s podcast for The Journal of Community and Supportive Oncology, Dr David Henry highlights two Original Reports, one on the effectiveness and safety of ipilimumab therapy in advanced melanoma, and another on the feasibility of implementing a community-based randomized trial of yoga for women who are undergoing chemotherapy for breast cancer. Also in the line-up are a Review article on sleep disorders in patients with cancer; a Community Translations examination of palonosetron and netupitant for the prevention of chemotherapy-induced nausea and vomiting in cancer patients; and Case Reports on distant skin metastases as primary presentation of gastric cancer, and sarcoidosis, complete heart block, and warm autoimmune hemolytic anemia in a young woman. The bimonthly New Therapies feature focuses on hard-to-treat tumors, specifically, glioblastoma, bone sarcoma, and liver cancer.

Click here for patient information on epilepsy basics.

Click here for patient information on epilepsy basics.

Click here for patient information on epilepsy basics.

Practically everyone who lives in America has heard about the Baltimore riots, precipitated by the death of a man while in police custody. Their scope was unprecedented; their implications, far reaching. I, like many Americans, stayed glued to the news to keep abreast of the latest updates for a variety of reasons, one of which was that I live and work nearby, and personal safety was a major concern. At the peak of the violence, when people were leaving the city in droves, I kept in close contact with my brother, a physician who works in a hospital at the epicenter of the chaos. Fortunately, he got out safely, as did most people. Yet many, including citizens and police officers, were injured, some seriously so.

No matter where you stand regarding the events surrounding the riots, the fact remains that we as physicians are not infrequently called upon to care for patients who have victimized or been victimized by others. We care for those who are slowly destroying themselves and endangering others with their abuse of drugs and alcohol, yet refuse any help we offer for their substance abuse. Some hospitalists work in hospitals with booming prison wards, and thus frequently care for murderers, thieves, child abusers, and others whom we may secretly fear, yet openly pledge to protect, respect, and care for. While I could not find a good scholarly article addressing how we as physicians do versus how we should handle these situations, I believe many of us have struggled with the personal emotions and ethical dilemmas raised by some of these cases.

How much can we and should we get involved? How do we mask our personal opinions of patients who have committed egregious acts and provide not only the best care possible, but do so while treating them with the respect and dignity that we allow for other patients? And if we go the extra mile to provide emotional support and encouragement, will we really have any positive impact on them, or will they just shut us out? Where do we draw the line between just being health care providers and being compassionate, nonjudgmental clinicians who can really impact their lives?

I don’t think there is an easy answer to any of these questions, and each patient is different. But I believe that many people still look up to their health care providers, and there will be those times when we can be more than their doctor; we can be their (much-needed) friend. Meanwhile, we need to guard against the natural human inclination to act as judge and jury toward those who have committed acts we personally find reprehensible. Every patient deserves our very best medical care, even when we cannot find it within ourselves to give this service with a smile.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

Practically everyone who lives in America has heard about the Baltimore riots, precipitated by the death of a man while in police custody. Their scope was unprecedented; their implications, far reaching. I, like many Americans, stayed glued to the news to keep abreast of the latest updates for a variety of reasons, one of which was that I live and work nearby, and personal safety was a major concern. At the peak of the violence, when people were leaving the city in droves, I kept in close contact with my brother, a physician who works in a hospital at the epicenter of the chaos. Fortunately, he got out safely, as did most people. Yet many, including citizens and police officers, were injured, some seriously so.

No matter where you stand regarding the events surrounding the riots, the fact remains that we as physicians are not infrequently called upon to care for patients who have victimized or been victimized by others. We care for those who are slowly destroying themselves and endangering others with their abuse of drugs and alcohol, yet refuse any help we offer for their substance abuse. Some hospitalists work in hospitals with booming prison wards, and thus frequently care for murderers, thieves, child abusers, and others whom we may secretly fear, yet openly pledge to protect, respect, and care for. While I could not find a good scholarly article addressing how we as physicians do versus how we should handle these situations, I believe many of us have struggled with the personal emotions and ethical dilemmas raised by some of these cases.

How much can we and should we get involved? How do we mask our personal opinions of patients who have committed egregious acts and provide not only the best care possible, but do so while treating them with the respect and dignity that we allow for other patients? And if we go the extra mile to provide emotional support and encouragement, will we really have any positive impact on them, or will they just shut us out? Where do we draw the line between just being health care providers and being compassionate, nonjudgmental clinicians who can really impact their lives?

I don’t think there is an easy answer to any of these questions, and each patient is different. But I believe that many people still look up to their health care providers, and there will be those times when we can be more than their doctor; we can be their (much-needed) friend. Meanwhile, we need to guard against the natural human inclination to act as judge and jury toward those who have committed acts we personally find reprehensible. Every patient deserves our very best medical care, even when we cannot find it within ourselves to give this service with a smile.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

Practically everyone who lives in America has heard about the Baltimore riots, precipitated by the death of a man while in police custody. Their scope was unprecedented; their implications, far reaching. I, like many Americans, stayed glued to the news to keep abreast of the latest updates for a variety of reasons, one of which was that I live and work nearby, and personal safety was a major concern. At the peak of the violence, when people were leaving the city in droves, I kept in close contact with my brother, a physician who works in a hospital at the epicenter of the chaos. Fortunately, he got out safely, as did most people. Yet many, including citizens and police officers, were injured, some seriously so.

No matter where you stand regarding the events surrounding the riots, the fact remains that we as physicians are not infrequently called upon to care for patients who have victimized or been victimized by others. We care for those who are slowly destroying themselves and endangering others with their abuse of drugs and alcohol, yet refuse any help we offer for their substance abuse. Some hospitalists work in hospitals with booming prison wards, and thus frequently care for murderers, thieves, child abusers, and others whom we may secretly fear, yet openly pledge to protect, respect, and care for. While I could not find a good scholarly article addressing how we as physicians do versus how we should handle these situations, I believe many of us have struggled with the personal emotions and ethical dilemmas raised by some of these cases.

How much can we and should we get involved? How do we mask our personal opinions of patients who have committed egregious acts and provide not only the best care possible, but do so while treating them with the respect and dignity that we allow for other patients? And if we go the extra mile to provide emotional support and encouragement, will we really have any positive impact on them, or will they just shut us out? Where do we draw the line between just being health care providers and being compassionate, nonjudgmental clinicians who can really impact their lives?

I don’t think there is an easy answer to any of these questions, and each patient is different. But I believe that many people still look up to their health care providers, and there will be those times when we can be more than their doctor; we can be their (much-needed) friend. Meanwhile, we need to guard against the natural human inclination to act as judge and jury toward those who have committed acts we personally find reprehensible. Every patient deserves our very best medical care, even when we cannot find it within ourselves to give this service with a smile.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

 

 

AACR Annual Meeting 2015

 

PHILADELPHIA—A retrospective study has revealed factors that appear to influence a person’s susceptibility to Waldenström’s macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) and other malignancies.

Study investigators looked at patients diagnosed with WM or LPL over a 20-year period and found about a 50% excess of second primary cancers in this population.

The patients had a significantly increased risk of multiple hematologic and solid tumor malignancies, and a few of these malignancies had shared susceptibility factors with WM/LPL.

The investigators believe that identifying these factors may prove useful for determining genetic susceptibility to WM/LPL.

Mary L. McMaster, MD, of the National Cancer Institute in Bethesda, Maryland, and her colleagues presented these findings at the AACR Annual Meeting 2015 (abstract 3709).

The team used data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SSER) database to evaluate the risk of subsequent primary cancer in 3825 patients diagnosed with WM (n=2163) or LPL (n=1662) from 1992 to 2011. The patients’ median age was 70, most of them were male (n=2221), and most were white (n=3153).

Dr McMaster said she and her colleagues looked at both WM and LPL in this study because SEER does not include information about immunoglobulin subtype, which makes it difficult to identify all WM cases with absolute certainty.

“[D]epending on what information a pathologist has when they review a bone marrow biopsy, for example, they may or may not know whether there’s IgM present,” Dr McMaster said. “So you may have a diagnosis of LPL and not have the information required to make the diagnosis of WM. For that reason, we combined both entities for this study.”

Dr McMaster and her colleagues calculated the observed-to-expected standardized incidence ratios (SIRs) for invasive cancers. After adjusting for multiple comparisons, the team found that survivors of WM/LPL had a significantly increased risk of developing a second primary malignancy (SIR=1.49).

This increased risk was seen for males and females and persisted throughout follow-up. The risk was higher for patients younger than 65 years of age (SIR=1.95).

Hematologic malignancies

WM/LPL survivors had a significantly increased risk of several hematologic malignancies. The SIR was 4.09 for all hematologic malignancies, 4.29 for lymphomas, and 3.16 for leukemias.

Dr McMaster pointed out that several lymphoma subtypes can have lymphoplasmacytic differentiation, the most common being marginal zone lymphoma. And this could potentially result in misclassification.

“So we actually ran the study with and without marginal zone lymphoma and saw no difference in the results,” she said. “So we don’t think misclassification accounts for the majority of what we’re seeing.”

The investigators found that WM/LPL survivors had the highest risk of developing Burkitt lymphoma (SIR=13.45), followed by Hodgkin lymphoma (SIR=9.80), T-cell non-Hodgkin lymphoma (SIR=6.62), mantle cell lymphoma (SIR=5.37), diffuse large B-cell lymphoma (DLBCL, SIR=4.76), multiple myeloma (SIR=4.40), any non-Hodgkin lymphoma (SIR=4.08), and acute myeloid leukemia (AML, SIR=3.27).

“Waldenström’s is known to transform, on occasion, to DLBCL,” Dr McMaster said. “So that may well account for the excess of DLBCL that we see in this population.”

She also noted that, prior to the early 2000s, WM was typically treated with alkylating agents. And alkylating agents have been linked to an increased risk of AML.

In this population, the risk of AML peaked 5 to 10 years after WM/LPL diagnosis and was only present in patients treated prior to 2002. This suggests the AML observed in this study was likely treatment-related.

Dr McMaster and her colleagues also found that WM/LPL survivors did not have a significantly increased risk of developing acute lymphocytic leukemia (SIR=0), hairy cell leukemia (SIR=0), chronic lymphocytic leukemia/small lymphocytic lymphoma (SIR=0.97), or follicular lymphoma (SIR=2.25).

Solid tumors

WM/LPL survivors did have a significantly increased risk of certain solid tumor malignancies. The overall SIR for solid tumors was 1.21.

The risk was significant for non-epithelial skin cancers (SIR=5.15), thyroid cancers (SIR=3.13), melanoma (SIR=1.72), and cancers of the lung and bronchus (SIR=1.44) or respiratory system (SIR=1.42).

“Melanoma has an immunological basis, as does Waldenström’s, so we think there may be some shared etiology there,” Dr McMaster said.

She also noted that a strong risk factor for thyroid cancer, particularly papillary thyroid cancer, is a history of autoimmune thyroid disease.

“Autoimmune disease of any sort is a risk factor for Waldenström’s macroglobulinemia,” she said. “So again, we think there might be a basis for shared susceptibility there.”

Dr McMaster said this research suggests that multiple primary cancers may occur in a single individual because of shared genetic susceptibility, shared environmental exposures, treatment effects, or chance. She believes future research will show that both genetic and environmental factors contribute to WM.

Investigators are currently conducting whole-exome sequencing studies and genome-wide association studies in patients with familial and spontaneous WM, with the hopes of identifying genes that contribute to WM susceptibility.

 

 

AACR Annual Meeting 2015

 

PHILADELPHIA—A retrospective study has revealed factors that appear to influence a person’s susceptibility to Waldenström’s macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) and other malignancies.

Study investigators looked at patients diagnosed with WM or LPL over a 20-year period and found about a 50% excess of second primary cancers in this population.

The patients had a significantly increased risk of multiple hematologic and solid tumor malignancies, and a few of these malignancies had shared susceptibility factors with WM/LPL.

The investigators believe that identifying these factors may prove useful for determining genetic susceptibility to WM/LPL.

Mary L. McMaster, MD, of the National Cancer Institute in Bethesda, Maryland, and her colleagues presented these findings at the AACR Annual Meeting 2015 (abstract 3709).

The team used data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SSER) database to evaluate the risk of subsequent primary cancer in 3825 patients diagnosed with WM (n=2163) or LPL (n=1662) from 1992 to 2011. The patients’ median age was 70, most of them were male (n=2221), and most were white (n=3153).

Dr McMaster said she and her colleagues looked at both WM and LPL in this study because SEER does not include information about immunoglobulin subtype, which makes it difficult to identify all WM cases with absolute certainty.

“[D]epending on what information a pathologist has when they review a bone marrow biopsy, for example, they may or may not know whether there’s IgM present,” Dr McMaster said. “So you may have a diagnosis of LPL and not have the information required to make the diagnosis of WM. For that reason, we combined both entities for this study.”

Dr McMaster and her colleagues calculated the observed-to-expected standardized incidence ratios (SIRs) for invasive cancers. After adjusting for multiple comparisons, the team found that survivors of WM/LPL had a significantly increased risk of developing a second primary malignancy (SIR=1.49).

This increased risk was seen for males and females and persisted throughout follow-up. The risk was higher for patients younger than 65 years of age (SIR=1.95).

Hematologic malignancies

WM/LPL survivors had a significantly increased risk of several hematologic malignancies. The SIR was 4.09 for all hematologic malignancies, 4.29 for lymphomas, and 3.16 for leukemias.

Dr McMaster pointed out that several lymphoma subtypes can have lymphoplasmacytic differentiation, the most common being marginal zone lymphoma. And this could potentially result in misclassification.

“So we actually ran the study with and without marginal zone lymphoma and saw no difference in the results,” she said. “So we don’t think misclassification accounts for the majority of what we’re seeing.”

The investigators found that WM/LPL survivors had the highest risk of developing Burkitt lymphoma (SIR=13.45), followed by Hodgkin lymphoma (SIR=9.80), T-cell non-Hodgkin lymphoma (SIR=6.62), mantle cell lymphoma (SIR=5.37), diffuse large B-cell lymphoma (DLBCL, SIR=4.76), multiple myeloma (SIR=4.40), any non-Hodgkin lymphoma (SIR=4.08), and acute myeloid leukemia (AML, SIR=3.27).

“Waldenström’s is known to transform, on occasion, to DLBCL,” Dr McMaster said. “So that may well account for the excess of DLBCL that we see in this population.”

She also noted that, prior to the early 2000s, WM was typically treated with alkylating agents. And alkylating agents have been linked to an increased risk of AML.

In this population, the risk of AML peaked 5 to 10 years after WM/LPL diagnosis and was only present in patients treated prior to 2002. This suggests the AML observed in this study was likely treatment-related.

Dr McMaster and her colleagues also found that WM/LPL survivors did not have a significantly increased risk of developing acute lymphocytic leukemia (SIR=0), hairy cell leukemia (SIR=0), chronic lymphocytic leukemia/small lymphocytic lymphoma (SIR=0.97), or follicular lymphoma (SIR=2.25).

Solid tumors

WM/LPL survivors did have a significantly increased risk of certain solid tumor malignancies. The overall SIR for solid tumors was 1.21.

The risk was significant for non-epithelial skin cancers (SIR=5.15), thyroid cancers (SIR=3.13), melanoma (SIR=1.72), and cancers of the lung and bronchus (SIR=1.44) or respiratory system (SIR=1.42).

“Melanoma has an immunological basis, as does Waldenström’s, so we think there may be some shared etiology there,” Dr McMaster said.

She also noted that a strong risk factor for thyroid cancer, particularly papillary thyroid cancer, is a history of autoimmune thyroid disease.

“Autoimmune disease of any sort is a risk factor for Waldenström’s macroglobulinemia,” she said. “So again, we think there might be a basis for shared susceptibility there.”

Dr McMaster said this research suggests that multiple primary cancers may occur in a single individual because of shared genetic susceptibility, shared environmental exposures, treatment effects, or chance. She believes future research will show that both genetic and environmental factors contribute to WM.

Investigators are currently conducting whole-exome sequencing studies and genome-wide association studies in patients with familial and spontaneous WM, with the hopes of identifying genes that contribute to WM susceptibility.

 

 

AACR Annual Meeting 2015

 

PHILADELPHIA—A retrospective study has revealed factors that appear to influence a person’s susceptibility to Waldenström’s macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) and other malignancies.

Study investigators looked at patients diagnosed with WM or LPL over a 20-year period and found about a 50% excess of second primary cancers in this population.

The patients had a significantly increased risk of multiple hematologic and solid tumor malignancies, and a few of these malignancies had shared susceptibility factors with WM/LPL.

The investigators believe that identifying these factors may prove useful for determining genetic susceptibility to WM/LPL.

Mary L. McMaster, MD, of the National Cancer Institute in Bethesda, Maryland, and her colleagues presented these findings at the AACR Annual Meeting 2015 (abstract 3709).

The team used data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SSER) database to evaluate the risk of subsequent primary cancer in 3825 patients diagnosed with WM (n=2163) or LPL (n=1662) from 1992 to 2011. The patients’ median age was 70, most of them were male (n=2221), and most were white (n=3153).

Dr McMaster said she and her colleagues looked at both WM and LPL in this study because SEER does not include information about immunoglobulin subtype, which makes it difficult to identify all WM cases with absolute certainty.

“[D]epending on what information a pathologist has when they review a bone marrow biopsy, for example, they may or may not know whether there’s IgM present,” Dr McMaster said. “So you may have a diagnosis of LPL and not have the information required to make the diagnosis of WM. For that reason, we combined both entities for this study.”

Dr McMaster and her colleagues calculated the observed-to-expected standardized incidence ratios (SIRs) for invasive cancers. After adjusting for multiple comparisons, the team found that survivors of WM/LPL had a significantly increased risk of developing a second primary malignancy (SIR=1.49).

This increased risk was seen for males and females and persisted throughout follow-up. The risk was higher for patients younger than 65 years of age (SIR=1.95).

Hematologic malignancies

WM/LPL survivors had a significantly increased risk of several hematologic malignancies. The SIR was 4.09 for all hematologic malignancies, 4.29 for lymphomas, and 3.16 for leukemias.

Dr McMaster pointed out that several lymphoma subtypes can have lymphoplasmacytic differentiation, the most common being marginal zone lymphoma. And this could potentially result in misclassification.

“So we actually ran the study with and without marginal zone lymphoma and saw no difference in the results,” she said. “So we don’t think misclassification accounts for the majority of what we’re seeing.”

The investigators found that WM/LPL survivors had the highest risk of developing Burkitt lymphoma (SIR=13.45), followed by Hodgkin lymphoma (SIR=9.80), T-cell non-Hodgkin lymphoma (SIR=6.62), mantle cell lymphoma (SIR=5.37), diffuse large B-cell lymphoma (DLBCL, SIR=4.76), multiple myeloma (SIR=4.40), any non-Hodgkin lymphoma (SIR=4.08), and acute myeloid leukemia (AML, SIR=3.27).

“Waldenström’s is known to transform, on occasion, to DLBCL,” Dr McMaster said. “So that may well account for the excess of DLBCL that we see in this population.”

She also noted that, prior to the early 2000s, WM was typically treated with alkylating agents. And alkylating agents have been linked to an increased risk of AML.

In this population, the risk of AML peaked 5 to 10 years after WM/LPL diagnosis and was only present in patients treated prior to 2002. This suggests the AML observed in this study was likely treatment-related.

Dr McMaster and her colleagues also found that WM/LPL survivors did not have a significantly increased risk of developing acute lymphocytic leukemia (SIR=0), hairy cell leukemia (SIR=0), chronic lymphocytic leukemia/small lymphocytic lymphoma (SIR=0.97), or follicular lymphoma (SIR=2.25).

Solid tumors

WM/LPL survivors did have a significantly increased risk of certain solid tumor malignancies. The overall SIR for solid tumors was 1.21.

The risk was significant for non-epithelial skin cancers (SIR=5.15), thyroid cancers (SIR=3.13), melanoma (SIR=1.72), and cancers of the lung and bronchus (SIR=1.44) or respiratory system (SIR=1.42).

“Melanoma has an immunological basis, as does Waldenström’s, so we think there may be some shared etiology there,” Dr McMaster said.

She also noted that a strong risk factor for thyroid cancer, particularly papillary thyroid cancer, is a history of autoimmune thyroid disease.

“Autoimmune disease of any sort is a risk factor for Waldenström’s macroglobulinemia,” she said. “So again, we think there might be a basis for shared susceptibility there.”

Dr McMaster said this research suggests that multiple primary cancers may occur in a single individual because of shared genetic susceptibility, shared environmental exposures, treatment effects, or chance. She believes future research will show that both genetic and environmental factors contribute to WM.

Investigators are currently conducting whole-exome sequencing studies and genome-wide association studies in patients with familial and spontaneous WM, with the hopes of identifying genes that contribute to WM susceptibility.