ACS Surgery News

There is no advantage to weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for elderly patients with advanced non–small cell lung cancer, according to phase III study results published online Jan. 12 in the Journal of Clinical Oncology.

For the study, 276 chemotherapy-naive patients aged 70 years or older with stage III, stage IV, or recurrent non–small cell lung cancer (NSCLC) who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel 60 mg/m² on day 1, every 3 weeks, or docetaxel 20 mg/m² plus cisplatin 25 mg/m² on days 1, 8, and 15 every 4 weeks.

At the interim analysis, overall survival was inferior among patients who received docetaxel plus cisplatin, compared with those who received docetaxel only (hazard ratio, 1.56; 95% confidence interval, 0.98 to 2.49), Dr. Tetsuya Abe of Niigata (Japan) Cancer Center Hospital and his associates reported (J. Clin. Onc. 2015 Jan. 12. [doi:10.1200/JCO.2014.55.8627]).

©Sergey Nivens/thinkstockphotos.com

The investigators terminated the study early after finding the predictive probability that the treatment arm would be statistically superior to the monotherapy arm on final analysis was less than 1%. The median survival time as 14.8 months for the monotherapy arm and 13.3 months for the docetaxel plus cisplatin arm (HR, 1.18; 95% CI, 0.83 to 1.69).

Toxicity varied between arms. The rates of neutropenia were higher with docetaxel alone, while rates of grade 3 or greater anemia, anorexia, and hyponatremia were higher in the combination arm, they said.

Docetaxel every 3 weeks remains the standard treatment for elderly patients with advanced NSCLC, Dr. Abe and associates concluded.

Dr. Abe reported having no financial disclosures. Other authors reported honoraria from sanofi-aventis and Bristol-Myers Squibb.

[email protected]

On Twitter @nikolaideslaura

There is no advantage to weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for elderly patients with advanced non–small cell lung cancer, according to phase III study results published online Jan. 12 in the Journal of Clinical Oncology.

For the study, 276 chemotherapy-naive patients aged 70 years or older with stage III, stage IV, or recurrent non–small cell lung cancer (NSCLC) who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel 60 mg/m² on day 1, every 3 weeks, or docetaxel 20 mg/m² plus cisplatin 25 mg/m² on days 1, 8, and 15 every 4 weeks.

At the interim analysis, overall survival was inferior among patients who received docetaxel plus cisplatin, compared with those who received docetaxel only (hazard ratio, 1.56; 95% confidence interval, 0.98 to 2.49), Dr. Tetsuya Abe of Niigata (Japan) Cancer Center Hospital and his associates reported (J. Clin. Onc. 2015 Jan. 12. [doi:10.1200/JCO.2014.55.8627]).

©Sergey Nivens/thinkstockphotos.com

The investigators terminated the study early after finding the predictive probability that the treatment arm would be statistically superior to the monotherapy arm on final analysis was less than 1%. The median survival time as 14.8 months for the monotherapy arm and 13.3 months for the docetaxel plus cisplatin arm (HR, 1.18; 95% CI, 0.83 to 1.69).

Toxicity varied between arms. The rates of neutropenia were higher with docetaxel alone, while rates of grade 3 or greater anemia, anorexia, and hyponatremia were higher in the combination arm, they said.

Docetaxel every 3 weeks remains the standard treatment for elderly patients with advanced NSCLC, Dr. Abe and associates concluded.

Dr. Abe reported having no financial disclosures. Other authors reported honoraria from sanofi-aventis and Bristol-Myers Squibb.

[email protected]

On Twitter @nikolaideslaura

There is no advantage to weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for elderly patients with advanced non–small cell lung cancer, according to phase III study results published online Jan. 12 in the Journal of Clinical Oncology.

For the study, 276 chemotherapy-naive patients aged 70 years or older with stage III, stage IV, or recurrent non–small cell lung cancer (NSCLC) who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel 60 mg/m² on day 1, every 3 weeks, or docetaxel 20 mg/m² plus cisplatin 25 mg/m² on days 1, 8, and 15 every 4 weeks.

At the interim analysis, overall survival was inferior among patients who received docetaxel plus cisplatin, compared with those who received docetaxel only (hazard ratio, 1.56; 95% confidence interval, 0.98 to 2.49), Dr. Tetsuya Abe of Niigata (Japan) Cancer Center Hospital and his associates reported (J. Clin. Onc. 2015 Jan. 12. [doi:10.1200/JCO.2014.55.8627]).

©Sergey Nivens/thinkstockphotos.com

The investigators terminated the study early after finding the predictive probability that the treatment arm would be statistically superior to the monotherapy arm on final analysis was less than 1%. The median survival time as 14.8 months for the monotherapy arm and 13.3 months for the docetaxel plus cisplatin arm (HR, 1.18; 95% CI, 0.83 to 1.69).

Toxicity varied between arms. The rates of neutropenia were higher with docetaxel alone, while rates of grade 3 or greater anemia, anorexia, and hyponatremia were higher in the combination arm, they said.

Docetaxel every 3 weeks remains the standard treatment for elderly patients with advanced NSCLC, Dr. Abe and associates concluded.

Dr. Abe reported having no financial disclosures. Other authors reported honoraria from sanofi-aventis and Bristol-Myers Squibb.

[email protected]

On Twitter @nikolaideslaura

Almost one in five hysterectomies for benign indications were unnecessary, based on 2013 data from 52 Michigan hospitals.

Uterine pathology reports did not match or support the indication for surgery in 18% of the 3,397 hysterectomies reviewed from the Michigan Surgical Quality Collaborative, a state-wide program to improve surgical care. In women under 40 years old, pathology did not support surgery in 38% of hysterectomies for benign indications.

Endometriosis and chronic pain were the most common reasons for unnecessary uterus removal; pathology was unsupportive of surgery in about 40% of those cases. Pathology also was unsupportive in about 14% of women with fibroid or acute uterine bleeding (AUB) and in about 20% of the remaining cases, which were mostly indicated for a blend of bleeding, pain, and other problems (Am. J. Obstet. Gynecol. 2014 Dec 23 [doi:http://dx.doi.org/10.1016/j.ajog.2014.11.031]).

Almost half of the women had no documentation in their charts that alternatives to hysterectomy were tried or even considered. Hormonal management, operative hysteroscopy, endometrial ablation, levonorgestrel intrauterine devices (IUDs), and other approaches were documented in 68% of women under 40 years old, but documentation was less likely in women over 40 years old. Alternatives approaches were more likely in women with larger uteri and in women with endometriosis, but were, overall, “underutilized,” Dr. Daniel Morgan, an associate professor of obstetrics and gynecology at the University of Michigan in Ann Arbor, and his fellow researchers concluded.

Parity, body mass index, insurance, and common medical comorbidities did not seem to influence the use of alternatives in the study.

The researchers noted that checklists for preoperative appropriateness have been shown in previous studies to reduce the rate of benign hysterectomies, and increase the likelihood that pathology will support the reason for the operation.

The checklist approach “could help standardize treatment and ensure appropriate uterine-sparing management has been offered. The use of electronic medical records systems could potentially facilitate this type of standardization with relative ease,” the researchers wrote.

Also, the levonorgestrel IUD, “a highly effective, cost-saving intervention for women with acute uterine bleeding and pelvic pain, was considered [in] only 12%” of the Michigan cases. Increasing its use is another “important area for quality improvement and cost savings,” they added.

“We are now in the process of developing institution-specific reports ... on use of alternatives prior to hysterectomy and rates of negative pathology. It is our goal that each institution in the Collaborative will see their data and act on it accordingly. We hope that it will lead to more use (or at least consideration) of alternatives to hysterectomy and lower rates of negative pathology.”

The Michigan Surgical Quality Collaborative is funded by Blue Cross and Blue Shield of Michigan/Blue Care Network. Dr. Morgan reported no conflicts of interest.

[email protected]

Almost one in five hysterectomies for benign indications were unnecessary, based on 2013 data from 52 Michigan hospitals.

Uterine pathology reports did not match or support the indication for surgery in 18% of the 3,397 hysterectomies reviewed from the Michigan Surgical Quality Collaborative, a state-wide program to improve surgical care. In women under 40 years old, pathology did not support surgery in 38% of hysterectomies for benign indications.

Endometriosis and chronic pain were the most common reasons for unnecessary uterus removal; pathology was unsupportive of surgery in about 40% of those cases. Pathology also was unsupportive in about 14% of women with fibroid or acute uterine bleeding (AUB) and in about 20% of the remaining cases, which were mostly indicated for a blend of bleeding, pain, and other problems (Am. J. Obstet. Gynecol. 2014 Dec 23 [doi:http://dx.doi.org/10.1016/j.ajog.2014.11.031]).

Almost half of the women had no documentation in their charts that alternatives to hysterectomy were tried or even considered. Hormonal management, operative hysteroscopy, endometrial ablation, levonorgestrel intrauterine devices (IUDs), and other approaches were documented in 68% of women under 40 years old, but documentation was less likely in women over 40 years old. Alternatives approaches were more likely in women with larger uteri and in women with endometriosis, but were, overall, “underutilized,” Dr. Daniel Morgan, an associate professor of obstetrics and gynecology at the University of Michigan in Ann Arbor, and his fellow researchers concluded.

Parity, body mass index, insurance, and common medical comorbidities did not seem to influence the use of alternatives in the study.

The researchers noted that checklists for preoperative appropriateness have been shown in previous studies to reduce the rate of benign hysterectomies, and increase the likelihood that pathology will support the reason for the operation.

The checklist approach “could help standardize treatment and ensure appropriate uterine-sparing management has been offered. The use of electronic medical records systems could potentially facilitate this type of standardization with relative ease,” the researchers wrote.

Also, the levonorgestrel IUD, “a highly effective, cost-saving intervention for women with acute uterine bleeding and pelvic pain, was considered [in] only 12%” of the Michigan cases. Increasing its use is another “important area for quality improvement and cost savings,” they added.

“We are now in the process of developing institution-specific reports ... on use of alternatives prior to hysterectomy and rates of negative pathology. It is our goal that each institution in the Collaborative will see their data and act on it accordingly. We hope that it will lead to more use (or at least consideration) of alternatives to hysterectomy and lower rates of negative pathology.”

The Michigan Surgical Quality Collaborative is funded by Blue Cross and Blue Shield of Michigan/Blue Care Network. Dr. Morgan reported no conflicts of interest.

[email protected]

Almost one in five hysterectomies for benign indications were unnecessary, based on 2013 data from 52 Michigan hospitals.

Uterine pathology reports did not match or support the indication for surgery in 18% of the 3,397 hysterectomies reviewed from the Michigan Surgical Quality Collaborative, a state-wide program to improve surgical care. In women under 40 years old, pathology did not support surgery in 38% of hysterectomies for benign indications.

Endometriosis and chronic pain were the most common reasons for unnecessary uterus removal; pathology was unsupportive of surgery in about 40% of those cases. Pathology also was unsupportive in about 14% of women with fibroid or acute uterine bleeding (AUB) and in about 20% of the remaining cases, which were mostly indicated for a blend of bleeding, pain, and other problems (Am. J. Obstet. Gynecol. 2014 Dec 23 [doi:http://dx.doi.org/10.1016/j.ajog.2014.11.031]).

Almost half of the women had no documentation in their charts that alternatives to hysterectomy were tried or even considered. Hormonal management, operative hysteroscopy, endometrial ablation, levonorgestrel intrauterine devices (IUDs), and other approaches were documented in 68% of women under 40 years old, but documentation was less likely in women over 40 years old. Alternatives approaches were more likely in women with larger uteri and in women with endometriosis, but were, overall, “underutilized,” Dr. Daniel Morgan, an associate professor of obstetrics and gynecology at the University of Michigan in Ann Arbor, and his fellow researchers concluded.

Parity, body mass index, insurance, and common medical comorbidities did not seem to influence the use of alternatives in the study.

The researchers noted that checklists for preoperative appropriateness have been shown in previous studies to reduce the rate of benign hysterectomies, and increase the likelihood that pathology will support the reason for the operation.

The checklist approach “could help standardize treatment and ensure appropriate uterine-sparing management has been offered. The use of electronic medical records systems could potentially facilitate this type of standardization with relative ease,” the researchers wrote.

Also, the levonorgestrel IUD, “a highly effective, cost-saving intervention for women with acute uterine bleeding and pelvic pain, was considered [in] only 12%” of the Michigan cases. Increasing its use is another “important area for quality improvement and cost savings,” they added.

“We are now in the process of developing institution-specific reports ... on use of alternatives prior to hysterectomy and rates of negative pathology. It is our goal that each institution in the Collaborative will see their data and act on it accordingly. We hope that it will lead to more use (or at least consideration) of alternatives to hysterectomy and lower rates of negative pathology.”

The Michigan Surgical Quality Collaborative is funded by Blue Cross and Blue Shield of Michigan/Blue Care Network. Dr. Morgan reported no conflicts of interest.

[email protected]

VANCOUVER, B.C. – Trendelenburg position does not materially increase ventilator pressures during laparoscopic gynecologic surgery, according to investigators from McMaster University in Hamilton, Ont.

The use of the Trendelenburg position can sometimes cause tension in the operating room. Surgeons need to roll the small bowel out of the pelvis to get access to their gynecologic targets, but anesthesiologists worry that they’ll have to turn up ventilator pressures – and risk barotrauma – if women are placed in a head-down position. It’s unclear from previous studies if pressures really need to be increased when using a moderate Trendelenburg position, Dr. Stephen Bates, a professor of obstetrics and gynecology at McMaster University, said at a meeting sponsored by the AAGL.

To find out, Dr. Bates and his colleagues monitored peak inspiratory pressures (PIP), pneumoperitoneum pressures, degrees of Trendelenburg, and other factors as 100 women underwent laparoscopic hysterectomies performed by a total of seven surgeons. The women were aged 46 years, on average, and had a mean body mass index of 29 kg/m².

The surgeons opted for an average of 10 degrees Trendelenburg, which resulted in a 1.9 cm H₂0 (7%) increase in PIP from horizontal positioning, up from a mean of 26.7 to 28.6 cm H₂0.

“By all anesthesia standards, this is a trivial change and clinically insignificant,” Dr. Bates said in an interview. “The traditional dogma is that if you put patients in Trendelenburg, you’ll increase the difficulty of ventilating them. That was not the case.”

But body mass index, and to a greater degree pneumoperitoneum pressures, did predict increased ventilator pressures among the women.

“The higher pneumoperitoneum pressures are, the harder it is to ventilate,” Dr. Bates said. “There’s [almost] a linear relationship between PnP [pneumoperitoneum pressures] and ventilator pressures.”

When pneumoperitoneum pressures were reduced from 15 to 10 mm Hg, PIP fell by approximately 10%, but the surgeons – all blinded to the reduction in PnP – did not notice any deterioration in their surgical views, he said.

Taken together, the findings suggest a new way to negotiate Trendelenburg positioning in the operating room. “Anesthesiologists and gynecologic surgeons should consider minimizing the pneumoperitoneum pressure rather than reducing the degree of Trendelenburg,” Dr. Bates said.

The researchers also tested an inflatable pillow that lifted women’s buttocks a few inches above the table. The hope was that it would reduce the degree of Trendelenburg needed for their operations, and subsequently reduce PIP. Surgeons were able to decrease Trendelenburg by about 4 degrees with the pillow, but consistent with the study’s overall findings, it made no real difference in PIP. There was a clinically insignificant drop of 0.3 cm H₂0, from a mean of 28.6 to 28.3 cm H₂0, Dr. Bates said.

Dr. Bates reported having no financial disclosures.

[email protected]

VANCOUVER, B.C. – Trendelenburg position does not materially increase ventilator pressures during laparoscopic gynecologic surgery, according to investigators from McMaster University in Hamilton, Ont.

The use of the Trendelenburg position can sometimes cause tension in the operating room. Surgeons need to roll the small bowel out of the pelvis to get access to their gynecologic targets, but anesthesiologists worry that they’ll have to turn up ventilator pressures – and risk barotrauma – if women are placed in a head-down position. It’s unclear from previous studies if pressures really need to be increased when using a moderate Trendelenburg position, Dr. Stephen Bates, a professor of obstetrics and gynecology at McMaster University, said at a meeting sponsored by the AAGL.

To find out, Dr. Bates and his colleagues monitored peak inspiratory pressures (PIP), pneumoperitoneum pressures, degrees of Trendelenburg, and other factors as 100 women underwent laparoscopic hysterectomies performed by a total of seven surgeons. The women were aged 46 years, on average, and had a mean body mass index of 29 kg/m².

The surgeons opted for an average of 10 degrees Trendelenburg, which resulted in a 1.9 cm H₂0 (7%) increase in PIP from horizontal positioning, up from a mean of 26.7 to 28.6 cm H₂0.

“By all anesthesia standards, this is a trivial change and clinically insignificant,” Dr. Bates said in an interview. “The traditional dogma is that if you put patients in Trendelenburg, you’ll increase the difficulty of ventilating them. That was not the case.”

But body mass index, and to a greater degree pneumoperitoneum pressures, did predict increased ventilator pressures among the women.

“The higher pneumoperitoneum pressures are, the harder it is to ventilate,” Dr. Bates said. “There’s [almost] a linear relationship between PnP [pneumoperitoneum pressures] and ventilator pressures.”

When pneumoperitoneum pressures were reduced from 15 to 10 mm Hg, PIP fell by approximately 10%, but the surgeons – all blinded to the reduction in PnP – did not notice any deterioration in their surgical views, he said.

Taken together, the findings suggest a new way to negotiate Trendelenburg positioning in the operating room. “Anesthesiologists and gynecologic surgeons should consider minimizing the pneumoperitoneum pressure rather than reducing the degree of Trendelenburg,” Dr. Bates said.

The researchers also tested an inflatable pillow that lifted women’s buttocks a few inches above the table. The hope was that it would reduce the degree of Trendelenburg needed for their operations, and subsequently reduce PIP. Surgeons were able to decrease Trendelenburg by about 4 degrees with the pillow, but consistent with the study’s overall findings, it made no real difference in PIP. There was a clinically insignificant drop of 0.3 cm H₂0, from a mean of 28.6 to 28.3 cm H₂0, Dr. Bates said.

Dr. Bates reported having no financial disclosures.

[email protected]

VANCOUVER, B.C. – Trendelenburg position does not materially increase ventilator pressures during laparoscopic gynecologic surgery, according to investigators from McMaster University in Hamilton, Ont.

The use of the Trendelenburg position can sometimes cause tension in the operating room. Surgeons need to roll the small bowel out of the pelvis to get access to their gynecologic targets, but anesthesiologists worry that they’ll have to turn up ventilator pressures – and risk barotrauma – if women are placed in a head-down position. It’s unclear from previous studies if pressures really need to be increased when using a moderate Trendelenburg position, Dr. Stephen Bates, a professor of obstetrics and gynecology at McMaster University, said at a meeting sponsored by the AAGL.

To find out, Dr. Bates and his colleagues monitored peak inspiratory pressures (PIP), pneumoperitoneum pressures, degrees of Trendelenburg, and other factors as 100 women underwent laparoscopic hysterectomies performed by a total of seven surgeons. The women were aged 46 years, on average, and had a mean body mass index of 29 kg/m².

The surgeons opted for an average of 10 degrees Trendelenburg, which resulted in a 1.9 cm H₂0 (7%) increase in PIP from horizontal positioning, up from a mean of 26.7 to 28.6 cm H₂0.

“By all anesthesia standards, this is a trivial change and clinically insignificant,” Dr. Bates said in an interview. “The traditional dogma is that if you put patients in Trendelenburg, you’ll increase the difficulty of ventilating them. That was not the case.”

But body mass index, and to a greater degree pneumoperitoneum pressures, did predict increased ventilator pressures among the women.

“The higher pneumoperitoneum pressures are, the harder it is to ventilate,” Dr. Bates said. “There’s [almost] a linear relationship between PnP [pneumoperitoneum pressures] and ventilator pressures.”

When pneumoperitoneum pressures were reduced from 15 to 10 mm Hg, PIP fell by approximately 10%, but the surgeons – all blinded to the reduction in PnP – did not notice any deterioration in their surgical views, he said.

Taken together, the findings suggest a new way to negotiate Trendelenburg positioning in the operating room. “Anesthesiologists and gynecologic surgeons should consider minimizing the pneumoperitoneum pressure rather than reducing the degree of Trendelenburg,” Dr. Bates said.

The researchers also tested an inflatable pillow that lifted women’s buttocks a few inches above the table. The hope was that it would reduce the degree of Trendelenburg needed for their operations, and subsequently reduce PIP. Surgeons were able to decrease Trendelenburg by about 4 degrees with the pillow, but consistent with the study’s overall findings, it made no real difference in PIP. There was a clinically insignificant drop of 0.3 cm H₂0, from a mean of 28.6 to 28.3 cm H₂0, Dr. Bates said.

Dr. Bates reported having no financial disclosures.

[email protected]

CORONADO, CALIF. – Skin injury following fenestrated endovascular aortic stent grafting is less prevalent than expected, results from a single-center retrospective study showed.

“Radiation-induced skin injury is a serious potential complication of fluoroscopically guided interventions,” Dr. Melissa L. Kirkwood said at the annual meeting of the Western Vascular Society. “These injuries are associated with a threshold radiation dose, above which the severity of injury increases with increasing dose. Instances of these injuries are mostly limited to case reports of coronary interventions, TIPS procedures, and neuroembolizations.”

These radiation-induced skin lesions can be classified as prompt, early, mid-term, or late depending on when they present following the fluoroscopically guided intervention. “The National Cancer Institute has defined four grades of skin injury, with the most frequent being transient erythema, a prompt reaction within the first 24 hours occurring at skin doses as low as 2 Gy,” said Dr. Kirkwood of the division of vascular and endovascular surgery at the University of Texas Southwestern Medical Center, Dallas. “With increasing skin doses, more severe effects present themselves. Atrophy, ulceration, and necrosis are possibilities.”

She went on to note that fenestrated endovascular aneurysm repairs often require high doses of radiation, yet the prevalence of deterministic skin injury following these cases is unknown. In a recent study, Dr. Kirkwood and her associates retrospectively reviewed 61 complex fluoroscopically guided interventions that met substantial radiation dose level criteria (SRDL), which is defined by the National Council on Radiation and Protection Measurements as a reference air kerma (RAK) greater than or equal to 5 Gy (J. Vasc. Surg. 2014; 60[3]:742-8). “Despite mean peak skin doses as high as 6.5 Gy, ranging up to 18.5 Gy, we did not detect any skin injuries in this cohort,” Dr. Kirkwood said. “That study, however, was limited by its retrospective design. There was no postoperative protocol in place to ensure that a thorough skin exam was performed on each patient at every follow-up visit. Therefore, we hypothesized that a more thorough postoperative follow-up of patients would detect some skin injury following these cases.”

For the current study, she and her associates sought to examine the prevalence of deterministic effects after FEVAR as well as well as any patient characteristics that may predispose patients to skin injury.

In June 2013, the researchers implemented a new policy regarding the follow-up of FEVAR patients, which involved a full skin exam at postoperative week 2 and 4, and at 3 and 6 months, as well as questioning patients about any skin-related complaints. For the current study, they retrospectively reviewed all FEVARs over a 7-month period after the change in policy and highlighted all the cases that reached a RAK of 5 Gy or greater. The RAK was the dose metric used in this study. It is a measure of the radiation dose to air at the interventional reference point, which, on standard fluoroscopes, is 15 cm along the beam axis toward the focal spot from isocenter. Dr. Kirkwood characterized RAK as “the best real-time indicator of patient dose, because it roughly estimates the dose at the entry point on the patient’s skin.” Peak skin dose, a dose index, and simulated skin dose maps were calculated using customized software employing input data from fluoroscopic machine logs.

Of 317 cases performed, 22 met or exceeded a RAK of 5 Gy. Of these, 21 were FEVARs and one was an embolization. Most patients (91%) were male and their mean body mass index was 30 kg/m². Comorbidities and risk factors for skin injury included smoking, diabetes, and the concomitant applications of chemotherapeutic agents.

Dr. Kirkwood reported that the average RAK for all FEVARs was 8 Gy, with a range of 5-11 Gy. Slightly more than half of patients (52%) had multiple fluoroscopically guided interventions within 6 months of their SRDL event. The average RAK for this subset of patients was 10 Gy (range of 5 to 15).

The mean peak skin dose for all FEVARs was 5 Gy (a range of 2 to 10 Gy), and the dose index was 0.69. The average peak skin dose for the subset of patients with multiple procedures was 7 Gy (a range of 3 to 9 Gy).

In terms of the follow-up, all 21 FEVAR patients were examined at the 1- or 2-week mark, 81% were examined at 1 month, 52% were examined at 3 months, and 62% were examined at 6 months. No radiation skin injuries were reported. “Based on the published data, we would expect to see all grades of skin injury, especially in the cohort of the 5-10 Gy,” Dr. Kirkwood said.

In the previous study, conducted prior to the new follow-up policy, the dose index for FEVARs was 0.78, “meaning that the peak skin dose that the patient received could be roughly estimated as 78% of the RAK dose displayed on the monitor,” Dr. Kirkwood explained. “In the current work, the dose index decreased to 60%. This suggests that surgeons in our group have now more appropriately and effectively employed strategies to decrease radiation dose to the patient. However, even when the best operating practice is employed, FEVARs still continue to require high radiation doses in order to complete. “

The present study demonstrated that deterministic skin injuries “are uncommon after FEVAR, even at high RAK levels and regardless of cumulative dose,” she concluded. “Even with more comprehensive patient follow-up, the fact that no skin injuries were reported suggests that skin injuries in this patient cohort are less prevalent than the published guidelines would predict.”

Dr. Kirkwood reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – Skin injury following fenestrated endovascular aortic stent grafting is less prevalent than expected, results from a single-center retrospective study showed.

“Radiation-induced skin injury is a serious potential complication of fluoroscopically guided interventions,” Dr. Melissa L. Kirkwood said at the annual meeting of the Western Vascular Society. “These injuries are associated with a threshold radiation dose, above which the severity of injury increases with increasing dose. Instances of these injuries are mostly limited to case reports of coronary interventions, TIPS procedures, and neuroembolizations.”

These radiation-induced skin lesions can be classified as prompt, early, mid-term, or late depending on when they present following the fluoroscopically guided intervention. “The National Cancer Institute has defined four grades of skin injury, with the most frequent being transient erythema, a prompt reaction within the first 24 hours occurring at skin doses as low as 2 Gy,” said Dr. Kirkwood of the division of vascular and endovascular surgery at the University of Texas Southwestern Medical Center, Dallas. “With increasing skin doses, more severe effects present themselves. Atrophy, ulceration, and necrosis are possibilities.”

She went on to note that fenestrated endovascular aneurysm repairs often require high doses of radiation, yet the prevalence of deterministic skin injury following these cases is unknown. In a recent study, Dr. Kirkwood and her associates retrospectively reviewed 61 complex fluoroscopically guided interventions that met substantial radiation dose level criteria (SRDL), which is defined by the National Council on Radiation and Protection Measurements as a reference air kerma (RAK) greater than or equal to 5 Gy (J. Vasc. Surg. 2014; 60[3]:742-8). “Despite mean peak skin doses as high as 6.5 Gy, ranging up to 18.5 Gy, we did not detect any skin injuries in this cohort,” Dr. Kirkwood said. “That study, however, was limited by its retrospective design. There was no postoperative protocol in place to ensure that a thorough skin exam was performed on each patient at every follow-up visit. Therefore, we hypothesized that a more thorough postoperative follow-up of patients would detect some skin injury following these cases.”

For the current study, she and her associates sought to examine the prevalence of deterministic effects after FEVAR as well as well as any patient characteristics that may predispose patients to skin injury.

In June 2013, the researchers implemented a new policy regarding the follow-up of FEVAR patients, which involved a full skin exam at postoperative week 2 and 4, and at 3 and 6 months, as well as questioning patients about any skin-related complaints. For the current study, they retrospectively reviewed all FEVARs over a 7-month period after the change in policy and highlighted all the cases that reached a RAK of 5 Gy or greater. The RAK was the dose metric used in this study. It is a measure of the radiation dose to air at the interventional reference point, which, on standard fluoroscopes, is 15 cm along the beam axis toward the focal spot from isocenter. Dr. Kirkwood characterized RAK as “the best real-time indicator of patient dose, because it roughly estimates the dose at the entry point on the patient’s skin.” Peak skin dose, a dose index, and simulated skin dose maps were calculated using customized software employing input data from fluoroscopic machine logs.

Of 317 cases performed, 22 met or exceeded a RAK of 5 Gy. Of these, 21 were FEVARs and one was an embolization. Most patients (91%) were male and their mean body mass index was 30 kg/m². Comorbidities and risk factors for skin injury included smoking, diabetes, and the concomitant applications of chemotherapeutic agents.

Dr. Kirkwood reported that the average RAK for all FEVARs was 8 Gy, with a range of 5-11 Gy. Slightly more than half of patients (52%) had multiple fluoroscopically guided interventions within 6 months of their SRDL event. The average RAK for this subset of patients was 10 Gy (range of 5 to 15).

The mean peak skin dose for all FEVARs was 5 Gy (a range of 2 to 10 Gy), and the dose index was 0.69. The average peak skin dose for the subset of patients with multiple procedures was 7 Gy (a range of 3 to 9 Gy).

In terms of the follow-up, all 21 FEVAR patients were examined at the 1- or 2-week mark, 81% were examined at 1 month, 52% were examined at 3 months, and 62% were examined at 6 months. No radiation skin injuries were reported. “Based on the published data, we would expect to see all grades of skin injury, especially in the cohort of the 5-10 Gy,” Dr. Kirkwood said.

In the previous study, conducted prior to the new follow-up policy, the dose index for FEVARs was 0.78, “meaning that the peak skin dose that the patient received could be roughly estimated as 78% of the RAK dose displayed on the monitor,” Dr. Kirkwood explained. “In the current work, the dose index decreased to 60%. This suggests that surgeons in our group have now more appropriately and effectively employed strategies to decrease radiation dose to the patient. However, even when the best operating practice is employed, FEVARs still continue to require high radiation doses in order to complete. “

The present study demonstrated that deterministic skin injuries “are uncommon after FEVAR, even at high RAK levels and regardless of cumulative dose,” she concluded. “Even with more comprehensive patient follow-up, the fact that no skin injuries were reported suggests that skin injuries in this patient cohort are less prevalent than the published guidelines would predict.”

Dr. Kirkwood reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – Skin injury following fenestrated endovascular aortic stent grafting is less prevalent than expected, results from a single-center retrospective study showed.

“Radiation-induced skin injury is a serious potential complication of fluoroscopically guided interventions,” Dr. Melissa L. Kirkwood said at the annual meeting of the Western Vascular Society. “These injuries are associated with a threshold radiation dose, above which the severity of injury increases with increasing dose. Instances of these injuries are mostly limited to case reports of coronary interventions, TIPS procedures, and neuroembolizations.”

These radiation-induced skin lesions can be classified as prompt, early, mid-term, or late depending on when they present following the fluoroscopically guided intervention. “The National Cancer Institute has defined four grades of skin injury, with the most frequent being transient erythema, a prompt reaction within the first 24 hours occurring at skin doses as low as 2 Gy,” said Dr. Kirkwood of the division of vascular and endovascular surgery at the University of Texas Southwestern Medical Center, Dallas. “With increasing skin doses, more severe effects present themselves. Atrophy, ulceration, and necrosis are possibilities.”

She went on to note that fenestrated endovascular aneurysm repairs often require high doses of radiation, yet the prevalence of deterministic skin injury following these cases is unknown. In a recent study, Dr. Kirkwood and her associates retrospectively reviewed 61 complex fluoroscopically guided interventions that met substantial radiation dose level criteria (SRDL), which is defined by the National Council on Radiation and Protection Measurements as a reference air kerma (RAK) greater than or equal to 5 Gy (J. Vasc. Surg. 2014; 60[3]:742-8). “Despite mean peak skin doses as high as 6.5 Gy, ranging up to 18.5 Gy, we did not detect any skin injuries in this cohort,” Dr. Kirkwood said. “That study, however, was limited by its retrospective design. There was no postoperative protocol in place to ensure that a thorough skin exam was performed on each patient at every follow-up visit. Therefore, we hypothesized that a more thorough postoperative follow-up of patients would detect some skin injury following these cases.”

For the current study, she and her associates sought to examine the prevalence of deterministic effects after FEVAR as well as well as any patient characteristics that may predispose patients to skin injury.

In June 2013, the researchers implemented a new policy regarding the follow-up of FEVAR patients, which involved a full skin exam at postoperative week 2 and 4, and at 3 and 6 months, as well as questioning patients about any skin-related complaints. For the current study, they retrospectively reviewed all FEVARs over a 7-month period after the change in policy and highlighted all the cases that reached a RAK of 5 Gy or greater. The RAK was the dose metric used in this study. It is a measure of the radiation dose to air at the interventional reference point, which, on standard fluoroscopes, is 15 cm along the beam axis toward the focal spot from isocenter. Dr. Kirkwood characterized RAK as “the best real-time indicator of patient dose, because it roughly estimates the dose at the entry point on the patient’s skin.” Peak skin dose, a dose index, and simulated skin dose maps were calculated using customized software employing input data from fluoroscopic machine logs.

Of 317 cases performed, 22 met or exceeded a RAK of 5 Gy. Of these, 21 were FEVARs and one was an embolization. Most patients (91%) were male and their mean body mass index was 30 kg/m². Comorbidities and risk factors for skin injury included smoking, diabetes, and the concomitant applications of chemotherapeutic agents.

Dr. Kirkwood reported that the average RAK for all FEVARs was 8 Gy, with a range of 5-11 Gy. Slightly more than half of patients (52%) had multiple fluoroscopically guided interventions within 6 months of their SRDL event. The average RAK for this subset of patients was 10 Gy (range of 5 to 15).

The mean peak skin dose for all FEVARs was 5 Gy (a range of 2 to 10 Gy), and the dose index was 0.69. The average peak skin dose for the subset of patients with multiple procedures was 7 Gy (a range of 3 to 9 Gy).

In terms of the follow-up, all 21 FEVAR patients were examined at the 1- or 2-week mark, 81% were examined at 1 month, 52% were examined at 3 months, and 62% were examined at 6 months. No radiation skin injuries were reported. “Based on the published data, we would expect to see all grades of skin injury, especially in the cohort of the 5-10 Gy,” Dr. Kirkwood said.

In the previous study, conducted prior to the new follow-up policy, the dose index for FEVARs was 0.78, “meaning that the peak skin dose that the patient received could be roughly estimated as 78% of the RAK dose displayed on the monitor,” Dr. Kirkwood explained. “In the current work, the dose index decreased to 60%. This suggests that surgeons in our group have now more appropriately and effectively employed strategies to decrease radiation dose to the patient. However, even when the best operating practice is employed, FEVARs still continue to require high radiation doses in order to complete. “

The present study demonstrated that deterministic skin injuries “are uncommon after FEVAR, even at high RAK levels and regardless of cumulative dose,” she concluded. “Even with more comprehensive patient follow-up, the fact that no skin injuries were reported suggests that skin injuries in this patient cohort are less prevalent than the published guidelines would predict.”

Dr. Kirkwood reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

Doctors may have to wait a few extra days to get paid for Medicare services they administer, the Centers for Medicare and Medicaid Services announced.

Claims submitted during the first 14 days of 2015 and dated within that time period will be held to allow for the corrections of errors in the 2015 physician fee schedule. Claims submitted during that time but dated in 2014 will be processed normally. Contractors are expected to process the early 2015 claims beginning Jan. 15.

CMS expects minimal impact to physicians, as it is not required to pay clean electronic claims sooner than 14 days under law.

© crazydiva/Thinkstock

“I think this will have minimum impact,” American Academy of Family Physicians President Robert Wergin said in an interview. “It does affect your cash flow, but it has happened in the past, particularly around the time with SGR patches.”

Medicare tends to be among the faster payers in general, and the 14-day delay should not create any significant hardship as physicians should be prepared for this, Dr. Wergin added.

[email protected]

Doctors may have to wait a few extra days to get paid for Medicare services they administer, the Centers for Medicare and Medicaid Services announced.

Claims submitted during the first 14 days of 2015 and dated within that time period will be held to allow for the corrections of errors in the 2015 physician fee schedule. Claims submitted during that time but dated in 2014 will be processed normally. Contractors are expected to process the early 2015 claims beginning Jan. 15.

CMS expects minimal impact to physicians, as it is not required to pay clean electronic claims sooner than 14 days under law.

© crazydiva/Thinkstock

“I think this will have minimum impact,” American Academy of Family Physicians President Robert Wergin said in an interview. “It does affect your cash flow, but it has happened in the past, particularly around the time with SGR patches.”

Medicare tends to be among the faster payers in general, and the 14-day delay should not create any significant hardship as physicians should be prepared for this, Dr. Wergin added.

[email protected]

Doctors may have to wait a few extra days to get paid for Medicare services they administer, the Centers for Medicare and Medicaid Services announced.

Claims submitted during the first 14 days of 2015 and dated within that time period will be held to allow for the corrections of errors in the 2015 physician fee schedule. Claims submitted during that time but dated in 2014 will be processed normally. Contractors are expected to process the early 2015 claims beginning Jan. 15.

CMS expects minimal impact to physicians, as it is not required to pay clean electronic claims sooner than 14 days under law.

© crazydiva/Thinkstock

“I think this will have minimum impact,” American Academy of Family Physicians President Robert Wergin said in an interview. “It does affect your cash flow, but it has happened in the past, particularly around the time with SGR patches.”

Medicare tends to be among the faster payers in general, and the 14-day delay should not create any significant hardship as physicians should be prepared for this, Dr. Wergin added.

[email protected]

Obese patients in the Veterans Administration health system who underwent bariatric surgery had lower all-cause mortality 5 and 10 years after the procedure than did matched patients who didn’t have bariatric surgery, according to a report published online Jan. 5 in JAMA.

In a retrospective cohort study of severely obese VA patients across the country, 2,500 who underwent bariatric surgery during 2000-2011 were matched for body mass index (BMI), age, sex, diabetes status, race, and area of residence with 7,462 who did not. The mean age of the study participants was 52-53 years, and the mean BMI was 46-47, said Dr. David E. Arterburn of the Group Health Research Institute and the University of Washington, both in Seattle, and his associates.

During a mean follow-up of approximately 7 years, there were 263 deaths in the surgical group and 1,277 in the control group. Estimated all-cause mortality was 6.4% at 5 years and 13.8% at 10 years for surgical patients, compared with 10.4% and 23.9%, respectively, for control subjects. Bariatric surgery was not associated with any difference in mortality for the first year of follow-up but was associated with lower mortality at 1-5 years (hazard ratio, 0.45) and at 5 or more years (HR, 0.47) of follow-up, the investigators said (JAMA 2015 January 5 [doi:10.1001;jama.2014.16968]). Over time, the association between bariatric surgery and lower mortality did not change even though criteria for patient selection and types of bariatric procedures did. And the association remained robust across several subgroups of patients, including patients who did and patients who did not have diabetes.

This VA study population was predominantly male and middle-aged, so the findings expand the evidence of bariatric surgery’s mortality benefit beyond that observed in previous studies of predominantly younger, female populations, Dr. Arterburn and his associates said.

This was a retrospective, nonrandomized, observational study, so the association identified between bariatric surgery and improved mortality cannot be considered causal on the basis of these results. “Only randomized clinical trials could provide definitive evidence that bariatric surgery improves survival,” but large enough RCTs would be very difficult to conduct and prohibitively expensive. So, at least for the present, both clinicians and patient must rely on observational research results such as those from this study to inform their treatment decisions regarding bariatric surgery, the investigators added.

Obese patients in the Veterans Administration health system who underwent bariatric surgery had lower all-cause mortality 5 and 10 years after the procedure than did matched patients who didn’t have bariatric surgery, according to a report published online Jan. 5 in JAMA.

In a retrospective cohort study of severely obese VA patients across the country, 2,500 who underwent bariatric surgery during 2000-2011 were matched for body mass index (BMI), age, sex, diabetes status, race, and area of residence with 7,462 who did not. The mean age of the study participants was 52-53 years, and the mean BMI was 46-47, said Dr. David E. Arterburn of the Group Health Research Institute and the University of Washington, both in Seattle, and his associates.

During a mean follow-up of approximately 7 years, there were 263 deaths in the surgical group and 1,277 in the control group. Estimated all-cause mortality was 6.4% at 5 years and 13.8% at 10 years for surgical patients, compared with 10.4% and 23.9%, respectively, for control subjects. Bariatric surgery was not associated with any difference in mortality for the first year of follow-up but was associated with lower mortality at 1-5 years (hazard ratio, 0.45) and at 5 or more years (HR, 0.47) of follow-up, the investigators said (JAMA 2015 January 5 [doi:10.1001;jama.2014.16968]). Over time, the association between bariatric surgery and lower mortality did not change even though criteria for patient selection and types of bariatric procedures did. And the association remained robust across several subgroups of patients, including patients who did and patients who did not have diabetes.

This VA study population was predominantly male and middle-aged, so the findings expand the evidence of bariatric surgery’s mortality benefit beyond that observed in previous studies of predominantly younger, female populations, Dr. Arterburn and his associates said.

This was a retrospective, nonrandomized, observational study, so the association identified between bariatric surgery and improved mortality cannot be considered causal on the basis of these results. “Only randomized clinical trials could provide definitive evidence that bariatric surgery improves survival,” but large enough RCTs would be very difficult to conduct and prohibitively expensive. So, at least for the present, both clinicians and patient must rely on observational research results such as those from this study to inform their treatment decisions regarding bariatric surgery, the investigators added.

Obese patients in the Veterans Administration health system who underwent bariatric surgery had lower all-cause mortality 5 and 10 years after the procedure than did matched patients who didn’t have bariatric surgery, according to a report published online Jan. 5 in JAMA.

In a retrospective cohort study of severely obese VA patients across the country, 2,500 who underwent bariatric surgery during 2000-2011 were matched for body mass index (BMI), age, sex, diabetes status, race, and area of residence with 7,462 who did not. The mean age of the study participants was 52-53 years, and the mean BMI was 46-47, said Dr. David E. Arterburn of the Group Health Research Institute and the University of Washington, both in Seattle, and his associates.

During a mean follow-up of approximately 7 years, there were 263 deaths in the surgical group and 1,277 in the control group. Estimated all-cause mortality was 6.4% at 5 years and 13.8% at 10 years for surgical patients, compared with 10.4% and 23.9%, respectively, for control subjects. Bariatric surgery was not associated with any difference in mortality for the first year of follow-up but was associated with lower mortality at 1-5 years (hazard ratio, 0.45) and at 5 or more years (HR, 0.47) of follow-up, the investigators said (JAMA 2015 January 5 [doi:10.1001;jama.2014.16968]). Over time, the association between bariatric surgery and lower mortality did not change even though criteria for patient selection and types of bariatric procedures did. And the association remained robust across several subgroups of patients, including patients who did and patients who did not have diabetes.

This VA study population was predominantly male and middle-aged, so the findings expand the evidence of bariatric surgery’s mortality benefit beyond that observed in previous studies of predominantly younger, female populations, Dr. Arterburn and his associates said.

This was a retrospective, nonrandomized, observational study, so the association identified between bariatric surgery and improved mortality cannot be considered causal on the basis of these results. “Only randomized clinical trials could provide definitive evidence that bariatric surgery improves survival,” but large enough RCTs would be very difficult to conduct and prohibitively expensive. So, at least for the present, both clinicians and patient must rely on observational research results such as those from this study to inform their treatment decisions regarding bariatric surgery, the investigators added.

When President Lyndon B. Johnson signed Medicare into law on July 30, 1965, he vowed that the program would give seniors access to the “healing miracle of modern medicine” and save them from exhausting their savings when they became ill.

For the most part, the program has delivered on those bold promises. Americans over age 65 years are living longer, healthier lives, and they are doing so without fear that a trip to the hospital will lead to bankruptcy. That security has only increased over time, as Congress added prescription drug coverage and most recently, free preventive care. In 1972, the Medicare program was extended to the long-term disabled and those with end stage renal disease.

Medicare “fundamentally changed the way we thought about health in our nation for our seniors,” said Dr. Georges C. Benjamin, executive director of the American Public Health Association. “This probably was the most important tool to lift seniors out of poverty. The economic benefit of this, in addition to the health benefit, was enormous.”

Along with coverage of hospital stays and physician services for seniors under Medicare, the Social Security Act Amendments of 1965 also created Medicaid, a voluntary federal-state partnership to provide medical care and long-term care services to low-income Americans.

Changing medical practice

When combined with the Civil Rights Act of 1964, Medicare desegregated all hospitals that participated in the program. Prior to the start of Medicare on July 1, 1966, a large number of hospitals around the country were still racially segregated in some manner. In many areas of the South, a separate hospital system served the black community and were the only places where black physicians could train and practice (Milbank Q. 2005; 83: 247-69). But in a matter of months, hospitals across the country integrated their facilities and staff in a relative peaceful manner, according to a study conducted by the Commonwealth Fund.

Photo courtesy of the LBJ Presidential Library.

“Now, physicians of color could not be kept out of hospitals as a matter of policy,” Dr. Benjamin said. “It dramatically improved practice opportunities for physicians and access to care opportunities for patients.”

Stuart Guterman, Ph.D., vice president for Medicare and cost control at the Commonwealth Fund, said it’s one of the lesser-known elements of Medicare’s history that the law became an impetus to overcoming racial barriers for both patients and physicians.

Changing payment incentives

Medicare payments opened up a significant new stream of revenue for hospitals that made desegregation more palatable. But hospitals weren’t the only ones who benefited financially from the new program.

Despite the American Medical Association’s fight against the creation of Medicare, during which officials famously decried the program as “socialized medicine,” physicians were financial winners under the new law, at least at first.

Much like hospitals, doctors got paid for the first time for treating patients who they had previously seen as charity care. And, in those early years of the Medicare program, the government paid on a charge basis. The result was that Medicare spending was quickly out of control.

Cost controls were added first for hospital care. In 1983, Medicare adopted the inpatient hospital prospective payment system, which replaced hospitals’ cost-based payments with the diagnosis-related group (DRG) system.

“Changing the notion of what hospitals did from each individual service or each individual day to the hospital stay, really changed the way hospital care was looked at,” Dr. Guterman said.

It took somewhat longer for federal health officials to tackle payment on the physician side. Throughout the 1980s, Congress froze physician payment rates in an effort to address rising costs. In 1984, Congress established the Participating Physicians’ Program, which required physicians to accept assignment for all Medicare patients and services rather than on a service-by-service basis. It also barred balance billing of Medicare beneficiaries.

Photo courtesy of White House

In 1989, Congress made the most significant change yet to physician payment, creating the Resource-Based Relative Value Scale (RBRVS) under the Omnibus Budget Reconciliation Act. Medicare officials used the new RBRVS to establish a standardized physician payment schedule in 1992. Under the new system, payments were determined by calculating the costs of physician work, practice expenses, and professional liability insurance. Payments are then adjusted by a conversion factor and geographic cost differences.

“The impact of the fee schedule all depends on where you sit,” said Paul B. Ginsburg, Ph.D., director of health policy at the Schaeffer Center for Health Policy and Economics at the University of Southern California.

The fee schedule was positive for primary care physicians at first, but a flawed updating process over the decades led to differences in Medicare payments by specialty, largely favoring procedural specialists over those who billed for evaluation and management services.

But Dr. Ginsburg said Medicare is now on the cusp of an even more important payment change as federal officials begin to move away from fee-for-service and toward payment approaches that emphasize quality and value.

While some new payment model experiments have been promising, the attempts by the Centers for Medicare & Medicaid Services have been “fumbling,” Dr. Ginsburg said.

Changing physician satisfaction

Medicare beneficiaries are typically happier with their health coverage than individuals enrolled in private, employer-sponsored insurance and are less worried about financial barriers to care, Dr. Guterman said.

“I think it’s fair to say that it’s one of the more popular federal programs ever,” he said. “You hear people frequently talking about how touchy it is to make any changes to the program because people are very wary of having that benefit diluted.”

That’s not the case for physicians.

Courtesy of the Texas Medical Association.

“The physicians I’ve talked to over the last 2 years feel like they’re drowning in red tape,” said Dr. Austin King, president of the Texas Medical Association and a head and neck surgeon in Abilene.

The result is that physicians are becoming employees in large physician practices or hospitals, or they are moving to set up boutique practices, Dr. King said. “Right now, the physicians are not real happy with the program.”

Dr. King predicted that physicians will continue to move out of the program, creating patient access issues, unless Congress gives them a way to recoup their costs, such as through the practice of balance billing.

Resolving issues like the looming annual cuts from the Sustainable Growth Rate formula and eliminating the Affordable Care Act’s Independent Payment Advisory Board would put some predictability back into the system, Dr. King said, adding that it’s not enough because it would still leave the numerous regulatory requirements, which many physicians “agonize” over.

It’s that kind of agony that keeps Dr. Jane Orient, a general internist in Tucson, Ariz., from participating in Medicare. Dr. Orient opted out of the program in 1990, around the time that Medicare began requiring that physicians file claims for payment. Previously, patients could pay her directly for services and be reimbursed by Medicare.

“I decided I just could not do that,” said Dr. Orient, executive director of the Association of American Physicians and Surgeons. “For me to file the claim and figure out what all those E&M guidelines meant, was just impossible. I certainly couldn’t do it with the staff I had.”

The fundamental problem, said Rep. Michael C. Burgess (R-Texas), cochair of the Congressional Health Caucus and an ob.gyn., is that patients get their care covered at a price they can afford, while Medicare’s payment to physicians doesn’t cover the cost of care.

“What has always been a bad situation is getting worse and worse with every passing year,” Rep. Burgess said.

Rep. Phil Roe (R-Tenn.), cochair of the GOP Doctors Caucus, said the problem for lawmakers is that they must fix the physician payment system before patient access is significantly affected. How much time do they have?

Rep. Roe, an ob.gyn., said physicians will hang on for as long as they can. But if Medicare continues to cut payments, an access crisis is coming.

If Medicare’s solution to their financing problem is to cut providers, he said, physicians will look for a way out of the program, and that will start with large-scale retirements of older physicians. 

“They are all looking for the exit signs now,” Rep. Roe said.

This is the first in a series of articles tracing the 50-year history of Medicare and its impact on physicians and patients. Future articles will focus on the public health impact of Medicare, the origins of the Sustainable Growth Rate formula, and the long-term financial viability of the program.

[email protected]

On Twitter @maryellenny

When President Lyndon B. Johnson signed Medicare into law on July 30, 1965, he vowed that the program would give seniors access to the “healing miracle of modern medicine” and save them from exhausting their savings when they became ill.

For the most part, the program has delivered on those bold promises. Americans over age 65 years are living longer, healthier lives, and they are doing so without fear that a trip to the hospital will lead to bankruptcy. That security has only increased over time, as Congress added prescription drug coverage and most recently, free preventive care. In 1972, the Medicare program was extended to the long-term disabled and those with end stage renal disease.

Medicare “fundamentally changed the way we thought about health in our nation for our seniors,” said Dr. Georges C. Benjamin, executive director of the American Public Health Association. “This probably was the most important tool to lift seniors out of poverty. The economic benefit of this, in addition to the health benefit, was enormous.”

Along with coverage of hospital stays and physician services for seniors under Medicare, the Social Security Act Amendments of 1965 also created Medicaid, a voluntary federal-state partnership to provide medical care and long-term care services to low-income Americans.

Changing medical practice

When combined with the Civil Rights Act of 1964, Medicare desegregated all hospitals that participated in the program. Prior to the start of Medicare on July 1, 1966, a large number of hospitals around the country were still racially segregated in some manner. In many areas of the South, a separate hospital system served the black community and were the only places where black physicians could train and practice (Milbank Q. 2005; 83: 247-69). But in a matter of months, hospitals across the country integrated their facilities and staff in a relative peaceful manner, according to a study conducted by the Commonwealth Fund.

Photo courtesy of the LBJ Presidential Library.

“Now, physicians of color could not be kept out of hospitals as a matter of policy,” Dr. Benjamin said. “It dramatically improved practice opportunities for physicians and access to care opportunities for patients.”

Stuart Guterman, Ph.D., vice president for Medicare and cost control at the Commonwealth Fund, said it’s one of the lesser-known elements of Medicare’s history that the law became an impetus to overcoming racial barriers for both patients and physicians.

Changing payment incentives

Medicare payments opened up a significant new stream of revenue for hospitals that made desegregation more palatable. But hospitals weren’t the only ones who benefited financially from the new program.

Despite the American Medical Association’s fight against the creation of Medicare, during which officials famously decried the program as “socialized medicine,” physicians were financial winners under the new law, at least at first.

Much like hospitals, doctors got paid for the first time for treating patients who they had previously seen as charity care. And, in those early years of the Medicare program, the government paid on a charge basis. The result was that Medicare spending was quickly out of control.

Cost controls were added first for hospital care. In 1983, Medicare adopted the inpatient hospital prospective payment system, which replaced hospitals’ cost-based payments with the diagnosis-related group (DRG) system.

“Changing the notion of what hospitals did from each individual service or each individual day to the hospital stay, really changed the way hospital care was looked at,” Dr. Guterman said.

It took somewhat longer for federal health officials to tackle payment on the physician side. Throughout the 1980s, Congress froze physician payment rates in an effort to address rising costs. In 1984, Congress established the Participating Physicians’ Program, which required physicians to accept assignment for all Medicare patients and services rather than on a service-by-service basis. It also barred balance billing of Medicare beneficiaries.

Photo courtesy of White House

In 1989, Congress made the most significant change yet to physician payment, creating the Resource-Based Relative Value Scale (RBRVS) under the Omnibus Budget Reconciliation Act. Medicare officials used the new RBRVS to establish a standardized physician payment schedule in 1992. Under the new system, payments were determined by calculating the costs of physician work, practice expenses, and professional liability insurance. Payments are then adjusted by a conversion factor and geographic cost differences.

“The impact of the fee schedule all depends on where you sit,” said Paul B. Ginsburg, Ph.D., director of health policy at the Schaeffer Center for Health Policy and Economics at the University of Southern California.

The fee schedule was positive for primary care physicians at first, but a flawed updating process over the decades led to differences in Medicare payments by specialty, largely favoring procedural specialists over those who billed for evaluation and management services.

But Dr. Ginsburg said Medicare is now on the cusp of an even more important payment change as federal officials begin to move away from fee-for-service and toward payment approaches that emphasize quality and value.

While some new payment model experiments have been promising, the attempts by the Centers for Medicare & Medicaid Services have been “fumbling,” Dr. Ginsburg said.

Changing physician satisfaction

Medicare beneficiaries are typically happier with their health coverage than individuals enrolled in private, employer-sponsored insurance and are less worried about financial barriers to care, Dr. Guterman said.

“I think it’s fair to say that it’s one of the more popular federal programs ever,” he said. “You hear people frequently talking about how touchy it is to make any changes to the program because people are very wary of having that benefit diluted.”

That’s not the case for physicians.

Courtesy of the Texas Medical Association.

“The physicians I’ve talked to over the last 2 years feel like they’re drowning in red tape,” said Dr. Austin King, president of the Texas Medical Association and a head and neck surgeon in Abilene.

The result is that physicians are becoming employees in large physician practices or hospitals, or they are moving to set up boutique practices, Dr. King said. “Right now, the physicians are not real happy with the program.”

Dr. King predicted that physicians will continue to move out of the program, creating patient access issues, unless Congress gives them a way to recoup their costs, such as through the practice of balance billing.

Resolving issues like the looming annual cuts from the Sustainable Growth Rate formula and eliminating the Affordable Care Act’s Independent Payment Advisory Board would put some predictability back into the system, Dr. King said, adding that it’s not enough because it would still leave the numerous regulatory requirements, which many physicians “agonize” over.

It’s that kind of agony that keeps Dr. Jane Orient, a general internist in Tucson, Ariz., from participating in Medicare. Dr. Orient opted out of the program in 1990, around the time that Medicare began requiring that physicians file claims for payment. Previously, patients could pay her directly for services and be reimbursed by Medicare.

“I decided I just could not do that,” said Dr. Orient, executive director of the Association of American Physicians and Surgeons. “For me to file the claim and figure out what all those E&M guidelines meant, was just impossible. I certainly couldn’t do it with the staff I had.”

The fundamental problem, said Rep. Michael C. Burgess (R-Texas), cochair of the Congressional Health Caucus and an ob.gyn., is that patients get their care covered at a price they can afford, while Medicare’s payment to physicians doesn’t cover the cost of care.

“What has always been a bad situation is getting worse and worse with every passing year,” Rep. Burgess said.

Rep. Phil Roe (R-Tenn.), cochair of the GOP Doctors Caucus, said the problem for lawmakers is that they must fix the physician payment system before patient access is significantly affected. How much time do they have?

Rep. Roe, an ob.gyn., said physicians will hang on for as long as they can. But if Medicare continues to cut payments, an access crisis is coming.

If Medicare’s solution to their financing problem is to cut providers, he said, physicians will look for a way out of the program, and that will start with large-scale retirements of older physicians. 

“They are all looking for the exit signs now,” Rep. Roe said.

This is the first in a series of articles tracing the 50-year history of Medicare and its impact on physicians and patients. Future articles will focus on the public health impact of Medicare, the origins of the Sustainable Growth Rate formula, and the long-term financial viability of the program.

[email protected]

On Twitter @maryellenny

When President Lyndon B. Johnson signed Medicare into law on July 30, 1965, he vowed that the program would give seniors access to the “healing miracle of modern medicine” and save them from exhausting their savings when they became ill.

For the most part, the program has delivered on those bold promises. Americans over age 65 years are living longer, healthier lives, and they are doing so without fear that a trip to the hospital will lead to bankruptcy. That security has only increased over time, as Congress added prescription drug coverage and most recently, free preventive care. In 1972, the Medicare program was extended to the long-term disabled and those with end stage renal disease.

Medicare “fundamentally changed the way we thought about health in our nation for our seniors,” said Dr. Georges C. Benjamin, executive director of the American Public Health Association. “This probably was the most important tool to lift seniors out of poverty. The economic benefit of this, in addition to the health benefit, was enormous.”

Along with coverage of hospital stays and physician services for seniors under Medicare, the Social Security Act Amendments of 1965 also created Medicaid, a voluntary federal-state partnership to provide medical care and long-term care services to low-income Americans.

Changing medical practice

When combined with the Civil Rights Act of 1964, Medicare desegregated all hospitals that participated in the program. Prior to the start of Medicare on July 1, 1966, a large number of hospitals around the country were still racially segregated in some manner. In many areas of the South, a separate hospital system served the black community and were the only places where black physicians could train and practice (Milbank Q. 2005; 83: 247-69). But in a matter of months, hospitals across the country integrated their facilities and staff in a relative peaceful manner, according to a study conducted by the Commonwealth Fund.

Photo courtesy of the LBJ Presidential Library.

“Now, physicians of color could not be kept out of hospitals as a matter of policy,” Dr. Benjamin said. “It dramatically improved practice opportunities for physicians and access to care opportunities for patients.”

Stuart Guterman, Ph.D., vice president for Medicare and cost control at the Commonwealth Fund, said it’s one of the lesser-known elements of Medicare’s history that the law became an impetus to overcoming racial barriers for both patients and physicians.

Changing payment incentives

Medicare payments opened up a significant new stream of revenue for hospitals that made desegregation more palatable. But hospitals weren’t the only ones who benefited financially from the new program.

Despite the American Medical Association’s fight against the creation of Medicare, during which officials famously decried the program as “socialized medicine,” physicians were financial winners under the new law, at least at first.

Much like hospitals, doctors got paid for the first time for treating patients who they had previously seen as charity care. And, in those early years of the Medicare program, the government paid on a charge basis. The result was that Medicare spending was quickly out of control.

Cost controls were added first for hospital care. In 1983, Medicare adopted the inpatient hospital prospective payment system, which replaced hospitals’ cost-based payments with the diagnosis-related group (DRG) system.

“Changing the notion of what hospitals did from each individual service or each individual day to the hospital stay, really changed the way hospital care was looked at,” Dr. Guterman said.

It took somewhat longer for federal health officials to tackle payment on the physician side. Throughout the 1980s, Congress froze physician payment rates in an effort to address rising costs. In 1984, Congress established the Participating Physicians’ Program, which required physicians to accept assignment for all Medicare patients and services rather than on a service-by-service basis. It also barred balance billing of Medicare beneficiaries.

Photo courtesy of White House

In 1989, Congress made the most significant change yet to physician payment, creating the Resource-Based Relative Value Scale (RBRVS) under the Omnibus Budget Reconciliation Act. Medicare officials used the new RBRVS to establish a standardized physician payment schedule in 1992. Under the new system, payments were determined by calculating the costs of physician work, practice expenses, and professional liability insurance. Payments are then adjusted by a conversion factor and geographic cost differences.

“The impact of the fee schedule all depends on where you sit,” said Paul B. Ginsburg, Ph.D., director of health policy at the Schaeffer Center for Health Policy and Economics at the University of Southern California.

The fee schedule was positive for primary care physicians at first, but a flawed updating process over the decades led to differences in Medicare payments by specialty, largely favoring procedural specialists over those who billed for evaluation and management services.

But Dr. Ginsburg said Medicare is now on the cusp of an even more important payment change as federal officials begin to move away from fee-for-service and toward payment approaches that emphasize quality and value.

While some new payment model experiments have been promising, the attempts by the Centers for Medicare & Medicaid Services have been “fumbling,” Dr. Ginsburg said.

Changing physician satisfaction

Medicare beneficiaries are typically happier with their health coverage than individuals enrolled in private, employer-sponsored insurance and are less worried about financial barriers to care, Dr. Guterman said.

“I think it’s fair to say that it’s one of the more popular federal programs ever,” he said. “You hear people frequently talking about how touchy it is to make any changes to the program because people are very wary of having that benefit diluted.”

That’s not the case for physicians.

Courtesy of the Texas Medical Association.

“The physicians I’ve talked to over the last 2 years feel like they’re drowning in red tape,” said Dr. Austin King, president of the Texas Medical Association and a head and neck surgeon in Abilene.

The result is that physicians are becoming employees in large physician practices or hospitals, or they are moving to set up boutique practices, Dr. King said. “Right now, the physicians are not real happy with the program.”

Dr. King predicted that physicians will continue to move out of the program, creating patient access issues, unless Congress gives them a way to recoup their costs, such as through the practice of balance billing.

Resolving issues like the looming annual cuts from the Sustainable Growth Rate formula and eliminating the Affordable Care Act’s Independent Payment Advisory Board would put some predictability back into the system, Dr. King said, adding that it’s not enough because it would still leave the numerous regulatory requirements, which many physicians “agonize” over.

It’s that kind of agony that keeps Dr. Jane Orient, a general internist in Tucson, Ariz., from participating in Medicare. Dr. Orient opted out of the program in 1990, around the time that Medicare began requiring that physicians file claims for payment. Previously, patients could pay her directly for services and be reimbursed by Medicare.

“I decided I just could not do that,” said Dr. Orient, executive director of the Association of American Physicians and Surgeons. “For me to file the claim and figure out what all those E&M guidelines meant, was just impossible. I certainly couldn’t do it with the staff I had.”

The fundamental problem, said Rep. Michael C. Burgess (R-Texas), cochair of the Congressional Health Caucus and an ob.gyn., is that patients get their care covered at a price they can afford, while Medicare’s payment to physicians doesn’t cover the cost of care.

“What has always been a bad situation is getting worse and worse with every passing year,” Rep. Burgess said.

Rep. Phil Roe (R-Tenn.), cochair of the GOP Doctors Caucus, said the problem for lawmakers is that they must fix the physician payment system before patient access is significantly affected. How much time do they have?

Rep. Roe, an ob.gyn., said physicians will hang on for as long as they can. But if Medicare continues to cut payments, an access crisis is coming.

If Medicare’s solution to their financing problem is to cut providers, he said, physicians will look for a way out of the program, and that will start with large-scale retirements of older physicians. 

“They are all looking for the exit signs now,” Rep. Roe said.

This is the first in a series of articles tracing the 50-year history of Medicare and its impact on physicians and patients. Future articles will focus on the public health impact of Medicare, the origins of the Sustainable Growth Rate formula, and the long-term financial viability of the program.

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PHILADELPHIA – A bundled intervention including Staphylococcus aureus screening, decolonization, and targeted perioperative prophylaxis significantly decreased the rate of complex S. aureus surgical site infections in a multicenter quasi-experimental effectiveness study of patients undergoing cardiac operations or total joint arthroplasty.

The pooled rate of complex S. aureus surgical site infections (SSIs) decreased from 0.36% following 28,218 procedures performed during the preintervention period to 0.20% after 14,316 procedures performed during the intervention period (rate ratio, 0.58), Dr. Loreen A. Herwaldt of the University of Iowa, Iowa City, reported at an annual scientific meeting on infectious diseases.

Further, the number of months with no complex S. aureus SSIs increased from 2 of 39 months (5.1%) to 8 of 22 months (36.4%) Dr. Herwaldt said, noting that the median rate and range of complex SSIs became zero by intervention month 4.

©CDC/Janice Haney Carr

The decrease in SSIs was greatest for joint arthroplasties, she said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

Subgroup analyses also demonstrated significantly lower rates of complex SSIs for scheduled vs. nonscheduled or emergent operations (rate ratio, 0.55), fully adherent vs. partially or nonadherent operations (rate ratio, 0.26), and for operations in which the surgeon (in accordance with hospital participation) implemented at least some bundle elements vs. no bundle elements (rate ratio, 0.54), she said, explaining that surgeons could opt out of the study even if a hospital was participating.

The rate of complex SSIs caused by any pathogen also was reduced (rate ratio, 0.67).

“We were very pleased to note that gram negative SSIs did not increase. The rate ratio was 0.86, and the confidence interval did cross 1 and the P value was 0.67,” she said.

The study, known as STOP SSI, was conducted at 20 Hospital Corporation of America (HCA) hospitals in nine states from March 1, 2009, to March 31, 2014. Patients who tested positive for methicillin-resistant or methicillin-susceptible S. aureus on a preoperative nares screen within 30 days before surgery were asked to apply mupirocin intranasally twice daily for 5 days and to bathe with chlorhexidine gluconate once daily for 5 days prior to their operation, including on the night before and the morning of surgery. Those who tested negative for MRSA and MSSA bathed with chlorhexidine gluconate only on the night before surgery and the morning of surgery.

Those with MRSA were treated with vancomycin and cefazolin perioperatively, and those without MRSA received only cefazolin.

If the patient’s status was unknown at the time of the operation, the goal was to have the patient bathe in chlorhexidine and to give as many intranasal doses of mupirocin as possible before surgery. The patient was treated perioperatively with vancomycin and cefazolin, and if it was later determined that the patient was positive for MRSA, the mupirocin was continued after surgery until the patient had been treated for 5 days.

After a 3-month phase-in period, 48% of the hospitals were fully compliant with this protocol, and 20% were partially compliant.

The use of a bundled intervention similar to the one used in this study was shown in a recent meta-analysis (BMJ 2013;346:f2743) to be likely to reduce the rate of S. aureus SSIs, but the approach had not been studied in a multicenter trial, Dr. Herwaldt said.

“Implementation of this SSI bundle was associated with significantly lower rates of complex S. aureus SSIs in the total cohort and in the hip and knee arthroplasty group. It was not associated with an increase in gram-negative SSIs, and thus we feel that if people actually did implement this bundle, it could substantially reduce patient morbidity and the cost of care,” she concluded, noting that the effect was seen only with implementation of the full bundle.

The Agency for Healthcare Research and Quality funded the study. Dr. Herwaldt reported having no disclosures.

PHILADELPHIA – A bundled intervention including Staphylococcus aureus screening, decolonization, and targeted perioperative prophylaxis significantly decreased the rate of complex S. aureus surgical site infections in a multicenter quasi-experimental effectiveness study of patients undergoing cardiac operations or total joint arthroplasty.

The pooled rate of complex S. aureus surgical site infections (SSIs) decreased from 0.36% following 28,218 procedures performed during the preintervention period to 0.20% after 14,316 procedures performed during the intervention period (rate ratio, 0.58), Dr. Loreen A. Herwaldt of the University of Iowa, Iowa City, reported at an annual scientific meeting on infectious diseases.

Further, the number of months with no complex S. aureus SSIs increased from 2 of 39 months (5.1%) to 8 of 22 months (36.4%) Dr. Herwaldt said, noting that the median rate and range of complex SSIs became zero by intervention month 4.

©CDC/Janice Haney Carr

The decrease in SSIs was greatest for joint arthroplasties, she said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

Subgroup analyses also demonstrated significantly lower rates of complex SSIs for scheduled vs. nonscheduled or emergent operations (rate ratio, 0.55), fully adherent vs. partially or nonadherent operations (rate ratio, 0.26), and for operations in which the surgeon (in accordance with hospital participation) implemented at least some bundle elements vs. no bundle elements (rate ratio, 0.54), she said, explaining that surgeons could opt out of the study even if a hospital was participating.

The rate of complex SSIs caused by any pathogen also was reduced (rate ratio, 0.67).

“We were very pleased to note that gram negative SSIs did not increase. The rate ratio was 0.86, and the confidence interval did cross 1 and the P value was 0.67,” she said.

The study, known as STOP SSI, was conducted at 20 Hospital Corporation of America (HCA) hospitals in nine states from March 1, 2009, to March 31, 2014. Patients who tested positive for methicillin-resistant or methicillin-susceptible S. aureus on a preoperative nares screen within 30 days before surgery were asked to apply mupirocin intranasally twice daily for 5 days and to bathe with chlorhexidine gluconate once daily for 5 days prior to their operation, including on the night before and the morning of surgery. Those who tested negative for MRSA and MSSA bathed with chlorhexidine gluconate only on the night before surgery and the morning of surgery.

Those with MRSA were treated with vancomycin and cefazolin perioperatively, and those without MRSA received only cefazolin.

If the patient’s status was unknown at the time of the operation, the goal was to have the patient bathe in chlorhexidine and to give as many intranasal doses of mupirocin as possible before surgery. The patient was treated perioperatively with vancomycin and cefazolin, and if it was later determined that the patient was positive for MRSA, the mupirocin was continued after surgery until the patient had been treated for 5 days.

After a 3-month phase-in period, 48% of the hospitals were fully compliant with this protocol, and 20% were partially compliant.

The use of a bundled intervention similar to the one used in this study was shown in a recent meta-analysis (BMJ 2013;346:f2743) to be likely to reduce the rate of S. aureus SSIs, but the approach had not been studied in a multicenter trial, Dr. Herwaldt said.

“Implementation of this SSI bundle was associated with significantly lower rates of complex S. aureus SSIs in the total cohort and in the hip and knee arthroplasty group. It was not associated with an increase in gram-negative SSIs, and thus we feel that if people actually did implement this bundle, it could substantially reduce patient morbidity and the cost of care,” she concluded, noting that the effect was seen only with implementation of the full bundle.

The Agency for Healthcare Research and Quality funded the study. Dr. Herwaldt reported having no disclosures.

PHILADELPHIA – A bundled intervention including Staphylococcus aureus screening, decolonization, and targeted perioperative prophylaxis significantly decreased the rate of complex S. aureus surgical site infections in a multicenter quasi-experimental effectiveness study of patients undergoing cardiac operations or total joint arthroplasty.

The pooled rate of complex S. aureus surgical site infections (SSIs) decreased from 0.36% following 28,218 procedures performed during the preintervention period to 0.20% after 14,316 procedures performed during the intervention period (rate ratio, 0.58), Dr. Loreen A. Herwaldt of the University of Iowa, Iowa City, reported at an annual scientific meeting on infectious diseases.

Further, the number of months with no complex S. aureus SSIs increased from 2 of 39 months (5.1%) to 8 of 22 months (36.4%) Dr. Herwaldt said, noting that the median rate and range of complex SSIs became zero by intervention month 4.

©CDC/Janice Haney Carr

The decrease in SSIs was greatest for joint arthroplasties, she said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

Subgroup analyses also demonstrated significantly lower rates of complex SSIs for scheduled vs. nonscheduled or emergent operations (rate ratio, 0.55), fully adherent vs. partially or nonadherent operations (rate ratio, 0.26), and for operations in which the surgeon (in accordance with hospital participation) implemented at least some bundle elements vs. no bundle elements (rate ratio, 0.54), she said, explaining that surgeons could opt out of the study even if a hospital was participating.

The rate of complex SSIs caused by any pathogen also was reduced (rate ratio, 0.67).

“We were very pleased to note that gram negative SSIs did not increase. The rate ratio was 0.86, and the confidence interval did cross 1 and the P value was 0.67,” she said.

The study, known as STOP SSI, was conducted at 20 Hospital Corporation of America (HCA) hospitals in nine states from March 1, 2009, to March 31, 2014. Patients who tested positive for methicillin-resistant or methicillin-susceptible S. aureus on a preoperative nares screen within 30 days before surgery were asked to apply mupirocin intranasally twice daily for 5 days and to bathe with chlorhexidine gluconate once daily for 5 days prior to their operation, including on the night before and the morning of surgery. Those who tested negative for MRSA and MSSA bathed with chlorhexidine gluconate only on the night before surgery and the morning of surgery.

Those with MRSA were treated with vancomycin and cefazolin perioperatively, and those without MRSA received only cefazolin.

If the patient’s status was unknown at the time of the operation, the goal was to have the patient bathe in chlorhexidine and to give as many intranasal doses of mupirocin as possible before surgery. The patient was treated perioperatively with vancomycin and cefazolin, and if it was later determined that the patient was positive for MRSA, the mupirocin was continued after surgery until the patient had been treated for 5 days.

After a 3-month phase-in period, 48% of the hospitals were fully compliant with this protocol, and 20% were partially compliant.

The use of a bundled intervention similar to the one used in this study was shown in a recent meta-analysis (BMJ 2013;346:f2743) to be likely to reduce the rate of S. aureus SSIs, but the approach had not been studied in a multicenter trial, Dr. Herwaldt said.

“Implementation of this SSI bundle was associated with significantly lower rates of complex S. aureus SSIs in the total cohort and in the hip and knee arthroplasty group. It was not associated with an increase in gram-negative SSIs, and thus we feel that if people actually did implement this bundle, it could substantially reduce patient morbidity and the cost of care,” she concluded, noting that the effect was seen only with implementation of the full bundle.

The Agency for Healthcare Research and Quality funded the study. Dr. Herwaldt reported having no disclosures.