Smoking is a significant risk factor for seropositive rheumatoid arthritis, and quitting may delay or even prevent the disease, a study has found.

American Heart Association

In a paper published in Arthritis Care & Research, researchers report the analysis of data from 230,732 women – including 1,528 individuals with rheumatoid arthritis – participating in the Nurses’ Health Study (NHS) and NHS II.

They saw that current smokers had a significant 67% increased risk for seropositive rheumatoid arthritis (RA), compared with never smokers, while those who smoked 25 or more cigarettes per day had a 92% higher risk.

There was an increasing trend of association between pack-years of smoking and seropositive RA such that 35 pack-years of exposure was associated with a 2.3-fold higher risk for seropositive RA, compared with never smokers (P less than .0001).

Xinyi Liu of the division of rheumatology, immunology, and allergy at Brigham and Women’s Hospital, Boston, and her coauthors noted that the population attributable risk of RA from smoking was 14% and that smoking could contribute up to 35% of seropositive RA risk.

“Although the biologic mechanisms linking smoking with increased risk for developing RA are still not clear, components in cigarette smoke, such as nicotine, hydrocarbons, and carbon monoxide, are known to have aberrant effects on the immune system,” the authors wrote.

The good news was that sustained smoking cessation significantly reduced the risk of RA and seropositive RA, and those benefits increased with the amount of time since the individual stopped smoking.

Women who had quit smoking at least 30 years prior showed a 22% lower risk of all RA and a 37% lower risk of seropositive RA, compared with those who had quit within the previous 5 years. However, even 30 years after quitting, there was still a 30% higher risk of seropositive rheumatoid arthritis, compared with the risk among women who had never smoked.

“While smoking cessation may not decrease RA risk to the level of a never smoker, our findings provide evidence that a behavior change of smoking cessation may delay or even prevent the onset of seropositive RA,” the authors wrote. “These results could provide rationale for a smoking intervention trial among active smokers to prevent the formation of RA-related autoantibodies or to prevent the progression to RA among those at elevated risk for seropositive RA.”

Commenting on the difference in associations with seropositive and seronegative rheumatoid arthritis and smoking behavior, the authors wrote this suggested these two types of the disease may represent separate phenotypes with different risk factors.

The National Institutes of Health supported the study. No conflicts of interest were declared.

SOURCE: Liu X et al. Arthritis Care Res. 2019 Feb 21. doi: 10.1002/acr.23837.

Smoking is a significant risk factor for seropositive rheumatoid arthritis, and quitting may delay or even prevent the disease, a study has found.

American Heart Association

In a paper published in Arthritis Care & Research, researchers report the analysis of data from 230,732 women – including 1,528 individuals with rheumatoid arthritis – participating in the Nurses’ Health Study (NHS) and NHS II.

They saw that current smokers had a significant 67% increased risk for seropositive rheumatoid arthritis (RA), compared with never smokers, while those who smoked 25 or more cigarettes per day had a 92% higher risk.

There was an increasing trend of association between pack-years of smoking and seropositive RA such that 35 pack-years of exposure was associated with a 2.3-fold higher risk for seropositive RA, compared with never smokers (P less than .0001).

Xinyi Liu of the division of rheumatology, immunology, and allergy at Brigham and Women’s Hospital, Boston, and her coauthors noted that the population attributable risk of RA from smoking was 14% and that smoking could contribute up to 35% of seropositive RA risk.

“Although the biologic mechanisms linking smoking with increased risk for developing RA are still not clear, components in cigarette smoke, such as nicotine, hydrocarbons, and carbon monoxide, are known to have aberrant effects on the immune system,” the authors wrote.

The good news was that sustained smoking cessation significantly reduced the risk of RA and seropositive RA, and those benefits increased with the amount of time since the individual stopped smoking.

Women who had quit smoking at least 30 years prior showed a 22% lower risk of all RA and a 37% lower risk of seropositive RA, compared with those who had quit within the previous 5 years. However, even 30 years after quitting, there was still a 30% higher risk of seropositive rheumatoid arthritis, compared with the risk among women who had never smoked.

“While smoking cessation may not decrease RA risk to the level of a never smoker, our findings provide evidence that a behavior change of smoking cessation may delay or even prevent the onset of seropositive RA,” the authors wrote. “These results could provide rationale for a smoking intervention trial among active smokers to prevent the formation of RA-related autoantibodies or to prevent the progression to RA among those at elevated risk for seropositive RA.”

Commenting on the difference in associations with seropositive and seronegative rheumatoid arthritis and smoking behavior, the authors wrote this suggested these two types of the disease may represent separate phenotypes with different risk factors.

The National Institutes of Health supported the study. No conflicts of interest were declared.

SOURCE: Liu X et al. Arthritis Care Res. 2019 Feb 21. doi: 10.1002/acr.23837.

Smoking is a significant risk factor for seropositive rheumatoid arthritis, and quitting may delay or even prevent the disease, a study has found.

American Heart Association

In a paper published in Arthritis Care & Research, researchers report the analysis of data from 230,732 women – including 1,528 individuals with rheumatoid arthritis – participating in the Nurses’ Health Study (NHS) and NHS II.

They saw that current smokers had a significant 67% increased risk for seropositive rheumatoid arthritis (RA), compared with never smokers, while those who smoked 25 or more cigarettes per day had a 92% higher risk.

There was an increasing trend of association between pack-years of smoking and seropositive RA such that 35 pack-years of exposure was associated with a 2.3-fold higher risk for seropositive RA, compared with never smokers (P less than .0001).

Xinyi Liu of the division of rheumatology, immunology, and allergy at Brigham and Women’s Hospital, Boston, and her coauthors noted that the population attributable risk of RA from smoking was 14% and that smoking could contribute up to 35% of seropositive RA risk.

“Although the biologic mechanisms linking smoking with increased risk for developing RA are still not clear, components in cigarette smoke, such as nicotine, hydrocarbons, and carbon monoxide, are known to have aberrant effects on the immune system,” the authors wrote.

The good news was that sustained smoking cessation significantly reduced the risk of RA and seropositive RA, and those benefits increased with the amount of time since the individual stopped smoking.

Women who had quit smoking at least 30 years prior showed a 22% lower risk of all RA and a 37% lower risk of seropositive RA, compared with those who had quit within the previous 5 years. However, even 30 years after quitting, there was still a 30% higher risk of seropositive rheumatoid arthritis, compared with the risk among women who had never smoked.

“While smoking cessation may not decrease RA risk to the level of a never smoker, our findings provide evidence that a behavior change of smoking cessation may delay or even prevent the onset of seropositive RA,” the authors wrote. “These results could provide rationale for a smoking intervention trial among active smokers to prevent the formation of RA-related autoantibodies or to prevent the progression to RA among those at elevated risk for seropositive RA.”

Commenting on the difference in associations with seropositive and seronegative rheumatoid arthritis and smoking behavior, the authors wrote this suggested these two types of the disease may represent separate phenotypes with different risk factors.

The National Institutes of Health supported the study. No conflicts of interest were declared.

SOURCE: Liu X et al. Arthritis Care Res. 2019 Feb 21. doi: 10.1002/acr.23837.

A retrospective study suggests a four-drug regimen can be effective salvage therapy for patients with relapsed or refractory classical Hodgkin lymphoma.

The regimen – brentuximab vedotin plus ifosfamide, gemcitabine, and vinorelbine (BV-IGEV) – produced responses in 27 of 28 patients studied, allowing them to undergo autologous hematopoietic stem cell transplant (HSCT).

After HSCT, the estimated 2-year progression-free survival (PFS) was 87.1% and the overall survival (OS) was 73.5%.

Though this study was limited by its small population and retrospective nature, the results “warrant further investigation,” according to Khadega A. Abuelgasim, MD, of King Abdullah International Medical Research Center in Riyadh, Saudi Arabia, and colleagues.

The researchers reported the results in a letter to Bone Marrow Transplantation.

The study included 28 patients with classical Hodgkin lymphoma, 15 of them male. The patients’ median age at HSCT was 25 years (range, 15-49 years). Twenty patients (71%) had constitutional symptoms at diagnosis, and eight (29%) had bulky disease.

Twenty-three patients (82%) received doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) as frontline therapy, and four (14%) received ABVD followed by escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone. One patient received a different frontline regimen.

The median time to relapse was 7.9 months (range, 1.9-133 months), and 12 patients (43%) were refractory to frontline treatment.

Half of patients (n = 14) received BV-IGEV as first salvage. The regimen was given as follows: ifosfamide at 2,000 mg/m² on days 1-4, gemcitabine at 800 mg/m² on days 1 and 4, vinorelbine at 20 mg/m² on day 1, prednisolone at 100 mg on days 1-4, and BV at a dose of 1.8 mg/kg on day 1 of each 3-week IGEV course.

All patients received at least two cycles of BV-IGEV and were assessed for response after one or two cycles. The median follow-up was 17 months (range, 0-65 months).

Twenty patients (71%) had a complete metabolic response to BV-IGEV, seven (25%) had a partial metabolic response, and one patient (4%) had stable disease. The patient with stable disease went on to receive another salvage regimen and achieved a partial response to that regimen.

The most common adverse events during BV-IGEV treatment were grade 3-4 neutropenia (n = 27; 96%) and thrombocytopenia (n = 25; 89%). Febrile neutropenia was also common (n = 16; 57%), as were mucositis (n = 6; 21%) and diarrhea (n = 6; 21%). Six patients had a reduction in BV dose because of an adverse event.

All patients underwent autologous HSCT. They received carmustine, etoposide, cytarabine, and melphalan as conditioning beforehand, and 18 patients (64%) received consolidative BV after transplant.

PFS and OS were calculated from the date of stem cell infusion. The estimated 2-year PFS was 87.1%, and the estimated 2-year OS was 73.5%.

Patients who received BV-IGEV as first salvage fared better than those who received the regimen as second salvage. The PFS rates were 100% and 75%, respectively (P = .0078), and OS rates were 100% and 50%, respectively (P = .08).

Six patients relapsed after HSCT, and three died. Two patients died of progressive disease and one died of pulmonary infection.

These results suggest BV-IGEV can produce high response rates without compromising stem cell mobilization, but the combination should be investigated further, according to the researchers.

The researchers reported having no conflicts of interest.

jensmith@mdedge.com

SOURCE: Abuelgasim KA et al. Bone Marrow Transplant. 2019 Jan 30. doi: 10.1038/s41409-019-0454-z.

A retrospective study suggests a four-drug regimen can be effective salvage therapy for patients with relapsed or refractory classical Hodgkin lymphoma.

The regimen – brentuximab vedotin plus ifosfamide, gemcitabine, and vinorelbine (BV-IGEV) – produced responses in 27 of 28 patients studied, allowing them to undergo autologous hematopoietic stem cell transplant (HSCT).

After HSCT, the estimated 2-year progression-free survival (PFS) was 87.1% and the overall survival (OS) was 73.5%.

Though this study was limited by its small population and retrospective nature, the results “warrant further investigation,” according to Khadega A. Abuelgasim, MD, of King Abdullah International Medical Research Center in Riyadh, Saudi Arabia, and colleagues.

The researchers reported the results in a letter to Bone Marrow Transplantation.

The study included 28 patients with classical Hodgkin lymphoma, 15 of them male. The patients’ median age at HSCT was 25 years (range, 15-49 years). Twenty patients (71%) had constitutional symptoms at diagnosis, and eight (29%) had bulky disease.

Twenty-three patients (82%) received doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) as frontline therapy, and four (14%) received ABVD followed by escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone. One patient received a different frontline regimen.

The median time to relapse was 7.9 months (range, 1.9-133 months), and 12 patients (43%) were refractory to frontline treatment.

Half of patients (n = 14) received BV-IGEV as first salvage. The regimen was given as follows: ifosfamide at 2,000 mg/m² on days 1-4, gemcitabine at 800 mg/m² on days 1 and 4, vinorelbine at 20 mg/m² on day 1, prednisolone at 100 mg on days 1-4, and BV at a dose of 1.8 mg/kg on day 1 of each 3-week IGEV course.

All patients received at least two cycles of BV-IGEV and were assessed for response after one or two cycles. The median follow-up was 17 months (range, 0-65 months).

Twenty patients (71%) had a complete metabolic response to BV-IGEV, seven (25%) had a partial metabolic response, and one patient (4%) had stable disease. The patient with stable disease went on to receive another salvage regimen and achieved a partial response to that regimen.

The most common adverse events during BV-IGEV treatment were grade 3-4 neutropenia (n = 27; 96%) and thrombocytopenia (n = 25; 89%). Febrile neutropenia was also common (n = 16; 57%), as were mucositis (n = 6; 21%) and diarrhea (n = 6; 21%). Six patients had a reduction in BV dose because of an adverse event.

All patients underwent autologous HSCT. They received carmustine, etoposide, cytarabine, and melphalan as conditioning beforehand, and 18 patients (64%) received consolidative BV after transplant.

PFS and OS were calculated from the date of stem cell infusion. The estimated 2-year PFS was 87.1%, and the estimated 2-year OS was 73.5%.

Patients who received BV-IGEV as first salvage fared better than those who received the regimen as second salvage. The PFS rates were 100% and 75%, respectively (P = .0078), and OS rates were 100% and 50%, respectively (P = .08).

Six patients relapsed after HSCT, and three died. Two patients died of progressive disease and one died of pulmonary infection.

These results suggest BV-IGEV can produce high response rates without compromising stem cell mobilization, but the combination should be investigated further, according to the researchers.

The researchers reported having no conflicts of interest.

jensmith@mdedge.com

SOURCE: Abuelgasim KA et al. Bone Marrow Transplant. 2019 Jan 30. doi: 10.1038/s41409-019-0454-z.

A retrospective study suggests a four-drug regimen can be effective salvage therapy for patients with relapsed or refractory classical Hodgkin lymphoma.

The regimen – brentuximab vedotin plus ifosfamide, gemcitabine, and vinorelbine (BV-IGEV) – produced responses in 27 of 28 patients studied, allowing them to undergo autologous hematopoietic stem cell transplant (HSCT).

After HSCT, the estimated 2-year progression-free survival (PFS) was 87.1% and the overall survival (OS) was 73.5%.

Though this study was limited by its small population and retrospective nature, the results “warrant further investigation,” according to Khadega A. Abuelgasim, MD, of King Abdullah International Medical Research Center in Riyadh, Saudi Arabia, and colleagues.

The researchers reported the results in a letter to Bone Marrow Transplantation.

The study included 28 patients with classical Hodgkin lymphoma, 15 of them male. The patients’ median age at HSCT was 25 years (range, 15-49 years). Twenty patients (71%) had constitutional symptoms at diagnosis, and eight (29%) had bulky disease.

Twenty-three patients (82%) received doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) as frontline therapy, and four (14%) received ABVD followed by escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone. One patient received a different frontline regimen.

The median time to relapse was 7.9 months (range, 1.9-133 months), and 12 patients (43%) were refractory to frontline treatment.

Half of patients (n = 14) received BV-IGEV as first salvage. The regimen was given as follows: ifosfamide at 2,000 mg/m² on days 1-4, gemcitabine at 800 mg/m² on days 1 and 4, vinorelbine at 20 mg/m² on day 1, prednisolone at 100 mg on days 1-4, and BV at a dose of 1.8 mg/kg on day 1 of each 3-week IGEV course.

All patients received at least two cycles of BV-IGEV and were assessed for response after one or two cycles. The median follow-up was 17 months (range, 0-65 months).

Twenty patients (71%) had a complete metabolic response to BV-IGEV, seven (25%) had a partial metabolic response, and one patient (4%) had stable disease. The patient with stable disease went on to receive another salvage regimen and achieved a partial response to that regimen.

The most common adverse events during BV-IGEV treatment were grade 3-4 neutropenia (n = 27; 96%) and thrombocytopenia (n = 25; 89%). Febrile neutropenia was also common (n = 16; 57%), as were mucositis (n = 6; 21%) and diarrhea (n = 6; 21%). Six patients had a reduction in BV dose because of an adverse event.

All patients underwent autologous HSCT. They received carmustine, etoposide, cytarabine, and melphalan as conditioning beforehand, and 18 patients (64%) received consolidative BV after transplant.

PFS and OS were calculated from the date of stem cell infusion. The estimated 2-year PFS was 87.1%, and the estimated 2-year OS was 73.5%.

Patients who received BV-IGEV as first salvage fared better than those who received the regimen as second salvage. The PFS rates were 100% and 75%, respectively (P = .0078), and OS rates were 100% and 50%, respectively (P = .08).

Six patients relapsed after HSCT, and three died. Two patients died of progressive disease and one died of pulmonary infection.

These results suggest BV-IGEV can produce high response rates without compromising stem cell mobilization, but the combination should be investigated further, according to the researchers.

The researchers reported having no conflicts of interest.

jensmith@mdedge.com

SOURCE: Abuelgasim KA et al. Bone Marrow Transplant. 2019 Jan 30. doi: 10.1038/s41409-019-0454-z.

WAIKOLOA, HAWAII – “Nothing can ruin your day more than a lot of bleeding,” said Mohs surgeon Daniel Siegel, MD, clinical professor of dermatology at the State University of New York Downstate Medical Center, New York.

Vidyard Video

“Part of planning for surgery is to prevent that sort of problem,” and fortunately, when sutures and pressure don’t do the trick for excess bleeding, there are several hemostatic products that can be used, and some are very inexpensive. There’s even a “fancy form of potato starch” that can be left in the wound and sewn over, he said in an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation.

During the interview, Dr. Siegel described several options and how to use them. They are good products to have on hand in the clinic, just in case, he said.

SDEF/Global Academy for Medical Education and this news organization and are owned by the same parent company.
 

aotto@mdedge.com

WAIKOLOA, HAWAII – “Nothing can ruin your day more than a lot of bleeding,” said Mohs surgeon Daniel Siegel, MD, clinical professor of dermatology at the State University of New York Downstate Medical Center, New York.

Vidyard Video

“Part of planning for surgery is to prevent that sort of problem,” and fortunately, when sutures and pressure don’t do the trick for excess bleeding, there are several hemostatic products that can be used, and some are very inexpensive. There’s even a “fancy form of potato starch” that can be left in the wound and sewn over, he said in an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation.

During the interview, Dr. Siegel described several options and how to use them. They are good products to have on hand in the clinic, just in case, he said.

SDEF/Global Academy for Medical Education and this news organization and are owned by the same parent company.
 

aotto@mdedge.com

WAIKOLOA, HAWAII – “Nothing can ruin your day more than a lot of bleeding,” said Mohs surgeon Daniel Siegel, MD, clinical professor of dermatology at the State University of New York Downstate Medical Center, New York.

Vidyard Video

“Part of planning for surgery is to prevent that sort of problem,” and fortunately, when sutures and pressure don’t do the trick for excess bleeding, there are several hemostatic products that can be used, and some are very inexpensive. There’s even a “fancy form of potato starch” that can be left in the wound and sewn over, he said in an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation.

During the interview, Dr. Siegel described several options and how to use them. They are good products to have on hand in the clinic, just in case, he said.

SDEF/Global Academy for Medical Education and this news organization and are owned by the same parent company.
 

aotto@mdedge.com

Inducing labor at 41 weeks’ gestation for women with low-risk pregnancies was associated with a 1.4% lower risk of adverse perinatal outcomes, compared with expectant management until 42 weeks, according to results from a randomized, controlled noninferiority trial.

Bunwit/Getty Images

“As with every intervention in the natural birth process, the decision to induce labour must be made with caution, as the expected benefits should outweigh possible adverse effects for both mother and child,” wrote Judit K.J. Keulen, of the department of obstetrics and gynecology at Amsterdam University Medical Center, and her colleagues. “The results of our study should be used to inform women approaching a gestational age of 41 weeks, so they can weigh the respective outcomes and decide whether to be induced at 41 weeks or to continue pregnancy until 42 weeks.”

Ms. Keulen and her colleagues randomized 1,801 women from 123 primary care midwifery practices and 45 hospitals across the Netherlands to receive induction (n = 900) at 41 weeks or expectant management (n = 901) at 42 weeks between 2012 and 2016. The investigators used a composite of perinatal mortality measures, which included Apgar score less than 7 at 5 minutes, arterial pH less than 7.05, meconium aspiration syndrome, neonatal ICU admission, intracranial hemorrhage, and/or brachial plexus injury.

Overall, there were 15 adverse perinatal outcomes in the induction group (1.7%) and 28 adverse outcomes in the expectant management group (3.1%; absolute risk difference, −1.4%). A lower number of infants (n = 11; 1.2%) in the induction group had an Apgar score less than 7 at 5 minutes, compared with infants (n = 23; 2.6%) in the expectant management group (relative risk, 0.48), and there were zero infants and 3 infants (RR, 0.3%) in the induction and expectant management groups, respectively, who had an Apgar score less than 4 at 5 minutes.

Three (0.3%) infants in the induction group and 8 (0.9%) infants in the expectant management group were admitted to the NICU (RR, 0.38). There was one (0.1%) case of fetal death in the induction group and two (0.2%) cases in the expectant management group, but there were no neonatal deaths in either group. With regard to composite adverse maternal outcomes, there were no significant differences between the induction group (n = 122; 14%) and the expectant management group (n = 102; 11%) and both groups had the same number of cesarean sections (n = 97; 11%).

SOURCE: Keulen JKJ et al. BMJ. 2019 Feb 20. doi: 10.1136/bmj.l344.

Inducing labor at 41 weeks’ gestation for women with low-risk pregnancies was associated with a 1.4% lower risk of adverse perinatal outcomes, compared with expectant management until 42 weeks, according to results from a randomized, controlled noninferiority trial.

Bunwit/Getty Images

“As with every intervention in the natural birth process, the decision to induce labour must be made with caution, as the expected benefits should outweigh possible adverse effects for both mother and child,” wrote Judit K.J. Keulen, of the department of obstetrics and gynecology at Amsterdam University Medical Center, and her colleagues. “The results of our study should be used to inform women approaching a gestational age of 41 weeks, so they can weigh the respective outcomes and decide whether to be induced at 41 weeks or to continue pregnancy until 42 weeks.”

Ms. Keulen and her colleagues randomized 1,801 women from 123 primary care midwifery practices and 45 hospitals across the Netherlands to receive induction (n = 900) at 41 weeks or expectant management (n = 901) at 42 weeks between 2012 and 2016. The investigators used a composite of perinatal mortality measures, which included Apgar score less than 7 at 5 minutes, arterial pH less than 7.05, meconium aspiration syndrome, neonatal ICU admission, intracranial hemorrhage, and/or brachial plexus injury.

Overall, there were 15 adverse perinatal outcomes in the induction group (1.7%) and 28 adverse outcomes in the expectant management group (3.1%; absolute risk difference, −1.4%). A lower number of infants (n = 11; 1.2%) in the induction group had an Apgar score less than 7 at 5 minutes, compared with infants (n = 23; 2.6%) in the expectant management group (relative risk, 0.48), and there were zero infants and 3 infants (RR, 0.3%) in the induction and expectant management groups, respectively, who had an Apgar score less than 4 at 5 minutes.

Three (0.3%) infants in the induction group and 8 (0.9%) infants in the expectant management group were admitted to the NICU (RR, 0.38). There was one (0.1%) case of fetal death in the induction group and two (0.2%) cases in the expectant management group, but there were no neonatal deaths in either group. With regard to composite adverse maternal outcomes, there were no significant differences between the induction group (n = 122; 14%) and the expectant management group (n = 102; 11%) and both groups had the same number of cesarean sections (n = 97; 11%).

SOURCE: Keulen JKJ et al. BMJ. 2019 Feb 20. doi: 10.1136/bmj.l344.

Inducing labor at 41 weeks’ gestation for women with low-risk pregnancies was associated with a 1.4% lower risk of adverse perinatal outcomes, compared with expectant management until 42 weeks, according to results from a randomized, controlled noninferiority trial.

Bunwit/Getty Images

“As with every intervention in the natural birth process, the decision to induce labour must be made with caution, as the expected benefits should outweigh possible adverse effects for both mother and child,” wrote Judit K.J. Keulen, of the department of obstetrics and gynecology at Amsterdam University Medical Center, and her colleagues. “The results of our study should be used to inform women approaching a gestational age of 41 weeks, so they can weigh the respective outcomes and decide whether to be induced at 41 weeks or to continue pregnancy until 42 weeks.”

Ms. Keulen and her colleagues randomized 1,801 women from 123 primary care midwifery practices and 45 hospitals across the Netherlands to receive induction (n = 900) at 41 weeks or expectant management (n = 901) at 42 weeks between 2012 and 2016. The investigators used a composite of perinatal mortality measures, which included Apgar score less than 7 at 5 minutes, arterial pH less than 7.05, meconium aspiration syndrome, neonatal ICU admission, intracranial hemorrhage, and/or brachial plexus injury.

Overall, there were 15 adverse perinatal outcomes in the induction group (1.7%) and 28 adverse outcomes in the expectant management group (3.1%; absolute risk difference, −1.4%). A lower number of infants (n = 11; 1.2%) in the induction group had an Apgar score less than 7 at 5 minutes, compared with infants (n = 23; 2.6%) in the expectant management group (relative risk, 0.48), and there were zero infants and 3 infants (RR, 0.3%) in the induction and expectant management groups, respectively, who had an Apgar score less than 4 at 5 minutes.

Three (0.3%) infants in the induction group and 8 (0.9%) infants in the expectant management group were admitted to the NICU (RR, 0.38). There was one (0.1%) case of fetal death in the induction group and two (0.2%) cases in the expectant management group, but there were no neonatal deaths in either group. With regard to composite adverse maternal outcomes, there were no significant differences between the induction group (n = 122; 14%) and the expectant management group (n = 102; 11%) and both groups had the same number of cesarean sections (n = 97; 11%).

SOURCE: Keulen JKJ et al. BMJ. 2019 Feb 20. doi: 10.1136/bmj.l344.

Most hospitalists’ training likely included caring for patients in the ambulatory clinic, urgent care, and ED settings. One of the most important aspects of medical training is deciding which of the patients seen in these settings need to “be admitted” to a hospital because of risk, severity of illness, and/or need for certain medical services. In this context, “admit” is a synonym for “hospitalize.”

However, in today’s health care system, in which hospitalization costs are usually borne by a third-party payer, “admit” can have a very different meaning. For most payers, “admit” means “hospitalize as inpatient.” This is distinct from “hospitalize as an outpatient.” (“Observation” or “obs” is the most common example of a hospitalization as an outpatient.) In the medical payer world, inpatient and outpatient are often referred to as “statuses.” The distinction between inpatient versus outpatient status can affect payment and is based on rules that a hospital and payer have agreed upon. (Inpatient hospital care is generally paid at a higher rate than outpatient hospital care.) It is important for hospitalists to have a basic understanding of these rules because it can affect hospital billing, the hospitalist’s professional fees, beneficiary liability, and payer denials of inpatient care.

For years, Medicare’s definition of an inpatient hospitalization was primarily based on an expectation of a hospitalization of at least 24 hours and a physician’s judgment of the beneficiary’s need for inpatient hospital services. This judgment was to be based on the physician’s assessment of the patient’s severity of illness, the risk of an adverse outcome, and the hospital services required. (The exact definition by Centers for Medicare & Medicaid Services is much longer and can be found in the Medicare Benefits Policy Manual.¹) Under Medicare, defining a hospitalization as inpatient versus outpatient is especially important because they are billed to different Medicare programs (Part A for inpatient, Part B for outpatient), and both hospital reimbursement and the patient liability can vary significantly.

Not surprisingly, CMS found that how physicians were making status decisions for medically similar hospitalized patients varied greatly. CMS noted two major concerns: an overuse of inpatient for patients hospitalized overnight leading to increased charges to CMS and multiday observation hospitalizations for lower-acuity patients leading to excessive liability for Medicare beneficiaries. (Observation stays are billed under Part B, under which the beneficiary generally has a 20% copay.)

To address these concerns, in October 2013, CMS adjusted the definition of inpatient to include “the two-midnight rule.” Basically, CMS said that, in order to qualify for inpatient, the admitting physician should expect the beneficiary to require hospital care spanning at least two midnights, rather than the previous 24-hour benchmark, regardless of the severity of illness or risk of adverse outcome. (There are exceptions and exemptions to the two-midnight rule, which are discussed later in this article.)

The idea of the two-midnight rule was to address the two concerns noted above. Under this rule, most expected overnight hospitalizations should be outpatients, even if they are more than 24 hours in length, and any medically necessary outpatient hospitalization should be “converted” to inpatient if and when it is clear that a second midnight of hospitalization is medically necessary.

In January 2016, CMS amended the two-midnight rule to recognize, as it had done prior to October 2013, that some hospitalizations, based on physician judgment, would be appropriate for inpatient without an expectation of a hospitalization that spans at least two midnights. Unfortunately, CMS has not been forthcoming with guidance of examples of which hospitalizations would fall into this new category, other than to say they expect the use of this new provision would generally not be appropriate for a hospital stay of less than 24 hours.

As of today, physicians should order inpatient services under the following three situations:

• The physician expects the beneficiary to require hospital care spanning at least two midnights.
• The physician provides a service on Medicare’s inpatient-only list.
• The physician expects the beneficiary to require hospital care for less than two midnights but feels that inpatient services are nevertheless appropriate.

This most recently updated version of the two-midnight rule can be found in Section 42 CFR §412.3 of the Code of Federal Regulations.² Each of these three situations warrants additional discussion.
 

Care expected to span two midnights

The first situation is the one most applicable to hospitalists. In this circumstance there are three key points to remember.

The first point is that the two-midnight rule is based on a reasonable expectation of a need for hospitalization for at least two nights, not the actual length of hospitalization. Auditors, based on long-standing guidance from the CMS, should consider only the information known (or that should have been known) to the provider at the time the inpatient decision is made.

For example, if the expectation of the need for hospitalization of at least 2 midnights is well documented in the admission note, but the beneficiary improves more rapidly than expected and can be discharged before the second midnight, billing Medicare under Part A for inpatient admission remains appropriate. Auditors may look for provider documentation describing the unexpected improvement, and while such documentation is not an absolute requirement, its presence can be helpful in defending inpatient billing.

Other situations in which there can be an expectation of hospitalization of at least two midnights, but the actual length of stay does not meet this benchmark, are death, patients leaving against medical advice, or transfer to another hospital. For example, if a patient is hospitalized as an inpatient for bacterial endocarditis, and the documented plan of care includes at least 2 days of IV antibiotics and monitoring of cultures, inpatient remains appropriate even if the patient signs out against medical advice the following day.

The second key point to understand is that a night must be “medically necessary” to count toward the two-midnight benchmark. Hospital time spent receiving custodial care, because of excessive delays, or incurred because of the convenience of the beneficiary or provider does not count toward the two-midnight benchmark. For example, imagine a patient hospitalized with chest pain on Saturday evening and the attending physician determines that the patient requires serial cardiac isoenzymes and ECGs followed, most likely, by a noninvasive stress test. The attending physician, knowing that the hospital does not offer stress testing on Sunday, expects the patient to remain hospitalized at least until Monday, thus two midnights. However, in this situation, the second midnight (Sunday night) was not medically necessary and does not count toward the two midnight expectation.

The third key point to know is that the clock for calculating the two-midnight rule begins when the beneficiary starts receiving hospital care, not when the inpatient order is placed. Further, care that starts in the ED or at another hospital counts, too. In contrast, care at an outpatient clinic, an urgent care facility, or waiting-room time in an ED does not count.

When CMS implemented the two-midnight rule in 2013, they said that they would be open to exceptions. The first and only exception to date to the two-midnight rule is newly initiated and unanticipated mechanical ventilation. (This excludes anticipated intubations related to other care, such as procedures.) For example, inpatient is appropriate for a patient who requires hospitalization for an anaphylactic reaction or a drug overdose and needs intubation and mechanical ventilation, even if discharge is expected before a second midnight of hospital care.
 

CMS’s inpatient-only list

Each year, CMS publishes a list of procedures that CMS will pay only under Part A (that is, as inpatient). This list is updated quarterly (Addendum E) and can be found on the CMS website.³ Hospitalizations associated with the procedures on this list should always be inpatient, regardless of the expected length of stay.

It is important to note that the inpatient-only list is dynamic; it is revised annually, and procedures can come on or off the list. Notably, in January 2018, elective total knee replacements and laparoscopic radical prostatectomies came off the inpatient-only list. Most surgeons and proceduralists know whether the procedure they are performing is on this list, and they should advise hospitalists accordingly if the hospitalist is to be the attending of record and will be writing the admission order.
 

Inpatient services are nevertheless appropriate

The third situation, in which an inpatient admission is appropriate even when the admitting provider does not expect a two-midnight stay, was added to the two-midnight rule in January 2016. CMS states that the factors used in making this determination can be based on physician judgment and documented in the medical record.

At first reading, one might think that CMS is, in effect, returning to the definition of an inpatient prior to the two-midnight rule’s implementation in 2013. However, CMS has not offered clear guidance for its use, and they did not remove any of the previous two-midnight rule guidance. In the absence of clear guidance, hospitalists may be best served by not using this latest change to the two-midnight rule in determining which Medicare beneficiary hospitalizations are appropriate for inpatient designation.

A final, and critical, point about the two-midnight rule is that it only applies to traditional Medicare, and it does not apply to other payers, including commercial insurance and Medicaid. Medicare Advantage plans may or may not follow the two-midnight rule, depending on their contract with the hospital. Which patients are appropriate for inpatient designations are usually determined by the individual contract that the hospital has signed with that payer.

A better understanding of the two-midnight rule including to whom it applies, when it applies, and how to apply it will help you accurately determine which hospitalizations are appropriate for inpatient payment. With this understanding you will quickly become the hero of your hospital’s case managers and billing department.

Dr. Locke is senior physician advisor at the Johns Hopkins Hospital in Baltimore and president-elect of the American College of Physician Advisors. Dr. Hu is executive director of physician advisor services at the University of North Carolina Health Care System, Chapel Hill, and president of the American College of Physician Advisors.

References

1. Medicare Benefit Policy Manual. Chapter 1 - Inpatient Hospital Services Covered Under Part A. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c01.pdf.

2. Code of Federal Regulations. https://www.ecfr.gov/cgi-bin/text-idx?SID=958ee67a826285698204a34e1e5d6406&node=42:2.0.1.2.12.1.47.3&rgn=div8.

3. Current Procedural Terminology, Fourth Edition. https://www.cms.gov/apps/ama/license.asp?file=/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/CMS-1695-FC-2019-OPPS-FR-Addenda.zip.

Most hospitalists’ training likely included caring for patients in the ambulatory clinic, urgent care, and ED settings. One of the most important aspects of medical training is deciding which of the patients seen in these settings need to “be admitted” to a hospital because of risk, severity of illness, and/or need for certain medical services. In this context, “admit” is a synonym for “hospitalize.”

However, in today’s health care system, in which hospitalization costs are usually borne by a third-party payer, “admit” can have a very different meaning. For most payers, “admit” means “hospitalize as inpatient.” This is distinct from “hospitalize as an outpatient.” (“Observation” or “obs” is the most common example of a hospitalization as an outpatient.) In the medical payer world, inpatient and outpatient are often referred to as “statuses.” The distinction between inpatient versus outpatient status can affect payment and is based on rules that a hospital and payer have agreed upon. (Inpatient hospital care is generally paid at a higher rate than outpatient hospital care.) It is important for hospitalists to have a basic understanding of these rules because it can affect hospital billing, the hospitalist’s professional fees, beneficiary liability, and payer denials of inpatient care.

For years, Medicare’s definition of an inpatient hospitalization was primarily based on an expectation of a hospitalization of at least 24 hours and a physician’s judgment of the beneficiary’s need for inpatient hospital services. This judgment was to be based on the physician’s assessment of the patient’s severity of illness, the risk of an adverse outcome, and the hospital services required. (The exact definition by Centers for Medicare & Medicaid Services is much longer and can be found in the Medicare Benefits Policy Manual.¹) Under Medicare, defining a hospitalization as inpatient versus outpatient is especially important because they are billed to different Medicare programs (Part A for inpatient, Part B for outpatient), and both hospital reimbursement and the patient liability can vary significantly.

Not surprisingly, CMS found that how physicians were making status decisions for medically similar hospitalized patients varied greatly. CMS noted two major concerns: an overuse of inpatient for patients hospitalized overnight leading to increased charges to CMS and multiday observation hospitalizations for lower-acuity patients leading to excessive liability for Medicare beneficiaries. (Observation stays are billed under Part B, under which the beneficiary generally has a 20% copay.)

To address these concerns, in October 2013, CMS adjusted the definition of inpatient to include “the two-midnight rule.” Basically, CMS said that, in order to qualify for inpatient, the admitting physician should expect the beneficiary to require hospital care spanning at least two midnights, rather than the previous 24-hour benchmark, regardless of the severity of illness or risk of adverse outcome. (There are exceptions and exemptions to the two-midnight rule, which are discussed later in this article.)

The idea of the two-midnight rule was to address the two concerns noted above. Under this rule, most expected overnight hospitalizations should be outpatients, even if they are more than 24 hours in length, and any medically necessary outpatient hospitalization should be “converted” to inpatient if and when it is clear that a second midnight of hospitalization is medically necessary.

In January 2016, CMS amended the two-midnight rule to recognize, as it had done prior to October 2013, that some hospitalizations, based on physician judgment, would be appropriate for inpatient without an expectation of a hospitalization that spans at least two midnights. Unfortunately, CMS has not been forthcoming with guidance of examples of which hospitalizations would fall into this new category, other than to say they expect the use of this new provision would generally not be appropriate for a hospital stay of less than 24 hours.

As of today, physicians should order inpatient services under the following three situations:

• The physician expects the beneficiary to require hospital care spanning at least two midnights.
• The physician provides a service on Medicare’s inpatient-only list.
• The physician expects the beneficiary to require hospital care for less than two midnights but feels that inpatient services are nevertheless appropriate.

This most recently updated version of the two-midnight rule can be found in Section 42 CFR §412.3 of the Code of Federal Regulations.² Each of these three situations warrants additional discussion.
 

Care expected to span two midnights

The first situation is the one most applicable to hospitalists. In this circumstance there are three key points to remember.

The first point is that the two-midnight rule is based on a reasonable expectation of a need for hospitalization for at least two nights, not the actual length of hospitalization. Auditors, based on long-standing guidance from the CMS, should consider only the information known (or that should have been known) to the provider at the time the inpatient decision is made.

For example, if the expectation of the need for hospitalization of at least 2 midnights is well documented in the admission note, but the beneficiary improves more rapidly than expected and can be discharged before the second midnight, billing Medicare under Part A for inpatient admission remains appropriate. Auditors may look for provider documentation describing the unexpected improvement, and while such documentation is not an absolute requirement, its presence can be helpful in defending inpatient billing.

Other situations in which there can be an expectation of hospitalization of at least two midnights, but the actual length of stay does not meet this benchmark, are death, patients leaving against medical advice, or transfer to another hospital. For example, if a patient is hospitalized as an inpatient for bacterial endocarditis, and the documented plan of care includes at least 2 days of IV antibiotics and monitoring of cultures, inpatient remains appropriate even if the patient signs out against medical advice the following day.

The second key point to understand is that a night must be “medically necessary” to count toward the two-midnight benchmark. Hospital time spent receiving custodial care, because of excessive delays, or incurred because of the convenience of the beneficiary or provider does not count toward the two-midnight benchmark. For example, imagine a patient hospitalized with chest pain on Saturday evening and the attending physician determines that the patient requires serial cardiac isoenzymes and ECGs followed, most likely, by a noninvasive stress test. The attending physician, knowing that the hospital does not offer stress testing on Sunday, expects the patient to remain hospitalized at least until Monday, thus two midnights. However, in this situation, the second midnight (Sunday night) was not medically necessary and does not count toward the two midnight expectation.

The third key point to know is that the clock for calculating the two-midnight rule begins when the beneficiary starts receiving hospital care, not when the inpatient order is placed. Further, care that starts in the ED or at another hospital counts, too. In contrast, care at an outpatient clinic, an urgent care facility, or waiting-room time in an ED does not count.

When CMS implemented the two-midnight rule in 2013, they said that they would be open to exceptions. The first and only exception to date to the two-midnight rule is newly initiated and unanticipated mechanical ventilation. (This excludes anticipated intubations related to other care, such as procedures.) For example, inpatient is appropriate for a patient who requires hospitalization for an anaphylactic reaction or a drug overdose and needs intubation and mechanical ventilation, even if discharge is expected before a second midnight of hospital care.
 

CMS’s inpatient-only list

Each year, CMS publishes a list of procedures that CMS will pay only under Part A (that is, as inpatient). This list is updated quarterly (Addendum E) and can be found on the CMS website.³ Hospitalizations associated with the procedures on this list should always be inpatient, regardless of the expected length of stay.

It is important to note that the inpatient-only list is dynamic; it is revised annually, and procedures can come on or off the list. Notably, in January 2018, elective total knee replacements and laparoscopic radical prostatectomies came off the inpatient-only list. Most surgeons and proceduralists know whether the procedure they are performing is on this list, and they should advise hospitalists accordingly if the hospitalist is to be the attending of record and will be writing the admission order.
 

Inpatient services are nevertheless appropriate

The third situation, in which an inpatient admission is appropriate even when the admitting provider does not expect a two-midnight stay, was added to the two-midnight rule in January 2016. CMS states that the factors used in making this determination can be based on physician judgment and documented in the medical record.

At first reading, one might think that CMS is, in effect, returning to the definition of an inpatient prior to the two-midnight rule’s implementation in 2013. However, CMS has not offered clear guidance for its use, and they did not remove any of the previous two-midnight rule guidance. In the absence of clear guidance, hospitalists may be best served by not using this latest change to the two-midnight rule in determining which Medicare beneficiary hospitalizations are appropriate for inpatient designation.

A final, and critical, point about the two-midnight rule is that it only applies to traditional Medicare, and it does not apply to other payers, including commercial insurance and Medicaid. Medicare Advantage plans may or may not follow the two-midnight rule, depending on their contract with the hospital. Which patients are appropriate for inpatient designations are usually determined by the individual contract that the hospital has signed with that payer.

A better understanding of the two-midnight rule including to whom it applies, when it applies, and how to apply it will help you accurately determine which hospitalizations are appropriate for inpatient payment. With this understanding you will quickly become the hero of your hospital’s case managers and billing department.

Dr. Locke is senior physician advisor at the Johns Hopkins Hospital in Baltimore and president-elect of the American College of Physician Advisors. Dr. Hu is executive director of physician advisor services at the University of North Carolina Health Care System, Chapel Hill, and president of the American College of Physician Advisors.

References

1. Medicare Benefit Policy Manual. Chapter 1 - Inpatient Hospital Services Covered Under Part A. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c01.pdf.

2. Code of Federal Regulations. https://www.ecfr.gov/cgi-bin/text-idx?SID=958ee67a826285698204a34e1e5d6406&node=42:2.0.1.2.12.1.47.3&rgn=div8.

3. Current Procedural Terminology, Fourth Edition. https://www.cms.gov/apps/ama/license.asp?file=/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/CMS-1695-FC-2019-OPPS-FR-Addenda.zip.

Most hospitalists’ training likely included caring for patients in the ambulatory clinic, urgent care, and ED settings. One of the most important aspects of medical training is deciding which of the patients seen in these settings need to “be admitted” to a hospital because of risk, severity of illness, and/or need for certain medical services. In this context, “admit” is a synonym for “hospitalize.”

However, in today’s health care system, in which hospitalization costs are usually borne by a third-party payer, “admit” can have a very different meaning. For most payers, “admit” means “hospitalize as inpatient.” This is distinct from “hospitalize as an outpatient.” (“Observation” or “obs” is the most common example of a hospitalization as an outpatient.) In the medical payer world, inpatient and outpatient are often referred to as “statuses.” The distinction between inpatient versus outpatient status can affect payment and is based on rules that a hospital and payer have agreed upon. (Inpatient hospital care is generally paid at a higher rate than outpatient hospital care.) It is important for hospitalists to have a basic understanding of these rules because it can affect hospital billing, the hospitalist’s professional fees, beneficiary liability, and payer denials of inpatient care.

For years, Medicare’s definition of an inpatient hospitalization was primarily based on an expectation of a hospitalization of at least 24 hours and a physician’s judgment of the beneficiary’s need for inpatient hospital services. This judgment was to be based on the physician’s assessment of the patient’s severity of illness, the risk of an adverse outcome, and the hospital services required. (The exact definition by Centers for Medicare & Medicaid Services is much longer and can be found in the Medicare Benefits Policy Manual.¹) Under Medicare, defining a hospitalization as inpatient versus outpatient is especially important because they are billed to different Medicare programs (Part A for inpatient, Part B for outpatient), and both hospital reimbursement and the patient liability can vary significantly.

Not surprisingly, CMS found that how physicians were making status decisions for medically similar hospitalized patients varied greatly. CMS noted two major concerns: an overuse of inpatient for patients hospitalized overnight leading to increased charges to CMS and multiday observation hospitalizations for lower-acuity patients leading to excessive liability for Medicare beneficiaries. (Observation stays are billed under Part B, under which the beneficiary generally has a 20% copay.)

To address these concerns, in October 2013, CMS adjusted the definition of inpatient to include “the two-midnight rule.” Basically, CMS said that, in order to qualify for inpatient, the admitting physician should expect the beneficiary to require hospital care spanning at least two midnights, rather than the previous 24-hour benchmark, regardless of the severity of illness or risk of adverse outcome. (There are exceptions and exemptions to the two-midnight rule, which are discussed later in this article.)

The idea of the two-midnight rule was to address the two concerns noted above. Under this rule, most expected overnight hospitalizations should be outpatients, even if they are more than 24 hours in length, and any medically necessary outpatient hospitalization should be “converted” to inpatient if and when it is clear that a second midnight of hospitalization is medically necessary.

In January 2016, CMS amended the two-midnight rule to recognize, as it had done prior to October 2013, that some hospitalizations, based on physician judgment, would be appropriate for inpatient without an expectation of a hospitalization that spans at least two midnights. Unfortunately, CMS has not been forthcoming with guidance of examples of which hospitalizations would fall into this new category, other than to say they expect the use of this new provision would generally not be appropriate for a hospital stay of less than 24 hours.

As of today, physicians should order inpatient services under the following three situations:

• The physician expects the beneficiary to require hospital care spanning at least two midnights.
• The physician provides a service on Medicare’s inpatient-only list.
• The physician expects the beneficiary to require hospital care for less than two midnights but feels that inpatient services are nevertheless appropriate.

This most recently updated version of the two-midnight rule can be found in Section 42 CFR §412.3 of the Code of Federal Regulations.² Each of these three situations warrants additional discussion.
 

Care expected to span two midnights

The first situation is the one most applicable to hospitalists. In this circumstance there are three key points to remember.

The first point is that the two-midnight rule is based on a reasonable expectation of a need for hospitalization for at least two nights, not the actual length of hospitalization. Auditors, based on long-standing guidance from the CMS, should consider only the information known (or that should have been known) to the provider at the time the inpatient decision is made.

For example, if the expectation of the need for hospitalization of at least 2 midnights is well documented in the admission note, but the beneficiary improves more rapidly than expected and can be discharged before the second midnight, billing Medicare under Part A for inpatient admission remains appropriate. Auditors may look for provider documentation describing the unexpected improvement, and while such documentation is not an absolute requirement, its presence can be helpful in defending inpatient billing.

Other situations in which there can be an expectation of hospitalization of at least two midnights, but the actual length of stay does not meet this benchmark, are death, patients leaving against medical advice, or transfer to another hospital. For example, if a patient is hospitalized as an inpatient for bacterial endocarditis, and the documented plan of care includes at least 2 days of IV antibiotics and monitoring of cultures, inpatient remains appropriate even if the patient signs out against medical advice the following day.

The second key point to understand is that a night must be “medically necessary” to count toward the two-midnight benchmark. Hospital time spent receiving custodial care, because of excessive delays, or incurred because of the convenience of the beneficiary or provider does not count toward the two-midnight benchmark. For example, imagine a patient hospitalized with chest pain on Saturday evening and the attending physician determines that the patient requires serial cardiac isoenzymes and ECGs followed, most likely, by a noninvasive stress test. The attending physician, knowing that the hospital does not offer stress testing on Sunday, expects the patient to remain hospitalized at least until Monday, thus two midnights. However, in this situation, the second midnight (Sunday night) was not medically necessary and does not count toward the two midnight expectation.

The third key point to know is that the clock for calculating the two-midnight rule begins when the beneficiary starts receiving hospital care, not when the inpatient order is placed. Further, care that starts in the ED or at another hospital counts, too. In contrast, care at an outpatient clinic, an urgent care facility, or waiting-room time in an ED does not count.

When CMS implemented the two-midnight rule in 2013, they said that they would be open to exceptions. The first and only exception to date to the two-midnight rule is newly initiated and unanticipated mechanical ventilation. (This excludes anticipated intubations related to other care, such as procedures.) For example, inpatient is appropriate for a patient who requires hospitalization for an anaphylactic reaction or a drug overdose and needs intubation and mechanical ventilation, even if discharge is expected before a second midnight of hospital care.
 

CMS’s inpatient-only list

Each year, CMS publishes a list of procedures that CMS will pay only under Part A (that is, as inpatient). This list is updated quarterly (Addendum E) and can be found on the CMS website.³ Hospitalizations associated with the procedures on this list should always be inpatient, regardless of the expected length of stay.

It is important to note that the inpatient-only list is dynamic; it is revised annually, and procedures can come on or off the list. Notably, in January 2018, elective total knee replacements and laparoscopic radical prostatectomies came off the inpatient-only list. Most surgeons and proceduralists know whether the procedure they are performing is on this list, and they should advise hospitalists accordingly if the hospitalist is to be the attending of record and will be writing the admission order.
 

Inpatient services are nevertheless appropriate

The third situation, in which an inpatient admission is appropriate even when the admitting provider does not expect a two-midnight stay, was added to the two-midnight rule in January 2016. CMS states that the factors used in making this determination can be based on physician judgment and documented in the medical record.

At first reading, one might think that CMS is, in effect, returning to the definition of an inpatient prior to the two-midnight rule’s implementation in 2013. However, CMS has not offered clear guidance for its use, and they did not remove any of the previous two-midnight rule guidance. In the absence of clear guidance, hospitalists may be best served by not using this latest change to the two-midnight rule in determining which Medicare beneficiary hospitalizations are appropriate for inpatient designation.

A final, and critical, point about the two-midnight rule is that it only applies to traditional Medicare, and it does not apply to other payers, including commercial insurance and Medicaid. Medicare Advantage plans may or may not follow the two-midnight rule, depending on their contract with the hospital. Which patients are appropriate for inpatient designations are usually determined by the individual contract that the hospital has signed with that payer.

A better understanding of the two-midnight rule including to whom it applies, when it applies, and how to apply it will help you accurately determine which hospitalizations are appropriate for inpatient payment. With this understanding you will quickly become the hero of your hospital’s case managers and billing department.

Dr. Locke is senior physician advisor at the Johns Hopkins Hospital in Baltimore and president-elect of the American College of Physician Advisors. Dr. Hu is executive director of physician advisor services at the University of North Carolina Health Care System, Chapel Hill, and president of the American College of Physician Advisors.

References

1. Medicare Benefit Policy Manual. Chapter 1 - Inpatient Hospital Services Covered Under Part A. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c01.pdf.

2. Code of Federal Regulations. https://www.ecfr.gov/cgi-bin/text-idx?SID=958ee67a826285698204a34e1e5d6406&node=42:2.0.1.2.12.1.47.3&rgn=div8.

3. Current Procedural Terminology, Fourth Edition. https://www.cms.gov/apps/ama/license.asp?file=/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/CMS-1695-FC-2019-OPPS-FR-Addenda.zip.

The Food and Drug Administration has cleared Bio-Rad’s digital polymerase chain reaction (PCR) testing solution to monitor patients’ molecular response to treatment for chronic myeloid leukemia.

The QXDx AutoDG ddPCR System combines Bio-Rad’s Droplet Digital PCR technology and the QXDx BCR-ABL %IS Kit, according to the company.

This so-called liquid biopsy test can “precisely and reproducibly” monitor the molecular response to tyrosine kinase inhibitor therapy. The current standard – reverse transcription quantitative PCR – can have variable results, especially at low levels of disease, according to Bio-Rad.

FDA clearance means that the product is “substantially equivalent” to an already-approved product and can be sold in the United States, according to the agency.

cpalmer@mdedge.com

The Food and Drug Administration has cleared Bio-Rad’s digital polymerase chain reaction (PCR) testing solution to monitor patients’ molecular response to treatment for chronic myeloid leukemia.

The QXDx AutoDG ddPCR System combines Bio-Rad’s Droplet Digital PCR technology and the QXDx BCR-ABL %IS Kit, according to the company.

This so-called liquid biopsy test can “precisely and reproducibly” monitor the molecular response to tyrosine kinase inhibitor therapy. The current standard – reverse transcription quantitative PCR – can have variable results, especially at low levels of disease, according to Bio-Rad.

FDA clearance means that the product is “substantially equivalent” to an already-approved product and can be sold in the United States, according to the agency.

cpalmer@mdedge.com

The Food and Drug Administration has cleared Bio-Rad’s digital polymerase chain reaction (PCR) testing solution to monitor patients’ molecular response to treatment for chronic myeloid leukemia.

The QXDx AutoDG ddPCR System combines Bio-Rad’s Droplet Digital PCR technology and the QXDx BCR-ABL %IS Kit, according to the company.

This so-called liquid biopsy test can “precisely and reproducibly” monitor the molecular response to tyrosine kinase inhibitor therapy. The current standard – reverse transcription quantitative PCR – can have variable results, especially at low levels of disease, according to Bio-Rad.

FDA clearance means that the product is “substantially equivalent” to an already-approved product and can be sold in the United States, according to the agency.

cpalmer@mdedge.com

The gout drug febuxostat (Uloric) poses a significantly higher risk of all-cause and heart-related death than does the popular alternative drug allopurinol, the Food and Drug Administration declared on Feb. 21. The agency is now mandating a black-box warning.

“Health care professionals should reserve Uloric for use only in patients who have failed or do not tolerate allopurinol,” the FDA announced. “Counsel patients about the cardiovascular risk with Uloric,” the agency suggested, and advise them to seek medical attention at once if they have cardiac symptoms such as chest pain, shortness of breath, rapid or irregular heartbeat, or dizziness.

The FDA’s move comes a decade after it approved febuxostat as a gout treatment. As the FDA noted in its announcement, “the number of medicines to treat gout is limited, and there is an unmet need for treatments for this disease.”

Research has suggested that both febuxostat and allopurinol have similar efficacy. Some experts have recommended febuxostat as an alternative for patients who shouldn’t take allopurinol (Semin Arthritis Rheum. 2013 Dec;43[3]:367-75).

However, research has raised concerns about febuxostat’s cardiac risk. In its Feb. 21 statement, the FDA pointed to the findings of a 2010-2017 postmarket clinical trial of 6,190 patients with gout who were treated with febuxostat or allopurinol (N Engl J Med. 2018;378:1200-10).

“In patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year compared to 11 deaths from heart-related causes per 1,000 patients treated with allopurinol for a year,” the FDA said. “In addition, there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol.”

The gout drug febuxostat (Uloric) poses a significantly higher risk of all-cause and heart-related death than does the popular alternative drug allopurinol, the Food and Drug Administration declared on Feb. 21. The agency is now mandating a black-box warning.

“Health care professionals should reserve Uloric for use only in patients who have failed or do not tolerate allopurinol,” the FDA announced. “Counsel patients about the cardiovascular risk with Uloric,” the agency suggested, and advise them to seek medical attention at once if they have cardiac symptoms such as chest pain, shortness of breath, rapid or irregular heartbeat, or dizziness.

The FDA’s move comes a decade after it approved febuxostat as a gout treatment. As the FDA noted in its announcement, “the number of medicines to treat gout is limited, and there is an unmet need for treatments for this disease.”

Research has suggested that both febuxostat and allopurinol have similar efficacy. Some experts have recommended febuxostat as an alternative for patients who shouldn’t take allopurinol (Semin Arthritis Rheum. 2013 Dec;43[3]:367-75).

However, research has raised concerns about febuxostat’s cardiac risk. In its Feb. 21 statement, the FDA pointed to the findings of a 2010-2017 postmarket clinical trial of 6,190 patients with gout who were treated with febuxostat or allopurinol (N Engl J Med. 2018;378:1200-10).

“In patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year compared to 11 deaths from heart-related causes per 1,000 patients treated with allopurinol for a year,” the FDA said. “In addition, there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol.”

The gout drug febuxostat (Uloric) poses a significantly higher risk of all-cause and heart-related death than does the popular alternative drug allopurinol, the Food and Drug Administration declared on Feb. 21. The agency is now mandating a black-box warning.

“Health care professionals should reserve Uloric for use only in patients who have failed or do not tolerate allopurinol,” the FDA announced. “Counsel patients about the cardiovascular risk with Uloric,” the agency suggested, and advise them to seek medical attention at once if they have cardiac symptoms such as chest pain, shortness of breath, rapid or irregular heartbeat, or dizziness.

The FDA’s move comes a decade after it approved febuxostat as a gout treatment. As the FDA noted in its announcement, “the number of medicines to treat gout is limited, and there is an unmet need for treatments for this disease.”

Research has suggested that both febuxostat and allopurinol have similar efficacy. Some experts have recommended febuxostat as an alternative for patients who shouldn’t take allopurinol (Semin Arthritis Rheum. 2013 Dec;43[3]:367-75).

However, research has raised concerns about febuxostat’s cardiac risk. In its Feb. 21 statement, the FDA pointed to the findings of a 2010-2017 postmarket clinical trial of 6,190 patients with gout who were treated with febuxostat or allopurinol (N Engl J Med. 2018;378:1200-10).

“In patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year compared to 11 deaths from heart-related causes per 1,000 patients treated with allopurinol for a year,” the FDA said. “In addition, there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol.”

For patients with resectable stage I non–small cell lung cancer (NSCLC), stereotactic ablative radiotherapy (SABR) may lack the efficacy needed to replace surgical intervention, according to a recent phase II trial.

SABR provided a pathologic complete response rate (pCR) of 60%, which was “lower than hypothesized,” reported lead author David A. Palma, MD, PhD, of London (Ont.) Health Sciences Centre, and his colleagues.

“In patients with cancer who are fit for resection ... the role of SABR is controversial,” the investigators wrote in JAMA Oncology. “Although some recent studies suggest that SABR may achieve outcomes similar to surgery, others do not, and randomized clinical trials are currently under way to compare these 2 modalities.”

The present trial involved 40 adult patients with stage I NSCLC, good pulmonary function, and good performance status. Of these, 35 were evaluable for the primary endpoint, which was tumor pCR rate after SABR. Secondary endpoints were toxic effects, quality of life, distant control, regional control, and local control. Patients with tumors no larger than 3 cm in diameter were given 54 Gy in 3 fractions, while bigger tumors received 55 Gy in 5 fractions. Patients with tumors 2 cm or closer to the brachial plexus or mediastinum were given 60 Gy in 8 fractions. Ten weeks after SABR, sublobar resection or lobectomy was performed, via an open approach or with video-assisted thoracoscopic surgery (VATS).

Analysis revealed a pCR rate of 60%, which was lower than anticipated. One-month and 3-month survival rates were both 100%. After a median follow-up of 19 months, local control rate was 100%, but only three out of four patients (76%) had distant control, and half (53%) had regional control. After 2 years, three out of four patients were still alive (77%). Eighteen percent of patients experienced grade 3 or higher toxic effects.

“[T]he pCR rate of 60% at 10 weeks suggests that practitioners should be cautious in the use of SABR in patients with cancers who are fit for resection,” the investigators concluded.

The Ontario Institute for Cancer Research funded the study. Dr. Palma and Dr. Ward are patent holders for a computed tomography technology that assesses responses after radiotherapy. Dr. Louie reported honoraria from AstraZeneca and Varian Medical Systems Inc.

SOURCE: Palma et al. 2019 Feb 21. doi: 10.1001/jamaoncol.2018.6993.

For patients with resectable stage I non–small cell lung cancer (NSCLC), stereotactic ablative radiotherapy (SABR) may lack the efficacy needed to replace surgical intervention, according to a recent phase II trial.

SABR provided a pathologic complete response rate (pCR) of 60%, which was “lower than hypothesized,” reported lead author David A. Palma, MD, PhD, of London (Ont.) Health Sciences Centre, and his colleagues.

“In patients with cancer who are fit for resection ... the role of SABR is controversial,” the investigators wrote in JAMA Oncology. “Although some recent studies suggest that SABR may achieve outcomes similar to surgery, others do not, and randomized clinical trials are currently under way to compare these 2 modalities.”

The present trial involved 40 adult patients with stage I NSCLC, good pulmonary function, and good performance status. Of these, 35 were evaluable for the primary endpoint, which was tumor pCR rate after SABR. Secondary endpoints were toxic effects, quality of life, distant control, regional control, and local control. Patients with tumors no larger than 3 cm in diameter were given 54 Gy in 3 fractions, while bigger tumors received 55 Gy in 5 fractions. Patients with tumors 2 cm or closer to the brachial plexus or mediastinum were given 60 Gy in 8 fractions. Ten weeks after SABR, sublobar resection or lobectomy was performed, via an open approach or with video-assisted thoracoscopic surgery (VATS).

Analysis revealed a pCR rate of 60%, which was lower than anticipated. One-month and 3-month survival rates were both 100%. After a median follow-up of 19 months, local control rate was 100%, but only three out of four patients (76%) had distant control, and half (53%) had regional control. After 2 years, three out of four patients were still alive (77%). Eighteen percent of patients experienced grade 3 or higher toxic effects.

“[T]he pCR rate of 60% at 10 weeks suggests that practitioners should be cautious in the use of SABR in patients with cancers who are fit for resection,” the investigators concluded.

The Ontario Institute for Cancer Research funded the study. Dr. Palma and Dr. Ward are patent holders for a computed tomography technology that assesses responses after radiotherapy. Dr. Louie reported honoraria from AstraZeneca and Varian Medical Systems Inc.

SOURCE: Palma et al. 2019 Feb 21. doi: 10.1001/jamaoncol.2018.6993.

For patients with resectable stage I non–small cell lung cancer (NSCLC), stereotactic ablative radiotherapy (SABR) may lack the efficacy needed to replace surgical intervention, according to a recent phase II trial.

SABR provided a pathologic complete response rate (pCR) of 60%, which was “lower than hypothesized,” reported lead author David A. Palma, MD, PhD, of London (Ont.) Health Sciences Centre, and his colleagues.

“In patients with cancer who are fit for resection ... the role of SABR is controversial,” the investigators wrote in JAMA Oncology. “Although some recent studies suggest that SABR may achieve outcomes similar to surgery, others do not, and randomized clinical trials are currently under way to compare these 2 modalities.”

The present trial involved 40 adult patients with stage I NSCLC, good pulmonary function, and good performance status. Of these, 35 were evaluable for the primary endpoint, which was tumor pCR rate after SABR. Secondary endpoints were toxic effects, quality of life, distant control, regional control, and local control. Patients with tumors no larger than 3 cm in diameter were given 54 Gy in 3 fractions, while bigger tumors received 55 Gy in 5 fractions. Patients with tumors 2 cm or closer to the brachial plexus or mediastinum were given 60 Gy in 8 fractions. Ten weeks after SABR, sublobar resection or lobectomy was performed, via an open approach or with video-assisted thoracoscopic surgery (VATS).

Analysis revealed a pCR rate of 60%, which was lower than anticipated. One-month and 3-month survival rates were both 100%. After a median follow-up of 19 months, local control rate was 100%, but only three out of four patients (76%) had distant control, and half (53%) had regional control. After 2 years, three out of four patients were still alive (77%). Eighteen percent of patients experienced grade 3 or higher toxic effects.

“[T]he pCR rate of 60% at 10 weeks suggests that practitioners should be cautious in the use of SABR in patients with cancers who are fit for resection,” the investigators concluded.

The Ontario Institute for Cancer Research funded the study. Dr. Palma and Dr. Ward are patent holders for a computed tomography technology that assesses responses after radiotherapy. Dr. Louie reported honoraria from AstraZeneca and Varian Medical Systems Inc.

SOURCE: Palma et al. 2019 Feb 21. doi: 10.1001/jamaoncol.2018.6993.

Antipsychotics show no link to increased risk of major congenital malformations. Boomers will spike U.S. health costs, but growing uninsured will soften their impact. Don’t miss early joint involvement in psoriasis. And an algorithm provides practical clinical guidance on managing diabetes.

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Antipsychotics show no link to increased risk of major congenital malformations. Boomers will spike U.S. health costs, but growing uninsured will soften their impact. Don’t miss early joint involvement in psoriasis. And an algorithm provides practical clinical guidance on managing diabetes.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify

Antipsychotics show no link to increased risk of major congenital malformations. Boomers will spike U.S. health costs, but growing uninsured will soften their impact. Don’t miss early joint involvement in psoriasis. And an algorithm provides practical clinical guidance on managing diabetes.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify

In this episode, Kirti Magudia, MD, and Thomas Ng, MD, join host Nick Andrews to talk about their research regarding family leave for resident physicians in the nation’s top medical schools. The research was published in JAMA. Dr. Magudia talks about their experience doing this research, what they learned, and what the next steps are.

Apple Podcasts

Google Podcasts

Spotify
 

In this episode, Kirti Magudia, MD, and Thomas Ng, MD, join host Nick Andrews to talk about their research regarding family leave for resident physicians in the nation’s top medical schools. The research was published in JAMA. Dr. Magudia talks about their experience doing this research, what they learned, and what the next steps are.

Apple Podcasts

Google Podcasts

Spotify
 

In this episode, Kirti Magudia, MD, and Thomas Ng, MD, join host Nick Andrews to talk about their research regarding family leave for resident physicians in the nation’s top medical schools. The research was published in JAMA. Dr. Magudia talks about their experience doing this research, what they learned, and what the next steps are.

Apple Podcasts

Google Podcasts

Spotify