SAN ANTONIO – Clinicians don’t appear to mind too much when their red blood cell orders are flagged for review by a best practice alert system, and alert fatigue doesn’t seem to hamper patient blood management efforts, investigators in a single-center study reported.

Neil Osterweil/MDedge News

At the Medical University of South Carolina, Charleston (MUSC), if clinicians order RBC transfusions for patients with hemoglobin levels over 7.0 g/dL or for patients who did not have a hemoglobin determination over the past 24 hours, they receive a best practice alert. They must acknowledge it and cancel the order, or override it and document a reason in the medical record.

Although approximately 70% of alerts were overridden, the reasons for the overrides “were consistent over time and appropriate,” reported Jerry E. Squires, MD, PhD, and colleagues from MUSC in a poster presentation at the annual meeting of AABB, the group formerly known as the American Association of Blood Banks.

The goal of the study was to find out if the effectiveness of the alert was wearing out after months of active use by clinicians. “Is it true that they’re clicking too much and they’re inundated with other [best practice alerts], and are they even paying attention?” said coauthor Heather Toeppner, RN, also from MUSC, in an interview. “All in all, we found that the alert is making a lasting impression in our institution,” she said.

Transfusion clinical decision support systems that produce automated alerts for clinicians can improve usage and reduce waste of RBCs, but whether the effect is sustained over time was unknown, Ms. Toeppner said, prompting the investigators to study the effect of the RBC best practice alert over 10 months.

As noted, the alert is triggered when providers order RBCs for patients with hemoglobin levels over 7.0 g/dL or when there is no record of a hemoglobin test in the chart within the past 24 hours. Before the alert is triggered, however, the system reviews the record and excludes alerts for patients with specific conditions, such as concurrent surgery or sickle cell disease.

The authors found that the alert was triggered an average of 195 times per month over the 10 months studied. On average, 16% of the alerts resulted in a cancellation of the RBC order, and 71% of alerts were overridden.

“Most importantly, there was no trend suggesting that either cancellation of the RBC order or overriding the alert became more frequent over time,” the investigators wrote. “Similarly, reasons for overriding the alert were consistent over time, with ‘preparation for an invasive procedure’ and ‘active bleeding’ being the most common reasons for overriding the alert (32% and 23% of all overrides, respectively).”

Other common reasons for overrides included tachycardia, shortness of breath, hypotension, onset of chest pain, and acute coronary syndrome.

Interestingly, but perhaps not surprisingly, they found that overrides dropped sharply and changed orders rose by the same magnitude in July, when new residents started their rotations.

The investigators wrote that the relatively small number of alerts may be attributable to their institution’s robust patient blood management program and the intentional exclusion of orders for patients with specific diagnostic codes, including intraoperative patients, those with sickle cell disease, and all patients aged younger than 18 years.

The study was internally funded. The authors reported having no conflicts of interest.

SAN ANTONIO – Clinicians don’t appear to mind too much when their red blood cell orders are flagged for review by a best practice alert system, and alert fatigue doesn’t seem to hamper patient blood management efforts, investigators in a single-center study reported.

Neil Osterweil/MDedge News

At the Medical University of South Carolina, Charleston (MUSC), if clinicians order RBC transfusions for patients with hemoglobin levels over 7.0 g/dL or for patients who did not have a hemoglobin determination over the past 24 hours, they receive a best practice alert. They must acknowledge it and cancel the order, or override it and document a reason in the medical record.

Although approximately 70% of alerts were overridden, the reasons for the overrides “were consistent over time and appropriate,” reported Jerry E. Squires, MD, PhD, and colleagues from MUSC in a poster presentation at the annual meeting of AABB, the group formerly known as the American Association of Blood Banks.

The goal of the study was to find out if the effectiveness of the alert was wearing out after months of active use by clinicians. “Is it true that they’re clicking too much and they’re inundated with other [best practice alerts], and are they even paying attention?” said coauthor Heather Toeppner, RN, also from MUSC, in an interview. “All in all, we found that the alert is making a lasting impression in our institution,” she said.

Transfusion clinical decision support systems that produce automated alerts for clinicians can improve usage and reduce waste of RBCs, but whether the effect is sustained over time was unknown, Ms. Toeppner said, prompting the investigators to study the effect of the RBC best practice alert over 10 months.

As noted, the alert is triggered when providers order RBCs for patients with hemoglobin levels over 7.0 g/dL or when there is no record of a hemoglobin test in the chart within the past 24 hours. Before the alert is triggered, however, the system reviews the record and excludes alerts for patients with specific conditions, such as concurrent surgery or sickle cell disease.

The authors found that the alert was triggered an average of 195 times per month over the 10 months studied. On average, 16% of the alerts resulted in a cancellation of the RBC order, and 71% of alerts were overridden.

“Most importantly, there was no trend suggesting that either cancellation of the RBC order or overriding the alert became more frequent over time,” the investigators wrote. “Similarly, reasons for overriding the alert were consistent over time, with ‘preparation for an invasive procedure’ and ‘active bleeding’ being the most common reasons for overriding the alert (32% and 23% of all overrides, respectively).”

Other common reasons for overrides included tachycardia, shortness of breath, hypotension, onset of chest pain, and acute coronary syndrome.

Interestingly, but perhaps not surprisingly, they found that overrides dropped sharply and changed orders rose by the same magnitude in July, when new residents started their rotations.

The investigators wrote that the relatively small number of alerts may be attributable to their institution’s robust patient blood management program and the intentional exclusion of orders for patients with specific diagnostic codes, including intraoperative patients, those with sickle cell disease, and all patients aged younger than 18 years.

The study was internally funded. The authors reported having no conflicts of interest.

SAN ANTONIO – Clinicians don’t appear to mind too much when their red blood cell orders are flagged for review by a best practice alert system, and alert fatigue doesn’t seem to hamper patient blood management efforts, investigators in a single-center study reported.

Neil Osterweil/MDedge News

At the Medical University of South Carolina, Charleston (MUSC), if clinicians order RBC transfusions for patients with hemoglobin levels over 7.0 g/dL or for patients who did not have a hemoglobin determination over the past 24 hours, they receive a best practice alert. They must acknowledge it and cancel the order, or override it and document a reason in the medical record.

Although approximately 70% of alerts were overridden, the reasons for the overrides “were consistent over time and appropriate,” reported Jerry E. Squires, MD, PhD, and colleagues from MUSC in a poster presentation at the annual meeting of AABB, the group formerly known as the American Association of Blood Banks.

The goal of the study was to find out if the effectiveness of the alert was wearing out after months of active use by clinicians. “Is it true that they’re clicking too much and they’re inundated with other [best practice alerts], and are they even paying attention?” said coauthor Heather Toeppner, RN, also from MUSC, in an interview. “All in all, we found that the alert is making a lasting impression in our institution,” she said.

Transfusion clinical decision support systems that produce automated alerts for clinicians can improve usage and reduce waste of RBCs, but whether the effect is sustained over time was unknown, Ms. Toeppner said, prompting the investigators to study the effect of the RBC best practice alert over 10 months.

As noted, the alert is triggered when providers order RBCs for patients with hemoglobin levels over 7.0 g/dL or when there is no record of a hemoglobin test in the chart within the past 24 hours. Before the alert is triggered, however, the system reviews the record and excludes alerts for patients with specific conditions, such as concurrent surgery or sickle cell disease.

The authors found that the alert was triggered an average of 195 times per month over the 10 months studied. On average, 16% of the alerts resulted in a cancellation of the RBC order, and 71% of alerts were overridden.

“Most importantly, there was no trend suggesting that either cancellation of the RBC order or overriding the alert became more frequent over time,” the investigators wrote. “Similarly, reasons for overriding the alert were consistent over time, with ‘preparation for an invasive procedure’ and ‘active bleeding’ being the most common reasons for overriding the alert (32% and 23% of all overrides, respectively).”

Other common reasons for overrides included tachycardia, shortness of breath, hypotension, onset of chest pain, and acute coronary syndrome.

Interestingly, but perhaps not surprisingly, they found that overrides dropped sharply and changed orders rose by the same magnitude in July, when new residents started their rotations.

The investigators wrote that the relatively small number of alerts may be attributable to their institution’s robust patient blood management program and the intentional exclusion of orders for patients with specific diagnostic codes, including intraoperative patients, those with sickle cell disease, and all patients aged younger than 18 years.

The study was internally funded. The authors reported having no conflicts of interest.

WASHINGTON – Although severe, community-acquired sepsis in previously healthy U.S. adults is relatively uncommon, it occurs often enough to strike about 40,000 people annually, and when previously healthy people are hospitalized for severe sepsis, their rate of in-hospital mortality was double the rate in people with one or more comorbidities who have severe, community-acquired sepsis, based on a review of almost 7 million Americans hospitalized for sepsis.

The findings “underscore the importance of improving public awareness of sepsis and emphasizing early sepsis recognition and treatment in all patients,” including those without comorbidities, Chanu Rhee, MD, said at an annual scientific meeting on infectious diseases. He hypothesized that the increased sepsis mortality among previously healthy patients may have stemmed from factors such as delayed sepsis recognition resulting in hospitalization at a more advanced stage and less aggressive management.

In addition, “the findings provide context for high-profile reports about sepsis death in previously healthy people,” said Dr. Rhee, an infectious diseases and critical care physician at Brigham and Women’s Hospital in Boston. Dr. Rhee and associates found that, among patients hospitalized with what the researchers defined as “community-acquired” sepsis, 3% were judged previously healthy by having no identified major or minor comorbidity or pregnancy at the time of hospitalization, a percentage that – while small – still translates into roughly 40,000 such cases annually in the United States. That helps explain why every so often a headline appears about a famous person who died suddenly and unexpectedly from sepsis, he noted.

The study used data collected on hospitalized U.S. patients in the Cerner Health Facts, HCA Healthcare, and Institute for Health Metrics and Evaluation databases, which included about 6.7 million people total including 337,983 identified as having community-acquired sepsis, defined as patients who met the criteria for adult sepsis advanced by the Centers for Disease Control and Prevention within 2 days of their hospital admission. The researchers looked further into the hospital records of these patients and divided them into patients with one or more major comorbidities (96% of the cohort), patients who were pregnant or had a “minor” comorbidity such as a lipid disorder, benign neoplasm, or obesity (1% of the study group), or those with no chronic comorbidity (3%; the subgroup the researchers deemed previously healthy).

In a multivariate analysis that adjusted for patients’ age, sex, race, infection site, and illness severity at the time of hospital admission the researchers found that the rate of in-hospital death among the previously healthy patients was exactly twice the rate of those who had at least one major chronic comorbidity, Dr. Rhee reported. Differences in the treatment received by the previously-healthy patients or in their medical status compared with patients with a major comorbidity suggested that the previously health patients were sicker. They had a higher rate of mechanical ventilation, 30%, compared with about 18% for those with a comorbidity; a higher rate of acute kidney injury, about 43% in those previously healthy and 28% in those with a comorbidity; and a higher percentage had an elevated lactate level, about 41% among the previously healthy patients and about 22% among those with a comorbidity.

mzoler@mdedge.com

SOURCE: Alrawashdeh M et al. Open Forum Infect Dis. 2019 Oct 23;6. Abstract 891.

WASHINGTON – Although severe, community-acquired sepsis in previously healthy U.S. adults is relatively uncommon, it occurs often enough to strike about 40,000 people annually, and when previously healthy people are hospitalized for severe sepsis, their rate of in-hospital mortality was double the rate in people with one or more comorbidities who have severe, community-acquired sepsis, based on a review of almost 7 million Americans hospitalized for sepsis.

The findings “underscore the importance of improving public awareness of sepsis and emphasizing early sepsis recognition and treatment in all patients,” including those without comorbidities, Chanu Rhee, MD, said at an annual scientific meeting on infectious diseases. He hypothesized that the increased sepsis mortality among previously healthy patients may have stemmed from factors such as delayed sepsis recognition resulting in hospitalization at a more advanced stage and less aggressive management.

In addition, “the findings provide context for high-profile reports about sepsis death in previously healthy people,” said Dr. Rhee, an infectious diseases and critical care physician at Brigham and Women’s Hospital in Boston. Dr. Rhee and associates found that, among patients hospitalized with what the researchers defined as “community-acquired” sepsis, 3% were judged previously healthy by having no identified major or minor comorbidity or pregnancy at the time of hospitalization, a percentage that – while small – still translates into roughly 40,000 such cases annually in the United States. That helps explain why every so often a headline appears about a famous person who died suddenly and unexpectedly from sepsis, he noted.

The study used data collected on hospitalized U.S. patients in the Cerner Health Facts, HCA Healthcare, and Institute for Health Metrics and Evaluation databases, which included about 6.7 million people total including 337,983 identified as having community-acquired sepsis, defined as patients who met the criteria for adult sepsis advanced by the Centers for Disease Control and Prevention within 2 days of their hospital admission. The researchers looked further into the hospital records of these patients and divided them into patients with one or more major comorbidities (96% of the cohort), patients who were pregnant or had a “minor” comorbidity such as a lipid disorder, benign neoplasm, or obesity (1% of the study group), or those with no chronic comorbidity (3%; the subgroup the researchers deemed previously healthy).

In a multivariate analysis that adjusted for patients’ age, sex, race, infection site, and illness severity at the time of hospital admission the researchers found that the rate of in-hospital death among the previously healthy patients was exactly twice the rate of those who had at least one major chronic comorbidity, Dr. Rhee reported. Differences in the treatment received by the previously-healthy patients or in their medical status compared with patients with a major comorbidity suggested that the previously health patients were sicker. They had a higher rate of mechanical ventilation, 30%, compared with about 18% for those with a comorbidity; a higher rate of acute kidney injury, about 43% in those previously healthy and 28% in those with a comorbidity; and a higher percentage had an elevated lactate level, about 41% among the previously healthy patients and about 22% among those with a comorbidity.

mzoler@mdedge.com

SOURCE: Alrawashdeh M et al. Open Forum Infect Dis. 2019 Oct 23;6. Abstract 891.

WASHINGTON – Although severe, community-acquired sepsis in previously healthy U.S. adults is relatively uncommon, it occurs often enough to strike about 40,000 people annually, and when previously healthy people are hospitalized for severe sepsis, their rate of in-hospital mortality was double the rate in people with one or more comorbidities who have severe, community-acquired sepsis, based on a review of almost 7 million Americans hospitalized for sepsis.

The findings “underscore the importance of improving public awareness of sepsis and emphasizing early sepsis recognition and treatment in all patients,” including those without comorbidities, Chanu Rhee, MD, said at an annual scientific meeting on infectious diseases. He hypothesized that the increased sepsis mortality among previously healthy patients may have stemmed from factors such as delayed sepsis recognition resulting in hospitalization at a more advanced stage and less aggressive management.

In addition, “the findings provide context for high-profile reports about sepsis death in previously healthy people,” said Dr. Rhee, an infectious diseases and critical care physician at Brigham and Women’s Hospital in Boston. Dr. Rhee and associates found that, among patients hospitalized with what the researchers defined as “community-acquired” sepsis, 3% were judged previously healthy by having no identified major or minor comorbidity or pregnancy at the time of hospitalization, a percentage that – while small – still translates into roughly 40,000 such cases annually in the United States. That helps explain why every so often a headline appears about a famous person who died suddenly and unexpectedly from sepsis, he noted.

The study used data collected on hospitalized U.S. patients in the Cerner Health Facts, HCA Healthcare, and Institute for Health Metrics and Evaluation databases, which included about 6.7 million people total including 337,983 identified as having community-acquired sepsis, defined as patients who met the criteria for adult sepsis advanced by the Centers for Disease Control and Prevention within 2 days of their hospital admission. The researchers looked further into the hospital records of these patients and divided them into patients with one or more major comorbidities (96% of the cohort), patients who were pregnant or had a “minor” comorbidity such as a lipid disorder, benign neoplasm, or obesity (1% of the study group), or those with no chronic comorbidity (3%; the subgroup the researchers deemed previously healthy).

In a multivariate analysis that adjusted for patients’ age, sex, race, infection site, and illness severity at the time of hospital admission the researchers found that the rate of in-hospital death among the previously healthy patients was exactly twice the rate of those who had at least one major chronic comorbidity, Dr. Rhee reported. Differences in the treatment received by the previously-healthy patients or in their medical status compared with patients with a major comorbidity suggested that the previously health patients were sicker. They had a higher rate of mechanical ventilation, 30%, compared with about 18% for those with a comorbidity; a higher rate of acute kidney injury, about 43% in those previously healthy and 28% in those with a comorbidity; and a higher percentage had an elevated lactate level, about 41% among the previously healthy patients and about 22% among those with a comorbidity.

mzoler@mdedge.com

SOURCE: Alrawashdeh M et al. Open Forum Infect Dis. 2019 Oct 23;6. Abstract 891.

The annual Skin Disease Education Foundation’s Las Vegas Dermatology Seminar gets underway Thursday and will feature presentations on topics ranging from updates on acne, hyperhidrosis, and rosacea, to pigmentation disorders and connective tissue disease. The annual Psoriasis Forum at the meeting will feature talks on tumor necrosis factor inhibitors and interleukin-17 inhibitors, as well as presentations on phototherapy, emerging treatments, and IL-12/23 and IL-23 inhibitors. The Atopic Dermatology Forum will address new horizons in treatment, pediatric inflammatory disease, and the pathophysiology of atopic dermatitis.

The meeting wraps up on Saturday, with a slate of aesthetic dermatology presentations, kicking off with “Assessment of the Aging Face” and ending with “An Overview of Tissue-Tightening Devices.”

New this year is the Cutaneous Malignancies Forum, which is being held today, one day before the regular Las Vegas Dermatology Seminar program begins. With a focus on contemporary issues in effective diagnosis and treatment of cutaneous malignancies, the forum is cochaired by Sancy Leachman, MD, PhD, professor and chair of the department of dermatology, and the John D. Gray endowed chair in melanoma research, at Oregon Health & Science Center, Portland, and Mohammed Kashani-Sabet, MD, director of the Center for Melanoma Research and Treatment, at the California Pacific Medical Research Institute, San Francisco. The forum will feature four sessions: melanoma, keratinocyte carcinomas, cutaneous T-cell lymphoma, and Merkel cell carcinoma.

SDEF and this news organization are owned by the same parent company. For full coverage, go to www.mdedge.com/dermatology.
 

emechcatie@mdedge.com

The annual Skin Disease Education Foundation’s Las Vegas Dermatology Seminar gets underway Thursday and will feature presentations on topics ranging from updates on acne, hyperhidrosis, and rosacea, to pigmentation disorders and connective tissue disease. The annual Psoriasis Forum at the meeting will feature talks on tumor necrosis factor inhibitors and interleukin-17 inhibitors, as well as presentations on phototherapy, emerging treatments, and IL-12/23 and IL-23 inhibitors. The Atopic Dermatology Forum will address new horizons in treatment, pediatric inflammatory disease, and the pathophysiology of atopic dermatitis.

The meeting wraps up on Saturday, with a slate of aesthetic dermatology presentations, kicking off with “Assessment of the Aging Face” and ending with “An Overview of Tissue-Tightening Devices.”

New this year is the Cutaneous Malignancies Forum, which is being held today, one day before the regular Las Vegas Dermatology Seminar program begins. With a focus on contemporary issues in effective diagnosis and treatment of cutaneous malignancies, the forum is cochaired by Sancy Leachman, MD, PhD, professor and chair of the department of dermatology, and the John D. Gray endowed chair in melanoma research, at Oregon Health & Science Center, Portland, and Mohammed Kashani-Sabet, MD, director of the Center for Melanoma Research and Treatment, at the California Pacific Medical Research Institute, San Francisco. The forum will feature four sessions: melanoma, keratinocyte carcinomas, cutaneous T-cell lymphoma, and Merkel cell carcinoma.

SDEF and this news organization are owned by the same parent company. For full coverage, go to www.mdedge.com/dermatology.
 

emechcatie@mdedge.com

The annual Skin Disease Education Foundation’s Las Vegas Dermatology Seminar gets underway Thursday and will feature presentations on topics ranging from updates on acne, hyperhidrosis, and rosacea, to pigmentation disorders and connective tissue disease. The annual Psoriasis Forum at the meeting will feature talks on tumor necrosis factor inhibitors and interleukin-17 inhibitors, as well as presentations on phototherapy, emerging treatments, and IL-12/23 and IL-23 inhibitors. The Atopic Dermatology Forum will address new horizons in treatment, pediatric inflammatory disease, and the pathophysiology of atopic dermatitis.

The meeting wraps up on Saturday, with a slate of aesthetic dermatology presentations, kicking off with “Assessment of the Aging Face” and ending with “An Overview of Tissue-Tightening Devices.”

New this year is the Cutaneous Malignancies Forum, which is being held today, one day before the regular Las Vegas Dermatology Seminar program begins. With a focus on contemporary issues in effective diagnosis and treatment of cutaneous malignancies, the forum is cochaired by Sancy Leachman, MD, PhD, professor and chair of the department of dermatology, and the John D. Gray endowed chair in melanoma research, at Oregon Health & Science Center, Portland, and Mohammed Kashani-Sabet, MD, director of the Center for Melanoma Research and Treatment, at the California Pacific Medical Research Institute, San Francisco. The forum will feature four sessions: melanoma, keratinocyte carcinomas, cutaneous T-cell lymphoma, and Merkel cell carcinoma.

SDEF and this news organization are owned by the same parent company. For full coverage, go to www.mdedge.com/dermatology.
 

emechcatie@mdedge.com

WASHINGTON– Gene therapy for the treatment of rare diseases continues to develop and new products are entering the pipeline; however, more work is needed to make the gene therapy experience easier on patients and their families, according to members of a panel at the NORD Rare Diseases & Orphan Product Breakthrough Summit, held by the National Organization for Rare Disorders.

Companies developing gene therapy cite their main challenges as identifying patients, developing clinical trials, coordinating treatment and supporting families, managing reimbursement, and manufacturing the treatment, said Mark Rothera, president and CEO of Orchard Therapeutics, developer of ex vivo autologous hematopoietic stem cell gene therapy.

For families of patients with rare diseases who are undergoing gene therapy, challenges include struggles such as language barriers, lack of wifi, and separation from other family members for extended periods, according to Amy Price, mother of a gene therapy recipient, as well as principal consultant to Rarallel and an advocate for metachromatic leukodystrophy.

Ms. Price cited a survey she conducted of families with children who underwent gene therapy. She collected data from 16 families about their initial visit as part of a gene therapy trial; the trials included 14 families in Milan; 1 in Bethesda, Md.; and 1 in Paris. The average age of the patients at the start of the trial was 3 years, with a range of 8 months to 11 years. The trials were conducted between 1990 and 2018.

Families participating in the trials spent an average of 5.5 months in the city where the trial was conducted, and an average of 48 days in an isolation ward with their child at the start of the study.

The five biggest challenges were financial well-being (cited by 60% of survey respondents), social isolation/being away from support system (60%), fear of the unknown/long-term treatment diagnosis (73%), family separation (67%), and caring for other children simultaneous during the trial period (60%).

In addition, patients averaged 12 follow-up visits, and the most common secondary challenges cited in the survey included time spent at the hospital, emotional and physical stress on the patient, fear of test results and outcomes, exhaustion, time away from work and school, and travel logistics.

Other stressors include language barriers and not being in children’s hospital, Ms. Price said.

Ms. Price proposed patient-focused solutions such as addressing cultural challenges, connecting families to local resources, and providing clinical follow-up locally to reduce the burden of travel to the trial site.

WASHINGTON– Gene therapy for the treatment of rare diseases continues to develop and new products are entering the pipeline; however, more work is needed to make the gene therapy experience easier on patients and their families, according to members of a panel at the NORD Rare Diseases & Orphan Product Breakthrough Summit, held by the National Organization for Rare Disorders.

Companies developing gene therapy cite their main challenges as identifying patients, developing clinical trials, coordinating treatment and supporting families, managing reimbursement, and manufacturing the treatment, said Mark Rothera, president and CEO of Orchard Therapeutics, developer of ex vivo autologous hematopoietic stem cell gene therapy.

For families of patients with rare diseases who are undergoing gene therapy, challenges include struggles such as language barriers, lack of wifi, and separation from other family members for extended periods, according to Amy Price, mother of a gene therapy recipient, as well as principal consultant to Rarallel and an advocate for metachromatic leukodystrophy.

Ms. Price cited a survey she conducted of families with children who underwent gene therapy. She collected data from 16 families about their initial visit as part of a gene therapy trial; the trials included 14 families in Milan; 1 in Bethesda, Md.; and 1 in Paris. The average age of the patients at the start of the trial was 3 years, with a range of 8 months to 11 years. The trials were conducted between 1990 and 2018.

Families participating in the trials spent an average of 5.5 months in the city where the trial was conducted, and an average of 48 days in an isolation ward with their child at the start of the study.

The five biggest challenges were financial well-being (cited by 60% of survey respondents), social isolation/being away from support system (60%), fear of the unknown/long-term treatment diagnosis (73%), family separation (67%), and caring for other children simultaneous during the trial period (60%).

In addition, patients averaged 12 follow-up visits, and the most common secondary challenges cited in the survey included time spent at the hospital, emotional and physical stress on the patient, fear of test results and outcomes, exhaustion, time away from work and school, and travel logistics.

Other stressors include language barriers and not being in children’s hospital, Ms. Price said.

Ms. Price proposed patient-focused solutions such as addressing cultural challenges, connecting families to local resources, and providing clinical follow-up locally to reduce the burden of travel to the trial site.

WASHINGTON– Gene therapy for the treatment of rare diseases continues to develop and new products are entering the pipeline; however, more work is needed to make the gene therapy experience easier on patients and their families, according to members of a panel at the NORD Rare Diseases & Orphan Product Breakthrough Summit, held by the National Organization for Rare Disorders.

Companies developing gene therapy cite their main challenges as identifying patients, developing clinical trials, coordinating treatment and supporting families, managing reimbursement, and manufacturing the treatment, said Mark Rothera, president and CEO of Orchard Therapeutics, developer of ex vivo autologous hematopoietic stem cell gene therapy.

For families of patients with rare diseases who are undergoing gene therapy, challenges include struggles such as language barriers, lack of wifi, and separation from other family members for extended periods, according to Amy Price, mother of a gene therapy recipient, as well as principal consultant to Rarallel and an advocate for metachromatic leukodystrophy.

Ms. Price cited a survey she conducted of families with children who underwent gene therapy. She collected data from 16 families about their initial visit as part of a gene therapy trial; the trials included 14 families in Milan; 1 in Bethesda, Md.; and 1 in Paris. The average age of the patients at the start of the trial was 3 years, with a range of 8 months to 11 years. The trials were conducted between 1990 and 2018.

Families participating in the trials spent an average of 5.5 months in the city where the trial was conducted, and an average of 48 days in an isolation ward with their child at the start of the study.

The five biggest challenges were financial well-being (cited by 60% of survey respondents), social isolation/being away from support system (60%), fear of the unknown/long-term treatment diagnosis (73%), family separation (67%), and caring for other children simultaneous during the trial period (60%).

In addition, patients averaged 12 follow-up visits, and the most common secondary challenges cited in the survey included time spent at the hospital, emotional and physical stress on the patient, fear of test results and outcomes, exhaustion, time away from work and school, and travel logistics.

Other stressors include language barriers and not being in children’s hospital, Ms. Price said.

Ms. Price proposed patient-focused solutions such as addressing cultural challenges, connecting families to local resources, and providing clinical follow-up locally to reduce the burden of travel to the trial site.

Mint is the most popular flavor among school students who use Juul e-cigarettes, according to data from the 2019 Monitoring the Future study.

Almost half (47.1%) of the 12th graders who had used Juul e-cigarettes in the past 30 days reported that mint was the flavor they most often used, compared with 23.8% for mango and 8.6% for fruit, which is a combination of flavors, Adam M. Leventhal, PhD, of the University of Southern California, Los Angeles, and associates wrote in JAMA.

Mint was also the flavor most often used by 10th graders (43.5%), with mango again second at 27.3%, and fruit third at 10.8%. Eighth-grade students switched mango (33.5%) and mint (29.2%) but had fruit third again at 16.0%, the investigators reported, based on data for 1,739 respondents to the Monitoring the Future survey who had used a vaping product within the past 30 days.

Juul has suspended sales of four – mango, fruit, creme, and cucumber – of its original eight flavors, Dr. Leventhal and associates noted, and e-cigarette flavors other than tobacco, menthol, and mint have been prohibited by some local municipalities.

“The current findings raise uncertainty whether regulations or sales suspensions that exempt mint flavors are optimal strategies for reducing youth e-cigarette use,” they wrote.

As this article was being written, the Wall Street Journal had just reported that the Food and Drug Administration will ban mint and all other e-cigarette flavors except tobacco and menthol.

rfranki@mdedge.com

SOURCE: Leventhal AM et al. JAMA. 2019 Nov 5. doi: 10.1001/jama.2019.17968.

Mint is the most popular flavor among school students who use Juul e-cigarettes, according to data from the 2019 Monitoring the Future study.

Almost half (47.1%) of the 12th graders who had used Juul e-cigarettes in the past 30 days reported that mint was the flavor they most often used, compared with 23.8% for mango and 8.6% for fruit, which is a combination of flavors, Adam M. Leventhal, PhD, of the University of Southern California, Los Angeles, and associates wrote in JAMA.

Mint was also the flavor most often used by 10th graders (43.5%), with mango again second at 27.3%, and fruit third at 10.8%. Eighth-grade students switched mango (33.5%) and mint (29.2%) but had fruit third again at 16.0%, the investigators reported, based on data for 1,739 respondents to the Monitoring the Future survey who had used a vaping product within the past 30 days.

Juul has suspended sales of four – mango, fruit, creme, and cucumber – of its original eight flavors, Dr. Leventhal and associates noted, and e-cigarette flavors other than tobacco, menthol, and mint have been prohibited by some local municipalities.

“The current findings raise uncertainty whether regulations or sales suspensions that exempt mint flavors are optimal strategies for reducing youth e-cigarette use,” they wrote.

As this article was being written, the Wall Street Journal had just reported that the Food and Drug Administration will ban mint and all other e-cigarette flavors except tobacco and menthol.

rfranki@mdedge.com

SOURCE: Leventhal AM et al. JAMA. 2019 Nov 5. doi: 10.1001/jama.2019.17968.

Mint is the most popular flavor among school students who use Juul e-cigarettes, according to data from the 2019 Monitoring the Future study.

Almost half (47.1%) of the 12th graders who had used Juul e-cigarettes in the past 30 days reported that mint was the flavor they most often used, compared with 23.8% for mango and 8.6% for fruit, which is a combination of flavors, Adam M. Leventhal, PhD, of the University of Southern California, Los Angeles, and associates wrote in JAMA.

Mint was also the flavor most often used by 10th graders (43.5%), with mango again second at 27.3%, and fruit third at 10.8%. Eighth-grade students switched mango (33.5%) and mint (29.2%) but had fruit third again at 16.0%, the investigators reported, based on data for 1,739 respondents to the Monitoring the Future survey who had used a vaping product within the past 30 days.

Juul has suspended sales of four – mango, fruit, creme, and cucumber – of its original eight flavors, Dr. Leventhal and associates noted, and e-cigarette flavors other than tobacco, menthol, and mint have been prohibited by some local municipalities.

“The current findings raise uncertainty whether regulations or sales suspensions that exempt mint flavors are optimal strategies for reducing youth e-cigarette use,” they wrote.

As this article was being written, the Wall Street Journal had just reported that the Food and Drug Administration will ban mint and all other e-cigarette flavors except tobacco and menthol.

rfranki@mdedge.com

SOURCE: Leventhal AM et al. JAMA. 2019 Nov 5. doi: 10.1001/jama.2019.17968.

Background: Identifying paroxysmal atrial fibrillation (AFib) as the etiology of a transient ischemic attack (TIA) or stroke has implications for treatment as well as secondary prevention. Currently, there is not a universal, practical way to help determine which patients would benefit from prolonged cardiac monitoring to establish the diagnosis of AFib.

Dr. Phillips is a hospitalist at Beth Israel Deaconess Medical Center and instructor in medicine at Harvard Medical School.

Background: Identifying paroxysmal atrial fibrillation (AFib) as the etiology of a transient ischemic attack (TIA) or stroke has implications for treatment as well as secondary prevention. Currently, there is not a universal, practical way to help determine which patients would benefit from prolonged cardiac monitoring to establish the diagnosis of AFib.

Dr. Phillips is a hospitalist at Beth Israel Deaconess Medical Center and instructor in medicine at Harvard Medical School.

Background: Identifying paroxysmal atrial fibrillation (AFib) as the etiology of a transient ischemic attack (TIA) or stroke has implications for treatment as well as secondary prevention. Currently, there is not a universal, practical way to help determine which patients would benefit from prolonged cardiac monitoring to establish the diagnosis of AFib.

Dr. Phillips is a hospitalist at Beth Israel Deaconess Medical Center and instructor in medicine at Harvard Medical School.

SAN ANTONIO – Use of a large over-the-scope hemoclip for initial endoscopic treatment of severe nonvariceal upper gastrointestinal bleeding resulted in a markedly lower 30-day rebleeding rate compared with standard endoscopic hemostasis in the first-ever randomized prospective clinical trial addressing the issue, Dennis M. Jensen, MD, reported at the annual meeting of the American College of Gastroenterology.

Bruce Jancin/MDedge News

The over-the-scope clip also resulted in significantly fewer complications and cut the red blood cell transfusion rate in half, added Dr. Jensen, professor of medicine at the University of California, Los Angeles.

“The results appear to relate to the clip’s superior ability to obliterate critical arterial blood flow underneath the stigmata of hemorrhage and thereby reduce lesion rebleeding,” according to Dr. Jensen.

However, he emphasized a couple of caveats regarding this highly effective intervention.

First, it’s best reserved for patients with major stigmata of hemorrhage: that is, active arterial bleeding, a nonbleeding visible vessel, and/or adherent clot. That’s where all the benefit lies. Study participants with minor stigmata of hemorrhage – mere oozing bleeding or flat spots with arterial flow by Doppler – did just fine with standard endoscopic hemostasis, and in that setting the over-the-scope clip offered no additional benefit.

Second, there’s a significant learning curve involved in successful use of the clip.

“If someone’s going to be using this they have to get additional training. There’s a lot of tricks to using this,” the gastroenterologist cautioned.

The two-center prospective trial included 49 patients with severe nonvariceal upper GI bleeding who were randomized double-blind to the over-the-scope clip or standard hemostasis with hemoclips and/or application of a multipolar probe with epinephrine pre-injection as initial therapy. The severe bleeding was due to peptic ulcers in 40 patients and Dieulafoy’s lesions in the rest. All participants received high-dose proton pump inhibitor therapy after randomization.

The primary endpoint was clinically significant rebleeding within 30 days following initial therapy. This occurred in 7 of 25 patients (28%) on standard treatment and in 1 of 24 (4%) treated with the over-the-scope clip. This translated to an 85% relative risk reduction, with an impressive low number-needed-to-treat of 4.2.

Among the 35 patients with major stigmata of hemorrhage, the rebleeding rate was 35% in the over-the-scope clip group, compared with 6.3% with standard therapy, with a number-needed-to-treat of 3.5.

All four severe complications – a stroke, aspiration pneumonia, a case of severe heart failure, and a bleeding ischemic ulcer secondary to angiographic embolization – occurred in the standard therapy group. Patients in that group also averaged a 1.3-day-longer hospital length of stay and 2.8 more days in the ICU; however, those trends didn’t achieve statistical significance because of the small study size.

One audience member leapt to his feet to declare: “This is the study we’ve all been waiting for.” He pressed Dr. Jensen for technical details about the procedure.

Dr. Jensen explained that the large clip goes over an 11-mm-diameter endoscope with a 3-mm hood and no teeth. But he cautioned that some gastroenterologists in a busy community practice may find the procedure too time- and labor-intensive for their liking.

“It really takes two people to treat a duodenal ulcer. Somebody has to push quite firmly and suction very hard as you try to deploy this. By suctioning hard, the clip will burrow in so long as it’s centered on the stigmata of hemorrhage; that’s really key,” according to Dr. Jensen.

The procedure takes longer than standard endoscopic hemostasis because the over-the-scope clip limits visualization. So the patient must be scoped twice: the first time with a clipless diagnostic endoscope, so the operator can get his or her bearings; then that scope needs to be taken out, the patient is reintubated, and the over-the-scope clip is brought to bear.

“You shouldn’t just grab this off the shelf and try to use it in an emergency. You’ll really have problems. People have to be taught with porcine models and they need to review the stigmata,” Dr. Jensen said.

He reported having no financial conflicts regarding this study, conducted free of commercial support.

bjancin@mdedge.com

SOURCE: Jensen DM. ACG 2019, Abstract 8.

SAN ANTONIO – Use of a large over-the-scope hemoclip for initial endoscopic treatment of severe nonvariceal upper gastrointestinal bleeding resulted in a markedly lower 30-day rebleeding rate compared with standard endoscopic hemostasis in the first-ever randomized prospective clinical trial addressing the issue, Dennis M. Jensen, MD, reported at the annual meeting of the American College of Gastroenterology.

Bruce Jancin/MDedge News

The over-the-scope clip also resulted in significantly fewer complications and cut the red blood cell transfusion rate in half, added Dr. Jensen, professor of medicine at the University of California, Los Angeles.

“The results appear to relate to the clip’s superior ability to obliterate critical arterial blood flow underneath the stigmata of hemorrhage and thereby reduce lesion rebleeding,” according to Dr. Jensen.

However, he emphasized a couple of caveats regarding this highly effective intervention.

First, it’s best reserved for patients with major stigmata of hemorrhage: that is, active arterial bleeding, a nonbleeding visible vessel, and/or adherent clot. That’s where all the benefit lies. Study participants with minor stigmata of hemorrhage – mere oozing bleeding or flat spots with arterial flow by Doppler – did just fine with standard endoscopic hemostasis, and in that setting the over-the-scope clip offered no additional benefit.

Second, there’s a significant learning curve involved in successful use of the clip.

“If someone’s going to be using this they have to get additional training. There’s a lot of tricks to using this,” the gastroenterologist cautioned.

The two-center prospective trial included 49 patients with severe nonvariceal upper GI bleeding who were randomized double-blind to the over-the-scope clip or standard hemostasis with hemoclips and/or application of a multipolar probe with epinephrine pre-injection as initial therapy. The severe bleeding was due to peptic ulcers in 40 patients and Dieulafoy’s lesions in the rest. All participants received high-dose proton pump inhibitor therapy after randomization.

The primary endpoint was clinically significant rebleeding within 30 days following initial therapy. This occurred in 7 of 25 patients (28%) on standard treatment and in 1 of 24 (4%) treated with the over-the-scope clip. This translated to an 85% relative risk reduction, with an impressive low number-needed-to-treat of 4.2.

Among the 35 patients with major stigmata of hemorrhage, the rebleeding rate was 35% in the over-the-scope clip group, compared with 6.3% with standard therapy, with a number-needed-to-treat of 3.5.

All four severe complications – a stroke, aspiration pneumonia, a case of severe heart failure, and a bleeding ischemic ulcer secondary to angiographic embolization – occurred in the standard therapy group. Patients in that group also averaged a 1.3-day-longer hospital length of stay and 2.8 more days in the ICU; however, those trends didn’t achieve statistical significance because of the small study size.

One audience member leapt to his feet to declare: “This is the study we’ve all been waiting for.” He pressed Dr. Jensen for technical details about the procedure.

Dr. Jensen explained that the large clip goes over an 11-mm-diameter endoscope with a 3-mm hood and no teeth. But he cautioned that some gastroenterologists in a busy community practice may find the procedure too time- and labor-intensive for their liking.

“It really takes two people to treat a duodenal ulcer. Somebody has to push quite firmly and suction very hard as you try to deploy this. By suctioning hard, the clip will burrow in so long as it’s centered on the stigmata of hemorrhage; that’s really key,” according to Dr. Jensen.

The procedure takes longer than standard endoscopic hemostasis because the over-the-scope clip limits visualization. So the patient must be scoped twice: the first time with a clipless diagnostic endoscope, so the operator can get his or her bearings; then that scope needs to be taken out, the patient is reintubated, and the over-the-scope clip is brought to bear.

“You shouldn’t just grab this off the shelf and try to use it in an emergency. You’ll really have problems. People have to be taught with porcine models and they need to review the stigmata,” Dr. Jensen said.

He reported having no financial conflicts regarding this study, conducted free of commercial support.

bjancin@mdedge.com

SOURCE: Jensen DM. ACG 2019, Abstract 8.

SAN ANTONIO – Use of a large over-the-scope hemoclip for initial endoscopic treatment of severe nonvariceal upper gastrointestinal bleeding resulted in a markedly lower 30-day rebleeding rate compared with standard endoscopic hemostasis in the first-ever randomized prospective clinical trial addressing the issue, Dennis M. Jensen, MD, reported at the annual meeting of the American College of Gastroenterology.

Bruce Jancin/MDedge News

The over-the-scope clip also resulted in significantly fewer complications and cut the red blood cell transfusion rate in half, added Dr. Jensen, professor of medicine at the University of California, Los Angeles.

“The results appear to relate to the clip’s superior ability to obliterate critical arterial blood flow underneath the stigmata of hemorrhage and thereby reduce lesion rebleeding,” according to Dr. Jensen.

However, he emphasized a couple of caveats regarding this highly effective intervention.

First, it’s best reserved for patients with major stigmata of hemorrhage: that is, active arterial bleeding, a nonbleeding visible vessel, and/or adherent clot. That’s where all the benefit lies. Study participants with minor stigmata of hemorrhage – mere oozing bleeding or flat spots with arterial flow by Doppler – did just fine with standard endoscopic hemostasis, and in that setting the over-the-scope clip offered no additional benefit.

Second, there’s a significant learning curve involved in successful use of the clip.

“If someone’s going to be using this they have to get additional training. There’s a lot of tricks to using this,” the gastroenterologist cautioned.

The two-center prospective trial included 49 patients with severe nonvariceal upper GI bleeding who were randomized double-blind to the over-the-scope clip or standard hemostasis with hemoclips and/or application of a multipolar probe with epinephrine pre-injection as initial therapy. The severe bleeding was due to peptic ulcers in 40 patients and Dieulafoy’s lesions in the rest. All participants received high-dose proton pump inhibitor therapy after randomization.

The primary endpoint was clinically significant rebleeding within 30 days following initial therapy. This occurred in 7 of 25 patients (28%) on standard treatment and in 1 of 24 (4%) treated with the over-the-scope clip. This translated to an 85% relative risk reduction, with an impressive low number-needed-to-treat of 4.2.

Among the 35 patients with major stigmata of hemorrhage, the rebleeding rate was 35% in the over-the-scope clip group, compared with 6.3% with standard therapy, with a number-needed-to-treat of 3.5.

All four severe complications – a stroke, aspiration pneumonia, a case of severe heart failure, and a bleeding ischemic ulcer secondary to angiographic embolization – occurred in the standard therapy group. Patients in that group also averaged a 1.3-day-longer hospital length of stay and 2.8 more days in the ICU; however, those trends didn’t achieve statistical significance because of the small study size.

One audience member leapt to his feet to declare: “This is the study we’ve all been waiting for.” He pressed Dr. Jensen for technical details about the procedure.

Dr. Jensen explained that the large clip goes over an 11-mm-diameter endoscope with a 3-mm hood and no teeth. But he cautioned that some gastroenterologists in a busy community practice may find the procedure too time- and labor-intensive for their liking.

“It really takes two people to treat a duodenal ulcer. Somebody has to push quite firmly and suction very hard as you try to deploy this. By suctioning hard, the clip will burrow in so long as it’s centered on the stigmata of hemorrhage; that’s really key,” according to Dr. Jensen.

The procedure takes longer than standard endoscopic hemostasis because the over-the-scope clip limits visualization. So the patient must be scoped twice: the first time with a clipless diagnostic endoscope, so the operator can get his or her bearings; then that scope needs to be taken out, the patient is reintubated, and the over-the-scope clip is brought to bear.

“You shouldn’t just grab this off the shelf and try to use it in an emergency. You’ll really have problems. People have to be taught with porcine models and they need to review the stigmata,” Dr. Jensen said.

He reported having no financial conflicts regarding this study, conducted free of commercial support.

bjancin@mdedge.com

SOURCE: Jensen DM. ACG 2019, Abstract 8.

A 68-year-old woman is admitted to the hospital with a diagnosis of community-acquired pneumonia. Should you add probiotics to her antibiotic regimen to prevent infection with Clostridium difficile?

Clostridium difficile infection (CDI) leads to significant morbidity, mortality, and treatment failures. In 2011, it culminated in a cost of $4.8 billion and 29,000 deaths.^2,3 Risk factors for infection include antibiotic use, hospitalization, older age, and medical comorbidities.² Probiotics have been proposed as one way to prevent CDI.

Several systematic reviews have demonstrated efficacy for probiotics in the prevention of CDI, although not all of them followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines or focused specifically on hospitalized patients, who are at increased risk.^4-6 The largest high-quality randomized controlled trial (RCT) on the use of probiotics to prevent CDI, the PLACIDE trial, found no difference in CDI incidence between inpatients (ages 65 and older) who did and those who did not receive probiotics in addition to their oral or parenteral antibiotics; however, this trial had a lower incidence of CDI than was assumed in the power calculations.⁷ Guidelines from the American College of Gastroenterology and the Society for Healthcare Epidemiology of America do not include a recommendation for the use of probiotics in CDI prevention.^8,9

Given the conflicting and poor-quality evidence and lack of recommendations, an additional systematic review and meta-analysis was performed, following PRISMA guidelines and focusing on studies conducted only in hospitalized adults.

STUDY SUMMARY

Probiotics prevent CDI in this population

This meta-analysis of 19 RCTs evaluated the efficacy of probiotics for the prevention of CDI in 6261 hospitalized adults taking antibiotics. All patients were 18 or older (mean age, 68-69) and received antibiotics orally, intravenously, or via both routes, for any medical indication.

Trials were included if the intervention was for CDI prevention and if the probiotic strains used were Lactobacillus, Saccharomyces, Bifidobacterium, or Streptococcus (alone or in combination). Probiotic doses ranged from 4 billion to 900 billion colony-forming U/d and were started from 1 to 7 days after the first antibiotic dose. Duration of probiotic use was either fixed at 14 to 21 days or varied based on the duration of antibiotics (extending 3-14 d after the last antibiotic dose).

Control groups received matching placebo in all but 2 trials; those 2 used usual care of no probiotics as the control. Exclusion criteria included pregnancy, immunocompromise, intensive care, a prosthetic heart valve, and pre-existing gastrointestinal disorders.

[polldaddy:10452484]

Continue to: The risk for CDI...

The risk for CDI was lower in the probiotic group (range 0%-11%) than in the control group (0%-40%), with no heterogeneity when the data from all 19 studies were pooled (relative risk [RR], 0.42). The median incidence of CDI in the control groups from all studies was 4%, which yielded a number needed to treat (NNT) of 43.

The researchers examined the NNT at varying incidence rates. If the CDI incidence was 1.2%, the NNT to prevent 1 case of CDI was 144; if the incidence was 7.4%, the NNT was 23. Compared with control groups, there was a significant reduction in CDI if probiotics were started within 1 to 2 days of antibiotic initiation (RR, 0.32), but not if they were started at 3 to 7 days (RR, 0.70). There was no significant difference in adverse events (ie, cramping, nausea, fever, soft stools, flatulence, taste disturbance) between probiotic and control groups (14% vs 16%).

WHAT’S NEW

Added benefit if probiotics taken sooner

This high-quality meta-analysis shows that administration of probiotics to hospitalized patients—particularly when started within 1 to 2 days of initiating antibiotic therapy—can prevent CDI.

CAVEATS

Limited applicability, lack of recommendations

Findings from this meta-analysis do not apply to patients who are pregnant; who have an immunocompromising condition, a prosthetic heart valve, or a pre-existing gastrointestinal disorder (eg, irritable bowel disease, pancreatitis); or who require intensive care. In addition, specific recommendations as to the optimal probiotic species, dose, formulation, and duration of use cannot be made based on this meta-analysis. Lastly, findings from this study do not apply to patients treated with antibiotics in the ambulatory care setting.

CHALLENGES TO IMPLEMENTATION

Limited availability in hospitals

The largest barrier to giving probiotics to hospitalized adults is their availability on local hospital formularies. Probiotics are not technically a medication; they are not regulated or FDA-approved, and thus, insurance coverage and availability for inpatient use are limited. Lastly, US cost-effectiveness data are lacking, although such data would likely be favorable, given the high costs associated with treating CDI.

Continue to: ACKNOWLEDGMENT

 

 

ACKNOWLEDGMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[6]:351-352,354).

A 68-year-old woman is admitted to the hospital with a diagnosis of community-acquired pneumonia. Should you add probiotics to her antibiotic regimen to prevent infection with Clostridium difficile?

Clostridium difficile infection (CDI) leads to significant morbidity, mortality, and treatment failures. In 2011, it culminated in a cost of $4.8 billion and 29,000 deaths.^2,3 Risk factors for infection include antibiotic use, hospitalization, older age, and medical comorbidities.² Probiotics have been proposed as one way to prevent CDI.

Several systematic reviews have demonstrated efficacy for probiotics in the prevention of CDI, although not all of them followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines or focused specifically on hospitalized patients, who are at increased risk.^4-6 The largest high-quality randomized controlled trial (RCT) on the use of probiotics to prevent CDI, the PLACIDE trial, found no difference in CDI incidence between inpatients (ages 65 and older) who did and those who did not receive probiotics in addition to their oral or parenteral antibiotics; however, this trial had a lower incidence of CDI than was assumed in the power calculations.⁷ Guidelines from the American College of Gastroenterology and the Society for Healthcare Epidemiology of America do not include a recommendation for the use of probiotics in CDI prevention.^8,9

Given the conflicting and poor-quality evidence and lack of recommendations, an additional systematic review and meta-analysis was performed, following PRISMA guidelines and focusing on studies conducted only in hospitalized adults.

STUDY SUMMARY

Probiotics prevent CDI in this population

This meta-analysis of 19 RCTs evaluated the efficacy of probiotics for the prevention of CDI in 6261 hospitalized adults taking antibiotics. All patients were 18 or older (mean age, 68-69) and received antibiotics orally, intravenously, or via both routes, for any medical indication.

Trials were included if the intervention was for CDI prevention and if the probiotic strains used were Lactobacillus, Saccharomyces, Bifidobacterium, or Streptococcus (alone or in combination). Probiotic doses ranged from 4 billion to 900 billion colony-forming U/d and were started from 1 to 7 days after the first antibiotic dose. Duration of probiotic use was either fixed at 14 to 21 days or varied based on the duration of antibiotics (extending 3-14 d after the last antibiotic dose).

Control groups received matching placebo in all but 2 trials; those 2 used usual care of no probiotics as the control. Exclusion criteria included pregnancy, immunocompromise, intensive care, a prosthetic heart valve, and pre-existing gastrointestinal disorders.

[polldaddy:10452484]

Continue to: The risk for CDI...

The risk for CDI was lower in the probiotic group (range 0%-11%) than in the control group (0%-40%), with no heterogeneity when the data from all 19 studies were pooled (relative risk [RR], 0.42). The median incidence of CDI in the control groups from all studies was 4%, which yielded a number needed to treat (NNT) of 43.

The researchers examined the NNT at varying incidence rates. If the CDI incidence was 1.2%, the NNT to prevent 1 case of CDI was 144; if the incidence was 7.4%, the NNT was 23. Compared with control groups, there was a significant reduction in CDI if probiotics were started within 1 to 2 days of antibiotic initiation (RR, 0.32), but not if they were started at 3 to 7 days (RR, 0.70). There was no significant difference in adverse events (ie, cramping, nausea, fever, soft stools, flatulence, taste disturbance) between probiotic and control groups (14% vs 16%).

WHAT’S NEW

Added benefit if probiotics taken sooner

This high-quality meta-analysis shows that administration of probiotics to hospitalized patients—particularly when started within 1 to 2 days of initiating antibiotic therapy—can prevent CDI.

CAVEATS

Limited applicability, lack of recommendations

Findings from this meta-analysis do not apply to patients who are pregnant; who have an immunocompromising condition, a prosthetic heart valve, or a pre-existing gastrointestinal disorder (eg, irritable bowel disease, pancreatitis); or who require intensive care. In addition, specific recommendations as to the optimal probiotic species, dose, formulation, and duration of use cannot be made based on this meta-analysis. Lastly, findings from this study do not apply to patients treated with antibiotics in the ambulatory care setting.

CHALLENGES TO IMPLEMENTATION

Limited availability in hospitals

The largest barrier to giving probiotics to hospitalized adults is their availability on local hospital formularies. Probiotics are not technically a medication; they are not regulated or FDA-approved, and thus, insurance coverage and availability for inpatient use are limited. Lastly, US cost-effectiveness data are lacking, although such data would likely be favorable, given the high costs associated with treating CDI.

Continue to: ACKNOWLEDGMENT

 

 

ACKNOWLEDGMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[6]:351-352,354).

A 68-year-old woman is admitted to the hospital with a diagnosis of community-acquired pneumonia. Should you add probiotics to her antibiotic regimen to prevent infection with Clostridium difficile?

Clostridium difficile infection (CDI) leads to significant morbidity, mortality, and treatment failures. In 2011, it culminated in a cost of $4.8 billion and 29,000 deaths.^2,3 Risk factors for infection include antibiotic use, hospitalization, older age, and medical comorbidities.² Probiotics have been proposed as one way to prevent CDI.

Several systematic reviews have demonstrated efficacy for probiotics in the prevention of CDI, although not all of them followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines or focused specifically on hospitalized patients, who are at increased risk.^4-6 The largest high-quality randomized controlled trial (RCT) on the use of probiotics to prevent CDI, the PLACIDE trial, found no difference in CDI incidence between inpatients (ages 65 and older) who did and those who did not receive probiotics in addition to their oral or parenteral antibiotics; however, this trial had a lower incidence of CDI than was assumed in the power calculations.⁷ Guidelines from the American College of Gastroenterology and the Society for Healthcare Epidemiology of America do not include a recommendation for the use of probiotics in CDI prevention.^8,9

Given the conflicting and poor-quality evidence and lack of recommendations, an additional systematic review and meta-analysis was performed, following PRISMA guidelines and focusing on studies conducted only in hospitalized adults.

STUDY SUMMARY

Probiotics prevent CDI in this population

This meta-analysis of 19 RCTs evaluated the efficacy of probiotics for the prevention of CDI in 6261 hospitalized adults taking antibiotics. All patients were 18 or older (mean age, 68-69) and received antibiotics orally, intravenously, or via both routes, for any medical indication.

Trials were included if the intervention was for CDI prevention and if the probiotic strains used were Lactobacillus, Saccharomyces, Bifidobacterium, or Streptococcus (alone or in combination). Probiotic doses ranged from 4 billion to 900 billion colony-forming U/d and were started from 1 to 7 days after the first antibiotic dose. Duration of probiotic use was either fixed at 14 to 21 days or varied based on the duration of antibiotics (extending 3-14 d after the last antibiotic dose).

Control groups received matching placebo in all but 2 trials; those 2 used usual care of no probiotics as the control. Exclusion criteria included pregnancy, immunocompromise, intensive care, a prosthetic heart valve, and pre-existing gastrointestinal disorders.

[polldaddy:10452484]

Continue to: The risk for CDI...

The risk for CDI was lower in the probiotic group (range 0%-11%) than in the control group (0%-40%), with no heterogeneity when the data from all 19 studies were pooled (relative risk [RR], 0.42). The median incidence of CDI in the control groups from all studies was 4%, which yielded a number needed to treat (NNT) of 43.

The researchers examined the NNT at varying incidence rates. If the CDI incidence was 1.2%, the NNT to prevent 1 case of CDI was 144; if the incidence was 7.4%, the NNT was 23. Compared with control groups, there was a significant reduction in CDI if probiotics were started within 1 to 2 days of antibiotic initiation (RR, 0.32), but not if they were started at 3 to 7 days (RR, 0.70). There was no significant difference in adverse events (ie, cramping, nausea, fever, soft stools, flatulence, taste disturbance) between probiotic and control groups (14% vs 16%).

WHAT’S NEW

Added benefit if probiotics taken sooner

This high-quality meta-analysis shows that administration of probiotics to hospitalized patients—particularly when started within 1 to 2 days of initiating antibiotic therapy—can prevent CDI.

CAVEATS

Limited applicability, lack of recommendations

Findings from this meta-analysis do not apply to patients who are pregnant; who have an immunocompromising condition, a prosthetic heart valve, or a pre-existing gastrointestinal disorder (eg, irritable bowel disease, pancreatitis); or who require intensive care. In addition, specific recommendations as to the optimal probiotic species, dose, formulation, and duration of use cannot be made based on this meta-analysis. Lastly, findings from this study do not apply to patients treated with antibiotics in the ambulatory care setting.

CHALLENGES TO IMPLEMENTATION

Limited availability in hospitals

The largest barrier to giving probiotics to hospitalized adults is their availability on local hospital formularies. Probiotics are not technically a medication; they are not regulated or FDA-approved, and thus, insurance coverage and availability for inpatient use are limited. Lastly, US cost-effectiveness data are lacking, although such data would likely be favorable, given the high costs associated with treating CDI.

Continue to: ACKNOWLEDGMENT

 

 

ACKNOWLEDGMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[6]:351-352,354).

Training and alerts increase the likelihood that oncologists will discuss the costs of genomic testing and related treatments with their patients, suggests a nationally representative survey of oncologists.

“Testing can be expensive, and not all tests and related treatments are covered by health insurance,” note the investigators, who were led by K. Robin Yabroff, PhD, an epidemiologist and senior scientific director of the Surveillance and Health Services Research Program at the American Cancer Society in Atlanta.

Using data from the 2017 National Survey of Precision Medicine in Cancer Treatment, the investigators analyzed factors associated with cost discussions among 1,220 oncologists who had discussed genomic testing with their patients in the past year.

Results reported in the Journal of the National Cancer Institute showed that 50.0% of the oncologists often discussed the likely costs of genomic testing and related treatments with patients and 26.3% sometimes did, while 23.7% never or rarely did.

In adjusted analyses, oncologists were more likely to often discuss costs, versus rarely or never, if they had formal training in genomic testing (odds ratio, 1.74). And they were more likely to sometimes or often have these discussions if their practice had electronic medical record alerts for genomic testing (odds ratios, 2.09 and 2.22).

Additional physician factors positively associated with cost discussions were treating only solid cancers or both solid and hematologic cancers versus only hematologic cancers, and using next-generation sequencing gene panel tests. Additional practice factors showing positive associations included seeing a volume of 100 or more patients per month; having 10% or more of patients who were insured by Medicaid or were self-paying or uninsured; and being located in the West as compared with the Northeast.

When the survey was conducted, the cost of available genomic tests to inform treatment was $300 to more than $10,000, and molecularly targeted therapies commonly had a price tag exceeding $100,000 per year, Dr. Yabroff and coinvestigators note. Moreover, insurance coverage of this testing was in limbo.

“With rapid growth in the availability of genomic tests and targeted treatments for cancer and a large pipeline of treatments in development, improving provider discussions about expected out-of-pocket costs will be critical for ensuring informed patient treatment decision making and the opportunity to plan for treatment expenses and help address out-of-pocket costs by linking patients with available resources, and ensuring high-quality cancer care,” they maintain.

“Interventions targeting modifiable oncologist and practice factors, such as training in genomic testing and use of EMR alerts, may help improve cost discussions about genomic testing and related treatments,” the investigators conclude.

Dr. Yabroff did not disclose any relevant conflicts of interest. The study did not receive any specific funding; the survey was funded by the National Institutes of Health.

SOURCE: Yabroff KR et al. J Natl Cancer Inst. 2019 Nov 1. doi: 10.1093/jnci/djz173.

Training and alerts increase the likelihood that oncologists will discuss the costs of genomic testing and related treatments with their patients, suggests a nationally representative survey of oncologists.

“Testing can be expensive, and not all tests and related treatments are covered by health insurance,” note the investigators, who were led by K. Robin Yabroff, PhD, an epidemiologist and senior scientific director of the Surveillance and Health Services Research Program at the American Cancer Society in Atlanta.

Using data from the 2017 National Survey of Precision Medicine in Cancer Treatment, the investigators analyzed factors associated with cost discussions among 1,220 oncologists who had discussed genomic testing with their patients in the past year.

Results reported in the Journal of the National Cancer Institute showed that 50.0% of the oncologists often discussed the likely costs of genomic testing and related treatments with patients and 26.3% sometimes did, while 23.7% never or rarely did.

In adjusted analyses, oncologists were more likely to often discuss costs, versus rarely or never, if they had formal training in genomic testing (odds ratio, 1.74). And they were more likely to sometimes or often have these discussions if their practice had electronic medical record alerts for genomic testing (odds ratios, 2.09 and 2.22).

Additional physician factors positively associated with cost discussions were treating only solid cancers or both solid and hematologic cancers versus only hematologic cancers, and using next-generation sequencing gene panel tests. Additional practice factors showing positive associations included seeing a volume of 100 or more patients per month; having 10% or more of patients who were insured by Medicaid or were self-paying or uninsured; and being located in the West as compared with the Northeast.

When the survey was conducted, the cost of available genomic tests to inform treatment was $300 to more than $10,000, and molecularly targeted therapies commonly had a price tag exceeding $100,000 per year, Dr. Yabroff and coinvestigators note. Moreover, insurance coverage of this testing was in limbo.

“With rapid growth in the availability of genomic tests and targeted treatments for cancer and a large pipeline of treatments in development, improving provider discussions about expected out-of-pocket costs will be critical for ensuring informed patient treatment decision making and the opportunity to plan for treatment expenses and help address out-of-pocket costs by linking patients with available resources, and ensuring high-quality cancer care,” they maintain.

“Interventions targeting modifiable oncologist and practice factors, such as training in genomic testing and use of EMR alerts, may help improve cost discussions about genomic testing and related treatments,” the investigators conclude.

Dr. Yabroff did not disclose any relevant conflicts of interest. The study did not receive any specific funding; the survey was funded by the National Institutes of Health.

SOURCE: Yabroff KR et al. J Natl Cancer Inst. 2019 Nov 1. doi: 10.1093/jnci/djz173.

Training and alerts increase the likelihood that oncologists will discuss the costs of genomic testing and related treatments with their patients, suggests a nationally representative survey of oncologists.

“Testing can be expensive, and not all tests and related treatments are covered by health insurance,” note the investigators, who were led by K. Robin Yabroff, PhD, an epidemiologist and senior scientific director of the Surveillance and Health Services Research Program at the American Cancer Society in Atlanta.

Using data from the 2017 National Survey of Precision Medicine in Cancer Treatment, the investigators analyzed factors associated with cost discussions among 1,220 oncologists who had discussed genomic testing with their patients in the past year.

Results reported in the Journal of the National Cancer Institute showed that 50.0% of the oncologists often discussed the likely costs of genomic testing and related treatments with patients and 26.3% sometimes did, while 23.7% never or rarely did.

In adjusted analyses, oncologists were more likely to often discuss costs, versus rarely or never, if they had formal training in genomic testing (odds ratio, 1.74). And they were more likely to sometimes or often have these discussions if their practice had electronic medical record alerts for genomic testing (odds ratios, 2.09 and 2.22).

Additional physician factors positively associated with cost discussions were treating only solid cancers or both solid and hematologic cancers versus only hematologic cancers, and using next-generation sequencing gene panel tests. Additional practice factors showing positive associations included seeing a volume of 100 or more patients per month; having 10% or more of patients who were insured by Medicaid or were self-paying or uninsured; and being located in the West as compared with the Northeast.

When the survey was conducted, the cost of available genomic tests to inform treatment was $300 to more than $10,000, and molecularly targeted therapies commonly had a price tag exceeding $100,000 per year, Dr. Yabroff and coinvestigators note. Moreover, insurance coverage of this testing was in limbo.

“With rapid growth in the availability of genomic tests and targeted treatments for cancer and a large pipeline of treatments in development, improving provider discussions about expected out-of-pocket costs will be critical for ensuring informed patient treatment decision making and the opportunity to plan for treatment expenses and help address out-of-pocket costs by linking patients with available resources, and ensuring high-quality cancer care,” they maintain.

“Interventions targeting modifiable oncologist and practice factors, such as training in genomic testing and use of EMR alerts, may help improve cost discussions about genomic testing and related treatments,” the investigators conclude.

Dr. Yabroff did not disclose any relevant conflicts of interest. The study did not receive any specific funding; the survey was funded by the National Institutes of Health.

SOURCE: Yabroff KR et al. J Natl Cancer Inst. 2019 Nov 1. doi: 10.1093/jnci/djz173.

A Merit-based Incentive Payment System (MIPS) overhaul and evaluation and management changes to support the care of complex patients highlight the final Medicare physician fee schedule for 2020.

TheaDesign/Thinkstock

The new MIPS Value Pathways (MVPs) framework “aims to align and connect measures and activities across the quality, cost, promoting interoperability, and improvement activities performance categories of MIPS for different specialties or conditions,” the Centers for Medicare & Medicaid Services said in a fact sheet outlining the updates to the Quality Payment Program.

CMS noted that the framework will have measures aimed at population health and public health priorities, as well as reducing the reporting burden of the MIPS program and providing enhanced data and feedback to clinicians.

“We also intend to analyze existing Medicare information so that we can provide clinicians and patients with more information to improve health outcomes,” the agency wrote. “We believe the MVPs framework will help simplify MIPS, create a more cohesive and meaningful participation experience, improve value, reduce clinician burden, and better align with APMs [advanced alternative payment models] to help ease transition between the two tracks.

While the specifics of how the pathways will work are yet to be determined, the goal is to reduce the reporting burden while increasing its clinical applicability

Under the current MIPS structure, clinicians report on a specific number of measures chosen from a menu that may or may not be relevant to the care of patients with a specific disease, such as diabetes.

The MVPs framework will have some “foundation” measures in the first 2 years linked to promoting interoperability and population health that all clinicians will use. These, however, will be coupled with additional measures across the other MIPS categories (quality, cost, and improvement) that are specifically related to diabetes treatment. The expectation is that disease-specific measures plus foundation measures will add up to fewer measures than clinicians currently report, according to CMS.

Over the next 3-5 years, disease-specific measures will be refined and foundation measures expanded to include enhanced performance feedback and patient-reported outcomes.

“We recognize that this will be a significant shift in the way clinicians may potentially participate in MIPS, therefore we want to work closely with clinicians, patients, specialty societies, third parties, and others to establish the MVPs,” CMS officials said.

In the meantime, there are changes to the current MIPS program. Category weighting remains unchanged for the 2020 performance year (payable in 2022), with the performance threshold being 45 points and the exceptional performance threshold being 85 points.

In the quality performance category, the data completeness threshold is increased to 70%, while the agency continues to remove low-bar, standard-of-care process measures and adding new specialty sets, such as audiology, chiropractic medicine, pulmonology, and endocrinology.

In the cost category, 10 new episode-based measures were added to help expand access to this category. In the improvement activities category, CMS reduced barriers to obtaining a patient-centered medical home designation and increased the participation threshold for a practice from a single clinician to 50% of the clinicians in the practice. In the promoting interoperability category, the agency included queries to a prescription drug–monitoring program as an option measure, removed the verify opioid treatment–agreement measure, and reduced the threshold for a group to be considered hospital based from 100% to 75% being hospital based in order for a group to be excluded from reporting measures in this category.

One change not made in the MIPS update is threshold for exclusion from participating in the MIPS program, which has generated continued criticism over the years from the American Medical Group Association, which represents multispecialty practices.

“Overall, CMS expects Part B payment adjustments of 1.4% for those providers who participate in the program,” AMGA officials said in a statement. “However, Congress authorized up to a 9% payment adjustment for the 2020 performance year. While not every provider will achieve the highest possible adjustment, CMS’ continued policy of excluding otherwise eligible providers from participating in MIPS makes it impossible to achieve sustainable payments to cover the cost of participation. Thus, AMGA members have expressed that the program is no longer a viable tool for transitioning to value-based care.”

The physician fee schedule also finalized a number of provisions aimed at reducing administrative burden and increasing the time physicians have with patients. The changes will save clinicians 2.3 million hours per year in burden reduction, according to CMS.

New evaluation and management services (E/M) codes will allow clinicians to choose the appropriate level of coding based on either the medical decision making or time spent with the patient. In 2021, an add-on code will be implemented for prolonged service times for when clinicians spend more time treating complex patients, according to a CMS fact sheet.

Beginning in 2020, clinicians will be paid for care management services for patients with one serious and high-risk condition. Previously, a patient would need at least two serious and high-risk conditions for clinicians to get paid for care management services. For those with multiple chronic conditions, a Medicare-specific code has been added that covers patient visits that last beyond 20 minutes allowed in the current coding for chronic care management services.

The E/M changes are “a significant step in reducing administrative burden that gets in the way of patient care. Now it’s time for vendors and payors to take the necessary steps to align their systems with the E/M office visit code changes by the time the revisions are deployed on Jan. 1, 2021,” Patrice Harris, MD, president of the American Medical Association, said in a statement.

The American College of Physicians also applauded the change.

“Medicare has long undervalued E/M codes by internal medicine physicians, family physicians, and other cognitive and primary care physicians,” ACP said in a statement, adding that it is “extremely pleased that CMS’s final payment rules will strengthen primary and cognitive care by improving E/M codes and payment levels and reducing administrative burdens.”

The changes also will help address physician shortages, according to ACP officials.

“Fewer physicians are going into office-based internal medicine and other primary care disciplines in large part because Medicare and other payers have long undervalued their services and imposed unreasonable documentation requirements,” they wrote. “CMS’s new rule can help reverse this trend at a time when an aging population will need more primary care physicians, especially internal medicine specialists, to care for them.”

Opioid use disorder treatment programs will be covered by Medicare beginning in 2020. Enrolled opioid treatment programs will receive a bundled payment based on weekly episodes of care that cover Food and Drug Administration–approved medications that treat opioid use disorder, the dispensing and administering those medications, counseling, individual and group therapy, and toxicology testing.

The physician fee schedule also includes codes for telehealth services related to the opioid treatment bundle.

CMS also is finalizing updates on physician supervision of physician assistants to give physician assistants “greater flexibility to practice more broadly in the current health care system in accordance with state law and state scope of practice,” the fact sheet notes.

gtwachtman@mdedge.com

SOURCE: CMS Medicare Physician Fee Schedule for calendar year 2020.

A Merit-based Incentive Payment System (MIPS) overhaul and evaluation and management changes to support the care of complex patients highlight the final Medicare physician fee schedule for 2020.

TheaDesign/Thinkstock

The new MIPS Value Pathways (MVPs) framework “aims to align and connect measures and activities across the quality, cost, promoting interoperability, and improvement activities performance categories of MIPS for different specialties or conditions,” the Centers for Medicare & Medicaid Services said in a fact sheet outlining the updates to the Quality Payment Program.

CMS noted that the framework will have measures aimed at population health and public health priorities, as well as reducing the reporting burden of the MIPS program and providing enhanced data and feedback to clinicians.

“We also intend to analyze existing Medicare information so that we can provide clinicians and patients with more information to improve health outcomes,” the agency wrote. “We believe the MVPs framework will help simplify MIPS, create a more cohesive and meaningful participation experience, improve value, reduce clinician burden, and better align with APMs [advanced alternative payment models] to help ease transition between the two tracks.

While the specifics of how the pathways will work are yet to be determined, the goal is to reduce the reporting burden while increasing its clinical applicability

Under the current MIPS structure, clinicians report on a specific number of measures chosen from a menu that may or may not be relevant to the care of patients with a specific disease, such as diabetes.

The MVPs framework will have some “foundation” measures in the first 2 years linked to promoting interoperability and population health that all clinicians will use. These, however, will be coupled with additional measures across the other MIPS categories (quality, cost, and improvement) that are specifically related to diabetes treatment. The expectation is that disease-specific measures plus foundation measures will add up to fewer measures than clinicians currently report, according to CMS.

Over the next 3-5 years, disease-specific measures will be refined and foundation measures expanded to include enhanced performance feedback and patient-reported outcomes.

“We recognize that this will be a significant shift in the way clinicians may potentially participate in MIPS, therefore we want to work closely with clinicians, patients, specialty societies, third parties, and others to establish the MVPs,” CMS officials said.

In the meantime, there are changes to the current MIPS program. Category weighting remains unchanged for the 2020 performance year (payable in 2022), with the performance threshold being 45 points and the exceptional performance threshold being 85 points.

In the quality performance category, the data completeness threshold is increased to 70%, while the agency continues to remove low-bar, standard-of-care process measures and adding new specialty sets, such as audiology, chiropractic medicine, pulmonology, and endocrinology.

In the cost category, 10 new episode-based measures were added to help expand access to this category. In the improvement activities category, CMS reduced barriers to obtaining a patient-centered medical home designation and increased the participation threshold for a practice from a single clinician to 50% of the clinicians in the practice. In the promoting interoperability category, the agency included queries to a prescription drug–monitoring program as an option measure, removed the verify opioid treatment–agreement measure, and reduced the threshold for a group to be considered hospital based from 100% to 75% being hospital based in order for a group to be excluded from reporting measures in this category.

One change not made in the MIPS update is threshold for exclusion from participating in the MIPS program, which has generated continued criticism over the years from the American Medical Group Association, which represents multispecialty practices.

“Overall, CMS expects Part B payment adjustments of 1.4% for those providers who participate in the program,” AMGA officials said in a statement. “However, Congress authorized up to a 9% payment adjustment for the 2020 performance year. While not every provider will achieve the highest possible adjustment, CMS’ continued policy of excluding otherwise eligible providers from participating in MIPS makes it impossible to achieve sustainable payments to cover the cost of participation. Thus, AMGA members have expressed that the program is no longer a viable tool for transitioning to value-based care.”

The physician fee schedule also finalized a number of provisions aimed at reducing administrative burden and increasing the time physicians have with patients. The changes will save clinicians 2.3 million hours per year in burden reduction, according to CMS.

New evaluation and management services (E/M) codes will allow clinicians to choose the appropriate level of coding based on either the medical decision making or time spent with the patient. In 2021, an add-on code will be implemented for prolonged service times for when clinicians spend more time treating complex patients, according to a CMS fact sheet.

Beginning in 2020, clinicians will be paid for care management services for patients with one serious and high-risk condition. Previously, a patient would need at least two serious and high-risk conditions for clinicians to get paid for care management services. For those with multiple chronic conditions, a Medicare-specific code has been added that covers patient visits that last beyond 20 minutes allowed in the current coding for chronic care management services.

The E/M changes are “a significant step in reducing administrative burden that gets in the way of patient care. Now it’s time for vendors and payors to take the necessary steps to align their systems with the E/M office visit code changes by the time the revisions are deployed on Jan. 1, 2021,” Patrice Harris, MD, president of the American Medical Association, said in a statement.

The American College of Physicians also applauded the change.

“Medicare has long undervalued E/M codes by internal medicine physicians, family physicians, and other cognitive and primary care physicians,” ACP said in a statement, adding that it is “extremely pleased that CMS’s final payment rules will strengthen primary and cognitive care by improving E/M codes and payment levels and reducing administrative burdens.”

The changes also will help address physician shortages, according to ACP officials.

“Fewer physicians are going into office-based internal medicine and other primary care disciplines in large part because Medicare and other payers have long undervalued their services and imposed unreasonable documentation requirements,” they wrote. “CMS’s new rule can help reverse this trend at a time when an aging population will need more primary care physicians, especially internal medicine specialists, to care for them.”

Opioid use disorder treatment programs will be covered by Medicare beginning in 2020. Enrolled opioid treatment programs will receive a bundled payment based on weekly episodes of care that cover Food and Drug Administration–approved medications that treat opioid use disorder, the dispensing and administering those medications, counseling, individual and group therapy, and toxicology testing.

The physician fee schedule also includes codes for telehealth services related to the opioid treatment bundle.

CMS also is finalizing updates on physician supervision of physician assistants to give physician assistants “greater flexibility to practice more broadly in the current health care system in accordance with state law and state scope of practice,” the fact sheet notes.

gtwachtman@mdedge.com

SOURCE: CMS Medicare Physician Fee Schedule for calendar year 2020.

A Merit-based Incentive Payment System (MIPS) overhaul and evaluation and management changes to support the care of complex patients highlight the final Medicare physician fee schedule for 2020.

TheaDesign/Thinkstock

The new MIPS Value Pathways (MVPs) framework “aims to align and connect measures and activities across the quality, cost, promoting interoperability, and improvement activities performance categories of MIPS for different specialties or conditions,” the Centers for Medicare & Medicaid Services said in a fact sheet outlining the updates to the Quality Payment Program.

CMS noted that the framework will have measures aimed at population health and public health priorities, as well as reducing the reporting burden of the MIPS program and providing enhanced data and feedback to clinicians.

“We also intend to analyze existing Medicare information so that we can provide clinicians and patients with more information to improve health outcomes,” the agency wrote. “We believe the MVPs framework will help simplify MIPS, create a more cohesive and meaningful participation experience, improve value, reduce clinician burden, and better align with APMs [advanced alternative payment models] to help ease transition between the two tracks.

While the specifics of how the pathways will work are yet to be determined, the goal is to reduce the reporting burden while increasing its clinical applicability

Under the current MIPS structure, clinicians report on a specific number of measures chosen from a menu that may or may not be relevant to the care of patients with a specific disease, such as diabetes.

The MVPs framework will have some “foundation” measures in the first 2 years linked to promoting interoperability and population health that all clinicians will use. These, however, will be coupled with additional measures across the other MIPS categories (quality, cost, and improvement) that are specifically related to diabetes treatment. The expectation is that disease-specific measures plus foundation measures will add up to fewer measures than clinicians currently report, according to CMS.

Over the next 3-5 years, disease-specific measures will be refined and foundation measures expanded to include enhanced performance feedback and patient-reported outcomes.

“We recognize that this will be a significant shift in the way clinicians may potentially participate in MIPS, therefore we want to work closely with clinicians, patients, specialty societies, third parties, and others to establish the MVPs,” CMS officials said.

In the meantime, there are changes to the current MIPS program. Category weighting remains unchanged for the 2020 performance year (payable in 2022), with the performance threshold being 45 points and the exceptional performance threshold being 85 points.

In the quality performance category, the data completeness threshold is increased to 70%, while the agency continues to remove low-bar, standard-of-care process measures and adding new specialty sets, such as audiology, chiropractic medicine, pulmonology, and endocrinology.

In the cost category, 10 new episode-based measures were added to help expand access to this category. In the improvement activities category, CMS reduced barriers to obtaining a patient-centered medical home designation and increased the participation threshold for a practice from a single clinician to 50% of the clinicians in the practice. In the promoting interoperability category, the agency included queries to a prescription drug–monitoring program as an option measure, removed the verify opioid treatment–agreement measure, and reduced the threshold for a group to be considered hospital based from 100% to 75% being hospital based in order for a group to be excluded from reporting measures in this category.

One change not made in the MIPS update is threshold for exclusion from participating in the MIPS program, which has generated continued criticism over the years from the American Medical Group Association, which represents multispecialty practices.

“Overall, CMS expects Part B payment adjustments of 1.4% for those providers who participate in the program,” AMGA officials said in a statement. “However, Congress authorized up to a 9% payment adjustment for the 2020 performance year. While not every provider will achieve the highest possible adjustment, CMS’ continued policy of excluding otherwise eligible providers from participating in MIPS makes it impossible to achieve sustainable payments to cover the cost of participation. Thus, AMGA members have expressed that the program is no longer a viable tool for transitioning to value-based care.”

The physician fee schedule also finalized a number of provisions aimed at reducing administrative burden and increasing the time physicians have with patients. The changes will save clinicians 2.3 million hours per year in burden reduction, according to CMS.

New evaluation and management services (E/M) codes will allow clinicians to choose the appropriate level of coding based on either the medical decision making or time spent with the patient. In 2021, an add-on code will be implemented for prolonged service times for when clinicians spend more time treating complex patients, according to a CMS fact sheet.

Beginning in 2020, clinicians will be paid for care management services for patients with one serious and high-risk condition. Previously, a patient would need at least two serious and high-risk conditions for clinicians to get paid for care management services. For those with multiple chronic conditions, a Medicare-specific code has been added that covers patient visits that last beyond 20 minutes allowed in the current coding for chronic care management services.

The E/M changes are “a significant step in reducing administrative burden that gets in the way of patient care. Now it’s time for vendors and payors to take the necessary steps to align their systems with the E/M office visit code changes by the time the revisions are deployed on Jan. 1, 2021,” Patrice Harris, MD, president of the American Medical Association, said in a statement.

The American College of Physicians also applauded the change.

“Medicare has long undervalued E/M codes by internal medicine physicians, family physicians, and other cognitive and primary care physicians,” ACP said in a statement, adding that it is “extremely pleased that CMS’s final payment rules will strengthen primary and cognitive care by improving E/M codes and payment levels and reducing administrative burdens.”

The changes also will help address physician shortages, according to ACP officials.

“Fewer physicians are going into office-based internal medicine and other primary care disciplines in large part because Medicare and other payers have long undervalued their services and imposed unreasonable documentation requirements,” they wrote. “CMS’s new rule can help reverse this trend at a time when an aging population will need more primary care physicians, especially internal medicine specialists, to care for them.”

Opioid use disorder treatment programs will be covered by Medicare beginning in 2020. Enrolled opioid treatment programs will receive a bundled payment based on weekly episodes of care that cover Food and Drug Administration–approved medications that treat opioid use disorder, the dispensing and administering those medications, counseling, individual and group therapy, and toxicology testing.

The physician fee schedule also includes codes for telehealth services related to the opioid treatment bundle.

CMS also is finalizing updates on physician supervision of physician assistants to give physician assistants “greater flexibility to practice more broadly in the current health care system in accordance with state law and state scope of practice,” the fact sheet notes.

gtwachtman@mdedge.com

SOURCE: CMS Medicare Physician Fee Schedule for calendar year 2020.