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Ingenol mebutate for AKs gets thumbs-up from patients
VANCOUVER – Field therapy for actinic keratoses using topical ingenol mebutate resulted in improved patient-reported outcomes in an observational study, Dr. Thomas L. Diepgen reported at the World Congress of Dermatology.
Topical ingenol mebutate won regulatory approval for the field treatment of actinic keratoses on the strength of four randomized, double-blind placebo-controlled clinical trials, but patients and their physicians need to know how the drug performs in clinical practice. The answer is, quite well, said Dr. Diepgen of the University of Heidelberg (Germany), who presented the results of the observational study emphasizing patient-reported outcomes in 826 patients whose actinic keratoses (AKs) were treated with ingenol mebutate (Picato) in 292 German dermatologists’ offices.
Unlike in randomized clinical trials, where strict eligibility criteria often result in a skewed population of participants, this observational study provided a representative snapshot of German patients seeking AK therapy. Their mean age was 73 years, with a mean 6.2-year duration of AKs and a median baseline of 5 lesions. Eighty percent of patients had previously undergone other types of therapy for the AKs, and 34% of them had a history of nonmelanoma skin cancer.
Participants completed the Skindex-16 quality of life questionnaire at their baseline office visit, and again 8 weeks later. The Skindex-16 doesn’t ask disease-specific questions, but this 16-item questionnaire was employed in the earlier pivotal randomized trials (N. Engl. J. Med. 2012;366:1010-19), and investigators felt they should utilize the same instrument, said Dr. Diepgen.
Scores on the Skindex-16 improved significantly from a mean baseline of 24.3 out of a possible 96 points to 12.1 after 8 weeks.
Similarly, when patients were asked to rate their skin roughness, wrinkling, and/or blotchiness on a 0-3 scale, their mean scores fell from 1.46 at baseline to 0.69 at follow-up. Ninety-eight percent of patients reported no new skin anomalies such as hypopigmentation in the treatment area.
Session cochair Dr. Marc Bourcier of the University of Sherbrooke (Que.) observed that this study underscores that the timing of quality of life assessment makes an enormous difference. Had the assessment taken place at day 4, for example, when ingenol mebutate–induced skin irritation would have been prominent, the results would have been very different. Dr. Diepgen agreed, noting that he and his coinvestigators wanted to evaluate patients’ response to the long-lasting results of the treatment, rather than to the transient experience of the therapy.
The study was sponsored by Leo Pharma. Dr. Diepgen reported having received research grants and speakers fees, and/or serving on advisory boards for Leo and more than a dozen other pharmaceutical companies.
VANCOUVER – Field therapy for actinic keratoses using topical ingenol mebutate resulted in improved patient-reported outcomes in an observational study, Dr. Thomas L. Diepgen reported at the World Congress of Dermatology.
Topical ingenol mebutate won regulatory approval for the field treatment of actinic keratoses on the strength of four randomized, double-blind placebo-controlled clinical trials, but patients and their physicians need to know how the drug performs in clinical practice. The answer is, quite well, said Dr. Diepgen of the University of Heidelberg (Germany), who presented the results of the observational study emphasizing patient-reported outcomes in 826 patients whose actinic keratoses (AKs) were treated with ingenol mebutate (Picato) in 292 German dermatologists’ offices.
Unlike in randomized clinical trials, where strict eligibility criteria often result in a skewed population of participants, this observational study provided a representative snapshot of German patients seeking AK therapy. Their mean age was 73 years, with a mean 6.2-year duration of AKs and a median baseline of 5 lesions. Eighty percent of patients had previously undergone other types of therapy for the AKs, and 34% of them had a history of nonmelanoma skin cancer.
Participants completed the Skindex-16 quality of life questionnaire at their baseline office visit, and again 8 weeks later. The Skindex-16 doesn’t ask disease-specific questions, but this 16-item questionnaire was employed in the earlier pivotal randomized trials (N. Engl. J. Med. 2012;366:1010-19), and investigators felt they should utilize the same instrument, said Dr. Diepgen.
Scores on the Skindex-16 improved significantly from a mean baseline of 24.3 out of a possible 96 points to 12.1 after 8 weeks.
Similarly, when patients were asked to rate their skin roughness, wrinkling, and/or blotchiness on a 0-3 scale, their mean scores fell from 1.46 at baseline to 0.69 at follow-up. Ninety-eight percent of patients reported no new skin anomalies such as hypopigmentation in the treatment area.
Session cochair Dr. Marc Bourcier of the University of Sherbrooke (Que.) observed that this study underscores that the timing of quality of life assessment makes an enormous difference. Had the assessment taken place at day 4, for example, when ingenol mebutate–induced skin irritation would have been prominent, the results would have been very different. Dr. Diepgen agreed, noting that he and his coinvestigators wanted to evaluate patients’ response to the long-lasting results of the treatment, rather than to the transient experience of the therapy.
The study was sponsored by Leo Pharma. Dr. Diepgen reported having received research grants and speakers fees, and/or serving on advisory boards for Leo and more than a dozen other pharmaceutical companies.
VANCOUVER – Field therapy for actinic keratoses using topical ingenol mebutate resulted in improved patient-reported outcomes in an observational study, Dr. Thomas L. Diepgen reported at the World Congress of Dermatology.
Topical ingenol mebutate won regulatory approval for the field treatment of actinic keratoses on the strength of four randomized, double-blind placebo-controlled clinical trials, but patients and their physicians need to know how the drug performs in clinical practice. The answer is, quite well, said Dr. Diepgen of the University of Heidelberg (Germany), who presented the results of the observational study emphasizing patient-reported outcomes in 826 patients whose actinic keratoses (AKs) were treated with ingenol mebutate (Picato) in 292 German dermatologists’ offices.
Unlike in randomized clinical trials, where strict eligibility criteria often result in a skewed population of participants, this observational study provided a representative snapshot of German patients seeking AK therapy. Their mean age was 73 years, with a mean 6.2-year duration of AKs and a median baseline of 5 lesions. Eighty percent of patients had previously undergone other types of therapy for the AKs, and 34% of them had a history of nonmelanoma skin cancer.
Participants completed the Skindex-16 quality of life questionnaire at their baseline office visit, and again 8 weeks later. The Skindex-16 doesn’t ask disease-specific questions, but this 16-item questionnaire was employed in the earlier pivotal randomized trials (N. Engl. J. Med. 2012;366:1010-19), and investigators felt they should utilize the same instrument, said Dr. Diepgen.
Scores on the Skindex-16 improved significantly from a mean baseline of 24.3 out of a possible 96 points to 12.1 after 8 weeks.
Similarly, when patients were asked to rate their skin roughness, wrinkling, and/or blotchiness on a 0-3 scale, their mean scores fell from 1.46 at baseline to 0.69 at follow-up. Ninety-eight percent of patients reported no new skin anomalies such as hypopigmentation in the treatment area.
Session cochair Dr. Marc Bourcier of the University of Sherbrooke (Que.) observed that this study underscores that the timing of quality of life assessment makes an enormous difference. Had the assessment taken place at day 4, for example, when ingenol mebutate–induced skin irritation would have been prominent, the results would have been very different. Dr. Diepgen agreed, noting that he and his coinvestigators wanted to evaluate patients’ response to the long-lasting results of the treatment, rather than to the transient experience of the therapy.
The study was sponsored by Leo Pharma. Dr. Diepgen reported having received research grants and speakers fees, and/or serving on advisory boards for Leo and more than a dozen other pharmaceutical companies.
AT WCD 2015
Key clinical point: Field therapy for actinic keratoses using topical ingenol mebutate resulted in improved patient-reported outcomes.
Major finding: Mean scores on the Skindex-16, which reflects the quality of life impact of a patient’s skin disease, improved significantly from 24.3 pretreatment to 12.1 after 8 weeks.
Data source: A prospective observational study of patient-reported outcomes of ingenol mebutate therapy for actinic keratoses in 826 patients treated in 292 German dermatologists’ offices.
Disclosures: The study was sponsored by Leo Pharma, which markets ingenol mebutate. The presenter reported having received research grants and speakers’ fees, and/or serving on advisory boards for Leo and more than a dozen other pharmaceutical companies.
Simulated daylight PDT advantageous for AKs
VANCOUVER – Indoor simulated daylight photodynamic therapy for actinic keratoses sidesteps the major shortcoming of natural daylight PDT by providing a standardized, dermatologist-controlled light dose that’s not dependent upon the vagaries of weather, season, or outdoor temperature, Dr. Uwe Reinhold reported at the World Congress of Dermatology.
Daylight PDT, in which the photosensitizing agent is activated by natural light, is an increasingly popular concept that originated in Scandinavia but is starting to catch on in the United States. Daylight PDT is less expensive and far less painful than traditional PDT, in which the photosensitizer is activated by a pulsed dye laser or an intense pulsed light device. But on a rainy day or a cold, short, winter day, it can be a problem getting sufficient daylight outdoors to reliably activate the PDT, noted Dr. Reinhold of the Dermatology Center Bonn (Germany) Friedensplatz.
Dr. Reinhold and his colleagues solved that problem by installing a special lamp system on the ceiling of a treatment room in the office. The system enables a dermatologist to simultaneously treat several patients, who receive their 2-hour light dose while seated comfortably in the treatment room reading a book or resting.
Dr. Reinhold presented a retrospective study of 32 patients who underwent simulated daylight PDT (SDL-PDT) in his office. At baseline, the patients had a mean of 5.3 AKs on the scalp and/or face. At follow-up 12 weeks after their second and final SDL-PDT session, they averaged 0.4 AKs. Ninety-three percent of all AKs were cleared, and three-quarters of the patients were completely AK-free.
Traditional PDT is so painful that compliance becomes an issue, Dr. Reinhold noted. In contrast, SDL-PDT, like daylight PDT, is almost pain free. Pain assessment on a 0-10 visual analog scale conducted during the first SDL-PDT session showed mean scores of 0.1, 0.3, and 0.6 at 30, 60, and 90 minutes after illumination began. None of the patients required an analgesic, according to the dermatologist.
The procedure begins with curettage of hyperkeratotic lesions, followed by application of aminolevulinic acid (ALA) gel under occlusion for 30 minutes. Dr. Reinhold uses BF-200 (Ameluz), an ALA manufactured by Biofrontera, a German company, which is popular in Europe but not marketed in the United States. The gel contains 78 mg of ALA per gram. After the 30-minute incubation, the photosensitizer is removed and the special lights are switched on for 2 hours. Protective eye goggles aren’t needed. All patients receive a second treatment session 1 week later.
The lights Dr. Reinhold uses are Indoorlux, marketed by Swiss Red AG. One pair of lights is needed per patient. At a distance of 110-150 cm from the light source, the system produces 15,000-25,000 Lux. The lamps mimic the green and red components of daylight. The combined effective light dose at the wavelengths important in activating protoporphyrin IX so that it can destroy precancerous cells – green/yellow at 570-590 nm and orange/red at 620-640 nm – is 14.3-24.2 J/cm2, depending upon the distance from the light source. That’s comfortably above the 9.4-10.8 J/cm2 other investigators have determined is required for effective natural daylight PDT.
In the United States, however, as in Europe, SDL-PDT is currently an off-label therapy for AK treatment, he noted.
Dr. Reinhold reported serving as a consultant to Biofrontera and receiving speaking fees from the company.
VANCOUVER – Indoor simulated daylight photodynamic therapy for actinic keratoses sidesteps the major shortcoming of natural daylight PDT by providing a standardized, dermatologist-controlled light dose that’s not dependent upon the vagaries of weather, season, or outdoor temperature, Dr. Uwe Reinhold reported at the World Congress of Dermatology.
Daylight PDT, in which the photosensitizing agent is activated by natural light, is an increasingly popular concept that originated in Scandinavia but is starting to catch on in the United States. Daylight PDT is less expensive and far less painful than traditional PDT, in which the photosensitizer is activated by a pulsed dye laser or an intense pulsed light device. But on a rainy day or a cold, short, winter day, it can be a problem getting sufficient daylight outdoors to reliably activate the PDT, noted Dr. Reinhold of the Dermatology Center Bonn (Germany) Friedensplatz.
Dr. Reinhold and his colleagues solved that problem by installing a special lamp system on the ceiling of a treatment room in the office. The system enables a dermatologist to simultaneously treat several patients, who receive their 2-hour light dose while seated comfortably in the treatment room reading a book or resting.
Dr. Reinhold presented a retrospective study of 32 patients who underwent simulated daylight PDT (SDL-PDT) in his office. At baseline, the patients had a mean of 5.3 AKs on the scalp and/or face. At follow-up 12 weeks after their second and final SDL-PDT session, they averaged 0.4 AKs. Ninety-three percent of all AKs were cleared, and three-quarters of the patients were completely AK-free.
Traditional PDT is so painful that compliance becomes an issue, Dr. Reinhold noted. In contrast, SDL-PDT, like daylight PDT, is almost pain free. Pain assessment on a 0-10 visual analog scale conducted during the first SDL-PDT session showed mean scores of 0.1, 0.3, and 0.6 at 30, 60, and 90 minutes after illumination began. None of the patients required an analgesic, according to the dermatologist.
The procedure begins with curettage of hyperkeratotic lesions, followed by application of aminolevulinic acid (ALA) gel under occlusion for 30 minutes. Dr. Reinhold uses BF-200 (Ameluz), an ALA manufactured by Biofrontera, a German company, which is popular in Europe but not marketed in the United States. The gel contains 78 mg of ALA per gram. After the 30-minute incubation, the photosensitizer is removed and the special lights are switched on for 2 hours. Protective eye goggles aren’t needed. All patients receive a second treatment session 1 week later.
The lights Dr. Reinhold uses are Indoorlux, marketed by Swiss Red AG. One pair of lights is needed per patient. At a distance of 110-150 cm from the light source, the system produces 15,000-25,000 Lux. The lamps mimic the green and red components of daylight. The combined effective light dose at the wavelengths important in activating protoporphyrin IX so that it can destroy precancerous cells – green/yellow at 570-590 nm and orange/red at 620-640 nm – is 14.3-24.2 J/cm2, depending upon the distance from the light source. That’s comfortably above the 9.4-10.8 J/cm2 other investigators have determined is required for effective natural daylight PDT.
In the United States, however, as in Europe, SDL-PDT is currently an off-label therapy for AK treatment, he noted.
Dr. Reinhold reported serving as a consultant to Biofrontera and receiving speaking fees from the company.
VANCOUVER – Indoor simulated daylight photodynamic therapy for actinic keratoses sidesteps the major shortcoming of natural daylight PDT by providing a standardized, dermatologist-controlled light dose that’s not dependent upon the vagaries of weather, season, or outdoor temperature, Dr. Uwe Reinhold reported at the World Congress of Dermatology.
Daylight PDT, in which the photosensitizing agent is activated by natural light, is an increasingly popular concept that originated in Scandinavia but is starting to catch on in the United States. Daylight PDT is less expensive and far less painful than traditional PDT, in which the photosensitizer is activated by a pulsed dye laser or an intense pulsed light device. But on a rainy day or a cold, short, winter day, it can be a problem getting sufficient daylight outdoors to reliably activate the PDT, noted Dr. Reinhold of the Dermatology Center Bonn (Germany) Friedensplatz.
Dr. Reinhold and his colleagues solved that problem by installing a special lamp system on the ceiling of a treatment room in the office. The system enables a dermatologist to simultaneously treat several patients, who receive their 2-hour light dose while seated comfortably in the treatment room reading a book or resting.
Dr. Reinhold presented a retrospective study of 32 patients who underwent simulated daylight PDT (SDL-PDT) in his office. At baseline, the patients had a mean of 5.3 AKs on the scalp and/or face. At follow-up 12 weeks after their second and final SDL-PDT session, they averaged 0.4 AKs. Ninety-three percent of all AKs were cleared, and three-quarters of the patients were completely AK-free.
Traditional PDT is so painful that compliance becomes an issue, Dr. Reinhold noted. In contrast, SDL-PDT, like daylight PDT, is almost pain free. Pain assessment on a 0-10 visual analog scale conducted during the first SDL-PDT session showed mean scores of 0.1, 0.3, and 0.6 at 30, 60, and 90 minutes after illumination began. None of the patients required an analgesic, according to the dermatologist.
The procedure begins with curettage of hyperkeratotic lesions, followed by application of aminolevulinic acid (ALA) gel under occlusion for 30 minutes. Dr. Reinhold uses BF-200 (Ameluz), an ALA manufactured by Biofrontera, a German company, which is popular in Europe but not marketed in the United States. The gel contains 78 mg of ALA per gram. After the 30-minute incubation, the photosensitizer is removed and the special lights are switched on for 2 hours. Protective eye goggles aren’t needed. All patients receive a second treatment session 1 week later.
The lights Dr. Reinhold uses are Indoorlux, marketed by Swiss Red AG. One pair of lights is needed per patient. At a distance of 110-150 cm from the light source, the system produces 15,000-25,000 Lux. The lamps mimic the green and red components of daylight. The combined effective light dose at the wavelengths important in activating protoporphyrin IX so that it can destroy precancerous cells – green/yellow at 570-590 nm and orange/red at 620-640 nm – is 14.3-24.2 J/cm2, depending upon the distance from the light source. That’s comfortably above the 9.4-10.8 J/cm2 other investigators have determined is required for effective natural daylight PDT.
In the United States, however, as in Europe, SDL-PDT is currently an off-label therapy for AK treatment, he noted.
Dr. Reinhold reported serving as a consultant to Biofrontera and receiving speaking fees from the company.
AT WCD 2015
Key clinical point: A field containing multiple actinic keratoses can be treated virtually painlessly using lamps that simulate daylight to activate photodynamic therapy.
Major finding: 3 months after simulated daylight PDT, the mean number of AKs in treated patients was reduced from 5.3 at baseline to 0.4.
Data source: This was a retrospective study including 32 patients whose actinic keratoses was treated using simulated daylight PDT.
Disclosures: The study was supported by Biofrontera. The presenter reported serving as a consultant to and receiving speaking fees from the company.
FDA extends approval of ITP drug to kids
Photo courtesy of the FDA
The US Food and Drug Administration (FDA) has approved eltrombopag (Promacta) to treat children age 6 and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Eltrombopag is an oral thrombopoietin receptor agonist that works by inducing the stimulation and differentiation of megakaryocytes to increase platelet production.
The drug is already FDA-approved to treat adults with ITP.
The FDA’s latest approval of eltrombopag was based on data from the phase 2 PETIT trial and the phase 3 PETIT2 trial.
“Young patients with chronic ITP who have either an insufficient response to or side effects from standard therapies have limited treatment options, making this FDA approval of eltrombopag for children 6 years and older particularly important,” said James B. Bussel, MD, a professor at Weill Cornell Medical College in New York and lead investigator of the PETIT study.
“Through the eltrombopag studies, one of which is the largest randomized trial ever performed in children with chronic ITP, we discovered that Promacta—a treatment that can be taken once daily by mouth and shown to be well tolerated—can manage this disorder and help these young patients.”
PETIT trials: Efficacy
The PETIT trial included 67 ITP patients stratified by age cohort (12-17 years, 6-11 years, and 1-5 years). They were randomized (2:1) to receive eltrombopag or placebo for 7 weeks. Eltrombopag dose was titrated to a target platelet count of 50-200 x109/L.
The primary efficacy endpoint was the proportion of subjects achieving platelet counts of 50 x109/L or higher at least once between days 8 and 43 of the randomized period of the study.
Significantly more patients in the eltrombopag arm met this endpoint—62.2%—compared to 31.8% in the placebo arm (P=0.011).
The PETIT2 trial enrolled 92 patients with chronic ITP who were randomized (2:1) to receive eltrombopag or placebo for 13 weeks. The eltrombopag
dose was titrated to a target platelet count of 50-200 x109/L.
The primary efficacy endpoint was the proportion of subjects who achieve platelet counts of 50 x109/L or higher for at least 6 out of 8 weeks, between weeks 5 and 12 of the randomized period.
Significantly more patients in the eltrombopag arm met this endpoint—41.3%—compared to 3.4% of patients in the placebo arm (P<0.001).
PETIT trials: Safety
For both trials, there were 107 eltrombopag-treated patients evaluable for safety.
The most common adverse events occurring more frequently in the eltrombopag arms than the placebo arms were upper respiratory tract infection,
nasopharyngitis, cough, diarrhea, pyrexia, rhinitis, abdominal pain, oropharyngeal pain, toothache, increased ALT or AST, rash, and rhinorrhea.
Serious adverse events were reported in 8% of patients during the randomized part of both trials, although no serious adverse event occurred in more than 1 patient (1%).
An ALT elevation of at least 3 times the upper limit of normal occurred in 5% of eltrombopag-treated patients. Of those patients, 2% had ALT increases
of at least 5 times the upper limit of normal.
There were no deaths or thromboembolic events during either study.
Eltrombopag is marketed as Promacta in the US and Revolade in most countries outside the US. For more information on the drug, see the full prescribing information. 
Photo courtesy of the FDA
The US Food and Drug Administration (FDA) has approved eltrombopag (Promacta) to treat children age 6 and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Eltrombopag is an oral thrombopoietin receptor agonist that works by inducing the stimulation and differentiation of megakaryocytes to increase platelet production.
The drug is already FDA-approved to treat adults with ITP.
The FDA’s latest approval of eltrombopag was based on data from the phase 2 PETIT trial and the phase 3 PETIT2 trial.
“Young patients with chronic ITP who have either an insufficient response to or side effects from standard therapies have limited treatment options, making this FDA approval of eltrombopag for children 6 years and older particularly important,” said James B. Bussel, MD, a professor at Weill Cornell Medical College in New York and lead investigator of the PETIT study.
“Through the eltrombopag studies, one of which is the largest randomized trial ever performed in children with chronic ITP, we discovered that Promacta—a treatment that can be taken once daily by mouth and shown to be well tolerated—can manage this disorder and help these young patients.”
PETIT trials: Efficacy
The PETIT trial included 67 ITP patients stratified by age cohort (12-17 years, 6-11 years, and 1-5 years). They were randomized (2:1) to receive eltrombopag or placebo for 7 weeks. Eltrombopag dose was titrated to a target platelet count of 50-200 x109/L.
The primary efficacy endpoint was the proportion of subjects achieving platelet counts of 50 x109/L or higher at least once between days 8 and 43 of the randomized period of the study.
Significantly more patients in the eltrombopag arm met this endpoint—62.2%—compared to 31.8% in the placebo arm (P=0.011).
The PETIT2 trial enrolled 92 patients with chronic ITP who were randomized (2:1) to receive eltrombopag or placebo for 13 weeks. The eltrombopag
dose was titrated to a target platelet count of 50-200 x109/L.
The primary efficacy endpoint was the proportion of subjects who achieve platelet counts of 50 x109/L or higher for at least 6 out of 8 weeks, between weeks 5 and 12 of the randomized period.
Significantly more patients in the eltrombopag arm met this endpoint—41.3%—compared to 3.4% of patients in the placebo arm (P<0.001).
PETIT trials: Safety
For both trials, there were 107 eltrombopag-treated patients evaluable for safety.
The most common adverse events occurring more frequently in the eltrombopag arms than the placebo arms were upper respiratory tract infection,
nasopharyngitis, cough, diarrhea, pyrexia, rhinitis, abdominal pain, oropharyngeal pain, toothache, increased ALT or AST, rash, and rhinorrhea.
Serious adverse events were reported in 8% of patients during the randomized part of both trials, although no serious adverse event occurred in more than 1 patient (1%).
An ALT elevation of at least 3 times the upper limit of normal occurred in 5% of eltrombopag-treated patients. Of those patients, 2% had ALT increases
of at least 5 times the upper limit of normal.
There were no deaths or thromboembolic events during either study.
Eltrombopag is marketed as Promacta in the US and Revolade in most countries outside the US. For more information on the drug, see the full prescribing information.
Photo courtesy of the FDA
The US Food and Drug Administration (FDA) has approved eltrombopag (Promacta) to treat children age 6 and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Eltrombopag is an oral thrombopoietin receptor agonist that works by inducing the stimulation and differentiation of megakaryocytes to increase platelet production.
The drug is already FDA-approved to treat adults with ITP.
The FDA’s latest approval of eltrombopag was based on data from the phase 2 PETIT trial and the phase 3 PETIT2 trial.
“Young patients with chronic ITP who have either an insufficient response to or side effects from standard therapies have limited treatment options, making this FDA approval of eltrombopag for children 6 years and older particularly important,” said James B. Bussel, MD, a professor at Weill Cornell Medical College in New York and lead investigator of the PETIT study.
“Through the eltrombopag studies, one of which is the largest randomized trial ever performed in children with chronic ITP, we discovered that Promacta—a treatment that can be taken once daily by mouth and shown to be well tolerated—can manage this disorder and help these young patients.”
PETIT trials: Efficacy
The PETIT trial included 67 ITP patients stratified by age cohort (12-17 years, 6-11 years, and 1-5 years). They were randomized (2:1) to receive eltrombopag or placebo for 7 weeks. Eltrombopag dose was titrated to a target platelet count of 50-200 x109/L.
The primary efficacy endpoint was the proportion of subjects achieving platelet counts of 50 x109/L or higher at least once between days 8 and 43 of the randomized period of the study.
Significantly more patients in the eltrombopag arm met this endpoint—62.2%—compared to 31.8% in the placebo arm (P=0.011).
The PETIT2 trial enrolled 92 patients with chronic ITP who were randomized (2:1) to receive eltrombopag or placebo for 13 weeks. The eltrombopag
dose was titrated to a target platelet count of 50-200 x109/L.
The primary efficacy endpoint was the proportion of subjects who achieve platelet counts of 50 x109/L or higher for at least 6 out of 8 weeks, between weeks 5 and 12 of the randomized period.
Significantly more patients in the eltrombopag arm met this endpoint—41.3%—compared to 3.4% of patients in the placebo arm (P<0.001).
PETIT trials: Safety
For both trials, there were 107 eltrombopag-treated patients evaluable for safety.
The most common adverse events occurring more frequently in the eltrombopag arms than the placebo arms were upper respiratory tract infection,
nasopharyngitis, cough, diarrhea, pyrexia, rhinitis, abdominal pain, oropharyngeal pain, toothache, increased ALT or AST, rash, and rhinorrhea.
Serious adverse events were reported in 8% of patients during the randomized part of both trials, although no serious adverse event occurred in more than 1 patient (1%).
An ALT elevation of at least 3 times the upper limit of normal occurred in 5% of eltrombopag-treated patients. Of those patients, 2% had ALT increases
of at least 5 times the upper limit of normal.
There were no deaths or thromboembolic events during either study.
Eltrombopag is marketed as Promacta in the US and Revolade in most countries outside the US. For more information on the drug, see the full prescribing information.
IDH1 inhibitor gets orphan designation for AML
The US Food and Drug Administration (FDA) has granted orphan designation for AG-120 to treat patients with acute myeloid leukemia (AML) who harbor an isocitrate dehydrogenase-1 (IDH1) mutation.
AG-120 is an oral, selective inhibitor of the mutated IDH1 protein that is under investigation in two phase 1 clinical trials, one in hematologic malignancies and one in advanced solid tumors.
The FDA granted AG-120 fast track designation last month.
“Receiving orphan drug designation for AG-120 is an important milestone as we continue to move this program to late-stage development,” said Chris Bowden, MD, chief medical officer of Agios Pharmaceuticals, Inc., the company developing AG-120.
“We are pleased with the progress we are making in the clinic and look forward to presenting new data from our ongoing phase 1 study of AG-120 at the Congress of the European Hematology Association later this week.”
Phase 1 trial
Results from the phase 1 study of AG-120 in patients with hematologic malignancies were previously presented at the EORTC-NCI-AACR symposium in November 2014.
The data included 17 patients with relapsed and/or refractory AML who had received a median of 2 prior treatments. The patients were scheduled to receive AG-120 in 1 of 4 dose groups: 100 mg twice a day, 300 mg once a day, 500 mg once a day, and 800 mg once a day over continuous, 28-day cycles.
Of the 14 patients evaluable for response, 7 responded. Four patients achieved a complete response, 2 had a complete response in the marrow, and 1 had a partial response.
Responses occurred at all the dose levels tested. The maximum-tolerated dose was not reached. All responding patients were still on AG-120 at the time of presentation, and 1 patient with stable disease remained on the drug.
Researchers said AG-120 was generally well-tolerated. The majority of adverse events were grade 1 and 2. The most common of these were nausea, fatigue, and dyspnea.
Eight patients experienced serious adverse events, but these were primarily related to disease progression.
One patient experienced a dose-limiting toxicity of asymptomatic grade 3 QT prolongation at the highest dose tested, which improved to grade 1 with dose reduction. The patient was in complete remission and remained on AG-120 at the time of presentation.
There were 6 patient deaths, all unrelated to AG-120. Five deaths occurred after patients discontinued treatment due to progressive disease, and 1 patient died due to disease-related intracranial hemorrhage while on treatment.
About orphan designation
The FDA grants orphan designation to encourage companies to develop therapies for diseases that affect fewer than 200,000 individuals in the US.
Orphan designation provides a company with research and development tax credits, an opportunity to obtain grant funding, exemption from FDA application fees, and other benefits.
If the FDA approves AG-120 to treat patients with AML, orphan designation will provide Agios with 7 years of marketing exclusivity in the US.
The US Food and Drug Administration (FDA) has granted orphan designation for AG-120 to treat patients with acute myeloid leukemia (AML) who harbor an isocitrate dehydrogenase-1 (IDH1) mutation.
AG-120 is an oral, selective inhibitor of the mutated IDH1 protein that is under investigation in two phase 1 clinical trials, one in hematologic malignancies and one in advanced solid tumors.
The FDA granted AG-120 fast track designation last month.
“Receiving orphan drug designation for AG-120 is an important milestone as we continue to move this program to late-stage development,” said Chris Bowden, MD, chief medical officer of Agios Pharmaceuticals, Inc., the company developing AG-120.
“We are pleased with the progress we are making in the clinic and look forward to presenting new data from our ongoing phase 1 study of AG-120 at the Congress of the European Hematology Association later this week.”
Phase 1 trial
Results from the phase 1 study of AG-120 in patients with hematologic malignancies were previously presented at the EORTC-NCI-AACR symposium in November 2014.
The data included 17 patients with relapsed and/or refractory AML who had received a median of 2 prior treatments. The patients were scheduled to receive AG-120 in 1 of 4 dose groups: 100 mg twice a day, 300 mg once a day, 500 mg once a day, and 800 mg once a day over continuous, 28-day cycles.
Of the 14 patients evaluable for response, 7 responded. Four patients achieved a complete response, 2 had a complete response in the marrow, and 1 had a partial response.
Responses occurred at all the dose levels tested. The maximum-tolerated dose was not reached. All responding patients were still on AG-120 at the time of presentation, and 1 patient with stable disease remained on the drug.
Researchers said AG-120 was generally well-tolerated. The majority of adverse events were grade 1 and 2. The most common of these were nausea, fatigue, and dyspnea.
Eight patients experienced serious adverse events, but these were primarily related to disease progression.
One patient experienced a dose-limiting toxicity of asymptomatic grade 3 QT prolongation at the highest dose tested, which improved to grade 1 with dose reduction. The patient was in complete remission and remained on AG-120 at the time of presentation.
There were 6 patient deaths, all unrelated to AG-120. Five deaths occurred after patients discontinued treatment due to progressive disease, and 1 patient died due to disease-related intracranial hemorrhage while on treatment.
About orphan designation
The FDA grants orphan designation to encourage companies to develop therapies for diseases that affect fewer than 200,000 individuals in the US.
Orphan designation provides a company with research and development tax credits, an opportunity to obtain grant funding, exemption from FDA application fees, and other benefits.
If the FDA approves AG-120 to treat patients with AML, orphan designation will provide Agios with 7 years of marketing exclusivity in the US.
The US Food and Drug Administration (FDA) has granted orphan designation for AG-120 to treat patients with acute myeloid leukemia (AML) who harbor an isocitrate dehydrogenase-1 (IDH1) mutation.
AG-120 is an oral, selective inhibitor of the mutated IDH1 protein that is under investigation in two phase 1 clinical trials, one in hematologic malignancies and one in advanced solid tumors.
The FDA granted AG-120 fast track designation last month.
“Receiving orphan drug designation for AG-120 is an important milestone as we continue to move this program to late-stage development,” said Chris Bowden, MD, chief medical officer of Agios Pharmaceuticals, Inc., the company developing AG-120.
“We are pleased with the progress we are making in the clinic and look forward to presenting new data from our ongoing phase 1 study of AG-120 at the Congress of the European Hematology Association later this week.”
Phase 1 trial
Results from the phase 1 study of AG-120 in patients with hematologic malignancies were previously presented at the EORTC-NCI-AACR symposium in November 2014.
The data included 17 patients with relapsed and/or refractory AML who had received a median of 2 prior treatments. The patients were scheduled to receive AG-120 in 1 of 4 dose groups: 100 mg twice a day, 300 mg once a day, 500 mg once a day, and 800 mg once a day over continuous, 28-day cycles.
Of the 14 patients evaluable for response, 7 responded. Four patients achieved a complete response, 2 had a complete response in the marrow, and 1 had a partial response.
Responses occurred at all the dose levels tested. The maximum-tolerated dose was not reached. All responding patients were still on AG-120 at the time of presentation, and 1 patient with stable disease remained on the drug.
Researchers said AG-120 was generally well-tolerated. The majority of adverse events were grade 1 and 2. The most common of these were nausea, fatigue, and dyspnea.
Eight patients experienced serious adverse events, but these were primarily related to disease progression.
One patient experienced a dose-limiting toxicity of asymptomatic grade 3 QT prolongation at the highest dose tested, which improved to grade 1 with dose reduction. The patient was in complete remission and remained on AG-120 at the time of presentation.
There were 6 patient deaths, all unrelated to AG-120. Five deaths occurred after patients discontinued treatment due to progressive disease, and 1 patient died due to disease-related intracranial hemorrhage while on treatment.
About orphan designation
The FDA grants orphan designation to encourage companies to develop therapies for diseases that affect fewer than 200,000 individuals in the US.
Orphan designation provides a company with research and development tax credits, an opportunity to obtain grant funding, exemption from FDA application fees, and other benefits.
If the FDA approves AG-120 to treat patients with AML, orphan designation will provide Agios with 7 years of marketing exclusivity in the US.
There may be room for improvement with VTE prophylaxis, team says
Photo courtesy of the CDC
Results of a large, retrospective study suggest a need for more frequent use of post-discharge thromboprophylaxis in colorectal surgery patients.
Although the overall rate of venous thromboembolism (VTE) in this study was low, nearly 40% of the VTEs occurred after hospital discharge.
And discharge prophylaxis was used in a small percentage of patients. So researchers believe this may be an area for improvement in patient care.
The team described this research in JAMA Surgery alongside a related commentary.
The study was conducted by the Colorectal Writing Group for the Surgical Care and Outcomes Assessment Program-Comparative Effectiveness Research Translation Network (SCOAP-CERTAIN) Collaborative.
The group analyzed data from 16,120 patients who underwent colorectal surgery between 2006 and 2011 at 52 hospitals in Washington. The goal was to determine whether the incidence of VTE had changed with evolving prophylaxis patterns.
The researchers found the use of VTE prophylaxis increased significantly during the study period, but there was no significant change in VTE incidence.
The use of perioperative prophylaxis increased from 31.6% (323/1021) to 86.4% (3007/3480). The use of postoperative, in-hospital prophylaxis increased from 59.6% (603/1012) to 91.4% (3223/3527). And the use of discharge prophylaxis increased from 8.6% to 11.7%. Overall, 10.6% of patients (1399/13,230) were discharged on VTE prophylaxis.
The incidence of any VTE up to 90 days after surgery was 2.2% (360/16,120), and 60.6% of these events (218/360) occurred during a patient’s hospital stay.
The unadjusted, 90-day VTE rate increased during the study period, from 1.2% in 2006 to 3.0% in 2011 (P<0.01 for trend). However, there were no significant differences in VTE incidence over time after the researchers adjusted for patient and operative variables (P=0.09).
The researchers also found that patients who underwent abdominal operations had higher rates of 90-day VTE than patients who had pelvic operations—2.5% vs 1.8%. And patients undergoing cancer-related operations had a similar incidence of VTE as patients having operations not related to malignancy—2.1% vs 2.3%.
These results were surprising because previous research suggested that VTE rates tend to be higher among cancer patients and those who undergo pelvic surgery, said study author Scott R. Steele, MD, of Madigan Army Medical Center in Tacoma, Washington.
Dr Steele also noted that this study suggests a low overall rate of VTE in patients who undergo colorectal surgery, but discharge prophylaxis may be an area for quality improvement. Nearly 40% of VTEs occurred after hospital discharge, and only about 11% of patients received discharge prophylaxis.
Still, he said researchers would need to conduct a large-scale, randomized trial to confirm a benefit for discharge prophylaxis in these patients.
Photo courtesy of the CDC
Results of a large, retrospective study suggest a need for more frequent use of post-discharge thromboprophylaxis in colorectal surgery patients.
Although the overall rate of venous thromboembolism (VTE) in this study was low, nearly 40% of the VTEs occurred after hospital discharge.
And discharge prophylaxis was used in a small percentage of patients. So researchers believe this may be an area for improvement in patient care.
The team described this research in JAMA Surgery alongside a related commentary.
The study was conducted by the Colorectal Writing Group for the Surgical Care and Outcomes Assessment Program-Comparative Effectiveness Research Translation Network (SCOAP-CERTAIN) Collaborative.
The group analyzed data from 16,120 patients who underwent colorectal surgery between 2006 and 2011 at 52 hospitals in Washington. The goal was to determine whether the incidence of VTE had changed with evolving prophylaxis patterns.
The researchers found the use of VTE prophylaxis increased significantly during the study period, but there was no significant change in VTE incidence.
The use of perioperative prophylaxis increased from 31.6% (323/1021) to 86.4% (3007/3480). The use of postoperative, in-hospital prophylaxis increased from 59.6% (603/1012) to 91.4% (3223/3527). And the use of discharge prophylaxis increased from 8.6% to 11.7%. Overall, 10.6% of patients (1399/13,230) were discharged on VTE prophylaxis.
The incidence of any VTE up to 90 days after surgery was 2.2% (360/16,120), and 60.6% of these events (218/360) occurred during a patient’s hospital stay.
The unadjusted, 90-day VTE rate increased during the study period, from 1.2% in 2006 to 3.0% in 2011 (P<0.01 for trend). However, there were no significant differences in VTE incidence over time after the researchers adjusted for patient and operative variables (P=0.09).
The researchers also found that patients who underwent abdominal operations had higher rates of 90-day VTE than patients who had pelvic operations—2.5% vs 1.8%. And patients undergoing cancer-related operations had a similar incidence of VTE as patients having operations not related to malignancy—2.1% vs 2.3%.
These results were surprising because previous research suggested that VTE rates tend to be higher among cancer patients and those who undergo pelvic surgery, said study author Scott R. Steele, MD, of Madigan Army Medical Center in Tacoma, Washington.
Dr Steele also noted that this study suggests a low overall rate of VTE in patients who undergo colorectal surgery, but discharge prophylaxis may be an area for quality improvement. Nearly 40% of VTEs occurred after hospital discharge, and only about 11% of patients received discharge prophylaxis.
Still, he said researchers would need to conduct a large-scale, randomized trial to confirm a benefit for discharge prophylaxis in these patients.
Photo courtesy of the CDC
Results of a large, retrospective study suggest a need for more frequent use of post-discharge thromboprophylaxis in colorectal surgery patients.
Although the overall rate of venous thromboembolism (VTE) in this study was low, nearly 40% of the VTEs occurred after hospital discharge.
And discharge prophylaxis was used in a small percentage of patients. So researchers believe this may be an area for improvement in patient care.
The team described this research in JAMA Surgery alongside a related commentary.
The study was conducted by the Colorectal Writing Group for the Surgical Care and Outcomes Assessment Program-Comparative Effectiveness Research Translation Network (SCOAP-CERTAIN) Collaborative.
The group analyzed data from 16,120 patients who underwent colorectal surgery between 2006 and 2011 at 52 hospitals in Washington. The goal was to determine whether the incidence of VTE had changed with evolving prophylaxis patterns.
The researchers found the use of VTE prophylaxis increased significantly during the study period, but there was no significant change in VTE incidence.
The use of perioperative prophylaxis increased from 31.6% (323/1021) to 86.4% (3007/3480). The use of postoperative, in-hospital prophylaxis increased from 59.6% (603/1012) to 91.4% (3223/3527). And the use of discharge prophylaxis increased from 8.6% to 11.7%. Overall, 10.6% of patients (1399/13,230) were discharged on VTE prophylaxis.
The incidence of any VTE up to 90 days after surgery was 2.2% (360/16,120), and 60.6% of these events (218/360) occurred during a patient’s hospital stay.
The unadjusted, 90-day VTE rate increased during the study period, from 1.2% in 2006 to 3.0% in 2011 (P<0.01 for trend). However, there were no significant differences in VTE incidence over time after the researchers adjusted for patient and operative variables (P=0.09).
The researchers also found that patients who underwent abdominal operations had higher rates of 90-day VTE than patients who had pelvic operations—2.5% vs 1.8%. And patients undergoing cancer-related operations had a similar incidence of VTE as patients having operations not related to malignancy—2.1% vs 2.3%.
These results were surprising because previous research suggested that VTE rates tend to be higher among cancer patients and those who undergo pelvic surgery, said study author Scott R. Steele, MD, of Madigan Army Medical Center in Tacoma, Washington.
Dr Steele also noted that this study suggests a low overall rate of VTE in patients who undergo colorectal surgery, but discharge prophylaxis may be an area for quality improvement. Nearly 40% of VTEs occurred after hospital discharge, and only about 11% of patients received discharge prophylaxis.
Still, he said researchers would need to conduct a large-scale, randomized trial to confirm a benefit for discharge prophylaxis in these patients.
Drug granted orphan status for hemophilia A
The US Food and Drug Administration (FDA) has granted orphan drug designation to the investigational agent ATX-F8-117 for use in patients with hemophilia A.
The drug is designed to prevent the development of factor VIII (FVIII) inhibitors in patients receiving FVIII therapy or treat patients who already have FVIII inhibitors.
ATX-F8-117 received orphan designation from the European Medicines Agency in November 2014.
“These designations emphasize the need for an effective treatment for hemophilia A patients developing factor VIII inhibitors that occurs in approximately 30% of patients,” said Keith Martin, CEO of Apitope, the company developing ATX-F8-117.
“This results in poor clotting of the blood, leading to severe health issues. This orphan drug designation follows extensive preclinical evaluation, and we look forward to advancing a clinical development program for this important medical condition.”
ATX-F8-117 consists of 2 peptides derived from FVIII. Research conducted by Apitope investigators has shown that ATX-F8-117 induces T-cell tolerance toward FVIII in HLA-DRB1*1501 transgenic mice and decreases FVIII inhibitor formation in mice with FVIII neutralizing antibodies.
About orphan designation
The FDA grants orphan designation to encourage companies to develop therapies for diseases that affect fewer than 200,000 individuals in the US.
Orphan designation provides a company with research and development tax credits, an opportunity to obtain grant funding, exemption from FDA application fees, and other benefits.
If ATX-F8-117 is approved to treat patients with hemophilia A, orphan designation will provide Apitope with 7 years of marketing exclusivity in the US.
The US Food and Drug Administration (FDA) has granted orphan drug designation to the investigational agent ATX-F8-117 for use in patients with hemophilia A.
The drug is designed to prevent the development of factor VIII (FVIII) inhibitors in patients receiving FVIII therapy or treat patients who already have FVIII inhibitors.
ATX-F8-117 received orphan designation from the European Medicines Agency in November 2014.
“These designations emphasize the need for an effective treatment for hemophilia A patients developing factor VIII inhibitors that occurs in approximately 30% of patients,” said Keith Martin, CEO of Apitope, the company developing ATX-F8-117.
“This results in poor clotting of the blood, leading to severe health issues. This orphan drug designation follows extensive preclinical evaluation, and we look forward to advancing a clinical development program for this important medical condition.”
ATX-F8-117 consists of 2 peptides derived from FVIII. Research conducted by Apitope investigators has shown that ATX-F8-117 induces T-cell tolerance toward FVIII in HLA-DRB1*1501 transgenic mice and decreases FVIII inhibitor formation in mice with FVIII neutralizing antibodies.
About orphan designation
The FDA grants orphan designation to encourage companies to develop therapies for diseases that affect fewer than 200,000 individuals in the US.
Orphan designation provides a company with research and development tax credits, an opportunity to obtain grant funding, exemption from FDA application fees, and other benefits.
If ATX-F8-117 is approved to treat patients with hemophilia A, orphan designation will provide Apitope with 7 years of marketing exclusivity in the US.
The US Food and Drug Administration (FDA) has granted orphan drug designation to the investigational agent ATX-F8-117 for use in patients with hemophilia A.
The drug is designed to prevent the development of factor VIII (FVIII) inhibitors in patients receiving FVIII therapy or treat patients who already have FVIII inhibitors.
ATX-F8-117 received orphan designation from the European Medicines Agency in November 2014.
“These designations emphasize the need for an effective treatment for hemophilia A patients developing factor VIII inhibitors that occurs in approximately 30% of patients,” said Keith Martin, CEO of Apitope, the company developing ATX-F8-117.
“This results in poor clotting of the blood, leading to severe health issues. This orphan drug designation follows extensive preclinical evaluation, and we look forward to advancing a clinical development program for this important medical condition.”
ATX-F8-117 consists of 2 peptides derived from FVIII. Research conducted by Apitope investigators has shown that ATX-F8-117 induces T-cell tolerance toward FVIII in HLA-DRB1*1501 transgenic mice and decreases FVIII inhibitor formation in mice with FVIII neutralizing antibodies.
About orphan designation
The FDA grants orphan designation to encourage companies to develop therapies for diseases that affect fewer than 200,000 individuals in the US.
Orphan designation provides a company with research and development tax credits, an opportunity to obtain grant funding, exemption from FDA application fees, and other benefits.
If ATX-F8-117 is approved to treat patients with hemophilia A, orphan designation will provide Apitope with 7 years of marketing exclusivity in the US.
The Rural Surgeon: Surgical practice in the Indian Health Service
Only last week I thought to myself: an almost perfect surgery day. A few endoscopy cases, a breast case, a parathyroid adenoma, and a gastrectomy. I remind myself from time to time how fortunate I am to have the diversity of cases that I am afforded by my unique rural location and employment in the Indian Health Service (IHS).
Over 2 decades ago with what seemed to be an upheaval in health care, I decided to either leave surgery altogether or find some alternative to the business side of medicine that I was experiencing in the world of my private surgical practice. It was 1993 and the Health Security Act was being formulated with a task force with a paucity of physician input. It looked like medicine was headed to a period of increasing bureaucracy and decreased autonomy.
While thumbing through one of the recruiting magazines, I noticed an article about an internal medicine physician and his wife, an obstetrician/ gynecologist, who together joined the Indian Health Service. I made some inquiries.
I knew nothing about the Indian Health Service. I had a picture in my mind of a remote barren reservation working with doctors who couldn’t get a job in the real world. What I found was the best career I could have imagined.
I landed in a rural community in Oklahoma. The colleagues that I have come to know have been some of the best I have seen anywhere. I have had the distinct privilege of taking care of patients who are for the most part very grateful for the care I can give them.
I can recall during the interview process I was concerned that as a non-Native, I might not be accepted by the patients in this part of the country. My concerns were dispelled. I have felt accepted and appreciated.
What I found was that in many ways, my Native American patients are similar to the rural patients I have had in private practice. In the Native American culture, elders are respected. Family is very important – not just the nuclear family but the extended family, cousins, and multiple generations. Patients are proud of their heritage. There is a sense of interdependence and connection. I have been blessed to be a part of healing ceremonies that have left a lasting influence on my approach to disease, health, and spirituality.
Many of these patients have limited resources and astounding health burdens. Native Americans are disproportionately afflicted with diabetes, cardiovascular disease, and obesity. Because of these health problems, programs that address these specific issues have been developed within our system. We have a diabetic clinic that includes foot care, eye care, nutritional counseling, general medicine, and pharmacy needs as well as extensive education about prevention and disease control. We have also developed a Healthy Eating for Life Program (HELP) involving a multidisciplinary approach to weight loss that includes a cognitive behavioral health program, one-on-one education with a certified bariatric nurse, support groups, nutritional instruction, and for some patients, surgical intervention.
Patients may access the Indian and Tribal Health Systems regardless of insurance status. While our practice is not totally devoid of the business aspects of medicine, most of the time we are unaware of the patients’ insurance status. Procedures or diagnostic studies that cannot be done onsite are sometimes covered through contract health services.
Our facility was built with the intent of providing health care for the adjacent counties, but by the time it was completed the need had already outstripped the resources. While funding has improved over the years, the rising costs of medical care and increases in the volume of the service population have continued to translate into unmet needs, especially for services not directly provided in our facility.
There are many physicians who have come and gone during my tenure. Some have Indian Health Service scholarship paybacks that they fulfill and move on, and others may be in transition from one greener pasture to another. The surgical service has grown from two surgeons to six. We have a good mix of youth and seasoned doctors, with half the group over 40 and half younger. The gender mix is also balanced with three females and three males.
There is a plethora of pathology. Most of us have carved out niches of surgical interest. We average 150 referrals per week, which translates into plenty to do. There are no turf battles. We have not adopted the hospitalist model. The surgeons here round and follow their own patients, which is great for continuity. Our patients appreciate seeing the same doctor. We are not, however, tethered to the facility. The surgeon on call will graciously cover any patients if needed, and we are fortunate in that we all have similar practice styles. Thus, we have cross coverage by surgeons who think and operate similarly.
We have had the pleasure of hosting both fellowship trained surgeons (vascular and trauma) and general surgeons interested in a rural lifestyle and Native medicine. The facility is also a teaching hospital. An array of students including surgical technicians, Certified Registered Nurse Anesthetist (CRNA) students, residents, medical students, and U.S. Army Special Forces all rotate through our operating rooms.
One of the benefits of the Indian Health Service is that you are part of a system. Sometimes one can forget that point amid the daily work. Going to meetings specifically geared toward IHS issues is often very rewarding. You are a part of something much bigger than your own practice. Progress is defined over time – a decrease in amputation rates as hemoglobin A1C’s improve, a system-wide approach to colorectal cancer screening, the development of a tumor registry that specifically tracks cancer for Native Americans (no longer grouping them under “white” or lost under “other”).
Although we are rural surgeons, we do not work in isolation. All of our providers are board certified. We are currently the only facility in Oklahoma participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP).
In training, we were encouraged to be aggressive and work independently. It was the era of the pyramid system. No one cared how much sleep you got or when you last ate, and yet there was a team approach among the residents. That same independence is fostered here but in a much more conducive environment.
Many of us sought surgical careers because we truly enjoyed being in the operating room, the haven. We liked the technical aspects, the challenges. We joked that we liked our patients asleep, either on early morning rounds or in the surgical suite.
Where once clinic was a necessary evil, I now enjoy the interaction and find I can often do as much for the patient or family in the clinic as I can in the operating room.
I have also found that with the support of administration, we can have an impact on care beyond the individual level. We can affect the health status of an entire population.
There has been much progress in this system over the last 2 decades and there continues to be room for even more. The key may be in the name: Indian Health Service. I would encourage those who think they might find this type of practice intriguing to explore www.ihs.gov and look under career opportunities.
Dr. Hope Baluh is an ACS fellow. She serves as chief of surgery at Cherokee Nation W.W. Hastings Hospital in Oklahoma and is a recent graduate from Johns Hopkins School of Public Health.
Only last week I thought to myself: an almost perfect surgery day. A few endoscopy cases, a breast case, a parathyroid adenoma, and a gastrectomy. I remind myself from time to time how fortunate I am to have the diversity of cases that I am afforded by my unique rural location and employment in the Indian Health Service (IHS).
Over 2 decades ago with what seemed to be an upheaval in health care, I decided to either leave surgery altogether or find some alternative to the business side of medicine that I was experiencing in the world of my private surgical practice. It was 1993 and the Health Security Act was being formulated with a task force with a paucity of physician input. It looked like medicine was headed to a period of increasing bureaucracy and decreased autonomy.
While thumbing through one of the recruiting magazines, I noticed an article about an internal medicine physician and his wife, an obstetrician/ gynecologist, who together joined the Indian Health Service. I made some inquiries.
I knew nothing about the Indian Health Service. I had a picture in my mind of a remote barren reservation working with doctors who couldn’t get a job in the real world. What I found was the best career I could have imagined.
I landed in a rural community in Oklahoma. The colleagues that I have come to know have been some of the best I have seen anywhere. I have had the distinct privilege of taking care of patients who are for the most part very grateful for the care I can give them.
I can recall during the interview process I was concerned that as a non-Native, I might not be accepted by the patients in this part of the country. My concerns were dispelled. I have felt accepted and appreciated.
What I found was that in many ways, my Native American patients are similar to the rural patients I have had in private practice. In the Native American culture, elders are respected. Family is very important – not just the nuclear family but the extended family, cousins, and multiple generations. Patients are proud of their heritage. There is a sense of interdependence and connection. I have been blessed to be a part of healing ceremonies that have left a lasting influence on my approach to disease, health, and spirituality.
Many of these patients have limited resources and astounding health burdens. Native Americans are disproportionately afflicted with diabetes, cardiovascular disease, and obesity. Because of these health problems, programs that address these specific issues have been developed within our system. We have a diabetic clinic that includes foot care, eye care, nutritional counseling, general medicine, and pharmacy needs as well as extensive education about prevention and disease control. We have also developed a Healthy Eating for Life Program (HELP) involving a multidisciplinary approach to weight loss that includes a cognitive behavioral health program, one-on-one education with a certified bariatric nurse, support groups, nutritional instruction, and for some patients, surgical intervention.
Patients may access the Indian and Tribal Health Systems regardless of insurance status. While our practice is not totally devoid of the business aspects of medicine, most of the time we are unaware of the patients’ insurance status. Procedures or diagnostic studies that cannot be done onsite are sometimes covered through contract health services.
Our facility was built with the intent of providing health care for the adjacent counties, but by the time it was completed the need had already outstripped the resources. While funding has improved over the years, the rising costs of medical care and increases in the volume of the service population have continued to translate into unmet needs, especially for services not directly provided in our facility.
There are many physicians who have come and gone during my tenure. Some have Indian Health Service scholarship paybacks that they fulfill and move on, and others may be in transition from one greener pasture to another. The surgical service has grown from two surgeons to six. We have a good mix of youth and seasoned doctors, with half the group over 40 and half younger. The gender mix is also balanced with three females and three males.
There is a plethora of pathology. Most of us have carved out niches of surgical interest. We average 150 referrals per week, which translates into plenty to do. There are no turf battles. We have not adopted the hospitalist model. The surgeons here round and follow their own patients, which is great for continuity. Our patients appreciate seeing the same doctor. We are not, however, tethered to the facility. The surgeon on call will graciously cover any patients if needed, and we are fortunate in that we all have similar practice styles. Thus, we have cross coverage by surgeons who think and operate similarly.
We have had the pleasure of hosting both fellowship trained surgeons (vascular and trauma) and general surgeons interested in a rural lifestyle and Native medicine. The facility is also a teaching hospital. An array of students including surgical technicians, Certified Registered Nurse Anesthetist (CRNA) students, residents, medical students, and U.S. Army Special Forces all rotate through our operating rooms.
One of the benefits of the Indian Health Service is that you are part of a system. Sometimes one can forget that point amid the daily work. Going to meetings specifically geared toward IHS issues is often very rewarding. You are a part of something much bigger than your own practice. Progress is defined over time – a decrease in amputation rates as hemoglobin A1C’s improve, a system-wide approach to colorectal cancer screening, the development of a tumor registry that specifically tracks cancer for Native Americans (no longer grouping them under “white” or lost under “other”).
Although we are rural surgeons, we do not work in isolation. All of our providers are board certified. We are currently the only facility in Oklahoma participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP).
In training, we were encouraged to be aggressive and work independently. It was the era of the pyramid system. No one cared how much sleep you got or when you last ate, and yet there was a team approach among the residents. That same independence is fostered here but in a much more conducive environment.
Many of us sought surgical careers because we truly enjoyed being in the operating room, the haven. We liked the technical aspects, the challenges. We joked that we liked our patients asleep, either on early morning rounds or in the surgical suite.
Where once clinic was a necessary evil, I now enjoy the interaction and find I can often do as much for the patient or family in the clinic as I can in the operating room.
I have also found that with the support of administration, we can have an impact on care beyond the individual level. We can affect the health status of an entire population.
There has been much progress in this system over the last 2 decades and there continues to be room for even more. The key may be in the name: Indian Health Service. I would encourage those who think they might find this type of practice intriguing to explore www.ihs.gov and look under career opportunities.
Dr. Hope Baluh is an ACS fellow. She serves as chief of surgery at Cherokee Nation W.W. Hastings Hospital in Oklahoma and is a recent graduate from Johns Hopkins School of Public Health.
Only last week I thought to myself: an almost perfect surgery day. A few endoscopy cases, a breast case, a parathyroid adenoma, and a gastrectomy. I remind myself from time to time how fortunate I am to have the diversity of cases that I am afforded by my unique rural location and employment in the Indian Health Service (IHS).
Over 2 decades ago with what seemed to be an upheaval in health care, I decided to either leave surgery altogether or find some alternative to the business side of medicine that I was experiencing in the world of my private surgical practice. It was 1993 and the Health Security Act was being formulated with a task force with a paucity of physician input. It looked like medicine was headed to a period of increasing bureaucracy and decreased autonomy.
While thumbing through one of the recruiting magazines, I noticed an article about an internal medicine physician and his wife, an obstetrician/ gynecologist, who together joined the Indian Health Service. I made some inquiries.
I knew nothing about the Indian Health Service. I had a picture in my mind of a remote barren reservation working with doctors who couldn’t get a job in the real world. What I found was the best career I could have imagined.
I landed in a rural community in Oklahoma. The colleagues that I have come to know have been some of the best I have seen anywhere. I have had the distinct privilege of taking care of patients who are for the most part very grateful for the care I can give them.
I can recall during the interview process I was concerned that as a non-Native, I might not be accepted by the patients in this part of the country. My concerns were dispelled. I have felt accepted and appreciated.
What I found was that in many ways, my Native American patients are similar to the rural patients I have had in private practice. In the Native American culture, elders are respected. Family is very important – not just the nuclear family but the extended family, cousins, and multiple generations. Patients are proud of their heritage. There is a sense of interdependence and connection. I have been blessed to be a part of healing ceremonies that have left a lasting influence on my approach to disease, health, and spirituality.
Many of these patients have limited resources and astounding health burdens. Native Americans are disproportionately afflicted with diabetes, cardiovascular disease, and obesity. Because of these health problems, programs that address these specific issues have been developed within our system. We have a diabetic clinic that includes foot care, eye care, nutritional counseling, general medicine, and pharmacy needs as well as extensive education about prevention and disease control. We have also developed a Healthy Eating for Life Program (HELP) involving a multidisciplinary approach to weight loss that includes a cognitive behavioral health program, one-on-one education with a certified bariatric nurse, support groups, nutritional instruction, and for some patients, surgical intervention.
Patients may access the Indian and Tribal Health Systems regardless of insurance status. While our practice is not totally devoid of the business aspects of medicine, most of the time we are unaware of the patients’ insurance status. Procedures or diagnostic studies that cannot be done onsite are sometimes covered through contract health services.
Our facility was built with the intent of providing health care for the adjacent counties, but by the time it was completed the need had already outstripped the resources. While funding has improved over the years, the rising costs of medical care and increases in the volume of the service population have continued to translate into unmet needs, especially for services not directly provided in our facility.
There are many physicians who have come and gone during my tenure. Some have Indian Health Service scholarship paybacks that they fulfill and move on, and others may be in transition from one greener pasture to another. The surgical service has grown from two surgeons to six. We have a good mix of youth and seasoned doctors, with half the group over 40 and half younger. The gender mix is also balanced with three females and three males.
There is a plethora of pathology. Most of us have carved out niches of surgical interest. We average 150 referrals per week, which translates into plenty to do. There are no turf battles. We have not adopted the hospitalist model. The surgeons here round and follow their own patients, which is great for continuity. Our patients appreciate seeing the same doctor. We are not, however, tethered to the facility. The surgeon on call will graciously cover any patients if needed, and we are fortunate in that we all have similar practice styles. Thus, we have cross coverage by surgeons who think and operate similarly.
We have had the pleasure of hosting both fellowship trained surgeons (vascular and trauma) and general surgeons interested in a rural lifestyle and Native medicine. The facility is also a teaching hospital. An array of students including surgical technicians, Certified Registered Nurse Anesthetist (CRNA) students, residents, medical students, and U.S. Army Special Forces all rotate through our operating rooms.
One of the benefits of the Indian Health Service is that you are part of a system. Sometimes one can forget that point amid the daily work. Going to meetings specifically geared toward IHS issues is often very rewarding. You are a part of something much bigger than your own practice. Progress is defined over time – a decrease in amputation rates as hemoglobin A1C’s improve, a system-wide approach to colorectal cancer screening, the development of a tumor registry that specifically tracks cancer for Native Americans (no longer grouping them under “white” or lost under “other”).
Although we are rural surgeons, we do not work in isolation. All of our providers are board certified. We are currently the only facility in Oklahoma participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP).
In training, we were encouraged to be aggressive and work independently. It was the era of the pyramid system. No one cared how much sleep you got or when you last ate, and yet there was a team approach among the residents. That same independence is fostered here but in a much more conducive environment.
Many of us sought surgical careers because we truly enjoyed being in the operating room, the haven. We liked the technical aspects, the challenges. We joked that we liked our patients asleep, either on early morning rounds or in the surgical suite.
Where once clinic was a necessary evil, I now enjoy the interaction and find I can often do as much for the patient or family in the clinic as I can in the operating room.
I have also found that with the support of administration, we can have an impact on care beyond the individual level. We can affect the health status of an entire population.
There has been much progress in this system over the last 2 decades and there continues to be room for even more. The key may be in the name: Indian Health Service. I would encourage those who think they might find this type of practice intriguing to explore www.ihs.gov and look under career opportunities.
Dr. Hope Baluh is an ACS fellow. She serves as chief of surgery at Cherokee Nation W.W. Hastings Hospital in Oklahoma and is a recent graduate from Johns Hopkins School of Public Health.
From the Washington Office
As mentioned at the end of last month’s column, in the wake of the permanent repeal of the SGR, it will be necessary for surgeons to become familiar with an entire new lexicon of acronyms. That being said, I would like to first borrow a line from Kevin Bacon at the end of the movie Animal House and assure you that “all is well.”
The first of the new acronyms is MIPS – Merit-based Incentive Payment System.
To start, there is good news for several reasons. First, the MIPS program does not go into effect until 2019. This gives all surgeons ample opportunity to become educated and to prepare for the new program. In addition, most surgeons are already familiar with most, if not all, of the individual components of MIPS. Finally, MIPS provides payment updates based on each surgeon’s individual performance. These updates are independent of an arbitrarily set aggregate spending target as was the case previously under the SGR.
Surgeons who treat few Medicare patients or who receive a significant portion of their revenue from an eligible Alternative Payment Model program (APM) will be excluded from the MIPS program. APMs will be discussed in a later edition of this column.
MIPS will provide annual updates, again starting in 2019, based on individual performance in four categories: Quality, Resource Use, Electronic Health Record Meaningful Use and Clinical Practice Improvement Activities.
Surgeons participating in MIPS will receive an individual composite score of 0-100 based on their performance in the aforementioned four categories. Each individual composite score will then be compared to a performance threshold. The threshold consists of the mean or median of the composite performance scores for all MIPS-eligible professionals during a performance period prior to the current period. The threshold resets each year such that an individual’s score in 1 year does not impact their composite score the following year. All those with an individual composite performance score above the threshold will receive a positive payment adjustment, while those with an individual composite performance score below the threshold will receive a negative payment adjustment.
Positive adjustments can be up to 4% in 2019 and grow to 9% in 2022. Should the number of providers achieving high composite scores be low, the positive adjustments can be increased by up to a factor of three. If the number of those over the threshold far exceeds the number of those below the threshold, the incentives are scaled back to ensure budget neutrality. An additional $500 million per year is available for the top 75% of providers above the performance threshold. This ensures that in a circumstance where all physicians met the MIPS threshold, there would be funds available for positive updates.
Similarly, negative adjustments will be capped at 4% in 2019, rising to 9% in 2022. Those whose composite performance score falls in the lowest quartile below the threshold (i.e., with a performance threshold set at 60, those with scores between 0 and 15), will be subject to the maximum possible payment adjustment. Those with composite performance scores closer to the threshold will be subject to proportionally smaller negative payment adjustments.
The quality component of the MIPS will consist of quality measures currently used in existing quality performance programs. Specifically, these are the PQRS (Physician Quality Reporting System), the VBM (Value-Based Modifier program), and EHR-MU (Electronic Health Record Meaningful Use), with which most surgeons are already familiar. The Secretary of the Department of Health & Human Services will also solicit other measures from professional organizations such as ACS. Composite measures from QCDR (Qualified Clinical Data Registries) may also be used. The College is working with CMS to determine how to ensure its data registries, NSQIP and the SSR (Surgeon Specific Registry), can be utilized to meet the QCDR requirements.
The resource use component of MIPS will also include measures used in the current VBM program. The methodology by which these measures are applied will be enhanced through public input to include directly engaging providers. Surgeons will be allowed to report their specific role in treating patients. This provision seeks to allay concerns that the current methodology and attribution rules fail to accurately link the cost of services to the correct, specific professional. Additionally, research and public input will be sought on how to improve risk-adjustment methodologies such that surgeons are not penalized for providing care to sicker patients whose care is more costly.
With regard to the EHR-MU component of MIPS, the current EHR-MU requirements will continue to apply. ACS continues to advocate for changes to the EHR-MU program to make it easier for surgeons to comply with the requirements. Electronic health records are required to be interoperable by 2018 and vendors are prohibited from deliberately blocking information sharing with another vendor’s product.
In next month’s column, we will discuss the final component category of MIPS, the CPIA (Clinical Practice Improvement Activities) and the APMs as mentioned above.
Until next month …
Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.
As mentioned at the end of last month’s column, in the wake of the permanent repeal of the SGR, it will be necessary for surgeons to become familiar with an entire new lexicon of acronyms. That being said, I would like to first borrow a line from Kevin Bacon at the end of the movie Animal House and assure you that “all is well.”
The first of the new acronyms is MIPS – Merit-based Incentive Payment System.
To start, there is good news for several reasons. First, the MIPS program does not go into effect until 2019. This gives all surgeons ample opportunity to become educated and to prepare for the new program. In addition, most surgeons are already familiar with most, if not all, of the individual components of MIPS. Finally, MIPS provides payment updates based on each surgeon’s individual performance. These updates are independent of an arbitrarily set aggregate spending target as was the case previously under the SGR.
Surgeons who treat few Medicare patients or who receive a significant portion of their revenue from an eligible Alternative Payment Model program (APM) will be excluded from the MIPS program. APMs will be discussed in a later edition of this column.
MIPS will provide annual updates, again starting in 2019, based on individual performance in four categories: Quality, Resource Use, Electronic Health Record Meaningful Use and Clinical Practice Improvement Activities.
Surgeons participating in MIPS will receive an individual composite score of 0-100 based on their performance in the aforementioned four categories. Each individual composite score will then be compared to a performance threshold. The threshold consists of the mean or median of the composite performance scores for all MIPS-eligible professionals during a performance period prior to the current period. The threshold resets each year such that an individual’s score in 1 year does not impact their composite score the following year. All those with an individual composite performance score above the threshold will receive a positive payment adjustment, while those with an individual composite performance score below the threshold will receive a negative payment adjustment.
Positive adjustments can be up to 4% in 2019 and grow to 9% in 2022. Should the number of providers achieving high composite scores be low, the positive adjustments can be increased by up to a factor of three. If the number of those over the threshold far exceeds the number of those below the threshold, the incentives are scaled back to ensure budget neutrality. An additional $500 million per year is available for the top 75% of providers above the performance threshold. This ensures that in a circumstance where all physicians met the MIPS threshold, there would be funds available for positive updates.
Similarly, negative adjustments will be capped at 4% in 2019, rising to 9% in 2022. Those whose composite performance score falls in the lowest quartile below the threshold (i.e., with a performance threshold set at 60, those with scores between 0 and 15), will be subject to the maximum possible payment adjustment. Those with composite performance scores closer to the threshold will be subject to proportionally smaller negative payment adjustments.
The quality component of the MIPS will consist of quality measures currently used in existing quality performance programs. Specifically, these are the PQRS (Physician Quality Reporting System), the VBM (Value-Based Modifier program), and EHR-MU (Electronic Health Record Meaningful Use), with which most surgeons are already familiar. The Secretary of the Department of Health & Human Services will also solicit other measures from professional organizations such as ACS. Composite measures from QCDR (Qualified Clinical Data Registries) may also be used. The College is working with CMS to determine how to ensure its data registries, NSQIP and the SSR (Surgeon Specific Registry), can be utilized to meet the QCDR requirements.
The resource use component of MIPS will also include measures used in the current VBM program. The methodology by which these measures are applied will be enhanced through public input to include directly engaging providers. Surgeons will be allowed to report their specific role in treating patients. This provision seeks to allay concerns that the current methodology and attribution rules fail to accurately link the cost of services to the correct, specific professional. Additionally, research and public input will be sought on how to improve risk-adjustment methodologies such that surgeons are not penalized for providing care to sicker patients whose care is more costly.
With regard to the EHR-MU component of MIPS, the current EHR-MU requirements will continue to apply. ACS continues to advocate for changes to the EHR-MU program to make it easier for surgeons to comply with the requirements. Electronic health records are required to be interoperable by 2018 and vendors are prohibited from deliberately blocking information sharing with another vendor’s product.
In next month’s column, we will discuss the final component category of MIPS, the CPIA (Clinical Practice Improvement Activities) and the APMs as mentioned above.
Until next month …
Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.
As mentioned at the end of last month’s column, in the wake of the permanent repeal of the SGR, it will be necessary for surgeons to become familiar with an entire new lexicon of acronyms. That being said, I would like to first borrow a line from Kevin Bacon at the end of the movie Animal House and assure you that “all is well.”
The first of the new acronyms is MIPS – Merit-based Incentive Payment System.
To start, there is good news for several reasons. First, the MIPS program does not go into effect until 2019. This gives all surgeons ample opportunity to become educated and to prepare for the new program. In addition, most surgeons are already familiar with most, if not all, of the individual components of MIPS. Finally, MIPS provides payment updates based on each surgeon’s individual performance. These updates are independent of an arbitrarily set aggregate spending target as was the case previously under the SGR.
Surgeons who treat few Medicare patients or who receive a significant portion of their revenue from an eligible Alternative Payment Model program (APM) will be excluded from the MIPS program. APMs will be discussed in a later edition of this column.
MIPS will provide annual updates, again starting in 2019, based on individual performance in four categories: Quality, Resource Use, Electronic Health Record Meaningful Use and Clinical Practice Improvement Activities.
Surgeons participating in MIPS will receive an individual composite score of 0-100 based on their performance in the aforementioned four categories. Each individual composite score will then be compared to a performance threshold. The threshold consists of the mean or median of the composite performance scores for all MIPS-eligible professionals during a performance period prior to the current period. The threshold resets each year such that an individual’s score in 1 year does not impact their composite score the following year. All those with an individual composite performance score above the threshold will receive a positive payment adjustment, while those with an individual composite performance score below the threshold will receive a negative payment adjustment.
Positive adjustments can be up to 4% in 2019 and grow to 9% in 2022. Should the number of providers achieving high composite scores be low, the positive adjustments can be increased by up to a factor of three. If the number of those over the threshold far exceeds the number of those below the threshold, the incentives are scaled back to ensure budget neutrality. An additional $500 million per year is available for the top 75% of providers above the performance threshold. This ensures that in a circumstance where all physicians met the MIPS threshold, there would be funds available for positive updates.
Similarly, negative adjustments will be capped at 4% in 2019, rising to 9% in 2022. Those whose composite performance score falls in the lowest quartile below the threshold (i.e., with a performance threshold set at 60, those with scores between 0 and 15), will be subject to the maximum possible payment adjustment. Those with composite performance scores closer to the threshold will be subject to proportionally smaller negative payment adjustments.
The quality component of the MIPS will consist of quality measures currently used in existing quality performance programs. Specifically, these are the PQRS (Physician Quality Reporting System), the VBM (Value-Based Modifier program), and EHR-MU (Electronic Health Record Meaningful Use), with which most surgeons are already familiar. The Secretary of the Department of Health & Human Services will also solicit other measures from professional organizations such as ACS. Composite measures from QCDR (Qualified Clinical Data Registries) may also be used. The College is working with CMS to determine how to ensure its data registries, NSQIP and the SSR (Surgeon Specific Registry), can be utilized to meet the QCDR requirements.
The resource use component of MIPS will also include measures used in the current VBM program. The methodology by which these measures are applied will be enhanced through public input to include directly engaging providers. Surgeons will be allowed to report their specific role in treating patients. This provision seeks to allay concerns that the current methodology and attribution rules fail to accurately link the cost of services to the correct, specific professional. Additionally, research and public input will be sought on how to improve risk-adjustment methodologies such that surgeons are not penalized for providing care to sicker patients whose care is more costly.
With regard to the EHR-MU component of MIPS, the current EHR-MU requirements will continue to apply. ACS continues to advocate for changes to the EHR-MU program to make it easier for surgeons to comply with the requirements. Electronic health records are required to be interoperable by 2018 and vendors are prohibited from deliberately blocking information sharing with another vendor’s product.
In next month’s column, we will discuss the final component category of MIPS, the CPIA (Clinical Practice Improvement Activities) and the APMs as mentioned above.
Until next month …
Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.
The right choice? Too little too soon?
The case being presented at Surgical Morbidity and Mortality Conference was all too familiar to many of the surgeons in the auditorium. After extensive discussions with the surgeon, an elderly man had undergone a risky operation. Although the operation had gone well, the patient had several setbacks in the first 48 hours requiring a second trip to the operating room. The patient was back in the surgical ICU fully ventilated on minimal pressors less than 24 hours after leaving the operating room the second time when the patient’s two sons and a daughter approached the surgeon to talk about the plan moving forward.
This was not a surprising turn of events since the patient’s wife had died several years earlier and he was in close contact with his children. They all lived in the area and had been present in the waiting room during both of his trips to the operating room. In accordance with the accepted standards for surrogate decision making, since the patient was not able to make decisions for himself, the appropriate surrogates were the two sons and a daughter. What was surprising to the surgeon was that now, less than 24 hours after leaving the operating room, the children were unanimous in their request that the patient’s life-supporting measures be stopped. Although there was no written advance directive, all the children felt strongly that their father would not have been wanted to be kept alive through “artificial means.”
This request created a series of quandaries for the attending surgeon. First, the surgeon felt that the patient had fully understood the small risks of complications and he had wanted to proceed with the operation despite understanding these risks. Second, the surgeon fully believed that the patient had a good chance for a complete recovery after surgery despite the complication. Based on the belief that the current requirement for intubation and ventilation was a temporary one, the surgeon felt that to withdraw support of the patient for a reversible problem so soon after surgery would be evidence of her not respecting the patient’s specifically stated wishes that he wanted to have surgery and recover from it.
The ensuing M&M discussion focused on a series of important questions. Had the patient fully understood the risks of the operation? His surgeon felt that he had, and she believed that the patient would not have wanted her to “give up” so soon after the operation. Someone asked whether the surgeon should have been willing to perform a high-risk operation on an elderly patient without having had the sons and daughter present to participate in the preoperative discussions. Such a scenario might have avoided the circumstance of the surgeon having a different understanding of the patient’s wishes than was currently being expressed by the sons and daughter. However, the logistics of requiring a competent adult patient who is living independently to bring his sons and daughter to the consultation before the surgeon was willing to operate seemed problematic.
It became clear that from the surgeon’s point of view (as well as from the majority of us at the M&M conference) that when the patient agreed to have the operation, he was not only agreeing to the surgery but also to the necessary perioperative care to allow him to recover. On the other hand, the family (who were now the appropriate surrogate decision makers) believed that the operation was over and all further treatments were open to discussion and should be evaluated based on what they believed their father’s wishes would have been.
What should be done when the surgeon’s responsibility to respect what she believes the patient’s wishes were are in conflict with the surrogate decision makers? Unfortunately, there is no clear answer to this question. The closer in time one is to the operation, the more the patient’s initial decision to proceed with surgery seemingly should hold sway. The further away from the operation, the more the family members’ interpretation of the patient’s wishes should guide decisions about treatments.
The surgeon in this case seemed to have reached an excellent compromise with the family. Based on the belief that the need for intubation and ventilation was short term, the surgeon convinced the family to allow aggressive treatment for 48 hours. She had expressed to the family that she felt she had a responsibility to their father to try to get him safely through this early part of the recovery. After the 48-hour time-limited trial, the surgeon and the family would meet again to discuss his status. If there had been improvements, then the same aggressive treatments would be continued in the hopes that the patient would soon be able to make his own decisions. Alternatively, if there was not improvement over the next 2 days, the surgeon agreed that further interventions would all be reassessed in accordance with what the family believed would have been their father’s wishes.
Although the patient ultimately did not recover, the surgeon felt that she had lived up to her responsibility to respect her patient’s decision to have surgery, while not completely ignoring the family’s wishes. The family also felt that the surgeon had been respectful of their own interpretation of their father’s goals and values. Sometimes in the ethical care of surgical patients, there is not a right and a wrong answer, but a series of compromises that we all hope will lead to the best outcome for our patients.
Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.
The case being presented at Surgical Morbidity and Mortality Conference was all too familiar to many of the surgeons in the auditorium. After extensive discussions with the surgeon, an elderly man had undergone a risky operation. Although the operation had gone well, the patient had several setbacks in the first 48 hours requiring a second trip to the operating room. The patient was back in the surgical ICU fully ventilated on minimal pressors less than 24 hours after leaving the operating room the second time when the patient’s two sons and a daughter approached the surgeon to talk about the plan moving forward.
This was not a surprising turn of events since the patient’s wife had died several years earlier and he was in close contact with his children. They all lived in the area and had been present in the waiting room during both of his trips to the operating room. In accordance with the accepted standards for surrogate decision making, since the patient was not able to make decisions for himself, the appropriate surrogates were the two sons and a daughter. What was surprising to the surgeon was that now, less than 24 hours after leaving the operating room, the children were unanimous in their request that the patient’s life-supporting measures be stopped. Although there was no written advance directive, all the children felt strongly that their father would not have been wanted to be kept alive through “artificial means.”
This request created a series of quandaries for the attending surgeon. First, the surgeon felt that the patient had fully understood the small risks of complications and he had wanted to proceed with the operation despite understanding these risks. Second, the surgeon fully believed that the patient had a good chance for a complete recovery after surgery despite the complication. Based on the belief that the current requirement for intubation and ventilation was a temporary one, the surgeon felt that to withdraw support of the patient for a reversible problem so soon after surgery would be evidence of her not respecting the patient’s specifically stated wishes that he wanted to have surgery and recover from it.
The ensuing M&M discussion focused on a series of important questions. Had the patient fully understood the risks of the operation? His surgeon felt that he had, and she believed that the patient would not have wanted her to “give up” so soon after the operation. Someone asked whether the surgeon should have been willing to perform a high-risk operation on an elderly patient without having had the sons and daughter present to participate in the preoperative discussions. Such a scenario might have avoided the circumstance of the surgeon having a different understanding of the patient’s wishes than was currently being expressed by the sons and daughter. However, the logistics of requiring a competent adult patient who is living independently to bring his sons and daughter to the consultation before the surgeon was willing to operate seemed problematic.
It became clear that from the surgeon’s point of view (as well as from the majority of us at the M&M conference) that when the patient agreed to have the operation, he was not only agreeing to the surgery but also to the necessary perioperative care to allow him to recover. On the other hand, the family (who were now the appropriate surrogate decision makers) believed that the operation was over and all further treatments were open to discussion and should be evaluated based on what they believed their father’s wishes would have been.
What should be done when the surgeon’s responsibility to respect what she believes the patient’s wishes were are in conflict with the surrogate decision makers? Unfortunately, there is no clear answer to this question. The closer in time one is to the operation, the more the patient’s initial decision to proceed with surgery seemingly should hold sway. The further away from the operation, the more the family members’ interpretation of the patient’s wishes should guide decisions about treatments.
The surgeon in this case seemed to have reached an excellent compromise with the family. Based on the belief that the need for intubation and ventilation was short term, the surgeon convinced the family to allow aggressive treatment for 48 hours. She had expressed to the family that she felt she had a responsibility to their father to try to get him safely through this early part of the recovery. After the 48-hour time-limited trial, the surgeon and the family would meet again to discuss his status. If there had been improvements, then the same aggressive treatments would be continued in the hopes that the patient would soon be able to make his own decisions. Alternatively, if there was not improvement over the next 2 days, the surgeon agreed that further interventions would all be reassessed in accordance with what the family believed would have been their father’s wishes.
Although the patient ultimately did not recover, the surgeon felt that she had lived up to her responsibility to respect her patient’s decision to have surgery, while not completely ignoring the family’s wishes. The family also felt that the surgeon had been respectful of their own interpretation of their father’s goals and values. Sometimes in the ethical care of surgical patients, there is not a right and a wrong answer, but a series of compromises that we all hope will lead to the best outcome for our patients.
Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.
The case being presented at Surgical Morbidity and Mortality Conference was all too familiar to many of the surgeons in the auditorium. After extensive discussions with the surgeon, an elderly man had undergone a risky operation. Although the operation had gone well, the patient had several setbacks in the first 48 hours requiring a second trip to the operating room. The patient was back in the surgical ICU fully ventilated on minimal pressors less than 24 hours after leaving the operating room the second time when the patient’s two sons and a daughter approached the surgeon to talk about the plan moving forward.
This was not a surprising turn of events since the patient’s wife had died several years earlier and he was in close contact with his children. They all lived in the area and had been present in the waiting room during both of his trips to the operating room. In accordance with the accepted standards for surrogate decision making, since the patient was not able to make decisions for himself, the appropriate surrogates were the two sons and a daughter. What was surprising to the surgeon was that now, less than 24 hours after leaving the operating room, the children were unanimous in their request that the patient’s life-supporting measures be stopped. Although there was no written advance directive, all the children felt strongly that their father would not have been wanted to be kept alive through “artificial means.”
This request created a series of quandaries for the attending surgeon. First, the surgeon felt that the patient had fully understood the small risks of complications and he had wanted to proceed with the operation despite understanding these risks. Second, the surgeon fully believed that the patient had a good chance for a complete recovery after surgery despite the complication. Based on the belief that the current requirement for intubation and ventilation was a temporary one, the surgeon felt that to withdraw support of the patient for a reversible problem so soon after surgery would be evidence of her not respecting the patient’s specifically stated wishes that he wanted to have surgery and recover from it.
The ensuing M&M discussion focused on a series of important questions. Had the patient fully understood the risks of the operation? His surgeon felt that he had, and she believed that the patient would not have wanted her to “give up” so soon after the operation. Someone asked whether the surgeon should have been willing to perform a high-risk operation on an elderly patient without having had the sons and daughter present to participate in the preoperative discussions. Such a scenario might have avoided the circumstance of the surgeon having a different understanding of the patient’s wishes than was currently being expressed by the sons and daughter. However, the logistics of requiring a competent adult patient who is living independently to bring his sons and daughter to the consultation before the surgeon was willing to operate seemed problematic.
It became clear that from the surgeon’s point of view (as well as from the majority of us at the M&M conference) that when the patient agreed to have the operation, he was not only agreeing to the surgery but also to the necessary perioperative care to allow him to recover. On the other hand, the family (who were now the appropriate surrogate decision makers) believed that the operation was over and all further treatments were open to discussion and should be evaluated based on what they believed their father’s wishes would have been.
What should be done when the surgeon’s responsibility to respect what she believes the patient’s wishes were are in conflict with the surrogate decision makers? Unfortunately, there is no clear answer to this question. The closer in time one is to the operation, the more the patient’s initial decision to proceed with surgery seemingly should hold sway. The further away from the operation, the more the family members’ interpretation of the patient’s wishes should guide decisions about treatments.
The surgeon in this case seemed to have reached an excellent compromise with the family. Based on the belief that the need for intubation and ventilation was short term, the surgeon convinced the family to allow aggressive treatment for 48 hours. She had expressed to the family that she felt she had a responsibility to their father to try to get him safely through this early part of the recovery. After the 48-hour time-limited trial, the surgeon and the family would meet again to discuss his status. If there had been improvements, then the same aggressive treatments would be continued in the hopes that the patient would soon be able to make his own decisions. Alternatively, if there was not improvement over the next 2 days, the surgeon agreed that further interventions would all be reassessed in accordance with what the family believed would have been their father’s wishes.
Although the patient ultimately did not recover, the surgeon felt that she had lived up to her responsibility to respect her patient’s decision to have surgery, while not completely ignoring the family’s wishes. The family also felt that the surgeon had been respectful of their own interpretation of their father’s goals and values. Sometimes in the ethical care of surgical patients, there is not a right and a wrong answer, but a series of compromises that we all hope will lead to the best outcome for our patients.
Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.
Send all my records
They put Bill’s chart on my desk, with a cover sheet. “I authorize you to send all my medical records,” it read, over his signature. The destination was a dermatologist across town.
I reviewed Bill’s record. His last visit was 6 months ago, just a skin check to mop up some solar keratoses. One of many such visits over 20 years. A basal cell on the shoulder 10 years ago. Nothing eventful.
“What happened?” I wondered, as I signed off on sending his chart. Had I missed a skin cancer?
That thought brought to mind Maxine. She, too, had been my patient for many years. Her niece still comes in.
Maxine had a history of sun damage, along with a few low-grade skin cancers. One day I biopsied a hand lesion. It was a squamous cell. I called her with the results and referred her to a surgeon. Nothing new or special, or so it seemed.
A few weeks later I got Maxine’s letter. “Send all my medical records.”
So I had not missed her squamous cell, but she still wanted out. How come?
Over the course of a clinical career, patients drop out. They move away, pass away, change insurance, retire to Florida or Arizona. Sometimes they come back, years later. They lost their job in L.A., or moved back to nurse a sick parent. Perhaps they got their old insurance back, or their new doctor stopped accepting the kind they had. It’s been 5 years, 10 years. You didn’t even notice they were gone.
The same thing happens of course in other aspects of life. People move in and out of our orbit: school chums, work mates, parents of kids who play with our kids, neighbors. They grow up, move away, get lost somehow. Unless they reappear, we often don’t realize they aren’t there anymore.
Most of the time there was no special event, no angry falling out. Lives just diverged. We lost whatever we had in common. Nothing personal.
But former acquaintances don’t generally send you a note officially severing relations, a letter notifying you to, “Forget about me. You won’t be seeing me again.”
If we got such a letter, we might actually be relieved. Chances are, though, that if we weren’t expecting it (or secretly wishing for it), we would wonder what it was about. Was there a quarrel we didn’t even know about?
Chances are we wouldn’t try too hard to find out what the problem was, though. Whatever we did manage to learn would probably be unpleasant and unfixable.
The same is true when patients ask us to send all their records. Most people stay, unless something propels them to move on. Absent a shift in geography or health insurance, whatever did overcome their inertia it is probably not something we want to know.
“This will happen to you,” I tell my students. “Count on it. Patients will ask for their records. They may send you a note of complaint. ‘You didn’t find the skin cancer on mother’s leg,’ they may say. Or else, ‘Your treatments were useless. I went to another doctor who actually knew what was wrong and gave me what I needed.’ ” Nowadays, people put such sentiments into unfavorable online reviews.
“When you get letters or read reviews like those,” I advise, “count to 10 before you respond. Then count to 10 again. Then don’t respond. I’ve tried doing it the other way and regretted it every time.
“Mostly, there’s no potential litigation involved,” I continue. “If there is a threatened suit, you’ll need an attorney to respond anyway. Otherwise, learn what you can from the patient’s disappointment, file the letter, note the review, send all the records, and move on.”
We doctors tend to be an ingratiating sort. Because we try to help people, we want them to like us. Many will, often to excess. But good as we ever get, try as hard as we can, not everybody will like us. That’s life, in and out of medical practice.
Rejection is never pleasant. Experience thickens the skin, but even then a signed request to “Send all my records” can sting. Even after all these years, it still does.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years.
They put Bill’s chart on my desk, with a cover sheet. “I authorize you to send all my medical records,” it read, over his signature. The destination was a dermatologist across town.
I reviewed Bill’s record. His last visit was 6 months ago, just a skin check to mop up some solar keratoses. One of many such visits over 20 years. A basal cell on the shoulder 10 years ago. Nothing eventful.
“What happened?” I wondered, as I signed off on sending his chart. Had I missed a skin cancer?
That thought brought to mind Maxine. She, too, had been my patient for many years. Her niece still comes in.
Maxine had a history of sun damage, along with a few low-grade skin cancers. One day I biopsied a hand lesion. It was a squamous cell. I called her with the results and referred her to a surgeon. Nothing new or special, or so it seemed.
A few weeks later I got Maxine’s letter. “Send all my medical records.”
So I had not missed her squamous cell, but she still wanted out. How come?
Over the course of a clinical career, patients drop out. They move away, pass away, change insurance, retire to Florida or Arizona. Sometimes they come back, years later. They lost their job in L.A., or moved back to nurse a sick parent. Perhaps they got their old insurance back, or their new doctor stopped accepting the kind they had. It’s been 5 years, 10 years. You didn’t even notice they were gone.
The same thing happens of course in other aspects of life. People move in and out of our orbit: school chums, work mates, parents of kids who play with our kids, neighbors. They grow up, move away, get lost somehow. Unless they reappear, we often don’t realize they aren’t there anymore.
Most of the time there was no special event, no angry falling out. Lives just diverged. We lost whatever we had in common. Nothing personal.
But former acquaintances don’t generally send you a note officially severing relations, a letter notifying you to, “Forget about me. You won’t be seeing me again.”
If we got such a letter, we might actually be relieved. Chances are, though, that if we weren’t expecting it (or secretly wishing for it), we would wonder what it was about. Was there a quarrel we didn’t even know about?
Chances are we wouldn’t try too hard to find out what the problem was, though. Whatever we did manage to learn would probably be unpleasant and unfixable.
The same is true when patients ask us to send all their records. Most people stay, unless something propels them to move on. Absent a shift in geography or health insurance, whatever did overcome their inertia it is probably not something we want to know.
“This will happen to you,” I tell my students. “Count on it. Patients will ask for their records. They may send you a note of complaint. ‘You didn’t find the skin cancer on mother’s leg,’ they may say. Or else, ‘Your treatments were useless. I went to another doctor who actually knew what was wrong and gave me what I needed.’ ” Nowadays, people put such sentiments into unfavorable online reviews.
“When you get letters or read reviews like those,” I advise, “count to 10 before you respond. Then count to 10 again. Then don’t respond. I’ve tried doing it the other way and regretted it every time.
“Mostly, there’s no potential litigation involved,” I continue. “If there is a threatened suit, you’ll need an attorney to respond anyway. Otherwise, learn what you can from the patient’s disappointment, file the letter, note the review, send all the records, and move on.”
We doctors tend to be an ingratiating sort. Because we try to help people, we want them to like us. Many will, often to excess. But good as we ever get, try as hard as we can, not everybody will like us. That’s life, in and out of medical practice.
Rejection is never pleasant. Experience thickens the skin, but even then a signed request to “Send all my records” can sting. Even after all these years, it still does.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years.
They put Bill’s chart on my desk, with a cover sheet. “I authorize you to send all my medical records,” it read, over his signature. The destination was a dermatologist across town.
I reviewed Bill’s record. His last visit was 6 months ago, just a skin check to mop up some solar keratoses. One of many such visits over 20 years. A basal cell on the shoulder 10 years ago. Nothing eventful.
“What happened?” I wondered, as I signed off on sending his chart. Had I missed a skin cancer?
That thought brought to mind Maxine. She, too, had been my patient for many years. Her niece still comes in.
Maxine had a history of sun damage, along with a few low-grade skin cancers. One day I biopsied a hand lesion. It was a squamous cell. I called her with the results and referred her to a surgeon. Nothing new or special, or so it seemed.
A few weeks later I got Maxine’s letter. “Send all my medical records.”
So I had not missed her squamous cell, but she still wanted out. How come?
Over the course of a clinical career, patients drop out. They move away, pass away, change insurance, retire to Florida or Arizona. Sometimes they come back, years later. They lost their job in L.A., or moved back to nurse a sick parent. Perhaps they got their old insurance back, or their new doctor stopped accepting the kind they had. It’s been 5 years, 10 years. You didn’t even notice they were gone.
The same thing happens of course in other aspects of life. People move in and out of our orbit: school chums, work mates, parents of kids who play with our kids, neighbors. They grow up, move away, get lost somehow. Unless they reappear, we often don’t realize they aren’t there anymore.
Most of the time there was no special event, no angry falling out. Lives just diverged. We lost whatever we had in common. Nothing personal.
But former acquaintances don’t generally send you a note officially severing relations, a letter notifying you to, “Forget about me. You won’t be seeing me again.”
If we got such a letter, we might actually be relieved. Chances are, though, that if we weren’t expecting it (or secretly wishing for it), we would wonder what it was about. Was there a quarrel we didn’t even know about?
Chances are we wouldn’t try too hard to find out what the problem was, though. Whatever we did manage to learn would probably be unpleasant and unfixable.
The same is true when patients ask us to send all their records. Most people stay, unless something propels them to move on. Absent a shift in geography or health insurance, whatever did overcome their inertia it is probably not something we want to know.
“This will happen to you,” I tell my students. “Count on it. Patients will ask for their records. They may send you a note of complaint. ‘You didn’t find the skin cancer on mother’s leg,’ they may say. Or else, ‘Your treatments were useless. I went to another doctor who actually knew what was wrong and gave me what I needed.’ ” Nowadays, people put such sentiments into unfavorable online reviews.
“When you get letters or read reviews like those,” I advise, “count to 10 before you respond. Then count to 10 again. Then don’t respond. I’ve tried doing it the other way and regretted it every time.
“Mostly, there’s no potential litigation involved,” I continue. “If there is a threatened suit, you’ll need an attorney to respond anyway. Otherwise, learn what you can from the patient’s disappointment, file the letter, note the review, send all the records, and move on.”
We doctors tend to be an ingratiating sort. Because we try to help people, we want them to like us. Many will, often to excess. But good as we ever get, try as hard as we can, not everybody will like us. That’s life, in and out of medical practice.
Rejection is never pleasant. Experience thickens the skin, but even then a signed request to “Send all my records” can sting. Even after all these years, it still does.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years.
