Small devices carried in pockets during rounds can enable hospitalists to make quick decisions at the bedside, enhance and teach physical exam skills, streamline patient flow through the hospital, and potentially avoid the cost and risk of exposure to radiation. Point-of-care (POC) ultrasound enhances both patient satisfaction and the clinician’s professional satisfaction. Hospital medicine will be the next field to rapidly assimilate its use.

POC, or “bedside,” ultrasound has been used by ob-gyns, vascular access, and procedural teams for quite some time. Of late, emergency medicine and critical care physicians have adopted its use. It offers the advantage of gaining immediate information regarding the patient through dynamic imaging and the ability to integrate that information into the clinical picture. This enables providers to make decisions about patient care in real time.

With the advent of affordable handheld devices with quality images, rounding with these devices has become practical for hospitalists. Hospitalists should rapidly embrace this skill set. POC ultrasound can be very useful to quickly improve patient diagnosis, patient satisfaction, patient safety, length of stay, and provider satisfaction.

For example, in patients complaining of dyspnea, for which there is not a clear diagnosis of COPD, congestive heart failure, pulmonary embolism, or pneumonia, a focused cardiac ultrasound can rapidly differentiate between right ventricular dysfunction, left ventricular dysfunction, pericardial effusion, or a hyperdynamic heart. Lung ultrasound with diffuse or focal “B lines,” focal consolidation, and/or pleural effusion can assist in differentiating the cause as well.

POC ultrasound also is a teaching tool that can enhance exam skills. Hospitalists can confirm exam findings and teach as they palpate the liver or percuss the chest. Performing a procedure such as paracentesis or a central line with ultrasound guidance is now considered standard of care in some centers. The literature shows ultrasound guidance is safer even when compared to clinicians skilled in landmark techniques. In addition, many hospitalists and/or trainees will work in areas where 24-7 echo, interventional radiologists, and ultrasound techs are not available. Hospitalists need to know how to use POC ultrasound to serve patients well.

POC ultrasound can also be used in daily care. For heart failure patients, watching the B lines (pulmonary edema), pleural effusions, and inferior vena cava size can avoid over- or under-diuresis and reduce length of stay and cost. The same can be said for patients with percutaneous catheters to ensure proper drainage of the pockets of fluid in the chest or abdomen.

It is important to know the limitations of POC ultrasound. It is best used to answer binary questions (e.g., pericardial effusion present or not). It is a skill to be acquired and honed, and it requires specialized training. There are many one- to two-day courses as well simulators and other means. The basics of image acquisition and interpretation can be found online, and much of it is free. Manufacturers often are willing to provide machines to practice with.

Many patients enjoy seeing the images and having a better understanding of their disease process, which leads to improved patient satisfaction. Overall, there are many benefits for hospitalists.

Gordon Johnson, MD, hospitalist and president, Oregon/Southwest Washington SHM Chapter

Small devices carried in pockets during rounds can enable hospitalists to make quick decisions at the bedside, enhance and teach physical exam skills, streamline patient flow through the hospital, and potentially avoid the cost and risk of exposure to radiation. Point-of-care (POC) ultrasound enhances both patient satisfaction and the clinician’s professional satisfaction. Hospital medicine will be the next field to rapidly assimilate its use.

POC, or “bedside,” ultrasound has been used by ob-gyns, vascular access, and procedural teams for quite some time. Of late, emergency medicine and critical care physicians have adopted its use. It offers the advantage of gaining immediate information regarding the patient through dynamic imaging and the ability to integrate that information into the clinical picture. This enables providers to make decisions about patient care in real time.

With the advent of affordable handheld devices with quality images, rounding with these devices has become practical for hospitalists. Hospitalists should rapidly embrace this skill set. POC ultrasound can be very useful to quickly improve patient diagnosis, patient satisfaction, patient safety, length of stay, and provider satisfaction.

For example, in patients complaining of dyspnea, for which there is not a clear diagnosis of COPD, congestive heart failure, pulmonary embolism, or pneumonia, a focused cardiac ultrasound can rapidly differentiate between right ventricular dysfunction, left ventricular dysfunction, pericardial effusion, or a hyperdynamic heart. Lung ultrasound with diffuse or focal “B lines,” focal consolidation, and/or pleural effusion can assist in differentiating the cause as well.

POC ultrasound also is a teaching tool that can enhance exam skills. Hospitalists can confirm exam findings and teach as they palpate the liver or percuss the chest. Performing a procedure such as paracentesis or a central line with ultrasound guidance is now considered standard of care in some centers. The literature shows ultrasound guidance is safer even when compared to clinicians skilled in landmark techniques. In addition, many hospitalists and/or trainees will work in areas where 24-7 echo, interventional radiologists, and ultrasound techs are not available. Hospitalists need to know how to use POC ultrasound to serve patients well.

POC ultrasound can also be used in daily care. For heart failure patients, watching the B lines (pulmonary edema), pleural effusions, and inferior vena cava size can avoid over- or under-diuresis and reduce length of stay and cost. The same can be said for patients with percutaneous catheters to ensure proper drainage of the pockets of fluid in the chest or abdomen.

It is important to know the limitations of POC ultrasound. It is best used to answer binary questions (e.g., pericardial effusion present or not). It is a skill to be acquired and honed, and it requires specialized training. There are many one- to two-day courses as well simulators and other means. The basics of image acquisition and interpretation can be found online, and much of it is free. Manufacturers often are willing to provide machines to practice with.

Many patients enjoy seeing the images and having a better understanding of their disease process, which leads to improved patient satisfaction. Overall, there are many benefits for hospitalists.

Gordon Johnson, MD, hospitalist and president, Oregon/Southwest Washington SHM Chapter

Small devices carried in pockets during rounds can enable hospitalists to make quick decisions at the bedside, enhance and teach physical exam skills, streamline patient flow through the hospital, and potentially avoid the cost and risk of exposure to radiation. Point-of-care (POC) ultrasound enhances both patient satisfaction and the clinician’s professional satisfaction. Hospital medicine will be the next field to rapidly assimilate its use.

POC, or “bedside,” ultrasound has been used by ob-gyns, vascular access, and procedural teams for quite some time. Of late, emergency medicine and critical care physicians have adopted its use. It offers the advantage of gaining immediate information regarding the patient through dynamic imaging and the ability to integrate that information into the clinical picture. This enables providers to make decisions about patient care in real time.

With the advent of affordable handheld devices with quality images, rounding with these devices has become practical for hospitalists. Hospitalists should rapidly embrace this skill set. POC ultrasound can be very useful to quickly improve patient diagnosis, patient satisfaction, patient safety, length of stay, and provider satisfaction.

For example, in patients complaining of dyspnea, for which there is not a clear diagnosis of COPD, congestive heart failure, pulmonary embolism, or pneumonia, a focused cardiac ultrasound can rapidly differentiate between right ventricular dysfunction, left ventricular dysfunction, pericardial effusion, or a hyperdynamic heart. Lung ultrasound with diffuse or focal “B lines,” focal consolidation, and/or pleural effusion can assist in differentiating the cause as well.

POC ultrasound also is a teaching tool that can enhance exam skills. Hospitalists can confirm exam findings and teach as they palpate the liver or percuss the chest. Performing a procedure such as paracentesis or a central line with ultrasound guidance is now considered standard of care in some centers. The literature shows ultrasound guidance is safer even when compared to clinicians skilled in landmark techniques. In addition, many hospitalists and/or trainees will work in areas where 24-7 echo, interventional radiologists, and ultrasound techs are not available. Hospitalists need to know how to use POC ultrasound to serve patients well.

POC ultrasound can also be used in daily care. For heart failure patients, watching the B lines (pulmonary edema), pleural effusions, and inferior vena cava size can avoid over- or under-diuresis and reduce length of stay and cost. The same can be said for patients with percutaneous catheters to ensure proper drainage of the pockets of fluid in the chest or abdomen.

It is important to know the limitations of POC ultrasound. It is best used to answer binary questions (e.g., pericardial effusion present or not). It is a skill to be acquired and honed, and it requires specialized training. There are many one- to two-day courses as well simulators and other means. The basics of image acquisition and interpretation can be found online, and much of it is free. Manufacturers often are willing to provide machines to practice with.

Many patients enjoy seeing the images and having a better understanding of their disease process, which leads to improved patient satisfaction. Overall, there are many benefits for hospitalists.

Gordon Johnson, MD, hospitalist and president, Oregon/Southwest Washington SHM Chapter

Child receiving RTS,S

Photo by Caitlin Kleiboer

Results from a phase 2 study of the malaria vaccine RTS,S (also known as RTS,S/AS01 or Mosquirix) suggest its efficacy decreases over time, and this decline is fastest in children living in areas with higher-than-average rates of malaria.

Researchers say the results suggest the benefits of the vaccine are likely to vary across different populations and highlight the need for more research to

determine the most effective way of using RTS,S, which last year became the first malaria vaccine to receive a green light from the European Medicines Agency.

“We found that 3-dose vaccination with RTS,S was initially protective, but this was offset by a rebound in later years among children exposed to higher-than-average levels of malaria-carrying mosquitoes,” said Philip Bejon, PhD, of the Kenya Medical Research Institute–Wellcome Trust Programme in Kilifi, Kenya.

Dr Bejon and his colleagues reported these results in NEJM.

The researchers followed 447 children who had received 3 doses of either RTS,S or a rabies (control) vaccine when they were 5 months to 17 months old.

After 7 years, there were 312 children still involved in the study. During the first year, the risk of getting malaria in the vaccinated children was 35.9% less than in the control group. After 7 years, this protection fell to 3.6%.

And in children exposed to higher-than-average rates of malaria, there were slightly more cases of malaria in the vaccinated group than the control group—1002 and 992 cases, respectively—5 years after vaccination.

This “rebound” effect, which has been seen in previous studies, is thought to occur because children initially protected by the vaccine develop their natural immunity against malaria more slowly than unvaccinated children.

Results from a phase 3 study showed that 3 doses of RTS,S reduced the risk of malaria in young children by 28% over 4 years, but this improved to 36% when children were given a fourth dose 18 months after the first dose. Longer-term follow up of these children is ongoing.

“Overall, our study shows that RTS,S can benefit children but suggests that a fourth dose may be important for sustaining this protection over the long term and to protect against a potential rebound,” said Ally Olotu, PhD, of the Kenya Medical Research Institute–Wellcome Trust Programme.

“Results from 3 sites involved in the original phase 3 study that are continuing follow up, and the WHO’s planned pilot program, will tell us more about the vaccine’s efficacy in different settings and help determine which populations would benefit most from receiving it as part of a wider vaccination strategy.”

Child receiving RTS,S

Photo by Caitlin Kleiboer

Results from a phase 2 study of the malaria vaccine RTS,S (also known as RTS,S/AS01 or Mosquirix) suggest its efficacy decreases over time, and this decline is fastest in children living in areas with higher-than-average rates of malaria.

Researchers say the results suggest the benefits of the vaccine are likely to vary across different populations and highlight the need for more research to

determine the most effective way of using RTS,S, which last year became the first malaria vaccine to receive a green light from the European Medicines Agency.

“We found that 3-dose vaccination with RTS,S was initially protective, but this was offset by a rebound in later years among children exposed to higher-than-average levels of malaria-carrying mosquitoes,” said Philip Bejon, PhD, of the Kenya Medical Research Institute–Wellcome Trust Programme in Kilifi, Kenya.

Dr Bejon and his colleagues reported these results in NEJM.

The researchers followed 447 children who had received 3 doses of either RTS,S or a rabies (control) vaccine when they were 5 months to 17 months old.

After 7 years, there were 312 children still involved in the study. During the first year, the risk of getting malaria in the vaccinated children was 35.9% less than in the control group. After 7 years, this protection fell to 3.6%.

And in children exposed to higher-than-average rates of malaria, there were slightly more cases of malaria in the vaccinated group than the control group—1002 and 992 cases, respectively—5 years after vaccination.

This “rebound” effect, which has been seen in previous studies, is thought to occur because children initially protected by the vaccine develop their natural immunity against malaria more slowly than unvaccinated children.

Results from a phase 3 study showed that 3 doses of RTS,S reduced the risk of malaria in young children by 28% over 4 years, but this improved to 36% when children were given a fourth dose 18 months after the first dose. Longer-term follow up of these children is ongoing.

“Overall, our study shows that RTS,S can benefit children but suggests that a fourth dose may be important for sustaining this protection over the long term and to protect against a potential rebound,” said Ally Olotu, PhD, of the Kenya Medical Research Institute–Wellcome Trust Programme.

“Results from 3 sites involved in the original phase 3 study that are continuing follow up, and the WHO’s planned pilot program, will tell us more about the vaccine’s efficacy in different settings and help determine which populations would benefit most from receiving it as part of a wider vaccination strategy.”

Child receiving RTS,S

Photo by Caitlin Kleiboer

Results from a phase 2 study of the malaria vaccine RTS,S (also known as RTS,S/AS01 or Mosquirix) suggest its efficacy decreases over time, and this decline is fastest in children living in areas with higher-than-average rates of malaria.

Researchers say the results suggest the benefits of the vaccine are likely to vary across different populations and highlight the need for more research to

determine the most effective way of using RTS,S, which last year became the first malaria vaccine to receive a green light from the European Medicines Agency.

“We found that 3-dose vaccination with RTS,S was initially protective, but this was offset by a rebound in later years among children exposed to higher-than-average levels of malaria-carrying mosquitoes,” said Philip Bejon, PhD, of the Kenya Medical Research Institute–Wellcome Trust Programme in Kilifi, Kenya.

Dr Bejon and his colleagues reported these results in NEJM.

The researchers followed 447 children who had received 3 doses of either RTS,S or a rabies (control) vaccine when they were 5 months to 17 months old.

After 7 years, there were 312 children still involved in the study. During the first year, the risk of getting malaria in the vaccinated children was 35.9% less than in the control group. After 7 years, this protection fell to 3.6%.

And in children exposed to higher-than-average rates of malaria, there were slightly more cases of malaria in the vaccinated group than the control group—1002 and 992 cases, respectively—5 years after vaccination.

This “rebound” effect, which has been seen in previous studies, is thought to occur because children initially protected by the vaccine develop their natural immunity against malaria more slowly than unvaccinated children.

Results from a phase 3 study showed that 3 doses of RTS,S reduced the risk of malaria in young children by 28% over 4 years, but this improved to 36% when children were given a fourth dose 18 months after the first dose. Longer-term follow up of these children is ongoing.

“Overall, our study shows that RTS,S can benefit children but suggests that a fourth dose may be important for sustaining this protection over the long term and to protect against a potential rebound,” said Ally Olotu, PhD, of the Kenya Medical Research Institute–Wellcome Trust Programme.

“Results from 3 sites involved in the original phase 3 study that are continuing follow up, and the WHO’s planned pilot program, will tell us more about the vaccine’s efficacy in different settings and help determine which populations would benefit most from receiving it as part of a wider vaccination strategy.”

Last year, Congress put an end to the Sustainable Growth Rate (SGR), which had become a yearly battle fought on behalf of and by physicians to prevent significant last-minute cuts to Medicare reimbursement. Many hoped its replacement would provide more stability and certainty.

However, that replacement, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), has been anything but clear. On April 27, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a Notice of Proposed Rulemaking in what it called a “first step” in implementing MACRA. CMS accepted feedback and input on the proposed rule through June 27, 2016.

The Society of Hospital Medicine worked to provide comment on what it sees as the biggest concerns of hospitalists.

For example, it remains unclear what quality markers CMS will use to evaluate hospitalists under MACRA, says Rush University Medical Center’s Suparna Dutta, MD, MPH, a hospitalist, assistant professor of medicine, and member of the SHM Public Policy Committee (PPC). “The biggest piece is, what will be used universally for all hospitalists and attributed to the work that we do?”

MACRA represents “a milestone” in efforts to “advance a healthcare system that rewards better care, smarter spending, and healthier people,” U.S. Department of Health & Human Services Secretary Sylvia M. Burwell said in a statement issued the day the proposed rule was announced.

What it is designed to do, says Ron Greeno, MD, MHM, president-elect of SHM, PPC chair, and senior advisor for medical affairs at TeamHealth, is push physicians to move toward alternative payment models.

To achieve this, MACRA creates a framework called the Quality Payment Program, which offers physicians two paths for value-over-volume-based payments: MIPS, for Merit-Based Incentive Payment System, and APMs, for Advanced Alternative Payment Models. The benchmark period for both pathways begins Jan. 1, 2017, and MACRA reimbursement would begin Jan. 1, 2019.

Under MIPS, current quality measurement programs are streamlined into a single payment adjustment, including the Physician Value-Based Modifier, the Electronic Health Record (EHR) Incentive Program and the Physician Quality Reporting System (PQRS).

Physicians will not assume risk on the MIPS pathway, but payment adjustments will be based on their MIPS score, which grows each year through 2022 and ranges that year from +9% to -9%. It will be budget neutral: The top half of scorers will see increases in payments, while the bottom half will see cuts. Additional adjustments will be given to top performers through 2024.

However, as Dr. Dutta and fellow PPC member Lauren Doctoroff, MD, FHM, a hospitalist at Beth Israel Deaconess Medical Center and instructor at Harvard Medical School, wrote for The Hospitalist in March 2016, it is not yet clear how MIPS scores will be calculated for hospitalists.

“The problem is that there is not a typical hospitalist in terms of the work that we do,” Dr. Dutta says. “It depends on the hospital and the types of responsibilities the hospitalists have and the types of patients they care for.”

CMS says 50% of the MIPS score will come from six reported measures that reflect different specialties and practices; 25% will come from technology use, with a focus on interoperability and information exchange; 15% will come from clinical improvement practices, like care coordination; and 10% will be based on cost, chosen from among 40 episode-specific measures.

The new hospitalist billing code, which has not yet been implemented, should be a tremendous help under MACRA, Dr. Dutta says. “As CMS plans on using peer-comparison groups for quality and cost measures, it is really important that we now have a specialty billing code for hospitalists, which should ensure we have a fair and valid comparison pool for any metrics we are measured on for MIPS.”

The second path may be much harder for hospitalists to achieve since it requires that physicians share in risk and reward and participate in alternative payment models like Next Generation ACO or the Comprehensive Primary Care Plus model.

Most hospitalists will not be candidates for taking on risks under APM since physicians need to achieve a threshold for taking on more than nominal financial risk, Dr. Dutta says, noting SHM’s efforts to better understand the implications.

“It depends on the the percentage of patients you’re seeing in an APM, and you might hit your threshold if your market has a lot of Medicare ACOs or risk-sharing, but it’s not something hospitalists can consistently plan on,” Dr. Dutta says.

Most hospitalists have little control over whether their facility participates in an APM, Dr. Dutta says, but allowing the APM to which a patient belongs count toward the care provided by hospitalists—though a patient may align with several APMs—may help reach these thresholds.

Feedback from SHM to CMS also included asking to allow the Bundled Payments for Care Improvement Initiative (BPCI) to qualify for APM and seeking clarification into whether hospitalists can tap into cost and quality metrics hospitals are already reporting to CMS.

“Hospitals are collecting a certain amount of data because they have to for Medicare, and that might be a good indicator of what hospitalists are doing,” Dr. Dutta says. This includes services like DVT prophylaxis after surgery in hospitals where hospitalists provide a majority of post-operative care or safety measures like CLABSI (central line–associated bloodstream infection) rates.

To stay up to date with MACRA, visit SHM’s MACRA website and follow @SHMadvocacy on Twitter. TH

Corrected version July 13, 2016.

Kelly April Tyrrell is a freelance writer in Madison, Wis.

Last year, Congress put an end to the Sustainable Growth Rate (SGR), which had become a yearly battle fought on behalf of and by physicians to prevent significant last-minute cuts to Medicare reimbursement. Many hoped its replacement would provide more stability and certainty.

However, that replacement, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), has been anything but clear. On April 27, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a Notice of Proposed Rulemaking in what it called a “first step” in implementing MACRA. CMS accepted feedback and input on the proposed rule through June 27, 2016.

The Society of Hospital Medicine worked to provide comment on what it sees as the biggest concerns of hospitalists.

For example, it remains unclear what quality markers CMS will use to evaluate hospitalists under MACRA, says Rush University Medical Center’s Suparna Dutta, MD, MPH, a hospitalist, assistant professor of medicine, and member of the SHM Public Policy Committee (PPC). “The biggest piece is, what will be used universally for all hospitalists and attributed to the work that we do?”

MACRA represents “a milestone” in efforts to “advance a healthcare system that rewards better care, smarter spending, and healthier people,” U.S. Department of Health & Human Services Secretary Sylvia M. Burwell said in a statement issued the day the proposed rule was announced.

What it is designed to do, says Ron Greeno, MD, MHM, president-elect of SHM, PPC chair, and senior advisor for medical affairs at TeamHealth, is push physicians to move toward alternative payment models.

To achieve this, MACRA creates a framework called the Quality Payment Program, which offers physicians two paths for value-over-volume-based payments: MIPS, for Merit-Based Incentive Payment System, and APMs, for Advanced Alternative Payment Models. The benchmark period for both pathways begins Jan. 1, 2017, and MACRA reimbursement would begin Jan. 1, 2019.

Under MIPS, current quality measurement programs are streamlined into a single payment adjustment, including the Physician Value-Based Modifier, the Electronic Health Record (EHR) Incentive Program and the Physician Quality Reporting System (PQRS).

Physicians will not assume risk on the MIPS pathway, but payment adjustments will be based on their MIPS score, which grows each year through 2022 and ranges that year from +9% to -9%. It will be budget neutral: The top half of scorers will see increases in payments, while the bottom half will see cuts. Additional adjustments will be given to top performers through 2024.

However, as Dr. Dutta and fellow PPC member Lauren Doctoroff, MD, FHM, a hospitalist at Beth Israel Deaconess Medical Center and instructor at Harvard Medical School, wrote for The Hospitalist in March 2016, it is not yet clear how MIPS scores will be calculated for hospitalists.

“The problem is that there is not a typical hospitalist in terms of the work that we do,” Dr. Dutta says. “It depends on the hospital and the types of responsibilities the hospitalists have and the types of patients they care for.”

CMS says 50% of the MIPS score will come from six reported measures that reflect different specialties and practices; 25% will come from technology use, with a focus on interoperability and information exchange; 15% will come from clinical improvement practices, like care coordination; and 10% will be based on cost, chosen from among 40 episode-specific measures.

The new hospitalist billing code, which has not yet been implemented, should be a tremendous help under MACRA, Dr. Dutta says. “As CMS plans on using peer-comparison groups for quality and cost measures, it is really important that we now have a specialty billing code for hospitalists, which should ensure we have a fair and valid comparison pool for any metrics we are measured on for MIPS.”

The second path may be much harder for hospitalists to achieve since it requires that physicians share in risk and reward and participate in alternative payment models like Next Generation ACO or the Comprehensive Primary Care Plus model.

Most hospitalists will not be candidates for taking on risks under APM since physicians need to achieve a threshold for taking on more than nominal financial risk, Dr. Dutta says, noting SHM’s efforts to better understand the implications.

“It depends on the the percentage of patients you’re seeing in an APM, and you might hit your threshold if your market has a lot of Medicare ACOs or risk-sharing, but it’s not something hospitalists can consistently plan on,” Dr. Dutta says.

Most hospitalists have little control over whether their facility participates in an APM, Dr. Dutta says, but allowing the APM to which a patient belongs count toward the care provided by hospitalists—though a patient may align with several APMs—may help reach these thresholds.

Feedback from SHM to CMS also included asking to allow the Bundled Payments for Care Improvement Initiative (BPCI) to qualify for APM and seeking clarification into whether hospitalists can tap into cost and quality metrics hospitals are already reporting to CMS.

“Hospitals are collecting a certain amount of data because they have to for Medicare, and that might be a good indicator of what hospitalists are doing,” Dr. Dutta says. This includes services like DVT prophylaxis after surgery in hospitals where hospitalists provide a majority of post-operative care or safety measures like CLABSI (central line–associated bloodstream infection) rates.

To stay up to date with MACRA, visit SHM’s MACRA website and follow @SHMadvocacy on Twitter. TH

Corrected version July 13, 2016.

Kelly April Tyrrell is a freelance writer in Madison, Wis.

Last year, Congress put an end to the Sustainable Growth Rate (SGR), which had become a yearly battle fought on behalf of and by physicians to prevent significant last-minute cuts to Medicare reimbursement. Many hoped its replacement would provide more stability and certainty.

However, that replacement, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), has been anything but clear. On April 27, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a Notice of Proposed Rulemaking in what it called a “first step” in implementing MACRA. CMS accepted feedback and input on the proposed rule through June 27, 2016.

The Society of Hospital Medicine worked to provide comment on what it sees as the biggest concerns of hospitalists.

For example, it remains unclear what quality markers CMS will use to evaluate hospitalists under MACRA, says Rush University Medical Center’s Suparna Dutta, MD, MPH, a hospitalist, assistant professor of medicine, and member of the SHM Public Policy Committee (PPC). “The biggest piece is, what will be used universally for all hospitalists and attributed to the work that we do?”

MACRA represents “a milestone” in efforts to “advance a healthcare system that rewards better care, smarter spending, and healthier people,” U.S. Department of Health & Human Services Secretary Sylvia M. Burwell said in a statement issued the day the proposed rule was announced.

What it is designed to do, says Ron Greeno, MD, MHM, president-elect of SHM, PPC chair, and senior advisor for medical affairs at TeamHealth, is push physicians to move toward alternative payment models.

To achieve this, MACRA creates a framework called the Quality Payment Program, which offers physicians two paths for value-over-volume-based payments: MIPS, for Merit-Based Incentive Payment System, and APMs, for Advanced Alternative Payment Models. The benchmark period for both pathways begins Jan. 1, 2017, and MACRA reimbursement would begin Jan. 1, 2019.

Under MIPS, current quality measurement programs are streamlined into a single payment adjustment, including the Physician Value-Based Modifier, the Electronic Health Record (EHR) Incentive Program and the Physician Quality Reporting System (PQRS).

Physicians will not assume risk on the MIPS pathway, but payment adjustments will be based on their MIPS score, which grows each year through 2022 and ranges that year from +9% to -9%. It will be budget neutral: The top half of scorers will see increases in payments, while the bottom half will see cuts. Additional adjustments will be given to top performers through 2024.

However, as Dr. Dutta and fellow PPC member Lauren Doctoroff, MD, FHM, a hospitalist at Beth Israel Deaconess Medical Center and instructor at Harvard Medical School, wrote for The Hospitalist in March 2016, it is not yet clear how MIPS scores will be calculated for hospitalists.

“The problem is that there is not a typical hospitalist in terms of the work that we do,” Dr. Dutta says. “It depends on the hospital and the types of responsibilities the hospitalists have and the types of patients they care for.”

CMS says 50% of the MIPS score will come from six reported measures that reflect different specialties and practices; 25% will come from technology use, with a focus on interoperability and information exchange; 15% will come from clinical improvement practices, like care coordination; and 10% will be based on cost, chosen from among 40 episode-specific measures.

The new hospitalist billing code, which has not yet been implemented, should be a tremendous help under MACRA, Dr. Dutta says. “As CMS plans on using peer-comparison groups for quality and cost measures, it is really important that we now have a specialty billing code for hospitalists, which should ensure we have a fair and valid comparison pool for any metrics we are measured on for MIPS.”

The second path may be much harder for hospitalists to achieve since it requires that physicians share in risk and reward and participate in alternative payment models like Next Generation ACO or the Comprehensive Primary Care Plus model.

Most hospitalists will not be candidates for taking on risks under APM since physicians need to achieve a threshold for taking on more than nominal financial risk, Dr. Dutta says, noting SHM’s efforts to better understand the implications.

“It depends on the the percentage of patients you’re seeing in an APM, and you might hit your threshold if your market has a lot of Medicare ACOs or risk-sharing, but it’s not something hospitalists can consistently plan on,” Dr. Dutta says.

Most hospitalists have little control over whether their facility participates in an APM, Dr. Dutta says, but allowing the APM to which a patient belongs count toward the care provided by hospitalists—though a patient may align with several APMs—may help reach these thresholds.

Feedback from SHM to CMS also included asking to allow the Bundled Payments for Care Improvement Initiative (BPCI) to qualify for APM and seeking clarification into whether hospitalists can tap into cost and quality metrics hospitals are already reporting to CMS.

“Hospitals are collecting a certain amount of data because they have to for Medicare, and that might be a good indicator of what hospitalists are doing,” Dr. Dutta says. This includes services like DVT prophylaxis after surgery in hospitals where hospitalists provide a majority of post-operative care or safety measures like CLABSI (central line–associated bloodstream infection) rates.

To stay up to date with MACRA, visit SHM’s MACRA website and follow @SHMadvocacy on Twitter. TH

Corrected version July 13, 2016.

Kelly April Tyrrell is a freelance writer in Madison, Wis.

Neutrophil engulfing bacteria

Image by Volker Brinkmann

Researchers say they have discovered a way to predict which children with acute myeloid leukemia (AML) are at the highest risk of delayed neutrophil recovery.

The team examined the role of telomeres in neutrophil recovery and found that the length of a patient’s telomeres can indicate the rate of recovery following chemotherapy.

The group reported their findings in the Journal of Clinical Oncology.

“We were interested in telomere length as a marker of blood count recovery because defects in telomere maintenance are known risks for bone marrow failure and aplastic anemia,” said study author Maria Monica Gramatges, MD, PhD, of Baylor College of Medicine in Houston, Texas.

“We know that up to 15% to 20% of children can take 2 months or longer to recover their blood counts after a course of AML chemotherapy. Our goal was to understand if these children had an underlying genetic predisposition associated with an impaired capacity for recovery.”

Dr Gramatges and her colleagues hypothesized that short telomere length could be associated with a delay in neutrophil recovery.

So they obtained bone marrow samples from AML patients who recovered as expected (within 30 days) after each chemotherapy course (n=62), and from AML patients who experienced significant delays in recovery after chemotherapy (n=53).

The team then measured telomere length on each subject and categorized the group by quartile, from shortest to longest.

Subjects in the quartile with the shortest telomere lengths took the longest to recover, especially during the last 2 courses of chemotherapy. In an adjusted analysis, lower telomere content was significantly associated with prolonged neutropenia after the fourth (P=0.002) and fifth courses of chemotherapy (P=0.009).

The researchers said these results support the hypothesis that telomeres are an indicator of capacity for neutrophil recovery following chemotherapy.

Dr Gramatges hopes the results of this study will be helpful in further understanding which children are at a higher risk for prolonged myelosuppression and how to target those children with modified treatments, improved supportive care, and closer monitoring in order to prevent potential complications such as severe infections.

“A significant proportion of children with AML suffer from treatment-related toxicities, with some succumbing to complications of the therapies we give, rather than from the actual cancer itself,” Dr Gramatges said.

“We hope this research will help us identify those who are at a higher risk for delayed recovery and use this knowledge to reduce the morbidity and mortality associated with AML treatment.”

Neutrophil engulfing bacteria

Image by Volker Brinkmann

Researchers say they have discovered a way to predict which children with acute myeloid leukemia (AML) are at the highest risk of delayed neutrophil recovery.

The team examined the role of telomeres in neutrophil recovery and found that the length of a patient’s telomeres can indicate the rate of recovery following chemotherapy.

The group reported their findings in the Journal of Clinical Oncology.

“We were interested in telomere length as a marker of blood count recovery because defects in telomere maintenance are known risks for bone marrow failure and aplastic anemia,” said study author Maria Monica Gramatges, MD, PhD, of Baylor College of Medicine in Houston, Texas.

“We know that up to 15% to 20% of children can take 2 months or longer to recover their blood counts after a course of AML chemotherapy. Our goal was to understand if these children had an underlying genetic predisposition associated with an impaired capacity for recovery.”

Dr Gramatges and her colleagues hypothesized that short telomere length could be associated with a delay in neutrophil recovery.

So they obtained bone marrow samples from AML patients who recovered as expected (within 30 days) after each chemotherapy course (n=62), and from AML patients who experienced significant delays in recovery after chemotherapy (n=53).

The team then measured telomere length on each subject and categorized the group by quartile, from shortest to longest.

Subjects in the quartile with the shortest telomere lengths took the longest to recover, especially during the last 2 courses of chemotherapy. In an adjusted analysis, lower telomere content was significantly associated with prolonged neutropenia after the fourth (P=0.002) and fifth courses of chemotherapy (P=0.009).

The researchers said these results support the hypothesis that telomeres are an indicator of capacity for neutrophil recovery following chemotherapy.

Dr Gramatges hopes the results of this study will be helpful in further understanding which children are at a higher risk for prolonged myelosuppression and how to target those children with modified treatments, improved supportive care, and closer monitoring in order to prevent potential complications such as severe infections.

“A significant proportion of children with AML suffer from treatment-related toxicities, with some succumbing to complications of the therapies we give, rather than from the actual cancer itself,” Dr Gramatges said.

“We hope this research will help us identify those who are at a higher risk for delayed recovery and use this knowledge to reduce the morbidity and mortality associated with AML treatment.”

Neutrophil engulfing bacteria

Image by Volker Brinkmann

Researchers say they have discovered a way to predict which children with acute myeloid leukemia (AML) are at the highest risk of delayed neutrophil recovery.

The team examined the role of telomeres in neutrophil recovery and found that the length of a patient’s telomeres can indicate the rate of recovery following chemotherapy.

The group reported their findings in the Journal of Clinical Oncology.

“We were interested in telomere length as a marker of blood count recovery because defects in telomere maintenance are known risks for bone marrow failure and aplastic anemia,” said study author Maria Monica Gramatges, MD, PhD, of Baylor College of Medicine in Houston, Texas.

“We know that up to 15% to 20% of children can take 2 months or longer to recover their blood counts after a course of AML chemotherapy. Our goal was to understand if these children had an underlying genetic predisposition associated with an impaired capacity for recovery.”

Dr Gramatges and her colleagues hypothesized that short telomere length could be associated with a delay in neutrophil recovery.

So they obtained bone marrow samples from AML patients who recovered as expected (within 30 days) after each chemotherapy course (n=62), and from AML patients who experienced significant delays in recovery after chemotherapy (n=53).

The team then measured telomere length on each subject and categorized the group by quartile, from shortest to longest.

Subjects in the quartile with the shortest telomere lengths took the longest to recover, especially during the last 2 courses of chemotherapy. In an adjusted analysis, lower telomere content was significantly associated with prolonged neutropenia after the fourth (P=0.002) and fifth courses of chemotherapy (P=0.009).

The researchers said these results support the hypothesis that telomeres are an indicator of capacity for neutrophil recovery following chemotherapy.

Dr Gramatges hopes the results of this study will be helpful in further understanding which children are at a higher risk for prolonged myelosuppression and how to target those children with modified treatments, improved supportive care, and closer monitoring in order to prevent potential complications such as severe infections.

“A significant proportion of children with AML suffer from treatment-related toxicities, with some succumbing to complications of the therapies we give, rather than from the actual cancer itself,” Dr Gramatges said.

“We hope this research will help us identify those who are at a higher risk for delayed recovery and use this knowledge to reduce the morbidity and mortality associated with AML treatment.”

This 4-part video series is moderated by Jeffrey M. Weinberg, MD, and features discussion among dermatologists on this chronic inflammatory condition that has a significant impact on the quality of life of patients. Moderated by Jeffrey M. Weinberg, MD, this series covers pathogenesis, comorbidities, diagnosis, treatment, and patient education.

This video roundtable was produced by the Custom Programs division of Frontline Medical Communications. The editorial staff of Dermatology News was not involved in developing  the video roundtable.

Participants include:

• Robert G. Micheletti, MD
• George Han, MD, PhD
• Mary Ruth Buchness, MD

Disclosure: The faculty received modest honoraria from Frontline Medical Communications for their time participating in this roundtable, and maintained complete editorial control over all content presented.

Dr. Weinberg discloses that he has received honoraria from AbbVie Inc.

Dr. Buchness discloses that she is on the speakers’ bureau for AbbVie Inc.

Dr. Micheletti and Dr. Han have nothing to disclose.

This 4-part video series is moderated by Jeffrey M. Weinberg, MD, and features discussion among dermatologists on this chronic inflammatory condition that has a significant impact on the quality of life of patients. Moderated by Jeffrey M. Weinberg, MD, this series covers pathogenesis, comorbidities, diagnosis, treatment, and patient education.

This video roundtable was produced by the Custom Programs division of Frontline Medical Communications. The editorial staff of Dermatology News was not involved in developing  the video roundtable.

Participants include:

• Robert G. Micheletti, MD
• George Han, MD, PhD
• Mary Ruth Buchness, MD

Disclosure: The faculty received modest honoraria from Frontline Medical Communications for their time participating in this roundtable, and maintained complete editorial control over all content presented.

Dr. Weinberg discloses that he has received honoraria from AbbVie Inc.

Dr. Buchness discloses that she is on the speakers’ bureau for AbbVie Inc.

Dr. Micheletti and Dr. Han have nothing to disclose.

This 4-part video series is moderated by Jeffrey M. Weinberg, MD, and features discussion among dermatologists on this chronic inflammatory condition that has a significant impact on the quality of life of patients. Moderated by Jeffrey M. Weinberg, MD, this series covers pathogenesis, comorbidities, diagnosis, treatment, and patient education.

This video roundtable was produced by the Custom Programs division of Frontline Medical Communications. The editorial staff of Dermatology News was not involved in developing  the video roundtable.

Participants include:

• Robert G. Micheletti, MD
• George Han, MD, PhD
• Mary Ruth Buchness, MD

Disclosure: The faculty received modest honoraria from Frontline Medical Communications for their time participating in this roundtable, and maintained complete editorial control over all content presented.

Dr. Weinberg discloses that he has received honoraria from AbbVie Inc.

Dr. Buchness discloses that she is on the speakers’ bureau for AbbVie Inc.

Dr. Micheletti and Dr. Han have nothing to disclose.

The U.S. Supreme Court has refused to decide whether pharmacists with strongly held religious beliefs can be forced to dispense emergency contraception to patients.

Justices did not explain their June 28 denial of Stormans, Inc. vs. Wiesman, but the decision was made over the objection of Chief Justice John G. Roberts Jr., Associate Justice Samuel Alito Jr., and Associate Justice Clarence Thomas. In his dissent, Associate Justice Alito wrote the court should have heard the case to ensure that novel and concededly “unnecessary burden on religious objectors” does not trample fundamental rights.

©jsmith/iStockphoto

“If this is a sign of how religious liberty claims will be treated in the years ahead, those who value religious freedom have cause for great concern,” he wrote in his dissent.

At issue in the case is a 2007 rule by Washington state that a family-owned pharmacy in Olympia must provide Plan B contraception to patients. The “delivery rule” creates “a duty for pharmacists to deliver lawfully prescribed drugs or devices in a timely manner and does not allow for conscience-based decisions not to dispense the drug. The Stormans family, who own Ralph’s Thriftway, sued the state over the regulation, alleging violations of the free exercise, equal protection, and due process clauses of the Constitution. The business owners equate emergency contraception to abortion, and they argue that dispensing the medication violates their religious beliefs.

The 9th U.S. Circuit Court of Appeals sided with the state, calling the regulations “neutral and generally applicable.” The plaintiffs appealed to the Supreme Court. The denial by the high court allows the 9th Circuit decision to stand.

Nearly 20 court briefs were issued to the Supreme Court in the case, including briefs by the American Association of Pro-Life Obstetricians and Gynecologists and 4,609 individual health care professionals in support of the pharmacy.

“By effectively prohibiting exemptions for religious reasons, the state of Washington’s regulations depart radically from widely established norms within the health care industry protecting the individual conscience rights of health care professionals,” the health care professionals wrote in their brief. “Such norms favoring the freedom of conscience are particularly well established where, as here, the practitioner’s right to decline care applies to particular treatments, not to individual patients or classes of persons; and where, as here, declining treatment for reasons of religious conscience has no practical impact on quality or availability of care.”

[email protected]

On Twitter @legal_med

The U.S. Supreme Court has refused to decide whether pharmacists with strongly held religious beliefs can be forced to dispense emergency contraception to patients.

Justices did not explain their June 28 denial of Stormans, Inc. vs. Wiesman, but the decision was made over the objection of Chief Justice John G. Roberts Jr., Associate Justice Samuel Alito Jr., and Associate Justice Clarence Thomas. In his dissent, Associate Justice Alito wrote the court should have heard the case to ensure that novel and concededly “unnecessary burden on religious objectors” does not trample fundamental rights.

©jsmith/iStockphoto

“If this is a sign of how religious liberty claims will be treated in the years ahead, those who value religious freedom have cause for great concern,” he wrote in his dissent.

At issue in the case is a 2007 rule by Washington state that a family-owned pharmacy in Olympia must provide Plan B contraception to patients. The “delivery rule” creates “a duty for pharmacists to deliver lawfully prescribed drugs or devices in a timely manner and does not allow for conscience-based decisions not to dispense the drug. The Stormans family, who own Ralph’s Thriftway, sued the state over the regulation, alleging violations of the free exercise, equal protection, and due process clauses of the Constitution. The business owners equate emergency contraception to abortion, and they argue that dispensing the medication violates their religious beliefs.

The 9th U.S. Circuit Court of Appeals sided with the state, calling the regulations “neutral and generally applicable.” The plaintiffs appealed to the Supreme Court. The denial by the high court allows the 9th Circuit decision to stand.

Nearly 20 court briefs were issued to the Supreme Court in the case, including briefs by the American Association of Pro-Life Obstetricians and Gynecologists and 4,609 individual health care professionals in support of the pharmacy.

“By effectively prohibiting exemptions for religious reasons, the state of Washington’s regulations depart radically from widely established norms within the health care industry protecting the individual conscience rights of health care professionals,” the health care professionals wrote in their brief. “Such norms favoring the freedom of conscience are particularly well established where, as here, the practitioner’s right to decline care applies to particular treatments, not to individual patients or classes of persons; and where, as here, declining treatment for reasons of religious conscience has no practical impact on quality or availability of care.”

[email protected]

On Twitter @legal_med

The U.S. Supreme Court has refused to decide whether pharmacists with strongly held religious beliefs can be forced to dispense emergency contraception to patients.

Justices did not explain their June 28 denial of Stormans, Inc. vs. Wiesman, but the decision was made over the objection of Chief Justice John G. Roberts Jr., Associate Justice Samuel Alito Jr., and Associate Justice Clarence Thomas. In his dissent, Associate Justice Alito wrote the court should have heard the case to ensure that novel and concededly “unnecessary burden on religious objectors” does not trample fundamental rights.

©jsmith/iStockphoto

“If this is a sign of how religious liberty claims will be treated in the years ahead, those who value religious freedom have cause for great concern,” he wrote in his dissent.

At issue in the case is a 2007 rule by Washington state that a family-owned pharmacy in Olympia must provide Plan B contraception to patients. The “delivery rule” creates “a duty for pharmacists to deliver lawfully prescribed drugs or devices in a timely manner and does not allow for conscience-based decisions not to dispense the drug. The Stormans family, who own Ralph’s Thriftway, sued the state over the regulation, alleging violations of the free exercise, equal protection, and due process clauses of the Constitution. The business owners equate emergency contraception to abortion, and they argue that dispensing the medication violates their religious beliefs.

The 9th U.S. Circuit Court of Appeals sided with the state, calling the regulations “neutral and generally applicable.” The plaintiffs appealed to the Supreme Court. The denial by the high court allows the 9th Circuit decision to stand.

Nearly 20 court briefs were issued to the Supreme Court in the case, including briefs by the American Association of Pro-Life Obstetricians and Gynecologists and 4,609 individual health care professionals in support of the pharmacy.

“By effectively prohibiting exemptions for religious reasons, the state of Washington’s regulations depart radically from widely established norms within the health care industry protecting the individual conscience rights of health care professionals,” the health care professionals wrote in their brief. “Such norms favoring the freedom of conscience are particularly well established where, as here, the practitioner’s right to decline care applies to particular treatments, not to individual patients or classes of persons; and where, as here, declining treatment for reasons of religious conscience has no practical impact on quality or availability of care.”

[email protected]

On Twitter @legal_med

WASHINGTON - U.S. House of Representatives Speaker Paul Ryan unveiled a Republican healthcare agenda on Wednesday that would repeal Obamacare but keep some of its more popular provisions.

The proposal is part of Ryan's blueprint, titled "A Better Way," which offers a Republican alternative to the Democratic Party on policy issues ahead of the Nov. 8 election.

Earlier this month, Ryan, the country's highest-ranking elected Republican, released initiatives on national security and combating poverty. Proposals on regulation, tax reform and constitutional authority are expected in the coming weeks.

Republicans have challenged President Barack Obama's signature healthcare law, the Affordable Care Act, since it was enacted in 2010 after a bitter fight in Congress.

"Obamacare has limited choices for patients, driven up costs for consumers, and buried employers and health care providers under thousands of new regulations," a draft of the Ryan plan said. "This law cannot be fixed."

But Ryan's proposal would keep some popular aspects of the law, including not allowing people with pre-existing conditions to be denied coverage and permitting children to stay on their parents' coverage until age 26.

The Obama administration says some 20 million Americans have become insured as a result of the Affordable Care Act.

The Ryan plan recycles long-held Republican proposals like allowing consumers to buy health insurance across state lines, expanding the use of health savings accounts and giving states block grants to run the Medicaid program for the poor.

For people who do not get insurance through their jobs, the Republican plan would establish a refundable tax credit. Obamacare, by contrast, provides subsidies to some lower-income people to buy insurance if they do not qualify for Medicaid.

The Republican proposal would gradually increase the Medicare eligibility age, which currently is 65, to match that of the Social Security pension plan, which is 67 for people born in 1960 or later.

Like Obamacare's so-called Cadillac tax on expensive healthcare plans offered by employers, the Republican proposal would cap the tax deductibility of employer-based plans.

The Republican plan includes medical liability reform that would put a cap on non-economic damages awarded in lawsuits, a measure aimed at cutting overall healthcare costs.

Under Obamacare, many states expanded the number of people eligible for Medicaid. The Republican plan would allow states that decided to expand Medicaid before this year to keep the expansion, while preventing any new states from doing so.

WASHINGTON - U.S. House of Representatives Speaker Paul Ryan unveiled a Republican healthcare agenda on Wednesday that would repeal Obamacare but keep some of its more popular provisions.

The proposal is part of Ryan's blueprint, titled "A Better Way," which offers a Republican alternative to the Democratic Party on policy issues ahead of the Nov. 8 election.

Earlier this month, Ryan, the country's highest-ranking elected Republican, released initiatives on national security and combating poverty. Proposals on regulation, tax reform and constitutional authority are expected in the coming weeks.

Republicans have challenged President Barack Obama's signature healthcare law, the Affordable Care Act, since it was enacted in 2010 after a bitter fight in Congress.

"Obamacare has limited choices for patients, driven up costs for consumers, and buried employers and health care providers under thousands of new regulations," a draft of the Ryan plan said. "This law cannot be fixed."

But Ryan's proposal would keep some popular aspects of the law, including not allowing people with pre-existing conditions to be denied coverage and permitting children to stay on their parents' coverage until age 26.

The Obama administration says some 20 million Americans have become insured as a result of the Affordable Care Act.

The Ryan plan recycles long-held Republican proposals like allowing consumers to buy health insurance across state lines, expanding the use of health savings accounts and giving states block grants to run the Medicaid program for the poor.

For people who do not get insurance through their jobs, the Republican plan would establish a refundable tax credit. Obamacare, by contrast, provides subsidies to some lower-income people to buy insurance if they do not qualify for Medicaid.

The Republican proposal would gradually increase the Medicare eligibility age, which currently is 65, to match that of the Social Security pension plan, which is 67 for people born in 1960 or later.

Like Obamacare's so-called Cadillac tax on expensive healthcare plans offered by employers, the Republican proposal would cap the tax deductibility of employer-based plans.

The Republican plan includes medical liability reform that would put a cap on non-economic damages awarded in lawsuits, a measure aimed at cutting overall healthcare costs.

Under Obamacare, many states expanded the number of people eligible for Medicaid. The Republican plan would allow states that decided to expand Medicaid before this year to keep the expansion, while preventing any new states from doing so.

WASHINGTON - U.S. House of Representatives Speaker Paul Ryan unveiled a Republican healthcare agenda on Wednesday that would repeal Obamacare but keep some of its more popular provisions.

The proposal is part of Ryan's blueprint, titled "A Better Way," which offers a Republican alternative to the Democratic Party on policy issues ahead of the Nov. 8 election.

Earlier this month, Ryan, the country's highest-ranking elected Republican, released initiatives on national security and combating poverty. Proposals on regulation, tax reform and constitutional authority are expected in the coming weeks.

Republicans have challenged President Barack Obama's signature healthcare law, the Affordable Care Act, since it was enacted in 2010 after a bitter fight in Congress.

"Obamacare has limited choices for patients, driven up costs for consumers, and buried employers and health care providers under thousands of new regulations," a draft of the Ryan plan said. "This law cannot be fixed."

But Ryan's proposal would keep some popular aspects of the law, including not allowing people with pre-existing conditions to be denied coverage and permitting children to stay on their parents' coverage until age 26.

The Obama administration says some 20 million Americans have become insured as a result of the Affordable Care Act.

The Ryan plan recycles long-held Republican proposals like allowing consumers to buy health insurance across state lines, expanding the use of health savings accounts and giving states block grants to run the Medicaid program for the poor.

For people who do not get insurance through their jobs, the Republican plan would establish a refundable tax credit. Obamacare, by contrast, provides subsidies to some lower-income people to buy insurance if they do not qualify for Medicaid.

The Republican proposal would gradually increase the Medicare eligibility age, which currently is 65, to match that of the Social Security pension plan, which is 67 for people born in 1960 or later.

Like Obamacare's so-called Cadillac tax on expensive healthcare plans offered by employers, the Republican proposal would cap the tax deductibility of employer-based plans.

The Republican plan includes medical liability reform that would put a cap on non-economic damages awarded in lawsuits, a measure aimed at cutting overall healthcare costs.

Under Obamacare, many states expanded the number of people eligible for Medicaid. The Republican plan would allow states that decided to expand Medicaid before this year to keep the expansion, while preventing any new states from doing so.

In male patients with adult-onset germ cell tumors, cisplatin-based chemotherapy may be associated with hearing loss, according to the results of the large, multicenter Platinum Study.

For every 100-mg/m² increase in cumulative cisplatin dose, a 3.2-dB decline in overall hearing threshold occurred, Robert Frisina, PhD, of the University of South Florida, Tampa, and his associates reported (J Clin Oncol. 2016 Jun. doi: 10.1200/JCO.2016.66.8822).

©monkeybusinessimages/thinkstockphotos.com

A total of 488 men with adult-onset germ cell tumors who were treated with cisplatin-based chemotherapy were consented into this study, and completed questionnaires concerning neurotoxic symptoms, lifestyle habits, and medication use. Each patient underwent bone-conduction and speech-conducting threshold testing. Pure-tone air conduction thresholds were obtained bilaterally at speech frequency range (0.25 to 12 kHz). Classification of hearing loss and assessment of severity followed standardized criteria as defined by the American Speech-Language-Hearing Association. Median age at cancer diagnosis was 31 years; the median interval between chemotherapy and audiometric testing was 4.25 years. Median cumulative cisplatin dose was 400 mg/m². Increasing cumulative cisplatin dose was associated with increasing (worse) hearing thresholds at 4 kHz (P = .021), 6 kHz (P = .0017), 8 kHz (P less than .001), 10 kHz (P less than .001), and 12 kHz (P = .0013) after correcting for age.

Cumulative cisplatin doses above 300 mg/m² were associated with more severe hearing loss, compared with doses less than 300 mg/m² (odds ratio, 1.59; 95% confidence interval, 1.14-2.21; P = .0066).

Conductive hearing loss in the middle ear was not associated with drug exposure dosage levels. Hypertension was identified as a risk factor for hearing loss as impaired overall hearing threshold was significantly associated with hypertension when correcting for age and cisplatin dose (n = 60, P = .0066).

“Because alterations in the highly successful [germ cell tumor] regimens are unlikely, our results point to the importance of ongoing research aimed at the identification of genetic variants associated with cisplatin-related ototoxicity,” investigators wrote. They also suggested that cancer patients treated with cisplatin should be careful to avoid noise exposure, ototoxic drugs, and other factors that could further increase damage.

This study was funded by the National Cancer Institute. Dr. Frisina reported holding patents related to hearing loss products. Six other investigators reported serving in advisory roles, receiving financial compensation or honoraria from multiple pharmaceutical and biomedical companies.

[email protected]

On Twitter @jessnicolecraig

In male patients with adult-onset germ cell tumors, cisplatin-based chemotherapy may be associated with hearing loss, according to the results of the large, multicenter Platinum Study.

For every 100-mg/m² increase in cumulative cisplatin dose, a 3.2-dB decline in overall hearing threshold occurred, Robert Frisina, PhD, of the University of South Florida, Tampa, and his associates reported (J Clin Oncol. 2016 Jun. doi: 10.1200/JCO.2016.66.8822).

©monkeybusinessimages/thinkstockphotos.com

A total of 488 men with adult-onset germ cell tumors who were treated with cisplatin-based chemotherapy were consented into this study, and completed questionnaires concerning neurotoxic symptoms, lifestyle habits, and medication use. Each patient underwent bone-conduction and speech-conducting threshold testing. Pure-tone air conduction thresholds were obtained bilaterally at speech frequency range (0.25 to 12 kHz). Classification of hearing loss and assessment of severity followed standardized criteria as defined by the American Speech-Language-Hearing Association. Median age at cancer diagnosis was 31 years; the median interval between chemotherapy and audiometric testing was 4.25 years. Median cumulative cisplatin dose was 400 mg/m². Increasing cumulative cisplatin dose was associated with increasing (worse) hearing thresholds at 4 kHz (P = .021), 6 kHz (P = .0017), 8 kHz (P less than .001), 10 kHz (P less than .001), and 12 kHz (P = .0013) after correcting for age.

Cumulative cisplatin doses above 300 mg/m² were associated with more severe hearing loss, compared with doses less than 300 mg/m² (odds ratio, 1.59; 95% confidence interval, 1.14-2.21; P = .0066).

Conductive hearing loss in the middle ear was not associated with drug exposure dosage levels. Hypertension was identified as a risk factor for hearing loss as impaired overall hearing threshold was significantly associated with hypertension when correcting for age and cisplatin dose (n = 60, P = .0066).

“Because alterations in the highly successful [germ cell tumor] regimens are unlikely, our results point to the importance of ongoing research aimed at the identification of genetic variants associated with cisplatin-related ototoxicity,” investigators wrote. They also suggested that cancer patients treated with cisplatin should be careful to avoid noise exposure, ototoxic drugs, and other factors that could further increase damage.

This study was funded by the National Cancer Institute. Dr. Frisina reported holding patents related to hearing loss products. Six other investigators reported serving in advisory roles, receiving financial compensation or honoraria from multiple pharmaceutical and biomedical companies.

[email protected]

On Twitter @jessnicolecraig

In male patients with adult-onset germ cell tumors, cisplatin-based chemotherapy may be associated with hearing loss, according to the results of the large, multicenter Platinum Study.

For every 100-mg/m² increase in cumulative cisplatin dose, a 3.2-dB decline in overall hearing threshold occurred, Robert Frisina, PhD, of the University of South Florida, Tampa, and his associates reported (J Clin Oncol. 2016 Jun. doi: 10.1200/JCO.2016.66.8822).

©monkeybusinessimages/thinkstockphotos.com

A total of 488 men with adult-onset germ cell tumors who were treated with cisplatin-based chemotherapy were consented into this study, and completed questionnaires concerning neurotoxic symptoms, lifestyle habits, and medication use. Each patient underwent bone-conduction and speech-conducting threshold testing. Pure-tone air conduction thresholds were obtained bilaterally at speech frequency range (0.25 to 12 kHz). Classification of hearing loss and assessment of severity followed standardized criteria as defined by the American Speech-Language-Hearing Association. Median age at cancer diagnosis was 31 years; the median interval between chemotherapy and audiometric testing was 4.25 years. Median cumulative cisplatin dose was 400 mg/m². Increasing cumulative cisplatin dose was associated with increasing (worse) hearing thresholds at 4 kHz (P = .021), 6 kHz (P = .0017), 8 kHz (P less than .001), 10 kHz (P less than .001), and 12 kHz (P = .0013) after correcting for age.

Cumulative cisplatin doses above 300 mg/m² were associated with more severe hearing loss, compared with doses less than 300 mg/m² (odds ratio, 1.59; 95% confidence interval, 1.14-2.21; P = .0066).

Conductive hearing loss in the middle ear was not associated with drug exposure dosage levels. Hypertension was identified as a risk factor for hearing loss as impaired overall hearing threshold was significantly associated with hypertension when correcting for age and cisplatin dose (n = 60, P = .0066).

“Because alterations in the highly successful [germ cell tumor] regimens are unlikely, our results point to the importance of ongoing research aimed at the identification of genetic variants associated with cisplatin-related ototoxicity,” investigators wrote. They also suggested that cancer patients treated with cisplatin should be careful to avoid noise exposure, ototoxic drugs, and other factors that could further increase damage.

This study was funded by the National Cancer Institute. Dr. Frisina reported holding patents related to hearing loss products. Six other investigators reported serving in advisory roles, receiving financial compensation or honoraria from multiple pharmaceutical and biomedical companies.

[email protected]

On Twitter @jessnicolecraig

“Sticks and stones may break my bones, but words will never hurt me.” This mantra was the retort of choice for thousands of apparently resilient premillennial children. But you and I, and just about everyone else, know that words can be very hurtful. A recent article in the journal Eating and Weight Disorders entitled, “ ‘Don’t eat so much’: How parent comments relate to female weight satisfaction” (Eat Weight Disord. 2016 Jun 6. [Epub ahead of print]) reminds us that the pain can last forever.

In a retrospective study of 501 young women aged 20-35 years, the investigators asked whether the women could recall their parents making any comments about their weight when they were young children. What the authors discovered was that even among young women who were of normal weight, those who could recall their parents making a comment about their weight were more dissatisfied with their body weight than the young women who could not recall such a comment. However, if the comment had been about eating habits and not weight, then there was no significant association with weight dissatisfaction.

Before we rush out to send all of the parents of weight-dissatisfied young women on a guilt trip, let’s remember that this was a retrospective study. Let’s consider the not unlikely explanation that there may be something built into the psyche of weight-dissatisfied young women that sharpens their memory for negative comments from friends and family.

Regardless of how we interpret the findings from this study, it is probably safe to say that telling a young girl that she is overweight doesn’t help and should be avoided. This is just another example of how poorly chosen words can be hurtful. But it is also an example of how words alone are seldom shapers of positive behaviors. You can’t talk a picky eater into eating spinach anymore than you can talk the child in the middle of a tantrum into settling down. Good manners are best learned by modeling the behavior of respected adults and not by being subjected to a series of parental lectures. Telling a child she is overweight won’t solve the problem.

So what is the parent of an obese child to do? Unfortunately, many parents of obese children don’t perceive their child as being significantly overweight. But let’s assume we have cleared that hurdle of denial. If telling the child she is overweight is the wrong thing to do, then her parents are forced into using strategies that are subliminal, applied slowly and patiently – silently.

©SolStock/iStock

These strategies could include gradually decreasing the child’s screen time, hoping that it will be replaced by calorie-burning activities; changing the food available for all the inhabitants of the home to increase the likelihood that healthier choices will dominate; and decreasing serving sizes. It is critical that these changes are done so slowly that they go unnoticed by the child. If the child questions the changes, then the response should be that they are being done to help the entire family to be healthier, and that they are not being targeted at any one individual. Of course, the big problem is getting the rest of the family to buy into the changes so that the overweight child doesn’t become a scapegoat.

Shielding the overweight child from the blame game is much easier if the parents have been careful to avoid labeling from the moment they realized or accepted that the child had a weight problem. Here is where we pediatricians can play a critical role in our choice of words, and the setting in which we discuss the child’s weight with the parents. We must point out to the parents that their words can create a hurt that may not ever go away.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”

“Sticks and stones may break my bones, but words will never hurt me.” This mantra was the retort of choice for thousands of apparently resilient premillennial children. But you and I, and just about everyone else, know that words can be very hurtful. A recent article in the journal Eating and Weight Disorders entitled, “ ‘Don’t eat so much’: How parent comments relate to female weight satisfaction” (Eat Weight Disord. 2016 Jun 6. [Epub ahead of print]) reminds us that the pain can last forever.

In a retrospective study of 501 young women aged 20-35 years, the investigators asked whether the women could recall their parents making any comments about their weight when they were young children. What the authors discovered was that even among young women who were of normal weight, those who could recall their parents making a comment about their weight were more dissatisfied with their body weight than the young women who could not recall such a comment. However, if the comment had been about eating habits and not weight, then there was no significant association with weight dissatisfaction.

Before we rush out to send all of the parents of weight-dissatisfied young women on a guilt trip, let’s remember that this was a retrospective study. Let’s consider the not unlikely explanation that there may be something built into the psyche of weight-dissatisfied young women that sharpens their memory for negative comments from friends and family.

Regardless of how we interpret the findings from this study, it is probably safe to say that telling a young girl that she is overweight doesn’t help and should be avoided. This is just another example of how poorly chosen words can be hurtful. But it is also an example of how words alone are seldom shapers of positive behaviors. You can’t talk a picky eater into eating spinach anymore than you can talk the child in the middle of a tantrum into settling down. Good manners are best learned by modeling the behavior of respected adults and not by being subjected to a series of parental lectures. Telling a child she is overweight won’t solve the problem.

So what is the parent of an obese child to do? Unfortunately, many parents of obese children don’t perceive their child as being significantly overweight. But let’s assume we have cleared that hurdle of denial. If telling the child she is overweight is the wrong thing to do, then her parents are forced into using strategies that are subliminal, applied slowly and patiently – silently.

©SolStock/iStock

These strategies could include gradually decreasing the child’s screen time, hoping that it will be replaced by calorie-burning activities; changing the food available for all the inhabitants of the home to increase the likelihood that healthier choices will dominate; and decreasing serving sizes. It is critical that these changes are done so slowly that they go unnoticed by the child. If the child questions the changes, then the response should be that they are being done to help the entire family to be healthier, and that they are not being targeted at any one individual. Of course, the big problem is getting the rest of the family to buy into the changes so that the overweight child doesn’t become a scapegoat.

Shielding the overweight child from the blame game is much easier if the parents have been careful to avoid labeling from the moment they realized or accepted that the child had a weight problem. Here is where we pediatricians can play a critical role in our choice of words, and the setting in which we discuss the child’s weight with the parents. We must point out to the parents that their words can create a hurt that may not ever go away.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”

“Sticks and stones may break my bones, but words will never hurt me.” This mantra was the retort of choice for thousands of apparently resilient premillennial children. But you and I, and just about everyone else, know that words can be very hurtful. A recent article in the journal Eating and Weight Disorders entitled, “ ‘Don’t eat so much’: How parent comments relate to female weight satisfaction” (Eat Weight Disord. 2016 Jun 6. [Epub ahead of print]) reminds us that the pain can last forever.

In a retrospective study of 501 young women aged 20-35 years, the investigators asked whether the women could recall their parents making any comments about their weight when they were young children. What the authors discovered was that even among young women who were of normal weight, those who could recall their parents making a comment about their weight were more dissatisfied with their body weight than the young women who could not recall such a comment. However, if the comment had been about eating habits and not weight, then there was no significant association with weight dissatisfaction.

Before we rush out to send all of the parents of weight-dissatisfied young women on a guilt trip, let’s remember that this was a retrospective study. Let’s consider the not unlikely explanation that there may be something built into the psyche of weight-dissatisfied young women that sharpens their memory for negative comments from friends and family.

Regardless of how we interpret the findings from this study, it is probably safe to say that telling a young girl that she is overweight doesn’t help and should be avoided. This is just another example of how poorly chosen words can be hurtful. But it is also an example of how words alone are seldom shapers of positive behaviors. You can’t talk a picky eater into eating spinach anymore than you can talk the child in the middle of a tantrum into settling down. Good manners are best learned by modeling the behavior of respected adults and not by being subjected to a series of parental lectures. Telling a child she is overweight won’t solve the problem.

So what is the parent of an obese child to do? Unfortunately, many parents of obese children don’t perceive their child as being significantly overweight. But let’s assume we have cleared that hurdle of denial. If telling the child she is overweight is the wrong thing to do, then her parents are forced into using strategies that are subliminal, applied slowly and patiently – silently.

©SolStock/iStock

These strategies could include gradually decreasing the child’s screen time, hoping that it will be replaced by calorie-burning activities; changing the food available for all the inhabitants of the home to increase the likelihood that healthier choices will dominate; and decreasing serving sizes. It is critical that these changes are done so slowly that they go unnoticed by the child. If the child questions the changes, then the response should be that they are being done to help the entire family to be healthier, and that they are not being targeted at any one individual. Of course, the big problem is getting the rest of the family to buy into the changes so that the overweight child doesn’t become a scapegoat.

Shielding the overweight child from the blame game is much easier if the parents have been careful to avoid labeling from the moment they realized or accepted that the child had a weight problem. Here is where we pediatricians can play a critical role in our choice of words, and the setting in which we discuss the child’s weight with the parents. We must point out to the parents that their words can create a hurt that may not ever go away.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”

Now that the interleukin-17 inhibitor secukinumab and tumor necrosis factor inhibitors are competing options for treatment of patients with ankylosing spondylitis, the companies that make those drugs must feel pressure to find some sort of advantage for their agents.

How else to explain the remarkable pair of similar post hoc analyses presented in June at the European Congress of Rheumatology in London? One of the analyses was funded by Novartis – the company that markets secukinumab (Cosentyx) – and included several Novartis employees as coauthors. The second study, presented immediately afterward in the main session at the meeting devoted to ankylosing spondylitis (AS) treatments, had backing from AbbVie, which markets adalimumab (Humira), the largest-selling tumor necrosis factor inhibitor worldwide, and had several AbbVie employees as coauthors.

Both analyses used a “matching adjusted indirect comparison,” a fairly new way to compare the performance of interventions studied in two totally independent trials by propensity matching patients from each of the two trials. It’s purportedly a way to make a legitimate comparison in the absence of head-to-head data.

Making the two reports even more surreal was their use of essentially the same data.

The first report came from Walter P. Maksymowych, MD, an AS clinician and researcher from the University of Alberta, who with his coauthors used data collected on secukinumab in the MEASURE 1 pivotal trial and on adalimumab in the ATLAS pivotal trial. He spent much of his presentation describing the methods behind the indirect comparison, and I don’t think I can be blamed for calling the results of this Novartis-sponsored analysis predictable: overall better performance by secukinumab, compared “indirectly” with adalimumab for clinical responses and patient quality of life.

Mitchel L. Zoler/Frontline Medical News

The second report, the one sponsored by AbbVie, came from Keith A. Betts, PhD, a biostatistician who works for the Analysis Group, an international consulting firm. He also used the ATLAS database as the source for adalimumab outcomes, and differed marginally from Dr. Maksymowych by taking data on secukinumab patients from both the MEASURE 1 and MEASURE 2 pivotal trials. Although Dr. Betts also used the matching adjusted indirect comparison approach and broadened his data source modestly, his results showed a distinctly different outcome: similar efficacy for the two drugs. Dr. Betts also included a cost efficacy analysis, and in this part adalimumab showed superior performance after he factored in the cost per responding AS patient.

During the combined discussion period following the two talks, both presenters defended the legitimacy of their approaches, although Dr. Maksymowych conceded that these indirect comparisons are “hypothesis generating rather than producing a definitive answer.” But a couple of active European AS researchers rose to comment from the floor and discredit the whole process.

“These two presentations show why I am not a proponent of indirect comparisons. The statistical models squeeze the data until they confess,” said Robert Landewé, MD, an AS specialist at the University of Amsterdam. “This is now a commercial rather than a scientific clash between two important drugs. I challenge these companies to perform a head-to-head trial. Indirect comparisons are not good,” he concluded, to a round of audience applause.

“There are so many methodological issues,” said Désirée van der Heijde, MD, another Dutch AS clinician and researcher who rose to critique both studies. “The only thing you can rely on is head-to-head trials.”

I later spoke with Dr. Maksymowych, and he expressed some pessimism about the prospects for a fully-powered, head-to-head trial of an interleukin-17 inhibitor and tumor necrosis factor inhibitor because it would need to enroll so many patients. “Randomized studies of active comparators need to be huge because it’s hard to show improvements when the response rates are high,” he said. Plus, he added, it isn’t entirely about a drug’s efficacy against AS spinal symptoms anyway.

“We also have to think about the impact of treatment on other aspects of this disease, such as psoriasis and colitis, as well as radiographic disease progression,” he said. These aspects of the activity of both classes of drugs have not received much study in AS patients until now.

In other words, the battle between treatment options for AS has just begun, and seems likely to be fought on many fronts.

[email protected]

On Twitter @mitchelzoler

Now that the interleukin-17 inhibitor secukinumab and tumor necrosis factor inhibitors are competing options for treatment of patients with ankylosing spondylitis, the companies that make those drugs must feel pressure to find some sort of advantage for their agents.

How else to explain the remarkable pair of similar post hoc analyses presented in June at the European Congress of Rheumatology in London? One of the analyses was funded by Novartis – the company that markets secukinumab (Cosentyx) – and included several Novartis employees as coauthors. The second study, presented immediately afterward in the main session at the meeting devoted to ankylosing spondylitis (AS) treatments, had backing from AbbVie, which markets adalimumab (Humira), the largest-selling tumor necrosis factor inhibitor worldwide, and had several AbbVie employees as coauthors.

Both analyses used a “matching adjusted indirect comparison,” a fairly new way to compare the performance of interventions studied in two totally independent trials by propensity matching patients from each of the two trials. It’s purportedly a way to make a legitimate comparison in the absence of head-to-head data.

Making the two reports even more surreal was their use of essentially the same data.

The first report came from Walter P. Maksymowych, MD, an AS clinician and researcher from the University of Alberta, who with his coauthors used data collected on secukinumab in the MEASURE 1 pivotal trial and on adalimumab in the ATLAS pivotal trial. He spent much of his presentation describing the methods behind the indirect comparison, and I don’t think I can be blamed for calling the results of this Novartis-sponsored analysis predictable: overall better performance by secukinumab, compared “indirectly” with adalimumab for clinical responses and patient quality of life.

Mitchel L. Zoler/Frontline Medical News

The second report, the one sponsored by AbbVie, came from Keith A. Betts, PhD, a biostatistician who works for the Analysis Group, an international consulting firm. He also used the ATLAS database as the source for adalimumab outcomes, and differed marginally from Dr. Maksymowych by taking data on secukinumab patients from both the MEASURE 1 and MEASURE 2 pivotal trials. Although Dr. Betts also used the matching adjusted indirect comparison approach and broadened his data source modestly, his results showed a distinctly different outcome: similar efficacy for the two drugs. Dr. Betts also included a cost efficacy analysis, and in this part adalimumab showed superior performance after he factored in the cost per responding AS patient.

During the combined discussion period following the two talks, both presenters defended the legitimacy of their approaches, although Dr. Maksymowych conceded that these indirect comparisons are “hypothesis generating rather than producing a definitive answer.” But a couple of active European AS researchers rose to comment from the floor and discredit the whole process.

“These two presentations show why I am not a proponent of indirect comparisons. The statistical models squeeze the data until they confess,” said Robert Landewé, MD, an AS specialist at the University of Amsterdam. “This is now a commercial rather than a scientific clash between two important drugs. I challenge these companies to perform a head-to-head trial. Indirect comparisons are not good,” he concluded, to a round of audience applause.

“There are so many methodological issues,” said Désirée van der Heijde, MD, another Dutch AS clinician and researcher who rose to critique both studies. “The only thing you can rely on is head-to-head trials.”

I later spoke with Dr. Maksymowych, and he expressed some pessimism about the prospects for a fully-powered, head-to-head trial of an interleukin-17 inhibitor and tumor necrosis factor inhibitor because it would need to enroll so many patients. “Randomized studies of active comparators need to be huge because it’s hard to show improvements when the response rates are high,” he said. Plus, he added, it isn’t entirely about a drug’s efficacy against AS spinal symptoms anyway.

“We also have to think about the impact of treatment on other aspects of this disease, such as psoriasis and colitis, as well as radiographic disease progression,” he said. These aspects of the activity of both classes of drugs have not received much study in AS patients until now.

In other words, the battle between treatment options for AS has just begun, and seems likely to be fought on many fronts.

[email protected]

On Twitter @mitchelzoler

Now that the interleukin-17 inhibitor secukinumab and tumor necrosis factor inhibitors are competing options for treatment of patients with ankylosing spondylitis, the companies that make those drugs must feel pressure to find some sort of advantage for their agents.

How else to explain the remarkable pair of similar post hoc analyses presented in June at the European Congress of Rheumatology in London? One of the analyses was funded by Novartis – the company that markets secukinumab (Cosentyx) – and included several Novartis employees as coauthors. The second study, presented immediately afterward in the main session at the meeting devoted to ankylosing spondylitis (AS) treatments, had backing from AbbVie, which markets adalimumab (Humira), the largest-selling tumor necrosis factor inhibitor worldwide, and had several AbbVie employees as coauthors.

Both analyses used a “matching adjusted indirect comparison,” a fairly new way to compare the performance of interventions studied in two totally independent trials by propensity matching patients from each of the two trials. It’s purportedly a way to make a legitimate comparison in the absence of head-to-head data.

Making the two reports even more surreal was their use of essentially the same data.

The first report came from Walter P. Maksymowych, MD, an AS clinician and researcher from the University of Alberta, who with his coauthors used data collected on secukinumab in the MEASURE 1 pivotal trial and on adalimumab in the ATLAS pivotal trial. He spent much of his presentation describing the methods behind the indirect comparison, and I don’t think I can be blamed for calling the results of this Novartis-sponsored analysis predictable: overall better performance by secukinumab, compared “indirectly” with adalimumab for clinical responses and patient quality of life.

Mitchel L. Zoler/Frontline Medical News

The second report, the one sponsored by AbbVie, came from Keith A. Betts, PhD, a biostatistician who works for the Analysis Group, an international consulting firm. He also used the ATLAS database as the source for adalimumab outcomes, and differed marginally from Dr. Maksymowych by taking data on secukinumab patients from both the MEASURE 1 and MEASURE 2 pivotal trials. Although Dr. Betts also used the matching adjusted indirect comparison approach and broadened his data source modestly, his results showed a distinctly different outcome: similar efficacy for the two drugs. Dr. Betts also included a cost efficacy analysis, and in this part adalimumab showed superior performance after he factored in the cost per responding AS patient.

During the combined discussion period following the two talks, both presenters defended the legitimacy of their approaches, although Dr. Maksymowych conceded that these indirect comparisons are “hypothesis generating rather than producing a definitive answer.” But a couple of active European AS researchers rose to comment from the floor and discredit the whole process.

“These two presentations show why I am not a proponent of indirect comparisons. The statistical models squeeze the data until they confess,” said Robert Landewé, MD, an AS specialist at the University of Amsterdam. “This is now a commercial rather than a scientific clash between two important drugs. I challenge these companies to perform a head-to-head trial. Indirect comparisons are not good,” he concluded, to a round of audience applause.

“There are so many methodological issues,” said Désirée van der Heijde, MD, another Dutch AS clinician and researcher who rose to critique both studies. “The only thing you can rely on is head-to-head trials.”

I later spoke with Dr. Maksymowych, and he expressed some pessimism about the prospects for a fully-powered, head-to-head trial of an interleukin-17 inhibitor and tumor necrosis factor inhibitor because it would need to enroll so many patients. “Randomized studies of active comparators need to be huge because it’s hard to show improvements when the response rates are high,” he said. Plus, he added, it isn’t entirely about a drug’s efficacy against AS spinal symptoms anyway.

“We also have to think about the impact of treatment on other aspects of this disease, such as psoriasis and colitis, as well as radiographic disease progression,” he said. These aspects of the activity of both classes of drugs have not received much study in AS patients until now.

In other words, the battle between treatment options for AS has just begun, and seems likely to be fought on many fronts.

[email protected]

On Twitter @mitchelzoler