VIDEO: Awardee's work targets mucosal stem cells in Crohn’s, ulcerative colitis

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A series of important technological advances in cloning stem cells of the gastrointestinal tract is rewriting the basic concepts surrounding these cells and has the potential to advance understanding of GI conditions such as Barrett’s esophagus and Crohn’s disease, according to the winner of the 2016 AGA-Medtronic Research and Development Pilot Award in Technology.

The award is sponsored by Medtronic and administered through the AGA Research Foundation. “Medtronic is pleased to partner with the AGA Research Foundation in supporting research to improve patient outcomes,” said Vafa Jamali, president of Early Technologies’ business with Medtronic. “We are dedicated to support patient-friendly innovations enabling the early detection and treatment of chronic GI diseases and cancers.”

Eli Zimmerman/Frontline Medical News
From left, Dr. Michael L. Kochman, Dr. Wa Xian, Dr. Bani Chander-Roland, and Vafa Jamali.
Award winner Wa Xian, PhD, gave an update on her research at the 2017 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

“The enabling technology we developed is the means of cloning and propagating single mucosal stem cells from discrete regions of the gastrointestinal tract in their most immature form. What we have shown is that these stem cells from normal individuals are essentially immortal, are genetically stable, and, critically, are rigorously regiospecific,” Dr. Xian of the Institute of Molecular Medicine for the Prevention of Human Diseases, University of Texas Health Science Center, Houston, said in an interview.

“This regiospecificity – duodenum stem cells always yield duodenum epithelia, ascending colon stem cells produce ascending colon epithelia – has important implications for both regenerative medicine and drug discovery,” she added.

With regard to the dominant stem cell technologies in use today, including induced pluripotent stem cells and organoid cultures of the gastrointestinal tract, Dr. Xian’s technology represents a paradigm shift.

Dr. Xian’s system generates pure “ground state” stem cells that differentiate in 3-D culture to an epithelium indistinguishable from textbook images of in situ epithelia, at rates 250 times faster than intestinal organoid systems.

This system is being applied in major investigations into Barrett’s esophagus and inflammatory bowel disease in collaboration with investigators at multiple centers in the United States and Singapore.

For Barrett’s, Dr. Xian has developed patient-matched stem cells from endoscopic biopsies of esophageal, Barrett’s, and gastric cardia to show that each arises from distinct lineages, and that the Barrett’s stem cells accumulate genetic alterations not found in those of the matched normal epithelia. These stem cells have been adapted to a drug-screening platform to identify leads that specifically eliminate Barrett’s with an eye on preemptive therapies.

Her work on mucosal stem cells in patients with Crohn’s and ulcerative colitis is revealing a coexistence of normal and pathogenic stem cells in these patients that may alter concepts of both the etiology and treatment of these conditions.

Dr. Xian suggests that treatment of Crohn’s may become analogous to treatment of cancer – emphasizing preservation of healthy cells while eliminating diseased cells – and move therapy from the current effort to induce a quiescent inflammatory state to one in which the goal is cure.

“These findings appear to indicate that some of the chronic inflammatory conditions so prevalent in gastroenterology, as well as the cancers arising from them, may have as their basis profound alterations in mucosal stem cell biology,” she added.

Though it’s still early days with this technology, its single-cell resolution naturally melds with other emerging genomic and genome editing technologies into a powerful means of dissecting the molecular basis of disease and realizing the potential of autologous regenerative medicine, according to Dr. Xian.

Following Dr. Xian’s presentation, Michael L. Kochman, MD, who is executive committee chair of the AGA Center for GI Innovation and Technology, announced the winner of the 2017 AGA-Medtronic Research and Development Pilot Award in Technology. The award was presented to Bani Chander Roland, MD, of Lenox Hill Hospital & Northwell Health System, New York. Her research will involve assessment of the ileocecal valve.

“She has several aims in this proposal to really understand better the causes of ileosphincter dysfunction using a novel method of measuring ileocecal junction pressures,” reported Dr. Kochman. He explained that other parts of the proposal included ileocecal evaluation with wireless capsule endoscopy as well as an evaluation of flora across the GI tract.

A new award to foster innovation in GI medtech is also planned. In partnership with Boston Scientific, the AGA has established the AGA-Boston Scientific Technology and Innovation Pilot Award. This $30,000 research grant will support investigators at any career stage who are developing and testing new medical devices and technologies with applications in gastroenterology and hepatology. The details of the award will be available on the AGA’s website in May. Applications for the award will be accepted beginning in the fall.

 

 

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A series of important technological advances in cloning stem cells of the gastrointestinal tract is rewriting the basic concepts surrounding these cells and has the potential to advance understanding of GI conditions such as Barrett’s esophagus and Crohn’s disease, according to the winner of the 2016 AGA-Medtronic Research and Development Pilot Award in Technology.

The award is sponsored by Medtronic and administered through the AGA Research Foundation. “Medtronic is pleased to partner with the AGA Research Foundation in supporting research to improve patient outcomes,” said Vafa Jamali, president of Early Technologies’ business with Medtronic. “We are dedicated to support patient-friendly innovations enabling the early detection and treatment of chronic GI diseases and cancers.”

Eli Zimmerman/Frontline Medical News
From left, Dr. Michael L. Kochman, Dr. Wa Xian, Dr. Bani Chander-Roland, and Vafa Jamali.
Award winner Wa Xian, PhD, gave an update on her research at the 2017 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

“The enabling technology we developed is the means of cloning and propagating single mucosal stem cells from discrete regions of the gastrointestinal tract in their most immature form. What we have shown is that these stem cells from normal individuals are essentially immortal, are genetically stable, and, critically, are rigorously regiospecific,” Dr. Xian of the Institute of Molecular Medicine for the Prevention of Human Diseases, University of Texas Health Science Center, Houston, said in an interview.

“This regiospecificity – duodenum stem cells always yield duodenum epithelia, ascending colon stem cells produce ascending colon epithelia – has important implications for both regenerative medicine and drug discovery,” she added.

With regard to the dominant stem cell technologies in use today, including induced pluripotent stem cells and organoid cultures of the gastrointestinal tract, Dr. Xian’s technology represents a paradigm shift.

Dr. Xian’s system generates pure “ground state” stem cells that differentiate in 3-D culture to an epithelium indistinguishable from textbook images of in situ epithelia, at rates 250 times faster than intestinal organoid systems.

This system is being applied in major investigations into Barrett’s esophagus and inflammatory bowel disease in collaboration with investigators at multiple centers in the United States and Singapore.

For Barrett’s, Dr. Xian has developed patient-matched stem cells from endoscopic biopsies of esophageal, Barrett’s, and gastric cardia to show that each arises from distinct lineages, and that the Barrett’s stem cells accumulate genetic alterations not found in those of the matched normal epithelia. These stem cells have been adapted to a drug-screening platform to identify leads that specifically eliminate Barrett’s with an eye on preemptive therapies.

Her work on mucosal stem cells in patients with Crohn’s and ulcerative colitis is revealing a coexistence of normal and pathogenic stem cells in these patients that may alter concepts of both the etiology and treatment of these conditions.

Dr. Xian suggests that treatment of Crohn’s may become analogous to treatment of cancer – emphasizing preservation of healthy cells while eliminating diseased cells – and move therapy from the current effort to induce a quiescent inflammatory state to one in which the goal is cure.

“These findings appear to indicate that some of the chronic inflammatory conditions so prevalent in gastroenterology, as well as the cancers arising from them, may have as their basis profound alterations in mucosal stem cell biology,” she added.

Though it’s still early days with this technology, its single-cell resolution naturally melds with other emerging genomic and genome editing technologies into a powerful means of dissecting the molecular basis of disease and realizing the potential of autologous regenerative medicine, according to Dr. Xian.

Following Dr. Xian’s presentation, Michael L. Kochman, MD, who is executive committee chair of the AGA Center for GI Innovation and Technology, announced the winner of the 2017 AGA-Medtronic Research and Development Pilot Award in Technology. The award was presented to Bani Chander Roland, MD, of Lenox Hill Hospital & Northwell Health System, New York. Her research will involve assessment of the ileocecal valve.

“She has several aims in this proposal to really understand better the causes of ileosphincter dysfunction using a novel method of measuring ileocecal junction pressures,” reported Dr. Kochman. He explained that other parts of the proposal included ileocecal evaluation with wireless capsule endoscopy as well as an evaluation of flora across the GI tract.

A new award to foster innovation in GI medtech is also planned. In partnership with Boston Scientific, the AGA has established the AGA-Boston Scientific Technology and Innovation Pilot Award. This $30,000 research grant will support investigators at any career stage who are developing and testing new medical devices and technologies with applications in gastroenterology and hepatology. The details of the award will be available on the AGA’s website in May. Applications for the award will be accepted beginning in the fall.

 

 

A series of important technological advances in cloning stem cells of the gastrointestinal tract is rewriting the basic concepts surrounding these cells and has the potential to advance understanding of GI conditions such as Barrett’s esophagus and Crohn’s disease, according to the winner of the 2016 AGA-Medtronic Research and Development Pilot Award in Technology.

The award is sponsored by Medtronic and administered through the AGA Research Foundation. “Medtronic is pleased to partner with the AGA Research Foundation in supporting research to improve patient outcomes,” said Vafa Jamali, president of Early Technologies’ business with Medtronic. “We are dedicated to support patient-friendly innovations enabling the early detection and treatment of chronic GI diseases and cancers.”

Eli Zimmerman/Frontline Medical News
From left, Dr. Michael L. Kochman, Dr. Wa Xian, Dr. Bani Chander-Roland, and Vafa Jamali.
Award winner Wa Xian, PhD, gave an update on her research at the 2017 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

“The enabling technology we developed is the means of cloning and propagating single mucosal stem cells from discrete regions of the gastrointestinal tract in their most immature form. What we have shown is that these stem cells from normal individuals are essentially immortal, are genetically stable, and, critically, are rigorously regiospecific,” Dr. Xian of the Institute of Molecular Medicine for the Prevention of Human Diseases, University of Texas Health Science Center, Houston, said in an interview.

“This regiospecificity – duodenum stem cells always yield duodenum epithelia, ascending colon stem cells produce ascending colon epithelia – has important implications for both regenerative medicine and drug discovery,” she added.

With regard to the dominant stem cell technologies in use today, including induced pluripotent stem cells and organoid cultures of the gastrointestinal tract, Dr. Xian’s technology represents a paradigm shift.

Dr. Xian’s system generates pure “ground state” stem cells that differentiate in 3-D culture to an epithelium indistinguishable from textbook images of in situ epithelia, at rates 250 times faster than intestinal organoid systems.

This system is being applied in major investigations into Barrett’s esophagus and inflammatory bowel disease in collaboration with investigators at multiple centers in the United States and Singapore.

For Barrett’s, Dr. Xian has developed patient-matched stem cells from endoscopic biopsies of esophageal, Barrett’s, and gastric cardia to show that each arises from distinct lineages, and that the Barrett’s stem cells accumulate genetic alterations not found in those of the matched normal epithelia. These stem cells have been adapted to a drug-screening platform to identify leads that specifically eliminate Barrett’s with an eye on preemptive therapies.

Her work on mucosal stem cells in patients with Crohn’s and ulcerative colitis is revealing a coexistence of normal and pathogenic stem cells in these patients that may alter concepts of both the etiology and treatment of these conditions.

Dr. Xian suggests that treatment of Crohn’s may become analogous to treatment of cancer – emphasizing preservation of healthy cells while eliminating diseased cells – and move therapy from the current effort to induce a quiescent inflammatory state to one in which the goal is cure.

“These findings appear to indicate that some of the chronic inflammatory conditions so prevalent in gastroenterology, as well as the cancers arising from them, may have as their basis profound alterations in mucosal stem cell biology,” she added.

Though it’s still early days with this technology, its single-cell resolution naturally melds with other emerging genomic and genome editing technologies into a powerful means of dissecting the molecular basis of disease and realizing the potential of autologous regenerative medicine, according to Dr. Xian.

Following Dr. Xian’s presentation, Michael L. Kochman, MD, who is executive committee chair of the AGA Center for GI Innovation and Technology, announced the winner of the 2017 AGA-Medtronic Research and Development Pilot Award in Technology. The award was presented to Bani Chander Roland, MD, of Lenox Hill Hospital & Northwell Health System, New York. Her research will involve assessment of the ileocecal valve.

“She has several aims in this proposal to really understand better the causes of ileosphincter dysfunction using a novel method of measuring ileocecal junction pressures,” reported Dr. Kochman. He explained that other parts of the proposal included ileocecal evaluation with wireless capsule endoscopy as well as an evaluation of flora across the GI tract.

A new award to foster innovation in GI medtech is also planned. In partnership with Boston Scientific, the AGA has established the AGA-Boston Scientific Technology and Innovation Pilot Award. This $30,000 research grant will support investigators at any career stage who are developing and testing new medical devices and technologies with applications in gastroenterology and hepatology. The details of the award will be available on the AGA’s website in May. Applications for the award will be accepted beginning in the fall.

 

 

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Debulking called reasonable for unresectable liver cancer

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Cytoreductive debulking surgery for neuroendocrine liver metastases provides a lower but “reasonable” long-term survival, compared with curative intent surgery, according to results of a study presented at the annual meeting of the Americas Hepatico-Pancreato-Biliary Association.

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Cytoreductive debulking surgery for neuroendocrine liver metastases provides a lower but “reasonable” long-term survival, compared with curative intent surgery, according to results of a study presented at the annual meeting of the Americas Hepatico-Pancreato-Biliary Association.

 

Cytoreductive debulking surgery for neuroendocrine liver metastases provides a lower but “reasonable” long-term survival, compared with curative intent surgery, according to results of a study presented at the annual meeting of the Americas Hepatico-Pancreato-Biliary Association.

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Key clinical point: Surgical resection for neuroendocrine liver metastases offers the best chance for long-term survival, and debulking may be an option for patients for whom resection is not feasible.

Major finding: The 10-year overall survival was 77% in the curative intent surgery group, compared with 41% among the debulking patients.

Data source: A retrospective database study of 629 people with neuroendocrine liver metastases.

Disclosures: Dr. Bagante and Dr. Lee had no relevant financial disclosures.

Combining teamwork and technology when tragedy strikes

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I’m the new chief of service for the department of dermatology at Kaiser Permanente San Diego. We are hiring, so I’ve been working on my answers to astute questions about how we at Kaiser Permanente differ from other health systems and why I love our medical group. Many points of differentiation involve how we work as an integrated system and how we are compensated for effective care instead of simply volume of care.

Dr. Jeffrey Benabio
Unfortunately, this week I’ve developed a better answer. A tragedy struck one of our doctors. As I reflect on how we recovered as a team, I’ve found that this story captures what it means to be a Permanente physician.

There are more than 70 dermatologists and staff in our department, and we all play a role in meeting the access needs of our patients. When one of our docs emailed me at 4 a.m. to tell me of a terrible catastrophe that struck her family, it set off a somber day for our team. In addition to offering our sympathy to her, we got right to work to help her. She needed time off to be with her family, and like all of us, she had full schedules booked for weeks ahead.

By 6 a.m., our administrative team was aware and working to recover. We canceled her clinic, and, using scheduling software, identified dermatologists in our department who might be able to help. With a few clicks, we reassigned patients from her to me and others who immediately volunteered. This was seamless as far as the patients would be concerned. Patients coming in within hours that morning were picked up by other doctors; one by one, they added them to their schedules.

Every doctor in San Diego has a Kaiser Permanente–issued smartphone. These allowed us to quickly email, text, and message to coordinate our efforts. Each of us dermatologists connected to her in-basket in our electronic medical record and set to work sending out her biopsy results, answering her secure email messages, and calling her patients. Others volunteered to cover her call, and we reassigned her teledermatology shifts with just a click. By noon, all her responsibilities as a dermatologist had been accounted for, allowing her to focus on her family. Teamwork was enabled by our digital system of care.

This story isn’t a sales pitch. We wish it had never happened. But it might be the best answer to the question of why we love working here. When we combine team plus technology to care for our patients and to care for each other, there’s no medical group we’d rather be.

I hope this is the last tragedy to befall us as a department. And if it is not, I hope to have just this same team around me to cope.

I’m sure others have similar stories of how technology helped them work as a team. Please send them to me at [email protected]; I’d like to write a follow-up piece.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. He is @Dermdoc on Twitter. Write to him at [email protected].

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I’m the new chief of service for the department of dermatology at Kaiser Permanente San Diego. We are hiring, so I’ve been working on my answers to astute questions about how we at Kaiser Permanente differ from other health systems and why I love our medical group. Many points of differentiation involve how we work as an integrated system and how we are compensated for effective care instead of simply volume of care.

Dr. Jeffrey Benabio
Unfortunately, this week I’ve developed a better answer. A tragedy struck one of our doctors. As I reflect on how we recovered as a team, I’ve found that this story captures what it means to be a Permanente physician.

There are more than 70 dermatologists and staff in our department, and we all play a role in meeting the access needs of our patients. When one of our docs emailed me at 4 a.m. to tell me of a terrible catastrophe that struck her family, it set off a somber day for our team. In addition to offering our sympathy to her, we got right to work to help her. She needed time off to be with her family, and like all of us, she had full schedules booked for weeks ahead.

By 6 a.m., our administrative team was aware and working to recover. We canceled her clinic, and, using scheduling software, identified dermatologists in our department who might be able to help. With a few clicks, we reassigned patients from her to me and others who immediately volunteered. This was seamless as far as the patients would be concerned. Patients coming in within hours that morning were picked up by other doctors; one by one, they added them to their schedules.

Every doctor in San Diego has a Kaiser Permanente–issued smartphone. These allowed us to quickly email, text, and message to coordinate our efforts. Each of us dermatologists connected to her in-basket in our electronic medical record and set to work sending out her biopsy results, answering her secure email messages, and calling her patients. Others volunteered to cover her call, and we reassigned her teledermatology shifts with just a click. By noon, all her responsibilities as a dermatologist had been accounted for, allowing her to focus on her family. Teamwork was enabled by our digital system of care.

This story isn’t a sales pitch. We wish it had never happened. But it might be the best answer to the question of why we love working here. When we combine team plus technology to care for our patients and to care for each other, there’s no medical group we’d rather be.

I hope this is the last tragedy to befall us as a department. And if it is not, I hope to have just this same team around me to cope.

I’m sure others have similar stories of how technology helped them work as a team. Please send them to me at [email protected]; I’d like to write a follow-up piece.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. He is @Dermdoc on Twitter. Write to him at [email protected].

 

I’m the new chief of service for the department of dermatology at Kaiser Permanente San Diego. We are hiring, so I’ve been working on my answers to astute questions about how we at Kaiser Permanente differ from other health systems and why I love our medical group. Many points of differentiation involve how we work as an integrated system and how we are compensated for effective care instead of simply volume of care.

Dr. Jeffrey Benabio
Unfortunately, this week I’ve developed a better answer. A tragedy struck one of our doctors. As I reflect on how we recovered as a team, I’ve found that this story captures what it means to be a Permanente physician.

There are more than 70 dermatologists and staff in our department, and we all play a role in meeting the access needs of our patients. When one of our docs emailed me at 4 a.m. to tell me of a terrible catastrophe that struck her family, it set off a somber day for our team. In addition to offering our sympathy to her, we got right to work to help her. She needed time off to be with her family, and like all of us, she had full schedules booked for weeks ahead.

By 6 a.m., our administrative team was aware and working to recover. We canceled her clinic, and, using scheduling software, identified dermatologists in our department who might be able to help. With a few clicks, we reassigned patients from her to me and others who immediately volunteered. This was seamless as far as the patients would be concerned. Patients coming in within hours that morning were picked up by other doctors; one by one, they added them to their schedules.

Every doctor in San Diego has a Kaiser Permanente–issued smartphone. These allowed us to quickly email, text, and message to coordinate our efforts. Each of us dermatologists connected to her in-basket in our electronic medical record and set to work sending out her biopsy results, answering her secure email messages, and calling her patients. Others volunteered to cover her call, and we reassigned her teledermatology shifts with just a click. By noon, all her responsibilities as a dermatologist had been accounted for, allowing her to focus on her family. Teamwork was enabled by our digital system of care.

This story isn’t a sales pitch. We wish it had never happened. But it might be the best answer to the question of why we love working here. When we combine team plus technology to care for our patients and to care for each other, there’s no medical group we’d rather be.

I hope this is the last tragedy to befall us as a department. And if it is not, I hope to have just this same team around me to cope.

I’m sure others have similar stories of how technology helped them work as a team. Please send them to me at [email protected]; I’d like to write a follow-up piece.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. He is @Dermdoc on Twitter. Write to him at [email protected].

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Simple changes shorten door-to-insulin time for diabetic ketoacidosis

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– A few simple adjustments in standing orders shaved 20 minutes off the time one emergency department took to deliver insulin to pediatric patients with diabetic ketoacidosis, according to Mary Ellen Vajravelu, MD.

Door-to-insulin time decreased from a mean of 168 minutes to 146 minutes after the changes went into effect. Most of the time was saved in the period between starting the initial fluid bolus and starting the insulin, she said during an interview at the annual meeting of the Endocrine Society.

Dr. Mary Ellen Vajravelu
“We aren’t done yet, though. The next thing we want to tackle is trying to reduce the time from arrival to fluid bolus,” said Dr. Vajravelu of the Children’s Hospital of Philadelphia.

A single patient’s experience inspired the quality improvement project.

“A couple of years ago, we saw a patient in the emergency department with diabetic ketoacidosis who had to wait more than 6 hours before insulin was started,” she explained. “Fortunately, there were no adverse clinical outcomes from that,” but the case signaled that the treatment process needed some streamlining.

The International Society for Pediatric and Adolescent Diabetes recommends immediate fluid administration and insulin within 1-2 hours of starting fluid replacement.

The hospital had been following in-house recommendations for fluids, insulin, and labs for patients with diabetic ketoacidosis that were established in 2006 and 2011. When they examined a baseline cohort of patients treated from January to October 2014, they immediately saw that those order sets were not achieving the recommended times.

“We went back and looked at our cases and saw that overall, it was taking more than 2 hours from the time of arrival for these patients to get their insulin,” Dr. Vajravelu said.

She and her colleagues formed a quality improvement team consisting of physicians, nurses, and a pharmacist. They broke down the wait time into three components: arrival to fluid bolus, fluid bolus start to insulin start, and the overall arrival-to-insulin time. They then set specific time goals for each of those periods: giving fluids within 60 minutes of arrival, starting insulin 45-90 minutes from the bolus, and an overall door-to-insulin time of less than 120 minutes.

The team tried to determine key clinical drivers that were affecting these times. One of the first findings was a delay in diagnosing diabetic ketoacidosis (DKA). This was driven by lack of consistency in scoring patient acuity and problems with venous access.

“To address this, we standardized acuity scoring, got an IV team involved, and used point-of-care labs when possible, and educated our providers,” Dr. Vajravelu said.

The team also found that there were delays in ordering the insulin. These were driven by long wait times for intravenous fluids, by waiting for endocrinology consults, and by providers not being familiar with the DKA order sets.

To address these issues, the team changed the order set to use normal saline for all suspected DKA patients without waiting for lab results. The old orders called for delivering the fluid over a 1-hour period; that was changed to running it over 30 minutes, Dr. Vajravelu said. “That shaved off half an hour right there.”

The team examined reasons that insulin infusion was delayed. Pharmacy orders were a big part of this problem, one of which was the way the insulin was sent up from the pharmacy in a bag. “We changed that to being delivered in a syringe and tube system,” she explained.

They also changed the standing order for when insulin was started, from 60 minutes after fluid to 45 minutes.

These changes were instituted in November 2014, and the team trained clinicians on them through January 2015. Since then, the team has reassessed the situation several times, tracking 291 patients in all. They saw improvement in all three time periods, which was significant in two of them.

Arrival to fluid bolus time dropped significantly, from 55 minutes to 53 minutes – an improvement, even though the baseline time was still within the goal. Fluid bolus-to-insulin time fell significantly as well, from 96 minutes to 74 minutes – well within the new goal.

Overall arrival-to-insulin time thus decreased, from 168 minutes to 146 minutes. However, Dr. Vajravelu said, this is still longer than their goal of less than 120 minutes from door to treatment.

“We are now going back to try and see just where the delay still is,” she said. “It may be getting IV access; it may be labs. We need to tease that out.”

Fortunately, the consistent delays in treatment haven’t resulted in any adverse clinical outcomes.

“I think the biggest benefit we will see will be saving time and money in the emergency department,” Dr. Vajravelu predicted. “We hope to get patients out of there faster, getting them admitted into the hospital and treated in the appropriate department. Speeding up care and reducing waste go together in that sense.”

Dr. Vajravelu had no relevant financial disclosures.
 

 

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– A few simple adjustments in standing orders shaved 20 minutes off the time one emergency department took to deliver insulin to pediatric patients with diabetic ketoacidosis, according to Mary Ellen Vajravelu, MD.

Door-to-insulin time decreased from a mean of 168 minutes to 146 minutes after the changes went into effect. Most of the time was saved in the period between starting the initial fluid bolus and starting the insulin, she said during an interview at the annual meeting of the Endocrine Society.

Dr. Mary Ellen Vajravelu
“We aren’t done yet, though. The next thing we want to tackle is trying to reduce the time from arrival to fluid bolus,” said Dr. Vajravelu of the Children’s Hospital of Philadelphia.

A single patient’s experience inspired the quality improvement project.

“A couple of years ago, we saw a patient in the emergency department with diabetic ketoacidosis who had to wait more than 6 hours before insulin was started,” she explained. “Fortunately, there were no adverse clinical outcomes from that,” but the case signaled that the treatment process needed some streamlining.

The International Society for Pediatric and Adolescent Diabetes recommends immediate fluid administration and insulin within 1-2 hours of starting fluid replacement.

The hospital had been following in-house recommendations for fluids, insulin, and labs for patients with diabetic ketoacidosis that were established in 2006 and 2011. When they examined a baseline cohort of patients treated from January to October 2014, they immediately saw that those order sets were not achieving the recommended times.

“We went back and looked at our cases and saw that overall, it was taking more than 2 hours from the time of arrival for these patients to get their insulin,” Dr. Vajravelu said.

She and her colleagues formed a quality improvement team consisting of physicians, nurses, and a pharmacist. They broke down the wait time into three components: arrival to fluid bolus, fluid bolus start to insulin start, and the overall arrival-to-insulin time. They then set specific time goals for each of those periods: giving fluids within 60 minutes of arrival, starting insulin 45-90 minutes from the bolus, and an overall door-to-insulin time of less than 120 minutes.

The team tried to determine key clinical drivers that were affecting these times. One of the first findings was a delay in diagnosing diabetic ketoacidosis (DKA). This was driven by lack of consistency in scoring patient acuity and problems with venous access.

“To address this, we standardized acuity scoring, got an IV team involved, and used point-of-care labs when possible, and educated our providers,” Dr. Vajravelu said.

The team also found that there were delays in ordering the insulin. These were driven by long wait times for intravenous fluids, by waiting for endocrinology consults, and by providers not being familiar with the DKA order sets.

To address these issues, the team changed the order set to use normal saline for all suspected DKA patients without waiting for lab results. The old orders called for delivering the fluid over a 1-hour period; that was changed to running it over 30 minutes, Dr. Vajravelu said. “That shaved off half an hour right there.”

The team examined reasons that insulin infusion was delayed. Pharmacy orders were a big part of this problem, one of which was the way the insulin was sent up from the pharmacy in a bag. “We changed that to being delivered in a syringe and tube system,” she explained.

They also changed the standing order for when insulin was started, from 60 minutes after fluid to 45 minutes.

These changes were instituted in November 2014, and the team trained clinicians on them through January 2015. Since then, the team has reassessed the situation several times, tracking 291 patients in all. They saw improvement in all three time periods, which was significant in two of them.

Arrival to fluid bolus time dropped significantly, from 55 minutes to 53 minutes – an improvement, even though the baseline time was still within the goal. Fluid bolus-to-insulin time fell significantly as well, from 96 minutes to 74 minutes – well within the new goal.

Overall arrival-to-insulin time thus decreased, from 168 minutes to 146 minutes. However, Dr. Vajravelu said, this is still longer than their goal of less than 120 minutes from door to treatment.

“We are now going back to try and see just where the delay still is,” she said. “It may be getting IV access; it may be labs. We need to tease that out.”

Fortunately, the consistent delays in treatment haven’t resulted in any adverse clinical outcomes.

“I think the biggest benefit we will see will be saving time and money in the emergency department,” Dr. Vajravelu predicted. “We hope to get patients out of there faster, getting them admitted into the hospital and treated in the appropriate department. Speeding up care and reducing waste go together in that sense.”

Dr. Vajravelu had no relevant financial disclosures.
 

 

 

– A few simple adjustments in standing orders shaved 20 minutes off the time one emergency department took to deliver insulin to pediatric patients with diabetic ketoacidosis, according to Mary Ellen Vajravelu, MD.

Door-to-insulin time decreased from a mean of 168 minutes to 146 minutes after the changes went into effect. Most of the time was saved in the period between starting the initial fluid bolus and starting the insulin, she said during an interview at the annual meeting of the Endocrine Society.

Dr. Mary Ellen Vajravelu
“We aren’t done yet, though. The next thing we want to tackle is trying to reduce the time from arrival to fluid bolus,” said Dr. Vajravelu of the Children’s Hospital of Philadelphia.

A single patient’s experience inspired the quality improvement project.

“A couple of years ago, we saw a patient in the emergency department with diabetic ketoacidosis who had to wait more than 6 hours before insulin was started,” she explained. “Fortunately, there were no adverse clinical outcomes from that,” but the case signaled that the treatment process needed some streamlining.

The International Society for Pediatric and Adolescent Diabetes recommends immediate fluid administration and insulin within 1-2 hours of starting fluid replacement.

The hospital had been following in-house recommendations for fluids, insulin, and labs for patients with diabetic ketoacidosis that were established in 2006 and 2011. When they examined a baseline cohort of patients treated from January to October 2014, they immediately saw that those order sets were not achieving the recommended times.

“We went back and looked at our cases and saw that overall, it was taking more than 2 hours from the time of arrival for these patients to get their insulin,” Dr. Vajravelu said.

She and her colleagues formed a quality improvement team consisting of physicians, nurses, and a pharmacist. They broke down the wait time into three components: arrival to fluid bolus, fluid bolus start to insulin start, and the overall arrival-to-insulin time. They then set specific time goals for each of those periods: giving fluids within 60 minutes of arrival, starting insulin 45-90 minutes from the bolus, and an overall door-to-insulin time of less than 120 minutes.

The team tried to determine key clinical drivers that were affecting these times. One of the first findings was a delay in diagnosing diabetic ketoacidosis (DKA). This was driven by lack of consistency in scoring patient acuity and problems with venous access.

“To address this, we standardized acuity scoring, got an IV team involved, and used point-of-care labs when possible, and educated our providers,” Dr. Vajravelu said.

The team also found that there were delays in ordering the insulin. These were driven by long wait times for intravenous fluids, by waiting for endocrinology consults, and by providers not being familiar with the DKA order sets.

To address these issues, the team changed the order set to use normal saline for all suspected DKA patients without waiting for lab results. The old orders called for delivering the fluid over a 1-hour period; that was changed to running it over 30 minutes, Dr. Vajravelu said. “That shaved off half an hour right there.”

The team examined reasons that insulin infusion was delayed. Pharmacy orders were a big part of this problem, one of which was the way the insulin was sent up from the pharmacy in a bag. “We changed that to being delivered in a syringe and tube system,” she explained.

They also changed the standing order for when insulin was started, from 60 minutes after fluid to 45 minutes.

These changes were instituted in November 2014, and the team trained clinicians on them through January 2015. Since then, the team has reassessed the situation several times, tracking 291 patients in all. They saw improvement in all three time periods, which was significant in two of them.

Arrival to fluid bolus time dropped significantly, from 55 minutes to 53 minutes – an improvement, even though the baseline time was still within the goal. Fluid bolus-to-insulin time fell significantly as well, from 96 minutes to 74 minutes – well within the new goal.

Overall arrival-to-insulin time thus decreased, from 168 minutes to 146 minutes. However, Dr. Vajravelu said, this is still longer than their goal of less than 120 minutes from door to treatment.

“We are now going back to try and see just where the delay still is,” she said. “It may be getting IV access; it may be labs. We need to tease that out.”

Fortunately, the consistent delays in treatment haven’t resulted in any adverse clinical outcomes.

“I think the biggest benefit we will see will be saving time and money in the emergency department,” Dr. Vajravelu predicted. “We hope to get patients out of there faster, getting them admitted into the hospital and treated in the appropriate department. Speeding up care and reducing waste go together in that sense.”

Dr. Vajravelu had no relevant financial disclosures.
 

 

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AT ENDO 2017

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Key clinical point: A few easy changes to treatment pathways significantly shortened the time it took an emergency department to deliver insulin to patients with diabetic ketoacidosis.

Major finding: Overall door-to-insulin time decreased from 168 minutes to 146 minutes.

Data source: A 2-year quality improvement project involving 291 patients.

Disclosures: Dr. Vajravelu had no relevant financial disclosures.

Using genetics to predict CRC outcomes

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BOSTON – Gastroenterologists and GI surgeons had the opportunity to learn more about “Predicting Clinical Outcomes in CRC with Genetics” at the 2017 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Dr. Richard C. Boland
The talk provided answers to several important questions. What clinical issues do physicians want to solve in their CRC patients? What kinds of genetic tests are available? What questions do they address? And, is there an opportunity to develop a novel, disruptive technical approach to the somatic genetics of a CRC tumor?

“All cancers are genetic diseases, developing as a consequence of cumulative mutations. Each cancer is different, both in terms of total mutational burden, as well as the specific mutations that ‘drive’ the tumor,” explained Dr. Boland. “We will be able to stop tumor growth by inhibiting the driver mutation, once we know what that driver is. This will allow us to make more accurate prognoses and predict tumor responses to specific therapies. The hard part will be having effective therapies for each driver mutation.”

The presentation began with a discussion of optimizing CRC care using genetics, predictive tests (for defective DNA mismatch repair – dMMR), specific tumor mutations and blood tests (for miRNAs or other noncoding RNAs). It also covered the sensitivity of immunohistochemistry (IHC) for dMMR and potential problems with IHC.

Then it detailed an innovative technical proposal whose elements include developing a next-generation sequencing platform for CRC and performing microsatellite instability and other mutational testing for specific genes as test-guided therapies emerge. The session also provided an overview of germline mutation testing, including a description of genes that cause hereditary CRC, are on Myriad’s myRisk panel, and are included on Ambry’s 8 Test Panels.

“We think about 3% or so of CRCs have a strong genetic basis, but probably a lot more have weaker genetic bases,” said Dr. Boland. “When we find strongly penetrant germline mutations, it permits case finding and preventive intervention in family members. It also tells us a lot about how to care for the index individual, since all of these familial syndromes have a wide range of effects on patients.

“The technology driving this type of patient assessment is rapidly developing, and making it easier to find these mutations” he continued. “But it is also confusing when we find unexpected mutations in people who don’t seem to fit the classic disease descriptions.”

Attendees were taught why genetic test of CRCs can help direct patient care, how the tests can be efficiently done using a new diagnostic platform, and the state of germline testing and its interpretation.

Dr. Boland has given a lecture for Ambry Genetics (a genetics testing company) and may give others in the future.
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BOSTON – Gastroenterologists and GI surgeons had the opportunity to learn more about “Predicting Clinical Outcomes in CRC with Genetics” at the 2017 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Dr. Richard C. Boland
The talk provided answers to several important questions. What clinical issues do physicians want to solve in their CRC patients? What kinds of genetic tests are available? What questions do they address? And, is there an opportunity to develop a novel, disruptive technical approach to the somatic genetics of a CRC tumor?

“All cancers are genetic diseases, developing as a consequence of cumulative mutations. Each cancer is different, both in terms of total mutational burden, as well as the specific mutations that ‘drive’ the tumor,” explained Dr. Boland. “We will be able to stop tumor growth by inhibiting the driver mutation, once we know what that driver is. This will allow us to make more accurate prognoses and predict tumor responses to specific therapies. The hard part will be having effective therapies for each driver mutation.”

The presentation began with a discussion of optimizing CRC care using genetics, predictive tests (for defective DNA mismatch repair – dMMR), specific tumor mutations and blood tests (for miRNAs or other noncoding RNAs). It also covered the sensitivity of immunohistochemistry (IHC) for dMMR and potential problems with IHC.

Then it detailed an innovative technical proposal whose elements include developing a next-generation sequencing platform for CRC and performing microsatellite instability and other mutational testing for specific genes as test-guided therapies emerge. The session also provided an overview of germline mutation testing, including a description of genes that cause hereditary CRC, are on Myriad’s myRisk panel, and are included on Ambry’s 8 Test Panels.

“We think about 3% or so of CRCs have a strong genetic basis, but probably a lot more have weaker genetic bases,” said Dr. Boland. “When we find strongly penetrant germline mutations, it permits case finding and preventive intervention in family members. It also tells us a lot about how to care for the index individual, since all of these familial syndromes have a wide range of effects on patients.

“The technology driving this type of patient assessment is rapidly developing, and making it easier to find these mutations” he continued. “But it is also confusing when we find unexpected mutations in people who don’t seem to fit the classic disease descriptions.”

Attendees were taught why genetic test of CRCs can help direct patient care, how the tests can be efficiently done using a new diagnostic platform, and the state of germline testing and its interpretation.

Dr. Boland has given a lecture for Ambry Genetics (a genetics testing company) and may give others in the future.

 

BOSTON – Gastroenterologists and GI surgeons had the opportunity to learn more about “Predicting Clinical Outcomes in CRC with Genetics” at the 2017 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Dr. Richard C. Boland
The talk provided answers to several important questions. What clinical issues do physicians want to solve in their CRC patients? What kinds of genetic tests are available? What questions do they address? And, is there an opportunity to develop a novel, disruptive technical approach to the somatic genetics of a CRC tumor?

“All cancers are genetic diseases, developing as a consequence of cumulative mutations. Each cancer is different, both in terms of total mutational burden, as well as the specific mutations that ‘drive’ the tumor,” explained Dr. Boland. “We will be able to stop tumor growth by inhibiting the driver mutation, once we know what that driver is. This will allow us to make more accurate prognoses and predict tumor responses to specific therapies. The hard part will be having effective therapies for each driver mutation.”

The presentation began with a discussion of optimizing CRC care using genetics, predictive tests (for defective DNA mismatch repair – dMMR), specific tumor mutations and blood tests (for miRNAs or other noncoding RNAs). It also covered the sensitivity of immunohistochemistry (IHC) for dMMR and potential problems with IHC.

Then it detailed an innovative technical proposal whose elements include developing a next-generation sequencing platform for CRC and performing microsatellite instability and other mutational testing for specific genes as test-guided therapies emerge. The session also provided an overview of germline mutation testing, including a description of genes that cause hereditary CRC, are on Myriad’s myRisk panel, and are included on Ambry’s 8 Test Panels.

“We think about 3% or so of CRCs have a strong genetic basis, but probably a lot more have weaker genetic bases,” said Dr. Boland. “When we find strongly penetrant germline mutations, it permits case finding and preventive intervention in family members. It also tells us a lot about how to care for the index individual, since all of these familial syndromes have a wide range of effects on patients.

“The technology driving this type of patient assessment is rapidly developing, and making it easier to find these mutations” he continued. “But it is also confusing when we find unexpected mutations in people who don’t seem to fit the classic disease descriptions.”

Attendees were taught why genetic test of CRCs can help direct patient care, how the tests can be efficiently done using a new diagnostic platform, and the state of germline testing and its interpretation.

Dr. Boland has given a lecture for Ambry Genetics (a genetics testing company) and may give others in the future.
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FROM THE 2017 AGA TECH SUMMIT

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Crohn’s hospitalizations up significantly … or not

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Hospitalizations for Crohn’s disease were up by a statistically significant 35% from 2003 to 2013 … or they were up just 5%, according to the Centers for Disease Control and Prevention.

 

It depends on how you look at it. In 2013, age-adjusted hospitalization was 59.7 stays per 100,000 population for Crohn’s as any-listed diagnosis – indicating that patients had Crohn’s disease but that it was not necessarily the main reason they were being hospitalized – compared with 44.2 per 100,000 in 2003. That’s an increase of 35%, the CDC said (MMWR. 2017 Apr 14;66[14]:377-81).

Hospitalizations with Crohn’s as the first-listed diagnosis – making it the main reason for the admission – were up 5% over the same period: 18.2 stays per 100,000 pop. in 2003 and 19.1 per 100,000 in 2013. That increase is not statistically significant, the CDC noted.

The increase in any-listed diagnosis “might represent greater physician awareness and diagnosis of Crohn’s disease or more complete coding of secondary diagnoses by physicians,” CDC investigators suggested.

Increases in hospitalizations for any-listed Crohn’s were significant for both men (40.5%) and women (31.6%). For first-listed Crohn’s, women saw a slight but not significant decrease of 1% while men had a significant 14.5% increase, according to the report, which was based on data from the National Inpatient Sample.

[email protected]

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Hospitalizations for Crohn’s disease were up by a statistically significant 35% from 2003 to 2013 … or they were up just 5%, according to the Centers for Disease Control and Prevention.

 

It depends on how you look at it. In 2013, age-adjusted hospitalization was 59.7 stays per 100,000 population for Crohn’s as any-listed diagnosis – indicating that patients had Crohn’s disease but that it was not necessarily the main reason they were being hospitalized – compared with 44.2 per 100,000 in 2003. That’s an increase of 35%, the CDC said (MMWR. 2017 Apr 14;66[14]:377-81).

Hospitalizations with Crohn’s as the first-listed diagnosis – making it the main reason for the admission – were up 5% over the same period: 18.2 stays per 100,000 pop. in 2003 and 19.1 per 100,000 in 2013. That increase is not statistically significant, the CDC noted.

The increase in any-listed diagnosis “might represent greater physician awareness and diagnosis of Crohn’s disease or more complete coding of secondary diagnoses by physicians,” CDC investigators suggested.

Increases in hospitalizations for any-listed Crohn’s were significant for both men (40.5%) and women (31.6%). For first-listed Crohn’s, women saw a slight but not significant decrease of 1% while men had a significant 14.5% increase, according to the report, which was based on data from the National Inpatient Sample.

[email protected]

 

Hospitalizations for Crohn’s disease were up by a statistically significant 35% from 2003 to 2013 … or they were up just 5%, according to the Centers for Disease Control and Prevention.

 

It depends on how you look at it. In 2013, age-adjusted hospitalization was 59.7 stays per 100,000 population for Crohn’s as any-listed diagnosis – indicating that patients had Crohn’s disease but that it was not necessarily the main reason they were being hospitalized – compared with 44.2 per 100,000 in 2003. That’s an increase of 35%, the CDC said (MMWR. 2017 Apr 14;66[14]:377-81).

Hospitalizations with Crohn’s as the first-listed diagnosis – making it the main reason for the admission – were up 5% over the same period: 18.2 stays per 100,000 pop. in 2003 and 19.1 per 100,000 in 2013. That increase is not statistically significant, the CDC noted.

The increase in any-listed diagnosis “might represent greater physician awareness and diagnosis of Crohn’s disease or more complete coding of secondary diagnoses by physicians,” CDC investigators suggested.

Increases in hospitalizations for any-listed Crohn’s were significant for both men (40.5%) and women (31.6%). For first-listed Crohn’s, women saw a slight but not significant decrease of 1% while men had a significant 14.5% increase, according to the report, which was based on data from the National Inpatient Sample.

[email protected]

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FROM MORBIDITY AND MORTALITY WEEKLY REPORT

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Medicaid reform: Work-based waivers may not fly

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The Trump administration may not be able to successfully implement the work requirements and other Medicaid eligibility caveats proffered by Health and Human Services Secretary Tom Price, MD, according to Jane Perkins, legal director for the National Health Law Program.

Dr. Tom Price


High mandatory premiums, cost sharing, lifetime limits, and drug testing “are of concern to us,” Ms. Perkins said at an April 13 press briefing. “They really change the complexion of Medicaid and Medicaid coverage for low-income people.”

These requirements “are not typically seen in Medicaid programs,” she said.

While Section 1115 of the Social Security Act “allows states to test novel approaches to providing medical assistance” via Medicaid waivers, it does not allow the HHS or the states to “ignore congressional mandates; to cut eligibility, services, or provider payments; or to use section 1115 to save money,” according to an issue brief by Ms. Perkins.

Seema Verma
Kentucky submitted a Medicaid waiver request to the Obama administration in August 2016; it was not acted upon and is still awaiting action by the HHS. Other states that are looking into waivers include Indiana, Arizona, Maine, Florida, and Montana.

When asked how work requirements harm people, Ms. Perkins responded that adding a work requirement to Medicaid eligibility gets things “backwards,” because a sick person needs health care before being able to return to work.

The work requirement would not save states much money, as nearly 8 in 10 adults on Medicaid are in a household that includes a worker and 59% of recipients work themselves, according to a Kaiser Family Foundation study. The adults affected by the work requirement would make up only a drop in the ocean of Medicaid spending. About two-thirds of that spending goes toward senior citizens, people with disabilities, children, and people in long term care, according to projections from the Congressional Budget Office.

johavel/Thinkstock
There’s also a question of whether Medicaid waivers would hold up when subjected to legal challenges. Heads of federal agencies are given broad rule-making authority; however, courts have previously rejected the argument that they have unlimited discretion. Secretaries must adhere to the Administrative Procedures Act, a federal law that limits how they implement regulations, requires time for public comment, and provides specific guidelines on the rule-making process. The law denies departments the ability to engage in rule making that is arbitrary or capricious.

The National Health Law program, which advocates for low-income Medicaid recipients, is following the waivers state-by-state with a network of lawyers who work with people with disabilities in each state.

“With this new openness to flexibility, we are certainly watching what is going on in the states,” Ms. Perkins said.
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The Trump administration may not be able to successfully implement the work requirements and other Medicaid eligibility caveats proffered by Health and Human Services Secretary Tom Price, MD, according to Jane Perkins, legal director for the National Health Law Program.

Dr. Tom Price


High mandatory premiums, cost sharing, lifetime limits, and drug testing “are of concern to us,” Ms. Perkins said at an April 13 press briefing. “They really change the complexion of Medicaid and Medicaid coverage for low-income people.”

These requirements “are not typically seen in Medicaid programs,” she said.

While Section 1115 of the Social Security Act “allows states to test novel approaches to providing medical assistance” via Medicaid waivers, it does not allow the HHS or the states to “ignore congressional mandates; to cut eligibility, services, or provider payments; or to use section 1115 to save money,” according to an issue brief by Ms. Perkins.

Seema Verma
Kentucky submitted a Medicaid waiver request to the Obama administration in August 2016; it was not acted upon and is still awaiting action by the HHS. Other states that are looking into waivers include Indiana, Arizona, Maine, Florida, and Montana.

When asked how work requirements harm people, Ms. Perkins responded that adding a work requirement to Medicaid eligibility gets things “backwards,” because a sick person needs health care before being able to return to work.

The work requirement would not save states much money, as nearly 8 in 10 adults on Medicaid are in a household that includes a worker and 59% of recipients work themselves, according to a Kaiser Family Foundation study. The adults affected by the work requirement would make up only a drop in the ocean of Medicaid spending. About two-thirds of that spending goes toward senior citizens, people with disabilities, children, and people in long term care, according to projections from the Congressional Budget Office.

johavel/Thinkstock
There’s also a question of whether Medicaid waivers would hold up when subjected to legal challenges. Heads of federal agencies are given broad rule-making authority; however, courts have previously rejected the argument that they have unlimited discretion. Secretaries must adhere to the Administrative Procedures Act, a federal law that limits how they implement regulations, requires time for public comment, and provides specific guidelines on the rule-making process. The law denies departments the ability to engage in rule making that is arbitrary or capricious.

The National Health Law program, which advocates for low-income Medicaid recipients, is following the waivers state-by-state with a network of lawyers who work with people with disabilities in each state.

“With this new openness to flexibility, we are certainly watching what is going on in the states,” Ms. Perkins said.

 

The Trump administration may not be able to successfully implement the work requirements and other Medicaid eligibility caveats proffered by Health and Human Services Secretary Tom Price, MD, according to Jane Perkins, legal director for the National Health Law Program.

Dr. Tom Price


High mandatory premiums, cost sharing, lifetime limits, and drug testing “are of concern to us,” Ms. Perkins said at an April 13 press briefing. “They really change the complexion of Medicaid and Medicaid coverage for low-income people.”

These requirements “are not typically seen in Medicaid programs,” she said.

While Section 1115 of the Social Security Act “allows states to test novel approaches to providing medical assistance” via Medicaid waivers, it does not allow the HHS or the states to “ignore congressional mandates; to cut eligibility, services, or provider payments; or to use section 1115 to save money,” according to an issue brief by Ms. Perkins.

Seema Verma
Kentucky submitted a Medicaid waiver request to the Obama administration in August 2016; it was not acted upon and is still awaiting action by the HHS. Other states that are looking into waivers include Indiana, Arizona, Maine, Florida, and Montana.

When asked how work requirements harm people, Ms. Perkins responded that adding a work requirement to Medicaid eligibility gets things “backwards,” because a sick person needs health care before being able to return to work.

The work requirement would not save states much money, as nearly 8 in 10 adults on Medicaid are in a household that includes a worker and 59% of recipients work themselves, according to a Kaiser Family Foundation study. The adults affected by the work requirement would make up only a drop in the ocean of Medicaid spending. About two-thirds of that spending goes toward senior citizens, people with disabilities, children, and people in long term care, according to projections from the Congressional Budget Office.

johavel/Thinkstock
There’s also a question of whether Medicaid waivers would hold up when subjected to legal challenges. Heads of federal agencies are given broad rule-making authority; however, courts have previously rejected the argument that they have unlimited discretion. Secretaries must adhere to the Administrative Procedures Act, a federal law that limits how they implement regulations, requires time for public comment, and provides specific guidelines on the rule-making process. The law denies departments the ability to engage in rule making that is arbitrary or capricious.

The National Health Law program, which advocates for low-income Medicaid recipients, is following the waivers state-by-state with a network of lawyers who work with people with disabilities in each state.

“With this new openness to flexibility, we are certainly watching what is going on in the states,” Ms. Perkins said.
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PTSD linked to cognitive decline in middle-aged women

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– Posttraumatic stress disorder is associated with worse cognitive function in middle-aged women, Jennifer A. Sumner, PhD, reported at the annual conference of the Anxiety and Depression Association of America.

The strongest link between PTSD and impaired cognitive function found in this new analysis from the Nurses’ Health Study 2 was observed among those women with elevated PTSD symptoms indicative of probable PTSD and comorbid depression, added Dr. Sumner, a clinical psychologist affiliated with Columbia University in New York.

Bruce Jancin/Frontline Medical News
Jennifer A. Sumner, PhD
“These results suggest that mental health is not just associated with psychological health but may also be associated with long-term brain health as well,” she said.

The findings are important, in part because they help fill a gender gap in PTSD research. The great majority of studies of PTSD and its long-term consequences for physical and mental health have focused on male military veterans. Yet PTSD is twice as common in women as in men and is on average more severe and causes more impairment in women as well.

Growing evidence suggests that brain aging and cognitive decline begin in midlife, long before the dysfunction becomes manifest as dementia. The Nurses’ Health Study 2 findings raise the testable hypothesis that PTSD might be a modifiable risk factor for early cognitive decline, Dr. Sumner observed.

The Nurses’ Health Study 2 is one of the largest ongoing longitudinal studies of women’s health in the world. Dr. Sumner’s analysis focused on 14,029 participants who in 2008 underwent assessment of lifetime exposure to 16 types of trauma included in the Brief Trauma Questionnaire, lifetime PTSD symptoms using the Short Screening Scale for PTSD, and current depressive symptoms via the Center for Epidemiologic Studies Depression Scale. The women then completed the Cogstate Brief Battery in 2014-2016. The Cogstate is a validated, sensitive, self-administered online cognitive battery that measures psychomotor speed, attention, working memory, and learning. It takes 10-15 minutes to complete.

Seventeen percent of women had both a lifetime history of exposure to trauma and probable PTSD based upon having four or more of the seven symptoms listed on the Short Screening Scale for PTSD. These women had, on average, a lower educational level, income, and self-assessed social standing, more medical comorbidities, and more depressive symptoms than the other subjects. However, in a multivariate analysis controlling for these potential confounders, the group with both trauma and PTSD performed significantly worse on the Cogstate measures of psychomotor speed/attention and learning/working memory than women with no trauma and no PTSD symptoms.

Similarly, the 17% of women with both probable PTSD and probable depression as defined by a score of 10 or more on the Center for Epidemiologic Studies Depression Scale demonstrated significantly worse cognitive function on the Cogstate, compared with women with neither condition.

In regard to potential mechanisms that might explain the observed association between PTSD and worse cognitive function, Dr. Sumner noted that other investigators have reported that PTSD is characterized by oxidative stress, systemic inflammation, and hypothalamic-pituitary-adrenal axis and neuroendocrine dysfunction. This could promote neuronal death. Moreover, PTSD also is associated with increased risk of poor health behaviors, including sleep disturbances, physical inactivity, obesity, and smoking, which also could contribute to cognitive decline down the line.

Dr. Sumner’s study, which was supported by the National Institutes of Health, recently has been published (Depress Anxiety. 2017 Apr;34[4]:356-66). She reported having no financial conflicts.
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– Posttraumatic stress disorder is associated with worse cognitive function in middle-aged women, Jennifer A. Sumner, PhD, reported at the annual conference of the Anxiety and Depression Association of America.

The strongest link between PTSD and impaired cognitive function found in this new analysis from the Nurses’ Health Study 2 was observed among those women with elevated PTSD symptoms indicative of probable PTSD and comorbid depression, added Dr. Sumner, a clinical psychologist affiliated with Columbia University in New York.

Bruce Jancin/Frontline Medical News
Jennifer A. Sumner, PhD
“These results suggest that mental health is not just associated with psychological health but may also be associated with long-term brain health as well,” she said.

The findings are important, in part because they help fill a gender gap in PTSD research. The great majority of studies of PTSD and its long-term consequences for physical and mental health have focused on male military veterans. Yet PTSD is twice as common in women as in men and is on average more severe and causes more impairment in women as well.

Growing evidence suggests that brain aging and cognitive decline begin in midlife, long before the dysfunction becomes manifest as dementia. The Nurses’ Health Study 2 findings raise the testable hypothesis that PTSD might be a modifiable risk factor for early cognitive decline, Dr. Sumner observed.

The Nurses’ Health Study 2 is one of the largest ongoing longitudinal studies of women’s health in the world. Dr. Sumner’s analysis focused on 14,029 participants who in 2008 underwent assessment of lifetime exposure to 16 types of trauma included in the Brief Trauma Questionnaire, lifetime PTSD symptoms using the Short Screening Scale for PTSD, and current depressive symptoms via the Center for Epidemiologic Studies Depression Scale. The women then completed the Cogstate Brief Battery in 2014-2016. The Cogstate is a validated, sensitive, self-administered online cognitive battery that measures psychomotor speed, attention, working memory, and learning. It takes 10-15 minutes to complete.

Seventeen percent of women had both a lifetime history of exposure to trauma and probable PTSD based upon having four or more of the seven symptoms listed on the Short Screening Scale for PTSD. These women had, on average, a lower educational level, income, and self-assessed social standing, more medical comorbidities, and more depressive symptoms than the other subjects. However, in a multivariate analysis controlling for these potential confounders, the group with both trauma and PTSD performed significantly worse on the Cogstate measures of psychomotor speed/attention and learning/working memory than women with no trauma and no PTSD symptoms.

Similarly, the 17% of women with both probable PTSD and probable depression as defined by a score of 10 or more on the Center for Epidemiologic Studies Depression Scale demonstrated significantly worse cognitive function on the Cogstate, compared with women with neither condition.

In regard to potential mechanisms that might explain the observed association between PTSD and worse cognitive function, Dr. Sumner noted that other investigators have reported that PTSD is characterized by oxidative stress, systemic inflammation, and hypothalamic-pituitary-adrenal axis and neuroendocrine dysfunction. This could promote neuronal death. Moreover, PTSD also is associated with increased risk of poor health behaviors, including sleep disturbances, physical inactivity, obesity, and smoking, which also could contribute to cognitive decline down the line.

Dr. Sumner’s study, which was supported by the National Institutes of Health, recently has been published (Depress Anxiety. 2017 Apr;34[4]:356-66). She reported having no financial conflicts.

 

– Posttraumatic stress disorder is associated with worse cognitive function in middle-aged women, Jennifer A. Sumner, PhD, reported at the annual conference of the Anxiety and Depression Association of America.

The strongest link between PTSD and impaired cognitive function found in this new analysis from the Nurses’ Health Study 2 was observed among those women with elevated PTSD symptoms indicative of probable PTSD and comorbid depression, added Dr. Sumner, a clinical psychologist affiliated with Columbia University in New York.

Bruce Jancin/Frontline Medical News
Jennifer A. Sumner, PhD
“These results suggest that mental health is not just associated with psychological health but may also be associated with long-term brain health as well,” she said.

The findings are important, in part because they help fill a gender gap in PTSD research. The great majority of studies of PTSD and its long-term consequences for physical and mental health have focused on male military veterans. Yet PTSD is twice as common in women as in men and is on average more severe and causes more impairment in women as well.

Growing evidence suggests that brain aging and cognitive decline begin in midlife, long before the dysfunction becomes manifest as dementia. The Nurses’ Health Study 2 findings raise the testable hypothesis that PTSD might be a modifiable risk factor for early cognitive decline, Dr. Sumner observed.

The Nurses’ Health Study 2 is one of the largest ongoing longitudinal studies of women’s health in the world. Dr. Sumner’s analysis focused on 14,029 participants who in 2008 underwent assessment of lifetime exposure to 16 types of trauma included in the Brief Trauma Questionnaire, lifetime PTSD symptoms using the Short Screening Scale for PTSD, and current depressive symptoms via the Center for Epidemiologic Studies Depression Scale. The women then completed the Cogstate Brief Battery in 2014-2016. The Cogstate is a validated, sensitive, self-administered online cognitive battery that measures psychomotor speed, attention, working memory, and learning. It takes 10-15 minutes to complete.

Seventeen percent of women had both a lifetime history of exposure to trauma and probable PTSD based upon having four or more of the seven symptoms listed on the Short Screening Scale for PTSD. These women had, on average, a lower educational level, income, and self-assessed social standing, more medical comorbidities, and more depressive symptoms than the other subjects. However, in a multivariate analysis controlling for these potential confounders, the group with both trauma and PTSD performed significantly worse on the Cogstate measures of psychomotor speed/attention and learning/working memory than women with no trauma and no PTSD symptoms.

Similarly, the 17% of women with both probable PTSD and probable depression as defined by a score of 10 or more on the Center for Epidemiologic Studies Depression Scale demonstrated significantly worse cognitive function on the Cogstate, compared with women with neither condition.

In regard to potential mechanisms that might explain the observed association between PTSD and worse cognitive function, Dr. Sumner noted that other investigators have reported that PTSD is characterized by oxidative stress, systemic inflammation, and hypothalamic-pituitary-adrenal axis and neuroendocrine dysfunction. This could promote neuronal death. Moreover, PTSD also is associated with increased risk of poor health behaviors, including sleep disturbances, physical inactivity, obesity, and smoking, which also could contribute to cognitive decline down the line.

Dr. Sumner’s study, which was supported by the National Institutes of Health, recently has been published (Depress Anxiety. 2017 Apr;34[4]:356-66). She reported having no financial conflicts.
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AT ANXIETY AND DEPRESSION CONFERENCE 2017

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Key clinical point: Posttraumatic stress disorder (PTSD) symptoms are inversely related to measures of cognitive function in middle-aged women.

Major finding: A large group of middle-aged civilian women with a history of exposure to trauma at any point in their lives along with elevated PTSD symptoms scored significantly worse on a cognitive function battery than women with no history of trauma or PTSD symptoms.

Data source: This was an analysis of more than 14,000 middle-aged women participating in the ongoing longitudinal Nurses’ Health Study 2.

Disclosures: The study was supported by the National Institutes of Health. Dr. Sumner reported having no financial conflicts.

Measuring Patient Satisfaction: How Do Patients Perceive Quality of Care Delivered by Dermatologists?

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Why the Affordable Care Act will be greatly modified

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Health care rationing is an uncomfortable topic, but one that responsible Americans should discuss. In particular, physicians should consider this topic, because our typical response to health care is that “everything should be covered.”

Health care has always been rationed. Historically, in the United States, health care has been apportioned capitalistically; that is, those who could afford health care got it and the rest – particularly the poor – scrambled. In Europe and Canada, universal or government health care is rationed by long wait times, limited range of services, and formulary restrictions. It is important to note that in almost all countries with universal health care, there is still the option of quick access and more comprehensive service via a neighboring country (to the United States from Canada, for example) or a separate additional private insurance option (England, Germany, and most of Europe).

Dr. Brett M. Coldiron


In the United States, the Affordable Care Act (ACA) changed the dynamic regarding insurance by adding mandates to cover preexisting conditions, mental health and substance abuse disorders, behavioral health treatment, prescription drugs, rehabilitative services, preventive care, and pediatric services including oral and vision care for children. In addition, adult children now can remain on their parents’ insurance plans until age 26. Also, when the Cadillac tax on expensive health insurance coverage was delayed until 2020, the excise payments were classified as tax deductible to the employer. Whew, did I leave anything out?

Advocates for the poor and those previously considered uninsurable were delighted by the ACA. The middle class was mollified with false reassurances that their premiums would go down, and that they could keep their current insurance plans and doctors.

Currently under the ACA, “poor” is generally defined as a reported income of 150% or less of the federal poverty level ($22,000-$45,000). The poor are eligible for health care that is very nearly free, according to Medicaid.gov. They are also protected from claims against their property. They effectively have first-dollar coverage, though they usually can’t see a specialist unless they go through the emergency department.

At age 65, Medicare takes over. Medicare is an insurance benefit workers contribute to for all their working lives. It doesn’t cover everything, but the relatively low $183 Part B deductible for office-based care sure takes the edge off. The average retirees collect three times what they put in, but they arguably could have made more if they had invested anywhere other than in the federal government.

So, the real crunch hits the middle class under age 65. Under the ACA, those earning up to $97,000 for a family of four get insurance subsidies to buy insurance on the exchanges. The real problem arises when a high deductible – the maximum for 2017 is between $13,000 and $14,000 – is combined with that level of income. There are over 20 million health care savings accounts in the United States, which ameliorate the cost for some, but health care savings accounts do not cover the entire deductible, and many cannot afford to self-fund them if their employer does not fund it for them.People simply do not have that kind of money put away in a disaster fund, and a major medical expense can easily wipe them out. If possible, they will ignore a medical problem; and if they can’t, they could risk financial toxicity by running up high-interest credit cards – with the predictable spiral of debt, collection agencies, credit ratings ruined, wages garnished, and even their homes repossessed. They aren’t going to use their health care coverage unless forced to by a disaster – or worse for the system, they have been saving their elective surgeries up and are ready for a major tune-up. The long list of mandated benefits has triggered a meltdown in the exchange markets and huge increases in premiums and deductibles for all insurance buyers. Who is going to pay for it? To quote the late Russell B. Long, former U.S. Senator:

Don’t tax you,

Don’t tax me,

Tax that fellow behind the tree.


Raising taxes and pouring even more money into the system might be a solution, but this is not likely to happen.

In the United States, the rationing of health care has been shifted from the poor to the middle class, and the middle class doesn’t like it. The situation will only change when the howling from the middle class is louder than the wailing from the formerly uninsurable and poor. As insurance premiums and deductibles continue to rocket up, I expect the howling will get louder.

So, either we agree to let insurance premiums continue to increase, our state budgets to explode, our taxes to go up, or we pare down the list of mandated benefits.

I am going on the record stating that we simply cannot afford “medical everything” for everybody. I think we should tighten up the benefit list considerably. What do you think?
 
 

 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

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Health care rationing is an uncomfortable topic, but one that responsible Americans should discuss. In particular, physicians should consider this topic, because our typical response to health care is that “everything should be covered.”

Health care has always been rationed. Historically, in the United States, health care has been apportioned capitalistically; that is, those who could afford health care got it and the rest – particularly the poor – scrambled. In Europe and Canada, universal or government health care is rationed by long wait times, limited range of services, and formulary restrictions. It is important to note that in almost all countries with universal health care, there is still the option of quick access and more comprehensive service via a neighboring country (to the United States from Canada, for example) or a separate additional private insurance option (England, Germany, and most of Europe).

Dr. Brett M. Coldiron


In the United States, the Affordable Care Act (ACA) changed the dynamic regarding insurance by adding mandates to cover preexisting conditions, mental health and substance abuse disorders, behavioral health treatment, prescription drugs, rehabilitative services, preventive care, and pediatric services including oral and vision care for children. In addition, adult children now can remain on their parents’ insurance plans until age 26. Also, when the Cadillac tax on expensive health insurance coverage was delayed until 2020, the excise payments were classified as tax deductible to the employer. Whew, did I leave anything out?

Advocates for the poor and those previously considered uninsurable were delighted by the ACA. The middle class was mollified with false reassurances that their premiums would go down, and that they could keep their current insurance plans and doctors.

Currently under the ACA, “poor” is generally defined as a reported income of 150% or less of the federal poverty level ($22,000-$45,000). The poor are eligible for health care that is very nearly free, according to Medicaid.gov. They are also protected from claims against their property. They effectively have first-dollar coverage, though they usually can’t see a specialist unless they go through the emergency department.

At age 65, Medicare takes over. Medicare is an insurance benefit workers contribute to for all their working lives. It doesn’t cover everything, but the relatively low $183 Part B deductible for office-based care sure takes the edge off. The average retirees collect three times what they put in, but they arguably could have made more if they had invested anywhere other than in the federal government.

So, the real crunch hits the middle class under age 65. Under the ACA, those earning up to $97,000 for a family of four get insurance subsidies to buy insurance on the exchanges. The real problem arises when a high deductible – the maximum for 2017 is between $13,000 and $14,000 – is combined with that level of income. There are over 20 million health care savings accounts in the United States, which ameliorate the cost for some, but health care savings accounts do not cover the entire deductible, and many cannot afford to self-fund them if their employer does not fund it for them.People simply do not have that kind of money put away in a disaster fund, and a major medical expense can easily wipe them out. If possible, they will ignore a medical problem; and if they can’t, they could risk financial toxicity by running up high-interest credit cards – with the predictable spiral of debt, collection agencies, credit ratings ruined, wages garnished, and even their homes repossessed. They aren’t going to use their health care coverage unless forced to by a disaster – or worse for the system, they have been saving their elective surgeries up and are ready for a major tune-up. The long list of mandated benefits has triggered a meltdown in the exchange markets and huge increases in premiums and deductibles for all insurance buyers. Who is going to pay for it? To quote the late Russell B. Long, former U.S. Senator:

Don’t tax you,

Don’t tax me,

Tax that fellow behind the tree.


Raising taxes and pouring even more money into the system might be a solution, but this is not likely to happen.

In the United States, the rationing of health care has been shifted from the poor to the middle class, and the middle class doesn’t like it. The situation will only change when the howling from the middle class is louder than the wailing from the formerly uninsurable and poor. As insurance premiums and deductibles continue to rocket up, I expect the howling will get louder.

So, either we agree to let insurance premiums continue to increase, our state budgets to explode, our taxes to go up, or we pare down the list of mandated benefits.

I am going on the record stating that we simply cannot afford “medical everything” for everybody. I think we should tighten up the benefit list considerably. What do you think?
 
 

 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

 

Health care rationing is an uncomfortable topic, but one that responsible Americans should discuss. In particular, physicians should consider this topic, because our typical response to health care is that “everything should be covered.”

Health care has always been rationed. Historically, in the United States, health care has been apportioned capitalistically; that is, those who could afford health care got it and the rest – particularly the poor – scrambled. In Europe and Canada, universal or government health care is rationed by long wait times, limited range of services, and formulary restrictions. It is important to note that in almost all countries with universal health care, there is still the option of quick access and more comprehensive service via a neighboring country (to the United States from Canada, for example) or a separate additional private insurance option (England, Germany, and most of Europe).

Dr. Brett M. Coldiron


In the United States, the Affordable Care Act (ACA) changed the dynamic regarding insurance by adding mandates to cover preexisting conditions, mental health and substance abuse disorders, behavioral health treatment, prescription drugs, rehabilitative services, preventive care, and pediatric services including oral and vision care for children. In addition, adult children now can remain on their parents’ insurance plans until age 26. Also, when the Cadillac tax on expensive health insurance coverage was delayed until 2020, the excise payments were classified as tax deductible to the employer. Whew, did I leave anything out?

Advocates for the poor and those previously considered uninsurable were delighted by the ACA. The middle class was mollified with false reassurances that their premiums would go down, and that they could keep their current insurance plans and doctors.

Currently under the ACA, “poor” is generally defined as a reported income of 150% or less of the federal poverty level ($22,000-$45,000). The poor are eligible for health care that is very nearly free, according to Medicaid.gov. They are also protected from claims against their property. They effectively have first-dollar coverage, though they usually can’t see a specialist unless they go through the emergency department.

At age 65, Medicare takes over. Medicare is an insurance benefit workers contribute to for all their working lives. It doesn’t cover everything, but the relatively low $183 Part B deductible for office-based care sure takes the edge off. The average retirees collect three times what they put in, but they arguably could have made more if they had invested anywhere other than in the federal government.

So, the real crunch hits the middle class under age 65. Under the ACA, those earning up to $97,000 for a family of four get insurance subsidies to buy insurance on the exchanges. The real problem arises when a high deductible – the maximum for 2017 is between $13,000 and $14,000 – is combined with that level of income. There are over 20 million health care savings accounts in the United States, which ameliorate the cost for some, but health care savings accounts do not cover the entire deductible, and many cannot afford to self-fund them if their employer does not fund it for them.People simply do not have that kind of money put away in a disaster fund, and a major medical expense can easily wipe them out. If possible, they will ignore a medical problem; and if they can’t, they could risk financial toxicity by running up high-interest credit cards – with the predictable spiral of debt, collection agencies, credit ratings ruined, wages garnished, and even their homes repossessed. They aren’t going to use their health care coverage unless forced to by a disaster – or worse for the system, they have been saving their elective surgeries up and are ready for a major tune-up. The long list of mandated benefits has triggered a meltdown in the exchange markets and huge increases in premiums and deductibles for all insurance buyers. Who is going to pay for it? To quote the late Russell B. Long, former U.S. Senator:

Don’t tax you,

Don’t tax me,

Tax that fellow behind the tree.


Raising taxes and pouring even more money into the system might be a solution, but this is not likely to happen.

In the United States, the rationing of health care has been shifted from the poor to the middle class, and the middle class doesn’t like it. The situation will only change when the howling from the middle class is louder than the wailing from the formerly uninsurable and poor. As insurance premiums and deductibles continue to rocket up, I expect the howling will get louder.

So, either we agree to let insurance premiums continue to increase, our state budgets to explode, our taxes to go up, or we pare down the list of mandated benefits.

I am going on the record stating that we simply cannot afford “medical everything” for everybody. I think we should tighten up the benefit list considerably. What do you think?
 
 

 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

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