Associate Fellows who are interested in pursuing the next level of membership and who meet the criteria for Fellowship are encouraged to start the application process now.

Applications for American College of Surgeons (ACS) Fellowship for induction at the 2018 Clinical Congress in Boston, MA, are due December 1, 2017.

ACS Fellowship is granted to physicians who devote their practice entirely to surgical services and who agree to practice in accordance with the College’s professional and ethical standards.

The College’s Fellowship Pledge and Statements on Principles, found on the ACS website at facs.org, outline the ACS standards of practice. All ACS Fellows and applicants for Fellowship are expected to adhere to these standards.

Surgeons voluntarily submit applications for Fellowship, thereby inviting an evaluation of their practice by their peers. In evaluating the eligibility of Fellowship applicants, the College investigates each applicant’s entire surgical practice. Applicants for Fellowship are required to provide to the appointed committees of the College all information deemed necessary for the investigation and evaluation of their surgical practice.

It is our intention that all Associate Fellows consider applying for Fellowship within the first six years of their surgical practice. To encourage that transition, Associate Fellowship is limited to surgeons who have been in practice less than six years.

Requirements

The basic requirements for Domestic (U.S. and Canada) Fellowship are as follows:

• Certification by an appropriate American Board of Medical Specialties surgical specialty board, an American Osteopathic Association surgical specialty board, or the Royal College of Surgeons in Canada

• One year of surgical practice after the completion of all formal training (including fellowships)

• A current appointment at a primary hospital with no reportable action pending

A full list of the domestic requirements can be accessed at facs.org/member-services/join/fellows. The list of requirements for International Fellowship is online at facs.org/member-services/join/international.

Associate Fellows who are current with their membership dues may apply online for free by visiting facs.org/member-services/join and clicking on the link for either Fellow or International Fellow. You will need your log-in information to access the application. If you do not have your log-in information, contact the College’s Member Services staff at 800-293-9623 or via e-mail at [email protected].

The application requests basic information regarding licensure, certification, education, and hospital affiliations. Applicants also are asked to provide the names of five Fellows of the College, preferably from their current practice location, to serve as references. Applicants do not need to request letters of recommendation; simply list the names in your application, and the College staff will contact your references.

If you need assistance finding ACS Fellows in your area, go to facs.org and click on the “Find a Surgeon” button.

When your application is processed, you will receive an e-mail notification providing details about the application timeline along with a request for your surgical case list.

All Fellowship applicants are required to participate in a personal interview by an ACS committee in their local area. Exceptions are made for military applicants. Following the interview, you will receive notification by July 15 of the action taken on your application. Approved applicants are designated as Initiates to be inducted as Fellows during the Convocation Ceremony at the Clinical Congress.

Contact Member Services with questions at any time throughout the application process. We look forward to you becoming a Fellow of the American College of Surgeons.

Associate Fellows who are interested in pursuing the next level of membership and who meet the criteria for Fellowship are encouraged to start the application process now.

Applications for American College of Surgeons (ACS) Fellowship for induction at the 2018 Clinical Congress in Boston, MA, are due December 1, 2017.

ACS Fellowship is granted to physicians who devote their practice entirely to surgical services and who agree to practice in accordance with the College’s professional and ethical standards.

The College’s Fellowship Pledge and Statements on Principles, found on the ACS website at facs.org, outline the ACS standards of practice. All ACS Fellows and applicants for Fellowship are expected to adhere to these standards.

Surgeons voluntarily submit applications for Fellowship, thereby inviting an evaluation of their practice by their peers. In evaluating the eligibility of Fellowship applicants, the College investigates each applicant’s entire surgical practice. Applicants for Fellowship are required to provide to the appointed committees of the College all information deemed necessary for the investigation and evaluation of their surgical practice.

It is our intention that all Associate Fellows consider applying for Fellowship within the first six years of their surgical practice. To encourage that transition, Associate Fellowship is limited to surgeons who have been in practice less than six years.

Requirements

The basic requirements for Domestic (U.S. and Canada) Fellowship are as follows:

• Certification by an appropriate American Board of Medical Specialties surgical specialty board, an American Osteopathic Association surgical specialty board, or the Royal College of Surgeons in Canada

• One year of surgical practice after the completion of all formal training (including fellowships)

• A current appointment at a primary hospital with no reportable action pending

A full list of the domestic requirements can be accessed at facs.org/member-services/join/fellows. The list of requirements for International Fellowship is online at facs.org/member-services/join/international.

Associate Fellows who are current with their membership dues may apply online for free by visiting facs.org/member-services/join and clicking on the link for either Fellow or International Fellow. You will need your log-in information to access the application. If you do not have your log-in information, contact the College’s Member Services staff at 800-293-9623 or via e-mail at [email protected].

The application requests basic information regarding licensure, certification, education, and hospital affiliations. Applicants also are asked to provide the names of five Fellows of the College, preferably from their current practice location, to serve as references. Applicants do not need to request letters of recommendation; simply list the names in your application, and the College staff will contact your references.

If you need assistance finding ACS Fellows in your area, go to facs.org and click on the “Find a Surgeon” button.

When your application is processed, you will receive an e-mail notification providing details about the application timeline along with a request for your surgical case list.

All Fellowship applicants are required to participate in a personal interview by an ACS committee in their local area. Exceptions are made for military applicants. Following the interview, you will receive notification by July 15 of the action taken on your application. Approved applicants are designated as Initiates to be inducted as Fellows during the Convocation Ceremony at the Clinical Congress.

Contact Member Services with questions at any time throughout the application process. We look forward to you becoming a Fellow of the American College of Surgeons.

Associate Fellows who are interested in pursuing the next level of membership and who meet the criteria for Fellowship are encouraged to start the application process now.

Applications for American College of Surgeons (ACS) Fellowship for induction at the 2018 Clinical Congress in Boston, MA, are due December 1, 2017.

ACS Fellowship is granted to physicians who devote their practice entirely to surgical services and who agree to practice in accordance with the College’s professional and ethical standards.

The College’s Fellowship Pledge and Statements on Principles, found on the ACS website at facs.org, outline the ACS standards of practice. All ACS Fellows and applicants for Fellowship are expected to adhere to these standards.

Surgeons voluntarily submit applications for Fellowship, thereby inviting an evaluation of their practice by their peers. In evaluating the eligibility of Fellowship applicants, the College investigates each applicant’s entire surgical practice. Applicants for Fellowship are required to provide to the appointed committees of the College all information deemed necessary for the investigation and evaluation of their surgical practice.

It is our intention that all Associate Fellows consider applying for Fellowship within the first six years of their surgical practice. To encourage that transition, Associate Fellowship is limited to surgeons who have been in practice less than six years.

Requirements

The basic requirements for Domestic (U.S. and Canada) Fellowship are as follows:

• Certification by an appropriate American Board of Medical Specialties surgical specialty board, an American Osteopathic Association surgical specialty board, or the Royal College of Surgeons in Canada

• One year of surgical practice after the completion of all formal training (including fellowships)

• A current appointment at a primary hospital with no reportable action pending

A full list of the domestic requirements can be accessed at facs.org/member-services/join/fellows. The list of requirements for International Fellowship is online at facs.org/member-services/join/international.

Associate Fellows who are current with their membership dues may apply online for free by visiting facs.org/member-services/join and clicking on the link for either Fellow or International Fellow. You will need your log-in information to access the application. If you do not have your log-in information, contact the College’s Member Services staff at 800-293-9623 or via e-mail at [email protected].

The application requests basic information regarding licensure, certification, education, and hospital affiliations. Applicants also are asked to provide the names of five Fellows of the College, preferably from their current practice location, to serve as references. Applicants do not need to request letters of recommendation; simply list the names in your application, and the College staff will contact your references.

If you need assistance finding ACS Fellows in your area, go to facs.org and click on the “Find a Surgeon” button.

When your application is processed, you will receive an e-mail notification providing details about the application timeline along with a request for your surgical case list.

All Fellowship applicants are required to participate in a personal interview by an ACS committee in their local area. Exceptions are made for military applicants. Following the interview, you will receive notification by July 15 of the action taken on your application. Approved applicants are designated as Initiates to be inducted as Fellows during the Convocation Ceremony at the Clinical Congress.

Contact Member Services with questions at any time throughout the application process. We look forward to you becoming a Fellow of the American College of Surgeons.

“Often, innovation is a product of desperation. I have seen too many of my patients die from opioid overdoses, and I’ve decided to create something that can stop this.”

This is the opening description of an innovative idea that Joseph Insler, MD, an early–career psychiatrist in Boston, pitched to the judges last October.

As one of the judges, this is how I described the item: “It’s like a Fitbit for people addicted to opioids, who are at risk of overdose. But, instead of tracking your footsteps and your sleep movements, it tracks your blood oxygen level, heart rate, and lack of movement. Based on an algorithm tuned to identify signs of an overdose, the Opioid Overdose Recovery Bracelet would give you a shot of medicine in your wrist. If you have accidentally overdosed, it will give you a premeasured dose of naloxone from its reservoir, likely saving your life.”

Courtesy Dr. Steven R. Daviss

New lab will set records

On May 21, at the APA annual meeting in San Diego, the third Innovation Lab event will take place with record sponsorship and funding. More than $30,000 in prizes will be awarded to winning teams in the following categories: Grand Prize, Audience Choice, Outstanding Progress, Most Promising Innovation, and Most Disruptive Innovation. New this year, the Accelerator Prize will be awarded to the alumni team that has made the most progress since its participation in a previous Innovation Lab. A special prize from Google, worth $20,000, will be given to the innovation that best uses the potential of Cloud services, including Web applications, software, and machine learning.

Courtesy Dr. Steven R. Daviss

Dr. Daviss is the chief medical informatics officer at M3 Information and chairs the American Psychiatric Association’s Committee on Mental Health Information Technology.

Psychiatry Innovation Lab alumni

Entrepreneurs from the October 2016 competition created products that addressed addiction, autism, Alzheimer’s, posttraumatic stress disorder, and other mental disorders.

Finalists

• Overdose Recovery Bracelet – “A novel solution to the opioid epidemic” – Joseph Insler
• Spectrum – “An app to encourage facial processing and emotion recognition in autism spectrum disorder” – Swathi Krishna
• Spring – “Enabling personalized behavioral healthcare using machine learning and big data” – April Koh
• Alzhelp – “Using augmented reality and intelligent personal assistant software to keep Alzheimer’s patients safe” – Akanksha Jain, Michelle Koh, and Priscilla Siow
• MiHelper – “Identifying patterns of distress and determining optimal periods for real time mental health interventions” – Kammarauche Isuzu and Mackenzie Drazan
• WEmbrace – “A mobile application for foreign-background psychiatric patients to effectively provide critical care” – Ellen Oh

Semifinalists

• Broadleaf Mental Health –“Reaching school-aged children in the rural eastern Himalayas” – Michael Matergia
• TechLink – “Connecting students and tech” – Akanksha Jain, Michelle Koh, and Priscilla Siow
• Beacon – “Smarter therapy. Together” – Shrenik Jain and Ravi Shah
• Muse – “Assisted meditation in mental health” – Graeme Moffat
• MiResource – “Helping adolescents find the right therapeutic fit” – Gabriela Asturias and Mackenzie Drazen
• BraVe Reality – “Virtual treatment for PTSD patients” – Monica Kullar
• SKNR – “A user-centric psychotherapy tool for the digital age” – Hyun-Hee Kim
• We2Link – “Connect better” – Michael Malone PRISM – “Helping patients gain insight through digital art mobile app” – Kenechi Ejebe and Whitney McFadden

SOURCE: Dr. Daviss

“Often, innovation is a product of desperation. I have seen too many of my patients die from opioid overdoses, and I’ve decided to create something that can stop this.”

This is the opening description of an innovative idea that Joseph Insler, MD, an early–career psychiatrist in Boston, pitched to the judges last October.

As one of the judges, this is how I described the item: “It’s like a Fitbit for people addicted to opioids, who are at risk of overdose. But, instead of tracking your footsteps and your sleep movements, it tracks your blood oxygen level, heart rate, and lack of movement. Based on an algorithm tuned to identify signs of an overdose, the Opioid Overdose Recovery Bracelet would give you a shot of medicine in your wrist. If you have accidentally overdosed, it will give you a premeasured dose of naloxone from its reservoir, likely saving your life.”

Courtesy Dr. Steven R. Daviss

New lab will set records

On May 21, at the APA annual meeting in San Diego, the third Innovation Lab event will take place with record sponsorship and funding. More than $30,000 in prizes will be awarded to winning teams in the following categories: Grand Prize, Audience Choice, Outstanding Progress, Most Promising Innovation, and Most Disruptive Innovation. New this year, the Accelerator Prize will be awarded to the alumni team that has made the most progress since its participation in a previous Innovation Lab. A special prize from Google, worth $20,000, will be given to the innovation that best uses the potential of Cloud services, including Web applications, software, and machine learning.

Courtesy Dr. Steven R. Daviss

Dr. Daviss is the chief medical informatics officer at M3 Information and chairs the American Psychiatric Association’s Committee on Mental Health Information Technology.

Psychiatry Innovation Lab alumni

Entrepreneurs from the October 2016 competition created products that addressed addiction, autism, Alzheimer’s, posttraumatic stress disorder, and other mental disorders.

Finalists

• Overdose Recovery Bracelet – “A novel solution to the opioid epidemic” – Joseph Insler
• Spectrum – “An app to encourage facial processing and emotion recognition in autism spectrum disorder” – Swathi Krishna
• Spring – “Enabling personalized behavioral healthcare using machine learning and big data” – April Koh
• Alzhelp – “Using augmented reality and intelligent personal assistant software to keep Alzheimer’s patients safe” – Akanksha Jain, Michelle Koh, and Priscilla Siow
• MiHelper – “Identifying patterns of distress and determining optimal periods for real time mental health interventions” – Kammarauche Isuzu and Mackenzie Drazan
• WEmbrace – “A mobile application for foreign-background psychiatric patients to effectively provide critical care” – Ellen Oh

Semifinalists

• Broadleaf Mental Health –“Reaching school-aged children in the rural eastern Himalayas” – Michael Matergia
• TechLink – “Connecting students and tech” – Akanksha Jain, Michelle Koh, and Priscilla Siow
• Beacon – “Smarter therapy. Together” – Shrenik Jain and Ravi Shah
• Muse – “Assisted meditation in mental health” – Graeme Moffat
• MiResource – “Helping adolescents find the right therapeutic fit” – Gabriela Asturias and Mackenzie Drazen
• BraVe Reality – “Virtual treatment for PTSD patients” – Monica Kullar
• SKNR – “A user-centric psychotherapy tool for the digital age” – Hyun-Hee Kim
• We2Link – “Connect better” – Michael Malone PRISM – “Helping patients gain insight through digital art mobile app” – Kenechi Ejebe and Whitney McFadden

SOURCE: Dr. Daviss

“Often, innovation is a product of desperation. I have seen too many of my patients die from opioid overdoses, and I’ve decided to create something that can stop this.”

This is the opening description of an innovative idea that Joseph Insler, MD, an early–career psychiatrist in Boston, pitched to the judges last October.

As one of the judges, this is how I described the item: “It’s like a Fitbit for people addicted to opioids, who are at risk of overdose. But, instead of tracking your footsteps and your sleep movements, it tracks your blood oxygen level, heart rate, and lack of movement. Based on an algorithm tuned to identify signs of an overdose, the Opioid Overdose Recovery Bracelet would give you a shot of medicine in your wrist. If you have accidentally overdosed, it will give you a premeasured dose of naloxone from its reservoir, likely saving your life.”

Courtesy Dr. Steven R. Daviss

New lab will set records

On May 21, at the APA annual meeting in San Diego, the third Innovation Lab event will take place with record sponsorship and funding. More than $30,000 in prizes will be awarded to winning teams in the following categories: Grand Prize, Audience Choice, Outstanding Progress, Most Promising Innovation, and Most Disruptive Innovation. New this year, the Accelerator Prize will be awarded to the alumni team that has made the most progress since its participation in a previous Innovation Lab. A special prize from Google, worth $20,000, will be given to the innovation that best uses the potential of Cloud services, including Web applications, software, and machine learning.

Courtesy Dr. Steven R. Daviss

Dr. Daviss is the chief medical informatics officer at M3 Information and chairs the American Psychiatric Association’s Committee on Mental Health Information Technology.

Psychiatry Innovation Lab alumni

Entrepreneurs from the October 2016 competition created products that addressed addiction, autism, Alzheimer’s, posttraumatic stress disorder, and other mental disorders.

Finalists

• Overdose Recovery Bracelet – “A novel solution to the opioid epidemic” – Joseph Insler
• Spectrum – “An app to encourage facial processing and emotion recognition in autism spectrum disorder” – Swathi Krishna
• Spring – “Enabling personalized behavioral healthcare using machine learning and big data” – April Koh
• Alzhelp – “Using augmented reality and intelligent personal assistant software to keep Alzheimer’s patients safe” – Akanksha Jain, Michelle Koh, and Priscilla Siow
• MiHelper – “Identifying patterns of distress and determining optimal periods for real time mental health interventions” – Kammarauche Isuzu and Mackenzie Drazan
• WEmbrace – “A mobile application for foreign-background psychiatric patients to effectively provide critical care” – Ellen Oh

Semifinalists

• Broadleaf Mental Health –“Reaching school-aged children in the rural eastern Himalayas” – Michael Matergia
• TechLink – “Connecting students and tech” – Akanksha Jain, Michelle Koh, and Priscilla Siow
• Beacon – “Smarter therapy. Together” – Shrenik Jain and Ravi Shah
• Muse – “Assisted meditation in mental health” – Graeme Moffat
• MiResource – “Helping adolescents find the right therapeutic fit” – Gabriela Asturias and Mackenzie Drazen
• BraVe Reality – “Virtual treatment for PTSD patients” – Monica Kullar
• SKNR – “A user-centric psychotherapy tool for the digital age” – Hyun-Hee Kim
• We2Link – “Connect better” – Michael Malone PRISM – “Helping patients gain insight through digital art mobile app” – Kenechi Ejebe and Whitney McFadden

SOURCE: Dr. Daviss

The number of outpatient visits involving CNS polypharmacy by adults aged 65 and older more than doubled between 2004 and 2013, especially among those who reside in rural areas, according to research published online ahead of print February 13 in JAMA Internal Medicine.

“With each new revision of the Beers Criteria, the list of psychotropic medications considered potentially inappropriate in the elderly has grown,” said Donovan T. Maust, MD, Assistant Professor of Geriatric Psychiatry at the University of Michigan in Ann Arbor. “Opioids have recently been included in a Beers measure of CNS polypharmacy. Prescribing related drug combinations also received increased regulatory attention when the US Food and Drug Administration recently ordered a black box warning to alert patients of serious risks, including death, caused by opioids coprescribed with CNS depressants,” he said.

Dr. Maust and his colleagues analyzed data on 97,910 outpatients age 65 and older from the National Ambulatory Medical Care Survey (NAMCS) from 2004 through 2013. Patients met Beers CNS polypharmacy criteria if three or more of the following medications were initiated or continued: antipsychotics, benzodiazepines, nonbenzodiazepine benzodiazepine receptor agonists, tricyclic antidepressants, selective serotonin reuptake inhibitors, and opioids. The researchers recorded as many as three visit diagnoses and included information collected from NAMCS such as chronic medical conditions, whether psychotherapy was provided or ordered, whether stress management or other mental health counseling services were provided or ordered, and time spent with physician.

Dr. Maust and his associates found that annual CNS polypharmacy visits by adults age 65 or older increased from 1.50 million in 2004 to 3.68 million in 2013, or from 0.6% of visits in 2004 to 1.4% in 2013 (adjusted odds ratio [AOR], 3.12). The largest increases were observed among rural visits and among visits with no mental health or pain diagnoses (AOR, 4.99 and 2.65, respectively).

More than two-thirds of polypharmacy visits (68%) were by women, and 17% were by individuals who lived in rural areas. In addition, nearly half of polypharmacy visits studied (46%) included neither mental health nor pain diagnoses. No significant demographic differences were observed between polypharmacy visits with and without opioids. “Older adults have become more open to mental health treatment,” the researchers concluded. “Because of limited access to specialty care and a preference to receive treatment in primary care settings, it is unsurprising that mental health treatment has expanded in nonpsychiatric settings.”

—Doug Brunk

Suggested Reading

Maust DT, Gerlach LB, Gibson A, et al. Trends in central nervous system-active polypharmacy among older adults seen in outpatient care in the United States. JAMA Intern Med. 2017 Feb 13 [Epub ahead of print].

The number of outpatient visits involving CNS polypharmacy by adults aged 65 and older more than doubled between 2004 and 2013, especially among those who reside in rural areas, according to research published online ahead of print February 13 in JAMA Internal Medicine.

“With each new revision of the Beers Criteria, the list of psychotropic medications considered potentially inappropriate in the elderly has grown,” said Donovan T. Maust, MD, Assistant Professor of Geriatric Psychiatry at the University of Michigan in Ann Arbor. “Opioids have recently been included in a Beers measure of CNS polypharmacy. Prescribing related drug combinations also received increased regulatory attention when the US Food and Drug Administration recently ordered a black box warning to alert patients of serious risks, including death, caused by opioids coprescribed with CNS depressants,” he said.

Dr. Maust and his colleagues analyzed data on 97,910 outpatients age 65 and older from the National Ambulatory Medical Care Survey (NAMCS) from 2004 through 2013. Patients met Beers CNS polypharmacy criteria if three or more of the following medications were initiated or continued: antipsychotics, benzodiazepines, nonbenzodiazepine benzodiazepine receptor agonists, tricyclic antidepressants, selective serotonin reuptake inhibitors, and opioids. The researchers recorded as many as three visit diagnoses and included information collected from NAMCS such as chronic medical conditions, whether psychotherapy was provided or ordered, whether stress management or other mental health counseling services were provided or ordered, and time spent with physician.

Dr. Maust and his associates found that annual CNS polypharmacy visits by adults age 65 or older increased from 1.50 million in 2004 to 3.68 million in 2013, or from 0.6% of visits in 2004 to 1.4% in 2013 (adjusted odds ratio [AOR], 3.12). The largest increases were observed among rural visits and among visits with no mental health or pain diagnoses (AOR, 4.99 and 2.65, respectively).

More than two-thirds of polypharmacy visits (68%) were by women, and 17% were by individuals who lived in rural areas. In addition, nearly half of polypharmacy visits studied (46%) included neither mental health nor pain diagnoses. No significant demographic differences were observed between polypharmacy visits with and without opioids. “Older adults have become more open to mental health treatment,” the researchers concluded. “Because of limited access to specialty care and a preference to receive treatment in primary care settings, it is unsurprising that mental health treatment has expanded in nonpsychiatric settings.”

—Doug Brunk

Suggested Reading

Maust DT, Gerlach LB, Gibson A, et al. Trends in central nervous system-active polypharmacy among older adults seen in outpatient care in the United States. JAMA Intern Med. 2017 Feb 13 [Epub ahead of print].

The number of outpatient visits involving CNS polypharmacy by adults aged 65 and older more than doubled between 2004 and 2013, especially among those who reside in rural areas, according to research published online ahead of print February 13 in JAMA Internal Medicine.

“With each new revision of the Beers Criteria, the list of psychotropic medications considered potentially inappropriate in the elderly has grown,” said Donovan T. Maust, MD, Assistant Professor of Geriatric Psychiatry at the University of Michigan in Ann Arbor. “Opioids have recently been included in a Beers measure of CNS polypharmacy. Prescribing related drug combinations also received increased regulatory attention when the US Food and Drug Administration recently ordered a black box warning to alert patients of serious risks, including death, caused by opioids coprescribed with CNS depressants,” he said.

Dr. Maust and his colleagues analyzed data on 97,910 outpatients age 65 and older from the National Ambulatory Medical Care Survey (NAMCS) from 2004 through 2013. Patients met Beers CNS polypharmacy criteria if three or more of the following medications were initiated or continued: antipsychotics, benzodiazepines, nonbenzodiazepine benzodiazepine receptor agonists, tricyclic antidepressants, selective serotonin reuptake inhibitors, and opioids. The researchers recorded as many as three visit diagnoses and included information collected from NAMCS such as chronic medical conditions, whether psychotherapy was provided or ordered, whether stress management or other mental health counseling services were provided or ordered, and time spent with physician.

Dr. Maust and his associates found that annual CNS polypharmacy visits by adults age 65 or older increased from 1.50 million in 2004 to 3.68 million in 2013, or from 0.6% of visits in 2004 to 1.4% in 2013 (adjusted odds ratio [AOR], 3.12). The largest increases were observed among rural visits and among visits with no mental health or pain diagnoses (AOR, 4.99 and 2.65, respectively).

More than two-thirds of polypharmacy visits (68%) were by women, and 17% were by individuals who lived in rural areas. In addition, nearly half of polypharmacy visits studied (46%) included neither mental health nor pain diagnoses. No significant demographic differences were observed between polypharmacy visits with and without opioids. “Older adults have become more open to mental health treatment,” the researchers concluded. “Because of limited access to specialty care and a preference to receive treatment in primary care settings, it is unsurprising that mental health treatment has expanded in nonpsychiatric settings.”

—Doug Brunk

Suggested Reading

Maust DT, Gerlach LB, Gibson A, et al. Trends in central nervous system-active polypharmacy among older adults seen in outpatient care in the United States. JAMA Intern Med. 2017 Feb 13 [Epub ahead of print].

Rates of heroin use and heroin use disorder rose dramatically between 2001-2002 and 2012-2013, and the trend was greatest among the white population. The rise among white individuals could be tied to the opioid epidemic, because nonmedical opioid also rose disproportionately in that group, according to research published online March 29.

The findings come from an analysis of 43,093 people who responded to the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), and 36,309 respondents to the 2012-2013 NESARC-III.

PaulPaladin/thinkstock

NESARC and NESARC-III were funded by the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse. The authors received funding from several sources, including the National Institute on Drug Abuse, the New York State Psychiatric Institute, and the J. William Fulbright and the Colciencias doctoral scholarships. One of the study authors, Deborah S. Hasin, PhD, was a principal investigator on a study that was funded by InVentiv Health Consulting, which pool funds from nine pharmaceutical companies.

Rates of heroin use and heroin use disorder rose dramatically between 2001-2002 and 2012-2013, and the trend was greatest among the white population. The rise among white individuals could be tied to the opioid epidemic, because nonmedical opioid also rose disproportionately in that group, according to research published online March 29.

The findings come from an analysis of 43,093 people who responded to the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), and 36,309 respondents to the 2012-2013 NESARC-III.

PaulPaladin/thinkstock

NESARC and NESARC-III were funded by the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse. The authors received funding from several sources, including the National Institute on Drug Abuse, the New York State Psychiatric Institute, and the J. William Fulbright and the Colciencias doctoral scholarships. One of the study authors, Deborah S. Hasin, PhD, was a principal investigator on a study that was funded by InVentiv Health Consulting, which pool funds from nine pharmaceutical companies.

Rates of heroin use and heroin use disorder rose dramatically between 2001-2002 and 2012-2013, and the trend was greatest among the white population. The rise among white individuals could be tied to the opioid epidemic, because nonmedical opioid also rose disproportionately in that group, according to research published online March 29.

The findings come from an analysis of 43,093 people who responded to the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), and 36,309 respondents to the 2012-2013 NESARC-III.

PaulPaladin/thinkstock

NESARC and NESARC-III were funded by the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse. The authors received funding from several sources, including the National Institute on Drug Abuse, the New York State Psychiatric Institute, and the J. William Fulbright and the Colciencias doctoral scholarships. One of the study authors, Deborah S. Hasin, PhD, was a principal investigator on a study that was funded by InVentiv Health Consulting, which pool funds from nine pharmaceutical companies.

ORLANDO—Patients with multiple sclerosis (MS) and their physicians still consider self-injected immunomodulating medications as first-line agents, according to the results of a study presented at the ACTRIMS 2017 Forum. The results, based on data from a community health–based suburban neurology practice, also indicated that a smaller percentage than expected of patients on injectable medications switched to an oral medication, and a majority of untreated patients at the initial visit chose to start a self-injectable medication if they started anything.

There are currently 14 FDA-approved immunomodulating medications available for MS and one currently awaiting approval. “This has resulted in patients, in consultation with physicians, having the opportunity to switch from medications that are self injected to medications taken orally or by IV infusion,” said Susan M. Rubin, MD, and colleagues from the Department of Neurology at NorthShore University HealthSystem in Evanston, Illinois. “We speculated that this would result in a high level of treatment changes away from self-injected treatments to the newer options,” Dr. Rubin and colleagues said.

They optimized their electronic medical record by building structured clinical documentation support (SCDS) tools specific to MS practice that standardize initial and annual follow-up visits, write progress notes, and capture data. The toolkit they built documents immunomodulating medications taken, tracks efficacy and adverse events, and notes reasons for discontinuation.

Patients with MS who were referred to the Department of Neurology at NorthShore University HealthSystem were evaluated at initial and annual follow-up visits using SCDS tools by one of three subspecialty neurologists. The researchers created descriptive reports of their cohort, including gender, age at disease onset, disease duration, use of immunomodulating medications, and Expanded Disability Status Scale scores. Patient-reported treatments at their initial visit were compared with treatments at their first annual follow-up visit.

Of the 105 patients in the study, 78% were female. Disease duration was zero to 43 years, with a mean duration of six years. Nearly three-quarters (74%) were not on an immunomodulating medication at first visit. Of those on medication at first visit, 77% were taking an injectable medication. At the annual follow-up visit, 51% started or changed medication, and 49% remained on the same medication. Of the patients who started treatment, 65% started a self-injection medication, 26% started an oral medication, and 9% started an infusion agent.

“Despite the availability of new treatments,” the researchers said, “patients and their physicians were generally content with the current treatment.” They hypothesized that safety concerns reduced the likelihood of change. “It appears that both patients and physicians prioritized safety over possibly greater efficacy when switching medication.”

—Glenn S. Williams

ORLANDO—Patients with multiple sclerosis (MS) and their physicians still consider self-injected immunomodulating medications as first-line agents, according to the results of a study presented at the ACTRIMS 2017 Forum. The results, based on data from a community health–based suburban neurology practice, also indicated that a smaller percentage than expected of patients on injectable medications switched to an oral medication, and a majority of untreated patients at the initial visit chose to start a self-injectable medication if they started anything.

There are currently 14 FDA-approved immunomodulating medications available for MS and one currently awaiting approval. “This has resulted in patients, in consultation with physicians, having the opportunity to switch from medications that are self injected to medications taken orally or by IV infusion,” said Susan M. Rubin, MD, and colleagues from the Department of Neurology at NorthShore University HealthSystem in Evanston, Illinois. “We speculated that this would result in a high level of treatment changes away from self-injected treatments to the newer options,” Dr. Rubin and colleagues said.

They optimized their electronic medical record by building structured clinical documentation support (SCDS) tools specific to MS practice that standardize initial and annual follow-up visits, write progress notes, and capture data. The toolkit they built documents immunomodulating medications taken, tracks efficacy and adverse events, and notes reasons for discontinuation.

Patients with MS who were referred to the Department of Neurology at NorthShore University HealthSystem were evaluated at initial and annual follow-up visits using SCDS tools by one of three subspecialty neurologists. The researchers created descriptive reports of their cohort, including gender, age at disease onset, disease duration, use of immunomodulating medications, and Expanded Disability Status Scale scores. Patient-reported treatments at their initial visit were compared with treatments at their first annual follow-up visit.

Of the 105 patients in the study, 78% were female. Disease duration was zero to 43 years, with a mean duration of six years. Nearly three-quarters (74%) were not on an immunomodulating medication at first visit. Of those on medication at first visit, 77% were taking an injectable medication. At the annual follow-up visit, 51% started or changed medication, and 49% remained on the same medication. Of the patients who started treatment, 65% started a self-injection medication, 26% started an oral medication, and 9% started an infusion agent.

“Despite the availability of new treatments,” the researchers said, “patients and their physicians were generally content with the current treatment.” They hypothesized that safety concerns reduced the likelihood of change. “It appears that both patients and physicians prioritized safety over possibly greater efficacy when switching medication.”

—Glenn S. Williams

ORLANDO—Patients with multiple sclerosis (MS) and their physicians still consider self-injected immunomodulating medications as first-line agents, according to the results of a study presented at the ACTRIMS 2017 Forum. The results, based on data from a community health–based suburban neurology practice, also indicated that a smaller percentage than expected of patients on injectable medications switched to an oral medication, and a majority of untreated patients at the initial visit chose to start a self-injectable medication if they started anything.

There are currently 14 FDA-approved immunomodulating medications available for MS and one currently awaiting approval. “This has resulted in patients, in consultation with physicians, having the opportunity to switch from medications that are self injected to medications taken orally or by IV infusion,” said Susan M. Rubin, MD, and colleagues from the Department of Neurology at NorthShore University HealthSystem in Evanston, Illinois. “We speculated that this would result in a high level of treatment changes away from self-injected treatments to the newer options,” Dr. Rubin and colleagues said.

They optimized their electronic medical record by building structured clinical documentation support (SCDS) tools specific to MS practice that standardize initial and annual follow-up visits, write progress notes, and capture data. The toolkit they built documents immunomodulating medications taken, tracks efficacy and adverse events, and notes reasons for discontinuation.

Patients with MS who were referred to the Department of Neurology at NorthShore University HealthSystem were evaluated at initial and annual follow-up visits using SCDS tools by one of three subspecialty neurologists. The researchers created descriptive reports of their cohort, including gender, age at disease onset, disease duration, use of immunomodulating medications, and Expanded Disability Status Scale scores. Patient-reported treatments at their initial visit were compared with treatments at their first annual follow-up visit.

Of the 105 patients in the study, 78% were female. Disease duration was zero to 43 years, with a mean duration of six years. Nearly three-quarters (74%) were not on an immunomodulating medication at first visit. Of those on medication at first visit, 77% were taking an injectable medication. At the annual follow-up visit, 51% started or changed medication, and 49% remained on the same medication. Of the patients who started treatment, 65% started a self-injection medication, 26% started an oral medication, and 9% started an infusion agent.

“Despite the availability of new treatments,” the researchers said, “patients and their physicians were generally content with the current treatment.” They hypothesized that safety concerns reduced the likelihood of change. “It appears that both patients and physicians prioritized safety over possibly greater efficacy when switching medication.”

—Glenn S. Williams

Vitamin D as a Risk Factor

Epidemiologic literature first suggested that vitamin D status might be related to the risk of MS. Researchers demonstrated that MS prevalence increases with distance from the equator. A series of retrospective and case–control studies subsequently suggested that patients with MS had lower levels of vitamin D than healthy individuals. These data, however, left open the possibility that having MS and its associated intolerance of heat led to reduced sun exposure, and thus lower levels of vitamin D.

In 2006, Munger and colleagues prospectively examined serum samples obtained from more than seven million US military personnel. They found that, among whites, the risk of MS significantly decreased with increasing levels of 25-hydroxyvitamin D. The effect was most significant in people with vitamin D levels higher than 40 ng/mL. The same association was observed in a later Swedish study that used 30 ng/mL as its threshold for vitamin D sufficiency. In 2016, Munger et al found that insufficient maternal vitamin D during pregnancy may increase the risk of MS in offspring.

Although research by Lucas and colleagues indicated an inverse association between serum vitamin D level and risk of MS, they found a stronger inverse association between ultraviolet (UV) light exposure and risk of MS. The strength of the latter association did not change, whether exposure was measured by skin damage or self-report. In 2017, however, Nielsen and colleagues compared serum vitamin D levels in newborns who subsequently developed MS with those of newborns who did not develop MS. They found a strong association between higher neonatal levels of vitamin D and lower risk of subsequent MS. “One could argue [that] this [result] makes the vitamin D hypothesis stronger than the UV [hypothesis], since the babies, in all likelihood, had not been exposed to much UV [light] at the time they were born,” said Dr. Mowry.

Vitamin D as a Prognostic Factor

Other research has suggested that serum vitamin D level may predict disease activity in MS. Dr. Mowry and colleagues evaluated blood samples taken from children who presented for longitudinal follow-up at pediatric MS centers. The total follow-up period was approximately 18 months. After adjusting for covariates, they found a strong association between higher levels of vitamin D and lower risk of subsequent relapse. “Each 10-ng/mL higher level of vitamin D … was associated with about a one-third reduction in the risk of subsequent relapse,” said Dr. Mowry. A prospective study conducted in Australia found similar results.

In 2012, Dr. Mowry and colleagues measured vitamin D levels in blood samples from 469 patients with relapsing-remitting MS or clinically isolated syndrome (CIS). They found that each additional 10-ng/mL increment of vitamin D level was associated with an approximately 15% lower risk of subsequent new T2 lesions and with an approximately 32% reduced risk of subsequent gadolinium-enhancing lesions. Higher levels of vitamin D also were associated with lower risk of subsequent relapse, but this finding was not statistically significant.

To discover whether vitamin D influences markers known to predict long-term disability, Dr. Mowry and colleagues examined data from a study of atorvastatin in 65 patients with CIS. They measured vitamin D levels at baseline and at month six, and the follow-up period was as long as 18 months. They found that each additional 10-ng/mL increment in vitamin D level was associated with an additional 7.8 mL of preserved gray matter volume. They also observed a trend toward an inverse association between vitamin D levels and the composite end point of three or more new T2 lesions or one or more relapses within a year.

Is Vitamin D Supplementation Appropriate?

“Just because [vitamin D] is available over the counter does not make it safe or effective,” and the supplement should be studied further in clinical trials, said Dr. Mowry. In 2010, Burton et al found that a dose of as much as 40,000 IU/day of vitamin D was safe in the short term and might have immunomodulatory effects in patients with MS. Furthermore, a small Finnish study suggested that a dose of 20,000 IU/week of vitamin D was safe in patients with MS, and also might slow the accumulation of disability.

Hupperts et al studied patients with relapsing-remitting MS who were receiving interferon beta-1a. They randomized 229 participants to vitamin D or placebo and followed them for 48 weeks. In preliminary analyses, the investigators found no difference between treatment groups with respect to the outcome of no evidence of disease activity. Patients who received vitamin D had a lower annualized relapse rate than controls, but the difference was not statistically significant. The active group did have significantly fewer gadolinium-enhancing lesions and new T2 hyperintense lesions, compared with controls, however.

In addition, Dr. Mowry and colleagues are comparing the effects of 5,000-IU and 600-IU doses of vitamin D in patients with MS who are receiving glatiramer acetate. The ongoing study is sponsored by the National MS Society. European studies of the clinical benefit of vitamin D also are under way.

Although the benefits of vitamin D are not completely understood, many neurologists recommend supplementation to their patients with MS. Pharmacokinetic studies have not shown a difference between daily, weekly, or monthly dosing regimens. “As long as you give the same dose of vitamin D, you will get the levels … to the same general area,” said Dr. Mowry. Nevertheless, some studies in other patient populations suggest that very high doses of vitamin D given monthly are probably toxic.

Many studies have suggested that vitamin D3 may be more potent than vitamin D2. “I tend to use [vitamin] D3 when I am supplementing,” said Dr. Mowry. “I aim for levels between 40 and 60 ng/mL, based on our observational data.... For my patients, that largely means they need somewhere between 2,000 and 4,000 IU/day, although sometimes more. I usually recheck the level in three months, based on what we know about the kinetics of vitamin D supplementation. I am cautious in individuals who may be at risk for hypercalcemia or hypercalciuria.”

—Erik Greb

Suggested Reading

Burton JM, Kimball S, Vieth R, et al. A phase I/II dose-escalation trial of vitamin D3 and calcium in multiple sclerosis. Neurology. 2010;74(23):1852-1859.

Mowry EM. Vitamin D: evidence for its role as a prognostic factor in multiple sclerosis. J Neurol Sci. 2011; 311(1-2):19-22.

Mowry EM, Pelletier D, Gao Z, et al. Vitamin D in clinically isolated syndrome: evidence for possible neuroprotection. Eur J Neurol. 2016;23(2):327-332.

Mowry EM, Waubant E, McCulloch CE, et al. Vitamin D status predicts new brain magnetic resonance imaging activity in multiple sclerosis. Ann Neurol. 2012;72(2):234-240.

Munger KL, Åivo J, Hongell K, et al. Vitamin D status during pregnancy and risk of multiple sclerosis in offspring of women in the Finnish Maternity Cohort. JAMA Neurol. 2016;73(5):515-519.

Munger KL, Levin LI, Hollis BW, et al. Serum 25-hydroxyvitamin D levels and risk of multiple sclerosis. JAMA. 2006;296(23):2832-2838.

Nielsen NM, Munger KL, Koch-Henriksen N, et al. Neonatal vitamin D status and risk of multiple sclerosis: a population-based case-control study. Neurology. 2017;88(1):44-51.

Tremlett H, van der Mei IA, Pittas F, et al. Monthly ambient sunlight, infections and relapse rates in multiple sclerosis. Neuroepidemiology. 2008;31(4):271-279.

Vitamin D as a Risk Factor

Epidemiologic literature first suggested that vitamin D status might be related to the risk of MS. Researchers demonstrated that MS prevalence increases with distance from the equator. A series of retrospective and case–control studies subsequently suggested that patients with MS had lower levels of vitamin D than healthy individuals. These data, however, left open the possibility that having MS and its associated intolerance of heat led to reduced sun exposure, and thus lower levels of vitamin D.

In 2006, Munger and colleagues prospectively examined serum samples obtained from more than seven million US military personnel. They found that, among whites, the risk of MS significantly decreased with increasing levels of 25-hydroxyvitamin D. The effect was most significant in people with vitamin D levels higher than 40 ng/mL. The same association was observed in a later Swedish study that used 30 ng/mL as its threshold for vitamin D sufficiency. In 2016, Munger et al found that insufficient maternal vitamin D during pregnancy may increase the risk of MS in offspring.

Although research by Lucas and colleagues indicated an inverse association between serum vitamin D level and risk of MS, they found a stronger inverse association between ultraviolet (UV) light exposure and risk of MS. The strength of the latter association did not change, whether exposure was measured by skin damage or self-report. In 2017, however, Nielsen and colleagues compared serum vitamin D levels in newborns who subsequently developed MS with those of newborns who did not develop MS. They found a strong association between higher neonatal levels of vitamin D and lower risk of subsequent MS. “One could argue [that] this [result] makes the vitamin D hypothesis stronger than the UV [hypothesis], since the babies, in all likelihood, had not been exposed to much UV [light] at the time they were born,” said Dr. Mowry.

Vitamin D as a Prognostic Factor

Other research has suggested that serum vitamin D level may predict disease activity in MS. Dr. Mowry and colleagues evaluated blood samples taken from children who presented for longitudinal follow-up at pediatric MS centers. The total follow-up period was approximately 18 months. After adjusting for covariates, they found a strong association between higher levels of vitamin D and lower risk of subsequent relapse. “Each 10-ng/mL higher level of vitamin D … was associated with about a one-third reduction in the risk of subsequent relapse,” said Dr. Mowry. A prospective study conducted in Australia found similar results.

In 2012, Dr. Mowry and colleagues measured vitamin D levels in blood samples from 469 patients with relapsing-remitting MS or clinically isolated syndrome (CIS). They found that each additional 10-ng/mL increment of vitamin D level was associated with an approximately 15% lower risk of subsequent new T2 lesions and with an approximately 32% reduced risk of subsequent gadolinium-enhancing lesions. Higher levels of vitamin D also were associated with lower risk of subsequent relapse, but this finding was not statistically significant.

To discover whether vitamin D influences markers known to predict long-term disability, Dr. Mowry and colleagues examined data from a study of atorvastatin in 65 patients with CIS. They measured vitamin D levels at baseline and at month six, and the follow-up period was as long as 18 months. They found that each additional 10-ng/mL increment in vitamin D level was associated with an additional 7.8 mL of preserved gray matter volume. They also observed a trend toward an inverse association between vitamin D levels and the composite end point of three or more new T2 lesions or one or more relapses within a year.

Is Vitamin D Supplementation Appropriate?

“Just because [vitamin D] is available over the counter does not make it safe or effective,” and the supplement should be studied further in clinical trials, said Dr. Mowry. In 2010, Burton et al found that a dose of as much as 40,000 IU/day of vitamin D was safe in the short term and might have immunomodulatory effects in patients with MS. Furthermore, a small Finnish study suggested that a dose of 20,000 IU/week of vitamin D was safe in patients with MS, and also might slow the accumulation of disability.

Hupperts et al studied patients with relapsing-remitting MS who were receiving interferon beta-1a. They randomized 229 participants to vitamin D or placebo and followed them for 48 weeks. In preliminary analyses, the investigators found no difference between treatment groups with respect to the outcome of no evidence of disease activity. Patients who received vitamin D had a lower annualized relapse rate than controls, but the difference was not statistically significant. The active group did have significantly fewer gadolinium-enhancing lesions and new T2 hyperintense lesions, compared with controls, however.

In addition, Dr. Mowry and colleagues are comparing the effects of 5,000-IU and 600-IU doses of vitamin D in patients with MS who are receiving glatiramer acetate. The ongoing study is sponsored by the National MS Society. European studies of the clinical benefit of vitamin D also are under way.

Although the benefits of vitamin D are not completely understood, many neurologists recommend supplementation to their patients with MS. Pharmacokinetic studies have not shown a difference between daily, weekly, or monthly dosing regimens. “As long as you give the same dose of vitamin D, you will get the levels … to the same general area,” said Dr. Mowry. Nevertheless, some studies in other patient populations suggest that very high doses of vitamin D given monthly are probably toxic.

Many studies have suggested that vitamin D3 may be more potent than vitamin D2. “I tend to use [vitamin] D3 when I am supplementing,” said Dr. Mowry. “I aim for levels between 40 and 60 ng/mL, based on our observational data.... For my patients, that largely means they need somewhere between 2,000 and 4,000 IU/day, although sometimes more. I usually recheck the level in three months, based on what we know about the kinetics of vitamin D supplementation. I am cautious in individuals who may be at risk for hypercalcemia or hypercalciuria.”

—Erik Greb

Suggested Reading

Burton JM, Kimball S, Vieth R, et al. A phase I/II dose-escalation trial of vitamin D3 and calcium in multiple sclerosis. Neurology. 2010;74(23):1852-1859.

Mowry EM. Vitamin D: evidence for its role as a prognostic factor in multiple sclerosis. J Neurol Sci. 2011; 311(1-2):19-22.

Mowry EM, Pelletier D, Gao Z, et al. Vitamin D in clinically isolated syndrome: evidence for possible neuroprotection. Eur J Neurol. 2016;23(2):327-332.

Mowry EM, Waubant E, McCulloch CE, et al. Vitamin D status predicts new brain magnetic resonance imaging activity in multiple sclerosis. Ann Neurol. 2012;72(2):234-240.

Munger KL, Åivo J, Hongell K, et al. Vitamin D status during pregnancy and risk of multiple sclerosis in offspring of women in the Finnish Maternity Cohort. JAMA Neurol. 2016;73(5):515-519.

Munger KL, Levin LI, Hollis BW, et al. Serum 25-hydroxyvitamin D levels and risk of multiple sclerosis. JAMA. 2006;296(23):2832-2838.

Nielsen NM, Munger KL, Koch-Henriksen N, et al. Neonatal vitamin D status and risk of multiple sclerosis: a population-based case-control study. Neurology. 2017;88(1):44-51.

Tremlett H, van der Mei IA, Pittas F, et al. Monthly ambient sunlight, infections and relapse rates in multiple sclerosis. Neuroepidemiology. 2008;31(4):271-279.

Vitamin D as a Risk Factor

Epidemiologic literature first suggested that vitamin D status might be related to the risk of MS. Researchers demonstrated that MS prevalence increases with distance from the equator. A series of retrospective and case–control studies subsequently suggested that patients with MS had lower levels of vitamin D than healthy individuals. These data, however, left open the possibility that having MS and its associated intolerance of heat led to reduced sun exposure, and thus lower levels of vitamin D.

In 2006, Munger and colleagues prospectively examined serum samples obtained from more than seven million US military personnel. They found that, among whites, the risk of MS significantly decreased with increasing levels of 25-hydroxyvitamin D. The effect was most significant in people with vitamin D levels higher than 40 ng/mL. The same association was observed in a later Swedish study that used 30 ng/mL as its threshold for vitamin D sufficiency. In 2016, Munger et al found that insufficient maternal vitamin D during pregnancy may increase the risk of MS in offspring.

Although research by Lucas and colleagues indicated an inverse association between serum vitamin D level and risk of MS, they found a stronger inverse association between ultraviolet (UV) light exposure and risk of MS. The strength of the latter association did not change, whether exposure was measured by skin damage or self-report. In 2017, however, Nielsen and colleagues compared serum vitamin D levels in newborns who subsequently developed MS with those of newborns who did not develop MS. They found a strong association between higher neonatal levels of vitamin D and lower risk of subsequent MS. “One could argue [that] this [result] makes the vitamin D hypothesis stronger than the UV [hypothesis], since the babies, in all likelihood, had not been exposed to much UV [light] at the time they were born,” said Dr. Mowry.

Vitamin D as a Prognostic Factor

Other research has suggested that serum vitamin D level may predict disease activity in MS. Dr. Mowry and colleagues evaluated blood samples taken from children who presented for longitudinal follow-up at pediatric MS centers. The total follow-up period was approximately 18 months. After adjusting for covariates, they found a strong association between higher levels of vitamin D and lower risk of subsequent relapse. “Each 10-ng/mL higher level of vitamin D … was associated with about a one-third reduction in the risk of subsequent relapse,” said Dr. Mowry. A prospective study conducted in Australia found similar results.

In 2012, Dr. Mowry and colleagues measured vitamin D levels in blood samples from 469 patients with relapsing-remitting MS or clinically isolated syndrome (CIS). They found that each additional 10-ng/mL increment of vitamin D level was associated with an approximately 15% lower risk of subsequent new T2 lesions and with an approximately 32% reduced risk of subsequent gadolinium-enhancing lesions. Higher levels of vitamin D also were associated with lower risk of subsequent relapse, but this finding was not statistically significant.

To discover whether vitamin D influences markers known to predict long-term disability, Dr. Mowry and colleagues examined data from a study of atorvastatin in 65 patients with CIS. They measured vitamin D levels at baseline and at month six, and the follow-up period was as long as 18 months. They found that each additional 10-ng/mL increment in vitamin D level was associated with an additional 7.8 mL of preserved gray matter volume. They also observed a trend toward an inverse association between vitamin D levels and the composite end point of three or more new T2 lesions or one or more relapses within a year.

Is Vitamin D Supplementation Appropriate?

“Just because [vitamin D] is available over the counter does not make it safe or effective,” and the supplement should be studied further in clinical trials, said Dr. Mowry. In 2010, Burton et al found that a dose of as much as 40,000 IU/day of vitamin D was safe in the short term and might have immunomodulatory effects in patients with MS. Furthermore, a small Finnish study suggested that a dose of 20,000 IU/week of vitamin D was safe in patients with MS, and also might slow the accumulation of disability.

Hupperts et al studied patients with relapsing-remitting MS who were receiving interferon beta-1a. They randomized 229 participants to vitamin D or placebo and followed them for 48 weeks. In preliminary analyses, the investigators found no difference between treatment groups with respect to the outcome of no evidence of disease activity. Patients who received vitamin D had a lower annualized relapse rate than controls, but the difference was not statistically significant. The active group did have significantly fewer gadolinium-enhancing lesions and new T2 hyperintense lesions, compared with controls, however.

In addition, Dr. Mowry and colleagues are comparing the effects of 5,000-IU and 600-IU doses of vitamin D in patients with MS who are receiving glatiramer acetate. The ongoing study is sponsored by the National MS Society. European studies of the clinical benefit of vitamin D also are under way.

Although the benefits of vitamin D are not completely understood, many neurologists recommend supplementation to their patients with MS. Pharmacokinetic studies have not shown a difference between daily, weekly, or monthly dosing regimens. “As long as you give the same dose of vitamin D, you will get the levels … to the same general area,” said Dr. Mowry. Nevertheless, some studies in other patient populations suggest that very high doses of vitamin D given monthly are probably toxic.

Many studies have suggested that vitamin D3 may be more potent than vitamin D2. “I tend to use [vitamin] D3 when I am supplementing,” said Dr. Mowry. “I aim for levels between 40 and 60 ng/mL, based on our observational data.... For my patients, that largely means they need somewhere between 2,000 and 4,000 IU/day, although sometimes more. I usually recheck the level in three months, based on what we know about the kinetics of vitamin D supplementation. I am cautious in individuals who may be at risk for hypercalcemia or hypercalciuria.”

—Erik Greb

Suggested Reading

Burton JM, Kimball S, Vieth R, et al. A phase I/II dose-escalation trial of vitamin D3 and calcium in multiple sclerosis. Neurology. 2010;74(23):1852-1859.

Mowry EM. Vitamin D: evidence for its role as a prognostic factor in multiple sclerosis. J Neurol Sci. 2011; 311(1-2):19-22.

Mowry EM, Pelletier D, Gao Z, et al. Vitamin D in clinically isolated syndrome: evidence for possible neuroprotection. Eur J Neurol. 2016;23(2):327-332.

Mowry EM, Waubant E, McCulloch CE, et al. Vitamin D status predicts new brain magnetic resonance imaging activity in multiple sclerosis. Ann Neurol. 2012;72(2):234-240.

Munger KL, Åivo J, Hongell K, et al. Vitamin D status during pregnancy and risk of multiple sclerosis in offspring of women in the Finnish Maternity Cohort. JAMA Neurol. 2016;73(5):515-519.

Munger KL, Levin LI, Hollis BW, et al. Serum 25-hydroxyvitamin D levels and risk of multiple sclerosis. JAMA. 2006;296(23):2832-2838.

Nielsen NM, Munger KL, Koch-Henriksen N, et al. Neonatal vitamin D status and risk of multiple sclerosis: a population-based case-control study. Neurology. 2017;88(1):44-51.

Tremlett H, van der Mei IA, Pittas F, et al. Monthly ambient sunlight, infections and relapse rates in multiple sclerosis. Neuroepidemiology. 2008;31(4):271-279.

EXPERT COMMENTARY

Care of women with pelvic floor disorders, primarily urinary incontinence and POP, involves:

• assessing the patient’s symptoms and determining how bothersome they are
• educating the patient about her condition and the options for treatment
• initiating treatment with the most conservative and least invasive therapies.

Safe treatments include PFMT and pessaries, and both can be effective. However, since approximately 25% of women experience one or more pelvic floor disorders during their life, surgical repair of these disorders is common. The lifetime risk of surgery for stress urinary incontinence (SUI) or POP is 20%,¹ and one-third of patients will undergo reoperation for the same condition. Midurethral mesh slings are the gold standard for surgical management of SUI.² Use of transvaginal mesh for primary prolapse repairs, however, is associated with challenging adverse effects, and its use should be reserved for carefully selected patients.

Data from 3 recent studies contribute to our evidence base on various treatments for pelvic floor disorders.

Details of the studies

PFMT for secondary prevention of POP. In a study conducted in the United Kingdom and New Zealand, Hagen and colleagues randomly assigned 414 women with POP, with or without symptoms, to an intervention group or a control group. The women had previously participated in a longitudinal study of postpartum pelvic floor function. Participants in the intervention group (n = 207) received 5 formal sessions of PFMT over 16 weeks, followed by Pilates-based classes focused on pelvic floor exercises; those in the control group (n = 207) received an informational leaflet about prolapse and lifestyle. The primary outcome was self-reported prolapse symptoms, assessed with the POP Symptom Score (POP-SS) at 2 years.

At study end, the mean (SD) POP-SS score in the intervention group was 3.2 (3.4), compared with a mean (SD) score of 4.2 (4.4) in the control group (adjusted mean difference, −1.01; 95% confidence interval [CI], −1.70 to −0.33; P = .004).

Investigators’ interpretation. The researchers concluded that the participants in the PFMT group had a small but significant—and clinically important—decrease in prolapse symptoms.

The PROSPECT study: Standard versus augmented surgical repair. In a multicenter trial in the United Kingdom by Glazener and associates, 1,352 women with symptomatic POP were randomly allocated to surgical repair with native tissue alone (standard repair) or to standard surgical repair augmented either with polypropylene mesh or with biological graft. The primary outcomes were participant-reported prolapse symptoms (assessed with POP-SS) and prolapse-related quality of life scores; these were measured at 1 year and at 2 years.

One year after surgery, failure rates (defined as prolapse beyond the hymen) were similar in all groups (range, 14%–18%); serious adverse events were also similar in all surgical groups (range, 6%–10%). Overall, 6% of women underwent reoperation for recurrent symptoms. Among women randomly assigned to repair with mesh, 12% to 14% experienced mesh-related adverse events; three-quarters of these women ultimately required surgical excision of the mesh.

Study takeaway. Thus, in terms of effectiveness, quality of life, and adverse effects, augmentation of a vaginal surgical repair with either mesh or graft material did not improve the outcomes of women with POP.

Adverse events after surgical procedures for pelvic floor disorders. In Scotland, Morling and colleagues performed a retrospective observational cohort study of first-time surgeries for SUI (mesh or colposuspension; 16,660 procedures) and prolapse (mesh or native tissue; 18,986 procedures).

After 5 years of follow-up, women who underwent midurethral mesh sling placement or colposuspension had similar rates of repeat surgery for recurrent SUI (adjusted incidence rate ratio, 0.90; 95% CI, 0.73–1.11). Use of mesh slings was associated with fewer immediate complications (adjusted relative risk, 0.44; 95% CI, 0.36–0.55) compared with nonmesh surgery.

Among women who underwent surgery for prolapse, those who had anterior and posterior repair with mesh experienced higher late complication rates than those who underwent native tissue repair. Risk for subsequent prolapse repair was similar with mesh and native-tissue procedures.

Authors’ commentary. The researchers noted that their data support the use of mesh procedures for incontinence but additional research on longer-term outcomes would be useful. However, for prolapse repair, the study results do not decidedly favor any one vault repair procedure.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

Care of women with pelvic floor disorders, primarily urinary incontinence and POP, involves:

• assessing the patient’s symptoms and determining how bothersome they are
• educating the patient about her condition and the options for treatment
• initiating treatment with the most conservative and least invasive therapies.

Safe treatments include PFMT and pessaries, and both can be effective. However, since approximately 25% of women experience one or more pelvic floor disorders during their life, surgical repair of these disorders is common. The lifetime risk of surgery for stress urinary incontinence (SUI) or POP is 20%,¹ and one-third of patients will undergo reoperation for the same condition. Midurethral mesh slings are the gold standard for surgical management of SUI.² Use of transvaginal mesh for primary prolapse repairs, however, is associated with challenging adverse effects, and its use should be reserved for carefully selected patients.

Data from 3 recent studies contribute to our evidence base on various treatments for pelvic floor disorders.

Details of the studies

PFMT for secondary prevention of POP. In a study conducted in the United Kingdom and New Zealand, Hagen and colleagues randomly assigned 414 women with POP, with or without symptoms, to an intervention group or a control group. The women had previously participated in a longitudinal study of postpartum pelvic floor function. Participants in the intervention group (n = 207) received 5 formal sessions of PFMT over 16 weeks, followed by Pilates-based classes focused on pelvic floor exercises; those in the control group (n = 207) received an informational leaflet about prolapse and lifestyle. The primary outcome was self-reported prolapse symptoms, assessed with the POP Symptom Score (POP-SS) at 2 years.

At study end, the mean (SD) POP-SS score in the intervention group was 3.2 (3.4), compared with a mean (SD) score of 4.2 (4.4) in the control group (adjusted mean difference, −1.01; 95% confidence interval [CI], −1.70 to −0.33; P = .004).

Investigators’ interpretation. The researchers concluded that the participants in the PFMT group had a small but significant—and clinically important—decrease in prolapse symptoms.

The PROSPECT study: Standard versus augmented surgical repair. In a multicenter trial in the United Kingdom by Glazener and associates, 1,352 women with symptomatic POP were randomly allocated to surgical repair with native tissue alone (standard repair) or to standard surgical repair augmented either with polypropylene mesh or with biological graft. The primary outcomes were participant-reported prolapse symptoms (assessed with POP-SS) and prolapse-related quality of life scores; these were measured at 1 year and at 2 years.

One year after surgery, failure rates (defined as prolapse beyond the hymen) were similar in all groups (range, 14%–18%); serious adverse events were also similar in all surgical groups (range, 6%–10%). Overall, 6% of women underwent reoperation for recurrent symptoms. Among women randomly assigned to repair with mesh, 12% to 14% experienced mesh-related adverse events; three-quarters of these women ultimately required surgical excision of the mesh.

Study takeaway. Thus, in terms of effectiveness, quality of life, and adverse effects, augmentation of a vaginal surgical repair with either mesh or graft material did not improve the outcomes of women with POP.

Adverse events after surgical procedures for pelvic floor disorders. In Scotland, Morling and colleagues performed a retrospective observational cohort study of first-time surgeries for SUI (mesh or colposuspension; 16,660 procedures) and prolapse (mesh or native tissue; 18,986 procedures).

After 5 years of follow-up, women who underwent midurethral mesh sling placement or colposuspension had similar rates of repeat surgery for recurrent SUI (adjusted incidence rate ratio, 0.90; 95% CI, 0.73–1.11). Use of mesh slings was associated with fewer immediate complications (adjusted relative risk, 0.44; 95% CI, 0.36–0.55) compared with nonmesh surgery.

Among women who underwent surgery for prolapse, those who had anterior and posterior repair with mesh experienced higher late complication rates than those who underwent native tissue repair. Risk for subsequent prolapse repair was similar with mesh and native-tissue procedures.

Authors’ commentary. The researchers noted that their data support the use of mesh procedures for incontinence but additional research on longer-term outcomes would be useful. However, for prolapse repair, the study results do not decidedly favor any one vault repair procedure.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

Care of women with pelvic floor disorders, primarily urinary incontinence and POP, involves:

• assessing the patient’s symptoms and determining how bothersome they are
• educating the patient about her condition and the options for treatment
• initiating treatment with the most conservative and least invasive therapies.

Safe treatments include PFMT and pessaries, and both can be effective. However, since approximately 25% of women experience one or more pelvic floor disorders during their life, surgical repair of these disorders is common. The lifetime risk of surgery for stress urinary incontinence (SUI) or POP is 20%,¹ and one-third of patients will undergo reoperation for the same condition. Midurethral mesh slings are the gold standard for surgical management of SUI.² Use of transvaginal mesh for primary prolapse repairs, however, is associated with challenging adverse effects, and its use should be reserved for carefully selected patients.

Data from 3 recent studies contribute to our evidence base on various treatments for pelvic floor disorders.

Details of the studies

PFMT for secondary prevention of POP. In a study conducted in the United Kingdom and New Zealand, Hagen and colleagues randomly assigned 414 women with POP, with or without symptoms, to an intervention group or a control group. The women had previously participated in a longitudinal study of postpartum pelvic floor function. Participants in the intervention group (n = 207) received 5 formal sessions of PFMT over 16 weeks, followed by Pilates-based classes focused on pelvic floor exercises; those in the control group (n = 207) received an informational leaflet about prolapse and lifestyle. The primary outcome was self-reported prolapse symptoms, assessed with the POP Symptom Score (POP-SS) at 2 years.

At study end, the mean (SD) POP-SS score in the intervention group was 3.2 (3.4), compared with a mean (SD) score of 4.2 (4.4) in the control group (adjusted mean difference, −1.01; 95% confidence interval [CI], −1.70 to −0.33; P = .004).

Investigators’ interpretation. The researchers concluded that the participants in the PFMT group had a small but significant—and clinically important—decrease in prolapse symptoms.

The PROSPECT study: Standard versus augmented surgical repair. In a multicenter trial in the United Kingdom by Glazener and associates, 1,352 women with symptomatic POP were randomly allocated to surgical repair with native tissue alone (standard repair) or to standard surgical repair augmented either with polypropylene mesh or with biological graft. The primary outcomes were participant-reported prolapse symptoms (assessed with POP-SS) and prolapse-related quality of life scores; these were measured at 1 year and at 2 years.

One year after surgery, failure rates (defined as prolapse beyond the hymen) were similar in all groups (range, 14%–18%); serious adverse events were also similar in all surgical groups (range, 6%–10%). Overall, 6% of women underwent reoperation for recurrent symptoms. Among women randomly assigned to repair with mesh, 12% to 14% experienced mesh-related adverse events; three-quarters of these women ultimately required surgical excision of the mesh.

Study takeaway. Thus, in terms of effectiveness, quality of life, and adverse effects, augmentation of a vaginal surgical repair with either mesh or graft material did not improve the outcomes of women with POP.

Adverse events after surgical procedures for pelvic floor disorders. In Scotland, Morling and colleagues performed a retrospective observational cohort study of first-time surgeries for SUI (mesh or colposuspension; 16,660 procedures) and prolapse (mesh or native tissue; 18,986 procedures).

After 5 years of follow-up, women who underwent midurethral mesh sling placement or colposuspension had similar rates of repeat surgery for recurrent SUI (adjusted incidence rate ratio, 0.90; 95% CI, 0.73–1.11). Use of mesh slings was associated with fewer immediate complications (adjusted relative risk, 0.44; 95% CI, 0.36–0.55) compared with nonmesh surgery.

Among women who underwent surgery for prolapse, those who had anterior and posterior repair with mesh experienced higher late complication rates than those who underwent native tissue repair. Risk for subsequent prolapse repair was similar with mesh and native-tissue procedures.

Authors’ commentary. The researchers noted that their data support the use of mesh procedures for incontinence but additional research on longer-term outcomes would be useful. However, for prolapse repair, the study results do not decidedly favor any one vault repair procedure.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The Justice Department has joined a California whistle-blower’s lawsuit that accuses insurance giant UnitedHealth Group of fraud in its popular Medicare Advantage health plans.

Justice officials filed legal papers to intervene in the suit, first brought by whistle-blower James Swoben in 2009, on Friday in federal court in Los Angeles. On Monday, they sought a court order to combine Mr. Swoben’s case with that of another whistle-blower.

Mr. Swoben has accused the insurer of “gaming” the Medicare Advantage payment system by “making patients look sicker than they are,” said his attorney, William K. Hanagami. Mr. Hanagami said the combined cases could prove to be among the “larger frauds” ever against Medicare, with damages that he speculates could top $1 billion.

UnitedHealth spokesman Matt Burns denied any wrongdoing by the company. “We are honored to serve millions of seniors through Medicare Advantage, proud of the access to quality health care we provided, and confident we complied with program rules,” he wrote in an email.

Mr. Burns also said that “litigating against Medicare Advantage plans to create new rules through the courts will not fix widely acknowledged government policy shortcomings or help Medicare Advantage members and is wrong.”

Medicare Advantage is a popular alternative to traditional Medicare. The privately run health plans have enrolled more than 18 million elderly and people with disabilities – about a third of those eligible for Medicare – at a cost to taxpayers of more than $150 billion a year.

Although the plans generally enjoy strong support in Congress, they have been the target of at least a half-dozen whistle-blower lawsuits alleging patterns of overbilling and fraud. In most of the prior cases, Justice Department officials have decided not to intervene, which often limits the financial recovery by the government and also by whistle-blowers, who can be awarded a portion of recovered funds. A decision to intervene means that the Justice Department is taking over the investigation of the case, greatly raising the stakes.

“This is a very big development and sends a strong signal that the Trump administration is very serious when it comes to fighting fraud in the health care arena,” said Patrick Burns, associate director of Taxpayers Against Fraud in Washington, a nonprofit supported by whistle-blowers and their lawyers. Burns said the “winners here are going to be American taxpayers.”

Patrick Burns also contends that the cases against UnitedHealth could potentially exceed $1 billion in damages, which would place them among the top two or three whistle-blower–prompted cases on record.

“This is not one company engaged in episodic bad behavior, but a lucrative business plan that appears to be national in scope,” he said.

On Monday, the government said it wants to consolidate the Swoben case with another whistle-blower action filed in 2011 by former UnitedHealth executive Benjamin Poehling and unsealed in March by a federal judge. Mr. Poehling also has alleged that the insurer generated hundreds of millions of dollars or more in overpayments.

When Congress created the current Medicare Advantage program in 2003, it expected to pay higher rates for sicker patients than for people in good health using a formula called a risk score.

But, overspending tied to inflated risk scores has repeatedly been cited by government auditors, including the Government Accountability Office. A series of articles published in 2014 by the Center for Public Integrity found that these improper payments have cost taxpayers tens of billions of dollars.

“If the goal of fraud is to artificially increase risk scores and you do that wholesale, that results in some rather significant dollars,” Mr. Hanagami said.

David Lipschutz, senior policy attorney for the Center for Medicare Advocacy, a nonprofit offering legal assistance and other resources for those eligible for Medicare, said his group is “deeply concerned by ongoing improper payments” to Medicare Advantage health plans.

These overpayments “undermine the finances of the overall Medicare program,” he said in an emailed statement. He said his group supports “more rigorous oversight” of payments made to the health plans.

The two whistle-blower complaints allege that UnitedHealth has had a practice of asking the government to reimburse it for underpayments but did not report claims for which it had received too much money, despite knowing some of these claims had inflated risk scores.

The federal Centers for Medicare & Medicaid Services said in draft regulations issued in January 2014 that it would begin requiring that Medicare Advantage plans report any improper payment – either too much or too little.

These reviews “cannot be designed only to identify diagnoses that would trigger additional payments,” the proposal stated.

But CMS backed off the regulation’s reporting requirements in the face of opposition from the insurance industry. The agency didn’t say why it did so.

The Justice Department said in an April 2016 amicus brief in the Swoben case that the CMS decision not to move ahead with the reporting regulation “does not relieve defendants of the broad obligation to exercise due diligence in ensuring the accuracy” of claims submitted for payment.

The Justice Department concluded in the brief that the insurers “chose not to connect the dots,” even though they knew of both overpayments and underpayments. Instead, the insurers “acted in a deliberately ignorant or reckless manner in falsely certifying the accuracy, completeness, and truthfulness of submitted data,” the 2016 brief states.

The Justice Department has said it also is investigating risk-score payments to other Medicare Advantage insurers, but has not said whether it plans to take action against any of them.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
 

The Justice Department has joined a California whistle-blower’s lawsuit that accuses insurance giant UnitedHealth Group of fraud in its popular Medicare Advantage health plans.

Justice officials filed legal papers to intervene in the suit, first brought by whistle-blower James Swoben in 2009, on Friday in federal court in Los Angeles. On Monday, they sought a court order to combine Mr. Swoben’s case with that of another whistle-blower.

Mr. Swoben has accused the insurer of “gaming” the Medicare Advantage payment system by “making patients look sicker than they are,” said his attorney, William K. Hanagami. Mr. Hanagami said the combined cases could prove to be among the “larger frauds” ever against Medicare, with damages that he speculates could top $1 billion.

UnitedHealth spokesman Matt Burns denied any wrongdoing by the company. “We are honored to serve millions of seniors through Medicare Advantage, proud of the access to quality health care we provided, and confident we complied with program rules,” he wrote in an email.

Mr. Burns also said that “litigating against Medicare Advantage plans to create new rules through the courts will not fix widely acknowledged government policy shortcomings or help Medicare Advantage members and is wrong.”

Medicare Advantage is a popular alternative to traditional Medicare. The privately run health plans have enrolled more than 18 million elderly and people with disabilities – about a third of those eligible for Medicare – at a cost to taxpayers of more than $150 billion a year.

Although the plans generally enjoy strong support in Congress, they have been the target of at least a half-dozen whistle-blower lawsuits alleging patterns of overbilling and fraud. In most of the prior cases, Justice Department officials have decided not to intervene, which often limits the financial recovery by the government and also by whistle-blowers, who can be awarded a portion of recovered funds. A decision to intervene means that the Justice Department is taking over the investigation of the case, greatly raising the stakes.

“This is a very big development and sends a strong signal that the Trump administration is very serious when it comes to fighting fraud in the health care arena,” said Patrick Burns, associate director of Taxpayers Against Fraud in Washington, a nonprofit supported by whistle-blowers and their lawyers. Burns said the “winners here are going to be American taxpayers.”

Patrick Burns also contends that the cases against UnitedHealth could potentially exceed $1 billion in damages, which would place them among the top two or three whistle-blower–prompted cases on record.

“This is not one company engaged in episodic bad behavior, but a lucrative business plan that appears to be national in scope,” he said.

On Monday, the government said it wants to consolidate the Swoben case with another whistle-blower action filed in 2011 by former UnitedHealth executive Benjamin Poehling and unsealed in March by a federal judge. Mr. Poehling also has alleged that the insurer generated hundreds of millions of dollars or more in overpayments.

When Congress created the current Medicare Advantage program in 2003, it expected to pay higher rates for sicker patients than for people in good health using a formula called a risk score.

But, overspending tied to inflated risk scores has repeatedly been cited by government auditors, including the Government Accountability Office. A series of articles published in 2014 by the Center for Public Integrity found that these improper payments have cost taxpayers tens of billions of dollars.

“If the goal of fraud is to artificially increase risk scores and you do that wholesale, that results in some rather significant dollars,” Mr. Hanagami said.

David Lipschutz, senior policy attorney for the Center for Medicare Advocacy, a nonprofit offering legal assistance and other resources for those eligible for Medicare, said his group is “deeply concerned by ongoing improper payments” to Medicare Advantage health plans.

These overpayments “undermine the finances of the overall Medicare program,” he said in an emailed statement. He said his group supports “more rigorous oversight” of payments made to the health plans.

The two whistle-blower complaints allege that UnitedHealth has had a practice of asking the government to reimburse it for underpayments but did not report claims for which it had received too much money, despite knowing some of these claims had inflated risk scores.

The federal Centers for Medicare & Medicaid Services said in draft regulations issued in January 2014 that it would begin requiring that Medicare Advantage plans report any improper payment – either too much or too little.

These reviews “cannot be designed only to identify diagnoses that would trigger additional payments,” the proposal stated.

But CMS backed off the regulation’s reporting requirements in the face of opposition from the insurance industry. The agency didn’t say why it did so.

The Justice Department said in an April 2016 amicus brief in the Swoben case that the CMS decision not to move ahead with the reporting regulation “does not relieve defendants of the broad obligation to exercise due diligence in ensuring the accuracy” of claims submitted for payment.

The Justice Department concluded in the brief that the insurers “chose not to connect the dots,” even though they knew of both overpayments and underpayments. Instead, the insurers “acted in a deliberately ignorant or reckless manner in falsely certifying the accuracy, completeness, and truthfulness of submitted data,” the 2016 brief states.

The Justice Department has said it also is investigating risk-score payments to other Medicare Advantage insurers, but has not said whether it plans to take action against any of them.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
 

The Justice Department has joined a California whistle-blower’s lawsuit that accuses insurance giant UnitedHealth Group of fraud in its popular Medicare Advantage health plans.

Justice officials filed legal papers to intervene in the suit, first brought by whistle-blower James Swoben in 2009, on Friday in federal court in Los Angeles. On Monday, they sought a court order to combine Mr. Swoben’s case with that of another whistle-blower.

Mr. Swoben has accused the insurer of “gaming” the Medicare Advantage payment system by “making patients look sicker than they are,” said his attorney, William K. Hanagami. Mr. Hanagami said the combined cases could prove to be among the “larger frauds” ever against Medicare, with damages that he speculates could top $1 billion.

UnitedHealth spokesman Matt Burns denied any wrongdoing by the company. “We are honored to serve millions of seniors through Medicare Advantage, proud of the access to quality health care we provided, and confident we complied with program rules,” he wrote in an email.

Mr. Burns also said that “litigating against Medicare Advantage plans to create new rules through the courts will not fix widely acknowledged government policy shortcomings or help Medicare Advantage members and is wrong.”

Medicare Advantage is a popular alternative to traditional Medicare. The privately run health plans have enrolled more than 18 million elderly and people with disabilities – about a third of those eligible for Medicare – at a cost to taxpayers of more than $150 billion a year.

Although the plans generally enjoy strong support in Congress, they have been the target of at least a half-dozen whistle-blower lawsuits alleging patterns of overbilling and fraud. In most of the prior cases, Justice Department officials have decided not to intervene, which often limits the financial recovery by the government and also by whistle-blowers, who can be awarded a portion of recovered funds. A decision to intervene means that the Justice Department is taking over the investigation of the case, greatly raising the stakes.

“This is a very big development and sends a strong signal that the Trump administration is very serious when it comes to fighting fraud in the health care arena,” said Patrick Burns, associate director of Taxpayers Against Fraud in Washington, a nonprofit supported by whistle-blowers and their lawyers. Burns said the “winners here are going to be American taxpayers.”

Patrick Burns also contends that the cases against UnitedHealth could potentially exceed $1 billion in damages, which would place them among the top two or three whistle-blower–prompted cases on record.

“This is not one company engaged in episodic bad behavior, but a lucrative business plan that appears to be national in scope,” he said.

On Monday, the government said it wants to consolidate the Swoben case with another whistle-blower action filed in 2011 by former UnitedHealth executive Benjamin Poehling and unsealed in March by a federal judge. Mr. Poehling also has alleged that the insurer generated hundreds of millions of dollars or more in overpayments.

When Congress created the current Medicare Advantage program in 2003, it expected to pay higher rates for sicker patients than for people in good health using a formula called a risk score.

But, overspending tied to inflated risk scores has repeatedly been cited by government auditors, including the Government Accountability Office. A series of articles published in 2014 by the Center for Public Integrity found that these improper payments have cost taxpayers tens of billions of dollars.

“If the goal of fraud is to artificially increase risk scores and you do that wholesale, that results in some rather significant dollars,” Mr. Hanagami said.

David Lipschutz, senior policy attorney for the Center for Medicare Advocacy, a nonprofit offering legal assistance and other resources for those eligible for Medicare, said his group is “deeply concerned by ongoing improper payments” to Medicare Advantage health plans.

These overpayments “undermine the finances of the overall Medicare program,” he said in an emailed statement. He said his group supports “more rigorous oversight” of payments made to the health plans.

The two whistle-blower complaints allege that UnitedHealth has had a practice of asking the government to reimburse it for underpayments but did not report claims for which it had received too much money, despite knowing some of these claims had inflated risk scores.

The federal Centers for Medicare & Medicaid Services said in draft regulations issued in January 2014 that it would begin requiring that Medicare Advantage plans report any improper payment – either too much or too little.

These reviews “cannot be designed only to identify diagnoses that would trigger additional payments,” the proposal stated.

But CMS backed off the regulation’s reporting requirements in the face of opposition from the insurance industry. The agency didn’t say why it did so.

The Justice Department said in an April 2016 amicus brief in the Swoben case that the CMS decision not to move ahead with the reporting regulation “does not relieve defendants of the broad obligation to exercise due diligence in ensuring the accuracy” of claims submitted for payment.

The Justice Department concluded in the brief that the insurers “chose not to connect the dots,” even though they knew of both overpayments and underpayments. Instead, the insurers “acted in a deliberately ignorant or reckless manner in falsely certifying the accuracy, completeness, and truthfulness of submitted data,” the 2016 brief states.

The Justice Department has said it also is investigating risk-score payments to other Medicare Advantage insurers, but has not said whether it plans to take action against any of them.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
 

ORLANDO—RNA expression patterns are highly dynamic, even at the earliest stages of multiple sclerosis (MS) pathogenesis, according to research presented at the ACTRIMS 2017 Forum. Machine learning methods trained and validated with these gene targets are a highly accurate tool that could provide actionable data for health care providers who suspect MS.

RNA sequencing was performed to identify differentially expressed protein-coding and noncoding RNA genes at distinct stages of MS, compared with controls. Expression levels of these genes were validated by real-time polymerase chain reaction (PCR) across all 979 subjects recruited. Ratios of gene expression data were used as inputs to train machine learning classifiers capable of multicategory comparisons. An independent validation testing set consisting of individuals across each control and disease class was used to evaluate the performance of these classifiers. In contrast to protein-coding gene targets where gene expression differences were often twofold or less, lncRNAs were highly differentially expressed across each of the experimental groups compared. Training and validation of machine learning methods revealed that lncRNA gene expression inputs resulted in higher overall accuracy and confidence of machine learning predictions than did protein-coding genes, resulting in greater than 90% accuracy in the validation testing set. 

—Glenn S. Williams

ORLANDO—RNA expression patterns are highly dynamic, even at the earliest stages of multiple sclerosis (MS) pathogenesis, according to research presented at the ACTRIMS 2017 Forum. Machine learning methods trained and validated with these gene targets are a highly accurate tool that could provide actionable data for health care providers who suspect MS.

RNA sequencing was performed to identify differentially expressed protein-coding and noncoding RNA genes at distinct stages of MS, compared with controls. Expression levels of these genes were validated by real-time polymerase chain reaction (PCR) across all 979 subjects recruited. Ratios of gene expression data were used as inputs to train machine learning classifiers capable of multicategory comparisons. An independent validation testing set consisting of individuals across each control and disease class was used to evaluate the performance of these classifiers. In contrast to protein-coding gene targets where gene expression differences were often twofold or less, lncRNAs were highly differentially expressed across each of the experimental groups compared. Training and validation of machine learning methods revealed that lncRNA gene expression inputs resulted in higher overall accuracy and confidence of machine learning predictions than did protein-coding genes, resulting in greater than 90% accuracy in the validation testing set. 

—Glenn S. Williams

ORLANDO—RNA expression patterns are highly dynamic, even at the earliest stages of multiple sclerosis (MS) pathogenesis, according to research presented at the ACTRIMS 2017 Forum. Machine learning methods trained and validated with these gene targets are a highly accurate tool that could provide actionable data for health care providers who suspect MS.

RNA sequencing was performed to identify differentially expressed protein-coding and noncoding RNA genes at distinct stages of MS, compared with controls. Expression levels of these genes were validated by real-time polymerase chain reaction (PCR) across all 979 subjects recruited. Ratios of gene expression data were used as inputs to train machine learning classifiers capable of multicategory comparisons. An independent validation testing set consisting of individuals across each control and disease class was used to evaluate the performance of these classifiers. In contrast to protein-coding gene targets where gene expression differences were often twofold or less, lncRNAs were highly differentially expressed across each of the experimental groups compared. Training and validation of machine learning methods revealed that lncRNA gene expression inputs resulted in higher overall accuracy and confidence of machine learning predictions than did protein-coding genes, resulting in greater than 90% accuracy in the validation testing set. 

—Glenn S. Williams

Henri R. Ford, MD, MHA, FACS, FAAP, vice-president and surgeon-in-chief, Children’s Hospital Los Angeles; professor of surgery and vice-dean for medical education, Keck School of Medicine, University of Southern California; and member of the American College of Surgeons Board of Regents, was accorded Honorary Fellowship in the Royal College of Surgeons of England (RCSEng) on March 7 in London, U.K.

A world-renowned Haitian-American surgeon, Dr. Ford played a prominent role in organizing and leading medical teams in response to the catastrophic 2010 earthquake in Haiti. Born in Haiti, Dr. Ford regularly returns to his native country to teach, lead operating teams, and assist in developing surgical systems, which the island nation historically has lacked. His accomplishments there are myriad. For example, in May 2015, Dr. Ford led a team of health care professionals that made history by completing the first separation of conjoined twins in Haiti. (Read more about the operation at www.cbsnews.com/news/more-than-just-a-surgery-conjoined-twins-separated-in-haiti/.)

Dr. Ford and his family fled Haiti’s oppressive regime and came to the U.S. when he was 13 years old. He received his medical degree from Harvard Medical School, Boston, MA, and trained in general surgery at Weill Cornell Medical College, New York, NY. He completed his pediatric surgical training at Children’s Hospital of Pittsburgh, PA. Prior to joining Children’s Hospital Los Angeles in 2005, Dr. Ford was professor and chief, division of pediatric surgery, and surgeon-in-chief, Children’s Hospital of Pittsburgh and the University of Pittsburgh School of Medicine.

Su-Anna Boddy, MS, FRCS, council member for the RCSEng, introduced Dr. Ford at the ceremony and spoke of his accomplishments, and Clare Marx, CBE, DL, PRCS, RCSEng president, formally awarded him the honor.
 

Henri R. Ford, MD, MHA, FACS, FAAP, vice-president and surgeon-in-chief, Children’s Hospital Los Angeles; professor of surgery and vice-dean for medical education, Keck School of Medicine, University of Southern California; and member of the American College of Surgeons Board of Regents, was accorded Honorary Fellowship in the Royal College of Surgeons of England (RCSEng) on March 7 in London, U.K.

A world-renowned Haitian-American surgeon, Dr. Ford played a prominent role in organizing and leading medical teams in response to the catastrophic 2010 earthquake in Haiti. Born in Haiti, Dr. Ford regularly returns to his native country to teach, lead operating teams, and assist in developing surgical systems, which the island nation historically has lacked. His accomplishments there are myriad. For example, in May 2015, Dr. Ford led a team of health care professionals that made history by completing the first separation of conjoined twins in Haiti. (Read more about the operation at www.cbsnews.com/news/more-than-just-a-surgery-conjoined-twins-separated-in-haiti/.)

Dr. Ford and his family fled Haiti’s oppressive regime and came to the U.S. when he was 13 years old. He received his medical degree from Harvard Medical School, Boston, MA, and trained in general surgery at Weill Cornell Medical College, New York, NY. He completed his pediatric surgical training at Children’s Hospital of Pittsburgh, PA. Prior to joining Children’s Hospital Los Angeles in 2005, Dr. Ford was professor and chief, division of pediatric surgery, and surgeon-in-chief, Children’s Hospital of Pittsburgh and the University of Pittsburgh School of Medicine.

Su-Anna Boddy, MS, FRCS, council member for the RCSEng, introduced Dr. Ford at the ceremony and spoke of his accomplishments, and Clare Marx, CBE, DL, PRCS, RCSEng president, formally awarded him the honor.
 

Henri R. Ford, MD, MHA, FACS, FAAP, vice-president and surgeon-in-chief, Children’s Hospital Los Angeles; professor of surgery and vice-dean for medical education, Keck School of Medicine, University of Southern California; and member of the American College of Surgeons Board of Regents, was accorded Honorary Fellowship in the Royal College of Surgeons of England (RCSEng) on March 7 in London, U.K.

A world-renowned Haitian-American surgeon, Dr. Ford played a prominent role in organizing and leading medical teams in response to the catastrophic 2010 earthquake in Haiti. Born in Haiti, Dr. Ford regularly returns to his native country to teach, lead operating teams, and assist in developing surgical systems, which the island nation historically has lacked. His accomplishments there are myriad. For example, in May 2015, Dr. Ford led a team of health care professionals that made history by completing the first separation of conjoined twins in Haiti. (Read more about the operation at www.cbsnews.com/news/more-than-just-a-surgery-conjoined-twins-separated-in-haiti/.)

Dr. Ford and his family fled Haiti’s oppressive regime and came to the U.S. when he was 13 years old. He received his medical degree from Harvard Medical School, Boston, MA, and trained in general surgery at Weill Cornell Medical College, New York, NY. He completed his pediatric surgical training at Children’s Hospital of Pittsburgh, PA. Prior to joining Children’s Hospital Los Angeles in 2005, Dr. Ford was professor and chief, division of pediatric surgery, and surgeon-in-chief, Children’s Hospital of Pittsburgh and the University of Pittsburgh School of Medicine.

Su-Anna Boddy, MS, FRCS, council member for the RCSEng, introduced Dr. Ford at the ceremony and spoke of his accomplishments, and Clare Marx, CBE, DL, PRCS, RCSEng president, formally awarded him the honor.