ACS Surgery News

SAN FRANCISCO – The distance of a breast cancer from a woman’s nipple added to the ability of nomograms to predict sentinel lymph node positivity, based on a study of data from 401 breast cancers.

The data came from 395 patients who had clinical stage T1 (85% of the cohort) or T2 tumors and underwent prebiopsy ultrasounds at the Mayo Clinic, Rochester, Minn. The investigators performed a second review of the images to measure the tumors’ distance from the nipple.

Nomograms published online by the Memorial Sloan-Kettering Cancer Center and by the University of Texas M.D. Anderson Cancer Center do a reasonably good job of discriminating which newly diagnosed breast cancer patients who have not undergone neoadjuvant therapy are likely to have positive and negative sentinel nodes. Using those two nomograms alone on the patients in the study produced an area under the curve (AUC) of 0.71 for the Memorial Sloan-Kettering nomogram and 0.74 for the M.D. Anderson nomogram. Adding a tumor-to-nipple distance of 2 cm or less improved the AUCs to 0.73 and 0.76, respectively, Dr. Miraj Shah-Khan and her coinvestigators reported.

Sentinel lymph nodes were positive in 20% of the 401 tumors; 17 of 33 tumors within 2 cm of the nipple had positive sentinel lymph nodes (52%), compared with 17% of 368 tumors farther than 2 cm from the nipple, Dr. Shah-Khan, of the Medical College of Wisconsin, Milwaukee, and her associates reported in a poster presented at a breast cancer symposium sponsored by the American Society of Clinical Oncology.

In each subgroup of probability predicted by the nomograms, tumor-to-nipple distance helped to refine the probability of a positive node.

When the Memorial Sloan-Kettering nomogram predicted less than a 25% chance of node positivity, adding a tumor-to-nipple distance of 2 cm or less changed the probability to 35%, compared with 11% if the distance was greater than 2 cm. A probability of 25%-49% from the same nomogram changed to 62% if a tumor was within 2 cm of the nipple or 29% for tumors farther from the nipple. A probability of 50% or greater from the nomogram changed to 100% if a tumor was within 2 cm of the nipple or 32% if it was farther away.

When the M.D. Anderson nomogram predicted less than a 25% chance of node positivity, adding a tumor-to-nipple distance of 2 cm or less changed the probability to 42%, compared with 14% if the distance was greater than 2 cm. A probability of 25%-49% from the same nomogram changed to 83% if a tumor was within 2 cm of the nipple or 40% for tumors farther from the nipple. A probability of 50% or greater from the nomogram changed to 100% if a tumor was within 2 cm of the nipple or 67% if it was farther away, she reported.

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. Shah-Khan reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – The distance of a breast cancer from a woman’s nipple added to the ability of nomograms to predict sentinel lymph node positivity, based on a study of data from 401 breast cancers.

The data came from 395 patients who had clinical stage T1 (85% of the cohort) or T2 tumors and underwent prebiopsy ultrasounds at the Mayo Clinic, Rochester, Minn. The investigators performed a second review of the images to measure the tumors’ distance from the nipple.

Nomograms published online by the Memorial Sloan-Kettering Cancer Center and by the University of Texas M.D. Anderson Cancer Center do a reasonably good job of discriminating which newly diagnosed breast cancer patients who have not undergone neoadjuvant therapy are likely to have positive and negative sentinel nodes. Using those two nomograms alone on the patients in the study produced an area under the curve (AUC) of 0.71 for the Memorial Sloan-Kettering nomogram and 0.74 for the M.D. Anderson nomogram. Adding a tumor-to-nipple distance of 2 cm or less improved the AUCs to 0.73 and 0.76, respectively, Dr. Miraj Shah-Khan and her coinvestigators reported.

Sentinel lymph nodes were positive in 20% of the 401 tumors; 17 of 33 tumors within 2 cm of the nipple had positive sentinel lymph nodes (52%), compared with 17% of 368 tumors farther than 2 cm from the nipple, Dr. Shah-Khan, of the Medical College of Wisconsin, Milwaukee, and her associates reported in a poster presented at a breast cancer symposium sponsored by the American Society of Clinical Oncology.

In each subgroup of probability predicted by the nomograms, tumor-to-nipple distance helped to refine the probability of a positive node.

When the Memorial Sloan-Kettering nomogram predicted less than a 25% chance of node positivity, adding a tumor-to-nipple distance of 2 cm or less changed the probability to 35%, compared with 11% if the distance was greater than 2 cm. A probability of 25%-49% from the same nomogram changed to 62% if a tumor was within 2 cm of the nipple or 29% for tumors farther from the nipple. A probability of 50% or greater from the nomogram changed to 100% if a tumor was within 2 cm of the nipple or 32% if it was farther away.

When the M.D. Anderson nomogram predicted less than a 25% chance of node positivity, adding a tumor-to-nipple distance of 2 cm or less changed the probability to 42%, compared with 14% if the distance was greater than 2 cm. A probability of 25%-49% from the same nomogram changed to 83% if a tumor was within 2 cm of the nipple or 40% for tumors farther from the nipple. A probability of 50% or greater from the nomogram changed to 100% if a tumor was within 2 cm of the nipple or 67% if it was farther away, she reported.

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. Shah-Khan reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – The distance of a breast cancer from a woman’s nipple added to the ability of nomograms to predict sentinel lymph node positivity, based on a study of data from 401 breast cancers.

The data came from 395 patients who had clinical stage T1 (85% of the cohort) or T2 tumors and underwent prebiopsy ultrasounds at the Mayo Clinic, Rochester, Minn. The investigators performed a second review of the images to measure the tumors’ distance from the nipple.

Nomograms published online by the Memorial Sloan-Kettering Cancer Center and by the University of Texas M.D. Anderson Cancer Center do a reasonably good job of discriminating which newly diagnosed breast cancer patients who have not undergone neoadjuvant therapy are likely to have positive and negative sentinel nodes. Using those two nomograms alone on the patients in the study produced an area under the curve (AUC) of 0.71 for the Memorial Sloan-Kettering nomogram and 0.74 for the M.D. Anderson nomogram. Adding a tumor-to-nipple distance of 2 cm or less improved the AUCs to 0.73 and 0.76, respectively, Dr. Miraj Shah-Khan and her coinvestigators reported.

Sentinel lymph nodes were positive in 20% of the 401 tumors; 17 of 33 tumors within 2 cm of the nipple had positive sentinel lymph nodes (52%), compared with 17% of 368 tumors farther than 2 cm from the nipple, Dr. Shah-Khan, of the Medical College of Wisconsin, Milwaukee, and her associates reported in a poster presented at a breast cancer symposium sponsored by the American Society of Clinical Oncology.

In each subgroup of probability predicted by the nomograms, tumor-to-nipple distance helped to refine the probability of a positive node.

When the Memorial Sloan-Kettering nomogram predicted less than a 25% chance of node positivity, adding a tumor-to-nipple distance of 2 cm or less changed the probability to 35%, compared with 11% if the distance was greater than 2 cm. A probability of 25%-49% from the same nomogram changed to 62% if a tumor was within 2 cm of the nipple or 29% for tumors farther from the nipple. A probability of 50% or greater from the nomogram changed to 100% if a tumor was within 2 cm of the nipple or 32% if it was farther away.

When the M.D. Anderson nomogram predicted less than a 25% chance of node positivity, adding a tumor-to-nipple distance of 2 cm or less changed the probability to 42%, compared with 14% if the distance was greater than 2 cm. A probability of 25%-49% from the same nomogram changed to 83% if a tumor was within 2 cm of the nipple or 40% for tumors farther from the nipple. A probability of 50% or greater from the nomogram changed to 100% if a tumor was within 2 cm of the nipple or 67% if it was farther away, she reported.

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. Shah-Khan reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

Medicare has hired a contractor to ferret out and recover improper bonuses paid to physicians for quality reporting and electronic prescribing efforts.

Under a $9.9 million contract, Arch Systems of Baltimore will validate the accuracy of data submitted to the Electronic Prescribing Incentive Program (eRx) and Physician Quality Reporting System (PQRS), specifically targeting quality data submitted through registries and the group practice reporting option. Data submitted via the widely used claims-based reporting option could be included in subsequent reviews.

"Since the inception of the PQRS and eRx incentive programs, there have been reports uncovering data-integrity issues and misunderstandings regarding data submissions, and suspicious attempts of ‘gaming’ the system to earn the PQRS and/or eRx incentive payment," according to documents from the Centers for Medicare & Medicaid Services. "Despite extensive education and outreach efforts, mandatory support calls, and special training sessions, these data issues persist."

The data have been validated once already, CMS spokesperson Don McLeod said in an interview. During these checks, the agency discovered issues in which information submitted by eligible providers did not match data in the agency’s records.

"The intent is to ensure that the data that is used by aligning programs [such as the Physician Value Based Payment Modifier or the Physician Compare website] is accurate and valid," he said.

Most registries are run by third parties, but all are certified by CMS. The agency is seeking to verify that the data sent by registries on behalf of providers are accurate.

Physicians have been encouraged to incorporate registries into their practices because of the potential to improve quality at the point of care, according to Dr. Bruce Bagley, interim president and CEO of TransforMED, a subsidiary of the American Academy of Family Physicians. Some registries can produce a list of patients with a specific condition, give a snapshot of applicable quality measures, and show gaps in care.

The scope of the review raises a concern of creating another program similar to the CMS recovery audit contractors program, said Dr. Richard Duszak Jr., a Memphis, Tenn., radiologist and chief medical officer of the Harvey L. Neiman Health Policy Institute at the American College of Radiology. The RAC program poses a significant administrative burden for practices as they seek to recoup overpayments to physicians and hospitals. RAC audits have forced providers to return $5.4 billion since October 2009.

Dr. Duszak and Dr. Bagley said they that have not heard of instances of fraudulent quality reporting. If anything, physicians have struggled with capturing clinical encounters that could be reported for quality measures used to earn bonuses, Dr. Duszak said.

"The auditor will find, far and away, the underreporting of metrics for services that were truly performed," Dr. Duszak said.

He also questioned why practices would "game" the system. Reporting PQRS and eRx encounters is difficult and the paperwork is burdensome, he said.

In 2011, 266,521 eligible professionals earned PQRS incentives that averaged $1,059 and totaled $240.4 million, according to data released by the CMS in April. About $270 million in eRx bonuses was paid to 174,189 health care providers that year. For PQRS, nearly 63,000 providers used registries while just 92 practices sent data via the group practice reporting option.

PQRS data will be critical going forward as the CMS uses quality reporting for its value-based modifier program, said Brian Whitman, associate director of regulatory affairs at the American College of Cardiology. The ACC maintains a PQRS registry for its members and has been supportive of using it to submit data and improve quality of patient care.

"This is only going to become more important as they apply ‘teeth’ to the program through the value-based modifier program," Mr. Whitman said.

The modifier will be used to adjust Medicare pay for physicians practicing in groups of 100 or more eligible health care providers – a total of about 216,000 medical doctors in 1,100 groups – in 2015.

Those physicians who do not participate in PQRS or decline to have the CMS calculate group performance based on quality measures on administrative claims in 2013 could see their payments cut by 1% in 2015.

CMS has proposed expanding the modifier to 491,000 physicians in groups of 10 or more eligible professionals in 2016. That proposal could be finalized in the 2014 Medicare physician fee schedule, expected later this fall.

Medicare has hired a contractor to ferret out and recover improper bonuses paid to physicians for quality reporting and electronic prescribing efforts.

Under a $9.9 million contract, Arch Systems of Baltimore will validate the accuracy of data submitted to the Electronic Prescribing Incentive Program (eRx) and Physician Quality Reporting System (PQRS), specifically targeting quality data submitted through registries and the group practice reporting option. Data submitted via the widely used claims-based reporting option could be included in subsequent reviews.

"Since the inception of the PQRS and eRx incentive programs, there have been reports uncovering data-integrity issues and misunderstandings regarding data submissions, and suspicious attempts of ‘gaming’ the system to earn the PQRS and/or eRx incentive payment," according to documents from the Centers for Medicare & Medicaid Services. "Despite extensive education and outreach efforts, mandatory support calls, and special training sessions, these data issues persist."

The data have been validated once already, CMS spokesperson Don McLeod said in an interview. During these checks, the agency discovered issues in which information submitted by eligible providers did not match data in the agency’s records.

"The intent is to ensure that the data that is used by aligning programs [such as the Physician Value Based Payment Modifier or the Physician Compare website] is accurate and valid," he said.

Most registries are run by third parties, but all are certified by CMS. The agency is seeking to verify that the data sent by registries on behalf of providers are accurate.

Physicians have been encouraged to incorporate registries into their practices because of the potential to improve quality at the point of care, according to Dr. Bruce Bagley, interim president and CEO of TransforMED, a subsidiary of the American Academy of Family Physicians. Some registries can produce a list of patients with a specific condition, give a snapshot of applicable quality measures, and show gaps in care.

The scope of the review raises a concern of creating another program similar to the CMS recovery audit contractors program, said Dr. Richard Duszak Jr., a Memphis, Tenn., radiologist and chief medical officer of the Harvey L. Neiman Health Policy Institute at the American College of Radiology. The RAC program poses a significant administrative burden for practices as they seek to recoup overpayments to physicians and hospitals. RAC audits have forced providers to return $5.4 billion since October 2009.

Dr. Duszak and Dr. Bagley said they that have not heard of instances of fraudulent quality reporting. If anything, physicians have struggled with capturing clinical encounters that could be reported for quality measures used to earn bonuses, Dr. Duszak said.

"The auditor will find, far and away, the underreporting of metrics for services that were truly performed," Dr. Duszak said.

He also questioned why practices would "game" the system. Reporting PQRS and eRx encounters is difficult and the paperwork is burdensome, he said.

In 2011, 266,521 eligible professionals earned PQRS incentives that averaged $1,059 and totaled $240.4 million, according to data released by the CMS in April. About $270 million in eRx bonuses was paid to 174,189 health care providers that year. For PQRS, nearly 63,000 providers used registries while just 92 practices sent data via the group practice reporting option.

PQRS data will be critical going forward as the CMS uses quality reporting for its value-based modifier program, said Brian Whitman, associate director of regulatory affairs at the American College of Cardiology. The ACC maintains a PQRS registry for its members and has been supportive of using it to submit data and improve quality of patient care.

"This is only going to become more important as they apply ‘teeth’ to the program through the value-based modifier program," Mr. Whitman said.

The modifier will be used to adjust Medicare pay for physicians practicing in groups of 100 or more eligible health care providers – a total of about 216,000 medical doctors in 1,100 groups – in 2015.

Those physicians who do not participate in PQRS or decline to have the CMS calculate group performance based on quality measures on administrative claims in 2013 could see their payments cut by 1% in 2015.

CMS has proposed expanding the modifier to 491,000 physicians in groups of 10 or more eligible professionals in 2016. That proposal could be finalized in the 2014 Medicare physician fee schedule, expected later this fall.

Medicare has hired a contractor to ferret out and recover improper bonuses paid to physicians for quality reporting and electronic prescribing efforts.

Under a $9.9 million contract, Arch Systems of Baltimore will validate the accuracy of data submitted to the Electronic Prescribing Incentive Program (eRx) and Physician Quality Reporting System (PQRS), specifically targeting quality data submitted through registries and the group practice reporting option. Data submitted via the widely used claims-based reporting option could be included in subsequent reviews.

"Since the inception of the PQRS and eRx incentive programs, there have been reports uncovering data-integrity issues and misunderstandings regarding data submissions, and suspicious attempts of ‘gaming’ the system to earn the PQRS and/or eRx incentive payment," according to documents from the Centers for Medicare & Medicaid Services. "Despite extensive education and outreach efforts, mandatory support calls, and special training sessions, these data issues persist."

The data have been validated once already, CMS spokesperson Don McLeod said in an interview. During these checks, the agency discovered issues in which information submitted by eligible providers did not match data in the agency’s records.

"The intent is to ensure that the data that is used by aligning programs [such as the Physician Value Based Payment Modifier or the Physician Compare website] is accurate and valid," he said.

Most registries are run by third parties, but all are certified by CMS. The agency is seeking to verify that the data sent by registries on behalf of providers are accurate.

Physicians have been encouraged to incorporate registries into their practices because of the potential to improve quality at the point of care, according to Dr. Bruce Bagley, interim president and CEO of TransforMED, a subsidiary of the American Academy of Family Physicians. Some registries can produce a list of patients with a specific condition, give a snapshot of applicable quality measures, and show gaps in care.

The scope of the review raises a concern of creating another program similar to the CMS recovery audit contractors program, said Dr. Richard Duszak Jr., a Memphis, Tenn., radiologist and chief medical officer of the Harvey L. Neiman Health Policy Institute at the American College of Radiology. The RAC program poses a significant administrative burden for practices as they seek to recoup overpayments to physicians and hospitals. RAC audits have forced providers to return $5.4 billion since October 2009.

Dr. Duszak and Dr. Bagley said they that have not heard of instances of fraudulent quality reporting. If anything, physicians have struggled with capturing clinical encounters that could be reported for quality measures used to earn bonuses, Dr. Duszak said.

"The auditor will find, far and away, the underreporting of metrics for services that were truly performed," Dr. Duszak said.

He also questioned why practices would "game" the system. Reporting PQRS and eRx encounters is difficult and the paperwork is burdensome, he said.

In 2011, 266,521 eligible professionals earned PQRS incentives that averaged $1,059 and totaled $240.4 million, according to data released by the CMS in April. About $270 million in eRx bonuses was paid to 174,189 health care providers that year. For PQRS, nearly 63,000 providers used registries while just 92 practices sent data via the group practice reporting option.

PQRS data will be critical going forward as the CMS uses quality reporting for its value-based modifier program, said Brian Whitman, associate director of regulatory affairs at the American College of Cardiology. The ACC maintains a PQRS registry for its members and has been supportive of using it to submit data and improve quality of patient care.

"This is only going to become more important as they apply ‘teeth’ to the program through the value-based modifier program," Mr. Whitman said.

The modifier will be used to adjust Medicare pay for physicians practicing in groups of 100 or more eligible health care providers – a total of about 216,000 medical doctors in 1,100 groups – in 2015.

Those physicians who do not participate in PQRS or decline to have the CMS calculate group performance based on quality measures on administrative claims in 2013 could see their payments cut by 1% in 2015.

CMS has proposed expanding the modifier to 491,000 physicians in groups of 10 or more eligible professionals in 2016. That proposal could be finalized in the 2014 Medicare physician fee schedule, expected later this fall.

Medicare is dropping its requirement that bariatric surgery facilities be certified.

In a controversial move, officials at the Centers for Medicare and Medicaid Services (CMS) announced Sept. 24 that the evidence is sufficient to conclude that certification does not improve health outcomes for Medicare beneficiaries. As a result, the agency will no longer make certification a condition of Medicare coverage.

The decision reverses the agency’s February 2006 requirements. Since then, Medicare has covered bariatric procedures only when performed at facilities that were either certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center or certified by the American Society for Metabolic and Bariatric Surgery (ASMBS) as a Bariatric Surgery Center of Excellence.

In their announcement, CMS officials said they were leaning in this direction in June when they proposed to lift the certification requirement and asked for public comments.

The response overwhelmingly supported certification. Of the 483 comments received, only 92 favored eliminating the certification requirement.

The change was opposed by physician groups including the ASMBS and the ACS, which operate the certification programs referenced in the previous CMS coverage policy. The groups warned the CMS that dropping the certification requirement would put the safety of vulnerable Medicare patients at risk.

Dr. Jaime Ponce, ASMBS President, said in a statement that he was "disappointed" in the Medicare decision but encouraged that private insurers such as Blue Cross Blue Shield, Aetna, Cigna, and Optum/United Healthcare continue to support accreditation.

The CMS agreed that there is a role for accreditation programs going forward, but said that they are not necessary to ensure safe outcomes for Medicare beneficiaries.

"The removal of a coverage requirement does not require facilities to discontinue practices which they find beneficial," according to the decision memo.

Facilities may choose to continue with certification in order to distinguish themselves from the competition, for instance.

"While CMS agrees with the value of the multidisciplinary team approach and structure, we do not believe that every valued endeavor needs to be buttressed by a Medicare mandate," the memo states. "We expect all facilities to strive to provide the proper equipment and services to meet the needs of its patient population."

CMS officials reviewed nine studies to determine if certification meaningfully improved health outcomes for Medicare beneficiaries. The results were "mixed," the agency said, but overall the evidence showed "no consistent statistical or clinically meaningful difference." Further, nothing in the literature suggested a worsening of outcomes without certification.

The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed, the CMS wrote.

The policy switch was requested by health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the Center for Healthcare Outcomes and Policy at the University of Michigan, Ann Arbor. The scientists asserted that certified facilities were no safer than noncertified ones and that mortality and serious complication rates for bariatric surgery had declined across the country.

The CMS coverage decision did not make changes to the bariatric procedures covered by the agency. Medicare will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body mass index of 35 kg/m² or greater in those with at least one comorbidity related to obesity who previously have been unsuccessful with medical treatment for obesity.

[email protected]

Medicare is dropping its requirement that bariatric surgery facilities be certified.

In a controversial move, officials at the Centers for Medicare and Medicaid Services (CMS) announced Sept. 24 that the evidence is sufficient to conclude that certification does not improve health outcomes for Medicare beneficiaries. As a result, the agency will no longer make certification a condition of Medicare coverage.

The decision reverses the agency’s February 2006 requirements. Since then, Medicare has covered bariatric procedures only when performed at facilities that were either certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center or certified by the American Society for Metabolic and Bariatric Surgery (ASMBS) as a Bariatric Surgery Center of Excellence.

In their announcement, CMS officials said they were leaning in this direction in June when they proposed to lift the certification requirement and asked for public comments.

The response overwhelmingly supported certification. Of the 483 comments received, only 92 favored eliminating the certification requirement.

The change was opposed by physician groups including the ASMBS and the ACS, which operate the certification programs referenced in the previous CMS coverage policy. The groups warned the CMS that dropping the certification requirement would put the safety of vulnerable Medicare patients at risk.

Dr. Jaime Ponce, ASMBS President, said in a statement that he was "disappointed" in the Medicare decision but encouraged that private insurers such as Blue Cross Blue Shield, Aetna, Cigna, and Optum/United Healthcare continue to support accreditation.

The CMS agreed that there is a role for accreditation programs going forward, but said that they are not necessary to ensure safe outcomes for Medicare beneficiaries.

"The removal of a coverage requirement does not require facilities to discontinue practices which they find beneficial," according to the decision memo.

Facilities may choose to continue with certification in order to distinguish themselves from the competition, for instance.

"While CMS agrees with the value of the multidisciplinary team approach and structure, we do not believe that every valued endeavor needs to be buttressed by a Medicare mandate," the memo states. "We expect all facilities to strive to provide the proper equipment and services to meet the needs of its patient population."

CMS officials reviewed nine studies to determine if certification meaningfully improved health outcomes for Medicare beneficiaries. The results were "mixed," the agency said, but overall the evidence showed "no consistent statistical or clinically meaningful difference." Further, nothing in the literature suggested a worsening of outcomes without certification.

The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed, the CMS wrote.

The policy switch was requested by health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the Center for Healthcare Outcomes and Policy at the University of Michigan, Ann Arbor. The scientists asserted that certified facilities were no safer than noncertified ones and that mortality and serious complication rates for bariatric surgery had declined across the country.

The CMS coverage decision did not make changes to the bariatric procedures covered by the agency. Medicare will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body mass index of 35 kg/m² or greater in those with at least one comorbidity related to obesity who previously have been unsuccessful with medical treatment for obesity.

[email protected]

Medicare is dropping its requirement that bariatric surgery facilities be certified.

In a controversial move, officials at the Centers for Medicare and Medicaid Services (CMS) announced Sept. 24 that the evidence is sufficient to conclude that certification does not improve health outcomes for Medicare beneficiaries. As a result, the agency will no longer make certification a condition of Medicare coverage.

The decision reverses the agency’s February 2006 requirements. Since then, Medicare has covered bariatric procedures only when performed at facilities that were either certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center or certified by the American Society for Metabolic and Bariatric Surgery (ASMBS) as a Bariatric Surgery Center of Excellence.

In their announcement, CMS officials said they were leaning in this direction in June when they proposed to lift the certification requirement and asked for public comments.

The response overwhelmingly supported certification. Of the 483 comments received, only 92 favored eliminating the certification requirement.

The change was opposed by physician groups including the ASMBS and the ACS, which operate the certification programs referenced in the previous CMS coverage policy. The groups warned the CMS that dropping the certification requirement would put the safety of vulnerable Medicare patients at risk.

Dr. Jaime Ponce, ASMBS President, said in a statement that he was "disappointed" in the Medicare decision but encouraged that private insurers such as Blue Cross Blue Shield, Aetna, Cigna, and Optum/United Healthcare continue to support accreditation.

The CMS agreed that there is a role for accreditation programs going forward, but said that they are not necessary to ensure safe outcomes for Medicare beneficiaries.

"The removal of a coverage requirement does not require facilities to discontinue practices which they find beneficial," according to the decision memo.

Facilities may choose to continue with certification in order to distinguish themselves from the competition, for instance.

"While CMS agrees with the value of the multidisciplinary team approach and structure, we do not believe that every valued endeavor needs to be buttressed by a Medicare mandate," the memo states. "We expect all facilities to strive to provide the proper equipment and services to meet the needs of its patient population."

CMS officials reviewed nine studies to determine if certification meaningfully improved health outcomes for Medicare beneficiaries. The results were "mixed," the agency said, but overall the evidence showed "no consistent statistical or clinically meaningful difference." Further, nothing in the literature suggested a worsening of outcomes without certification.

The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed, the CMS wrote.

The policy switch was requested by health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the Center for Healthcare Outcomes and Policy at the University of Michigan, Ann Arbor. The scientists asserted that certified facilities were no safer than noncertified ones and that mortality and serious complication rates for bariatric surgery had declined across the country.

The CMS coverage decision did not make changes to the bariatric procedures covered by the agency. Medicare will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body mass index of 35 kg/m² or greater in those with at least one comorbidity related to obesity who previously have been unsuccessful with medical treatment for obesity.

[email protected]

A paradigm shift in scientific communication occurred in 1450 when Johannes Gutenberg invented the printing press. Before then, dissemination of information depended on the painstaking copying of manuscripts and books by monks in monasteries or the sharing of insights within a limited community by means of letters. A natural spinoff from the ability to mass produce written documents was the invention of the journal, the first one entirely devoted to science being the Philosophical Transactions of the Royal Society of London in 1665. Since then there has been a remarkably steady increase in the number of journals of 3.5% per year that brings us to the 2012 census of approximately 28,100 scholarly, peer-reviewed journals that collectively publish 1.9 million articles a year (The STM Report 2012. The Hague: International Association of Scientific, Technical and Medical Publishers). As a result, the publishing industry has flourished and billions of trees have been sacrificed to the cause of scientific communication.

The first sign of a decline in the paper flood appeared in 1991 when the initial electronic journal was published. The next paradigm shift in communication was about to take place. Now, nearly all of the greater than 28,000 journals have adopted this new technology and are available via the Internet. However, the move away from print publication has been more gradual with many journals still offering print as well as electronic editions.

There have been several reasons, some now outmoded, for preserving the print technology that is now more than half a millennium old. First is the issue of portability. When digital publications could only be read via computer, there was a significant inconvenience factor. But in 2013 there are few surgeons who do not possess one or more of the many portable digital devices that make the surgical literature readily accessible almost anywhere on the planet. Print’s advantage over digital in portability has clearly been negated by these devices. There has been concern in some quarters that without a paper print anchor there is risk that some scientific writings could be lost forever through a major Internet implosion or to a lesser extent from disappearance of a journal’s archives upon cessation of publication or termination of an electronic subscription. Recently developed digital preservation services such as Portico, LOCKSS and CLOCKSS (controlled lots of copies keep stuff safe) have been enlisted by libraries to ensure the safeguarding in perpetuity of the digitally published material they have purchased. These new approaches have proven highly reliable. Finally, advertisers who contribute a significant fraction of the revenue for many journals have been hesitant in some cases to display their wares online rather than in a print format. This appears to be gradually changing.

Despite these barriers, most of them perceived rather than real, there has been an ever-increasing shift from print to digital. Our medical libraries are leading the way. The Ebling Medical Library at the University of Wisconsin is likely typical. Of the 1,200 journals it receives at a cost of $1.2 million, only 37 are in print format. As a result, "the stacks" that represented quiet and comforting study space when we were students are disappearing with considerable savings for these often financially strapped institutions. Access to the majority of these electronic journals is purchased in packages from the major medical publishing houses such as Elsevier, Wolters Kluwer, and Wiley. Two-thirds of Elsevier’s revenue last year was based on digital products ("Global Publishing Leaders 2013: Reed Elsevier Group," Publishers’ Weekly, July 19, 2013. Website accessed 9/13/2013).

At the individual subscription level, a major impetus to keeping print publications afloat is the society owned or sponsored journal. Journals not associated with a society have experienced a marked decline in their print subscriptions over the past decade. As the number of surgeons accessing information from digital mobile devices reaches the tipping point, it is likely that the print edition of many surgical journals, even those affiliated with societies, will eventually disappear.

The logical conclusion from this analysis is that print editions of scientific journals are likely to be either nonexistent or rare within the next decade or two. Digital is less expensive, accessible almost anywhere, and provides increasingly efficient search engines to target one’s reading. Those of you who continue to prefer paper are best advised to purchase a good printer because the printed material you read in the future will likely be produced by you rather than by some distant publishing house.

Dr. Rikkers is Editor in Chief of Surgery News.

A paradigm shift in scientific communication occurred in 1450 when Johannes Gutenberg invented the printing press. Before then, dissemination of information depended on the painstaking copying of manuscripts and books by monks in monasteries or the sharing of insights within a limited community by means of letters. A natural spinoff from the ability to mass produce written documents was the invention of the journal, the first one entirely devoted to science being the Philosophical Transactions of the Royal Society of London in 1665. Since then there has been a remarkably steady increase in the number of journals of 3.5% per year that brings us to the 2012 census of approximately 28,100 scholarly, peer-reviewed journals that collectively publish 1.9 million articles a year (The STM Report 2012. The Hague: International Association of Scientific, Technical and Medical Publishers). As a result, the publishing industry has flourished and billions of trees have been sacrificed to the cause of scientific communication.

The first sign of a decline in the paper flood appeared in 1991 when the initial electronic journal was published. The next paradigm shift in communication was about to take place. Now, nearly all of the greater than 28,000 journals have adopted this new technology and are available via the Internet. However, the move away from print publication has been more gradual with many journals still offering print as well as electronic editions.

There have been several reasons, some now outmoded, for preserving the print technology that is now more than half a millennium old. First is the issue of portability. When digital publications could only be read via computer, there was a significant inconvenience factor. But in 2013 there are few surgeons who do not possess one or more of the many portable digital devices that make the surgical literature readily accessible almost anywhere on the planet. Print’s advantage over digital in portability has clearly been negated by these devices. There has been concern in some quarters that without a paper print anchor there is risk that some scientific writings could be lost forever through a major Internet implosion or to a lesser extent from disappearance of a journal’s archives upon cessation of publication or termination of an electronic subscription. Recently developed digital preservation services such as Portico, LOCKSS and CLOCKSS (controlled lots of copies keep stuff safe) have been enlisted by libraries to ensure the safeguarding in perpetuity of the digitally published material they have purchased. These new approaches have proven highly reliable. Finally, advertisers who contribute a significant fraction of the revenue for many journals have been hesitant in some cases to display their wares online rather than in a print format. This appears to be gradually changing.

Despite these barriers, most of them perceived rather than real, there has been an ever-increasing shift from print to digital. Our medical libraries are leading the way. The Ebling Medical Library at the University of Wisconsin is likely typical. Of the 1,200 journals it receives at a cost of $1.2 million, only 37 are in print format. As a result, "the stacks" that represented quiet and comforting study space when we were students are disappearing with considerable savings for these often financially strapped institutions. Access to the majority of these electronic journals is purchased in packages from the major medical publishing houses such as Elsevier, Wolters Kluwer, and Wiley. Two-thirds of Elsevier’s revenue last year was based on digital products ("Global Publishing Leaders 2013: Reed Elsevier Group," Publishers’ Weekly, July 19, 2013. Website accessed 9/13/2013).

At the individual subscription level, a major impetus to keeping print publications afloat is the society owned or sponsored journal. Journals not associated with a society have experienced a marked decline in their print subscriptions over the past decade. As the number of surgeons accessing information from digital mobile devices reaches the tipping point, it is likely that the print edition of many surgical journals, even those affiliated with societies, will eventually disappear.

The logical conclusion from this analysis is that print editions of scientific journals are likely to be either nonexistent or rare within the next decade or two. Digital is less expensive, accessible almost anywhere, and provides increasingly efficient search engines to target one’s reading. Those of you who continue to prefer paper are best advised to purchase a good printer because the printed material you read in the future will likely be produced by you rather than by some distant publishing house.

Dr. Rikkers is Editor in Chief of Surgery News.

A paradigm shift in scientific communication occurred in 1450 when Johannes Gutenberg invented the printing press. Before then, dissemination of information depended on the painstaking copying of manuscripts and books by monks in monasteries or the sharing of insights within a limited community by means of letters. A natural spinoff from the ability to mass produce written documents was the invention of the journal, the first one entirely devoted to science being the Philosophical Transactions of the Royal Society of London in 1665. Since then there has been a remarkably steady increase in the number of journals of 3.5% per year that brings us to the 2012 census of approximately 28,100 scholarly, peer-reviewed journals that collectively publish 1.9 million articles a year (The STM Report 2012. The Hague: International Association of Scientific, Technical and Medical Publishers). As a result, the publishing industry has flourished and billions of trees have been sacrificed to the cause of scientific communication.

The first sign of a decline in the paper flood appeared in 1991 when the initial electronic journal was published. The next paradigm shift in communication was about to take place. Now, nearly all of the greater than 28,000 journals have adopted this new technology and are available via the Internet. However, the move away from print publication has been more gradual with many journals still offering print as well as electronic editions.

There have been several reasons, some now outmoded, for preserving the print technology that is now more than half a millennium old. First is the issue of portability. When digital publications could only be read via computer, there was a significant inconvenience factor. But in 2013 there are few surgeons who do not possess one or more of the many portable digital devices that make the surgical literature readily accessible almost anywhere on the planet. Print’s advantage over digital in portability has clearly been negated by these devices. There has been concern in some quarters that without a paper print anchor there is risk that some scientific writings could be lost forever through a major Internet implosion or to a lesser extent from disappearance of a journal’s archives upon cessation of publication or termination of an electronic subscription. Recently developed digital preservation services such as Portico, LOCKSS and CLOCKSS (controlled lots of copies keep stuff safe) have been enlisted by libraries to ensure the safeguarding in perpetuity of the digitally published material they have purchased. These new approaches have proven highly reliable. Finally, advertisers who contribute a significant fraction of the revenue for many journals have been hesitant in some cases to display their wares online rather than in a print format. This appears to be gradually changing.

Despite these barriers, most of them perceived rather than real, there has been an ever-increasing shift from print to digital. Our medical libraries are leading the way. The Ebling Medical Library at the University of Wisconsin is likely typical. Of the 1,200 journals it receives at a cost of $1.2 million, only 37 are in print format. As a result, "the stacks" that represented quiet and comforting study space when we were students are disappearing with considerable savings for these often financially strapped institutions. Access to the majority of these electronic journals is purchased in packages from the major medical publishing houses such as Elsevier, Wolters Kluwer, and Wiley. Two-thirds of Elsevier’s revenue last year was based on digital products ("Global Publishing Leaders 2013: Reed Elsevier Group," Publishers’ Weekly, July 19, 2013. Website accessed 9/13/2013).

At the individual subscription level, a major impetus to keeping print publications afloat is the society owned or sponsored journal. Journals not associated with a society have experienced a marked decline in their print subscriptions over the past decade. As the number of surgeons accessing information from digital mobile devices reaches the tipping point, it is likely that the print edition of many surgical journals, even those affiliated with societies, will eventually disappear.

The logical conclusion from this analysis is that print editions of scientific journals are likely to be either nonexistent or rare within the next decade or two. Digital is less expensive, accessible almost anywhere, and provides increasingly efficient search engines to target one’s reading. Those of you who continue to prefer paper are best advised to purchase a good printer because the printed material you read in the future will likely be produced by you rather than by some distant publishing house.

Dr. Rikkers is Editor in Chief of Surgery News.

The Food and Drug Administration is moving forward with plans to create a unique identification system for medical devices over the next several years.

In a final rule published Sept. 24, the agency outlined a schedule for placing a unique ID number on most medical devices over 7 years and launching a publicly searchable database with all of the product information.

The new Unique Device Identification (UDI) system requires medical device manufacturers to create a unique number for every version or model of a device. The number will include the lot or batch number, device expiration date, and manufacturing date. That information will then be incorporated into the Global Unique Device Identification Database (GUDID), run by the FDA. The new database will not store identifying patient information, according to the agency.

The new system should help to improve adverse event reporting, allow for faster recalls, and reduce counterfeiting and device diversion, according to the FDA.

"A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used," Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, said in a statement. "In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development."

While there are no requirements for physicians under the new regulations, FDA officials wrote that they anticipate physicians and other providers will include the unique identifiers in patients’ electronic health records and personal health records to help improve postmarket surveillance, adverse event reporting, and recalls.

Manufacturers of high-risk medical devices, those in class III, are required to place the identifiers on the label and packaging by Sept. 24, 2014. They must also submit information to GUDID within 1 year. Manufacturers of implantable, life-supporting, and life-sustaining devices have until Sept. 24, 2015, to comply.

For moderate-risk devices (class II), manufacturers have 3 years to transition their labeling; and for low-risk devices (class I) they have 5 years. For certain class I and unclassified devices, the compliance date is pushed out to 2020.

The FDA noted that many low-risk devices are exempt from some or all of the labeling requirements in the final rule.

The final rule was called an improvement over a July 2012 proposed rule by the medical device industry. The Advanced Medical Technology Association (AdvaMed) said the final rule made some key changes, such as not requiring that the ID number be marked directly on implants and allowing manufacturers an extra 3 years for devices that are already out in circulation. The FDA is also allowing firms that produce class III devices to petition for a 1-year extension if the extra time is necessary to protect public health.

Implementing the UDI system will be "costly and challenging," Janet Trunzo, senior executive vice president for technology and regulatory affairs at AdvaMed, said in a statement. "It is imperative that it is implemented correctly the first time, and that its ongoing use is practical, economical, and of value to patients, health care providers, industry, and FDA."

The Pew Charitable Trusts, a watchdog group, applauded the FDA for getting the UDI system off the ground. But the final rule is only the first step, Josh Rising, director of Pew’s medical devices initiative, said in a statement. Hospitals, health plans, and physicians need to integrate the identifiers into patients’ health records and insurance billing transactions before the benefits can be fully realized, he said.

[email protected]

The Food and Drug Administration is moving forward with plans to create a unique identification system for medical devices over the next several years.

In a final rule published Sept. 24, the agency outlined a schedule for placing a unique ID number on most medical devices over 7 years and launching a publicly searchable database with all of the product information.

The new Unique Device Identification (UDI) system requires medical device manufacturers to create a unique number for every version or model of a device. The number will include the lot or batch number, device expiration date, and manufacturing date. That information will then be incorporated into the Global Unique Device Identification Database (GUDID), run by the FDA. The new database will not store identifying patient information, according to the agency.

The new system should help to improve adverse event reporting, allow for faster recalls, and reduce counterfeiting and device diversion, according to the FDA.

"A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used," Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, said in a statement. "In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development."

While there are no requirements for physicians under the new regulations, FDA officials wrote that they anticipate physicians and other providers will include the unique identifiers in patients’ electronic health records and personal health records to help improve postmarket surveillance, adverse event reporting, and recalls.

Manufacturers of high-risk medical devices, those in class III, are required to place the identifiers on the label and packaging by Sept. 24, 2014. They must also submit information to GUDID within 1 year. Manufacturers of implantable, life-supporting, and life-sustaining devices have until Sept. 24, 2015, to comply.

For moderate-risk devices (class II), manufacturers have 3 years to transition their labeling; and for low-risk devices (class I) they have 5 years. For certain class I and unclassified devices, the compliance date is pushed out to 2020.

The FDA noted that many low-risk devices are exempt from some or all of the labeling requirements in the final rule.

The final rule was called an improvement over a July 2012 proposed rule by the medical device industry. The Advanced Medical Technology Association (AdvaMed) said the final rule made some key changes, such as not requiring that the ID number be marked directly on implants and allowing manufacturers an extra 3 years for devices that are already out in circulation. The FDA is also allowing firms that produce class III devices to petition for a 1-year extension if the extra time is necessary to protect public health.

Implementing the UDI system will be "costly and challenging," Janet Trunzo, senior executive vice president for technology and regulatory affairs at AdvaMed, said in a statement. "It is imperative that it is implemented correctly the first time, and that its ongoing use is practical, economical, and of value to patients, health care providers, industry, and FDA."

The Pew Charitable Trusts, a watchdog group, applauded the FDA for getting the UDI system off the ground. But the final rule is only the first step, Josh Rising, director of Pew’s medical devices initiative, said in a statement. Hospitals, health plans, and physicians need to integrate the identifiers into patients’ health records and insurance billing transactions before the benefits can be fully realized, he said.

[email protected]

The Food and Drug Administration is moving forward with plans to create a unique identification system for medical devices over the next several years.

In a final rule published Sept. 24, the agency outlined a schedule for placing a unique ID number on most medical devices over 7 years and launching a publicly searchable database with all of the product information.

The new Unique Device Identification (UDI) system requires medical device manufacturers to create a unique number for every version or model of a device. The number will include the lot or batch number, device expiration date, and manufacturing date. That information will then be incorporated into the Global Unique Device Identification Database (GUDID), run by the FDA. The new database will not store identifying patient information, according to the agency.

The new system should help to improve adverse event reporting, allow for faster recalls, and reduce counterfeiting and device diversion, according to the FDA.

"A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used," Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, said in a statement. "In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development."

While there are no requirements for physicians under the new regulations, FDA officials wrote that they anticipate physicians and other providers will include the unique identifiers in patients’ electronic health records and personal health records to help improve postmarket surveillance, adverse event reporting, and recalls.

Manufacturers of high-risk medical devices, those in class III, are required to place the identifiers on the label and packaging by Sept. 24, 2014. They must also submit information to GUDID within 1 year. Manufacturers of implantable, life-supporting, and life-sustaining devices have until Sept. 24, 2015, to comply.

For moderate-risk devices (class II), manufacturers have 3 years to transition their labeling; and for low-risk devices (class I) they have 5 years. For certain class I and unclassified devices, the compliance date is pushed out to 2020.

The FDA noted that many low-risk devices are exempt from some or all of the labeling requirements in the final rule.

The final rule was called an improvement over a July 2012 proposed rule by the medical device industry. The Advanced Medical Technology Association (AdvaMed) said the final rule made some key changes, such as not requiring that the ID number be marked directly on implants and allowing manufacturers an extra 3 years for devices that are already out in circulation. The FDA is also allowing firms that produce class III devices to petition for a 1-year extension if the extra time is necessary to protect public health.

Implementing the UDI system will be "costly and challenging," Janet Trunzo, senior executive vice president for technology and regulatory affairs at AdvaMed, said in a statement. "It is imperative that it is implemented correctly the first time, and that its ongoing use is practical, economical, and of value to patients, health care providers, industry, and FDA."

The Pew Charitable Trusts, a watchdog group, applauded the FDA for getting the UDI system off the ground. But the final rule is only the first step, Josh Rising, director of Pew’s medical devices initiative, said in a statement. Hospitals, health plans, and physicians need to integrate the identifiers into patients’ health records and insurance billing transactions before the benefits can be fully realized, he said.

[email protected]

ATLANTA – Five common radiation therapy practices are not adequately supported by evidence and may not be the best choice for many patients, radiation oncology experts said at the annual meeting of the American Society for Radiation Oncology (ASTRO).

The evidence-based recommendations on radiation therapy for breast cancer, prostate cancer, and bone metastases are part of the national "Choosing Wisely" campaign, which is aimed at improving the quality of care by reducing or eliminating overuse of tests and procedures. This campaign is about "removal of waste to improve quality and safety, and doing no harm to patients," said Daniel Wolfson, executive vice president and chief operating officer of the American Board of Internal Medicine (ABIM) Foundation, which is leading the Choosing Wisely campaign.

Medical societies in various disciplines have released recommendations geared toward individual clinical disciplines, and now it’s ASTRO’s turn, said Dr. Michael L. Steinberg, chairman of ASTRO’s board of directors, in a briefing announcing the guidelines. "The list serves only as a starting point for a detailed conversation between a patient and physician, and to ensure patient-centered care, which is a core principle of ASTRO."

The five recommendations are:

• Don’t initiate whole-breast radiotherapy as a part of breast conservation therapy in women aged 50 years and older with early-stage invasive breast cancer without considering shorter treatment schedules.

"We’ve known for years that whole-breast radiation improves local control and improves survival, and has cosmetic advantages over mastectomy," Dr. Steinberg said. In recent years, however, randomized clinical trials have demonstrated that shorter courses of therapy – less than 4 weeks, compared with 5 weeks for conventionally fractionated radiation – produce equivalent tumor control and cosmetic outcomes.

• Don’t initiate management of patients who have low-risk prostate cancer without discussing active surveillance.

Patients with low-risk prostate cancer should discuss "reasonable management options" with their physicians, including active surveillance. With this recommendation, ASTRO is "reinforcing the shared decision-making model," Dr. Steinberg said.

• Don’t routinely use extended fractionation schemes (more than 10 fractions) for palliation of bone metastases.

Patients with bone metastases may derive equivalent pain relief from 30 Gy in 10 fractions, 20 Gy over 5 fractions, or even a single 8-Gy fraction, studies suggest. The single-fraction option is more convenient for patients, but it may be associated with a marginally higher need for retreatment of the same site. Patients who are not ambulatory, have transportation problems, or a limited prognosis may be good candidates for the single-fraction option, the guidelines say.

• Don’t routinely recommend proton-beam therapy for prostate cancer outside of a prospective clinical trial or registry.

"There is no clear evidence that proton-beam therapy for prostate cancer offers any clinical advantage over other forms of definitive radiation therapy. Clinical trials are necessary to establish a possible advantage of this expensive therapy," the Choosing Wisely guidelines state.

At ASTRO 2012, investigators reported that men who receive proton-beam radiotherapy for prostate cancer have modestly better bowel function in the short term than do those who receive conformal or intensity-modulated radiation, but the effect is transient. In addition, proton-beam therapy is estimated to cost about 70% more than external-beam radiotherapy for the treatment of prostate cancer.

• Don’t routinely use intensity-modulated radiation therapy (IMRT) to deliver whole-breast radiotherapy as part of breast conservation therapy.

"Clinical trials have suggested lower rates of skin toxicity after using modern 3D conformal techniques relative to older methods of 2D planning. In these trials, the term ‘IMRT’ has generally been applied to describe methods that are more accurately defined as field-in-field 3D conformal radiotherapy. While IMRT may be of benefit in select cases where the anatomy is unusual, its routine use has not been demonstrated to provide significant clinical advantage," the guidelines note.

The cost difference between 3D conformal radiotherapy and IMRT for whole-breast radiotherapy is approximately $7,000, according to Dr. Steinberg.

"These are not ‘never do this’ recommendations, these are ‘engage the patient in the shared-decision paradigm’ guidelines, because there may be patients that are better treated with, let’s say, IMRT [for whole-breast radiotherapy]," he said.

Asked whether the Choosing Wisely guidelines in radiation oncology and other disciplines might be used by insurers to justify denying reimbursement for certain procedures, Mr. Wolfson said that "we haven’t seen that, and whether it comes to be will be the question, but we would sharply criticize that [approach]."

ATLANTA – Five common radiation therapy practices are not adequately supported by evidence and may not be the best choice for many patients, radiation oncology experts said at the annual meeting of the American Society for Radiation Oncology (ASTRO).

The evidence-based recommendations on radiation therapy for breast cancer, prostate cancer, and bone metastases are part of the national "Choosing Wisely" campaign, which is aimed at improving the quality of care by reducing or eliminating overuse of tests and procedures. This campaign is about "removal of waste to improve quality and safety, and doing no harm to patients," said Daniel Wolfson, executive vice president and chief operating officer of the American Board of Internal Medicine (ABIM) Foundation, which is leading the Choosing Wisely campaign.

Medical societies in various disciplines have released recommendations geared toward individual clinical disciplines, and now it’s ASTRO’s turn, said Dr. Michael L. Steinberg, chairman of ASTRO’s board of directors, in a briefing announcing the guidelines. "The list serves only as a starting point for a detailed conversation between a patient and physician, and to ensure patient-centered care, which is a core principle of ASTRO."

The five recommendations are:

• Don’t initiate whole-breast radiotherapy as a part of breast conservation therapy in women aged 50 years and older with early-stage invasive breast cancer without considering shorter treatment schedules.

"We’ve known for years that whole-breast radiation improves local control and improves survival, and has cosmetic advantages over mastectomy," Dr. Steinberg said. In recent years, however, randomized clinical trials have demonstrated that shorter courses of therapy – less than 4 weeks, compared with 5 weeks for conventionally fractionated radiation – produce equivalent tumor control and cosmetic outcomes.

• Don’t initiate management of patients who have low-risk prostate cancer without discussing active surveillance.

Patients with low-risk prostate cancer should discuss "reasonable management options" with their physicians, including active surveillance. With this recommendation, ASTRO is "reinforcing the shared decision-making model," Dr. Steinberg said.

• Don’t routinely use extended fractionation schemes (more than 10 fractions) for palliation of bone metastases.

Patients with bone metastases may derive equivalent pain relief from 30 Gy in 10 fractions, 20 Gy over 5 fractions, or even a single 8-Gy fraction, studies suggest. The single-fraction option is more convenient for patients, but it may be associated with a marginally higher need for retreatment of the same site. Patients who are not ambulatory, have transportation problems, or a limited prognosis may be good candidates for the single-fraction option, the guidelines say.

• Don’t routinely recommend proton-beam therapy for prostate cancer outside of a prospective clinical trial or registry.

"There is no clear evidence that proton-beam therapy for prostate cancer offers any clinical advantage over other forms of definitive radiation therapy. Clinical trials are necessary to establish a possible advantage of this expensive therapy," the Choosing Wisely guidelines state.

At ASTRO 2012, investigators reported that men who receive proton-beam radiotherapy for prostate cancer have modestly better bowel function in the short term than do those who receive conformal or intensity-modulated radiation, but the effect is transient. In addition, proton-beam therapy is estimated to cost about 70% more than external-beam radiotherapy for the treatment of prostate cancer.

• Don’t routinely use intensity-modulated radiation therapy (IMRT) to deliver whole-breast radiotherapy as part of breast conservation therapy.

"Clinical trials have suggested lower rates of skin toxicity after using modern 3D conformal techniques relative to older methods of 2D planning. In these trials, the term ‘IMRT’ has generally been applied to describe methods that are more accurately defined as field-in-field 3D conformal radiotherapy. While IMRT may be of benefit in select cases where the anatomy is unusual, its routine use has not been demonstrated to provide significant clinical advantage," the guidelines note.

The cost difference between 3D conformal radiotherapy and IMRT for whole-breast radiotherapy is approximately $7,000, according to Dr. Steinberg.

"These are not ‘never do this’ recommendations, these are ‘engage the patient in the shared-decision paradigm’ guidelines, because there may be patients that are better treated with, let’s say, IMRT [for whole-breast radiotherapy]," he said.

Asked whether the Choosing Wisely guidelines in radiation oncology and other disciplines might be used by insurers to justify denying reimbursement for certain procedures, Mr. Wolfson said that "we haven’t seen that, and whether it comes to be will be the question, but we would sharply criticize that [approach]."

ATLANTA – Five common radiation therapy practices are not adequately supported by evidence and may not be the best choice for many patients, radiation oncology experts said at the annual meeting of the American Society for Radiation Oncology (ASTRO).

The evidence-based recommendations on radiation therapy for breast cancer, prostate cancer, and bone metastases are part of the national "Choosing Wisely" campaign, which is aimed at improving the quality of care by reducing or eliminating overuse of tests and procedures. This campaign is about "removal of waste to improve quality and safety, and doing no harm to patients," said Daniel Wolfson, executive vice president and chief operating officer of the American Board of Internal Medicine (ABIM) Foundation, which is leading the Choosing Wisely campaign.

Medical societies in various disciplines have released recommendations geared toward individual clinical disciplines, and now it’s ASTRO’s turn, said Dr. Michael L. Steinberg, chairman of ASTRO’s board of directors, in a briefing announcing the guidelines. "The list serves only as a starting point for a detailed conversation between a patient and physician, and to ensure patient-centered care, which is a core principle of ASTRO."

The five recommendations are:

• Don’t initiate whole-breast radiotherapy as a part of breast conservation therapy in women aged 50 years and older with early-stage invasive breast cancer without considering shorter treatment schedules.

"We’ve known for years that whole-breast radiation improves local control and improves survival, and has cosmetic advantages over mastectomy," Dr. Steinberg said. In recent years, however, randomized clinical trials have demonstrated that shorter courses of therapy – less than 4 weeks, compared with 5 weeks for conventionally fractionated radiation – produce equivalent tumor control and cosmetic outcomes.

• Don’t initiate management of patients who have low-risk prostate cancer without discussing active surveillance.

Patients with low-risk prostate cancer should discuss "reasonable management options" with their physicians, including active surveillance. With this recommendation, ASTRO is "reinforcing the shared decision-making model," Dr. Steinberg said.

• Don’t routinely use extended fractionation schemes (more than 10 fractions) for palliation of bone metastases.

Patients with bone metastases may derive equivalent pain relief from 30 Gy in 10 fractions, 20 Gy over 5 fractions, or even a single 8-Gy fraction, studies suggest. The single-fraction option is more convenient for patients, but it may be associated with a marginally higher need for retreatment of the same site. Patients who are not ambulatory, have transportation problems, or a limited prognosis may be good candidates for the single-fraction option, the guidelines say.

• Don’t routinely recommend proton-beam therapy for prostate cancer outside of a prospective clinical trial or registry.

"There is no clear evidence that proton-beam therapy for prostate cancer offers any clinical advantage over other forms of definitive radiation therapy. Clinical trials are necessary to establish a possible advantage of this expensive therapy," the Choosing Wisely guidelines state.

At ASTRO 2012, investigators reported that men who receive proton-beam radiotherapy for prostate cancer have modestly better bowel function in the short term than do those who receive conformal or intensity-modulated radiation, but the effect is transient. In addition, proton-beam therapy is estimated to cost about 70% more than external-beam radiotherapy for the treatment of prostate cancer.

• Don’t routinely use intensity-modulated radiation therapy (IMRT) to deliver whole-breast radiotherapy as part of breast conservation therapy.

"Clinical trials have suggested lower rates of skin toxicity after using modern 3D conformal techniques relative to older methods of 2D planning. In these trials, the term ‘IMRT’ has generally been applied to describe methods that are more accurately defined as field-in-field 3D conformal radiotherapy. While IMRT may be of benefit in select cases where the anatomy is unusual, its routine use has not been demonstrated to provide significant clinical advantage," the guidelines note.

The cost difference between 3D conformal radiotherapy and IMRT for whole-breast radiotherapy is approximately $7,000, according to Dr. Steinberg.

"These are not ‘never do this’ recommendations, these are ‘engage the patient in the shared-decision paradigm’ guidelines, because there may be patients that are better treated with, let’s say, IMRT [for whole-breast radiotherapy]," he said.

Asked whether the Choosing Wisely guidelines in radiation oncology and other disciplines might be used by insurers to justify denying reimbursement for certain procedures, Mr. Wolfson said that "we haven’t seen that, and whether it comes to be will be the question, but we would sharply criticize that [approach]."

All stage IV colorectal cancer patients should be screened for Lynch syndrome, according to Dr. Douglas J. Hartman, and his colleagues at the University of Pittsburgh.

Published pathology models for predicting high microsatellite instability failed to identify up to 13% of Lynch syndrome–associated colorectal carcinomas in a study conducted by Dr. Hartman and his associates.

Current predictive pathology models for the detection of high microsatellite instability (MSI-H) colorectal cancers, including PREDICT and MSPath, rely primarily on right-sided tumor detection; however, Dr. Hartman and his associates determined that MSI-H tumors within the left colon and rectum were associated with Lynch syndrome in 57% of cases. In addition, revised Bethesda Guidelines for Lynch syndrome screening in colorectal cancer patients do not call for microsatellite instability testing in patients over age 60 years, yet 32% of left-sided tumors were identified in patients over age 60 years (Hum Pathol. 2013 Sep 10 [doi: 10.1016/j.humpath.2013.06.012]).

The researchers used MSI polymerase chain reaction (MSI-PCR) and DNA mismatch repair protein immunohistochemistry to prospectively analyze 1,292 colorectal cancers between January 2009 and July 2012. During 2009-2011, cases were evaluated using MSI-PCR only. In 2012, cases were first evaluated with immunohistochemistry. MSI-PCR was performed if there were any equivocal findings in the first round of testing.

MSI-H was found in 150 tumors; 112 were sporadic and 38 were probable Lynch syndrome as determined by BRAF V600E mutation, MLH1 promoter hypermethylation, cancer history, and germline mismatch repair gene mutation. All MSI-H tumors were analyzed for their grade, location, and histology; left-sided MSI-H tumors (n = 12; 57%) were more likely to be Lynch syndrome–related than were right-sided tumors (n = 26; 20%).

Neither PREDICT nor MSPath identified all Lynch syndrome–related tumors: PREDICT found 87% (33 of the 38), while MSPath identified 92% (35 of the 38). The researchers attributed these shortcomings to current predictive models’ "reliance on right-sided location."

"At our institution, we employ a universal screening approach for all resected colorectal carcinomas and biopsies from stage IV colorectal carcinomas regardless of patient age, tumor histology, and tumor location. Patients with tumors exhibiting loss of MSH2 and/or MSH6 and isolated loss of PMS2 are referred for further genetic counseling. Tumors with loss of MLH1 and PMS2 protein expression are further evaluated with BRAF mutation analysis and MLH1 promoter hypermethylation analysis before referral to genetic counseling," the authors wrote.

Contrary to some previously published data, the researchers also found that sporadic MSI-H tumors shared similar morphologies with tumors associated with probable Lynch syndrome, with the exception of a slightly higher proportion of sporadic MSI-H tumors (81%) demonstrating tumor infiltrating lymphocytes as compared with Lynch syndrome–associated tumors (61%).

The authors wrote that this is the "largest study" to date of consecutively identified Lynch syndrome–associated and sporadic tumors. As previous reports were based on retrospective data of primarily Lynch syndrome–associated tumors, those results were "vastly enriched for patients selected for analysis based on cancer-related personal or family history."

The failure of current predictive pathology models to predict all MSI-H and Lynch syndrome–related tumors, particularly left-sided ones, is a strong argument for universal screening, which "does not require widespread application of clinicopathologic criteria by clinicians and pathologists in order to select patients for testing." Further, universal screening is cost effective, and provides useful predictive and prognostic data in reducing cancer risks for patients and relatives who may or may not benefit from genetic counseling, particularly in patients over 60 years, for whom most of the MSI-H tumors were sporadic (91.5%), requiring no additional genetic counseling or testing.

Dr. Hartman and his associates reported no relevant disclosures.

[email protected]

All stage IV colorectal cancer patients should be screened for Lynch syndrome, according to Dr. Douglas J. Hartman, and his colleagues at the University of Pittsburgh.

Published pathology models for predicting high microsatellite instability failed to identify up to 13% of Lynch syndrome–associated colorectal carcinomas in a study conducted by Dr. Hartman and his associates.

Current predictive pathology models for the detection of high microsatellite instability (MSI-H) colorectal cancers, including PREDICT and MSPath, rely primarily on right-sided tumor detection; however, Dr. Hartman and his associates determined that MSI-H tumors within the left colon and rectum were associated with Lynch syndrome in 57% of cases. In addition, revised Bethesda Guidelines for Lynch syndrome screening in colorectal cancer patients do not call for microsatellite instability testing in patients over age 60 years, yet 32% of left-sided tumors were identified in patients over age 60 years (Hum Pathol. 2013 Sep 10 [doi: 10.1016/j.humpath.2013.06.012]).

The researchers used MSI polymerase chain reaction (MSI-PCR) and DNA mismatch repair protein immunohistochemistry to prospectively analyze 1,292 colorectal cancers between January 2009 and July 2012. During 2009-2011, cases were evaluated using MSI-PCR only. In 2012, cases were first evaluated with immunohistochemistry. MSI-PCR was performed if there were any equivocal findings in the first round of testing.

MSI-H was found in 150 tumors; 112 were sporadic and 38 were probable Lynch syndrome as determined by BRAF V600E mutation, MLH1 promoter hypermethylation, cancer history, and germline mismatch repair gene mutation. All MSI-H tumors were analyzed for their grade, location, and histology; left-sided MSI-H tumors (n = 12; 57%) were more likely to be Lynch syndrome–related than were right-sided tumors (n = 26; 20%).

Neither PREDICT nor MSPath identified all Lynch syndrome–related tumors: PREDICT found 87% (33 of the 38), while MSPath identified 92% (35 of the 38). The researchers attributed these shortcomings to current predictive models’ "reliance on right-sided location."

"At our institution, we employ a universal screening approach for all resected colorectal carcinomas and biopsies from stage IV colorectal carcinomas regardless of patient age, tumor histology, and tumor location. Patients with tumors exhibiting loss of MSH2 and/or MSH6 and isolated loss of PMS2 are referred for further genetic counseling. Tumors with loss of MLH1 and PMS2 protein expression are further evaluated with BRAF mutation analysis and MLH1 promoter hypermethylation analysis before referral to genetic counseling," the authors wrote.

Contrary to some previously published data, the researchers also found that sporadic MSI-H tumors shared similar morphologies with tumors associated with probable Lynch syndrome, with the exception of a slightly higher proportion of sporadic MSI-H tumors (81%) demonstrating tumor infiltrating lymphocytes as compared with Lynch syndrome–associated tumors (61%).

The authors wrote that this is the "largest study" to date of consecutively identified Lynch syndrome–associated and sporadic tumors. As previous reports were based on retrospective data of primarily Lynch syndrome–associated tumors, those results were "vastly enriched for patients selected for analysis based on cancer-related personal or family history."

The failure of current predictive pathology models to predict all MSI-H and Lynch syndrome–related tumors, particularly left-sided ones, is a strong argument for universal screening, which "does not require widespread application of clinicopathologic criteria by clinicians and pathologists in order to select patients for testing." Further, universal screening is cost effective, and provides useful predictive and prognostic data in reducing cancer risks for patients and relatives who may or may not benefit from genetic counseling, particularly in patients over 60 years, for whom most of the MSI-H tumors were sporadic (91.5%), requiring no additional genetic counseling or testing.

Dr. Hartman and his associates reported no relevant disclosures.

[email protected]

All stage IV colorectal cancer patients should be screened for Lynch syndrome, according to Dr. Douglas J. Hartman, and his colleagues at the University of Pittsburgh.

Published pathology models for predicting high microsatellite instability failed to identify up to 13% of Lynch syndrome–associated colorectal carcinomas in a study conducted by Dr. Hartman and his associates.

Current predictive pathology models for the detection of high microsatellite instability (MSI-H) colorectal cancers, including PREDICT and MSPath, rely primarily on right-sided tumor detection; however, Dr. Hartman and his associates determined that MSI-H tumors within the left colon and rectum were associated with Lynch syndrome in 57% of cases. In addition, revised Bethesda Guidelines for Lynch syndrome screening in colorectal cancer patients do not call for microsatellite instability testing in patients over age 60 years, yet 32% of left-sided tumors were identified in patients over age 60 years (Hum Pathol. 2013 Sep 10 [doi: 10.1016/j.humpath.2013.06.012]).

The researchers used MSI polymerase chain reaction (MSI-PCR) and DNA mismatch repair protein immunohistochemistry to prospectively analyze 1,292 colorectal cancers between January 2009 and July 2012. During 2009-2011, cases were evaluated using MSI-PCR only. In 2012, cases were first evaluated with immunohistochemistry. MSI-PCR was performed if there were any equivocal findings in the first round of testing.

MSI-H was found in 150 tumors; 112 were sporadic and 38 were probable Lynch syndrome as determined by BRAF V600E mutation, MLH1 promoter hypermethylation, cancer history, and germline mismatch repair gene mutation. All MSI-H tumors were analyzed for their grade, location, and histology; left-sided MSI-H tumors (n = 12; 57%) were more likely to be Lynch syndrome–related than were right-sided tumors (n = 26; 20%).

Neither PREDICT nor MSPath identified all Lynch syndrome–related tumors: PREDICT found 87% (33 of the 38), while MSPath identified 92% (35 of the 38). The researchers attributed these shortcomings to current predictive models’ "reliance on right-sided location."

"At our institution, we employ a universal screening approach for all resected colorectal carcinomas and biopsies from stage IV colorectal carcinomas regardless of patient age, tumor histology, and tumor location. Patients with tumors exhibiting loss of MSH2 and/or MSH6 and isolated loss of PMS2 are referred for further genetic counseling. Tumors with loss of MLH1 and PMS2 protein expression are further evaluated with BRAF mutation analysis and MLH1 promoter hypermethylation analysis before referral to genetic counseling," the authors wrote.

Contrary to some previously published data, the researchers also found that sporadic MSI-H tumors shared similar morphologies with tumors associated with probable Lynch syndrome, with the exception of a slightly higher proportion of sporadic MSI-H tumors (81%) demonstrating tumor infiltrating lymphocytes as compared with Lynch syndrome–associated tumors (61%).

The authors wrote that this is the "largest study" to date of consecutively identified Lynch syndrome–associated and sporadic tumors. As previous reports were based on retrospective data of primarily Lynch syndrome–associated tumors, those results were "vastly enriched for patients selected for analysis based on cancer-related personal or family history."

The failure of current predictive pathology models to predict all MSI-H and Lynch syndrome–related tumors, particularly left-sided ones, is a strong argument for universal screening, which "does not require widespread application of clinicopathologic criteria by clinicians and pathologists in order to select patients for testing." Further, universal screening is cost effective, and provides useful predictive and prognostic data in reducing cancer risks for patients and relatives who may or may not benefit from genetic counseling, particularly in patients over 60 years, for whom most of the MSI-H tumors were sporadic (91.5%), requiring no additional genetic counseling or testing.

Dr. Hartman and his associates reported no relevant disclosures.

[email protected]

Officials at the Food and Drug Administration have no plans to regulate mobile applications that let consumers compare their symptoms to a list of medical conditions, link patients to a portal with their own health information, or allow patients to measure and track their own vital signs.

But the agency has identified a limited scope of mobile medical apps that it intends to regulate because they function as medical devices and pose a potential safety risk if they malfunction. For instance, a mobile app that uses either internal or external sensors to create an electronic stethoscope would be regulated as a medical device.

The FDA issued a 43-page guidance document on Sept. 23 outlining its regulatory approach and listing examples of what will be regulated, what probably won’t be regulated, and what is not considered a medical app.

Copyright © 2013 Apple Inc. All rights reserved

In general, the FDA plans to regulate mobile apps that act as an extension of a medical device by displaying, storing, analyzing, or transmitting patient-specific medical data. Also, the agency will regulate apps that transform a mobile platform into a device, such as the attachment of electrocardiographic (ECG) electrodes to a mobile platform to measure, store, or display ECG signals.

Mobile apps will be regulated if they perform patient-specific diagnoses or make treatment recommendations. This type of app might use patient data to calculate a drug dosage or create a dosage plan for radiation therapy.

The agency does not plan to regulate apps that help patients self-manage their health conditions, provide tools for patients to track their health information, automate simple tasks for providers, or allow patients and providers to interact with a personal health record or an electronic health record.

"Although many mobile apps pertain to health, of which many may be medical devices, we are only continuing our oversight for a very small subset of those mobile apps that are medical devices," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said during a press briefing. "We believe this approach will promote innovation, while protecting patient safety, by focusing on those mobile apps that pose greater risk to patients."

But even if an app is deemed a mobile medical app by the FDA, the agency does not intend to regulate apps that pose minimal risks to consumers. For instance, a mobile app that prompts consumers to enter which herbs or drugs they would like to take concurrently and provides drug interaction information could be considered a medical device, according to the guidance document. But because it poses a low risk to the public, the agency does not intend to regulate it at this time.

The FDA first issued draft guidance on mobile medical apps in July 2011. This final guidance document represents the agency’s current thinking on the topic, but it is not binding on either the agency or the public.

"Regulating mobile apps is nothing new for us," Dr. Shuren said. Over the past 15 years, the FDA has cleared more than 75 apps, with about 20 of those receiving approval in the past year.

The guidance also makes clear that physicians who create mobile medical apps, or who customize a medical app for their own professional use, are not subject to regulation as long as they aren’t promoting it for general use by others. Even if the physician allows the app to be used by others in a group practice, he or she is still not considered a manufacturer under the FDA guidance.

The guidance does not apply to clinical decision support software. That software will be addressed as part of a larger health information technology regulatory framework that the FDA is working on in collaboration with the Office of the National Coordinator for Health Information Technology.

[email protected]

On Twitter @MaryEllenNY

Officials at the Food and Drug Administration have no plans to regulate mobile applications that let consumers compare their symptoms to a list of medical conditions, link patients to a portal with their own health information, or allow patients to measure and track their own vital signs.

But the agency has identified a limited scope of mobile medical apps that it intends to regulate because they function as medical devices and pose a potential safety risk if they malfunction. For instance, a mobile app that uses either internal or external sensors to create an electronic stethoscope would be regulated as a medical device.

The FDA issued a 43-page guidance document on Sept. 23 outlining its regulatory approach and listing examples of what will be regulated, what probably won’t be regulated, and what is not considered a medical app.

Copyright © 2013 Apple Inc. All rights reserved

In general, the FDA plans to regulate mobile apps that act as an extension of a medical device by displaying, storing, analyzing, or transmitting patient-specific medical data. Also, the agency will regulate apps that transform a mobile platform into a device, such as the attachment of electrocardiographic (ECG) electrodes to a mobile platform to measure, store, or display ECG signals.

Mobile apps will be regulated if they perform patient-specific diagnoses or make treatment recommendations. This type of app might use patient data to calculate a drug dosage or create a dosage plan for radiation therapy.

The agency does not plan to regulate apps that help patients self-manage their health conditions, provide tools for patients to track their health information, automate simple tasks for providers, or allow patients and providers to interact with a personal health record or an electronic health record.

"Although many mobile apps pertain to health, of which many may be medical devices, we are only continuing our oversight for a very small subset of those mobile apps that are medical devices," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said during a press briefing. "We believe this approach will promote innovation, while protecting patient safety, by focusing on those mobile apps that pose greater risk to patients."

But even if an app is deemed a mobile medical app by the FDA, the agency does not intend to regulate apps that pose minimal risks to consumers. For instance, a mobile app that prompts consumers to enter which herbs or drugs they would like to take concurrently and provides drug interaction information could be considered a medical device, according to the guidance document. But because it poses a low risk to the public, the agency does not intend to regulate it at this time.

The FDA first issued draft guidance on mobile medical apps in July 2011. This final guidance document represents the agency’s current thinking on the topic, but it is not binding on either the agency or the public.

"Regulating mobile apps is nothing new for us," Dr. Shuren said. Over the past 15 years, the FDA has cleared more than 75 apps, with about 20 of those receiving approval in the past year.

The guidance also makes clear that physicians who create mobile medical apps, or who customize a medical app for their own professional use, are not subject to regulation as long as they aren’t promoting it for general use by others. Even if the physician allows the app to be used by others in a group practice, he or she is still not considered a manufacturer under the FDA guidance.

The guidance does not apply to clinical decision support software. That software will be addressed as part of a larger health information technology regulatory framework that the FDA is working on in collaboration with the Office of the National Coordinator for Health Information Technology.

[email protected]

On Twitter @MaryEllenNY

Officials at the Food and Drug Administration have no plans to regulate mobile applications that let consumers compare their symptoms to a list of medical conditions, link patients to a portal with their own health information, or allow patients to measure and track their own vital signs.

But the agency has identified a limited scope of mobile medical apps that it intends to regulate because they function as medical devices and pose a potential safety risk if they malfunction. For instance, a mobile app that uses either internal or external sensors to create an electronic stethoscope would be regulated as a medical device.

The FDA issued a 43-page guidance document on Sept. 23 outlining its regulatory approach and listing examples of what will be regulated, what probably won’t be regulated, and what is not considered a medical app.

Copyright © 2013 Apple Inc. All rights reserved

In general, the FDA plans to regulate mobile apps that act as an extension of a medical device by displaying, storing, analyzing, or transmitting patient-specific medical data. Also, the agency will regulate apps that transform a mobile platform into a device, such as the attachment of electrocardiographic (ECG) electrodes to a mobile platform to measure, store, or display ECG signals.

Mobile apps will be regulated if they perform patient-specific diagnoses or make treatment recommendations. This type of app might use patient data to calculate a drug dosage or create a dosage plan for radiation therapy.

The agency does not plan to regulate apps that help patients self-manage their health conditions, provide tools for patients to track their health information, automate simple tasks for providers, or allow patients and providers to interact with a personal health record or an electronic health record.

"Although many mobile apps pertain to health, of which many may be medical devices, we are only continuing our oversight for a very small subset of those mobile apps that are medical devices," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said during a press briefing. "We believe this approach will promote innovation, while protecting patient safety, by focusing on those mobile apps that pose greater risk to patients."

But even if an app is deemed a mobile medical app by the FDA, the agency does not intend to regulate apps that pose minimal risks to consumers. For instance, a mobile app that prompts consumers to enter which herbs or drugs they would like to take concurrently and provides drug interaction information could be considered a medical device, according to the guidance document. But because it poses a low risk to the public, the agency does not intend to regulate it at this time.

The FDA first issued draft guidance on mobile medical apps in July 2011. This final guidance document represents the agency’s current thinking on the topic, but it is not binding on either the agency or the public.

"Regulating mobile apps is nothing new for us," Dr. Shuren said. Over the past 15 years, the FDA has cleared more than 75 apps, with about 20 of those receiving approval in the past year.

The guidance also makes clear that physicians who create mobile medical apps, or who customize a medical app for their own professional use, are not subject to regulation as long as they aren’t promoting it for general use by others. Even if the physician allows the app to be used by others in a group practice, he or she is still not considered a manufacturer under the FDA guidance.

The guidance does not apply to clinical decision support software. That software will be addressed as part of a larger health information technology regulatory framework that the FDA is working on in collaboration with the Office of the National Coordinator for Health Information Technology.

[email protected]

On Twitter @MaryEllenNY