Alicia Ault

The American Board of Internal Medicine is making several changes to its maintenance of certification requirements, but, so far, it is not enough to quell the still-growing tide of anger and resentment against the process.

The ABIM announced the changes just ahead of a July 15 "summit" with 26 specialty societies that receive certification through the organization, and outlined them in a detailed letter that was sent to internal medicine diplomates on July 28. That correspondence also responded in detail to a May 7 letter sent by the American College of Physicians (ACP) on behalf of 14 medical societies, enumerating their concerns about the process.

The American Gastroenterological Association, which attended the July 15 meeting, has a number of concerns about the administrative burden of maintenance of certification, the cost of the requirements, and implications for failing to complete a flawed process.

Dr. Lawrence S. Kim, AGAF, who’s in private practice in Denver, attended the meeting on behalf of the AGA. He noted that "gastroenterologists feel increasingly threatened by recent changes to the ABIM recertification process. We are all struggling to adapt to a brave new world of narrowing networks and ever-increasing public scrutiny. In this milieu, loss of board certification represents a true calamity to the professional lives of our physicians and in many cases, presents a truly existential threat to their livelihoods."

Recently, the AGA Governing Board discussed why the ABIM is in charge of saying what the requirements are for keeping certification in gastroenterology.

"It’s time to take charge of our profession and be proactive, setting the criteria for recertification in our specialty. To that end, AGA has joined with other societies to advocate for changes to the system. We have visited the ABIM to share concerns and push for changes to help GIs meet the requirements," said Dr. Suzanne Rose, AGA Governing Board Education Councillor.

Meanwhile, 3,000 or so physicians have signed on to a "Pledge of Non-Compliance" with the ABIM’s requirements. The pledge was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology at the Scripps Clinic, La Jolla, Calif., and colleagues who have formed Physicians for Certification Change, an anti-MOC organization. Dr. Teirstein also launched a petition drive in March to overhaul the MOC process. That petition had about 18,000 signees at press time.

There are several other organizations hoping to derail or significantly change the ABIM’s requirements, including the Association of American Physicians and Surgeons, Change Board Certification, and Docs4PatientCare. In addition, many of the 26 professional societies, including AGA, whose members are certified by the ABIM, have been very organized in presenting their discontent.

The ABIM understands the frustration, said Dr. Richard Baron, ABIM president and chief executive officer, in an interview. "One of the things that people have said is that we’re not listening," he said. That is one reason why the ABIM decided to hold what he called a "listening session" on July 15. "We’re a learning organization," he added, noting that the ABIM will "continue to evolve the program," based on the feedback it receives from individuals and from professional societies, among others.

Dr. Baron also acknowledges that by presenting an entirely new MOC process this year, "our timing was not propitious." The ABIM outlined pressures on physicians in the July 28 letter, counting among them "dealing with the Affordable Care Act," fulfilling meaningful use requirements, and responding to changes in payment and practice models, including team-based care.

The ABIM is making a handful of changes to address some of the concerns, including "broadening the kinds of educational activities that can count for self-assessment of knowledge," said Dr. Baron. That is, the ABIM will be broadening the continuing medical education that will count toward the self-assessment of medical knowledge portion of the MOC requirements. Physicians must earn 100 MOC points every 5 years. At least 20 points must be self-assessment of medical knowledge and at least 20 points must be self-evaluation of practice assessment. The remaining 60 points can be either type of MOC.

There have also been a huge number of complaints about the self-evaluation of practice assessment MOC, often referred to as practice improvement modules or PIM’s. There will be less direct data collection by the ABIM, and more of a focus "on improvement activities doctors may already be doing in their practice," Dr. Baron said.

But Dr. Kim noted that it might not be that simple. Existing EMR products do not have the capability to assess most subspecialty-specific measures. "We urge the ABIM to bring its influence to bear on the health IT industry, to develop standardized templates and reports," said Dr. Kim. Ideally, maintenance of certification practice assessments will harmonize with federal quality reporting programs.

Among other things, ABIM is also looking at changes to the secure exam and whether it needs to change how it describes on its website whether physicians are meeting MOC requirements (see related story on p. 5 for more details on ABIM changes).

However, many at the July meeting questioned whether the current exam truly reflects physicians’ clinical abilities. Pass rates for the recertification exam have steadily declined over recent years for many subspecialties. AGA has communicated this concern to ABIM on several occasions, helping to instigate the new changes to ABIM’s governance and operational structure.

"AGA wants a role in determining the components of recertification. We will ensure the requirements are a reflection of competent clinical practice," said Dr. Rose.

Despite the newly announced changes from ABIM, critics remain dissatisfied.

Dr. Ron Benbassat, an internist in Beverly Hills, Calif. and a founder of Change Board Certification, said, "No one is drinking the ABIM’s Koolaid." He added, "The momentum is increasing and I believe we’re reaching the tipping point. As to what form it will take – widespread noncompliance or political or legal, I don’t have the answer."

Dr. Teirstein was a bit more muted in his criticism. "They are certainly taking many good steps. But, the devil will be in the details." He, like many physicians, said that he still sees the ABIM’s fees as a big problem. "To reestablish credibility, ABIM will need to roll back its fee schedule," said Dr. Teirstein.

The ABIM charges $1,940 for a 10-year basic internal medicine certification, which includes a secure examination for each specialty the diplomate chooses to maintain, access to all ABIM self-evaluation products, and any CME credit a physician can claim through completion of an ABIM module. There are basically four requirements: MOC participants have to take a secure exam; they have to complete a module that contains knowledge and patient management questions; another module is on practice improvement; and, a third covers a survey of patient safety and satisfaction.

The fees vary for different practices within the field of internal medicine: $2,060 for a focused practice in hospital medicine for 10 years and $2,560 for any subspecialty – including gastroenterology – for the 10 years.

"Physicians are forced to spend unreasonable time and expense to collect this data," says Dr. Kim. "The time needed to fulfill new expanded MOC requirements should not come at the expense of time spent on patient care."

The ABIM said in its July 28 letter that extensive evidence does exist that the ABIM process works – with more than half of the studies coming from non-ABIM researchers – but that maybe it hasn’t done the best job of communicating that to diplomates. However, it does say it welcomes partnering on new projects "and a broader discussion of [sic] potential research agenda."

Many say that they are in favor of requiring lifelong learning, but that the ABIM has gone about it the wrong way. Dr. Steven Weinberger, chief executive of the ACP, said that his organization wants to see more customization of the secure board exam "so that it’s more relevant to a particular physician’s practice."

Many who attended the ABIM’s July 15 meeting said that they felt like the organization had heard their concerns. But they are still waiting to see what will happen next.

The changes already announced "are a very good start," said Dr. Weinberger, who said that the ACP hopes that the ABIM board might make more changes at its meeting in August.

Likewise, Dr. Eric Green, chair of the MOC Task Force at the Society of General Internal Medicine, said that the SGIM would continue to work in cooperation with the ABIM. The question is how much the ABIM will use the input from the subspecialty societies, he said.

Dr. Christopher White, professor and chairman of medicine at the Ochsner Clinical School, New Orleans, a founding member of Physicians for Certification Change, who has signed the pledge of noncompliance, is a bit more skeptical. "I think the ABIM is going to have to be a lot less arrogant," he said, calling for more accountability by the organization.

[email protected]

The American Board of Internal Medicine is making several changes to its maintenance of certification requirements, but, so far, it is not enough to quell the still-growing tide of anger and resentment against the process.

The ABIM announced the changes just ahead of a July 15 "summit" with 26 specialty societies that receive certification through the organization, and outlined them in a detailed letter that was sent to internal medicine diplomates on July 28. That correspondence also responded in detail to a May 7 letter sent by the American College of Physicians (ACP) on behalf of 14 medical societies, enumerating their concerns about the process.

The American Gastroenterological Association, which attended the July 15 meeting, has a number of concerns about the administrative burden of maintenance of certification, the cost of the requirements, and implications for failing to complete a flawed process.

Dr. Lawrence S. Kim, AGAF, who’s in private practice in Denver, attended the meeting on behalf of the AGA. He noted that "gastroenterologists feel increasingly threatened by recent changes to the ABIM recertification process. We are all struggling to adapt to a brave new world of narrowing networks and ever-increasing public scrutiny. In this milieu, loss of board certification represents a true calamity to the professional lives of our physicians and in many cases, presents a truly existential threat to their livelihoods."

Recently, the AGA Governing Board discussed why the ABIM is in charge of saying what the requirements are for keeping certification in gastroenterology.

"It’s time to take charge of our profession and be proactive, setting the criteria for recertification in our specialty. To that end, AGA has joined with other societies to advocate for changes to the system. We have visited the ABIM to share concerns and push for changes to help GIs meet the requirements," said Dr. Suzanne Rose, AGA Governing Board Education Councillor.

Meanwhile, 3,000 or so physicians have signed on to a "Pledge of Non-Compliance" with the ABIM’s requirements. The pledge was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology at the Scripps Clinic, La Jolla, Calif., and colleagues who have formed Physicians for Certification Change, an anti-MOC organization. Dr. Teirstein also launched a petition drive in March to overhaul the MOC process. That petition had about 18,000 signees at press time.

There are several other organizations hoping to derail or significantly change the ABIM’s requirements, including the Association of American Physicians and Surgeons, Change Board Certification, and Docs4PatientCare. In addition, many of the 26 professional societies, including AGA, whose members are certified by the ABIM, have been very organized in presenting their discontent.

The ABIM understands the frustration, said Dr. Richard Baron, ABIM president and chief executive officer, in an interview. "One of the things that people have said is that we’re not listening," he said. That is one reason why the ABIM decided to hold what he called a "listening session" on July 15. "We’re a learning organization," he added, noting that the ABIM will "continue to evolve the program," based on the feedback it receives from individuals and from professional societies, among others.

Dr. Baron also acknowledges that by presenting an entirely new MOC process this year, "our timing was not propitious." The ABIM outlined pressures on physicians in the July 28 letter, counting among them "dealing with the Affordable Care Act," fulfilling meaningful use requirements, and responding to changes in payment and practice models, including team-based care.

The ABIM is making a handful of changes to address some of the concerns, including "broadening the kinds of educational activities that can count for self-assessment of knowledge," said Dr. Baron. That is, the ABIM will be broadening the continuing medical education that will count toward the self-assessment of medical knowledge portion of the MOC requirements. Physicians must earn 100 MOC points every 5 years. At least 20 points must be self-assessment of medical knowledge and at least 20 points must be self-evaluation of practice assessment. The remaining 60 points can be either type of MOC.

There have also been a huge number of complaints about the self-evaluation of practice assessment MOC, often referred to as practice improvement modules or PIM’s. There will be less direct data collection by the ABIM, and more of a focus "on improvement activities doctors may already be doing in their practice," Dr. Baron said.

But Dr. Kim noted that it might not be that simple. Existing EMR products do not have the capability to assess most subspecialty-specific measures. "We urge the ABIM to bring its influence to bear on the health IT industry, to develop standardized templates and reports," said Dr. Kim. Ideally, maintenance of certification practice assessments will harmonize with federal quality reporting programs.

Among other things, ABIM is also looking at changes to the secure exam and whether it needs to change how it describes on its website whether physicians are meeting MOC requirements (see related story on p. 5 for more details on ABIM changes).

However, many at the July meeting questioned whether the current exam truly reflects physicians’ clinical abilities. Pass rates for the recertification exam have steadily declined over recent years for many subspecialties. AGA has communicated this concern to ABIM on several occasions, helping to instigate the new changes to ABIM’s governance and operational structure.

"AGA wants a role in determining the components of recertification. We will ensure the requirements are a reflection of competent clinical practice," said Dr. Rose.

Despite the newly announced changes from ABIM, critics remain dissatisfied.

Dr. Ron Benbassat, an internist in Beverly Hills, Calif. and a founder of Change Board Certification, said, "No one is drinking the ABIM’s Koolaid." He added, "The momentum is increasing and I believe we’re reaching the tipping point. As to what form it will take – widespread noncompliance or political or legal, I don’t have the answer."

Dr. Teirstein was a bit more muted in his criticism. "They are certainly taking many good steps. But, the devil will be in the details." He, like many physicians, said that he still sees the ABIM’s fees as a big problem. "To reestablish credibility, ABIM will need to roll back its fee schedule," said Dr. Teirstein.

The ABIM charges $1,940 for a 10-year basic internal medicine certification, which includes a secure examination for each specialty the diplomate chooses to maintain, access to all ABIM self-evaluation products, and any CME credit a physician can claim through completion of an ABIM module. There are basically four requirements: MOC participants have to take a secure exam; they have to complete a module that contains knowledge and patient management questions; another module is on practice improvement; and, a third covers a survey of patient safety and satisfaction.

The fees vary for different practices within the field of internal medicine: $2,060 for a focused practice in hospital medicine for 10 years and $2,560 for any subspecialty – including gastroenterology – for the 10 years.

"Physicians are forced to spend unreasonable time and expense to collect this data," says Dr. Kim. "The time needed to fulfill new expanded MOC requirements should not come at the expense of time spent on patient care."

The ABIM said in its July 28 letter that extensive evidence does exist that the ABIM process works – with more than half of the studies coming from non-ABIM researchers – but that maybe it hasn’t done the best job of communicating that to diplomates. However, it does say it welcomes partnering on new projects "and a broader discussion of [sic] potential research agenda."

Many say that they are in favor of requiring lifelong learning, but that the ABIM has gone about it the wrong way. Dr. Steven Weinberger, chief executive of the ACP, said that his organization wants to see more customization of the secure board exam "so that it’s more relevant to a particular physician’s practice."

Many who attended the ABIM’s July 15 meeting said that they felt like the organization had heard their concerns. But they are still waiting to see what will happen next.

The changes already announced "are a very good start," said Dr. Weinberger, who said that the ACP hopes that the ABIM board might make more changes at its meeting in August.

Likewise, Dr. Eric Green, chair of the MOC Task Force at the Society of General Internal Medicine, said that the SGIM would continue to work in cooperation with the ABIM. The question is how much the ABIM will use the input from the subspecialty societies, he said.

Dr. Christopher White, professor and chairman of medicine at the Ochsner Clinical School, New Orleans, a founding member of Physicians for Certification Change, who has signed the pledge of noncompliance, is a bit more skeptical. "I think the ABIM is going to have to be a lot less arrogant," he said, calling for more accountability by the organization.

[email protected]

The American Board of Internal Medicine is making several changes to its maintenance of certification requirements, but, so far, it is not enough to quell the still-growing tide of anger and resentment against the process.

The ABIM announced the changes just ahead of a July 15 "summit" with 26 specialty societies that receive certification through the organization, and outlined them in a detailed letter that was sent to internal medicine diplomates on July 28. That correspondence also responded in detail to a May 7 letter sent by the American College of Physicians (ACP) on behalf of 14 medical societies, enumerating their concerns about the process.

The American Gastroenterological Association, which attended the July 15 meeting, has a number of concerns about the administrative burden of maintenance of certification, the cost of the requirements, and implications for failing to complete a flawed process.

Dr. Lawrence S. Kim, AGAF, who’s in private practice in Denver, attended the meeting on behalf of the AGA. He noted that "gastroenterologists feel increasingly threatened by recent changes to the ABIM recertification process. We are all struggling to adapt to a brave new world of narrowing networks and ever-increasing public scrutiny. In this milieu, loss of board certification represents a true calamity to the professional lives of our physicians and in many cases, presents a truly existential threat to their livelihoods."

Recently, the AGA Governing Board discussed why the ABIM is in charge of saying what the requirements are for keeping certification in gastroenterology.

"It’s time to take charge of our profession and be proactive, setting the criteria for recertification in our specialty. To that end, AGA has joined with other societies to advocate for changes to the system. We have visited the ABIM to share concerns and push for changes to help GIs meet the requirements," said Dr. Suzanne Rose, AGA Governing Board Education Councillor.

Meanwhile, 3,000 or so physicians have signed on to a "Pledge of Non-Compliance" with the ABIM’s requirements. The pledge was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology at the Scripps Clinic, La Jolla, Calif., and colleagues who have formed Physicians for Certification Change, an anti-MOC organization. Dr. Teirstein also launched a petition drive in March to overhaul the MOC process. That petition had about 18,000 signees at press time.

There are several other organizations hoping to derail or significantly change the ABIM’s requirements, including the Association of American Physicians and Surgeons, Change Board Certification, and Docs4PatientCare. In addition, many of the 26 professional societies, including AGA, whose members are certified by the ABIM, have been very organized in presenting their discontent.

The ABIM understands the frustration, said Dr. Richard Baron, ABIM president and chief executive officer, in an interview. "One of the things that people have said is that we’re not listening," he said. That is one reason why the ABIM decided to hold what he called a "listening session" on July 15. "We’re a learning organization," he added, noting that the ABIM will "continue to evolve the program," based on the feedback it receives from individuals and from professional societies, among others.

Dr. Baron also acknowledges that by presenting an entirely new MOC process this year, "our timing was not propitious." The ABIM outlined pressures on physicians in the July 28 letter, counting among them "dealing with the Affordable Care Act," fulfilling meaningful use requirements, and responding to changes in payment and practice models, including team-based care.

The ABIM is making a handful of changes to address some of the concerns, including "broadening the kinds of educational activities that can count for self-assessment of knowledge," said Dr. Baron. That is, the ABIM will be broadening the continuing medical education that will count toward the self-assessment of medical knowledge portion of the MOC requirements. Physicians must earn 100 MOC points every 5 years. At least 20 points must be self-assessment of medical knowledge and at least 20 points must be self-evaluation of practice assessment. The remaining 60 points can be either type of MOC.

There have also been a huge number of complaints about the self-evaluation of practice assessment MOC, often referred to as practice improvement modules or PIM’s. There will be less direct data collection by the ABIM, and more of a focus "on improvement activities doctors may already be doing in their practice," Dr. Baron said.

But Dr. Kim noted that it might not be that simple. Existing EMR products do not have the capability to assess most subspecialty-specific measures. "We urge the ABIM to bring its influence to bear on the health IT industry, to develop standardized templates and reports," said Dr. Kim. Ideally, maintenance of certification practice assessments will harmonize with federal quality reporting programs.

Among other things, ABIM is also looking at changes to the secure exam and whether it needs to change how it describes on its website whether physicians are meeting MOC requirements (see related story on p. 5 for more details on ABIM changes).

However, many at the July meeting questioned whether the current exam truly reflects physicians’ clinical abilities. Pass rates for the recertification exam have steadily declined over recent years for many subspecialties. AGA has communicated this concern to ABIM on several occasions, helping to instigate the new changes to ABIM’s governance and operational structure.

"AGA wants a role in determining the components of recertification. We will ensure the requirements are a reflection of competent clinical practice," said Dr. Rose.

Despite the newly announced changes from ABIM, critics remain dissatisfied.

Dr. Ron Benbassat, an internist in Beverly Hills, Calif. and a founder of Change Board Certification, said, "No one is drinking the ABIM’s Koolaid." He added, "The momentum is increasing and I believe we’re reaching the tipping point. As to what form it will take – widespread noncompliance or political or legal, I don’t have the answer."

Dr. Teirstein was a bit more muted in his criticism. "They are certainly taking many good steps. But, the devil will be in the details." He, like many physicians, said that he still sees the ABIM’s fees as a big problem. "To reestablish credibility, ABIM will need to roll back its fee schedule," said Dr. Teirstein.

The ABIM charges $1,940 for a 10-year basic internal medicine certification, which includes a secure examination for each specialty the diplomate chooses to maintain, access to all ABIM self-evaluation products, and any CME credit a physician can claim through completion of an ABIM module. There are basically four requirements: MOC participants have to take a secure exam; they have to complete a module that contains knowledge and patient management questions; another module is on practice improvement; and, a third covers a survey of patient safety and satisfaction.

The fees vary for different practices within the field of internal medicine: $2,060 for a focused practice in hospital medicine for 10 years and $2,560 for any subspecialty – including gastroenterology – for the 10 years.

"Physicians are forced to spend unreasonable time and expense to collect this data," says Dr. Kim. "The time needed to fulfill new expanded MOC requirements should not come at the expense of time spent on patient care."

The ABIM said in its July 28 letter that extensive evidence does exist that the ABIM process works – with more than half of the studies coming from non-ABIM researchers – but that maybe it hasn’t done the best job of communicating that to diplomates. However, it does say it welcomes partnering on new projects "and a broader discussion of [sic] potential research agenda."

Many say that they are in favor of requiring lifelong learning, but that the ABIM has gone about it the wrong way. Dr. Steven Weinberger, chief executive of the ACP, said that his organization wants to see more customization of the secure board exam "so that it’s more relevant to a particular physician’s practice."

Many who attended the ABIM’s July 15 meeting said that they felt like the organization had heard their concerns. But they are still waiting to see what will happen next.

The changes already announced "are a very good start," said Dr. Weinberger, who said that the ACP hopes that the ABIM board might make more changes at its meeting in August.

Likewise, Dr. Eric Green, chair of the MOC Task Force at the Society of General Internal Medicine, said that the SGIM would continue to work in cooperation with the ABIM. The question is how much the ABIM will use the input from the subspecialty societies, he said.

Dr. Christopher White, professor and chairman of medicine at the Ochsner Clinical School, New Orleans, a founding member of Physicians for Certification Change, who has signed the pledge of noncompliance, is a bit more skeptical. "I think the ABIM is going to have to be a lot less arrogant," he said, calling for more accountability by the organization.

[email protected]

WASHINGTON – When two Ebola-infected patients were airlifted to Emory University Hospital in Atlanta in early August, dedicated staffers were prepared to care for the patients. But those staffers had to act quickly to deal with unanticipated challenges that came from regulators and some of the hospital’s contractors, who initially refused to dispose of the mountains of medical waste generated by the patients and the clinicians who cared for them, according to Dr. Aneesh Mehta.

Dr. Mehta, associate chief of Emory’s infectious disease service, was one of the primary attending physicians for Nancy Writebol and Dr. Kent Brantly, who recovered from their Ebola infections and were discharged from Emory’s isolation unit on Aug. 19 and Aug. 21.

Alicia Ault/Frontline Medical News

The lessons learned from caring for these initial patients are now being applied to Emory’s latest Ebola-infected patient, who arrived at the facility from West Africa on Sept. 9, said Dr. Mehta, who spoke on the logistics, successes, and challenges of caring for Ebola-infected patients at Emory at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The local civil authorities asked that the Emory unit not introduce any untreated patient waste into the municipal waste stream. The staff disinfected with bleach or detergents all of the patients’ liquid wastes for more than 5 minutes before flushing them down the toilet.

And there was plenty of other potentially hazardous and infectious material that had to be addressed. At the peak of the patients’ illness, up to 40 bags a day of medical waste were being produced, said Dr. Mehta.

Initially, the hospital’s waste management contractor refused to pick up the medical waste for several days. To manage the situation temporarily, the Emory staff "went to Home Depot and bought up every large trash can and sealed canister that we could get," said Dr. Mehta. The filled cans were kept in a containment room until the hospital completed negotiations with the contractor to pick up the waste.

Even the commercial courier company that the hospital had always used to transport infectious and potentially lethal samples to the labs at the Centers for Disease Control and Prevention "suddenly said ‘no,’ " Dr. Mehta said. "If the label said ‘CDC’ on it, they refused to touch it."

Even some Emory staffers who had previously handled and packed dangerous samples for shipping refused to come to the isolation unit’s lab, said Dr. Mehta. The hospital’s safety officers had to train some of the dedicated Ebola staff to pack samples appropriately for shipping.

But even as the hospital dealt with these issues and the growing media circus, the Ebola staff stayed focused, Dr. Mehta said. "It was very chaotic outside, but very calm in the hospital and with our team."

The hospital spent a lot of time on communications – with the public, with staff, and with other patients in the hospital and their families. Emory held twice-daily town halls with staff to give information and answer questions, and also sent regular e-mail updates about the Ebola patients. Every inpatient and new admission was given a letter explaining why Emory had taken the patients, and physician and administrative leaders rounded throughout the hospital to answer questions.

Emory already had a "serious communicable diseases" unit, which it created in 2002 as a place to receive any CDC workers who might be exposed to pathogens on the job. The six-room unit has a patient room on each end, with a private bathroom in each, a staff dressing area, and an anteroom that was used as a staging area for nurses.

After the decision to accept the Ebola-infected patients, a new point-of-care lab facility was built in less than 72 hours in an adjoining office space, said Dr. Mehta. Having this kind of dedicated unit was not absolutely necessary, but it allowed the staff to more conveniently perform chemistry, hematology, blood gas, urinalysis, coagulation, and malaria tests and get immediate results. Having a dedicated lab space also limited the exposure fears of staff elsewhere in the hospital.

To prevent transmission of the virus, the unit followed the CDC’s recommendations, which included keeping a detailed log of anyone who entered and exited a patient room, using disposable equipment whenever possible, and using personal protective equipment that included gloves, fluid-resistant or impermeable gowns, and goggles or face shields. Initially, the Emory caregivers had leg and foot coverings because the patients had vomited blood before arriving, and one of the patients had fulminant diarrhea, up to four liters per day, said Dr. Mehta.

Because the disease can be transmitted from protective gear, all staff had a refresher course on appropriate use of the gear, everyone was observed by another team member when putting on or taking off the gear, and reminders about appropriate use of the gear were placed on the walls of the unit and in the changing area.

The clinical care team met every day to review plans and protocols and to answer staff questions. Twice daily, all personnel had to enter into an online registry their body temperatures and any symptoms. Dr. Mehta told the ICAAC audience that he had just completed his 21-day observation period.

The patient care itself was far from clear cut, as there is no proven treatment and Emory officials initially were not clear on the availability of any experimental therapy, said Dr. Mehta. The CDC helped to monitor the patients’ viral load, and both patients had marked electrolyte imbalances, including hypokalemia, hypocalcemia, and hyponatremia, as well as severe nutritional deficiencies. Both required significant potassium replacement.

Both patients received a three-dose course of Zmapp, which consists of three monoclonal antibodies and is under development by Mapp Biopharmaceutical. While in Africa, Dr. Brantly also had received a transfusion of plasma from a patient who was recovering from the Ebola virus.

High-level, one-on-one nursing care also was noted as a significant factor in patient recovery, said Dr. Mehta.

"It’s hard to derive a lot of meaningful data from the care of those two patients," Dr. Mehta said. It’s not clear yet which of these factors – Zmapp, the transfusion, the supportive care, or the combination – was responsible for the patients’ recovery.

Emory will publish its experiences in Ebola care, but "the real front line is in West Africa," Dr. Mehta added.

[email protected]

On Twitter @aliciaault

WASHINGTON – When two Ebola-infected patients were airlifted to Emory University Hospital in Atlanta in early August, dedicated staffers were prepared to care for the patients. But those staffers had to act quickly to deal with unanticipated challenges that came from regulators and some of the hospital’s contractors, who initially refused to dispose of the mountains of medical waste generated by the patients and the clinicians who cared for them, according to Dr. Aneesh Mehta.

Dr. Mehta, associate chief of Emory’s infectious disease service, was one of the primary attending physicians for Nancy Writebol and Dr. Kent Brantly, who recovered from their Ebola infections and were discharged from Emory’s isolation unit on Aug. 19 and Aug. 21.

Alicia Ault/Frontline Medical News

The lessons learned from caring for these initial patients are now being applied to Emory’s latest Ebola-infected patient, who arrived at the facility from West Africa on Sept. 9, said Dr. Mehta, who spoke on the logistics, successes, and challenges of caring for Ebola-infected patients at Emory at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The local civil authorities asked that the Emory unit not introduce any untreated patient waste into the municipal waste stream. The staff disinfected with bleach or detergents all of the patients’ liquid wastes for more than 5 minutes before flushing them down the toilet.

And there was plenty of other potentially hazardous and infectious material that had to be addressed. At the peak of the patients’ illness, up to 40 bags a day of medical waste were being produced, said Dr. Mehta.

Initially, the hospital’s waste management contractor refused to pick up the medical waste for several days. To manage the situation temporarily, the Emory staff "went to Home Depot and bought up every large trash can and sealed canister that we could get," said Dr. Mehta. The filled cans were kept in a containment room until the hospital completed negotiations with the contractor to pick up the waste.

Even the commercial courier company that the hospital had always used to transport infectious and potentially lethal samples to the labs at the Centers for Disease Control and Prevention "suddenly said ‘no,’ " Dr. Mehta said. "If the label said ‘CDC’ on it, they refused to touch it."

Even some Emory staffers who had previously handled and packed dangerous samples for shipping refused to come to the isolation unit’s lab, said Dr. Mehta. The hospital’s safety officers had to train some of the dedicated Ebola staff to pack samples appropriately for shipping.

But even as the hospital dealt with these issues and the growing media circus, the Ebola staff stayed focused, Dr. Mehta said. "It was very chaotic outside, but very calm in the hospital and with our team."

The hospital spent a lot of time on communications – with the public, with staff, and with other patients in the hospital and their families. Emory held twice-daily town halls with staff to give information and answer questions, and also sent regular e-mail updates about the Ebola patients. Every inpatient and new admission was given a letter explaining why Emory had taken the patients, and physician and administrative leaders rounded throughout the hospital to answer questions.

Emory already had a "serious communicable diseases" unit, which it created in 2002 as a place to receive any CDC workers who might be exposed to pathogens on the job. The six-room unit has a patient room on each end, with a private bathroom in each, a staff dressing area, and an anteroom that was used as a staging area for nurses.

After the decision to accept the Ebola-infected patients, a new point-of-care lab facility was built in less than 72 hours in an adjoining office space, said Dr. Mehta. Having this kind of dedicated unit was not absolutely necessary, but it allowed the staff to more conveniently perform chemistry, hematology, blood gas, urinalysis, coagulation, and malaria tests and get immediate results. Having a dedicated lab space also limited the exposure fears of staff elsewhere in the hospital.

To prevent transmission of the virus, the unit followed the CDC’s recommendations, which included keeping a detailed log of anyone who entered and exited a patient room, using disposable equipment whenever possible, and using personal protective equipment that included gloves, fluid-resistant or impermeable gowns, and goggles or face shields. Initially, the Emory caregivers had leg and foot coverings because the patients had vomited blood before arriving, and one of the patients had fulminant diarrhea, up to four liters per day, said Dr. Mehta.

Because the disease can be transmitted from protective gear, all staff had a refresher course on appropriate use of the gear, everyone was observed by another team member when putting on or taking off the gear, and reminders about appropriate use of the gear were placed on the walls of the unit and in the changing area.

The clinical care team met every day to review plans and protocols and to answer staff questions. Twice daily, all personnel had to enter into an online registry their body temperatures and any symptoms. Dr. Mehta told the ICAAC audience that he had just completed his 21-day observation period.

The patient care itself was far from clear cut, as there is no proven treatment and Emory officials initially were not clear on the availability of any experimental therapy, said Dr. Mehta. The CDC helped to monitor the patients’ viral load, and both patients had marked electrolyte imbalances, including hypokalemia, hypocalcemia, and hyponatremia, as well as severe nutritional deficiencies. Both required significant potassium replacement.

Both patients received a three-dose course of Zmapp, which consists of three monoclonal antibodies and is under development by Mapp Biopharmaceutical. While in Africa, Dr. Brantly also had received a transfusion of plasma from a patient who was recovering from the Ebola virus.

High-level, one-on-one nursing care also was noted as a significant factor in patient recovery, said Dr. Mehta.

"It’s hard to derive a lot of meaningful data from the care of those two patients," Dr. Mehta said. It’s not clear yet which of these factors – Zmapp, the transfusion, the supportive care, or the combination – was responsible for the patients’ recovery.

Emory will publish its experiences in Ebola care, but "the real front line is in West Africa," Dr. Mehta added.

[email protected]

On Twitter @aliciaault

WASHINGTON – When two Ebola-infected patients were airlifted to Emory University Hospital in Atlanta in early August, dedicated staffers were prepared to care for the patients. But those staffers had to act quickly to deal with unanticipated challenges that came from regulators and some of the hospital’s contractors, who initially refused to dispose of the mountains of medical waste generated by the patients and the clinicians who cared for them, according to Dr. Aneesh Mehta.

Dr. Mehta, associate chief of Emory’s infectious disease service, was one of the primary attending physicians for Nancy Writebol and Dr. Kent Brantly, who recovered from their Ebola infections and were discharged from Emory’s isolation unit on Aug. 19 and Aug. 21.

Alicia Ault/Frontline Medical News

The lessons learned from caring for these initial patients are now being applied to Emory’s latest Ebola-infected patient, who arrived at the facility from West Africa on Sept. 9, said Dr. Mehta, who spoke on the logistics, successes, and challenges of caring for Ebola-infected patients at Emory at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The local civil authorities asked that the Emory unit not introduce any untreated patient waste into the municipal waste stream. The staff disinfected with bleach or detergents all of the patients’ liquid wastes for more than 5 minutes before flushing them down the toilet.

And there was plenty of other potentially hazardous and infectious material that had to be addressed. At the peak of the patients’ illness, up to 40 bags a day of medical waste were being produced, said Dr. Mehta.

Initially, the hospital’s waste management contractor refused to pick up the medical waste for several days. To manage the situation temporarily, the Emory staff "went to Home Depot and bought up every large trash can and sealed canister that we could get," said Dr. Mehta. The filled cans were kept in a containment room until the hospital completed negotiations with the contractor to pick up the waste.

Even the commercial courier company that the hospital had always used to transport infectious and potentially lethal samples to the labs at the Centers for Disease Control and Prevention "suddenly said ‘no,’ " Dr. Mehta said. "If the label said ‘CDC’ on it, they refused to touch it."

Even some Emory staffers who had previously handled and packed dangerous samples for shipping refused to come to the isolation unit’s lab, said Dr. Mehta. The hospital’s safety officers had to train some of the dedicated Ebola staff to pack samples appropriately for shipping.

But even as the hospital dealt with these issues and the growing media circus, the Ebola staff stayed focused, Dr. Mehta said. "It was very chaotic outside, but very calm in the hospital and with our team."

The hospital spent a lot of time on communications – with the public, with staff, and with other patients in the hospital and their families. Emory held twice-daily town halls with staff to give information and answer questions, and also sent regular e-mail updates about the Ebola patients. Every inpatient and new admission was given a letter explaining why Emory had taken the patients, and physician and administrative leaders rounded throughout the hospital to answer questions.

Emory already had a "serious communicable diseases" unit, which it created in 2002 as a place to receive any CDC workers who might be exposed to pathogens on the job. The six-room unit has a patient room on each end, with a private bathroom in each, a staff dressing area, and an anteroom that was used as a staging area for nurses.

After the decision to accept the Ebola-infected patients, a new point-of-care lab facility was built in less than 72 hours in an adjoining office space, said Dr. Mehta. Having this kind of dedicated unit was not absolutely necessary, but it allowed the staff to more conveniently perform chemistry, hematology, blood gas, urinalysis, coagulation, and malaria tests and get immediate results. Having a dedicated lab space also limited the exposure fears of staff elsewhere in the hospital.

To prevent transmission of the virus, the unit followed the CDC’s recommendations, which included keeping a detailed log of anyone who entered and exited a patient room, using disposable equipment whenever possible, and using personal protective equipment that included gloves, fluid-resistant or impermeable gowns, and goggles or face shields. Initially, the Emory caregivers had leg and foot coverings because the patients had vomited blood before arriving, and one of the patients had fulminant diarrhea, up to four liters per day, said Dr. Mehta.

Because the disease can be transmitted from protective gear, all staff had a refresher course on appropriate use of the gear, everyone was observed by another team member when putting on or taking off the gear, and reminders about appropriate use of the gear were placed on the walls of the unit and in the changing area.

The clinical care team met every day to review plans and protocols and to answer staff questions. Twice daily, all personnel had to enter into an online registry their body temperatures and any symptoms. Dr. Mehta told the ICAAC audience that he had just completed his 21-day observation period.

The patient care itself was far from clear cut, as there is no proven treatment and Emory officials initially were not clear on the availability of any experimental therapy, said Dr. Mehta. The CDC helped to monitor the patients’ viral load, and both patients had marked electrolyte imbalances, including hypokalemia, hypocalcemia, and hyponatremia, as well as severe nutritional deficiencies. Both required significant potassium replacement.

Both patients received a three-dose course of Zmapp, which consists of three monoclonal antibodies and is under development by Mapp Biopharmaceutical. While in Africa, Dr. Brantly also had received a transfusion of plasma from a patient who was recovering from the Ebola virus.

High-level, one-on-one nursing care also was noted as a significant factor in patient recovery, said Dr. Mehta.

"It’s hard to derive a lot of meaningful data from the care of those two patients," Dr. Mehta said. It’s not clear yet which of these factors – Zmapp, the transfusion, the supportive care, or the combination – was responsible for the patients’ recovery.

Emory will publish its experiences in Ebola care, but "the real front line is in West Africa," Dr. Mehta added.

[email protected]

On Twitter @aliciaault

WASHINGTON – With each day of hospitalization, the risk rises by 1% for contracting an infection with a gram-negative, multidrug-resistant organism, based on results from a single-hospital retrospective study.

While conventional wisdom holds that infection risk increases with duration of hospitalization, the study is the first to quantify the potential risk of contracting a multidrug-resistant infection based on length of stay. And while the results may not be applicable to all patients at all hospitals, the findings do give clinicians a sense of the risk posed by a prolonged stay, according to John A. Bosso, Pharm.D., a professor in the College of Pharmacy at the Medical University of South Carolina, Charleston.

©Pixland/Thinkstockphotos.com

Dr. Bosso and his colleagues focused on gram-negative organisms because a colleague had compiled data for 949 episodes of documented gram-negative infections that occurred between 1998 and 2011 at the university hospital. A statement issued at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy noted that the Centers for Disease Control and Prevention has estimated that on any given day, 1 in 25 hospitalized patients has at least one health care–associated infection, and about a third of these are caused by gram-negative bacteria.

The study defined drug-resistant organisms as those that did not respond to treatment with one or more agents in three or more antibiotic classes. The five classes of antibiotics used in the cases studied included aminoglycosides, penicillins, cephalosporins, fluoroquinolones, and folic acid inhibitors. The largest percentage of isolates (38%) was taken from patients with blood stream infections; 29% had pneumonia, 23% had surgical site infections, 6% had urinary tract infections, and 4% had other infections.

Of the 949 organisms reviewed, 251 (26%) were determined to be multidrug resistant.

Ultimately, the type of infection was found to be unrelated to whether a patient had a multidrug-resistant infection. Certain pathogens were more likely to be multidrug resistant. About 56% of Enterobacter isolates, for example, were multidrug resistant as compared with 20% of all other organisms. Alternatively, Pseudomonas isolates were 44% less likely than other isolates to be multidrug resistant.

Length of stay seemed to have the greatest impact on contracting multidrug-resistant strains of gram-negative organisms, with risk maximizing at 10 days of hospitalization. Each day of hospitalization increased the likelihood of multidrug resistance by 1%, Dr. Bosso said.

The researchers were unable to determine the proportion of patients who were already colonized with a multidrug-resistant strain at admission from those who acquired their infections while hospitalized, said Dr. Bosso.

Dr. Bosso reported no financial conflicts of interest.

[email protected]

On Twitter @aliciaault

WASHINGTON – With each day of hospitalization, the risk rises by 1% for contracting an infection with a gram-negative, multidrug-resistant organism, based on results from a single-hospital retrospective study.

While conventional wisdom holds that infection risk increases with duration of hospitalization, the study is the first to quantify the potential risk of contracting a multidrug-resistant infection based on length of stay. And while the results may not be applicable to all patients at all hospitals, the findings do give clinicians a sense of the risk posed by a prolonged stay, according to John A. Bosso, Pharm.D., a professor in the College of Pharmacy at the Medical University of South Carolina, Charleston.

©Pixland/Thinkstockphotos.com

Dr. Bosso and his colleagues focused on gram-negative organisms because a colleague had compiled data for 949 episodes of documented gram-negative infections that occurred between 1998 and 2011 at the university hospital. A statement issued at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy noted that the Centers for Disease Control and Prevention has estimated that on any given day, 1 in 25 hospitalized patients has at least one health care–associated infection, and about a third of these are caused by gram-negative bacteria.

The study defined drug-resistant organisms as those that did not respond to treatment with one or more agents in three or more antibiotic classes. The five classes of antibiotics used in the cases studied included aminoglycosides, penicillins, cephalosporins, fluoroquinolones, and folic acid inhibitors. The largest percentage of isolates (38%) was taken from patients with blood stream infections; 29% had pneumonia, 23% had surgical site infections, 6% had urinary tract infections, and 4% had other infections.

Of the 949 organisms reviewed, 251 (26%) were determined to be multidrug resistant.

Ultimately, the type of infection was found to be unrelated to whether a patient had a multidrug-resistant infection. Certain pathogens were more likely to be multidrug resistant. About 56% of Enterobacter isolates, for example, were multidrug resistant as compared with 20% of all other organisms. Alternatively, Pseudomonas isolates were 44% less likely than other isolates to be multidrug resistant.

Length of stay seemed to have the greatest impact on contracting multidrug-resistant strains of gram-negative organisms, with risk maximizing at 10 days of hospitalization. Each day of hospitalization increased the likelihood of multidrug resistance by 1%, Dr. Bosso said.

The researchers were unable to determine the proportion of patients who were already colonized with a multidrug-resistant strain at admission from those who acquired their infections while hospitalized, said Dr. Bosso.

Dr. Bosso reported no financial conflicts of interest.

[email protected]

On Twitter @aliciaault

WASHINGTON – With each day of hospitalization, the risk rises by 1% for contracting an infection with a gram-negative, multidrug-resistant organism, based on results from a single-hospital retrospective study.

While conventional wisdom holds that infection risk increases with duration of hospitalization, the study is the first to quantify the potential risk of contracting a multidrug-resistant infection based on length of stay. And while the results may not be applicable to all patients at all hospitals, the findings do give clinicians a sense of the risk posed by a prolonged stay, according to John A. Bosso, Pharm.D., a professor in the College of Pharmacy at the Medical University of South Carolina, Charleston.

©Pixland/Thinkstockphotos.com

Dr. Bosso and his colleagues focused on gram-negative organisms because a colleague had compiled data for 949 episodes of documented gram-negative infections that occurred between 1998 and 2011 at the university hospital. A statement issued at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy noted that the Centers for Disease Control and Prevention has estimated that on any given day, 1 in 25 hospitalized patients has at least one health care–associated infection, and about a third of these are caused by gram-negative bacteria.

The study defined drug-resistant organisms as those that did not respond to treatment with one or more agents in three or more antibiotic classes. The five classes of antibiotics used in the cases studied included aminoglycosides, penicillins, cephalosporins, fluoroquinolones, and folic acid inhibitors. The largest percentage of isolates (38%) was taken from patients with blood stream infections; 29% had pneumonia, 23% had surgical site infections, 6% had urinary tract infections, and 4% had other infections.

Of the 949 organisms reviewed, 251 (26%) were determined to be multidrug resistant.

Ultimately, the type of infection was found to be unrelated to whether a patient had a multidrug-resistant infection. Certain pathogens were more likely to be multidrug resistant. About 56% of Enterobacter isolates, for example, were multidrug resistant as compared with 20% of all other organisms. Alternatively, Pseudomonas isolates were 44% less likely than other isolates to be multidrug resistant.

Length of stay seemed to have the greatest impact on contracting multidrug-resistant strains of gram-negative organisms, with risk maximizing at 10 days of hospitalization. Each day of hospitalization increased the likelihood of multidrug resistance by 1%, Dr. Bosso said.

The researchers were unable to determine the proportion of patients who were already colonized with a multidrug-resistant strain at admission from those who acquired their infections while hospitalized, said Dr. Bosso.

Dr. Bosso reported no financial conflicts of interest.

[email protected]

On Twitter @aliciaault

WASHINGTON – Early studies show that a new, combined antiviral regimen seems to suppress hepatitis C viremia while keeping HIV viremia stable in coinfected patients.

Dr. Joseph Eron presented phase II data from 63 patients who were enrolled in TURQUOISE-I. A total of 94% (59/63) of patients achieved a sustained virologic response (SVR) 12 weeks after completing 12 weeks of therapy, and 61 of 63 patients achieved an SVR 4 weeks after completing 12 or 24 weeks of therapy, Dr. Eron reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Alicia Ault/Frontline Medical News

The regimen included ABT-450 (an NS3-4A protease inhibitor that was identified by AbbVie and Enanta), which was combined with ritonavir and ombitasvir (another AbbVie drug, also known as ABT-267) into a single tablet, plus dasabuvir (ABT-333) and ribavirin. Ombitasvir is an NS5A inhibitor and dasabuvir is a non-nucleoside NS5B polymerase inhibitor.

To be included in TURQUOISE-I, patients have to be aged 18-70 years; be treatment naive or have previous pegylated interferon/ribavirin treatment experience; have hepatitis C virus (HCV) genotype 1 infection; have plasma HIV-1 RNA less than 40 copies/mL; and be taking a stable, qualifying HIV-1 antiretroviral therapy regimen, said Dr. Eron, a professor of medicine at the University of North Carolina, Chapel Hill.

Patients with cirrhosis are not excluded, but will not be enrolled if they have had prior therapy with direct-acting antivirals for HCV, or any current or past clinical evidence of liver decompensation.

All patients will be followed for 48 weeks after therapy is stopped. Thirty-one patients were given therapy for 12 weeks and then assessed for SVR at 12 weeks. Thirty-two patients were given therapy for 24 weeks and assessed 4 weeks later. Patients also were evaluated for end-of-treatment response, on-treatment virologic failure, and post-treatment HCV viral relapse.

At baseline, 59 patients in each arm were male, and 16 were African American. The mean age was 51 years. Six patients in each arm (19%) had cirrhosis. A high proportion in each arm (53/63 in the 12-week and 49/63 in the 24-week arm) had the interleukin-28B genotype, which is known to indicate a much harder-to-treat disease, Dr. Eron said.

At the end of treatment, only one patient in each arm was not responsive. Four weeks post therapy, 29 of 31 patients in the 12-week arm and 31 of 32 patients in the 24-week arm had an SVR.

Two patients had virologic failure. Both had been unresponsive to previous therapies, and both had the IL-28B genotype and resistance-associated variants at the time of failure.

No patient withdrew because of adverse events, but about 90% (57/63) experienced some side effect, with the most common being fatigue and insomnia. Six patients had to reduce their ribavirin dose because of a decline in hemoglobin levels, but they were still responsive to therapy. Five patients had a confirmed increase in HIV RNA higher than 40 copies/mL, but not above 200 copies/mL, said Dr. Eron. And all the patients remained suppressed on the same HIV regimen and without interrupting their HCV therapy, he said.

Soon, a cohort of patients on stable darunavir antiretroviral therapy will be enrolled and given the three-drug HCV regimen for 12 weeks. The full global TURQUOISE study will begin later in 2014, Dr. Eron said.

The study was sponsored by AbbVie. Dr. Eron received grant and research support from, and/or served as a consultant to, AbbVie, Bristol-Myers Squibb, and other companies. Other authors had numerous additional disclosures.

[email protected]

On Twitter @aliciaault

WASHINGTON – Early studies show that a new, combined antiviral regimen seems to suppress hepatitis C viremia while keeping HIV viremia stable in coinfected patients.

Dr. Joseph Eron presented phase II data from 63 patients who were enrolled in TURQUOISE-I. A total of 94% (59/63) of patients achieved a sustained virologic response (SVR) 12 weeks after completing 12 weeks of therapy, and 61 of 63 patients achieved an SVR 4 weeks after completing 12 or 24 weeks of therapy, Dr. Eron reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Alicia Ault/Frontline Medical News

The regimen included ABT-450 (an NS3-4A protease inhibitor that was identified by AbbVie and Enanta), which was combined with ritonavir and ombitasvir (another AbbVie drug, also known as ABT-267) into a single tablet, plus dasabuvir (ABT-333) and ribavirin. Ombitasvir is an NS5A inhibitor and dasabuvir is a non-nucleoside NS5B polymerase inhibitor.

To be included in TURQUOISE-I, patients have to be aged 18-70 years; be treatment naive or have previous pegylated interferon/ribavirin treatment experience; have hepatitis C virus (HCV) genotype 1 infection; have plasma HIV-1 RNA less than 40 copies/mL; and be taking a stable, qualifying HIV-1 antiretroviral therapy regimen, said Dr. Eron, a professor of medicine at the University of North Carolina, Chapel Hill.

Patients with cirrhosis are not excluded, but will not be enrolled if they have had prior therapy with direct-acting antivirals for HCV, or any current or past clinical evidence of liver decompensation.

All patients will be followed for 48 weeks after therapy is stopped. Thirty-one patients were given therapy for 12 weeks and then assessed for SVR at 12 weeks. Thirty-two patients were given therapy for 24 weeks and assessed 4 weeks later. Patients also were evaluated for end-of-treatment response, on-treatment virologic failure, and post-treatment HCV viral relapse.

At baseline, 59 patients in each arm were male, and 16 were African American. The mean age was 51 years. Six patients in each arm (19%) had cirrhosis. A high proportion in each arm (53/63 in the 12-week and 49/63 in the 24-week arm) had the interleukin-28B genotype, which is known to indicate a much harder-to-treat disease, Dr. Eron said.

At the end of treatment, only one patient in each arm was not responsive. Four weeks post therapy, 29 of 31 patients in the 12-week arm and 31 of 32 patients in the 24-week arm had an SVR.

Two patients had virologic failure. Both had been unresponsive to previous therapies, and both had the IL-28B genotype and resistance-associated variants at the time of failure.

No patient withdrew because of adverse events, but about 90% (57/63) experienced some side effect, with the most common being fatigue and insomnia. Six patients had to reduce their ribavirin dose because of a decline in hemoglobin levels, but they were still responsive to therapy. Five patients had a confirmed increase in HIV RNA higher than 40 copies/mL, but not above 200 copies/mL, said Dr. Eron. And all the patients remained suppressed on the same HIV regimen and without interrupting their HCV therapy, he said.

Soon, a cohort of patients on stable darunavir antiretroviral therapy will be enrolled and given the three-drug HCV regimen for 12 weeks. The full global TURQUOISE study will begin later in 2014, Dr. Eron said.

The study was sponsored by AbbVie. Dr. Eron received grant and research support from, and/or served as a consultant to, AbbVie, Bristol-Myers Squibb, and other companies. Other authors had numerous additional disclosures.

[email protected]

On Twitter @aliciaault

WASHINGTON – Early studies show that a new, combined antiviral regimen seems to suppress hepatitis C viremia while keeping HIV viremia stable in coinfected patients.

Dr. Joseph Eron presented phase II data from 63 patients who were enrolled in TURQUOISE-I. A total of 94% (59/63) of patients achieved a sustained virologic response (SVR) 12 weeks after completing 12 weeks of therapy, and 61 of 63 patients achieved an SVR 4 weeks after completing 12 or 24 weeks of therapy, Dr. Eron reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Alicia Ault/Frontline Medical News

The regimen included ABT-450 (an NS3-4A protease inhibitor that was identified by AbbVie and Enanta), which was combined with ritonavir and ombitasvir (another AbbVie drug, also known as ABT-267) into a single tablet, plus dasabuvir (ABT-333) and ribavirin. Ombitasvir is an NS5A inhibitor and dasabuvir is a non-nucleoside NS5B polymerase inhibitor.

To be included in TURQUOISE-I, patients have to be aged 18-70 years; be treatment naive or have previous pegylated interferon/ribavirin treatment experience; have hepatitis C virus (HCV) genotype 1 infection; have plasma HIV-1 RNA less than 40 copies/mL; and be taking a stable, qualifying HIV-1 antiretroviral therapy regimen, said Dr. Eron, a professor of medicine at the University of North Carolina, Chapel Hill.

Patients with cirrhosis are not excluded, but will not be enrolled if they have had prior therapy with direct-acting antivirals for HCV, or any current or past clinical evidence of liver decompensation.

All patients will be followed for 48 weeks after therapy is stopped. Thirty-one patients were given therapy for 12 weeks and then assessed for SVR at 12 weeks. Thirty-two patients were given therapy for 24 weeks and assessed 4 weeks later. Patients also were evaluated for end-of-treatment response, on-treatment virologic failure, and post-treatment HCV viral relapse.

At baseline, 59 patients in each arm were male, and 16 were African American. The mean age was 51 years. Six patients in each arm (19%) had cirrhosis. A high proportion in each arm (53/63 in the 12-week and 49/63 in the 24-week arm) had the interleukin-28B genotype, which is known to indicate a much harder-to-treat disease, Dr. Eron said.

At the end of treatment, only one patient in each arm was not responsive. Four weeks post therapy, 29 of 31 patients in the 12-week arm and 31 of 32 patients in the 24-week arm had an SVR.

Two patients had virologic failure. Both had been unresponsive to previous therapies, and both had the IL-28B genotype and resistance-associated variants at the time of failure.

No patient withdrew because of adverse events, but about 90% (57/63) experienced some side effect, with the most common being fatigue and insomnia. Six patients had to reduce their ribavirin dose because of a decline in hemoglobin levels, but they were still responsive to therapy. Five patients had a confirmed increase in HIV RNA higher than 40 copies/mL, but not above 200 copies/mL, said Dr. Eron. And all the patients remained suppressed on the same HIV regimen and without interrupting their HCV therapy, he said.

Soon, a cohort of patients on stable darunavir antiretroviral therapy will be enrolled and given the three-drug HCV regimen for 12 weeks. The full global TURQUOISE study will begin later in 2014, Dr. Eron said.

The study was sponsored by AbbVie. Dr. Eron received grant and research support from, and/or served as a consultant to, AbbVie, Bristol-Myers Squibb, and other companies. Other authors had numerous additional disclosures.

[email protected]

On Twitter @aliciaault

WASHINGTON – Two studies of men having sex with men suggest that hepatitis C transmission in that group might be on the cusp of a big increase, in part because of risky behavior such as unprotected anal intercourse and injection drug use.

One study was conducted among MSM in Switzerland, while another was a retrospective look at HIV-negative men in several sexual health clinics across London.

Alicia Ault/Frontline Medical News

In the Swiss study, researchers wanted to assess knowledge of HCV in MSM and also the prevalence of HCV in a local population. Regular screening for HCV in the MSM population was recommended by the European AIDS Clinical Society in June, but actual screening and knowledge is thought to be low, said Dr. Matthias Cavassini of Lausanne (Switzerland) Hospital.

He and his colleagues approached 918 MSM from June 2011 to August 2012 and asked them to participate in an anonymous questionnaire and, subsequently, to undergo HCV testing. Seventy-one percent – 654 – agreed. The vast majority who agreed – 82% – had been approached at a clinic for MSM that screens for sexually transmitted illnesses. The rest came from a sauna (13%), sex clubs (3.2%), a gay pride event (1.4%), and parks (0.3%).

The median age was 33; 512 identified as homosexual (78%) and 140 as bisexual (21%). Most (431) were HIV negative, although 62 preferred not to disclose HIV status. The median number of sexual partners was 5; the range was 0 to 400. Fifty-two percent (337) had a history of STI screening within the past year. When asked about HCV screening, 154 said they’d been tested, while 380 (58%) said they did not know.

Fifty-five percent (357) had unprotected anal intercourse – a primary HCV risk factor – in the past year. Thirty-three percent (219) had a history of drug use or were current users, but only four (0.6%) reported injection drug use.

Half had no knowledge about HCV. Of the 302 who did report knowledge, a striking 84% said they were aware that HCV could be transmitted through anal sex. Only 26% knew that it could not be transmitted through oral sex. There seemed to be no particular factor that predicted knowledge.

Of the 654 who consented to HCV screening, only one (0.15%) tested positive, said Dr. Cavassini. The man’s primary risk factor was unprotected anal intercourse in the previous year.

One case does not make an epidemic, but the high prevalence of unprotected anal intercourse argues for screening in the MSM population, he said. "Is this an accident waiting to happen?" asked Dr. Cavassini.

The British study was conducted by Dr. Katie McFaul and her colleagues at Chelsea and Westminster Hospital. They retrospectively reviewed charts for all HIV-negative MSM at three clinics between Jan. 2010 and May 2014, and identified just 44 who met the criteria for acute HCV.

Of those, 15 had a previous negative HCV test within the past year, 11 had significant ALT elevation, and 18 were clinically diagnosed with HCV from risk exposure, history, and symptoms. The median age was 37, and the median number of partners was 2, with a range of 1 to 100.

Looking more closely at behavior, Dr. McFaul found that 82% reported that they engaged in unprotected anal intercourse. Many also engaged in equally risky behavior, including group sex (28%), fisting (25%), or using drugs during sex, with about 20% of those reporting injection drug use.

Of the 44 with HCV, 29 knew the status of their partner or partners; 2 had a partner with HCV, 13 had a partner with HIV, and 6 had a partner with HIV and HCV. Thirteen had an STI at the time of HCV diagnosis.

Eight had received postexposure prophylaxis for HIV before their HCV diagnosis. Overall, 15 of the 44 had a spontaneous clearance of the HCV. Eleven received treatment. Eleven percent were lost to follow-up and 30% are being observed.

While HCV prevalence seemed low, it is likely not accurate, said Dr. McFaul, noting that she and her colleagues found that HCV screening in HIV-negative MSM was rarely conducted. A one-month snapshot at the three clinics found that 15% (565) of 3,811 HIV negative men who came for sexual health screening were tested.

Extrapolating the data to all 623,350 visits during the 2010-2014 study period, Dr. McFaul estimated that about 261,036 HIV-negative MSM visited. At the current 15% screening rate, 34,657 would have been screened for HCV. But that means that almost 200,000 were not screened for HCV.

"We suggest that hepatitis C screening should be performed at routine sexual health screening, particularly in individuals with risk factors, and in environments where there is a high hepatitis C prevalence," she said. Clinicians also "need to ask penetrating questions about penetrating activities.

"If you don’t take a temperature you won’t find a fever," she said. "I think we’ll find a higher prevalence then we currently see."

[email protected]

On Twitter @aliciaault

WASHINGTON – Two studies of men having sex with men suggest that hepatitis C transmission in that group might be on the cusp of a big increase, in part because of risky behavior such as unprotected anal intercourse and injection drug use.

One study was conducted among MSM in Switzerland, while another was a retrospective look at HIV-negative men in several sexual health clinics across London.

Alicia Ault/Frontline Medical News

In the Swiss study, researchers wanted to assess knowledge of HCV in MSM and also the prevalence of HCV in a local population. Regular screening for HCV in the MSM population was recommended by the European AIDS Clinical Society in June, but actual screening and knowledge is thought to be low, said Dr. Matthias Cavassini of Lausanne (Switzerland) Hospital.

He and his colleagues approached 918 MSM from June 2011 to August 2012 and asked them to participate in an anonymous questionnaire and, subsequently, to undergo HCV testing. Seventy-one percent – 654 – agreed. The vast majority who agreed – 82% – had been approached at a clinic for MSM that screens for sexually transmitted illnesses. The rest came from a sauna (13%), sex clubs (3.2%), a gay pride event (1.4%), and parks (0.3%).

The median age was 33; 512 identified as homosexual (78%) and 140 as bisexual (21%). Most (431) were HIV negative, although 62 preferred not to disclose HIV status. The median number of sexual partners was 5; the range was 0 to 400. Fifty-two percent (337) had a history of STI screening within the past year. When asked about HCV screening, 154 said they’d been tested, while 380 (58%) said they did not know.

Fifty-five percent (357) had unprotected anal intercourse – a primary HCV risk factor – in the past year. Thirty-three percent (219) had a history of drug use or were current users, but only four (0.6%) reported injection drug use.

Half had no knowledge about HCV. Of the 302 who did report knowledge, a striking 84% said they were aware that HCV could be transmitted through anal sex. Only 26% knew that it could not be transmitted through oral sex. There seemed to be no particular factor that predicted knowledge.

Of the 654 who consented to HCV screening, only one (0.15%) tested positive, said Dr. Cavassini. The man’s primary risk factor was unprotected anal intercourse in the previous year.

One case does not make an epidemic, but the high prevalence of unprotected anal intercourse argues for screening in the MSM population, he said. "Is this an accident waiting to happen?" asked Dr. Cavassini.

The British study was conducted by Dr. Katie McFaul and her colleagues at Chelsea and Westminster Hospital. They retrospectively reviewed charts for all HIV-negative MSM at three clinics between Jan. 2010 and May 2014, and identified just 44 who met the criteria for acute HCV.

Of those, 15 had a previous negative HCV test within the past year, 11 had significant ALT elevation, and 18 were clinically diagnosed with HCV from risk exposure, history, and symptoms. The median age was 37, and the median number of partners was 2, with a range of 1 to 100.

Looking more closely at behavior, Dr. McFaul found that 82% reported that they engaged in unprotected anal intercourse. Many also engaged in equally risky behavior, including group sex (28%), fisting (25%), or using drugs during sex, with about 20% of those reporting injection drug use.

Of the 44 with HCV, 29 knew the status of their partner or partners; 2 had a partner with HCV, 13 had a partner with HIV, and 6 had a partner with HIV and HCV. Thirteen had an STI at the time of HCV diagnosis.

Eight had received postexposure prophylaxis for HIV before their HCV diagnosis. Overall, 15 of the 44 had a spontaneous clearance of the HCV. Eleven received treatment. Eleven percent were lost to follow-up and 30% are being observed.

While HCV prevalence seemed low, it is likely not accurate, said Dr. McFaul, noting that she and her colleagues found that HCV screening in HIV-negative MSM was rarely conducted. A one-month snapshot at the three clinics found that 15% (565) of 3,811 HIV negative men who came for sexual health screening were tested.

Extrapolating the data to all 623,350 visits during the 2010-2014 study period, Dr. McFaul estimated that about 261,036 HIV-negative MSM visited. At the current 15% screening rate, 34,657 would have been screened for HCV. But that means that almost 200,000 were not screened for HCV.

"We suggest that hepatitis C screening should be performed at routine sexual health screening, particularly in individuals with risk factors, and in environments where there is a high hepatitis C prevalence," she said. Clinicians also "need to ask penetrating questions about penetrating activities.

"If you don’t take a temperature you won’t find a fever," she said. "I think we’ll find a higher prevalence then we currently see."

[email protected]

On Twitter @aliciaault

WASHINGTON – Two studies of men having sex with men suggest that hepatitis C transmission in that group might be on the cusp of a big increase, in part because of risky behavior such as unprotected anal intercourse and injection drug use.

One study was conducted among MSM in Switzerland, while another was a retrospective look at HIV-negative men in several sexual health clinics across London.

Alicia Ault/Frontline Medical News

In the Swiss study, researchers wanted to assess knowledge of HCV in MSM and also the prevalence of HCV in a local population. Regular screening for HCV in the MSM population was recommended by the European AIDS Clinical Society in June, but actual screening and knowledge is thought to be low, said Dr. Matthias Cavassini of Lausanne (Switzerland) Hospital.

He and his colleagues approached 918 MSM from June 2011 to August 2012 and asked them to participate in an anonymous questionnaire and, subsequently, to undergo HCV testing. Seventy-one percent – 654 – agreed. The vast majority who agreed – 82% – had been approached at a clinic for MSM that screens for sexually transmitted illnesses. The rest came from a sauna (13%), sex clubs (3.2%), a gay pride event (1.4%), and parks (0.3%).

The median age was 33; 512 identified as homosexual (78%) and 140 as bisexual (21%). Most (431) were HIV negative, although 62 preferred not to disclose HIV status. The median number of sexual partners was 5; the range was 0 to 400. Fifty-two percent (337) had a history of STI screening within the past year. When asked about HCV screening, 154 said they’d been tested, while 380 (58%) said they did not know.

Fifty-five percent (357) had unprotected anal intercourse – a primary HCV risk factor – in the past year. Thirty-three percent (219) had a history of drug use or were current users, but only four (0.6%) reported injection drug use.

Half had no knowledge about HCV. Of the 302 who did report knowledge, a striking 84% said they were aware that HCV could be transmitted through anal sex. Only 26% knew that it could not be transmitted through oral sex. There seemed to be no particular factor that predicted knowledge.

Of the 654 who consented to HCV screening, only one (0.15%) tested positive, said Dr. Cavassini. The man’s primary risk factor was unprotected anal intercourse in the previous year.

One case does not make an epidemic, but the high prevalence of unprotected anal intercourse argues for screening in the MSM population, he said. "Is this an accident waiting to happen?" asked Dr. Cavassini.

The British study was conducted by Dr. Katie McFaul and her colleagues at Chelsea and Westminster Hospital. They retrospectively reviewed charts for all HIV-negative MSM at three clinics between Jan. 2010 and May 2014, and identified just 44 who met the criteria for acute HCV.

Of those, 15 had a previous negative HCV test within the past year, 11 had significant ALT elevation, and 18 were clinically diagnosed with HCV from risk exposure, history, and symptoms. The median age was 37, and the median number of partners was 2, with a range of 1 to 100.

Looking more closely at behavior, Dr. McFaul found that 82% reported that they engaged in unprotected anal intercourse. Many also engaged in equally risky behavior, including group sex (28%), fisting (25%), or using drugs during sex, with about 20% of those reporting injection drug use.

Of the 44 with HCV, 29 knew the status of their partner or partners; 2 had a partner with HCV, 13 had a partner with HIV, and 6 had a partner with HIV and HCV. Thirteen had an STI at the time of HCV diagnosis.

Eight had received postexposure prophylaxis for HIV before their HCV diagnosis. Overall, 15 of the 44 had a spontaneous clearance of the HCV. Eleven received treatment. Eleven percent were lost to follow-up and 30% are being observed.

While HCV prevalence seemed low, it is likely not accurate, said Dr. McFaul, noting that she and her colleagues found that HCV screening in HIV-negative MSM was rarely conducted. A one-month snapshot at the three clinics found that 15% (565) of 3,811 HIV negative men who came for sexual health screening were tested.

Extrapolating the data to all 623,350 visits during the 2010-2014 study period, Dr. McFaul estimated that about 261,036 HIV-negative MSM visited. At the current 15% screening rate, 34,657 would have been screened for HCV. But that means that almost 200,000 were not screened for HCV.

"We suggest that hepatitis C screening should be performed at routine sexual health screening, particularly in individuals with risk factors, and in environments where there is a high hepatitis C prevalence," she said. Clinicians also "need to ask penetrating questions about penetrating activities.

"If you don’t take a temperature you won’t find a fever," she said. "I think we’ll find a higher prevalence then we currently see."

[email protected]

On Twitter @aliciaault

SILVER SPRING, MD. – The widespread and long-term use of sunscreens demands that manufacturers provide more long-term safety data and information on how the active ingredients affect the health of special populations including infants, children, the elderly, and those with skin conditions, according to an expert panel called by the Food and Drug Administration.

Sunscreen safety has become an increasingly more important concern, especially since they are intended to be applied over the entire body, multiple times a day, and for a lifetime, Dr. Theresa Michele, director of the FDA’s division of nonprescription clinical evaluation, said Sept. 5 at a meeting of the agency’s Nonprescription Drugs Advisory Committee. "We’re essentially talking about a cradle-to-grave product."

© Vesna Andjic/iStockphoto.com

FDA has been under pressure from physicians, consumers, manufacturers, and Congress to approve a backlog of eight ingredients that are generally available outside of the United States and to improve the process for reviewing new ingredients. The agency proposes to add carcinogenicity and developmental and reproductive toxicity to the required safety testing prior to approval.

Speaking at the meeting, a coalition of sunscreen manufacturers said that most of what was being requested by the FDA is redundant or not necessary. "Today’s sunscreen ingredients have a wealth of data to support their safety," said the Personal Care Products Council (PCPC) in a statement. The group also said that many of the ingredients had been used for decades, without any indication that they caused cancer or led to any significant safety issues.

Advisory committee members, however, said that their concerns were not allayed.

"If you don’t look for a signal you’re not going to find a signal," said Dr. David J. Margolis, professor of dermatology at the University of Pennsylvania, Philadelphia. Dr. Margolis said he was concerned about safety over the long term, and about perhaps too much reliance on rodent models.

"The penetration through rodent skin is different than the penetration through human skin," he said.

Dr. Geoffrey L. Rosenthal, professor of pediatrics at the University of Maryland, Baltimore, said that he was bothered by the lack of specific studies in children. "Unless you study them in kids, you just don’t know," he said.

Dr. Marissa J. Perman, a pediatric dermatologist at the Children’s Hospital of Philadelphia, agreed and said that the agency should also consider requiring studies in pregnant and lactating women.

Dr. Perman, who spoke on behalf of the American Academy of Pediatrics during the public section of the meeting, said that AAP also would like to see studies based on actual – not directed – sunscreen use and investigations of the effects of spray sunscreens and of nanoparticles on children.

Several panel members also said that they were concerned about the disconnect between real-world use of sunscreens and the amounts studied during trials. The PCPC said in its background materials that market data indicate that many people use sunscreen only once a week, and that among users, only about 22% reapply as often as directed on the label.

Some committee members said that they viewed sunscreens as drugs that should always be subject to the same review and approval process.

"It’s really shocking to me that these are not being regulated through the process by which drugs are regulated," said Lorraine Gudas, Ph.D., chairman of pharmacology at Cornell University, New York. She noted that little was known about the potential systemic effects of sunscreen ingredients.

The FDA is not required to follow the panel’s advice. Any change to how sunscreens are regulated would require issuing a new rule and going through a public comment period. An FDA official declined to say when that process might occur.

[email protected]

On Twitter @aliciaault

SILVER SPRING, MD. – The widespread and long-term use of sunscreens demands that manufacturers provide more long-term safety data and information on how the active ingredients affect the health of special populations including infants, children, the elderly, and those with skin conditions, according to an expert panel called by the Food and Drug Administration.

Sunscreen safety has become an increasingly more important concern, especially since they are intended to be applied over the entire body, multiple times a day, and for a lifetime, Dr. Theresa Michele, director of the FDA’s division of nonprescription clinical evaluation, said Sept. 5 at a meeting of the agency’s Nonprescription Drugs Advisory Committee. "We’re essentially talking about a cradle-to-grave product."

© Vesna Andjic/iStockphoto.com

FDA has been under pressure from physicians, consumers, manufacturers, and Congress to approve a backlog of eight ingredients that are generally available outside of the United States and to improve the process for reviewing new ingredients. The agency proposes to add carcinogenicity and developmental and reproductive toxicity to the required safety testing prior to approval.

Speaking at the meeting, a coalition of sunscreen manufacturers said that most of what was being requested by the FDA is redundant or not necessary. "Today’s sunscreen ingredients have a wealth of data to support their safety," said the Personal Care Products Council (PCPC) in a statement. The group also said that many of the ingredients had been used for decades, without any indication that they caused cancer or led to any significant safety issues.

Advisory committee members, however, said that their concerns were not allayed.

"If you don’t look for a signal you’re not going to find a signal," said Dr. David J. Margolis, professor of dermatology at the University of Pennsylvania, Philadelphia. Dr. Margolis said he was concerned about safety over the long term, and about perhaps too much reliance on rodent models.

"The penetration through rodent skin is different than the penetration through human skin," he said.

Dr. Geoffrey L. Rosenthal, professor of pediatrics at the University of Maryland, Baltimore, said that he was bothered by the lack of specific studies in children. "Unless you study them in kids, you just don’t know," he said.

Dr. Marissa J. Perman, a pediatric dermatologist at the Children’s Hospital of Philadelphia, agreed and said that the agency should also consider requiring studies in pregnant and lactating women.

Dr. Perman, who spoke on behalf of the American Academy of Pediatrics during the public section of the meeting, said that AAP also would like to see studies based on actual – not directed – sunscreen use and investigations of the effects of spray sunscreens and of nanoparticles on children.

Several panel members also said that they were concerned about the disconnect between real-world use of sunscreens and the amounts studied during trials. The PCPC said in its background materials that market data indicate that many people use sunscreen only once a week, and that among users, only about 22% reapply as often as directed on the label.

Some committee members said that they viewed sunscreens as drugs that should always be subject to the same review and approval process.

"It’s really shocking to me that these are not being regulated through the process by which drugs are regulated," said Lorraine Gudas, Ph.D., chairman of pharmacology at Cornell University, New York. She noted that little was known about the potential systemic effects of sunscreen ingredients.

The FDA is not required to follow the panel’s advice. Any change to how sunscreens are regulated would require issuing a new rule and going through a public comment period. An FDA official declined to say when that process might occur.

[email protected]

On Twitter @aliciaault

SILVER SPRING, MD. – The widespread and long-term use of sunscreens demands that manufacturers provide more long-term safety data and information on how the active ingredients affect the health of special populations including infants, children, the elderly, and those with skin conditions, according to an expert panel called by the Food and Drug Administration.

Sunscreen safety has become an increasingly more important concern, especially since they are intended to be applied over the entire body, multiple times a day, and for a lifetime, Dr. Theresa Michele, director of the FDA’s division of nonprescription clinical evaluation, said Sept. 5 at a meeting of the agency’s Nonprescription Drugs Advisory Committee. "We’re essentially talking about a cradle-to-grave product."

© Vesna Andjic/iStockphoto.com

FDA has been under pressure from physicians, consumers, manufacturers, and Congress to approve a backlog of eight ingredients that are generally available outside of the United States and to improve the process for reviewing new ingredients. The agency proposes to add carcinogenicity and developmental and reproductive toxicity to the required safety testing prior to approval.

Speaking at the meeting, a coalition of sunscreen manufacturers said that most of what was being requested by the FDA is redundant or not necessary. "Today’s sunscreen ingredients have a wealth of data to support their safety," said the Personal Care Products Council (PCPC) in a statement. The group also said that many of the ingredients had been used for decades, without any indication that they caused cancer or led to any significant safety issues.

Advisory committee members, however, said that their concerns were not allayed.

"If you don’t look for a signal you’re not going to find a signal," said Dr. David J. Margolis, professor of dermatology at the University of Pennsylvania, Philadelphia. Dr. Margolis said he was concerned about safety over the long term, and about perhaps too much reliance on rodent models.

"The penetration through rodent skin is different than the penetration through human skin," he said.

Dr. Geoffrey L. Rosenthal, professor of pediatrics at the University of Maryland, Baltimore, said that he was bothered by the lack of specific studies in children. "Unless you study them in kids, you just don’t know," he said.

Dr. Marissa J. Perman, a pediatric dermatologist at the Children’s Hospital of Philadelphia, agreed and said that the agency should also consider requiring studies in pregnant and lactating women.

Dr. Perman, who spoke on behalf of the American Academy of Pediatrics during the public section of the meeting, said that AAP also would like to see studies based on actual – not directed – sunscreen use and investigations of the effects of spray sunscreens and of nanoparticles on children.

Several panel members also said that they were concerned about the disconnect between real-world use of sunscreens and the amounts studied during trials. The PCPC said in its background materials that market data indicate that many people use sunscreen only once a week, and that among users, only about 22% reapply as often as directed on the label.

Some committee members said that they viewed sunscreens as drugs that should always be subject to the same review and approval process.

"It’s really shocking to me that these are not being regulated through the process by which drugs are regulated," said Lorraine Gudas, Ph.D., chairman of pharmacology at Cornell University, New York. She noted that little was known about the potential systemic effects of sunscreen ingredients.

The FDA is not required to follow the panel’s advice. Any change to how sunscreens are regulated would require issuing a new rule and going through a public comment period. An FDA official declined to say when that process might occur.

[email protected]

On Twitter @aliciaault

WASHINGTON – The current trend of low growth in health care spending is expected to end in 2016 as more patients gain insurance coverage and the U.S. population continues to age, according to an analysis from the Centers for Medicare & Medicaid Services.

For the fifth year in a row, overall health care spending in 2013 grew less than 4% – significantly lower than historical growth rates, Andrea Sisko, an economist in the Office of the Actuary at the CMS, said at a press briefing. Spending growth was down, in part, because of sequestration’s 2% Medicare cut and because Medicare beneficiaries used fewer physician and hospital services. Lingering effects of the 2009 recession also meant that privately insured patients spent less on health care.

Alicia Ault/Frontline Medical News

The Affordable Care Act had some impact on the growth in health spending in 2013, Ms. Sisko said. The ACA’s temporary increase in Medicaid primary care payments helped to almost double the growth in that program’s spending. Overall Medicaid spending grew almost 7% in 2013 (vs. 3% in 2012); physician payment increases by the states and enhanced benefits contributed to the overall spending growth. The analysis was published Sept. 3 in the journal Health Affairs (doi: 10.1377/hlthaff.2014.0560).

The change in Medicaid was one of few areas where the economists definitively could say that the ACA either fueled or restrained spending growth.

"We are no longer estimating or quantifying the impacts of the Affordable Care Act on national health spending," said Ms. Sisko, who noted that after 4 years, it has become difficult to tease out the law’s effects.

Overall spending on physician services grew 3.3% in 2013, but could grow by almost 6% in 2014. After a slight decline in 2015, growth is expected to be about 6% yearly from 2016 to 2023, according to the analysis.

Future growth in spending on physician services will come as more Americans gain health insurance coverage. The projected dip in 2015 is tied to the end of the temporary Medicaid pay boost, which ends in December2014. For 2016-2023, physician spending is expected to rebound as more U.S. residents become eligible for Medicare.

Spending for physician services is expected to make up about 20% of U.S. health care spending through 2023, with hospitals consuming 32% and prescription drugs 9%.

While future health care spending growth is expected to slightly outpace economic growth (6% for health care spending vs. 5% for overall spending), that growth rate is still lower than the 7% yearly increases seen in the 1990s and through the mid-2000s, Ms. Sisko said. The growth rates will be lower in part because they will be based on a historically low baseline of the last 4-5 years, Ms. Sisko added.

Drug costs, for instance, will not have the double-digit growth seen in the late 1990s, said coauthor Sean Keehan, also an economist at the CMS Office of the Actuary. Unlike in the 1990s, payers now seem to have more leverage to negotiate lower rates from physicians and hospitals, and thus keep costs and spending down.

The physician spending figures assume that Congress will override the fee cuts mandated by the Sustainable Growth Rate formula and instead keep fees flat in 2015, and then give a 0.6% increase from 2016 to 2023. They also assume that the budget sequestration will continue.

[email protected]

On Twitter @aliciaault

WASHINGTON – The current trend of low growth in health care spending is expected to end in 2016 as more patients gain insurance coverage and the U.S. population continues to age, according to an analysis from the Centers for Medicare & Medicaid Services.

For the fifth year in a row, overall health care spending in 2013 grew less than 4% – significantly lower than historical growth rates, Andrea Sisko, an economist in the Office of the Actuary at the CMS, said at a press briefing. Spending growth was down, in part, because of sequestration’s 2% Medicare cut and because Medicare beneficiaries used fewer physician and hospital services. Lingering effects of the 2009 recession also meant that privately insured patients spent less on health care.

Alicia Ault/Frontline Medical News

The Affordable Care Act had some impact on the growth in health spending in 2013, Ms. Sisko said. The ACA’s temporary increase in Medicaid primary care payments helped to almost double the growth in that program’s spending. Overall Medicaid spending grew almost 7% in 2013 (vs. 3% in 2012); physician payment increases by the states and enhanced benefits contributed to the overall spending growth. The analysis was published Sept. 3 in the journal Health Affairs (doi: 10.1377/hlthaff.2014.0560).

The change in Medicaid was one of few areas where the economists definitively could say that the ACA either fueled or restrained spending growth.

"We are no longer estimating or quantifying the impacts of the Affordable Care Act on national health spending," said Ms. Sisko, who noted that after 4 years, it has become difficult to tease out the law’s effects.

Overall spending on physician services grew 3.3% in 2013, but could grow by almost 6% in 2014. After a slight decline in 2015, growth is expected to be about 6% yearly from 2016 to 2023, according to the analysis.

Future growth in spending on physician services will come as more Americans gain health insurance coverage. The projected dip in 2015 is tied to the end of the temporary Medicaid pay boost, which ends in December2014. For 2016-2023, physician spending is expected to rebound as more U.S. residents become eligible for Medicare.

Spending for physician services is expected to make up about 20% of U.S. health care spending through 2023, with hospitals consuming 32% and prescription drugs 9%.

While future health care spending growth is expected to slightly outpace economic growth (6% for health care spending vs. 5% for overall spending), that growth rate is still lower than the 7% yearly increases seen in the 1990s and through the mid-2000s, Ms. Sisko said. The growth rates will be lower in part because they will be based on a historically low baseline of the last 4-5 years, Ms. Sisko added.

Drug costs, for instance, will not have the double-digit growth seen in the late 1990s, said coauthor Sean Keehan, also an economist at the CMS Office of the Actuary. Unlike in the 1990s, payers now seem to have more leverage to negotiate lower rates from physicians and hospitals, and thus keep costs and spending down.

The physician spending figures assume that Congress will override the fee cuts mandated by the Sustainable Growth Rate formula and instead keep fees flat in 2015, and then give a 0.6% increase from 2016 to 2023. They also assume that the budget sequestration will continue.

[email protected]

On Twitter @aliciaault

WASHINGTON – The current trend of low growth in health care spending is expected to end in 2016 as more patients gain insurance coverage and the U.S. population continues to age, according to an analysis from the Centers for Medicare & Medicaid Services.

For the fifth year in a row, overall health care spending in 2013 grew less than 4% – significantly lower than historical growth rates, Andrea Sisko, an economist in the Office of the Actuary at the CMS, said at a press briefing. Spending growth was down, in part, because of sequestration’s 2% Medicare cut and because Medicare beneficiaries used fewer physician and hospital services. Lingering effects of the 2009 recession also meant that privately insured patients spent less on health care.

Alicia Ault/Frontline Medical News

The Affordable Care Act had some impact on the growth in health spending in 2013, Ms. Sisko said. The ACA’s temporary increase in Medicaid primary care payments helped to almost double the growth in that program’s spending. Overall Medicaid spending grew almost 7% in 2013 (vs. 3% in 2012); physician payment increases by the states and enhanced benefits contributed to the overall spending growth. The analysis was published Sept. 3 in the journal Health Affairs (doi: 10.1377/hlthaff.2014.0560).

The change in Medicaid was one of few areas where the economists definitively could say that the ACA either fueled or restrained spending growth.

"We are no longer estimating or quantifying the impacts of the Affordable Care Act on national health spending," said Ms. Sisko, who noted that after 4 years, it has become difficult to tease out the law’s effects.

Overall spending on physician services grew 3.3% in 2013, but could grow by almost 6% in 2014. After a slight decline in 2015, growth is expected to be about 6% yearly from 2016 to 2023, according to the analysis.

Future growth in spending on physician services will come as more Americans gain health insurance coverage. The projected dip in 2015 is tied to the end of the temporary Medicaid pay boost, which ends in December2014. For 2016-2023, physician spending is expected to rebound as more U.S. residents become eligible for Medicare.

Spending for physician services is expected to make up about 20% of U.S. health care spending through 2023, with hospitals consuming 32% and prescription drugs 9%.

While future health care spending growth is expected to slightly outpace economic growth (6% for health care spending vs. 5% for overall spending), that growth rate is still lower than the 7% yearly increases seen in the 1990s and through the mid-2000s, Ms. Sisko said. The growth rates will be lower in part because they will be based on a historically low baseline of the last 4-5 years, Ms. Sisko added.

Drug costs, for instance, will not have the double-digit growth seen in the late 1990s, said coauthor Sean Keehan, also an economist at the CMS Office of the Actuary. Unlike in the 1990s, payers now seem to have more leverage to negotiate lower rates from physicians and hospitals, and thus keep costs and spending down.

The physician spending figures assume that Congress will override the fee cuts mandated by the Sustainable Growth Rate formula and instead keep fees flat in 2015, and then give a 0.6% increase from 2016 to 2023. They also assume that the budget sequestration will continue.

[email protected]

On Twitter @aliciaault

Finding healthy stool donors for fecal transplant may be a tough prospect.

That’s what Australian researchers have discovered in the course of the FOCUS trial, which aims to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis and in the induction of remission.

Dr. Sudarshan Paramsothy and his colleagues at the University of New South Wales, Sydney, and the University of Melbourne, reported findings from donor recruitment for the FOCUS (Faecal Microbiota Transplantation in Ulcerative Colitis) trial at the American Gastroenterological Association’s 2014 James W. Freston Conference in Chicago.

The FOCUS study began enrolling patients in November, and is continuing to enroll, said Dr. Paramsothy. He and his colleagues also are continuing to recruit fecal donors. The data presented in Chicago were on an initial recruitment effort.

Overall, after screening, only 10% of recruits were considered eligible donors.

The researchers recruited donors through letters, newspaper ads, and online solicitations. They were told that they would be reimbursed for their time and for the transportation of their stool donations to the study site.

After responding, recruits were told that they would be expected to make stool donations five times a week for a minimum of 6 weeks.

The researchers had 116 potential donors over a 7-month recruitment period. Forty-seven declined off the bat because of the 5-day-a-week donation requirement.

Twenty-seven had other issues, including medical cormibidities (13), risk factors for variant Crueztfeldt-Jakob disease (6), and recent antibiotic use (1), that disqualified them from the study.

Thirty-eight potentially healthy donors underwent stool and blood testing. Fifteen of those donors were found to have a variety of parasites or indications of active infection that excluded them from donation: 5 had Dientamoeba fragilis, 5 had Blastocystis hominis, 1 had B. hominis and D. fragilis, 1 had Giardia intestinalis and D. fragilis, and 1 had norovirus and Clostridium difficile toxin, and 2 had leukocytes or erythrocytes on stool microscopy. One donor had indeterminate hepatitis C serology.

While it is not uncommon for people to have asymptomatic parasite carriage in the gastrointestinal tract, "we did not expect it in such a high proportion," said Dr. Paramsothy. "Our screened donor population was not an at-risk group," he said, adding that they were otherwise healthy and had no risk factors or gastrointestinal symptoms.

"Our detection rates may have been slightly higher as donor stool samples were sent to a pathology center with expert, specialized GI parasitologists for review," Dr. Paramsothy said.

There’s also some question as to whether some parasites, such as Blastocystis and Dientamoeba, "are truly pathogenic or rather commensal organisms," he said, adding that it was thought better to exclude patients with these parasites if there were any doubt.

That left 22 potential donors. Further questioning found that two had used antibiotics in between recruitment and stool testing, and one was living with a household member who was positive for D. fragilis.

Of the 19 remaining, 1 dropped out and 18 were screened again. Three were excluded because of a body mass index over 30 kg/m², 1 because of illicit drug use, 1 because of irregular bowel movements after starting a new medication, and 1 because of uncontrolled anxiety and depression. Dr. Paramsothy said that high-BMI donors were excluded because some studies have shown that gut microbiota potentially influence insulin sensitivity and obesity. Illicit drug use is a red flag because it is potentially associated with blood-borne disease acquisition, he said.

At the end, there were only 12 healthy donors, 10% of the starting 116. Dr. Paramsothy said that it was not necessary to have a single donor for every single patient in the trial. He said he could not disclose currently the number needed for the study, however.

The donor results "suggest that while FMT is an exciting new therapy, it is difficult to identify appropriate and willing anonymous donors," Dr. Paramsothy said. But that should not have an overall impact on FMT as a therapy, he said – rather, it might just make it harder for a small practice to establish an in-house FMT program.

Dr. Paramsothy reported no relevant financial conflicts.

[email protected]

On Twitter @aliciaault

Finding healthy stool donors for fecal transplant may be a tough prospect.

That’s what Australian researchers have discovered in the course of the FOCUS trial, which aims to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis and in the induction of remission.

Dr. Sudarshan Paramsothy and his colleagues at the University of New South Wales, Sydney, and the University of Melbourne, reported findings from donor recruitment for the FOCUS (Faecal Microbiota Transplantation in Ulcerative Colitis) trial at the American Gastroenterological Association’s 2014 James W. Freston Conference in Chicago.

The FOCUS study began enrolling patients in November, and is continuing to enroll, said Dr. Paramsothy. He and his colleagues also are continuing to recruit fecal donors. The data presented in Chicago were on an initial recruitment effort.

Overall, after screening, only 10% of recruits were considered eligible donors.

The researchers recruited donors through letters, newspaper ads, and online solicitations. They were told that they would be reimbursed for their time and for the transportation of their stool donations to the study site.

After responding, recruits were told that they would be expected to make stool donations five times a week for a minimum of 6 weeks.

The researchers had 116 potential donors over a 7-month recruitment period. Forty-seven declined off the bat because of the 5-day-a-week donation requirement.

Twenty-seven had other issues, including medical cormibidities (13), risk factors for variant Crueztfeldt-Jakob disease (6), and recent antibiotic use (1), that disqualified them from the study.

Thirty-eight potentially healthy donors underwent stool and blood testing. Fifteen of those donors were found to have a variety of parasites or indications of active infection that excluded them from donation: 5 had Dientamoeba fragilis, 5 had Blastocystis hominis, 1 had B. hominis and D. fragilis, 1 had Giardia intestinalis and D. fragilis, and 1 had norovirus and Clostridium difficile toxin, and 2 had leukocytes or erythrocytes on stool microscopy. One donor had indeterminate hepatitis C serology.

While it is not uncommon for people to have asymptomatic parasite carriage in the gastrointestinal tract, "we did not expect it in such a high proportion," said Dr. Paramsothy. "Our screened donor population was not an at-risk group," he said, adding that they were otherwise healthy and had no risk factors or gastrointestinal symptoms.

"Our detection rates may have been slightly higher as donor stool samples were sent to a pathology center with expert, specialized GI parasitologists for review," Dr. Paramsothy said.

There’s also some question as to whether some parasites, such as Blastocystis and Dientamoeba, "are truly pathogenic or rather commensal organisms," he said, adding that it was thought better to exclude patients with these parasites if there were any doubt.

That left 22 potential donors. Further questioning found that two had used antibiotics in between recruitment and stool testing, and one was living with a household member who was positive for D. fragilis.

Of the 19 remaining, 1 dropped out and 18 were screened again. Three were excluded because of a body mass index over 30 kg/m², 1 because of illicit drug use, 1 because of irregular bowel movements after starting a new medication, and 1 because of uncontrolled anxiety and depression. Dr. Paramsothy said that high-BMI donors were excluded because some studies have shown that gut microbiota potentially influence insulin sensitivity and obesity. Illicit drug use is a red flag because it is potentially associated with blood-borne disease acquisition, he said.

At the end, there were only 12 healthy donors, 10% of the starting 116. Dr. Paramsothy said that it was not necessary to have a single donor for every single patient in the trial. He said he could not disclose currently the number needed for the study, however.

The donor results "suggest that while FMT is an exciting new therapy, it is difficult to identify appropriate and willing anonymous donors," Dr. Paramsothy said. But that should not have an overall impact on FMT as a therapy, he said – rather, it might just make it harder for a small practice to establish an in-house FMT program.

Dr. Paramsothy reported no relevant financial conflicts.

[email protected]

On Twitter @aliciaault

Finding healthy stool donors for fecal transplant may be a tough prospect.

That’s what Australian researchers have discovered in the course of the FOCUS trial, which aims to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis and in the induction of remission.

Dr. Sudarshan Paramsothy and his colleagues at the University of New South Wales, Sydney, and the University of Melbourne, reported findings from donor recruitment for the FOCUS (Faecal Microbiota Transplantation in Ulcerative Colitis) trial at the American Gastroenterological Association’s 2014 James W. Freston Conference in Chicago.

The FOCUS study began enrolling patients in November, and is continuing to enroll, said Dr. Paramsothy. He and his colleagues also are continuing to recruit fecal donors. The data presented in Chicago were on an initial recruitment effort.

Overall, after screening, only 10% of recruits were considered eligible donors.

The researchers recruited donors through letters, newspaper ads, and online solicitations. They were told that they would be reimbursed for their time and for the transportation of their stool donations to the study site.

After responding, recruits were told that they would be expected to make stool donations five times a week for a minimum of 6 weeks.

The researchers had 116 potential donors over a 7-month recruitment period. Forty-seven declined off the bat because of the 5-day-a-week donation requirement.

Twenty-seven had other issues, including medical cormibidities (13), risk factors for variant Crueztfeldt-Jakob disease (6), and recent antibiotic use (1), that disqualified them from the study.

Thirty-eight potentially healthy donors underwent stool and blood testing. Fifteen of those donors were found to have a variety of parasites or indications of active infection that excluded them from donation: 5 had Dientamoeba fragilis, 5 had Blastocystis hominis, 1 had B. hominis and D. fragilis, 1 had Giardia intestinalis and D. fragilis, and 1 had norovirus and Clostridium difficile toxin, and 2 had leukocytes or erythrocytes on stool microscopy. One donor had indeterminate hepatitis C serology.

While it is not uncommon for people to have asymptomatic parasite carriage in the gastrointestinal tract, "we did not expect it in such a high proportion," said Dr. Paramsothy. "Our screened donor population was not an at-risk group," he said, adding that they were otherwise healthy and had no risk factors or gastrointestinal symptoms.

"Our detection rates may have been slightly higher as donor stool samples were sent to a pathology center with expert, specialized GI parasitologists for review," Dr. Paramsothy said.

There’s also some question as to whether some parasites, such as Blastocystis and Dientamoeba, "are truly pathogenic or rather commensal organisms," he said, adding that it was thought better to exclude patients with these parasites if there were any doubt.

That left 22 potential donors. Further questioning found that two had used antibiotics in between recruitment and stool testing, and one was living with a household member who was positive for D. fragilis.

Of the 19 remaining, 1 dropped out and 18 were screened again. Three were excluded because of a body mass index over 30 kg/m², 1 because of illicit drug use, 1 because of irregular bowel movements after starting a new medication, and 1 because of uncontrolled anxiety and depression. Dr. Paramsothy said that high-BMI donors were excluded because some studies have shown that gut microbiota potentially influence insulin sensitivity and obesity. Illicit drug use is a red flag because it is potentially associated with blood-borne disease acquisition, he said.

At the end, there were only 12 healthy donors, 10% of the starting 116. Dr. Paramsothy said that it was not necessary to have a single donor for every single patient in the trial. He said he could not disclose currently the number needed for the study, however.

The donor results "suggest that while FMT is an exciting new therapy, it is difficult to identify appropriate and willing anonymous donors," Dr. Paramsothy said. But that should not have an overall impact on FMT as a therapy, he said – rather, it might just make it harder for a small practice to establish an in-house FMT program.

Dr. Paramsothy reported no relevant financial conflicts.

[email protected]

On Twitter @aliciaault

Dr. Karen DeSalvo is the fifth person to serve as National Coordinator for Health Information Technology at the Health and Human Services Department, but perhaps more than any of her predecessors, she is truly in the thick of the struggle to bring doctors, medical practices, and hospitals into the digital age.

Physicians face a major deadline this year: It’s the last year to sign up for the meaningful use incentive payment program created by the Health Information Technology for Economic and Clinical Health Act (HITECH). If they don’t participate, they lose out on the potential to recoup from the federal government at least a small portion of the money they’ve spent on electronic health record systems. And it’s becoming inevitable that not participating could mean being left behind by insurers, hospitals, and patients.

That’s causing a lot of anxiety. Dr. DeSalvo – a practicing internist – says that she feels doctors’ pain. She recently completed a national listening tour and says that what she learned from those sessions will help inform how the Office of the National Coordinator moves forward.

Dr. Karen DeSalvo is the fifth person to serve as National Coordinator for Health Information Technology at the Health and Human Services Department, but perhaps more than any of her predecessors, she is truly in the thick of the struggle to bring doctors, medical practices, and hospitals into the digital age.

Physicians face a major deadline this year: It’s the last year to sign up for the meaningful use incentive payment program created by the Health Information Technology for Economic and Clinical Health Act (HITECH). If they don’t participate, they lose out on the potential to recoup from the federal government at least a small portion of the money they’ve spent on electronic health record systems. And it’s becoming inevitable that not participating could mean being left behind by insurers, hospitals, and patients.

That’s causing a lot of anxiety. Dr. DeSalvo – a practicing internist – says that she feels doctors’ pain. She recently completed a national listening tour and says that what she learned from those sessions will help inform how the Office of the National Coordinator moves forward.

Dr. Karen DeSalvo is the fifth person to serve as National Coordinator for Health Information Technology at the Health and Human Services Department, but perhaps more than any of her predecessors, she is truly in the thick of the struggle to bring doctors, medical practices, and hospitals into the digital age.

Physicians face a major deadline this year: It’s the last year to sign up for the meaningful use incentive payment program created by the Health Information Technology for Economic and Clinical Health Act (HITECH). If they don’t participate, they lose out on the potential to recoup from the federal government at least a small portion of the money they’ve spent on electronic health record systems. And it’s becoming inevitable that not participating could mean being left behind by insurers, hospitals, and patients.

That’s causing a lot of anxiety. Dr. DeSalvo – a practicing internist – says that she feels doctors’ pain. She recently completed a national listening tour and says that what she learned from those sessions will help inform how the Office of the National Coordinator moves forward.

The U.S. Department of Health & Human Services has named a new chief executive officer to run the federal marketplace, which includes the healthcare.gov website.

Kevin Counihan, currently the CEO for Connecticut’s marketplace, has been named to run the federal marketplace. He also will be in charge of the Center for Consumer Information and Insurance Oversight (CCIIO), which regulates health insurance. HHS Secretary Sylvia Mathews Burwell announced in June that the department would be looking for a new CEO.

Mr. Counihan has served as CEO for Health Access CT since June 2012, after having served as chief marketing officer from 2006 to 2011 for the Commonwealth of Massachusetts Health Insurance Connector Authority, which administered that state’s health insurance exchange. Before that, he was a sales and marketing executive for Tufts Health Plan of Massachusetts and regional vice president for CIGNA.

"We are committed to instilling ongoing accountability for reaching milestones, measuring results, and ensuring a successful open enrollment period," Ms. Burwell said in a statement. Mr. Counihan "brings additional operational and technological expertise to the position and will be a clear, single point of contact for streamlined decision making."

Mr. Counihan will report to Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner.

[email protected]

On Twitter @aliciaault

The U.S. Department of Health & Human Services has named a new chief executive officer to run the federal marketplace, which includes the healthcare.gov website.

Kevin Counihan, currently the CEO for Connecticut’s marketplace, has been named to run the federal marketplace. He also will be in charge of the Center for Consumer Information and Insurance Oversight (CCIIO), which regulates health insurance. HHS Secretary Sylvia Mathews Burwell announced in June that the department would be looking for a new CEO.

Mr. Counihan has served as CEO for Health Access CT since June 2012, after having served as chief marketing officer from 2006 to 2011 for the Commonwealth of Massachusetts Health Insurance Connector Authority, which administered that state’s health insurance exchange. Before that, he was a sales and marketing executive for Tufts Health Plan of Massachusetts and regional vice president for CIGNA.

"We are committed to instilling ongoing accountability for reaching milestones, measuring results, and ensuring a successful open enrollment period," Ms. Burwell said in a statement. Mr. Counihan "brings additional operational and technological expertise to the position and will be a clear, single point of contact for streamlined decision making."

Mr. Counihan will report to Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner.

[email protected]

On Twitter @aliciaault

The U.S. Department of Health & Human Services has named a new chief executive officer to run the federal marketplace, which includes the healthcare.gov website.

Kevin Counihan, currently the CEO for Connecticut’s marketplace, has been named to run the federal marketplace. He also will be in charge of the Center for Consumer Information and Insurance Oversight (CCIIO), which regulates health insurance. HHS Secretary Sylvia Mathews Burwell announced in June that the department would be looking for a new CEO.

Mr. Counihan has served as CEO for Health Access CT since June 2012, after having served as chief marketing officer from 2006 to 2011 for the Commonwealth of Massachusetts Health Insurance Connector Authority, which administered that state’s health insurance exchange. Before that, he was a sales and marketing executive for Tufts Health Plan of Massachusetts and regional vice president for CIGNA.

"We are committed to instilling ongoing accountability for reaching milestones, measuring results, and ensuring a successful open enrollment period," Ms. Burwell said in a statement. Mr. Counihan "brings additional operational and technological expertise to the position and will be a clear, single point of contact for streamlined decision making."

Mr. Counihan will report to Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner.

[email protected]

On Twitter @aliciaault