Alicia Ault

Personalized medicine is a reality for many cancer patients, and getting closer for others, but the oncology community is struggling with a number of questions surrounding genomic testing, a key to providing that care.

As a result, oncology leaders have started to take a closer look at how to resolve these issues, and how to do it as quickly as possible.

Among the most basic questions are when to use the testing, what to do with the information that’s generated, and how to secure reimbursement for diagnostics that may not have fully proven their clinical utility.

The science of genomics – from profiling a tumor’s genetic make-up to sequencing a cancer patient’s entire genome – is growing exponentially, leading to a rush to commercialize diagnostics based on the discoveries and a push among big cancer centers to leverage the knowledge to help develop therapeutics and inform clinical trials. Meanwhile, the Food and Drug Administration hasn’t articulated a clear regulatory strategy around genomic testing.

"We need an infrastructure in place that quickly translates verified advances in treatment into practice," said Mark Fleury, Ph.D., of the American Cancer Society Cancer Action Network (ACS CAN). Now, genomic advances are relying on what he calls "passive diffusion."

Currently, there’s a kind of free-for-all, agreed Dr. Richard L. Schilsky, medical director of the American Society of Clinical Oncology.

"People need tests to guide treatment decisions, but there are very few controls over how tests are offered and developed," said Dr. Schilsky. He also noted that there is not a huge evidence base yet on the usefulness of some of the testing.

The oncology community is trying to bring some civility to the "Wild West" of genomics, starting by establishing standards, Dr. Schilsky said.

Among the issues being discussed:

• What genetic variants should oncologists be testing for in all common cancers?

• What is level of evidence that supports testing for those particular variants?

• What are the recommended clinical actions to be taken once certain variants are discovered?

• What information should be reported to the oncologist?

• What information should be reported to the patient, and how?

In early April, ASCO convened a meeting of representatives from clinical oncology, pathology, the genetic sequencing community, and the regulatory community, among others, to discuss those issues and more, Dr. Schilsky said. "We didn’t come away with any consensus, but we put all the issues on the table," he said.

ACS CAN held a policy forum in April to delve into some of the same issues.

"There are three main things you need to make personalized medicine work," said Dr. Fleury. The information generated has to be accurate, it has to somehow translate to having meaning for the disease, and the diagnostic has to provide some sort of change in treatment for the better, said Dr. Fleury. Now, though, "there are breakdowns in all three of those steps."

Understandably, said Dr. Fleury, payers don’t want to reimburse for tests or services that don’t provide any measurable utility. And, he said, the patient won’t want the information if he or she "doesn’t understand the usefulness."

Dr. Tanguy L. Seiwert of the department of medicine at the University of Chicago who focuses on head and neck and lung cancer, said, "Physicians want to do this, and there’s a growing movement that [genomic testing] is beneficial." But he added that the uncertainty over payment had helped contribute to an uncertainty overall about personalized medicine.

There’s not a lot of good data on exactly how many genomic tests are available – either as a single mutation test or a panel of tests – and how often they are being used.

The FDA has approved 19 diagnostics that are meant to help clinicians determine whether certain targeted therapies would be useful. They are used in colorectal, lung and breast cancers, gastrointestinal stromal tumors, and melanoma.

But that’s only a small fraction of the available tests. In July 2013, the Agency for Healthcare Research and Quality identified 178 different genetic tests for 10 common cancer conditions. Sixty-six were new since it last surveyed the field in 2011; the largest number of tests were being used for breast cancer.

The commercial potential of genomic testing is growing, despite the many outstanding questions. Myriad Genetics said in its most recent quarterly report that there was "wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes." Still, Myriad’s oncology testing revenues grew relatively slowly, by about 12% from the previous year to $102 million for the second quarter. Most of Myriad’s diagnostics are predictive, like its BRACAnalysis test. But the company is also branching out into genomics that will help guide treatment decisions.

In Oct. 2013, it launched the myPlan Lung Cancer test, which it says will help clinicians determine a newly diagnosed patient’s risk of dying from lung cancer within 5 years, and in turn help decide whether an early-stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.

Foundation Medicine, based in Cambridge, Mass., is working with drug makers to develop companion diagnostics for targeted chemotherapies but is also offering direct to oncologists genomic panels that provide analysis of up to 200 genes. One of the tests is for solid tumors and the other is for hematologic malignancies, sarcomas, and pediatric cancers. The company said in its most recent quarterly report that testing revenues had grown by a third from the year ago quarter.

The FDA is also approving new targeted therapies that would probably be made more useful through the use of genomic testing to winnow down the number of potential patients who could benefit. For instance, in May, the agency approved certinib (Zykadia), a drug that blocks the anaplastic lymphoma kinase (ALK) protein. There is an FDA-approved diagnostic – the Vysis ALK Break Apart FISH Probe Kit – designed to detect ALK gene mutations, but it’s indicated for use only to identify patients eligible for treatment with another therapy, crizotinib (Xalkori).

There’s nothing to stop off-label use, or use of so-called "home brew" tests that are developed in-house at hospitals or clinical labs but not FDA-approved.

The FDA may soon step up its regulation of those diagnostics, said ACS CAN’s Dr. Fleury. "They’ve been very public that they fully intend to bring high-risk lab tests into their purview," he said, adding that many in the field believe that the regulations have already been written. It appears that the only thing delaying those regulations from being issued is White House clearance, Dr. Fleury said.

Meanwhile, many institutions are moving on to next generation sequencing, which involves taking a look at hundreds of genes, not just a single variant. Even with a limited amount of tumor tissue, it maximizes the information that can be gleaned from a biopsy sample, said Dr. Schilsky. It may be less expensive and more efficient than conducting multiple different single mutation diagnostics, he said.

However, right now, "it gives you way more information than you could possibly use at any point in time," said Dr. Schilsky. And, many clinicians have difficulty interpreting such a huge amount of complex information.

Most payers are not approving reimbursement for these multiple gene panels, he said. Even so, "many cancer centers are doing this because they think it provides an important platform for their research, and it attracts patients to their institutions," said Dr. Schilsky.

Dr. Seiwert helped develop a multigene assay, which the University of Chicago recently began offering to its oncology patients. In general, it is not being covered by insurers, he said. But, while the cost of molecular diagnostics – which can run from $1,500-$8,000 per patient – is high, it is not that large when compared with the cost of many chemotherapies, he said. If the testing "leads to treatment that has a higher chance of working, then it’s a very small cost, compared with blindly using a drug," Dr. Seiwert said.

His cancer center is covering the cost of testing when it is not reimbursed. Dr. Schilsky said that, from what he has heard, that is not uncommon. "My understanding from many lab directors is that they are basically eating the costs," he said.

Partly because of economics, genomic testing has not disseminated out of the academic centers. Dr. Seiwert said that he thought that testing for specific mutations like EGFR in lung cancer or HER2 in breast cancer was becoming a standard of practice, but that it was a "moving target" in the community. And, when it comes to larger, multi-gene assays, "my sense is that this is largely confined to academic centers," he said.

Single mutation genomic testing, especially for lung cancer "should be the standard of care, but the evidence is that it has not permeated out to the smaller practices," said Dr. Fleury, of ACS CAN.

"When you come in, you should get the diagnosis and be tested for a mutation right away," said Dr. Fleury, who added that this is not happening on a widespread basis.

Oncologists can often be in an awkward position when a test they want to offer is not covered by the patient’s insurance. If the patient can’t afford the cost, they might feel like they’re not getting something that others can, said Dr. Seiwert. "It’s a messy situation," he said.

But, it’s one that oncologists at academic centers don’t have to encounter very often, as they usually find a way to cover the cost of testing.

"When it comes to genetic testing, we have both under- and over-utilization," said Dr. Fleury. "We need that happy medium."

Things will start evening out with the right infrastructure, Dr. Fleury said. He sees things falling into place with organizations like ASCO and ACS CAN developing guidelines and standards, and the FDA about to step up its oversight of genomic assays that are developed in-house by hospital and commercial labs.

Also, as the market evolves towards panels of tests, instead of just single mutations, the process will likely become more efficient, Dr. Fleury added.

Currently, for instance, there are only two targeted therapies and two companion diagnostics for lung cancer but a dozen known mutations. In the future, as more therapies are developed to go after those mutations, it won’t be cost-effective or efficient to conduct a dozen different tests with a dozen different charges and copays, said Dr. Fleury.

[email protected]

On Twitter @aliciaault

Personalized medicine is a reality for many cancer patients, and getting closer for others, but the oncology community is struggling with a number of questions surrounding genomic testing, a key to providing that care.

As a result, oncology leaders have started to take a closer look at how to resolve these issues, and how to do it as quickly as possible.

Among the most basic questions are when to use the testing, what to do with the information that’s generated, and how to secure reimbursement for diagnostics that may not have fully proven their clinical utility.

The science of genomics – from profiling a tumor’s genetic make-up to sequencing a cancer patient’s entire genome – is growing exponentially, leading to a rush to commercialize diagnostics based on the discoveries and a push among big cancer centers to leverage the knowledge to help develop therapeutics and inform clinical trials. Meanwhile, the Food and Drug Administration hasn’t articulated a clear regulatory strategy around genomic testing.

"We need an infrastructure in place that quickly translates verified advances in treatment into practice," said Mark Fleury, Ph.D., of the American Cancer Society Cancer Action Network (ACS CAN). Now, genomic advances are relying on what he calls "passive diffusion."

Currently, there’s a kind of free-for-all, agreed Dr. Richard L. Schilsky, medical director of the American Society of Clinical Oncology.

"People need tests to guide treatment decisions, but there are very few controls over how tests are offered and developed," said Dr. Schilsky. He also noted that there is not a huge evidence base yet on the usefulness of some of the testing.

The oncology community is trying to bring some civility to the "Wild West" of genomics, starting by establishing standards, Dr. Schilsky said.

Among the issues being discussed:

• What genetic variants should oncologists be testing for in all common cancers?

• What is level of evidence that supports testing for those particular variants?

• What are the recommended clinical actions to be taken once certain variants are discovered?

• What information should be reported to the oncologist?

• What information should be reported to the patient, and how?

In early April, ASCO convened a meeting of representatives from clinical oncology, pathology, the genetic sequencing community, and the regulatory community, among others, to discuss those issues and more, Dr. Schilsky said. "We didn’t come away with any consensus, but we put all the issues on the table," he said.

ACS CAN held a policy forum in April to delve into some of the same issues.

"There are three main things you need to make personalized medicine work," said Dr. Fleury. The information generated has to be accurate, it has to somehow translate to having meaning for the disease, and the diagnostic has to provide some sort of change in treatment for the better, said Dr. Fleury. Now, though, "there are breakdowns in all three of those steps."

Understandably, said Dr. Fleury, payers don’t want to reimburse for tests or services that don’t provide any measurable utility. And, he said, the patient won’t want the information if he or she "doesn’t understand the usefulness."

Dr. Tanguy L. Seiwert of the department of medicine at the University of Chicago who focuses on head and neck and lung cancer, said, "Physicians want to do this, and there’s a growing movement that [genomic testing] is beneficial." But he added that the uncertainty over payment had helped contribute to an uncertainty overall about personalized medicine.

There’s not a lot of good data on exactly how many genomic tests are available – either as a single mutation test or a panel of tests – and how often they are being used.

The FDA has approved 19 diagnostics that are meant to help clinicians determine whether certain targeted therapies would be useful. They are used in colorectal, lung and breast cancers, gastrointestinal stromal tumors, and melanoma.

But that’s only a small fraction of the available tests. In July 2013, the Agency for Healthcare Research and Quality identified 178 different genetic tests for 10 common cancer conditions. Sixty-six were new since it last surveyed the field in 2011; the largest number of tests were being used for breast cancer.

The commercial potential of genomic testing is growing, despite the many outstanding questions. Myriad Genetics said in its most recent quarterly report that there was "wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes." Still, Myriad’s oncology testing revenues grew relatively slowly, by about 12% from the previous year to $102 million for the second quarter. Most of Myriad’s diagnostics are predictive, like its BRACAnalysis test. But the company is also branching out into genomics that will help guide treatment decisions.

In Oct. 2013, it launched the myPlan Lung Cancer test, which it says will help clinicians determine a newly diagnosed patient’s risk of dying from lung cancer within 5 years, and in turn help decide whether an early-stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.

Foundation Medicine, based in Cambridge, Mass., is working with drug makers to develop companion diagnostics for targeted chemotherapies but is also offering direct to oncologists genomic panels that provide analysis of up to 200 genes. One of the tests is for solid tumors and the other is for hematologic malignancies, sarcomas, and pediatric cancers. The company said in its most recent quarterly report that testing revenues had grown by a third from the year ago quarter.

The FDA is also approving new targeted therapies that would probably be made more useful through the use of genomic testing to winnow down the number of potential patients who could benefit. For instance, in May, the agency approved certinib (Zykadia), a drug that blocks the anaplastic lymphoma kinase (ALK) protein. There is an FDA-approved diagnostic – the Vysis ALK Break Apart FISH Probe Kit – designed to detect ALK gene mutations, but it’s indicated for use only to identify patients eligible for treatment with another therapy, crizotinib (Xalkori).

There’s nothing to stop off-label use, or use of so-called "home brew" tests that are developed in-house at hospitals or clinical labs but not FDA-approved.

The FDA may soon step up its regulation of those diagnostics, said ACS CAN’s Dr. Fleury. "They’ve been very public that they fully intend to bring high-risk lab tests into their purview," he said, adding that many in the field believe that the regulations have already been written. It appears that the only thing delaying those regulations from being issued is White House clearance, Dr. Fleury said.

Meanwhile, many institutions are moving on to next generation sequencing, which involves taking a look at hundreds of genes, not just a single variant. Even with a limited amount of tumor tissue, it maximizes the information that can be gleaned from a biopsy sample, said Dr. Schilsky. It may be less expensive and more efficient than conducting multiple different single mutation diagnostics, he said.

However, right now, "it gives you way more information than you could possibly use at any point in time," said Dr. Schilsky. And, many clinicians have difficulty interpreting such a huge amount of complex information.

Most payers are not approving reimbursement for these multiple gene panels, he said. Even so, "many cancer centers are doing this because they think it provides an important platform for their research, and it attracts patients to their institutions," said Dr. Schilsky.

Dr. Seiwert helped develop a multigene assay, which the University of Chicago recently began offering to its oncology patients. In general, it is not being covered by insurers, he said. But, while the cost of molecular diagnostics – which can run from $1,500-$8,000 per patient – is high, it is not that large when compared with the cost of many chemotherapies, he said. If the testing "leads to treatment that has a higher chance of working, then it’s a very small cost, compared with blindly using a drug," Dr. Seiwert said.

His cancer center is covering the cost of testing when it is not reimbursed. Dr. Schilsky said that, from what he has heard, that is not uncommon. "My understanding from many lab directors is that they are basically eating the costs," he said.

Partly because of economics, genomic testing has not disseminated out of the academic centers. Dr. Seiwert said that he thought that testing for specific mutations like EGFR in lung cancer or HER2 in breast cancer was becoming a standard of practice, but that it was a "moving target" in the community. And, when it comes to larger, multi-gene assays, "my sense is that this is largely confined to academic centers," he said.

Single mutation genomic testing, especially for lung cancer "should be the standard of care, but the evidence is that it has not permeated out to the smaller practices," said Dr. Fleury, of ACS CAN.

"When you come in, you should get the diagnosis and be tested for a mutation right away," said Dr. Fleury, who added that this is not happening on a widespread basis.

Oncologists can often be in an awkward position when a test they want to offer is not covered by the patient’s insurance. If the patient can’t afford the cost, they might feel like they’re not getting something that others can, said Dr. Seiwert. "It’s a messy situation," he said.

But, it’s one that oncologists at academic centers don’t have to encounter very often, as they usually find a way to cover the cost of testing.

"When it comes to genetic testing, we have both under- and over-utilization," said Dr. Fleury. "We need that happy medium."

Things will start evening out with the right infrastructure, Dr. Fleury said. He sees things falling into place with organizations like ASCO and ACS CAN developing guidelines and standards, and the FDA about to step up its oversight of genomic assays that are developed in-house by hospital and commercial labs.

Also, as the market evolves towards panels of tests, instead of just single mutations, the process will likely become more efficient, Dr. Fleury added.

Currently, for instance, there are only two targeted therapies and two companion diagnostics for lung cancer but a dozen known mutations. In the future, as more therapies are developed to go after those mutations, it won’t be cost-effective or efficient to conduct a dozen different tests with a dozen different charges and copays, said Dr. Fleury.

[email protected]

On Twitter @aliciaault

Personalized medicine is a reality for many cancer patients, and getting closer for others, but the oncology community is struggling with a number of questions surrounding genomic testing, a key to providing that care.

As a result, oncology leaders have started to take a closer look at how to resolve these issues, and how to do it as quickly as possible.

Among the most basic questions are when to use the testing, what to do with the information that’s generated, and how to secure reimbursement for diagnostics that may not have fully proven their clinical utility.

The science of genomics – from profiling a tumor’s genetic make-up to sequencing a cancer patient’s entire genome – is growing exponentially, leading to a rush to commercialize diagnostics based on the discoveries and a push among big cancer centers to leverage the knowledge to help develop therapeutics and inform clinical trials. Meanwhile, the Food and Drug Administration hasn’t articulated a clear regulatory strategy around genomic testing.

"We need an infrastructure in place that quickly translates verified advances in treatment into practice," said Mark Fleury, Ph.D., of the American Cancer Society Cancer Action Network (ACS CAN). Now, genomic advances are relying on what he calls "passive diffusion."

Currently, there’s a kind of free-for-all, agreed Dr. Richard L. Schilsky, medical director of the American Society of Clinical Oncology.

"People need tests to guide treatment decisions, but there are very few controls over how tests are offered and developed," said Dr. Schilsky. He also noted that there is not a huge evidence base yet on the usefulness of some of the testing.

The oncology community is trying to bring some civility to the "Wild West" of genomics, starting by establishing standards, Dr. Schilsky said.

Among the issues being discussed:

• What genetic variants should oncologists be testing for in all common cancers?

• What is level of evidence that supports testing for those particular variants?

• What are the recommended clinical actions to be taken once certain variants are discovered?

• What information should be reported to the oncologist?

• What information should be reported to the patient, and how?

In early April, ASCO convened a meeting of representatives from clinical oncology, pathology, the genetic sequencing community, and the regulatory community, among others, to discuss those issues and more, Dr. Schilsky said. "We didn’t come away with any consensus, but we put all the issues on the table," he said.

ACS CAN held a policy forum in April to delve into some of the same issues.

"There are three main things you need to make personalized medicine work," said Dr. Fleury. The information generated has to be accurate, it has to somehow translate to having meaning for the disease, and the diagnostic has to provide some sort of change in treatment for the better, said Dr. Fleury. Now, though, "there are breakdowns in all three of those steps."

Understandably, said Dr. Fleury, payers don’t want to reimburse for tests or services that don’t provide any measurable utility. And, he said, the patient won’t want the information if he or she "doesn’t understand the usefulness."

Dr. Tanguy L. Seiwert of the department of medicine at the University of Chicago who focuses on head and neck and lung cancer, said, "Physicians want to do this, and there’s a growing movement that [genomic testing] is beneficial." But he added that the uncertainty over payment had helped contribute to an uncertainty overall about personalized medicine.

There’s not a lot of good data on exactly how many genomic tests are available – either as a single mutation test or a panel of tests – and how often they are being used.

The FDA has approved 19 diagnostics that are meant to help clinicians determine whether certain targeted therapies would be useful. They are used in colorectal, lung and breast cancers, gastrointestinal stromal tumors, and melanoma.

But that’s only a small fraction of the available tests. In July 2013, the Agency for Healthcare Research and Quality identified 178 different genetic tests for 10 common cancer conditions. Sixty-six were new since it last surveyed the field in 2011; the largest number of tests were being used for breast cancer.

The commercial potential of genomic testing is growing, despite the many outstanding questions. Myriad Genetics said in its most recent quarterly report that there was "wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes." Still, Myriad’s oncology testing revenues grew relatively slowly, by about 12% from the previous year to $102 million for the second quarter. Most of Myriad’s diagnostics are predictive, like its BRACAnalysis test. But the company is also branching out into genomics that will help guide treatment decisions.

In Oct. 2013, it launched the myPlan Lung Cancer test, which it says will help clinicians determine a newly diagnosed patient’s risk of dying from lung cancer within 5 years, and in turn help decide whether an early-stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.

Foundation Medicine, based in Cambridge, Mass., is working with drug makers to develop companion diagnostics for targeted chemotherapies but is also offering direct to oncologists genomic panels that provide analysis of up to 200 genes. One of the tests is for solid tumors and the other is for hematologic malignancies, sarcomas, and pediatric cancers. The company said in its most recent quarterly report that testing revenues had grown by a third from the year ago quarter.

The FDA is also approving new targeted therapies that would probably be made more useful through the use of genomic testing to winnow down the number of potential patients who could benefit. For instance, in May, the agency approved certinib (Zykadia), a drug that blocks the anaplastic lymphoma kinase (ALK) protein. There is an FDA-approved diagnostic – the Vysis ALK Break Apart FISH Probe Kit – designed to detect ALK gene mutations, but it’s indicated for use only to identify patients eligible for treatment with another therapy, crizotinib (Xalkori).

There’s nothing to stop off-label use, or use of so-called "home brew" tests that are developed in-house at hospitals or clinical labs but not FDA-approved.

The FDA may soon step up its regulation of those diagnostics, said ACS CAN’s Dr. Fleury. "They’ve been very public that they fully intend to bring high-risk lab tests into their purview," he said, adding that many in the field believe that the regulations have already been written. It appears that the only thing delaying those regulations from being issued is White House clearance, Dr. Fleury said.

Meanwhile, many institutions are moving on to next generation sequencing, which involves taking a look at hundreds of genes, not just a single variant. Even with a limited amount of tumor tissue, it maximizes the information that can be gleaned from a biopsy sample, said Dr. Schilsky. It may be less expensive and more efficient than conducting multiple different single mutation diagnostics, he said.

However, right now, "it gives you way more information than you could possibly use at any point in time," said Dr. Schilsky. And, many clinicians have difficulty interpreting such a huge amount of complex information.

Most payers are not approving reimbursement for these multiple gene panels, he said. Even so, "many cancer centers are doing this because they think it provides an important platform for their research, and it attracts patients to their institutions," said Dr. Schilsky.

Dr. Seiwert helped develop a multigene assay, which the University of Chicago recently began offering to its oncology patients. In general, it is not being covered by insurers, he said. But, while the cost of molecular diagnostics – which can run from $1,500-$8,000 per patient – is high, it is not that large when compared with the cost of many chemotherapies, he said. If the testing "leads to treatment that has a higher chance of working, then it’s a very small cost, compared with blindly using a drug," Dr. Seiwert said.

His cancer center is covering the cost of testing when it is not reimbursed. Dr. Schilsky said that, from what he has heard, that is not uncommon. "My understanding from many lab directors is that they are basically eating the costs," he said.

Partly because of economics, genomic testing has not disseminated out of the academic centers. Dr. Seiwert said that he thought that testing for specific mutations like EGFR in lung cancer or HER2 in breast cancer was becoming a standard of practice, but that it was a "moving target" in the community. And, when it comes to larger, multi-gene assays, "my sense is that this is largely confined to academic centers," he said.

Single mutation genomic testing, especially for lung cancer "should be the standard of care, but the evidence is that it has not permeated out to the smaller practices," said Dr. Fleury, of ACS CAN.

"When you come in, you should get the diagnosis and be tested for a mutation right away," said Dr. Fleury, who added that this is not happening on a widespread basis.

Oncologists can often be in an awkward position when a test they want to offer is not covered by the patient’s insurance. If the patient can’t afford the cost, they might feel like they’re not getting something that others can, said Dr. Seiwert. "It’s a messy situation," he said.

But, it’s one that oncologists at academic centers don’t have to encounter very often, as they usually find a way to cover the cost of testing.

"When it comes to genetic testing, we have both under- and over-utilization," said Dr. Fleury. "We need that happy medium."

Things will start evening out with the right infrastructure, Dr. Fleury said. He sees things falling into place with organizations like ASCO and ACS CAN developing guidelines and standards, and the FDA about to step up its oversight of genomic assays that are developed in-house by hospital and commercial labs.

Also, as the market evolves towards panels of tests, instead of just single mutations, the process will likely become more efficient, Dr. Fleury added.

Currently, for instance, there are only two targeted therapies and two companion diagnostics for lung cancer but a dozen known mutations. In the future, as more therapies are developed to go after those mutations, it won’t be cost-effective or efficient to conduct a dozen different tests with a dozen different charges and copays, said Dr. Fleury.

[email protected]

On Twitter @aliciaault

The American Board of Internal Medicine says that "a substantial majority" of the nation’s internists have met the new Maintenance of Certification requirements as of May 1, the deadline for doctors to be listed publicly on the ABIM’s website as having met those standards.

The ABIM reported that "despite vocal concerns" from physicians, some 150,000 have enrolled in the MOC program, 50,000 since the new requirements were instituted on Jan. 1.

As part of the new MOC, every 2 years, physicians who are certified by the ABIM must earn at least some points by completing some of the educational activities approved for MOC credit. At the 5-year mark, they must earn 100 points, as well as complete patient safety and patient survey activities, to be considered up to date. Previously, physicians were given 10 years to earn 100 points. They must also pass their board exam every 10 years.

"We are listening to the feedback we have received from the community about changes to our program, but at the same time the public is seeking a way to know that their doctor is ‘keeping up in their field,’" Dr. Richard Baron, ABIM president and chief executive officer, said in a statement.

A petition to overturn most of the MOC changes begun by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif., has collected more than 14,000 signatures since it was posted in late March.

According to the ABIM, since Jan. 1, physicians have claimed more than 245,000 hours of Continuing Medical Education (CME) through their MOC involvement, and nearly 20,000 physicians have already met their MOC requirements through 2015.

"MOC has clearly sparked a national conversation focused on what regular assessments are appropriate for ongoing specialty certification," Dr. Baron said. "We must look at how the MOC process meets the needs of physicians, patients, and others who rely on it as an indicator of a provider’s expertise."

The ABIM continues to say that MOC is needed because it is desired by patients and payers. "Those who choose to meet ABIM’s MOC requirements are differentiating themselves from some of their colleagues. They are saying, ‘I’m a cardiologist or oncologist, or whatever specialty they are certified in, who is meeting a standard set by my peers.’ That is a powerful statement to make to their patients, and to themselves," Dr. Clarence H. Braddock III, chair-elect of the ABIM Board of Directors, said in the ABIM statement.

The Board also said it is responding to criticism by making changes to the MOC program, including giving "credit" for activities physicians already are doing to maintain their knowledge base and improve their practices. It said it recognizes more than 270 programs created by medical societies, health systems, and others and that 32,000 ABIM diplomates already have fulfilled some requirements of MOC using those pathways.

"We recognize that the MOC program is not perfect, and we are committed to constant assessment of it," said Dr. Baron.

That may not be enough for some physicians.

Another group, Change Board Recertification, was started in 2010 with the aim of completely overhauling the MOC process.

[email protected]

On Twitter @aliciaault

The American Board of Internal Medicine says that "a substantial majority" of the nation’s internists have met the new Maintenance of Certification requirements as of May 1, the deadline for doctors to be listed publicly on the ABIM’s website as having met those standards.

The ABIM reported that "despite vocal concerns" from physicians, some 150,000 have enrolled in the MOC program, 50,000 since the new requirements were instituted on Jan. 1.

As part of the new MOC, every 2 years, physicians who are certified by the ABIM must earn at least some points by completing some of the educational activities approved for MOC credit. At the 5-year mark, they must earn 100 points, as well as complete patient safety and patient survey activities, to be considered up to date. Previously, physicians were given 10 years to earn 100 points. They must also pass their board exam every 10 years.

"We are listening to the feedback we have received from the community about changes to our program, but at the same time the public is seeking a way to know that their doctor is ‘keeping up in their field,’" Dr. Richard Baron, ABIM president and chief executive officer, said in a statement.

A petition to overturn most of the MOC changes begun by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif., has collected more than 14,000 signatures since it was posted in late March.

According to the ABIM, since Jan. 1, physicians have claimed more than 245,000 hours of Continuing Medical Education (CME) through their MOC involvement, and nearly 20,000 physicians have already met their MOC requirements through 2015.

"MOC has clearly sparked a national conversation focused on what regular assessments are appropriate for ongoing specialty certification," Dr. Baron said. "We must look at how the MOC process meets the needs of physicians, patients, and others who rely on it as an indicator of a provider’s expertise."

The ABIM continues to say that MOC is needed because it is desired by patients and payers. "Those who choose to meet ABIM’s MOC requirements are differentiating themselves from some of their colleagues. They are saying, ‘I’m a cardiologist or oncologist, or whatever specialty they are certified in, who is meeting a standard set by my peers.’ That is a powerful statement to make to their patients, and to themselves," Dr. Clarence H. Braddock III, chair-elect of the ABIM Board of Directors, said in the ABIM statement.

The Board also said it is responding to criticism by making changes to the MOC program, including giving "credit" for activities physicians already are doing to maintain their knowledge base and improve their practices. It said it recognizes more than 270 programs created by medical societies, health systems, and others and that 32,000 ABIM diplomates already have fulfilled some requirements of MOC using those pathways.

"We recognize that the MOC program is not perfect, and we are committed to constant assessment of it," said Dr. Baron.

That may not be enough for some physicians.

Another group, Change Board Recertification, was started in 2010 with the aim of completely overhauling the MOC process.

[email protected]

On Twitter @aliciaault

The American Board of Internal Medicine says that "a substantial majority" of the nation’s internists have met the new Maintenance of Certification requirements as of May 1, the deadline for doctors to be listed publicly on the ABIM’s website as having met those standards.

The ABIM reported that "despite vocal concerns" from physicians, some 150,000 have enrolled in the MOC program, 50,000 since the new requirements were instituted on Jan. 1.

As part of the new MOC, every 2 years, physicians who are certified by the ABIM must earn at least some points by completing some of the educational activities approved for MOC credit. At the 5-year mark, they must earn 100 points, as well as complete patient safety and patient survey activities, to be considered up to date. Previously, physicians were given 10 years to earn 100 points. They must also pass their board exam every 10 years.

"We are listening to the feedback we have received from the community about changes to our program, but at the same time the public is seeking a way to know that their doctor is ‘keeping up in their field,’" Dr. Richard Baron, ABIM president and chief executive officer, said in a statement.

A petition to overturn most of the MOC changes begun by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif., has collected more than 14,000 signatures since it was posted in late March.

According to the ABIM, since Jan. 1, physicians have claimed more than 245,000 hours of Continuing Medical Education (CME) through their MOC involvement, and nearly 20,000 physicians have already met their MOC requirements through 2015.

"MOC has clearly sparked a national conversation focused on what regular assessments are appropriate for ongoing specialty certification," Dr. Baron said. "We must look at how the MOC process meets the needs of physicians, patients, and others who rely on it as an indicator of a provider’s expertise."

The ABIM continues to say that MOC is needed because it is desired by patients and payers. "Those who choose to meet ABIM’s MOC requirements are differentiating themselves from some of their colleagues. They are saying, ‘I’m a cardiologist or oncologist, or whatever specialty they are certified in, who is meeting a standard set by my peers.’ That is a powerful statement to make to their patients, and to themselves," Dr. Clarence H. Braddock III, chair-elect of the ABIM Board of Directors, said in the ABIM statement.

The Board also said it is responding to criticism by making changes to the MOC program, including giving "credit" for activities physicians already are doing to maintain their knowledge base and improve their practices. It said it recognizes more than 270 programs created by medical societies, health systems, and others and that 32,000 ABIM diplomates already have fulfilled some requirements of MOC using those pathways.

"We recognize that the MOC program is not perfect, and we are committed to constant assessment of it," said Dr. Baron.

That may not be enough for some physicians.

Another group, Change Board Recertification, was started in 2010 with the aim of completely overhauling the MOC process.

[email protected]

On Twitter @aliciaault

Representatives of major insurance companies assured lawmakers that they have systems in place by which physicians can check whether patients newly insured through the state and federal health exchanges were up to date on payments for their premiums and thus eligible for coverage.

The insurers – Aetna, Cigna, Health Care Service Corporation, and Wellpoint – appeared May 7 before the House Energy and Commerce Oversight and Investigations Subcommittee to answer questions about how many enrollees under the Affordable Care Act’s state and federal health insurance exchanges have paid their premiums.

Rep. Michael Burgess (R-Tex.), a physician and a subcommittee member, said that he was especially concerned about the 90-day grace period that could create a situation in which care delivered by doctors is not covered by insurance companies.

The grace period was built into the Affordable Care Act.

According to the law, patients must pay their first month’s premium to be considered enrolled and verified as insured. After that, however, they have 90 days to pay the next premium. If the patient doesn’t pay for the second month, the insurer can hold or "pend" all claims. By the third month, if the patient still has not paid, the insurer can terminate the policy. The physician is left to collect from the patient whatever is owed for all outstanding claims.

The insurance company officials who testified at the hearing said that they had systems in place that gave physicians the ability to determine if a patient was current on payments and thus eligible for coverage. They did not give much detail beyond that.

Paul Wingle, executive director of individual business and public exchange operations and strategy at Aetna, said that doctors can call Aetna for updates on a patient’s payment status.

Brian Evanko, president of the individual segment at Cigna, said that physicians and hospitals can call or check online for a patient’s current insurance eligibility. J. Darren Rodgers, a senior vice president and marketing officer at Health Care Service Corporation, and Dennis Matheis, president of exchange strategy for Wellpoint, also said that their companies offered similar services for physicians to verify eligibility.

Rep. Burgess said that he still had concerns that physicians could end up delivering uncompensated care.

The insurers also said that, so far, it appears that a majority of exchange plan enrollees are paying their premiums.

Aetna enrolled 600,000 individuals by the third week in April. Of those, 500,000 have paid, said Mr. Wingle, noting that, since many enrollees have not reached the payment due date for coverage, the figure is "dynamic."

Cigna’s Mr. Evanko did not give enrollment or payment data.

Health Care Service Corporation had 830,000 applications for coverage – 600,000 on the exchanges and 230,000 from outside the exchanges, said Mr. Rodgers. In January, February, and March, 85%-88% of exchange plan enrollees had paid.

The payment rate dropped to 83% on April 1; May figures were incomplete, he said.

Mr. Matheis of Wellpoint testified that "we are seeing strong membership growth and large percentages of our newly enrolled customers are successfully paying their premiums by the due date."

He said that, overall, 70% of premiums have been paid, but that figure includes enrollees whose payments were not yet due. For those whose premium deadline has passed, the payment rate is up to 90%, said Mr. Matheis.

Rep. Tim Murphy (R-Pa.), chairman of the oversight and investigations subcommittee, said that the data submitted to the panel by insurers in late April "paints an uneven picture about the status of enrollment and payment through April 15."

A report issued by the Energy and Commerce Committee on April 30 claimed that data from insurers showed that 67% of the enrollees in the federal exchanges had paid their first month’s premium. Rep. Murphy said that the report showed a wild variation in payment rates by state, and that more information was needed.

"We recognize that many individuals still have time to pay their first month’s premium, which is why we have asked the insurers to update this information on May 20," he said.

[email protected]

On Twitter @aliciaault

Representatives of major insurance companies assured lawmakers that they have systems in place by which physicians can check whether patients newly insured through the state and federal health exchanges were up to date on payments for their premiums and thus eligible for coverage.

The insurers – Aetna, Cigna, Health Care Service Corporation, and Wellpoint – appeared May 7 before the House Energy and Commerce Oversight and Investigations Subcommittee to answer questions about how many enrollees under the Affordable Care Act’s state and federal health insurance exchanges have paid their premiums.

Rep. Michael Burgess (R-Tex.), a physician and a subcommittee member, said that he was especially concerned about the 90-day grace period that could create a situation in which care delivered by doctors is not covered by insurance companies.

The grace period was built into the Affordable Care Act.

According to the law, patients must pay their first month’s premium to be considered enrolled and verified as insured. After that, however, they have 90 days to pay the next premium. If the patient doesn’t pay for the second month, the insurer can hold or "pend" all claims. By the third month, if the patient still has not paid, the insurer can terminate the policy. The physician is left to collect from the patient whatever is owed for all outstanding claims.

The insurance company officials who testified at the hearing said that they had systems in place that gave physicians the ability to determine if a patient was current on payments and thus eligible for coverage. They did not give much detail beyond that.

Paul Wingle, executive director of individual business and public exchange operations and strategy at Aetna, said that doctors can call Aetna for updates on a patient’s payment status.

Brian Evanko, president of the individual segment at Cigna, said that physicians and hospitals can call or check online for a patient’s current insurance eligibility. J. Darren Rodgers, a senior vice president and marketing officer at Health Care Service Corporation, and Dennis Matheis, president of exchange strategy for Wellpoint, also said that their companies offered similar services for physicians to verify eligibility.

Rep. Burgess said that he still had concerns that physicians could end up delivering uncompensated care.

The insurers also said that, so far, it appears that a majority of exchange plan enrollees are paying their premiums.

Aetna enrolled 600,000 individuals by the third week in April. Of those, 500,000 have paid, said Mr. Wingle, noting that, since many enrollees have not reached the payment due date for coverage, the figure is "dynamic."

Cigna’s Mr. Evanko did not give enrollment or payment data.

Health Care Service Corporation had 830,000 applications for coverage – 600,000 on the exchanges and 230,000 from outside the exchanges, said Mr. Rodgers. In January, February, and March, 85%-88% of exchange plan enrollees had paid.

The payment rate dropped to 83% on April 1; May figures were incomplete, he said.

Mr. Matheis of Wellpoint testified that "we are seeing strong membership growth and large percentages of our newly enrolled customers are successfully paying their premiums by the due date."

He said that, overall, 70% of premiums have been paid, but that figure includes enrollees whose payments were not yet due. For those whose premium deadline has passed, the payment rate is up to 90%, said Mr. Matheis.

Rep. Tim Murphy (R-Pa.), chairman of the oversight and investigations subcommittee, said that the data submitted to the panel by insurers in late April "paints an uneven picture about the status of enrollment and payment through April 15."

A report issued by the Energy and Commerce Committee on April 30 claimed that data from insurers showed that 67% of the enrollees in the federal exchanges had paid their first month’s premium. Rep. Murphy said that the report showed a wild variation in payment rates by state, and that more information was needed.

"We recognize that many individuals still have time to pay their first month’s premium, which is why we have asked the insurers to update this information on May 20," he said.

[email protected]

On Twitter @aliciaault

Representatives of major insurance companies assured lawmakers that they have systems in place by which physicians can check whether patients newly insured through the state and federal health exchanges were up to date on payments for their premiums and thus eligible for coverage.

The insurers – Aetna, Cigna, Health Care Service Corporation, and Wellpoint – appeared May 7 before the House Energy and Commerce Oversight and Investigations Subcommittee to answer questions about how many enrollees under the Affordable Care Act’s state and federal health insurance exchanges have paid their premiums.

Rep. Michael Burgess (R-Tex.), a physician and a subcommittee member, said that he was especially concerned about the 90-day grace period that could create a situation in which care delivered by doctors is not covered by insurance companies.

The grace period was built into the Affordable Care Act.

According to the law, patients must pay their first month’s premium to be considered enrolled and verified as insured. After that, however, they have 90 days to pay the next premium. If the patient doesn’t pay for the second month, the insurer can hold or "pend" all claims. By the third month, if the patient still has not paid, the insurer can terminate the policy. The physician is left to collect from the patient whatever is owed for all outstanding claims.

The insurance company officials who testified at the hearing said that they had systems in place that gave physicians the ability to determine if a patient was current on payments and thus eligible for coverage. They did not give much detail beyond that.

Paul Wingle, executive director of individual business and public exchange operations and strategy at Aetna, said that doctors can call Aetna for updates on a patient’s payment status.

Brian Evanko, president of the individual segment at Cigna, said that physicians and hospitals can call or check online for a patient’s current insurance eligibility. J. Darren Rodgers, a senior vice president and marketing officer at Health Care Service Corporation, and Dennis Matheis, president of exchange strategy for Wellpoint, also said that their companies offered similar services for physicians to verify eligibility.

Rep. Burgess said that he still had concerns that physicians could end up delivering uncompensated care.

The insurers also said that, so far, it appears that a majority of exchange plan enrollees are paying their premiums.

Aetna enrolled 600,000 individuals by the third week in April. Of those, 500,000 have paid, said Mr. Wingle, noting that, since many enrollees have not reached the payment due date for coverage, the figure is "dynamic."

Cigna’s Mr. Evanko did not give enrollment or payment data.

Health Care Service Corporation had 830,000 applications for coverage – 600,000 on the exchanges and 230,000 from outside the exchanges, said Mr. Rodgers. In January, February, and March, 85%-88% of exchange plan enrollees had paid.

The payment rate dropped to 83% on April 1; May figures were incomplete, he said.

Mr. Matheis of Wellpoint testified that "we are seeing strong membership growth and large percentages of our newly enrolled customers are successfully paying their premiums by the due date."

He said that, overall, 70% of premiums have been paid, but that figure includes enrollees whose payments were not yet due. For those whose premium deadline has passed, the payment rate is up to 90%, said Mr. Matheis.

Rep. Tim Murphy (R-Pa.), chairman of the oversight and investigations subcommittee, said that the data submitted to the panel by insurers in late April "paints an uneven picture about the status of enrollment and payment through April 15."

A report issued by the Energy and Commerce Committee on April 30 claimed that data from insurers showed that 67% of the enrollees in the federal exchanges had paid their first month’s premium. Rep. Murphy said that the report showed a wild variation in payment rates by state, and that more information was needed.

"We recognize that many individuals still have time to pay their first month’s premium, which is why we have asked the insurers to update this information on May 20," he said.

[email protected]

On Twitter @aliciaault

The emergency department is a profit center for many hospitals – and could help drive profits even higher as the Affordable Care Act extends insurance coverage to more Americans.

Dr. Michael Wilson, an emergency physician at Brigham and Women’s Hospital, Boston, and David M. Cutler, Ph.D., an economics professor at Harvard University, Cambridge, Mass., looked at more than 11 million emergency department (ED) visits for which patient-level revenue information was available as well as 20 million observations with charge data.

Of those visits, 35% were covered by private insurance, 26% by Medicaid, 21% by Medicare, and 18% were uninsured.

Courtesy Brigham & Women's Hospital

They found that in 2009, hospitals generated ED revenues of about $79 billion, at a cost of $73 billion. The $6.1 billion profit translated into an almost 8% profit margin. The profits came primarily from private pay patients. Hospitals made a 40% margin on the privately insured, or about $17 billion, according to the analysis. This compensated for losses on Medicare (–6%), Medicaid (–40%), and the uninsured (–60%) (Health Affairs 2014;5792-9 [doi 10.1377/hlthaff.2013.0754]).

"One of the more surprising findings was just how dependent the emergency department is on payer mix," Dr. Wilson said, adding that EDs that do not have a large number of private pay patients may not be as profitable.

Dr. Wes Fields, *former chairman of the American College of Emergency Physicians’ Emergency Medicine Action Fund, agreed that payer mix is a key.

"For patients or policy makers trying to interpret the meaning of this study for their own community, it is important to remember that hospital profitability is like real estate valuation: ‘location, location, location,’  " Dr. Fields said.

A spokeswoman with the American Hospital Association said that it’s not just about payer mix. "It is hard to really measure the costs of ED care," said Marie Watteau, of the AHA. "Hospitals have to maintain the standby capacity of an ED 24/7 and that means having trauma teams at the ready. The costs to maintain that service is spread over all of the services provided by the hospital," she said.

Under the ACA, the number of paying patients should improve, Dr. Wilson said. He predicted that by 2023, profit margins would increase to 12%, using a scenario in which 50% of the uninsured remain uninsured, 25% gain private insurance, and 25% enroll in Medicaid. This also assumes that reimbursement for private insurance is at a rate that’s at the midpoint between employer-sponsored private insurance and Medicaid pay. Without the ACA, profit margins would continue to hover around 7%, they said.

Dr. Fields said he was a little skeptical that more Medicaid coverage would increase revenues or profits. Some studies have shown that people who gain Medicaid coverage often are high utilizers of EDs, he said. More use means adding more staff, which is one of the biggest costs for hospitals.

[email protected]

On Twitter @aliciaault

*Correction 5/8/14: A previous version of this story misidentified Dr. Wes Fields as the chairman of the American College of Emergency Physicians’ Emergency Medicine Action Fund. This version has been corrected and updated. 

The emergency department is a profit center for many hospitals – and could help drive profits even higher as the Affordable Care Act extends insurance coverage to more Americans.

Dr. Michael Wilson, an emergency physician at Brigham and Women’s Hospital, Boston, and David M. Cutler, Ph.D., an economics professor at Harvard University, Cambridge, Mass., looked at more than 11 million emergency department (ED) visits for which patient-level revenue information was available as well as 20 million observations with charge data.

Of those visits, 35% were covered by private insurance, 26% by Medicaid, 21% by Medicare, and 18% were uninsured.

Courtesy Brigham & Women's Hospital

They found that in 2009, hospitals generated ED revenues of about $79 billion, at a cost of $73 billion. The $6.1 billion profit translated into an almost 8% profit margin. The profits came primarily from private pay patients. Hospitals made a 40% margin on the privately insured, or about $17 billion, according to the analysis. This compensated for losses on Medicare (–6%), Medicaid (–40%), and the uninsured (–60%) (Health Affairs 2014;5792-9 [doi 10.1377/hlthaff.2013.0754]).

"One of the more surprising findings was just how dependent the emergency department is on payer mix," Dr. Wilson said, adding that EDs that do not have a large number of private pay patients may not be as profitable.

Dr. Wes Fields, *former chairman of the American College of Emergency Physicians’ Emergency Medicine Action Fund, agreed that payer mix is a key.

"For patients or policy makers trying to interpret the meaning of this study for their own community, it is important to remember that hospital profitability is like real estate valuation: ‘location, location, location,’  " Dr. Fields said.

A spokeswoman with the American Hospital Association said that it’s not just about payer mix. "It is hard to really measure the costs of ED care," said Marie Watteau, of the AHA. "Hospitals have to maintain the standby capacity of an ED 24/7 and that means having trauma teams at the ready. The costs to maintain that service is spread over all of the services provided by the hospital," she said.

Under the ACA, the number of paying patients should improve, Dr. Wilson said. He predicted that by 2023, profit margins would increase to 12%, using a scenario in which 50% of the uninsured remain uninsured, 25% gain private insurance, and 25% enroll in Medicaid. This also assumes that reimbursement for private insurance is at a rate that’s at the midpoint between employer-sponsored private insurance and Medicaid pay. Without the ACA, profit margins would continue to hover around 7%, they said.

Dr. Fields said he was a little skeptical that more Medicaid coverage would increase revenues or profits. Some studies have shown that people who gain Medicaid coverage often are high utilizers of EDs, he said. More use means adding more staff, which is one of the biggest costs for hospitals.

[email protected]

On Twitter @aliciaault

*Correction 5/8/14: A previous version of this story misidentified Dr. Wes Fields as the chairman of the American College of Emergency Physicians’ Emergency Medicine Action Fund. This version has been corrected and updated. 

The emergency department is a profit center for many hospitals – and could help drive profits even higher as the Affordable Care Act extends insurance coverage to more Americans.

Dr. Michael Wilson, an emergency physician at Brigham and Women’s Hospital, Boston, and David M. Cutler, Ph.D., an economics professor at Harvard University, Cambridge, Mass., looked at more than 11 million emergency department (ED) visits for which patient-level revenue information was available as well as 20 million observations with charge data.

Of those visits, 35% were covered by private insurance, 26% by Medicaid, 21% by Medicare, and 18% were uninsured.

Courtesy Brigham & Women's Hospital

They found that in 2009, hospitals generated ED revenues of about $79 billion, at a cost of $73 billion. The $6.1 billion profit translated into an almost 8% profit margin. The profits came primarily from private pay patients. Hospitals made a 40% margin on the privately insured, or about $17 billion, according to the analysis. This compensated for losses on Medicare (–6%), Medicaid (–40%), and the uninsured (–60%) (Health Affairs 2014;5792-9 [doi 10.1377/hlthaff.2013.0754]).

"One of the more surprising findings was just how dependent the emergency department is on payer mix," Dr. Wilson said, adding that EDs that do not have a large number of private pay patients may not be as profitable.

Dr. Wes Fields, *former chairman of the American College of Emergency Physicians’ Emergency Medicine Action Fund, agreed that payer mix is a key.

"For patients or policy makers trying to interpret the meaning of this study for their own community, it is important to remember that hospital profitability is like real estate valuation: ‘location, location, location,’  " Dr. Fields said.

A spokeswoman with the American Hospital Association said that it’s not just about payer mix. "It is hard to really measure the costs of ED care," said Marie Watteau, of the AHA. "Hospitals have to maintain the standby capacity of an ED 24/7 and that means having trauma teams at the ready. The costs to maintain that service is spread over all of the services provided by the hospital," she said.

Under the ACA, the number of paying patients should improve, Dr. Wilson said. He predicted that by 2023, profit margins would increase to 12%, using a scenario in which 50% of the uninsured remain uninsured, 25% gain private insurance, and 25% enroll in Medicaid. This also assumes that reimbursement for private insurance is at a rate that’s at the midpoint between employer-sponsored private insurance and Medicaid pay. Without the ACA, profit margins would continue to hover around 7%, they said.

Dr. Fields said he was a little skeptical that more Medicaid coverage would increase revenues or profits. Some studies have shown that people who gain Medicaid coverage often are high utilizers of EDs, he said. More use means adding more staff, which is one of the biggest costs for hospitals.

[email protected]

On Twitter @aliciaault

*Correction 5/8/14: A previous version of this story misidentified Dr. Wes Fields as the chairman of the American College of Emergency Physicians’ Emergency Medicine Action Fund. This version has been corrected and updated. 

Resistance against the American Board of Internal Medicine’s maintenance of certification process is growing, with an online petition to overturn the board’s most recent changes having collected more than 13,000 signatures at press time.

The petition was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif.

Dr. Teirstein said that he began the drive out of his own sense of frustration with the ABIM maintenance of certification (MOC) requirements. He e-mailed some physicians he knew and encouraged them to sign. The petition went viral soon after being posted on March 20, Dr. Teirstein said.

Those who sign the petition agree that:

• ABIM has made unreasonable changes in MOC requiring more frequent participation and higher fees.

• Scientific data demonstrating the benefit of MOC is lacking.

• MOC activities are complex, of questionable value, and detract from other worthwhile pursuits, including patient care and other educational activities.

• A test administered every 10 years for recertification is a sufficient metric for MOC.

The bottom line: Petition signers want the ABIM to overhaul the process and require recertification once every 10 years.

The ABIM took the effort seriously enough to respond on its Web site.

"As medical knowledge and practices continue to change, a continuous MOC program tells the community that a physician is staying up-to-date, has met a knowledge standard established by his or her physician peers, and is engaged in ongoing assessment of his or her practice," Dr. Richard Baron, ABIM president, said in the statement.

Physicians who commented on the petition did not agree.

Dr. Jesse Naghi, a third-year fellow at the University of California, San Diego, Sulpizio Cardiovascular Center, wrote, "Asking for more money on top of our already high recertification fees seems rather greedy."

"This is an arm-twisting and money-making scam by our own board," said Dr. Garrett Sanford, of Little Rock, Ark.

"We do recognize that there is a cost – for the large majority of our physicians, the entire program costs from $200 to $400 per year," said Dr. Baron, in his statement. "Our fee structure covers the costs of developing and administering the secure, computer-based exams at test centers nationwide, as well as the ongoing development and release of all ABIM self-assessment products," he said, adding, "I encourage the petition signers to visit ABIM’s revenue and expenses [Web page] for more information."

Some family physicians also have taken issue with MOC. One such, Dr. Edward Volpintesta of Bethel Conn., said in an interview that: "MOC, for both internists and family physicians has become an unnecessary and unreasonable source of strain and disillusionment for many primary care doctors.

"Once a physician has received initial certification there should be no reason to revoke it," he said.

The boards started out as a voluntary undertaking. Now, because they can be used for admittance to hospital medical staffs, a requirement for re-licensure, and by insurers as a physician qualifier, MOC has lost its voluntary status and is no de fecto mandatory.

"Clearly, our physician leadership organizations have not mustered the courage to defeat the MOC requirement. ... Perhaps the best way of solving this problem is to fight it out in court as the American Association of Physicians and Surgeons is doing," according to Dr. Volpintesta, who has been in practice for 40 years.

Petition signers also claim that contrary to the board’s contention, neither patients nor payers value the MOC process nor are they demanding that physicians prove they’ve met the requirements. They also say that there is no evidence that MOC improves quality of care.

Courtesy of Dr. Benbassat

The board does not agree. "There is a good deal of research demonstrating the value of MOC. From the validity of the examination, to the importance of independent assessments – clinicians are not good at evaluating their own weaknesses," according to Dr. Baron’s statement.

Dr. Baron also promised that the ABIM would create more ways for physicians to earn credit.

The ABIM’s open letter shows that "the petition has definitely had an impact," Dr. Teirstein said.

Dr. Ron Benbassat, a cofounder of Change Board Certification, a group that wants to scale back the MOC, called Dr. Baron’s remarks a "boilerplate political statement."

The MOC "should be eliminated, given the numerous CME programs that exist that are not only cost effective, but are incredibly successful, and do not take time away from patient care," said Dr. Benbassat, a board-certified internist in Beverly Hills, Calif., who has completed MOC once already.

Dr. Benbassat and the physicians who have joined Change Board Certification, believe that MOC should not be associated with hospital privileges, insurance reimbursement, or network participation. It should not be required for maintenance of licensure either, said Dr. Benbassat, who is concerned that ABIM is discussing tying licensure to MOC.

Meanwhile, the Association of American Physicians and Surgeons has filed suit against the American Board of Medical Specialties, claiming that the MOC process is a restraint of trade because it will effectively keep doctors from practicing if they do not participate. The suit was filed in the U.S. District Court for the District of New Jersey on April 23, and seeks to stop what it calls the ABMS’s "continuing violations of antitrust law and misrepresentations about the medical skills of physicians who decline to purchase and spend time on its program."

The organization is also aiming to get a refund of fees paid by its members to ABMS and its 24 member boards.

[email protected]

On Twitter @aliciaault

Resistance against the American Board of Internal Medicine’s maintenance of certification process is growing, with an online petition to overturn the board’s most recent changes having collected more than 13,000 signatures at press time.

The petition was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif.

Dr. Teirstein said that he began the drive out of his own sense of frustration with the ABIM maintenance of certification (MOC) requirements. He e-mailed some physicians he knew and encouraged them to sign. The petition went viral soon after being posted on March 20, Dr. Teirstein said.

Those who sign the petition agree that:

• ABIM has made unreasonable changes in MOC requiring more frequent participation and higher fees.

• Scientific data demonstrating the benefit of MOC is lacking.

• MOC activities are complex, of questionable value, and detract from other worthwhile pursuits, including patient care and other educational activities.

• A test administered every 10 years for recertification is a sufficient metric for MOC.

The bottom line: Petition signers want the ABIM to overhaul the process and require recertification once every 10 years.

The ABIM took the effort seriously enough to respond on its Web site.

"As medical knowledge and practices continue to change, a continuous MOC program tells the community that a physician is staying up-to-date, has met a knowledge standard established by his or her physician peers, and is engaged in ongoing assessment of his or her practice," Dr. Richard Baron, ABIM president, said in the statement.

Physicians who commented on the petition did not agree.

Dr. Jesse Naghi, a third-year fellow at the University of California, San Diego, Sulpizio Cardiovascular Center, wrote, "Asking for more money on top of our already high recertification fees seems rather greedy."

"This is an arm-twisting and money-making scam by our own board," said Dr. Garrett Sanford, of Little Rock, Ark.

"We do recognize that there is a cost – for the large majority of our physicians, the entire program costs from $200 to $400 per year," said Dr. Baron, in his statement. "Our fee structure covers the costs of developing and administering the secure, computer-based exams at test centers nationwide, as well as the ongoing development and release of all ABIM self-assessment products," he said, adding, "I encourage the petition signers to visit ABIM’s revenue and expenses [Web page] for more information."

Some family physicians also have taken issue with MOC. One such, Dr. Edward Volpintesta of Bethel Conn., said in an interview that: "MOC, for both internists and family physicians has become an unnecessary and unreasonable source of strain and disillusionment for many primary care doctors.

"Once a physician has received initial certification there should be no reason to revoke it," he said.

The boards started out as a voluntary undertaking. Now, because they can be used for admittance to hospital medical staffs, a requirement for re-licensure, and by insurers as a physician qualifier, MOC has lost its voluntary status and is no de fecto mandatory.

"Clearly, our physician leadership organizations have not mustered the courage to defeat the MOC requirement. ... Perhaps the best way of solving this problem is to fight it out in court as the American Association of Physicians and Surgeons is doing," according to Dr. Volpintesta, who has been in practice for 40 years.

Petition signers also claim that contrary to the board’s contention, neither patients nor payers value the MOC process nor are they demanding that physicians prove they’ve met the requirements. They also say that there is no evidence that MOC improves quality of care.

Courtesy of Dr. Benbassat

The board does not agree. "There is a good deal of research demonstrating the value of MOC. From the validity of the examination, to the importance of independent assessments – clinicians are not good at evaluating their own weaknesses," according to Dr. Baron’s statement.

Dr. Baron also promised that the ABIM would create more ways for physicians to earn credit.

The ABIM’s open letter shows that "the petition has definitely had an impact," Dr. Teirstein said.

Dr. Ron Benbassat, a cofounder of Change Board Certification, a group that wants to scale back the MOC, called Dr. Baron’s remarks a "boilerplate political statement."

The MOC "should be eliminated, given the numerous CME programs that exist that are not only cost effective, but are incredibly successful, and do not take time away from patient care," said Dr. Benbassat, a board-certified internist in Beverly Hills, Calif., who has completed MOC once already.

Dr. Benbassat and the physicians who have joined Change Board Certification, believe that MOC should not be associated with hospital privileges, insurance reimbursement, or network participation. It should not be required for maintenance of licensure either, said Dr. Benbassat, who is concerned that ABIM is discussing tying licensure to MOC.

Meanwhile, the Association of American Physicians and Surgeons has filed suit against the American Board of Medical Specialties, claiming that the MOC process is a restraint of trade because it will effectively keep doctors from practicing if they do not participate. The suit was filed in the U.S. District Court for the District of New Jersey on April 23, and seeks to stop what it calls the ABMS’s "continuing violations of antitrust law and misrepresentations about the medical skills of physicians who decline to purchase and spend time on its program."

The organization is also aiming to get a refund of fees paid by its members to ABMS and its 24 member boards.

[email protected]

On Twitter @aliciaault

Resistance against the American Board of Internal Medicine’s maintenance of certification process is growing, with an online petition to overturn the board’s most recent changes having collected more than 13,000 signatures at press time.

The petition was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif.

Dr. Teirstein said that he began the drive out of his own sense of frustration with the ABIM maintenance of certification (MOC) requirements. He e-mailed some physicians he knew and encouraged them to sign. The petition went viral soon after being posted on March 20, Dr. Teirstein said.

Those who sign the petition agree that:

• ABIM has made unreasonable changes in MOC requiring more frequent participation and higher fees.

• Scientific data demonstrating the benefit of MOC is lacking.

• MOC activities are complex, of questionable value, and detract from other worthwhile pursuits, including patient care and other educational activities.

• A test administered every 10 years for recertification is a sufficient metric for MOC.

The bottom line: Petition signers want the ABIM to overhaul the process and require recertification once every 10 years.

The ABIM took the effort seriously enough to respond on its Web site.

"As medical knowledge and practices continue to change, a continuous MOC program tells the community that a physician is staying up-to-date, has met a knowledge standard established by his or her physician peers, and is engaged in ongoing assessment of his or her practice," Dr. Richard Baron, ABIM president, said in the statement.

Physicians who commented on the petition did not agree.

Dr. Jesse Naghi, a third-year fellow at the University of California, San Diego, Sulpizio Cardiovascular Center, wrote, "Asking for more money on top of our already high recertification fees seems rather greedy."

"This is an arm-twisting and money-making scam by our own board," said Dr. Garrett Sanford, of Little Rock, Ark.

"We do recognize that there is a cost – for the large majority of our physicians, the entire program costs from $200 to $400 per year," said Dr. Baron, in his statement. "Our fee structure covers the costs of developing and administering the secure, computer-based exams at test centers nationwide, as well as the ongoing development and release of all ABIM self-assessment products," he said, adding, "I encourage the petition signers to visit ABIM’s revenue and expenses [Web page] for more information."

Some family physicians also have taken issue with MOC. One such, Dr. Edward Volpintesta of Bethel Conn., said in an interview that: "MOC, for both internists and family physicians has become an unnecessary and unreasonable source of strain and disillusionment for many primary care doctors.

"Once a physician has received initial certification there should be no reason to revoke it," he said.

The boards started out as a voluntary undertaking. Now, because they can be used for admittance to hospital medical staffs, a requirement for re-licensure, and by insurers as a physician qualifier, MOC has lost its voluntary status and is no de fecto mandatory.

"Clearly, our physician leadership organizations have not mustered the courage to defeat the MOC requirement. ... Perhaps the best way of solving this problem is to fight it out in court as the American Association of Physicians and Surgeons is doing," according to Dr. Volpintesta, who has been in practice for 40 years.

Petition signers also claim that contrary to the board’s contention, neither patients nor payers value the MOC process nor are they demanding that physicians prove they’ve met the requirements. They also say that there is no evidence that MOC improves quality of care.

Courtesy of Dr. Benbassat

The board does not agree. "There is a good deal of research demonstrating the value of MOC. From the validity of the examination, to the importance of independent assessments – clinicians are not good at evaluating their own weaknesses," according to Dr. Baron’s statement.

Dr. Baron also promised that the ABIM would create more ways for physicians to earn credit.

The ABIM’s open letter shows that "the petition has definitely had an impact," Dr. Teirstein said.

Dr. Ron Benbassat, a cofounder of Change Board Certification, a group that wants to scale back the MOC, called Dr. Baron’s remarks a "boilerplate political statement."

The MOC "should be eliminated, given the numerous CME programs that exist that are not only cost effective, but are incredibly successful, and do not take time away from patient care," said Dr. Benbassat, a board-certified internist in Beverly Hills, Calif., who has completed MOC once already.

Dr. Benbassat and the physicians who have joined Change Board Certification, believe that MOC should not be associated with hospital privileges, insurance reimbursement, or network participation. It should not be required for maintenance of licensure either, said Dr. Benbassat, who is concerned that ABIM is discussing tying licensure to MOC.

Meanwhile, the Association of American Physicians and Surgeons has filed suit against the American Board of Medical Specialties, claiming that the MOC process is a restraint of trade because it will effectively keep doctors from practicing if they do not participate. The suit was filed in the U.S. District Court for the District of New Jersey on April 23, and seeks to stop what it calls the ABMS’s "continuing violations of antitrust law and misrepresentations about the medical skills of physicians who decline to purchase and spend time on its program."

The organization is also aiming to get a refund of fees paid by its members to ABMS and its 24 member boards.

[email protected]

On Twitter @aliciaault

Resistance against the American Board of Internal Medicine’s maintenance of certification process is growing, with an online petition to overturn the board’s most recent changes having collected more than 13,000 signatures at press time.

The petition was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif.

Dr. Teirstein said that he began the drive out of his own sense of frustration with the ABIM maintenance of certification (MOC) requirements. He e-mailed some physicians he knew and encouraged them to sign. The petition went viral soon after being posted on March 20, Dr. Teirstein said.

Those who sign the petition agree that:

• ABIM has made unreasonable changes in MOC requiring more frequent participation and higher fees.

• Scientific data demonstrating the benefit of MOC is lacking.

• MOC activities are complex, of questionable value, and detract from other worthwhile pursuits, including patient care and other educational activities.

• A test administered every 10 years for recertification is a sufficient metric for MOC.

The bottom line: Petition signers want the ABIM to overhaul the process and require recertification once every 10 years.

The ABIM took the effort seriously enough to respond on its Web site.

"As medical knowledge and practices continue to change, a continuous MOC program tells the community that a physician is staying up-to-date, has met a knowledge standard established by his or her physician peers, and is engaged in ongoing assessment of his or her practice," Dr. Richard Baron, ABIM president, said in the statement.

Physicians who commented on the petition did not agree.

Dr. Jesse Naghi, a third-year fellow at the University of California, San Diego, Sulpizio Cardiovascular Center, wrote, "Asking for more money on top of our already high recertification fees seems rather greedy."

"This is an arm-twisting and money-making scam by our own board," said Dr. Garrett Sanford, of Little Rock, Ark.

"We do recognize that there is a cost – for the large majority of our physicians, the entire program costs from $200 to $400 per year," said Dr. Baron, in his statement. "Our fee structure covers the costs of developing and administering the secure, computer-based exams at test centers nationwide, as well as the ongoing development and release of all ABIM self-assessment products," he said, adding, "I encourage the petition signers to visit ABIM’s revenue and expenses [Web page] for more information."

Petition signers also claim that contrary to the board’s contention, neither patients nor payers value the MOC process nor are they demanding that physicians prove they’ve met the requirements. They also say that there is no evidence that MOC improves quality of care.

The board does not agree. "There is a good deal of research demonstrating the value of MOC. From the validity of the examination, to the importance of independent assessments – clinicians are not good at evaluating their own weaknesses," according to Dr. Baron’s statement.

Dr. Baron also promised that the ABIM would create more ways for physicians to earn credit.

The ABIM’s open letter shows that "the petition has definitely had an impact," Dr. Teirstein said.

Dr. Ron Benbassat, a cofounder of Change Board Certification, a group that wants to scale back the MOC, called Dr. Baron’s remarks a "boilerplate political statement."

Courtesy of Dr. Benbassat

The MOC "should be eliminated, given the numerous CME programs that exist that are not only cost effective, but are incredibly successful, and do not take time away from patient care," said Dr. Benbassat, a board-certified internist in Beverly Hills, Calif., who has completed MOC once already.

Dr. Benbassat and the physicians who have joined Change Board Certification, believe that MOC should not be associated with hospital privileges, insurance reimbursement, or network participation. It should not be required for maintenance of licensure either, said Dr. Benbassat, who is concerned that ABIM is discussing tying licensure to MOC.

Meanwhile, the Association of American Physicians and Surgeons has filed suit against the American Board of Medical Specialties, claiming that the MOC process is a restraint of trade because it will effectively keep doctors from practicing if they do not participate. The suit was filed in the U.S. District Court for the District of New Jersey on April 23, and seeks to stop what it calls the ABMS’s "continuing violations of antitrust law and misrepresentations about the medical skills of physicians who decline to purchase and spend time on its program."

The organization is also aiming to get a refund of fees paid by its members to ABMS and its 24 member boards.

[email protected]

On Twitter @aliciaault

Resistance against the American Board of Internal Medicine’s maintenance of certification process is growing, with an online petition to overturn the board’s most recent changes having collected more than 13,000 signatures at press time.

The petition was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif.

Dr. Teirstein said that he began the drive out of his own sense of frustration with the ABIM maintenance of certification (MOC) requirements. He e-mailed some physicians he knew and encouraged them to sign. The petition went viral soon after being posted on March 20, Dr. Teirstein said.

Those who sign the petition agree that:

• ABIM has made unreasonable changes in MOC requiring more frequent participation and higher fees.

• Scientific data demonstrating the benefit of MOC is lacking.

• MOC activities are complex, of questionable value, and detract from other worthwhile pursuits, including patient care and other educational activities.

• A test administered every 10 years for recertification is a sufficient metric for MOC.

The bottom line: Petition signers want the ABIM to overhaul the process and require recertification once every 10 years.

The ABIM took the effort seriously enough to respond on its Web site.

"As medical knowledge and practices continue to change, a continuous MOC program tells the community that a physician is staying up-to-date, has met a knowledge standard established by his or her physician peers, and is engaged in ongoing assessment of his or her practice," Dr. Richard Baron, ABIM president, said in the statement.

Physicians who commented on the petition did not agree.

Dr. Jesse Naghi, a third-year fellow at the University of California, San Diego, Sulpizio Cardiovascular Center, wrote, "Asking for more money on top of our already high recertification fees seems rather greedy."

"This is an arm-twisting and money-making scam by our own board," said Dr. Garrett Sanford, of Little Rock, Ark.

"We do recognize that there is a cost – for the large majority of our physicians, the entire program costs from $200 to $400 per year," said Dr. Baron, in his statement. "Our fee structure covers the costs of developing and administering the secure, computer-based exams at test centers nationwide, as well as the ongoing development and release of all ABIM self-assessment products," he said, adding, "I encourage the petition signers to visit ABIM’s revenue and expenses [Web page] for more information."

Petition signers also claim that contrary to the board’s contention, neither patients nor payers value the MOC process nor are they demanding that physicians prove they’ve met the requirements. They also say that there is no evidence that MOC improves quality of care.

The board does not agree. "There is a good deal of research demonstrating the value of MOC. From the validity of the examination, to the importance of independent assessments – clinicians are not good at evaluating their own weaknesses," according to Dr. Baron’s statement.

Dr. Baron also promised that the ABIM would create more ways for physicians to earn credit.

The ABIM’s open letter shows that "the petition has definitely had an impact," Dr. Teirstein said.

Dr. Ron Benbassat, a cofounder of Change Board Certification, a group that wants to scale back the MOC, called Dr. Baron’s remarks a "boilerplate political statement."

Courtesy of Dr. Benbassat

The MOC "should be eliminated, given the numerous CME programs that exist that are not only cost effective, but are incredibly successful, and do not take time away from patient care," said Dr. Benbassat, a board-certified internist in Beverly Hills, Calif., who has completed MOC once already.

Dr. Benbassat and the physicians who have joined Change Board Certification, believe that MOC should not be associated with hospital privileges, insurance reimbursement, or network participation. It should not be required for maintenance of licensure either, said Dr. Benbassat, who is concerned that ABIM is discussing tying licensure to MOC.

Meanwhile, the Association of American Physicians and Surgeons has filed suit against the American Board of Medical Specialties, claiming that the MOC process is a restraint of trade because it will effectively keep doctors from practicing if they do not participate. The suit was filed in the U.S. District Court for the District of New Jersey on April 23, and seeks to stop what it calls the ABMS’s "continuing violations of antitrust law and misrepresentations about the medical skills of physicians who decline to purchase and spend time on its program."

The organization is also aiming to get a refund of fees paid by its members to ABMS and its 24 member boards.

[email protected]

On Twitter @aliciaault

Resistance against the American Board of Internal Medicine’s maintenance of certification process is growing, with an online petition to overturn the board’s most recent changes having collected more than 13,000 signatures at press time.

The petition was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif.

Dr. Teirstein said that he began the drive out of his own sense of frustration with the ABIM maintenance of certification (MOC) requirements. He e-mailed some physicians he knew and encouraged them to sign. The petition went viral soon after being posted on March 20, Dr. Teirstein said.

Those who sign the petition agree that:

• ABIM has made unreasonable changes in MOC requiring more frequent participation and higher fees.

• Scientific data demonstrating the benefit of MOC is lacking.

• MOC activities are complex, of questionable value, and detract from other worthwhile pursuits, including patient care and other educational activities.

• A test administered every 10 years for recertification is a sufficient metric for MOC.

The bottom line: Petition signers want the ABIM to overhaul the process and require recertification once every 10 years.

The ABIM took the effort seriously enough to respond on its Web site.

"As medical knowledge and practices continue to change, a continuous MOC program tells the community that a physician is staying up-to-date, has met a knowledge standard established by his or her physician peers, and is engaged in ongoing assessment of his or her practice," Dr. Richard Baron, ABIM president, said in the statement.

Physicians who commented on the petition did not agree.

Dr. Jesse Naghi, a third-year fellow at the University of California, San Diego, Sulpizio Cardiovascular Center, wrote, "Asking for more money on top of our already high recertification fees seems rather greedy."

"This is an arm-twisting and money-making scam by our own board," said Dr. Garrett Sanford, of Little Rock, Ark.

"We do recognize that there is a cost – for the large majority of our physicians, the entire program costs from $200 to $400 per year," said Dr. Baron, in his statement. "Our fee structure covers the costs of developing and administering the secure, computer-based exams at test centers nationwide, as well as the ongoing development and release of all ABIM self-assessment products," he said, adding, "I encourage the petition signers to visit ABIM’s revenue and expenses [Web page] for more information."

Petition signers also claim that contrary to the board’s contention, neither patients nor payers value the MOC process nor are they demanding that physicians prove they’ve met the requirements. They also say that there is no evidence that MOC improves quality of care.

The board does not agree. "There is a good deal of research demonstrating the value of MOC. From the validity of the examination, to the importance of independent assessments – clinicians are not good at evaluating their own weaknesses," according to Dr. Baron’s statement.

Dr. Baron also promised that the ABIM would create more ways for physicians to earn credit.

The ABIM’s open letter shows that "the petition has definitely had an impact," Dr. Teirstein said.

Dr. Ron Benbassat, a cofounder of Change Board Certification, a group that wants to scale back the MOC, called Dr. Baron’s remarks a "boilerplate political statement."

Courtesy of Dr. Benbassat

The MOC "should be eliminated, given the numerous CME programs that exist that are not only cost effective, but are incredibly successful, and do not take time away from patient care," said Dr. Benbassat, a board-certified internist in Beverly Hills, Calif., who has completed MOC once already.

Dr. Benbassat and the physicians who have joined Change Board Certification, believe that MOC should not be associated with hospital privileges, insurance reimbursement, or network participation. It should not be required for maintenance of licensure either, said Dr. Benbassat, who is concerned that ABIM is discussing tying licensure to MOC.

Meanwhile, the Association of American Physicians and Surgeons has filed suit against the American Board of Medical Specialties, claiming that the MOC process is a restraint of trade because it will effectively keep doctors from practicing if they do not participate. The suit was filed in the U.S. District Court for the District of New Jersey on April 23, and seeks to stop what it calls the ABMS’s "continuing violations of antitrust law and misrepresentations about the medical skills of physicians who decline to purchase and spend time on its program."

The organization is also aiming to get a refund of fees paid by its members to ABMS and its 24 member boards.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration’s long-awaited proposal to regulate e-cigarettes, cigars, and other tobacco products as if they were cigarettes does not go far enough to protect the public, and especially children, from the harmful effects of tobacco products, including nicotine addiction, according to its critics.

And, they say, it gives manufacturers too much time to continue selling their products without oversight while the FDA takes an undetermined period of time to consider comments on the proposal and make the rule final.

© -goldy-/Thinkstockphotos.com

The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA authority to extend its regulation of tobacco over all tobacco-derived products. A few years ago, the agency indicated that it would "deem" all tobacco-derived products as similar to cigarettes but had not issued any regulation until now. The new proposal would extend the FDA’s power to regulate e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and dissolvable tobacco products.

"This proposed rule is the latest step in our efforts to make the next generation tobacco free," said HHS Secretary Kathleen Sebelius, in a statement. The regulation would also allow the FDA to determine whether products like e-cigarettes serve as a gateway to cigarette use, she told reporters.

Mitch Zeller, director of the FDA’s Center for Tobacco Products, said that the agency is "funding massive studies" to get a better handle on the potential benefits and risks of e-cigarettes and the patterns of use. "We have far more questions than answers about who is using e cigarettes and how they are being used," he told reporters, in a briefing.

Under the proposed rule, makers of tobacco products would have to:

• Register with the FDA and report product and ingredient listings.

• Only market new tobacco products after FDA review.

• Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole.

• Not distribute free samples.

FDA Commissioner Margaret A. Hamburg said the agency will take comments on the rule for 75 days and then, after analysis, make it final. But she would not give a timetable for when the rule would be made final.

Manufacturers who’ve had products on the market as of February 2007 will be required to submit applications for approval within 24 months of the final rule’s effective date. During that period, they will be allowed to continue to sell their products, subject only to a few regulations that will go into effect immediately. That would include a ban on retail and Internet sales to children under age 18 years; a prohibition on free samples; the requirement that companies register with the FDA; a prohibition on direct or implied claims that the products reduce the risks from tobacco use; and, a prohibition on vending machine sales unless located in facility that never admits youth.

The FDA would not ban Internet sales altogether or prohibit TV ads. The agency would have to issue separate rules on marketing and promotion, said Mr. Zeller.

There’s no proposed ban on flavored tobacco products. That will also require separate rules, once the agency has established jurisdiction over all the products deemed similar, said Mr. Zeller. The agency is also proposing to give so-called "premium" cigars that meet certain criteria a pass on most of the regulation.

Dr. Margaret Foti, CEO of the American Association of Cancer Research said in a statement that FDA regulation of "all tobacco products, including e-cigarettes and cigars," is imperative and that the agency should "prohibit the sale and marketing of these products to children. She added that "the proposed rule is an important step forward in expanding the FDA’s regulation of tobacco and protecting the health of the American people."

The Campaign for Tobacco-Free Kids lauded the FDA for moving forward, but also was disappointed in the decision to not regulate flavorings. The Campaign said in a statement that the flavorings, often found in cigars or e-cigarettes may appeal to youth. It also called the potential premium cigar loophole "deeply disturbing," adding that, "There is no justifiable public health rationale for exempting any category of cigars."

Noting that e-cigarette use is skyrocketing among young Americans, the Campaign said that, "Effective regulation by the FDA and the states is needed to minimize the potential harms of e-cigarettes and ensure any potential health benefits are supported by sound science."

A handful of Democratic senators and a House member who issued a recent report on the apparently concerted effort to market e-cigarettes to teenagers expressed dismay with the FDA proposal. The joint statement said: "Today, after years of waiting for the FDA to act, we are extremely disappointed by its failure to take comprehensive action to prevent e-cigarette companies from continuing to deploy marketing tactics aimed at luring children and teenagers into a candy-flavored nicotine addiction," they said. "As long as e-cigarette companies continue to take pages from Big Tobacco’s old and cynical marketing playbook, our children will remain vulnerable to the grave dangers of nicotine addiction," they added.

The American Cancer Society Cancer Action Network’s chief executive, John R. Seffrin, Ph.D., said that while the FDA’s action was an important step, it was still giving manufacturers a chance to skirt oversight, especially when it came to marketing to children. The companies are using tactics that include "marketing small flavored cigars that look like cigarettes, entering the e-cig market with promotions that could dramatically increase use among children and creating several new types of smokeless products," said Dr. Seffrin, in a statement.

He urged the agency to move quickly. "It should not take several more years for the FDA to be able to specify how it intends to regulate the unfettered marketing of many dangerous tobacco products," he said.

FDA Commissioner Hamburg said that the agency would move quickly. "We are eager to see this process move forward," she said.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration’s long-awaited proposal to regulate e-cigarettes, cigars, and other tobacco products as if they were cigarettes does not go far enough to protect the public, and especially children, from the harmful effects of tobacco products, including nicotine addiction, according to its critics.

And, they say, it gives manufacturers too much time to continue selling their products without oversight while the FDA takes an undetermined period of time to consider comments on the proposal and make the rule final.

© -goldy-/Thinkstockphotos.com

The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA authority to extend its regulation of tobacco over all tobacco-derived products. A few years ago, the agency indicated that it would "deem" all tobacco-derived products as similar to cigarettes but had not issued any regulation until now. The new proposal would extend the FDA’s power to regulate e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and dissolvable tobacco products.

"This proposed rule is the latest step in our efforts to make the next generation tobacco free," said HHS Secretary Kathleen Sebelius, in a statement. The regulation would also allow the FDA to determine whether products like e-cigarettes serve as a gateway to cigarette use, she told reporters.

Mitch Zeller, director of the FDA’s Center for Tobacco Products, said that the agency is "funding massive studies" to get a better handle on the potential benefits and risks of e-cigarettes and the patterns of use. "We have far more questions than answers about who is using e cigarettes and how they are being used," he told reporters, in a briefing.

Under the proposed rule, makers of tobacco products would have to:

• Register with the FDA and report product and ingredient listings.

• Only market new tobacco products after FDA review.

• Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole.

• Not distribute free samples.

FDA Commissioner Margaret A. Hamburg said the agency will take comments on the rule for 75 days and then, after analysis, make it final. But she would not give a timetable for when the rule would be made final.

Manufacturers who’ve had products on the market as of February 2007 will be required to submit applications for approval within 24 months of the final rule’s effective date. During that period, they will be allowed to continue to sell their products, subject only to a few regulations that will go into effect immediately. That would include a ban on retail and Internet sales to children under age 18 years; a prohibition on free samples; the requirement that companies register with the FDA; a prohibition on direct or implied claims that the products reduce the risks from tobacco use; and, a prohibition on vending machine sales unless located in facility that never admits youth.

The FDA would not ban Internet sales altogether or prohibit TV ads. The agency would have to issue separate rules on marketing and promotion, said Mr. Zeller.

There’s no proposed ban on flavored tobacco products. That will also require separate rules, once the agency has established jurisdiction over all the products deemed similar, said Mr. Zeller. The agency is also proposing to give so-called "premium" cigars that meet certain criteria a pass on most of the regulation.

Dr. Margaret Foti, CEO of the American Association of Cancer Research said in a statement that FDA regulation of "all tobacco products, including e-cigarettes and cigars," is imperative and that the agency should "prohibit the sale and marketing of these products to children. She added that "the proposed rule is an important step forward in expanding the FDA’s regulation of tobacco and protecting the health of the American people."

The Campaign for Tobacco-Free Kids lauded the FDA for moving forward, but also was disappointed in the decision to not regulate flavorings. The Campaign said in a statement that the flavorings, often found in cigars or e-cigarettes may appeal to youth. It also called the potential premium cigar loophole "deeply disturbing," adding that, "There is no justifiable public health rationale for exempting any category of cigars."

Noting that e-cigarette use is skyrocketing among young Americans, the Campaign said that, "Effective regulation by the FDA and the states is needed to minimize the potential harms of e-cigarettes and ensure any potential health benefits are supported by sound science."

A handful of Democratic senators and a House member who issued a recent report on the apparently concerted effort to market e-cigarettes to teenagers expressed dismay with the FDA proposal. The joint statement said: "Today, after years of waiting for the FDA to act, we are extremely disappointed by its failure to take comprehensive action to prevent e-cigarette companies from continuing to deploy marketing tactics aimed at luring children and teenagers into a candy-flavored nicotine addiction," they said. "As long as e-cigarette companies continue to take pages from Big Tobacco’s old and cynical marketing playbook, our children will remain vulnerable to the grave dangers of nicotine addiction," they added.

The American Cancer Society Cancer Action Network’s chief executive, John R. Seffrin, Ph.D., said that while the FDA’s action was an important step, it was still giving manufacturers a chance to skirt oversight, especially when it came to marketing to children. The companies are using tactics that include "marketing small flavored cigars that look like cigarettes, entering the e-cig market with promotions that could dramatically increase use among children and creating several new types of smokeless products," said Dr. Seffrin, in a statement.

He urged the agency to move quickly. "It should not take several more years for the FDA to be able to specify how it intends to regulate the unfettered marketing of many dangerous tobacco products," he said.

FDA Commissioner Hamburg said that the agency would move quickly. "We are eager to see this process move forward," she said.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration’s long-awaited proposal to regulate e-cigarettes, cigars, and other tobacco products as if they were cigarettes does not go far enough to protect the public, and especially children, from the harmful effects of tobacco products, including nicotine addiction, according to its critics.

And, they say, it gives manufacturers too much time to continue selling their products without oversight while the FDA takes an undetermined period of time to consider comments on the proposal and make the rule final.

© -goldy-/Thinkstockphotos.com

The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA authority to extend its regulation of tobacco over all tobacco-derived products. A few years ago, the agency indicated that it would "deem" all tobacco-derived products as similar to cigarettes but had not issued any regulation until now. The new proposal would extend the FDA’s power to regulate e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and dissolvable tobacco products.

"This proposed rule is the latest step in our efforts to make the next generation tobacco free," said HHS Secretary Kathleen Sebelius, in a statement. The regulation would also allow the FDA to determine whether products like e-cigarettes serve as a gateway to cigarette use, she told reporters.

Mitch Zeller, director of the FDA’s Center for Tobacco Products, said that the agency is "funding massive studies" to get a better handle on the potential benefits and risks of e-cigarettes and the patterns of use. "We have far more questions than answers about who is using e cigarettes and how they are being used," he told reporters, in a briefing.

Under the proposed rule, makers of tobacco products would have to:

• Register with the FDA and report product and ingredient listings.

• Only market new tobacco products after FDA review.

• Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole.

• Not distribute free samples.

FDA Commissioner Margaret A. Hamburg said the agency will take comments on the rule for 75 days and then, after analysis, make it final. But she would not give a timetable for when the rule would be made final.

Manufacturers who’ve had products on the market as of February 2007 will be required to submit applications for approval within 24 months of the final rule’s effective date. During that period, they will be allowed to continue to sell their products, subject only to a few regulations that will go into effect immediately. That would include a ban on retail and Internet sales to children under age 18 years; a prohibition on free samples; the requirement that companies register with the FDA; a prohibition on direct or implied claims that the products reduce the risks from tobacco use; and, a prohibition on vending machine sales unless located in facility that never admits youth.

The FDA would not ban Internet sales altogether or prohibit TV ads. The agency would have to issue separate rules on marketing and promotion, said Mr. Zeller.

There’s no proposed ban on flavored tobacco products. That will also require separate rules, once the agency has established jurisdiction over all the products deemed similar, said Mr. Zeller. The agency is also proposing to give so-called "premium" cigars that meet certain criteria a pass on most of the regulation.

Dr. Margaret Foti, CEO of the American Association of Cancer Research said in a statement that FDA regulation of "all tobacco products, including e-cigarettes and cigars," is imperative and that the agency should "prohibit the sale and marketing of these products to children. She added that "the proposed rule is an important step forward in expanding the FDA’s regulation of tobacco and protecting the health of the American people."

The Campaign for Tobacco-Free Kids lauded the FDA for moving forward, but also was disappointed in the decision to not regulate flavorings. The Campaign said in a statement that the flavorings, often found in cigars or e-cigarettes may appeal to youth. It also called the potential premium cigar loophole "deeply disturbing," adding that, "There is no justifiable public health rationale for exempting any category of cigars."

Noting that e-cigarette use is skyrocketing among young Americans, the Campaign said that, "Effective regulation by the FDA and the states is needed to minimize the potential harms of e-cigarettes and ensure any potential health benefits are supported by sound science."

A handful of Democratic senators and a House member who issued a recent report on the apparently concerted effort to market e-cigarettes to teenagers expressed dismay with the FDA proposal. The joint statement said: "Today, after years of waiting for the FDA to act, we are extremely disappointed by its failure to take comprehensive action to prevent e-cigarette companies from continuing to deploy marketing tactics aimed at luring children and teenagers into a candy-flavored nicotine addiction," they said. "As long as e-cigarette companies continue to take pages from Big Tobacco’s old and cynical marketing playbook, our children will remain vulnerable to the grave dangers of nicotine addiction," they added.

The American Cancer Society Cancer Action Network’s chief executive, John R. Seffrin, Ph.D., said that while the FDA’s action was an important step, it was still giving manufacturers a chance to skirt oversight, especially when it came to marketing to children. The companies are using tactics that include "marketing small flavored cigars that look like cigarettes, entering the e-cig market with promotions that could dramatically increase use among children and creating several new types of smokeless products," said Dr. Seffrin, in a statement.

He urged the agency to move quickly. "It should not take several more years for the FDA to be able to specify how it intends to regulate the unfettered marketing of many dangerous tobacco products," he said.

FDA Commissioner Hamburg said that the agency would move quickly. "We are eager to see this process move forward," she said.

[email protected]

On Twitter @aliciaault

ORLANDO – With Medicare seeing a sharp spike in payments for evaluation and management services, a proposed overhaul of Current Procedural Terminology E&M codes could force physicians to provide substantially more documentation of their medical decision making.

The American Medical Association’s CPT editorial panel is scheduled to vote in mid-May on a recommendation to make such changes to E&M codes.

If the CPT panel’s changes are substantial enough, it’s even possible that the Centers for Medicare and Medicaid Services may embark on a revaluation of all the E&M codes, said Dr. Glenn Littenberg, a past member of the CPT editorial panel and a current CPT adviser to the American Society for Gastrointestinal Endoscopy.

If CMS decided to do so, revaluation potentially could be a good thing – if it results in a higher valuation for decision making, said Dr. Robert Wergin, president-elect of the American Academy of Family Physicians. But "if the motivation is to put up a barrier to code appropriately for the level of complexity of visits, it’s another step to undervalue the cognitive area," he said.

The federal government has been taking a closer look at coding, with the concern that electronic health records are making it easier to upcode.

A report in 2012 by the U.S. Department of Health & Human Services (HHS) inspector general found that between 2001 and 2010, physicians had increased their billing for higher-level E&M codes. Medicare payments for E&M services increased by 48% during the same period, from $22.7 billion to $33.5 billion. The Office of Inspector General labeled E&M services as "vulnerable to fraud and abuse."

Coding is a physician’s lifeblood, said Dr. Wergin. The AAFP is waiting to get more details on the CPT panel’s recommendations before it can say whether it supports the changes, he said.

The American College of Physicians said its officials could not comment, citing confidentiality agreements for ACP members who are on the CPT panel.

Detail your decision making

According to Dr. Littenberg, the CPT panel is proposing much more detailed documentation of decision making, including describing the number and complexity of problems. Medical decision making will be one of the two requirements to qualify for moderate to extensive E&M services for an office visit, an established patient, or follow-up hospital care.

The proposal is more prescriptive than current requirements, "and harder to grasp and keep in mind during an encounter," said Dr. Littenberg, who is also a gastroenterologist in Pasadena, Calif. He said he is "concerned about the impact of this," adding, "there are things about this proposal I don’t like, and I’ve said as much at CPT."

Decision making "is critical at arriving at a diagnosis and treatment plan," Dr. Wergin said, but the AAFP believes that it needs to be better defined by the CPT. "Let’s define medical decision making in a more meaningful way that makes sense to people like me," said Dr. Wergin, who added, "I have a lot of complicated patients."

If the focus is only on the presenting problem, it tends to undervalue the decision making that goes into evaluating a patient who may have multiple comorbidities and perhaps social issues as well, Dr. Wergin explained. To truly evaluate a patient, decision making should look at that individual as a whole, not as one issue, he said.

It appears that the panel is moving in that direction, Dr. Littenberg observed, but it will also require clear documentation that "reflects our thought process."

Note the basics

Physicians should be thinking more in terms of what would be required in documentation to defend an audit, he cautioned. The history, physical, and what led to decisions about diagnosis and treatment – the basic thinking behind what happened on that particular day – need to be within the notes.

That kind of documentation "is actually not that complicated, and yet we fail to do it a large percentage of the time," said Dr. Littenberg.

"It can’t just be a recap of a problem list and continue the same therapy and ‘See you next year,’ " he said. "That’s not ever going to pass a high-level audit."

[email protected]

On Twitter @aliciaault

ORLANDO – With Medicare seeing a sharp spike in payments for evaluation and management services, a proposed overhaul of Current Procedural Terminology E&M codes could force physicians to provide substantially more documentation of their medical decision making.

The American Medical Association’s CPT editorial panel is scheduled to vote in mid-May on a recommendation to make such changes to E&M codes.

If the CPT panel’s changes are substantial enough, it’s even possible that the Centers for Medicare and Medicaid Services may embark on a revaluation of all the E&M codes, said Dr. Glenn Littenberg, a past member of the CPT editorial panel and a current CPT adviser to the American Society for Gastrointestinal Endoscopy.

If CMS decided to do so, revaluation potentially could be a good thing – if it results in a higher valuation for decision making, said Dr. Robert Wergin, president-elect of the American Academy of Family Physicians. But "if the motivation is to put up a barrier to code appropriately for the level of complexity of visits, it’s another step to undervalue the cognitive area," he said.

The federal government has been taking a closer look at coding, with the concern that electronic health records are making it easier to upcode.

A report in 2012 by the U.S. Department of Health & Human Services (HHS) inspector general found that between 2001 and 2010, physicians had increased their billing for higher-level E&M codes. Medicare payments for E&M services increased by 48% during the same period, from $22.7 billion to $33.5 billion. The Office of Inspector General labeled E&M services as "vulnerable to fraud and abuse."

Coding is a physician’s lifeblood, said Dr. Wergin. The AAFP is waiting to get more details on the CPT panel’s recommendations before it can say whether it supports the changes, he said.

The American College of Physicians said its officials could not comment, citing confidentiality agreements for ACP members who are on the CPT panel.

Detail your decision making

According to Dr. Littenberg, the CPT panel is proposing much more detailed documentation of decision making, including describing the number and complexity of problems. Medical decision making will be one of the two requirements to qualify for moderate to extensive E&M services for an office visit, an established patient, or follow-up hospital care.

The proposal is more prescriptive than current requirements, "and harder to grasp and keep in mind during an encounter," said Dr. Littenberg, who is also a gastroenterologist in Pasadena, Calif. He said he is "concerned about the impact of this," adding, "there are things about this proposal I don’t like, and I’ve said as much at CPT."

Decision making "is critical at arriving at a diagnosis and treatment plan," Dr. Wergin said, but the AAFP believes that it needs to be better defined by the CPT. "Let’s define medical decision making in a more meaningful way that makes sense to people like me," said Dr. Wergin, who added, "I have a lot of complicated patients."

If the focus is only on the presenting problem, it tends to undervalue the decision making that goes into evaluating a patient who may have multiple comorbidities and perhaps social issues as well, Dr. Wergin explained. To truly evaluate a patient, decision making should look at that individual as a whole, not as one issue, he said.

It appears that the panel is moving in that direction, Dr. Littenberg observed, but it will also require clear documentation that "reflects our thought process."

Note the basics

Physicians should be thinking more in terms of what would be required in documentation to defend an audit, he cautioned. The history, physical, and what led to decisions about diagnosis and treatment – the basic thinking behind what happened on that particular day – need to be within the notes.

That kind of documentation "is actually not that complicated, and yet we fail to do it a large percentage of the time," said Dr. Littenberg.

"It can’t just be a recap of a problem list and continue the same therapy and ‘See you next year,’ " he said. "That’s not ever going to pass a high-level audit."

[email protected]

On Twitter @aliciaault

ORLANDO – With Medicare seeing a sharp spike in payments for evaluation and management services, a proposed overhaul of Current Procedural Terminology E&M codes could force physicians to provide substantially more documentation of their medical decision making.

The American Medical Association’s CPT editorial panel is scheduled to vote in mid-May on a recommendation to make such changes to E&M codes.

If the CPT panel’s changes are substantial enough, it’s even possible that the Centers for Medicare and Medicaid Services may embark on a revaluation of all the E&M codes, said Dr. Glenn Littenberg, a past member of the CPT editorial panel and a current CPT adviser to the American Society for Gastrointestinal Endoscopy.

If CMS decided to do so, revaluation potentially could be a good thing – if it results in a higher valuation for decision making, said Dr. Robert Wergin, president-elect of the American Academy of Family Physicians. But "if the motivation is to put up a barrier to code appropriately for the level of complexity of visits, it’s another step to undervalue the cognitive area," he said.

The federal government has been taking a closer look at coding, with the concern that electronic health records are making it easier to upcode.

A report in 2012 by the U.S. Department of Health & Human Services (HHS) inspector general found that between 2001 and 2010, physicians had increased their billing for higher-level E&M codes. Medicare payments for E&M services increased by 48% during the same period, from $22.7 billion to $33.5 billion. The Office of Inspector General labeled E&M services as "vulnerable to fraud and abuse."

Coding is a physician’s lifeblood, said Dr. Wergin. The AAFP is waiting to get more details on the CPT panel’s recommendations before it can say whether it supports the changes, he said.

The American College of Physicians said its officials could not comment, citing confidentiality agreements for ACP members who are on the CPT panel.

Detail your decision making

According to Dr. Littenberg, the CPT panel is proposing much more detailed documentation of decision making, including describing the number and complexity of problems. Medical decision making will be one of the two requirements to qualify for moderate to extensive E&M services for an office visit, an established patient, or follow-up hospital care.

The proposal is more prescriptive than current requirements, "and harder to grasp and keep in mind during an encounter," said Dr. Littenberg, who is also a gastroenterologist in Pasadena, Calif. He said he is "concerned about the impact of this," adding, "there are things about this proposal I don’t like, and I’ve said as much at CPT."

Decision making "is critical at arriving at a diagnosis and treatment plan," Dr. Wergin said, but the AAFP believes that it needs to be better defined by the CPT. "Let’s define medical decision making in a more meaningful way that makes sense to people like me," said Dr. Wergin, who added, "I have a lot of complicated patients."

If the focus is only on the presenting problem, it tends to undervalue the decision making that goes into evaluating a patient who may have multiple comorbidities and perhaps social issues as well, Dr. Wergin explained. To truly evaluate a patient, decision making should look at that individual as a whole, not as one issue, he said.

It appears that the panel is moving in that direction, Dr. Littenberg observed, but it will also require clear documentation that "reflects our thought process."

Note the basics

Physicians should be thinking more in terms of what would be required in documentation to defend an audit, he cautioned. The history, physical, and what led to decisions about diagnosis and treatment – the basic thinking behind what happened on that particular day – need to be within the notes.

That kind of documentation "is actually not that complicated, and yet we fail to do it a large percentage of the time," said Dr. Littenberg.

"It can’t just be a recap of a problem list and continue the same therapy and ‘See you next year,’ " he said. "That’s not ever going to pass a high-level audit."

[email protected]

On Twitter @aliciaault

ORLANDO – The American Board of Internal Medicine is taking a potentially controversial step into the future by adding nonphysicians to both its main board and its subspecialty boards, a move that would give them a say in what defines being a good doctor.

The ABIM began the change in its governance process about 3 years ago, and took the first steps last July when it broke up its 29-member board of directors into two smaller panels: the board of directors and the ABIM council. The board will focus on governance issues, and the council will hone in on the assessment process itself. A few weeks ago, the board approved the addition of two new "public" members, including a health care executive and an official with a consumer organization.

*The subspecialty boards will remain the same, but add non-physician members. The boards will create exam committees, but those will be made up entirely of physicians.

Why the new structure?

Alicia Ault/Frontline Medical News

One of the ABIM’s core roles is "to offer a professionally sanctioned definition of what a good doctor is," said Dr. Richard J. Baron, president and chief executive officer of the ABIM, in an interview. Physicians have always defined what that means, he said. But the world has changed, and "the definition doesn’t just belong to doctors," said Dr. Baron, who is also a past chair of the ABIM board.

Physicians now have to answer to payers that want to reward performance and measure quality. They also have to answer to patients. "I think there’s an increasingly clear recognition that medicine is a service profession," said Dr. Baron.

"It’s hard for us to say whether we are meeting the needs of our patients if we don’t find ways to ask them if we are. That’s a pretty important evolutionary transformation in assessing how well we do what we do," he said. "Having patients around the table as we think about the standards that we generate will help us have some assurance that we’re actually doing that."

By the same token, as physicians start working more with health care teams, having a team member help define what makes a good doctor also makes sense, said Dr. Baron.

The ABIM will soon announce the names of the nonphysicians who were confirmed in April by the ABIM Board. One is a health care executive who has experience heading a Medicaid managed care company and has also been a senior official with the Department of Health & Human Services. The second is the leader of a widely respected consumer organization, said Dr. Baron.

The main board now has 12 directors, with a maximum of 15. Up to 20% of the board’s membership can be made up of noninternists.

The council has up to 18 members, and will:

• Determine the requirements for certification and maintenance of certification across all the internal medicine disciplines.

• Harmonize ABIM standards with those of other recognized physician education and assessment initiatives.

• Set and integrate operational policies and procedures across the specialty boards.

• Evaluate proposals for new specialties/focused practice areas.

Some subspecialty board members migrated to the council. And the council has some at-large members who have expertise in performance improvement, quality measures, or health information technology. The council also will add members who can offer the patient and caregiver perspective and the health care team perspective.

Overhaul of subspecialty boards

The ABIM also decided it was time to reorganize the subspecialty boards, in part so they could more effectively design quality improvement and performance assessment modules for the MOC (maintenance of certification) process.

The role of the subspecialty boards is to define, refine, and set standards in certification and MOC in the discipline; perform oversight/review of performance assessments in the discipline; and build partnerships with societies and other organizational stakeholders in support of ABIM work.

In the past, the subspecialty boards were mainly charged with developing the exam for each specialty. But as the certification and MOC processes have evolved, the subspecialty board members have not been equipped to flesh out the exam, said Dr. Baron.

Each new exam committee will have from six to eight members, with physicians from the particular specialty. But the committees also will have at least one community physician in nonacademic practice and two public, nonphysician members. This will include, for example, a nurse practitioner who’s part of a patient-centered medical home, or a diabetes educator. And it also will include someone who can give the patient or caregiver perspective, said Dr. Baron.

The ABIM has selected exam committee members for internal medicine, critical care medicine, endocrinology, diabetes and metabolism, gastroenterology, geriatric medicine, hematology, infectious disease, medical oncology, nephrology, pulmonary disease, and rheumatology. Members of the committees will be announced in July.

The cardiology committee will contain a handful of tertiary specialties, including adult congenital heart disease, advanced heart failure and transplant cardiology, cardiovascular disease, clinical cardiac electrophysiology, and interventional cardiology.

Other specialties will be addressed in the near future.

Acceptance slow

So far, the ABIM’s governance and structural shifts seem to have largely gone unnoticed by internists, said Dr. Baron. In part, it’s because governance is a bit of sausage making that may not be of interest to outsiders. But it’s also because of the understandable focus on the changes to the MOC process, he observed.

And, the changes to the ABIM board and its subspecialty boards aren’t likely to have an impact on certification or recertification exams in the near future, Dr. Baron said.

But it will have an impact. And the addition of nonphysicians may not be wholly embraced.

Dr. Baron recalled that while giving a talk about the governance changes at the American College of Cardiology’s annual meeting in March, an ACC physician member stood up and said that he could not imagine why the ABIM thought it made sense to have a patient on the board.

"[He] congratulated me with great sarcasm on my political correctness," Dr. Baron said. " ‘What do [patients] know about being a cardiologist?’ " the physician asked.

This is "a view that many members of our physician community have," Dr. Baron noted, but he believes others will see the merits of bringing in other stakeholders.

[email protected]

On Twitter @aliciaault

*Correction 4/24/14: A previous version of this story misstated that the ABIM would rename the subspecialty boards. The story has been updated. 

ORLANDO – The American Board of Internal Medicine is taking a potentially controversial step into the future by adding nonphysicians to both its main board and its subspecialty boards, a move that would give them a say in what defines being a good doctor.

The ABIM began the change in its governance process about 3 years ago, and took the first steps last July when it broke up its 29-member board of directors into two smaller panels: the board of directors and the ABIM council. The board will focus on governance issues, and the council will hone in on the assessment process itself. A few weeks ago, the board approved the addition of two new "public" members, including a health care executive and an official with a consumer organization.

*The subspecialty boards will remain the same, but add non-physician members. The boards will create exam committees, but those will be made up entirely of physicians.

Why the new structure?

Alicia Ault/Frontline Medical News

One of the ABIM’s core roles is "to offer a professionally sanctioned definition of what a good doctor is," said Dr. Richard J. Baron, president and chief executive officer of the ABIM, in an interview. Physicians have always defined what that means, he said. But the world has changed, and "the definition doesn’t just belong to doctors," said Dr. Baron, who is also a past chair of the ABIM board.

Physicians now have to answer to payers that want to reward performance and measure quality. They also have to answer to patients. "I think there’s an increasingly clear recognition that medicine is a service profession," said Dr. Baron.

"It’s hard for us to say whether we are meeting the needs of our patients if we don’t find ways to ask them if we are. That’s a pretty important evolutionary transformation in assessing how well we do what we do," he said. "Having patients around the table as we think about the standards that we generate will help us have some assurance that we’re actually doing that."

By the same token, as physicians start working more with health care teams, having a team member help define what makes a good doctor also makes sense, said Dr. Baron.

The ABIM will soon announce the names of the nonphysicians who were confirmed in April by the ABIM Board. One is a health care executive who has experience heading a Medicaid managed care company and has also been a senior official with the Department of Health & Human Services. The second is the leader of a widely respected consumer organization, said Dr. Baron.

The main board now has 12 directors, with a maximum of 15. Up to 20% of the board’s membership can be made up of noninternists.

The council has up to 18 members, and will:

• Determine the requirements for certification and maintenance of certification across all the internal medicine disciplines.

• Harmonize ABIM standards with those of other recognized physician education and assessment initiatives.

• Set and integrate operational policies and procedures across the specialty boards.

• Evaluate proposals for new specialties/focused practice areas.

Some subspecialty board members migrated to the council. And the council has some at-large members who have expertise in performance improvement, quality measures, or health information technology. The council also will add members who can offer the patient and caregiver perspective and the health care team perspective.

Overhaul of subspecialty boards

The ABIM also decided it was time to reorganize the subspecialty boards, in part so they could more effectively design quality improvement and performance assessment modules for the MOC (maintenance of certification) process.

The role of the subspecialty boards is to define, refine, and set standards in certification and MOC in the discipline; perform oversight/review of performance assessments in the discipline; and build partnerships with societies and other organizational stakeholders in support of ABIM work.

In the past, the subspecialty boards were mainly charged with developing the exam for each specialty. But as the certification and MOC processes have evolved, the subspecialty board members have not been equipped to flesh out the exam, said Dr. Baron.

Each new exam committee will have from six to eight members, with physicians from the particular specialty. But the committees also will have at least one community physician in nonacademic practice and two public, nonphysician members. This will include, for example, a nurse practitioner who’s part of a patient-centered medical home, or a diabetes educator. And it also will include someone who can give the patient or caregiver perspective, said Dr. Baron.

The ABIM has selected exam committee members for internal medicine, critical care medicine, endocrinology, diabetes and metabolism, gastroenterology, geriatric medicine, hematology, infectious disease, medical oncology, nephrology, pulmonary disease, and rheumatology. Members of the committees will be announced in July.

The cardiology committee will contain a handful of tertiary specialties, including adult congenital heart disease, advanced heart failure and transplant cardiology, cardiovascular disease, clinical cardiac electrophysiology, and interventional cardiology.

Other specialties will be addressed in the near future.

Acceptance slow

So far, the ABIM’s governance and structural shifts seem to have largely gone unnoticed by internists, said Dr. Baron. In part, it’s because governance is a bit of sausage making that may not be of interest to outsiders. But it’s also because of the understandable focus on the changes to the MOC process, he observed.

And, the changes to the ABIM board and its subspecialty boards aren’t likely to have an impact on certification or recertification exams in the near future, Dr. Baron said.

But it will have an impact. And the addition of nonphysicians may not be wholly embraced.

Dr. Baron recalled that while giving a talk about the governance changes at the American College of Cardiology’s annual meeting in March, an ACC physician member stood up and said that he could not imagine why the ABIM thought it made sense to have a patient on the board.

"[He] congratulated me with great sarcasm on my political correctness," Dr. Baron said. " ‘What do [patients] know about being a cardiologist?’ " the physician asked.

This is "a view that many members of our physician community have," Dr. Baron noted, but he believes others will see the merits of bringing in other stakeholders.

[email protected]

On Twitter @aliciaault

*Correction 4/24/14: A previous version of this story misstated that the ABIM would rename the subspecialty boards. The story has been updated. 

ORLANDO – The American Board of Internal Medicine is taking a potentially controversial step into the future by adding nonphysicians to both its main board and its subspecialty boards, a move that would give them a say in what defines being a good doctor.

The ABIM began the change in its governance process about 3 years ago, and took the first steps last July when it broke up its 29-member board of directors into two smaller panels: the board of directors and the ABIM council. The board will focus on governance issues, and the council will hone in on the assessment process itself. A few weeks ago, the board approved the addition of two new "public" members, including a health care executive and an official with a consumer organization.

*The subspecialty boards will remain the same, but add non-physician members. The boards will create exam committees, but those will be made up entirely of physicians.

Why the new structure?

Alicia Ault/Frontline Medical News

One of the ABIM’s core roles is "to offer a professionally sanctioned definition of what a good doctor is," said Dr. Richard J. Baron, president and chief executive officer of the ABIM, in an interview. Physicians have always defined what that means, he said. But the world has changed, and "the definition doesn’t just belong to doctors," said Dr. Baron, who is also a past chair of the ABIM board.

Physicians now have to answer to payers that want to reward performance and measure quality. They also have to answer to patients. "I think there’s an increasingly clear recognition that medicine is a service profession," said Dr. Baron.

"It’s hard for us to say whether we are meeting the needs of our patients if we don’t find ways to ask them if we are. That’s a pretty important evolutionary transformation in assessing how well we do what we do," he said. "Having patients around the table as we think about the standards that we generate will help us have some assurance that we’re actually doing that."

By the same token, as physicians start working more with health care teams, having a team member help define what makes a good doctor also makes sense, said Dr. Baron.

The ABIM will soon announce the names of the nonphysicians who were confirmed in April by the ABIM Board. One is a health care executive who has experience heading a Medicaid managed care company and has also been a senior official with the Department of Health & Human Services. The second is the leader of a widely respected consumer organization, said Dr. Baron.

The main board now has 12 directors, with a maximum of 15. Up to 20% of the board’s membership can be made up of noninternists.

The council has up to 18 members, and will:

• Determine the requirements for certification and maintenance of certification across all the internal medicine disciplines.

• Harmonize ABIM standards with those of other recognized physician education and assessment initiatives.

• Set and integrate operational policies and procedures across the specialty boards.

• Evaluate proposals for new specialties/focused practice areas.

Some subspecialty board members migrated to the council. And the council has some at-large members who have expertise in performance improvement, quality measures, or health information technology. The council also will add members who can offer the patient and caregiver perspective and the health care team perspective.

Overhaul of subspecialty boards

The ABIM also decided it was time to reorganize the subspecialty boards, in part so they could more effectively design quality improvement and performance assessment modules for the MOC (maintenance of certification) process.

The role of the subspecialty boards is to define, refine, and set standards in certification and MOC in the discipline; perform oversight/review of performance assessments in the discipline; and build partnerships with societies and other organizational stakeholders in support of ABIM work.

In the past, the subspecialty boards were mainly charged with developing the exam for each specialty. But as the certification and MOC processes have evolved, the subspecialty board members have not been equipped to flesh out the exam, said Dr. Baron.

Each new exam committee will have from six to eight members, with physicians from the particular specialty. But the committees also will have at least one community physician in nonacademic practice and two public, nonphysician members. This will include, for example, a nurse practitioner who’s part of a patient-centered medical home, or a diabetes educator. And it also will include someone who can give the patient or caregiver perspective, said Dr. Baron.

The ABIM has selected exam committee members for internal medicine, critical care medicine, endocrinology, diabetes and metabolism, gastroenterology, geriatric medicine, hematology, infectious disease, medical oncology, nephrology, pulmonary disease, and rheumatology. Members of the committees will be announced in July.

The cardiology committee will contain a handful of tertiary specialties, including adult congenital heart disease, advanced heart failure and transplant cardiology, cardiovascular disease, clinical cardiac electrophysiology, and interventional cardiology.

Other specialties will be addressed in the near future.

Acceptance slow

So far, the ABIM’s governance and structural shifts seem to have largely gone unnoticed by internists, said Dr. Baron. In part, it’s because governance is a bit of sausage making that may not be of interest to outsiders. But it’s also because of the understandable focus on the changes to the MOC process, he observed.

And, the changes to the ABIM board and its subspecialty boards aren’t likely to have an impact on certification or recertification exams in the near future, Dr. Baron said.

But it will have an impact. And the addition of nonphysicians may not be wholly embraced.

Dr. Baron recalled that while giving a talk about the governance changes at the American College of Cardiology’s annual meeting in March, an ACC physician member stood up and said that he could not imagine why the ABIM thought it made sense to have a patient on the board.

"[He] congratulated me with great sarcasm on my political correctness," Dr. Baron said. " ‘What do [patients] know about being a cardiologist?’ " the physician asked.

This is "a view that many members of our physician community have," Dr. Baron noted, but he believes others will see the merits of bringing in other stakeholders.

[email protected]

On Twitter @aliciaault

*Correction 4/24/14: A previous version of this story misstated that the ABIM would rename the subspecialty boards. The story has been updated. 

The Food and Drug Administration has approved ofatumumab (Arzerra injection, for intravenous infusion) in combination with chlorambucil, for previously untreated patients with chronic lymphocytic leukemia for whom fludarabine-based therapy is considered inappropriate.

Ofatumumab, an anti-CD20-directed monoclonal antibody, manufactured by GlaxoSmithKline, was originally given an accelerated approval in 2009. As a condition of that approval, the company was required to conduct further studies. The trial used as the basis of the April 17 approval fulfilled that postmarketing requirement, and accelerated approval was converted to regular approval, said the FDA.

That multicenter, randomized, open-label trial compared ofatumumab in combination with chlorambucil to chlorambucil alone. Patients received an intravenous infusion of ofatumumab on the following schedule: 300 mg on cycle 1, day 1; 1,000 mg on cycle 1, day 8; and 1,000 mg on day 1 of all subsequent 28-day cycles. In both arms, chlorambucil was given at a dose of 10 mg/meter orally on days 1 to 7, every 28 days. Ofatumumab patients were premedicated with acetaminophen, an antihistamine, and a glucocorticoid.

Median progression-free survival was 22.4 months for patients receiving the combination, compared with 13.1 months for those who were given chlorambucil alone. Progression-free survival was assessed by a blinded independent review committee using the 2008 International Workshop on Chronic Lymphocytic Leukemia update of the National Cancer Institute Working Group guidelines.

The most common adverse reactions of the ofatumumab-chlorambucil combination were infusion reactions, neutropenia, asthenia, headache, leukopenia, herpes simplex, lower respiratory tract infection, arthralgia, and upper abdominal pain. Sixty-seven percent of patients who received ofatumumab experienced one or more symptoms of infusion reaction; 10% experienced a grade 3 or greater infusion reaction.

In September, the FDA added a black box warning to ofatumumab’s label on the risk of reactivation of hepatitis B virus infection in patients with prior infection.

For previously untreated chronic lymphocytic leukemia, the recommended dose and schedule is 300 mg on day 1; followed 1 week later by 1,000 mg on day 8; followed by 1,000 mg on day 1 of subsequent 28-day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles, according to the FDA.

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On Twitter @aliciaault

The Food and Drug Administration has approved ofatumumab (Arzerra injection, for intravenous infusion) in combination with chlorambucil, for previously untreated patients with chronic lymphocytic leukemia for whom fludarabine-based therapy is considered inappropriate.

Ofatumumab, an anti-CD20-directed monoclonal antibody, manufactured by GlaxoSmithKline, was originally given an accelerated approval in 2009. As a condition of that approval, the company was required to conduct further studies. The trial used as the basis of the April 17 approval fulfilled that postmarketing requirement, and accelerated approval was converted to regular approval, said the FDA.

That multicenter, randomized, open-label trial compared ofatumumab in combination with chlorambucil to chlorambucil alone. Patients received an intravenous infusion of ofatumumab on the following schedule: 300 mg on cycle 1, day 1; 1,000 mg on cycle 1, day 8; and 1,000 mg on day 1 of all subsequent 28-day cycles. In both arms, chlorambucil was given at a dose of 10 mg/meter orally on days 1 to 7, every 28 days. Ofatumumab patients were premedicated with acetaminophen, an antihistamine, and a glucocorticoid.

Median progression-free survival was 22.4 months for patients receiving the combination, compared with 13.1 months for those who were given chlorambucil alone. Progression-free survival was assessed by a blinded independent review committee using the 2008 International Workshop on Chronic Lymphocytic Leukemia update of the National Cancer Institute Working Group guidelines.

The most common adverse reactions of the ofatumumab-chlorambucil combination were infusion reactions, neutropenia, asthenia, headache, leukopenia, herpes simplex, lower respiratory tract infection, arthralgia, and upper abdominal pain. Sixty-seven percent of patients who received ofatumumab experienced one or more symptoms of infusion reaction; 10% experienced a grade 3 or greater infusion reaction.

In September, the FDA added a black box warning to ofatumumab’s label on the risk of reactivation of hepatitis B virus infection in patients with prior infection.

For previously untreated chronic lymphocytic leukemia, the recommended dose and schedule is 300 mg on day 1; followed 1 week later by 1,000 mg on day 8; followed by 1,000 mg on day 1 of subsequent 28-day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles, according to the FDA.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved ofatumumab (Arzerra injection, for intravenous infusion) in combination with chlorambucil, for previously untreated patients with chronic lymphocytic leukemia for whom fludarabine-based therapy is considered inappropriate.

Ofatumumab, an anti-CD20-directed monoclonal antibody, manufactured by GlaxoSmithKline, was originally given an accelerated approval in 2009. As a condition of that approval, the company was required to conduct further studies. The trial used as the basis of the April 17 approval fulfilled that postmarketing requirement, and accelerated approval was converted to regular approval, said the FDA.

That multicenter, randomized, open-label trial compared ofatumumab in combination with chlorambucil to chlorambucil alone. Patients received an intravenous infusion of ofatumumab on the following schedule: 300 mg on cycle 1, day 1; 1,000 mg on cycle 1, day 8; and 1,000 mg on day 1 of all subsequent 28-day cycles. In both arms, chlorambucil was given at a dose of 10 mg/meter orally on days 1 to 7, every 28 days. Ofatumumab patients were premedicated with acetaminophen, an antihistamine, and a glucocorticoid.

Median progression-free survival was 22.4 months for patients receiving the combination, compared with 13.1 months for those who were given chlorambucil alone. Progression-free survival was assessed by a blinded independent review committee using the 2008 International Workshop on Chronic Lymphocytic Leukemia update of the National Cancer Institute Working Group guidelines.

The most common adverse reactions of the ofatumumab-chlorambucil combination were infusion reactions, neutropenia, asthenia, headache, leukopenia, herpes simplex, lower respiratory tract infection, arthralgia, and upper abdominal pain. Sixty-seven percent of patients who received ofatumumab experienced one or more symptoms of infusion reaction; 10% experienced a grade 3 or greater infusion reaction.

In September, the FDA added a black box warning to ofatumumab’s label on the risk of reactivation of hepatitis B virus infection in patients with prior infection.

For previously untreated chronic lymphocytic leukemia, the recommended dose and schedule is 300 mg on day 1; followed 1 week later by 1,000 mg on day 8; followed by 1,000 mg on day 1 of subsequent 28-day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles, according to the FDA.

[email protected]

On Twitter @aliciaault