ASCO issues to-do list on tobacco control

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ASCO issues to-do list on tobacco control

U.S. oncologists are calling on federal and state officials to beef up the regulation of tobacco products, increase research funding, and ensure access to cessation treatments through the new state-based insurance exchanges.

Physicians also need to "lead by example" by not smoking, treating tobacco dependence aggressively, lobbying for tobacco-free environments, and refusing to accept tobacco industry support, according to a policy statement from the American Society of Clinical Oncology. The statement was published July 29 in the Journal of Clinical Oncology (doi:10.1200/JCO.2013.48.8932). This is the first time ASCO has updated its policy on tobacco control since 2003.

The latest report reminds physicians, policy makers, and the public that the problem of tobacco cessation and control is not solved, said Dr. Clifford A. Hudis, president of the American Society of Clinical Oncology.

"While smoking cessation efforts have been rewarded in many populations with falling rates of cigarette and tobacco use, that’s not been uniform," said Dr. Hudis of Memorial Sloan-Kettering Cancer Center in New York. "It remains a dominant health care risk in the U.S. and specifically a cancer risk,"

But Dr. Hudis said he thinks ASCO’s message will resonate on Capitol Hill where lawmakers are looking for cost-effective policies. "This is an area where doing the right thing could yield unbelievable dividends in terms of savings for the system," he said.

One of those areas is in federally sponsored research. ASCO is seeking an increased federal role in research on a range of tobacco control areas from understanding the mechanisms of tobacco use to implementing tobacco cessation in specific populations including cancer patients and survivors. ASCO also wants to see tobacco use history and status included as a core data element that is collected throughout oncology clinical trials.

ASCO also supports coverage of tobacco cessation treatment insurance coverage and increased physician payments for evidence-based tobacco cessation services, such as intensive counseling, and FDA-approved medications. Although Medicare and Medicaid both cover tobacco cessation treatments, the ASCO report expresses concerns that these services could be left out of some health plans in the state-based insurance exchanges. ASCO wants to ensure when states set their essential health benefit packages for policies sold in the exchanges that they include a range of evidence-based services and drug therapies for tobacco cessation that are consistent with the recommendations of the U.S. Preventive Services Task Force.

Regulation is another area where ASCO officials are calling for more action.

The organization continues to support policies to increase the price of tobacco products in an effort to curb use and fund state tobacco control programs, including quit lines and youth prevention programs. ASCO supports a "substantial" increase in tobacco excises taxes, the establishment of minimum price laws for cigarettes that counteract industry discounts, and an increase on retail licensing fees.

All tobacco products should be regulated in the same way, ASCO said, without exemptions for cigars and cigarillos.

The organization also supports the 2011 recommendation from the FDA Tobacco Products Scientific Advisory Committee to remove menthol cigarettes from the market.

The ASCO recommendations come on the heels of a new scientific review by the Food and Drug Administration that shows that menthol cigarettes is likely associated with increased smoking initiation by teens and young adults. Menthol use is also likely associated with greater addiction, making it harder to quit. FDA officials concluded that menthol cigarettes, while not more toxic, likely pose a greater public health risk than did nonmenthol cigarettes.

The FDA is asking the public to offer suggestions for how menthol in cigarettes could be regulated.

The agency has also commissioned additional studies on the public health impact of menthol cigarettes, compared with regular cigarettes. The three studies will look at whether genetic differences in taste perceptions for menthol cigarettes, compare the smoke-related toxins and carcinogens between menthol and nonmenthol cigarettes, and consider the impact of menthol compounds on addiction.

Physicians also have a role to play when it comes to encouraging patients to quit and lobbying lawmakers on smoking-related regulations.

"Physicians are just one part of this discussion, though we can be leaders and motivators more broadly in the population," Dr. Hudis said.

But a new survey published on July 29 in the Journal of Oncology Practice shows that oncologists aren’t fully promoting smoking cessation in their practices (doi:10.1200/JOP.2013.001025).

The online survey of ASCO members conducted in 2012 shows that the vast majority of oncologists are asking patients about tobacco use at least initially. About 90% of the 1,197 respondents said they routinely asked patients about tobacco use at the initial visit and 84% advised patients to stop using tobacco.

 

 

But there was a significant drop off when it came to following up with treatment options. Only 44% routinely discuss medication options and only 39% provide other cessation support. The respondents cited inadequate training in tobacco cessation interventions and patient resistance as some of the barriers.

Dr. Hudis said sometimes tobacco cessation falls through the cracks for busy physicians. "That just reminds us that everyone in health care is stretched these days, working hard and balancing priorities," he said. "We just have to make sure that this remains front and center."

For its part, ASCO plans to help develop cessation tools and resources for providers to integrate into their practices. ASCO is also calling for a stronger focus on tobacco cessation both in medical training and continuing medical education courses. The organization is encouraging credentialing organizations to include questions about tobacco-dependence treatment in their exams. ASCO plans to partner with the American Board of Internal Medicine to make sure there is tobacco cessation content in the oncology specialty training boards.

[email protected]

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The American Society of Clinical Oncology is calling for officials to beef up the regulation of tobacco products, increase research funding, and ensure widespread access to cessation treatments.
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U.S. oncologists are calling on federal and state officials to beef up the regulation of tobacco products, increase research funding, and ensure access to cessation treatments through the new state-based insurance exchanges.

Physicians also need to "lead by example" by not smoking, treating tobacco dependence aggressively, lobbying for tobacco-free environments, and refusing to accept tobacco industry support, according to a policy statement from the American Society of Clinical Oncology. The statement was published July 29 in the Journal of Clinical Oncology (doi:10.1200/JCO.2013.48.8932). This is the first time ASCO has updated its policy on tobacco control since 2003.

The latest report reminds physicians, policy makers, and the public that the problem of tobacco cessation and control is not solved, said Dr. Clifford A. Hudis, president of the American Society of Clinical Oncology.

"While smoking cessation efforts have been rewarded in many populations with falling rates of cigarette and tobacco use, that’s not been uniform," said Dr. Hudis of Memorial Sloan-Kettering Cancer Center in New York. "It remains a dominant health care risk in the U.S. and specifically a cancer risk,"

But Dr. Hudis said he thinks ASCO’s message will resonate on Capitol Hill where lawmakers are looking for cost-effective policies. "This is an area where doing the right thing could yield unbelievable dividends in terms of savings for the system," he said.

One of those areas is in federally sponsored research. ASCO is seeking an increased federal role in research on a range of tobacco control areas from understanding the mechanisms of tobacco use to implementing tobacco cessation in specific populations including cancer patients and survivors. ASCO also wants to see tobacco use history and status included as a core data element that is collected throughout oncology clinical trials.

ASCO also supports coverage of tobacco cessation treatment insurance coverage and increased physician payments for evidence-based tobacco cessation services, such as intensive counseling, and FDA-approved medications. Although Medicare and Medicaid both cover tobacco cessation treatments, the ASCO report expresses concerns that these services could be left out of some health plans in the state-based insurance exchanges. ASCO wants to ensure when states set their essential health benefit packages for policies sold in the exchanges that they include a range of evidence-based services and drug therapies for tobacco cessation that are consistent with the recommendations of the U.S. Preventive Services Task Force.

Regulation is another area where ASCO officials are calling for more action.

The organization continues to support policies to increase the price of tobacco products in an effort to curb use and fund state tobacco control programs, including quit lines and youth prevention programs. ASCO supports a "substantial" increase in tobacco excises taxes, the establishment of minimum price laws for cigarettes that counteract industry discounts, and an increase on retail licensing fees.

All tobacco products should be regulated in the same way, ASCO said, without exemptions for cigars and cigarillos.

The organization also supports the 2011 recommendation from the FDA Tobacco Products Scientific Advisory Committee to remove menthol cigarettes from the market.

The ASCO recommendations come on the heels of a new scientific review by the Food and Drug Administration that shows that menthol cigarettes is likely associated with increased smoking initiation by teens and young adults. Menthol use is also likely associated with greater addiction, making it harder to quit. FDA officials concluded that menthol cigarettes, while not more toxic, likely pose a greater public health risk than did nonmenthol cigarettes.

The FDA is asking the public to offer suggestions for how menthol in cigarettes could be regulated.

The agency has also commissioned additional studies on the public health impact of menthol cigarettes, compared with regular cigarettes. The three studies will look at whether genetic differences in taste perceptions for menthol cigarettes, compare the smoke-related toxins and carcinogens between menthol and nonmenthol cigarettes, and consider the impact of menthol compounds on addiction.

Physicians also have a role to play when it comes to encouraging patients to quit and lobbying lawmakers on smoking-related regulations.

"Physicians are just one part of this discussion, though we can be leaders and motivators more broadly in the population," Dr. Hudis said.

But a new survey published on July 29 in the Journal of Oncology Practice shows that oncologists aren’t fully promoting smoking cessation in their practices (doi:10.1200/JOP.2013.001025).

The online survey of ASCO members conducted in 2012 shows that the vast majority of oncologists are asking patients about tobacco use at least initially. About 90% of the 1,197 respondents said they routinely asked patients about tobacco use at the initial visit and 84% advised patients to stop using tobacco.

 

 

But there was a significant drop off when it came to following up with treatment options. Only 44% routinely discuss medication options and only 39% provide other cessation support. The respondents cited inadequate training in tobacco cessation interventions and patient resistance as some of the barriers.

Dr. Hudis said sometimes tobacco cessation falls through the cracks for busy physicians. "That just reminds us that everyone in health care is stretched these days, working hard and balancing priorities," he said. "We just have to make sure that this remains front and center."

For its part, ASCO plans to help develop cessation tools and resources for providers to integrate into their practices. ASCO is also calling for a stronger focus on tobacco cessation both in medical training and continuing medical education courses. The organization is encouraging credentialing organizations to include questions about tobacco-dependence treatment in their exams. ASCO plans to partner with the American Board of Internal Medicine to make sure there is tobacco cessation content in the oncology specialty training boards.

[email protected]

©thinkstockphotos.com
The American Society of Clinical Oncology is calling for officials to beef up the regulation of tobacco products, increase research funding, and ensure widespread access to cessation treatments.

U.S. oncologists are calling on federal and state officials to beef up the regulation of tobacco products, increase research funding, and ensure access to cessation treatments through the new state-based insurance exchanges.

Physicians also need to "lead by example" by not smoking, treating tobacco dependence aggressively, lobbying for tobacco-free environments, and refusing to accept tobacco industry support, according to a policy statement from the American Society of Clinical Oncology. The statement was published July 29 in the Journal of Clinical Oncology (doi:10.1200/JCO.2013.48.8932). This is the first time ASCO has updated its policy on tobacco control since 2003.

The latest report reminds physicians, policy makers, and the public that the problem of tobacco cessation and control is not solved, said Dr. Clifford A. Hudis, president of the American Society of Clinical Oncology.

"While smoking cessation efforts have been rewarded in many populations with falling rates of cigarette and tobacco use, that’s not been uniform," said Dr. Hudis of Memorial Sloan-Kettering Cancer Center in New York. "It remains a dominant health care risk in the U.S. and specifically a cancer risk,"

But Dr. Hudis said he thinks ASCO’s message will resonate on Capitol Hill where lawmakers are looking for cost-effective policies. "This is an area where doing the right thing could yield unbelievable dividends in terms of savings for the system," he said.

One of those areas is in federally sponsored research. ASCO is seeking an increased federal role in research on a range of tobacco control areas from understanding the mechanisms of tobacco use to implementing tobacco cessation in specific populations including cancer patients and survivors. ASCO also wants to see tobacco use history and status included as a core data element that is collected throughout oncology clinical trials.

ASCO also supports coverage of tobacco cessation treatment insurance coverage and increased physician payments for evidence-based tobacco cessation services, such as intensive counseling, and FDA-approved medications. Although Medicare and Medicaid both cover tobacco cessation treatments, the ASCO report expresses concerns that these services could be left out of some health plans in the state-based insurance exchanges. ASCO wants to ensure when states set their essential health benefit packages for policies sold in the exchanges that they include a range of evidence-based services and drug therapies for tobacco cessation that are consistent with the recommendations of the U.S. Preventive Services Task Force.

Regulation is another area where ASCO officials are calling for more action.

The organization continues to support policies to increase the price of tobacco products in an effort to curb use and fund state tobacco control programs, including quit lines and youth prevention programs. ASCO supports a "substantial" increase in tobacco excises taxes, the establishment of minimum price laws for cigarettes that counteract industry discounts, and an increase on retail licensing fees.

All tobacco products should be regulated in the same way, ASCO said, without exemptions for cigars and cigarillos.

The organization also supports the 2011 recommendation from the FDA Tobacco Products Scientific Advisory Committee to remove menthol cigarettes from the market.

The ASCO recommendations come on the heels of a new scientific review by the Food and Drug Administration that shows that menthol cigarettes is likely associated with increased smoking initiation by teens and young adults. Menthol use is also likely associated with greater addiction, making it harder to quit. FDA officials concluded that menthol cigarettes, while not more toxic, likely pose a greater public health risk than did nonmenthol cigarettes.

The FDA is asking the public to offer suggestions for how menthol in cigarettes could be regulated.

The agency has also commissioned additional studies on the public health impact of menthol cigarettes, compared with regular cigarettes. The three studies will look at whether genetic differences in taste perceptions for menthol cigarettes, compare the smoke-related toxins and carcinogens between menthol and nonmenthol cigarettes, and consider the impact of menthol compounds on addiction.

Physicians also have a role to play when it comes to encouraging patients to quit and lobbying lawmakers on smoking-related regulations.

"Physicians are just one part of this discussion, though we can be leaders and motivators more broadly in the population," Dr. Hudis said.

But a new survey published on July 29 in the Journal of Oncology Practice shows that oncologists aren’t fully promoting smoking cessation in their practices (doi:10.1200/JOP.2013.001025).

The online survey of ASCO members conducted in 2012 shows that the vast majority of oncologists are asking patients about tobacco use at least initially. About 90% of the 1,197 respondents said they routinely asked patients about tobacco use at the initial visit and 84% advised patients to stop using tobacco.

 

 

But there was a significant drop off when it came to following up with treatment options. Only 44% routinely discuss medication options and only 39% provide other cessation support. The respondents cited inadequate training in tobacco cessation interventions and patient resistance as some of the barriers.

Dr. Hudis said sometimes tobacco cessation falls through the cracks for busy physicians. "That just reminds us that everyone in health care is stretched these days, working hard and balancing priorities," he said. "We just have to make sure that this remains front and center."

For its part, ASCO plans to help develop cessation tools and resources for providers to integrate into their practices. ASCO is also calling for a stronger focus on tobacco cessation both in medical training and continuing medical education courses. The organization is encouraging credentialing organizations to include questions about tobacco-dependence treatment in their exams. ASCO plans to partner with the American Board of Internal Medicine to make sure there is tobacco cessation content in the oncology specialty training boards.

[email protected]

©thinkstockphotos.com
The American Society of Clinical Oncology is calling for officials to beef up the regulation of tobacco products, increase research funding, and ensure widespread access to cessation treatments.
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Cigna to require counseling for some genetic tests

A good requirement: Genetic counseling
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Cigna to require counseling for some genetic tests

The health insurer Cigna soon will require its members to receive genetic counseling before they can undergo genetic testing for certain hereditary conditions.

The new policy, which takes effect Sept. 16, will apply to tests for the breast and ovarian cancer genes BRCA1 and BRCA2; colorectal cancer genetic screening; and long QT syndrome genetic tests for hereditary cardiac risk. The requirement will impact Cigna customers whose health plans require preauthorization.

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The health insurer Cigna soon will require its members to receive genetic counseling before they can undergo genetic testing for certain hereditary conditions.

Cigna members will be counseled by either a medical geneticist or a board-certified genetic counselor before the tests can be ordered by the physician. The process will be similar to the preauthorization used for other services, according to Dr. David Finley, national medical officer for enterprise affordability and policy for Cigna.

Final decisions on whether a genetic test will be covered will be made by a Cigna medical director, who will give "great weight" to the counselor’s recommendation, Dr. Finley said. Cigna plans to share that recommendation with the physician and is currently working out how to do so.

Cigna is the first large, national health insurer to make genetic counseling a requirement for the coverage of genetic testing, but some regional health plans have been experimenting with this approach.

Cigna officials see counseling as part of the evolving standard of care in genetic testing, Dr. Finley said. The aim of the new policy is to ensure that genetic testing meets generally accepted national criteria and to reduce inappropriate testing, he said.

"Many genetic tests are misunderstood by the individuals who are requesting them. Sometimes the tests are ordered by the doctor, and the individual does not meet nationally accepted testing criteria," Dr. Finley said. "We think that requiring genetic counseling will result in better informed individuals who will make better decisions regarding testing. It will also eliminate some unnecessary and potentially harmful testing, and will also help individuals become more educated and more involved in their health care decisions."

Dr. David Finley

The new policy is expected to have a minimal impact on physicians, Dr. Finley said. Physicians may be asked to help patients find a genetic counselor, though Cigna will list qualified counselors on its website and has contracted with InformedDNA to provide quick access to counselors.

The Cigna policy should actually make things easier for physicians, said David Nixon, the CEO of InformedDNA, because it will give them access to genetic specialists. "It’s just impossible for front-line physicians to keep up with the pace of change in genetics," he said.

As part of their service, InformedDNA counselors will review family history and then counsel patients during a 45-minute to 1-hour phone or online appointment. All appointments are scheduled within 10 days, Mr. Nixon said.

Aside from counseling, InformedDNA also will handle much of the added paperwork involved with testing. While the referring physician still orders the test, InformedDNA handles the administrative work associated with the test, Mr. Nixon said.

Cigna’s relationship with InformedDNA could provide much-needed resources for physicians who aren’t comfortable counseling patients on genetic testing on their own, said Dr. Howard P. Levy, assistant professor in the internal medicine and genetic medicine departments at Johns Hopkins University in Baltimore.

But the new policy also has the potential to add delays and costs to the genetic testing process, Dr. Levy said. For instance, what if a cardiologist who is well versed on long QT syndrome genetic tests counsels his patient, but they are then required to meet with a genetic counselor to review the same information? Dr. Levy said that scenario would just slow down the process for patients and duplicate services.

"In genetic testing, sometimes it’s useful to get other people’s perspectives and sometimes that’s not so necessary," said Dr. Levy.

[email protected]

Body

Amanda Gammon
The news that Cigna will now require patients to receive genetic counseling prior to having genetic testing relating to hereditary breast and ovarian cancer, colon cancer, and long QT syndrome is exciting and welcome. Genetic counselors and medical geneticists are uniquely trained to analyze patient medical and family histories to assess risk for hereditary disease. In addition, they have extensive experience in helping patients navigate the medical and psychosocial impacts of hereditary conditions, including the effects that extend to patients' families.

Among nongenetics specialists, studies have shown significant variability in providers' genetics knowledge, the type of genetic test they would order, the interpretation of genetic test results, and the medical management recommendations they would provide based on the results (Genet. Med. 2011;13:148-54; J. Genet. Couns. 2013 22:90-100; Am. J. Gastroenterol. 2002;97:729-33). Requiring genetic counseling prior to genetic testing helps ensure that patients receive comprehensive genetics risk assessment, precision in testing and interpretation of test results, psychosocial support, and access to current management recommendations, in addition to the expertise of their referring physician.

Dr. Randall Burt
As evidenced by Dr. Finley's comments, the goal of Cigna's new policy is to improve patient care and engagement. As new genetic testing options have recently become available (i.e., next-generation sequencing panels, whole exome and genome sequencing), genetics expertise is increasingly needed to identify the most appropriate test for each patient. Cigna's policy has the potential to increase provider awareness of genetics services and form new partnerships. In addition to Cigna's contract with InformedDNA, many local genetics clinics have the availability to see urgent patients, which should reduce concerns about patient wait times for genetic testing. We are hopeful that more insurance companies will follow Cigna's lead and show their support for the genetic counseling process as a valuable and increasingly crucial service for patients at risk for hereditary disease.

Amanda Gammon is at the University of Utah School of Medicine, Huntsman Cancer Institute, Salt Lake City. She has no financial conflicts of interest. Dr. Randall Burt is professor of medicine at the Huntsman Cancer Institute. He serves as a consultant for Myriad Genetics.
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Body

Amanda Gammon
The news that Cigna will now require patients to receive genetic counseling prior to having genetic testing relating to hereditary breast and ovarian cancer, colon cancer, and long QT syndrome is exciting and welcome. Genetic counselors and medical geneticists are uniquely trained to analyze patient medical and family histories to assess risk for hereditary disease. In addition, they have extensive experience in helping patients navigate the medical and psychosocial impacts of hereditary conditions, including the effects that extend to patients' families.

Among nongenetics specialists, studies have shown significant variability in providers' genetics knowledge, the type of genetic test they would order, the interpretation of genetic test results, and the medical management recommendations they would provide based on the results (Genet. Med. 2011;13:148-54; J. Genet. Couns. 2013 22:90-100; Am. J. Gastroenterol. 2002;97:729-33). Requiring genetic counseling prior to genetic testing helps ensure that patients receive comprehensive genetics risk assessment, precision in testing and interpretation of test results, psychosocial support, and access to current management recommendations, in addition to the expertise of their referring physician.

Dr. Randall Burt
As evidenced by Dr. Finley's comments, the goal of Cigna's new policy is to improve patient care and engagement. As new genetic testing options have recently become available (i.e., next-generation sequencing panels, whole exome and genome sequencing), genetics expertise is increasingly needed to identify the most appropriate test for each patient. Cigna's policy has the potential to increase provider awareness of genetics services and form new partnerships. In addition to Cigna's contract with InformedDNA, many local genetics clinics have the availability to see urgent patients, which should reduce concerns about patient wait times for genetic testing. We are hopeful that more insurance companies will follow Cigna's lead and show their support for the genetic counseling process as a valuable and increasingly crucial service for patients at risk for hereditary disease.

Amanda Gammon is at the University of Utah School of Medicine, Huntsman Cancer Institute, Salt Lake City. She has no financial conflicts of interest. Dr. Randall Burt is professor of medicine at the Huntsman Cancer Institute. He serves as a consultant for Myriad Genetics.
Body

Amanda Gammon
The news that Cigna will now require patients to receive genetic counseling prior to having genetic testing relating to hereditary breast and ovarian cancer, colon cancer, and long QT syndrome is exciting and welcome. Genetic counselors and medical geneticists are uniquely trained to analyze patient medical and family histories to assess risk for hereditary disease. In addition, they have extensive experience in helping patients navigate the medical and psychosocial impacts of hereditary conditions, including the effects that extend to patients' families.

Among nongenetics specialists, studies have shown significant variability in providers' genetics knowledge, the type of genetic test they would order, the interpretation of genetic test results, and the medical management recommendations they would provide based on the results (Genet. Med. 2011;13:148-54; J. Genet. Couns. 2013 22:90-100; Am. J. Gastroenterol. 2002;97:729-33). Requiring genetic counseling prior to genetic testing helps ensure that patients receive comprehensive genetics risk assessment, precision in testing and interpretation of test results, psychosocial support, and access to current management recommendations, in addition to the expertise of their referring physician.

Dr. Randall Burt
As evidenced by Dr. Finley's comments, the goal of Cigna's new policy is to improve patient care and engagement. As new genetic testing options have recently become available (i.e., next-generation sequencing panels, whole exome and genome sequencing), genetics expertise is increasingly needed to identify the most appropriate test for each patient. Cigna's policy has the potential to increase provider awareness of genetics services and form new partnerships. In addition to Cigna's contract with InformedDNA, many local genetics clinics have the availability to see urgent patients, which should reduce concerns about patient wait times for genetic testing. We are hopeful that more insurance companies will follow Cigna's lead and show their support for the genetic counseling process as a valuable and increasingly crucial service for patients at risk for hereditary disease.

Amanda Gammon is at the University of Utah School of Medicine, Huntsman Cancer Institute, Salt Lake City. She has no financial conflicts of interest. Dr. Randall Burt is professor of medicine at the Huntsman Cancer Institute. He serves as a consultant for Myriad Genetics.
Title
A good requirement: Genetic counseling
A good requirement: Genetic counseling

The health insurer Cigna soon will require its members to receive genetic counseling before they can undergo genetic testing for certain hereditary conditions.

The new policy, which takes effect Sept. 16, will apply to tests for the breast and ovarian cancer genes BRCA1 and BRCA2; colorectal cancer genetic screening; and long QT syndrome genetic tests for hereditary cardiac risk. The requirement will impact Cigna customers whose health plans require preauthorization.

©Kativ/iStockphoto
The health insurer Cigna soon will require its members to receive genetic counseling before they can undergo genetic testing for certain hereditary conditions.

Cigna members will be counseled by either a medical geneticist or a board-certified genetic counselor before the tests can be ordered by the physician. The process will be similar to the preauthorization used for other services, according to Dr. David Finley, national medical officer for enterprise affordability and policy for Cigna.

Final decisions on whether a genetic test will be covered will be made by a Cigna medical director, who will give "great weight" to the counselor’s recommendation, Dr. Finley said. Cigna plans to share that recommendation with the physician and is currently working out how to do so.

Cigna is the first large, national health insurer to make genetic counseling a requirement for the coverage of genetic testing, but some regional health plans have been experimenting with this approach.

Cigna officials see counseling as part of the evolving standard of care in genetic testing, Dr. Finley said. The aim of the new policy is to ensure that genetic testing meets generally accepted national criteria and to reduce inappropriate testing, he said.

"Many genetic tests are misunderstood by the individuals who are requesting them. Sometimes the tests are ordered by the doctor, and the individual does not meet nationally accepted testing criteria," Dr. Finley said. "We think that requiring genetic counseling will result in better informed individuals who will make better decisions regarding testing. It will also eliminate some unnecessary and potentially harmful testing, and will also help individuals become more educated and more involved in their health care decisions."

Dr. David Finley

The new policy is expected to have a minimal impact on physicians, Dr. Finley said. Physicians may be asked to help patients find a genetic counselor, though Cigna will list qualified counselors on its website and has contracted with InformedDNA to provide quick access to counselors.

The Cigna policy should actually make things easier for physicians, said David Nixon, the CEO of InformedDNA, because it will give them access to genetic specialists. "It’s just impossible for front-line physicians to keep up with the pace of change in genetics," he said.

As part of their service, InformedDNA counselors will review family history and then counsel patients during a 45-minute to 1-hour phone or online appointment. All appointments are scheduled within 10 days, Mr. Nixon said.

Aside from counseling, InformedDNA also will handle much of the added paperwork involved with testing. While the referring physician still orders the test, InformedDNA handles the administrative work associated with the test, Mr. Nixon said.

Cigna’s relationship with InformedDNA could provide much-needed resources for physicians who aren’t comfortable counseling patients on genetic testing on their own, said Dr. Howard P. Levy, assistant professor in the internal medicine and genetic medicine departments at Johns Hopkins University in Baltimore.

But the new policy also has the potential to add delays and costs to the genetic testing process, Dr. Levy said. For instance, what if a cardiologist who is well versed on long QT syndrome genetic tests counsels his patient, but they are then required to meet with a genetic counselor to review the same information? Dr. Levy said that scenario would just slow down the process for patients and duplicate services.

"In genetic testing, sometimes it’s useful to get other people’s perspectives and sometimes that’s not so necessary," said Dr. Levy.

[email protected]

The health insurer Cigna soon will require its members to receive genetic counseling before they can undergo genetic testing for certain hereditary conditions.

The new policy, which takes effect Sept. 16, will apply to tests for the breast and ovarian cancer genes BRCA1 and BRCA2; colorectal cancer genetic screening; and long QT syndrome genetic tests for hereditary cardiac risk. The requirement will impact Cigna customers whose health plans require preauthorization.

©Kativ/iStockphoto
The health insurer Cigna soon will require its members to receive genetic counseling before they can undergo genetic testing for certain hereditary conditions.

Cigna members will be counseled by either a medical geneticist or a board-certified genetic counselor before the tests can be ordered by the physician. The process will be similar to the preauthorization used for other services, according to Dr. David Finley, national medical officer for enterprise affordability and policy for Cigna.

Final decisions on whether a genetic test will be covered will be made by a Cigna medical director, who will give "great weight" to the counselor’s recommendation, Dr. Finley said. Cigna plans to share that recommendation with the physician and is currently working out how to do so.

Cigna is the first large, national health insurer to make genetic counseling a requirement for the coverage of genetic testing, but some regional health plans have been experimenting with this approach.

Cigna officials see counseling as part of the evolving standard of care in genetic testing, Dr. Finley said. The aim of the new policy is to ensure that genetic testing meets generally accepted national criteria and to reduce inappropriate testing, he said.

"Many genetic tests are misunderstood by the individuals who are requesting them. Sometimes the tests are ordered by the doctor, and the individual does not meet nationally accepted testing criteria," Dr. Finley said. "We think that requiring genetic counseling will result in better informed individuals who will make better decisions regarding testing. It will also eliminate some unnecessary and potentially harmful testing, and will also help individuals become more educated and more involved in their health care decisions."

Dr. David Finley

The new policy is expected to have a minimal impact on physicians, Dr. Finley said. Physicians may be asked to help patients find a genetic counselor, though Cigna will list qualified counselors on its website and has contracted with InformedDNA to provide quick access to counselors.

The Cigna policy should actually make things easier for physicians, said David Nixon, the CEO of InformedDNA, because it will give them access to genetic specialists. "It’s just impossible for front-line physicians to keep up with the pace of change in genetics," he said.

As part of their service, InformedDNA counselors will review family history and then counsel patients during a 45-minute to 1-hour phone or online appointment. All appointments are scheduled within 10 days, Mr. Nixon said.

Aside from counseling, InformedDNA also will handle much of the added paperwork involved with testing. While the referring physician still orders the test, InformedDNA handles the administrative work associated with the test, Mr. Nixon said.

Cigna’s relationship with InformedDNA could provide much-needed resources for physicians who aren’t comfortable counseling patients on genetic testing on their own, said Dr. Howard P. Levy, assistant professor in the internal medicine and genetic medicine departments at Johns Hopkins University in Baltimore.

But the new policy also has the potential to add delays and costs to the genetic testing process, Dr. Levy said. For instance, what if a cardiologist who is well versed on long QT syndrome genetic tests counsels his patient, but they are then required to meet with a genetic counselor to review the same information? Dr. Levy said that scenario would just slow down the process for patients and duplicate services.

"In genetic testing, sometimes it’s useful to get other people’s perspectives and sometimes that’s not so necessary," said Dr. Levy.

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Texas Medical Association fights for independent practices

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Three Texas medical societies have joined forces with one goal in mind: to save local physician practices.

The Texas Medical Association (TMA), along with the Dallas and Harris County medical societies, have formed a new physician services organization to deliver "survival tools" aimed at helping doctors to stay competitive as independent practices rather than becoming part of hospital systems.

"Physicians nowadays are faced with some real challenges with all of the changes that are taking place in health care," said Dr. Joseph H. Schneider, a pediatrician and member of the task force that worked on developing the organization.

Dr. Joseph H. Schneider

Dr. Schneider, the chief medical information officer at Baylor Health Care System in Dallas, cited the rapid growth in the number of Accountable Care Organizations (ACOs), pressure to adopt electronic health record (EHR) systems and meet federal meaningful use requirements, and the transition to ICD-10 in 2014 as just a few of the forces that make it a challenge for practices to stay afloat financially without the backing of a hospital.

"Physicians need help," he said.

The Physician Services Organization for Patient Care, the formation of which was formally announced in May, will identify tools that physicians can use to keep their practices competitive in today’s marketplace – everything from help shopping for an EHR to assistance mining quality data.

Dr. C. Bruce Malone, a past president of TMA, orthopedic surgeon, and member of the physician services organization task force, said TMA has already held several meetings with large insurers in the state in an effort to get physicians access to some of the data analytics tools used by health plans.

At the same time, the new organization will be launching pilot projects to test out the best ways to coordinate care between practices. These efforts are aimed at allowing physicians in small practices to participate in physician-led ACOs, something that would be difficult for practices with limited capital to do on their own, Dr. Malone said.

"When we say we think it can save independent practice, we don’t mean that it can preserve the status quo," Dr. Malone said. "We’re trying to create a situation where doctors can get together and create some kind of clinical integration. I don’t think there’s any question that in the future integration of the clinical practice will be the trend."

Dr. Norman H. Chenven

Dr. Norman H. Chenven, a family physician who founded the Austin Regional Clinic, is one of the physicians on the cutting edge of care coordination. His practice is part of a Pioneer ACO through the Medicare program and has care coordination contracts with several private insurers. The practice also has a history in the area of taking on financial risk for population health. In the 1980s and 1990s, the Austin Regional Clinic had success in caring for patients under the managed care model. That experience, coupled with the large size of the multispecialty practice, made it possible for them to move back into managing the health populations today, Dr. Chenven said.

But smaller practices don’t necessarily have the funds to make up-front investments in better care management, Dr. Chenven said, such as hiring case managers or purchasing new software. Those types of investments are important because they allow providers to assess patient needs before they come to the office and reach out to them for preventive care rather than waiting for health problems to develop, said Dr. Chenven, who has advised the TMA’s physician services organization task force.

Seeing that physicians in small practices in Texas might either be left out of the move to coordinated care or be forced to join hospitals, the TMA decided to put up the seed money to start the new physician services organization. The next step will be to choose partners among technology vendors, insurers, and hospitals that can either provide tools to practices or aid in pilot projects, Dr. Malone said. Physicians won’t be asked to pay to join the new organization, Dr. Malone said, but if they are involved in pilot projects, they will likely need to make investments in practice changes.

"This whole thing is not something that I think will increase the profit for a medical clinic, but I think it may ensure its survival," Dr. Malone said.

The work of the new physician services organization won’t be easy. A few years ago, with ACOs starting to emerge, a handful of physicians at TMA began trying to figure if they could connect physician practices that wanted to coordinate care in a "virtual multispecialty clinic." They started testing the concept in a small pilot in Abilene with Texas Blue Cross Blue Shield.

 

 

"The project wasn’t going all that well because we realized how complex it was to tie the groups together, even in a smaller town like Abilene," Dr. Malone said.

Since then they’ve scaled back the project, but they are still committed to testing the concept, he said.

The formation of the physician services organization in Texas is "very encouraging," said Paul B. Ginsburg, Ph.D., president of the Center for Studying Health System Change, a nonpartisan policy research organization. The question, he said, is whether the Physician Services Organization for Patient Care will be as successful in helping physicians to remain in private practice as the Independent Practice Associations (IPAs) that have developed in states like California and Massachusetts.

"I do believe that health care markets, particularly hospital markets, will be much more competitive if physicians are in physician organizations rather than hospital employees," Dr. Ginsburg said.

[email protected]

On Twitter @MaryEllenNY

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Three Texas medical societies have joined forces with one goal in mind: to save local physician practices.

The Texas Medical Association (TMA), along with the Dallas and Harris County medical societies, have formed a new physician services organization to deliver "survival tools" aimed at helping doctors to stay competitive as independent practices rather than becoming part of hospital systems.

"Physicians nowadays are faced with some real challenges with all of the changes that are taking place in health care," said Dr. Joseph H. Schneider, a pediatrician and member of the task force that worked on developing the organization.

Dr. Joseph H. Schneider

Dr. Schneider, the chief medical information officer at Baylor Health Care System in Dallas, cited the rapid growth in the number of Accountable Care Organizations (ACOs), pressure to adopt electronic health record (EHR) systems and meet federal meaningful use requirements, and the transition to ICD-10 in 2014 as just a few of the forces that make it a challenge for practices to stay afloat financially without the backing of a hospital.

"Physicians need help," he said.

The Physician Services Organization for Patient Care, the formation of which was formally announced in May, will identify tools that physicians can use to keep their practices competitive in today’s marketplace – everything from help shopping for an EHR to assistance mining quality data.

Dr. C. Bruce Malone, a past president of TMA, orthopedic surgeon, and member of the physician services organization task force, said TMA has already held several meetings with large insurers in the state in an effort to get physicians access to some of the data analytics tools used by health plans.

At the same time, the new organization will be launching pilot projects to test out the best ways to coordinate care between practices. These efforts are aimed at allowing physicians in small practices to participate in physician-led ACOs, something that would be difficult for practices with limited capital to do on their own, Dr. Malone said.

"When we say we think it can save independent practice, we don’t mean that it can preserve the status quo," Dr. Malone said. "We’re trying to create a situation where doctors can get together and create some kind of clinical integration. I don’t think there’s any question that in the future integration of the clinical practice will be the trend."

Dr. Norman H. Chenven

Dr. Norman H. Chenven, a family physician who founded the Austin Regional Clinic, is one of the physicians on the cutting edge of care coordination. His practice is part of a Pioneer ACO through the Medicare program and has care coordination contracts with several private insurers. The practice also has a history in the area of taking on financial risk for population health. In the 1980s and 1990s, the Austin Regional Clinic had success in caring for patients under the managed care model. That experience, coupled with the large size of the multispecialty practice, made it possible for them to move back into managing the health populations today, Dr. Chenven said.

But smaller practices don’t necessarily have the funds to make up-front investments in better care management, Dr. Chenven said, such as hiring case managers or purchasing new software. Those types of investments are important because they allow providers to assess patient needs before they come to the office and reach out to them for preventive care rather than waiting for health problems to develop, said Dr. Chenven, who has advised the TMA’s physician services organization task force.

Seeing that physicians in small practices in Texas might either be left out of the move to coordinated care or be forced to join hospitals, the TMA decided to put up the seed money to start the new physician services organization. The next step will be to choose partners among technology vendors, insurers, and hospitals that can either provide tools to practices or aid in pilot projects, Dr. Malone said. Physicians won’t be asked to pay to join the new organization, Dr. Malone said, but if they are involved in pilot projects, they will likely need to make investments in practice changes.

"This whole thing is not something that I think will increase the profit for a medical clinic, but I think it may ensure its survival," Dr. Malone said.

The work of the new physician services organization won’t be easy. A few years ago, with ACOs starting to emerge, a handful of physicians at TMA began trying to figure if they could connect physician practices that wanted to coordinate care in a "virtual multispecialty clinic." They started testing the concept in a small pilot in Abilene with Texas Blue Cross Blue Shield.

 

 

"The project wasn’t going all that well because we realized how complex it was to tie the groups together, even in a smaller town like Abilene," Dr. Malone said.

Since then they’ve scaled back the project, but they are still committed to testing the concept, he said.

The formation of the physician services organization in Texas is "very encouraging," said Paul B. Ginsburg, Ph.D., president of the Center for Studying Health System Change, a nonpartisan policy research organization. The question, he said, is whether the Physician Services Organization for Patient Care will be as successful in helping physicians to remain in private practice as the Independent Practice Associations (IPAs) that have developed in states like California and Massachusetts.

"I do believe that health care markets, particularly hospital markets, will be much more competitive if physicians are in physician organizations rather than hospital employees," Dr. Ginsburg said.

[email protected]

On Twitter @MaryEllenNY

Three Texas medical societies have joined forces with one goal in mind: to save local physician practices.

The Texas Medical Association (TMA), along with the Dallas and Harris County medical societies, have formed a new physician services organization to deliver "survival tools" aimed at helping doctors to stay competitive as independent practices rather than becoming part of hospital systems.

"Physicians nowadays are faced with some real challenges with all of the changes that are taking place in health care," said Dr. Joseph H. Schneider, a pediatrician and member of the task force that worked on developing the organization.

Dr. Joseph H. Schneider

Dr. Schneider, the chief medical information officer at Baylor Health Care System in Dallas, cited the rapid growth in the number of Accountable Care Organizations (ACOs), pressure to adopt electronic health record (EHR) systems and meet federal meaningful use requirements, and the transition to ICD-10 in 2014 as just a few of the forces that make it a challenge for practices to stay afloat financially without the backing of a hospital.

"Physicians need help," he said.

The Physician Services Organization for Patient Care, the formation of which was formally announced in May, will identify tools that physicians can use to keep their practices competitive in today’s marketplace – everything from help shopping for an EHR to assistance mining quality data.

Dr. C. Bruce Malone, a past president of TMA, orthopedic surgeon, and member of the physician services organization task force, said TMA has already held several meetings with large insurers in the state in an effort to get physicians access to some of the data analytics tools used by health plans.

At the same time, the new organization will be launching pilot projects to test out the best ways to coordinate care between practices. These efforts are aimed at allowing physicians in small practices to participate in physician-led ACOs, something that would be difficult for practices with limited capital to do on their own, Dr. Malone said.

"When we say we think it can save independent practice, we don’t mean that it can preserve the status quo," Dr. Malone said. "We’re trying to create a situation where doctors can get together and create some kind of clinical integration. I don’t think there’s any question that in the future integration of the clinical practice will be the trend."

Dr. Norman H. Chenven

Dr. Norman H. Chenven, a family physician who founded the Austin Regional Clinic, is one of the physicians on the cutting edge of care coordination. His practice is part of a Pioneer ACO through the Medicare program and has care coordination contracts with several private insurers. The practice also has a history in the area of taking on financial risk for population health. In the 1980s and 1990s, the Austin Regional Clinic had success in caring for patients under the managed care model. That experience, coupled with the large size of the multispecialty practice, made it possible for them to move back into managing the health populations today, Dr. Chenven said.

But smaller practices don’t necessarily have the funds to make up-front investments in better care management, Dr. Chenven said, such as hiring case managers or purchasing new software. Those types of investments are important because they allow providers to assess patient needs before they come to the office and reach out to them for preventive care rather than waiting for health problems to develop, said Dr. Chenven, who has advised the TMA’s physician services organization task force.

Seeing that physicians in small practices in Texas might either be left out of the move to coordinated care or be forced to join hospitals, the TMA decided to put up the seed money to start the new physician services organization. The next step will be to choose partners among technology vendors, insurers, and hospitals that can either provide tools to practices or aid in pilot projects, Dr. Malone said. Physicians won’t be asked to pay to join the new organization, Dr. Malone said, but if they are involved in pilot projects, they will likely need to make investments in practice changes.

"This whole thing is not something that I think will increase the profit for a medical clinic, but I think it may ensure its survival," Dr. Malone said.

The work of the new physician services organization won’t be easy. A few years ago, with ACOs starting to emerge, a handful of physicians at TMA began trying to figure if they could connect physician practices that wanted to coordinate care in a "virtual multispecialty clinic." They started testing the concept in a small pilot in Abilene with Texas Blue Cross Blue Shield.

 

 

"The project wasn’t going all that well because we realized how complex it was to tie the groups together, even in a smaller town like Abilene," Dr. Malone said.

Since then they’ve scaled back the project, but they are still committed to testing the concept, he said.

The formation of the physician services organization in Texas is "very encouraging," said Paul B. Ginsburg, Ph.D., president of the Center for Studying Health System Change, a nonpartisan policy research organization. The question, he said, is whether the Physician Services Organization for Patient Care will be as successful in helping physicians to remain in private practice as the Independent Practice Associations (IPAs) that have developed in states like California and Massachusetts.

"I do believe that health care markets, particularly hospital markets, will be much more competitive if physicians are in physician organizations rather than hospital employees," Dr. Ginsburg said.

[email protected]

On Twitter @MaryEllenNY

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FDA approves IV golimumab for RA treatment

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FDA approves IV golimumab for RA treatment

The Food and Drug Administration has approved a new infusion-version of golimumab, in combination with methotrexate, for the treatment of adults with moderately to severely active rheumatoid arthritis.

The approval, which was announced on July 18, provides another indication for the RA drug. The FDA originally approved golimumab in 2009 as a once-monthly subcutaneous injection treatment for moderately to severely active RA, active psoriatic arthritis, and active ankylosing spondylitis. The injection version of the drug was marketed under the name Simponi, while the new infusion version will go by the trade name Simponi Aria.

The drug’s manufacturer, Janssen Biotech, recommends a dosing regimen of 2 mg/kg given as an intravenous infusion at weeks 0 and 4, then every 8 weeks after. Infusions are given over a 30-minute period.

The dosing regimen allows for an improved infusion experience, Rob Bazemore, president of Janssen Biotech, said in a statement. "Patients can now receive this form of treatment administration with an anti-TNF therapy via a short infusion time of 30 minutes with a dosing regimen of every 8 weeks," he said.

But Dr. Daniel E. Furst, professor of rheumatology at the University of California, Los Angeles, said the latest approval won’t make a major difference in terms of treatment options for patients. The approval is more of a marketing boon for Janssen, which will be able to tout its availability as an infusion. As for the 30-minute infusion time, Dr. Furst said it is likely to appeal to some patients but is not significantly shorter than other infusion times.

"It really doesn’t make a big difference," said Dr. Furst, who performs clinical trial work for several TNF inhibitor drugs and non-TNF inhibitor drugs.

The latest approval was supported by the results of the phase III trial known as GO-FURTHER (Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy). The trial showed that the drug significantly improved the signs and symptoms of RA, improved physical function, and slowed the progression of structural damage, according to a statement from Janssen.

In the multicenter, double-blind, placebo-controlled study, researchers evaluated 592 adults with moderately to severely active RA who had at least six tender and six swollen joints at screening and baseline, as well as elevated C-reactive protein (CRP) levels at screening, and who had been receiving background methotrexate for at least 3 months.

They found that at week 14, nearly 60% of the patients who received golimumab plus methotrexate had significant improvements in their signs and symptoms, as determined by at least a 20% improvement in American College of Rheumatology criteria (ACR 20), the study’s primary endpoint. In comparison, only 25% of patients receiving placebo plus methotrexate had at least an ACR 20 response.

Adverse events were reported slightly more often among patients receiving IV golimumab (53%) than among patients receiving placebo (49%). Serious adverse events involving an infection were observed in 0.9% of IV golimumab patients, including one case of tuberculosis and one death from myocardial infarction secondary to community-acquired pneumonia. No serious infections occurred in placebo-treated patients.

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The Food and Drug Administration has approved a new infusion-version of golimumab, in combination with methotrexate, for the treatment of adults with moderately to severely active rheumatoid arthritis.

The approval, which was announced on July 18, provides another indication for the RA drug. The FDA originally approved golimumab in 2009 as a once-monthly subcutaneous injection treatment for moderately to severely active RA, active psoriatic arthritis, and active ankylosing spondylitis. The injection version of the drug was marketed under the name Simponi, while the new infusion version will go by the trade name Simponi Aria.

The drug’s manufacturer, Janssen Biotech, recommends a dosing regimen of 2 mg/kg given as an intravenous infusion at weeks 0 and 4, then every 8 weeks after. Infusions are given over a 30-minute period.

The dosing regimen allows for an improved infusion experience, Rob Bazemore, president of Janssen Biotech, said in a statement. "Patients can now receive this form of treatment administration with an anti-TNF therapy via a short infusion time of 30 minutes with a dosing regimen of every 8 weeks," he said.

But Dr. Daniel E. Furst, professor of rheumatology at the University of California, Los Angeles, said the latest approval won’t make a major difference in terms of treatment options for patients. The approval is more of a marketing boon for Janssen, which will be able to tout its availability as an infusion. As for the 30-minute infusion time, Dr. Furst said it is likely to appeal to some patients but is not significantly shorter than other infusion times.

"It really doesn’t make a big difference," said Dr. Furst, who performs clinical trial work for several TNF inhibitor drugs and non-TNF inhibitor drugs.

The latest approval was supported by the results of the phase III trial known as GO-FURTHER (Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy). The trial showed that the drug significantly improved the signs and symptoms of RA, improved physical function, and slowed the progression of structural damage, according to a statement from Janssen.

In the multicenter, double-blind, placebo-controlled study, researchers evaluated 592 adults with moderately to severely active RA who had at least six tender and six swollen joints at screening and baseline, as well as elevated C-reactive protein (CRP) levels at screening, and who had been receiving background methotrexate for at least 3 months.

They found that at week 14, nearly 60% of the patients who received golimumab plus methotrexate had significant improvements in their signs and symptoms, as determined by at least a 20% improvement in American College of Rheumatology criteria (ACR 20), the study’s primary endpoint. In comparison, only 25% of patients receiving placebo plus methotrexate had at least an ACR 20 response.

Adverse events were reported slightly more often among patients receiving IV golimumab (53%) than among patients receiving placebo (49%). Serious adverse events involving an infection were observed in 0.9% of IV golimumab patients, including one case of tuberculosis and one death from myocardial infarction secondary to community-acquired pneumonia. No serious infections occurred in placebo-treated patients.

[email protected]

The Food and Drug Administration has approved a new infusion-version of golimumab, in combination with methotrexate, for the treatment of adults with moderately to severely active rheumatoid arthritis.

The approval, which was announced on July 18, provides another indication for the RA drug. The FDA originally approved golimumab in 2009 as a once-monthly subcutaneous injection treatment for moderately to severely active RA, active psoriatic arthritis, and active ankylosing spondylitis. The injection version of the drug was marketed under the name Simponi, while the new infusion version will go by the trade name Simponi Aria.

The drug’s manufacturer, Janssen Biotech, recommends a dosing regimen of 2 mg/kg given as an intravenous infusion at weeks 0 and 4, then every 8 weeks after. Infusions are given over a 30-minute period.

The dosing regimen allows for an improved infusion experience, Rob Bazemore, president of Janssen Biotech, said in a statement. "Patients can now receive this form of treatment administration with an anti-TNF therapy via a short infusion time of 30 minutes with a dosing regimen of every 8 weeks," he said.

But Dr. Daniel E. Furst, professor of rheumatology at the University of California, Los Angeles, said the latest approval won’t make a major difference in terms of treatment options for patients. The approval is more of a marketing boon for Janssen, which will be able to tout its availability as an infusion. As for the 30-minute infusion time, Dr. Furst said it is likely to appeal to some patients but is not significantly shorter than other infusion times.

"It really doesn’t make a big difference," said Dr. Furst, who performs clinical trial work for several TNF inhibitor drugs and non-TNF inhibitor drugs.

The latest approval was supported by the results of the phase III trial known as GO-FURTHER (Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy). The trial showed that the drug significantly improved the signs and symptoms of RA, improved physical function, and slowed the progression of structural damage, according to a statement from Janssen.

In the multicenter, double-blind, placebo-controlled study, researchers evaluated 592 adults with moderately to severely active RA who had at least six tender and six swollen joints at screening and baseline, as well as elevated C-reactive protein (CRP) levels at screening, and who had been receiving background methotrexate for at least 3 months.

They found that at week 14, nearly 60% of the patients who received golimumab plus methotrexate had significant improvements in their signs and symptoms, as determined by at least a 20% improvement in American College of Rheumatology criteria (ACR 20), the study’s primary endpoint. In comparison, only 25% of patients receiving placebo plus methotrexate had at least an ACR 20 response.

Adverse events were reported slightly more often among patients receiving IV golimumab (53%) than among patients receiving placebo (49%). Serious adverse events involving an infection were observed in 0.9% of IV golimumab patients, including one case of tuberculosis and one death from myocardial infarction secondary to community-acquired pneumonia. No serious infections occurred in placebo-treated patients.

[email protected]

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Medicare may scrap certification for bariatric surgery centers

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Should bariatric surgery be performed in certified centers only? Medicare officials think the answer might be "no."

In a proposed decision memo issued in June, the Centers for Medicare and Medicaid Services said the evidence was sufficient to end the certification requirement and that continuing the current requirements would not improve health outcomes for Medicare beneficiaries.

While some physician experts support the proposal as improving access to bariatric surgery, others express concerns that quality and data collection efforts will suffer.

The proposal does not change which procedures are covered by Medicare. The agency will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body-mass index of 35 kg/m2 or greater who have at least one comorbidity related to obesity and have been unsuccessful with medical treatment for obesity.

Dr. Jaime Ponce

If the proposal is accepted, it would reverse the requirements the CMS put in place in February 2006. Since then, Medicare has covered only bariatric procedures performed at facilities that were certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center or by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence.

CMS officials reviewed eight studies to determine if facility certification meaningfully improved health outcomes for Medicare beneficiaries. The studies had "mixed" results, the agency said, but overall, the evidence showed "no consistent statistical or clinically meaningful difference" and there was nothing in the literature to suggest a worsening of outcomes.

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

"Since that 2006 determination, bariatric surgery has experienced a trend toward less invasive procedures and lower mortality and complication rates," according to the proposed decision memo.

The policy switch was requested by a trio of health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the university’s Center for Healthcare Outcomes and Policy. They asserted that certified hospitals were no safer than other facilities and that mortality and serious complication rates for bariatric surgery had declined across the country.

They called on the CMS to scrap the certification requirements but to encourage bariatric surgeons to participate in registry programs through their professional societies or through payer-supported collaborative improvement programs such as the one supported by Blue Cross Blue Shield of Michigan.

The Michigan researchers suggested that the agency incentivize physicians to participate in these quality improvement activities by tying them to programs such as the Physician Quality Reporting System.

Dr. Birkmeyer pointed to a study published earlier this year showing that the current certification policy has not led to better outcomes for patients (JAMA 2013;309:792-9). In the study, which Dr. Birkmeyer coauthored, the researchers found no statistically significant improvements in complications or reoperation rates after implementation of the CMS certification requirements after accounting for patient factors, changes in procedure type, and pre-existing time trends toward improved outcomes.

"There is absolutely no controversy about the fact that [the policy] didn’t steer people to safer hospitals," Dr. Birkmeyer said.

Access could improve under the proposed decision memo, Dr. Birkmeyer said. The current certification framework makes it harder for some Medicare patients to undergo bariatric surgery without traveling hours from home. The policy may also be disproportionately affecting minorities and low-income beneficiaries, Dr. Birkmeyer said.

The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery continue to support certification; however, they are working to revise their processes to create a single, unified program that will include a lower volume threshold for certification, dropping from a minimum of 125 cases a year to 50 cases a year, according to Dr. Jaime Ponce, president of the American Society for Metabolic and Bariatric Surgery and a bariatric surgeon in Chattanooga, Tenn.

The volume change should help to address some of the concerns about access by opening up certification to more programs, he said.

But Dr. Ponce said his group plans to fight the "dangerous" CMS proposal to drop certification requirements completely.

"We do believe that this could be very harmful for Medicare patients because if a patient that is very sick shows up in a community hospital that doesn’t have the right structure to take care of obese patients ... accidents are going to start happening again," he said.

The majority of the literature supports facility certification for bariatric surgery, Dr. Ponce said. As for those studies showing no difference in outcomes, the results weren’t reliable because the studies were conducted at a time when most of the facilities included were pursuing certification, he noted. Even those facilities that fell short of meeting certification requirements would have been developing a culture of safety and would likely have met many of the standards.

 

 

Dr. Ponce singled out a 2011 study in Annals of Surgery, which evaluated mortality among Medicare patients before and after the certification requirements took effect (Ann. Surg. 2011;254: 860-5). The study, which used Medicare data from 2004-2008, showed that mortality, readmission, and reoperation rates all declined after the coverage decision was implemented. The 90-day mortality rate dropped from 1.5% to 0.7%, while 90-day readmission rates decreased from 19.9% to 15.4%. The researchers also noted a decrease in payments for the procedures.

But gains in safety and cost-effectiveness could be lost if the CMS removes the certification requirements, Dr. Ponce said. Without clear requirements in place, hospitals will be unlikely to make the investments they are making today in equipment, personnel, and training, he said.

Another issue is what will happen to data collection if certification requirements are eliminated. Dr. Ponce said he’s concerned that data collection efforts would dry up without those mandates from the CMS.

"We will not have that data in order to improve the quality that we need to," he said.

A final decision on the coverage memo is expected in the fall.

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Should bariatric surgery be performed in certified centers only? Medicare officials think the answer might be "no."

In a proposed decision memo issued in June, the Centers for Medicare and Medicaid Services said the evidence was sufficient to end the certification requirement and that continuing the current requirements would not improve health outcomes for Medicare beneficiaries.

While some physician experts support the proposal as improving access to bariatric surgery, others express concerns that quality and data collection efforts will suffer.

The proposal does not change which procedures are covered by Medicare. The agency will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body-mass index of 35 kg/m2 or greater who have at least one comorbidity related to obesity and have been unsuccessful with medical treatment for obesity.

Dr. Jaime Ponce

If the proposal is accepted, it would reverse the requirements the CMS put in place in February 2006. Since then, Medicare has covered only bariatric procedures performed at facilities that were certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center or by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence.

CMS officials reviewed eight studies to determine if facility certification meaningfully improved health outcomes for Medicare beneficiaries. The studies had "mixed" results, the agency said, but overall, the evidence showed "no consistent statistical or clinically meaningful difference" and there was nothing in the literature to suggest a worsening of outcomes.

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

"Since that 2006 determination, bariatric surgery has experienced a trend toward less invasive procedures and lower mortality and complication rates," according to the proposed decision memo.

The policy switch was requested by a trio of health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the university’s Center for Healthcare Outcomes and Policy. They asserted that certified hospitals were no safer than other facilities and that mortality and serious complication rates for bariatric surgery had declined across the country.

They called on the CMS to scrap the certification requirements but to encourage bariatric surgeons to participate in registry programs through their professional societies or through payer-supported collaborative improvement programs such as the one supported by Blue Cross Blue Shield of Michigan.

The Michigan researchers suggested that the agency incentivize physicians to participate in these quality improvement activities by tying them to programs such as the Physician Quality Reporting System.

Dr. Birkmeyer pointed to a study published earlier this year showing that the current certification policy has not led to better outcomes for patients (JAMA 2013;309:792-9). In the study, which Dr. Birkmeyer coauthored, the researchers found no statistically significant improvements in complications or reoperation rates after implementation of the CMS certification requirements after accounting for patient factors, changes in procedure type, and pre-existing time trends toward improved outcomes.

"There is absolutely no controversy about the fact that [the policy] didn’t steer people to safer hospitals," Dr. Birkmeyer said.

Access could improve under the proposed decision memo, Dr. Birkmeyer said. The current certification framework makes it harder for some Medicare patients to undergo bariatric surgery without traveling hours from home. The policy may also be disproportionately affecting minorities and low-income beneficiaries, Dr. Birkmeyer said.

The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery continue to support certification; however, they are working to revise their processes to create a single, unified program that will include a lower volume threshold for certification, dropping from a minimum of 125 cases a year to 50 cases a year, according to Dr. Jaime Ponce, president of the American Society for Metabolic and Bariatric Surgery and a bariatric surgeon in Chattanooga, Tenn.

The volume change should help to address some of the concerns about access by opening up certification to more programs, he said.

But Dr. Ponce said his group plans to fight the "dangerous" CMS proposal to drop certification requirements completely.

"We do believe that this could be very harmful for Medicare patients because if a patient that is very sick shows up in a community hospital that doesn’t have the right structure to take care of obese patients ... accidents are going to start happening again," he said.

The majority of the literature supports facility certification for bariatric surgery, Dr. Ponce said. As for those studies showing no difference in outcomes, the results weren’t reliable because the studies were conducted at a time when most of the facilities included were pursuing certification, he noted. Even those facilities that fell short of meeting certification requirements would have been developing a culture of safety and would likely have met many of the standards.

 

 

Dr. Ponce singled out a 2011 study in Annals of Surgery, which evaluated mortality among Medicare patients before and after the certification requirements took effect (Ann. Surg. 2011;254: 860-5). The study, which used Medicare data from 2004-2008, showed that mortality, readmission, and reoperation rates all declined after the coverage decision was implemented. The 90-day mortality rate dropped from 1.5% to 0.7%, while 90-day readmission rates decreased from 19.9% to 15.4%. The researchers also noted a decrease in payments for the procedures.

But gains in safety and cost-effectiveness could be lost if the CMS removes the certification requirements, Dr. Ponce said. Without clear requirements in place, hospitals will be unlikely to make the investments they are making today in equipment, personnel, and training, he said.

Another issue is what will happen to data collection if certification requirements are eliminated. Dr. Ponce said he’s concerned that data collection efforts would dry up without those mandates from the CMS.

"We will not have that data in order to improve the quality that we need to," he said.

A final decision on the coverage memo is expected in the fall.

[email protected]

Should bariatric surgery be performed in certified centers only? Medicare officials think the answer might be "no."

In a proposed decision memo issued in June, the Centers for Medicare and Medicaid Services said the evidence was sufficient to end the certification requirement and that continuing the current requirements would not improve health outcomes for Medicare beneficiaries.

While some physician experts support the proposal as improving access to bariatric surgery, others express concerns that quality and data collection efforts will suffer.

The proposal does not change which procedures are covered by Medicare. The agency will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body-mass index of 35 kg/m2 or greater who have at least one comorbidity related to obesity and have been unsuccessful with medical treatment for obesity.

Dr. Jaime Ponce

If the proposal is accepted, it would reverse the requirements the CMS put in place in February 2006. Since then, Medicare has covered only bariatric procedures performed at facilities that were certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center or by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence.

CMS officials reviewed eight studies to determine if facility certification meaningfully improved health outcomes for Medicare beneficiaries. The studies had "mixed" results, the agency said, but overall, the evidence showed "no consistent statistical or clinically meaningful difference" and there was nothing in the literature to suggest a worsening of outcomes.

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

"Since that 2006 determination, bariatric surgery has experienced a trend toward less invasive procedures and lower mortality and complication rates," according to the proposed decision memo.

The policy switch was requested by a trio of health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the university’s Center for Healthcare Outcomes and Policy. They asserted that certified hospitals were no safer than other facilities and that mortality and serious complication rates for bariatric surgery had declined across the country.

They called on the CMS to scrap the certification requirements but to encourage bariatric surgeons to participate in registry programs through their professional societies or through payer-supported collaborative improvement programs such as the one supported by Blue Cross Blue Shield of Michigan.

The Michigan researchers suggested that the agency incentivize physicians to participate in these quality improvement activities by tying them to programs such as the Physician Quality Reporting System.

Dr. Birkmeyer pointed to a study published earlier this year showing that the current certification policy has not led to better outcomes for patients (JAMA 2013;309:792-9). In the study, which Dr. Birkmeyer coauthored, the researchers found no statistically significant improvements in complications or reoperation rates after implementation of the CMS certification requirements after accounting for patient factors, changes in procedure type, and pre-existing time trends toward improved outcomes.

"There is absolutely no controversy about the fact that [the policy] didn’t steer people to safer hospitals," Dr. Birkmeyer said.

Access could improve under the proposed decision memo, Dr. Birkmeyer said. The current certification framework makes it harder for some Medicare patients to undergo bariatric surgery without traveling hours from home. The policy may also be disproportionately affecting minorities and low-income beneficiaries, Dr. Birkmeyer said.

The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery continue to support certification; however, they are working to revise their processes to create a single, unified program that will include a lower volume threshold for certification, dropping from a minimum of 125 cases a year to 50 cases a year, according to Dr. Jaime Ponce, president of the American Society for Metabolic and Bariatric Surgery and a bariatric surgeon in Chattanooga, Tenn.

The volume change should help to address some of the concerns about access by opening up certification to more programs, he said.

But Dr. Ponce said his group plans to fight the "dangerous" CMS proposal to drop certification requirements completely.

"We do believe that this could be very harmful for Medicare patients because if a patient that is very sick shows up in a community hospital that doesn’t have the right structure to take care of obese patients ... accidents are going to start happening again," he said.

The majority of the literature supports facility certification for bariatric surgery, Dr. Ponce said. As for those studies showing no difference in outcomes, the results weren’t reliable because the studies were conducted at a time when most of the facilities included were pursuing certification, he noted. Even those facilities that fell short of meeting certification requirements would have been developing a culture of safety and would likely have met many of the standards.

 

 

Dr. Ponce singled out a 2011 study in Annals of Surgery, which evaluated mortality among Medicare patients before and after the certification requirements took effect (Ann. Surg. 2011;254: 860-5). The study, which used Medicare data from 2004-2008, showed that mortality, readmission, and reoperation rates all declined after the coverage decision was implemented. The 90-day mortality rate dropped from 1.5% to 0.7%, while 90-day readmission rates decreased from 19.9% to 15.4%. The researchers also noted a decrease in payments for the procedures.

But gains in safety and cost-effectiveness could be lost if the CMS removes the certification requirements, Dr. Ponce said. Without clear requirements in place, hospitals will be unlikely to make the investments they are making today in equipment, personnel, and training, he said.

Another issue is what will happen to data collection if certification requirements are eliminated. Dr. Ponce said he’s concerned that data collection efforts would dry up without those mandates from the CMS.

"We will not have that data in order to improve the quality that we need to," he said.

A final decision on the coverage memo is expected in the fall.

[email protected]

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Year 1: Pioneer ACOs deliver quality, some drop out

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In the first year of Medicare’s most aggressive test of the accountable care organization model, less than half of participating organizations cut costs enough to share the savings with the government, though all slowed overall costs and improved quality across the-board.

Of the 32 Pioneer ACOs, 13 generated enough savings in 2012 to share in the earnings with the Medicare program, though only two generated shared losses, according to first-year results released by Medicare July 16.

Overall, the successful ACOs took home about $76 million in shared savings, while Medicare earned nearly $33 million from shared savings and about $4 million from shared losses.

The Pioneers were also successful in lowering the overall cost growth for the 669,000 Medicare beneficiaries associated with their ACOs. Costs for those beneficiaries grew by 0.3% in 2012 compared with 0.8% for similar beneficiaries during the same time period.

Mr. Blair Childs

"If you want evidence of bending the cost curve, that’s a clear win," said Rob Lazerow, practice manager at The Advisory Board Company, a consulting firm specializing in health care.

The Pioneer ACO model, launched January 2012 under the Affordable Care Act, is a 3-year program that incentivizes health care systems to improve care and coordination to save money. Successful systems share in the savings; unsuccessful ones share in the losses.

To share in the savings, the Pioneer ACOs must meet quality standards and generate a minimum savings rate between 1% and 2.7% to account for normal variation in Medicare spending. The shared savings are determined by comparing the ACO’s performance to a benchmark, which is based on Medicare’s past spending for the group of patients associated with the ACO.

During the third year of the program, Pioneer ACOs that have achieved savings during the first 2 years can opt to move to a population-based payment model where they would receive a per-beneficiary per month payment to replace some or all of their Medicare fee-for-service payments.

In this first year, decreased hospital admissions and readmissions were partly responsible for the savings, according to officials at the Centers for Medicare and Medicaid Services. In terms of readmissions, 25 of the 32 Pioneer ACOs generated lower risk-adjusted readmission rates for their beneficiaries compared to the benchmark rate for all Medicare fee-for-service beneficiaries.

The Pioneer ACOs also outperformed other managed care populations on hypertension and cholesterol control. The median rate for hypertension control for diabetic beneficiaries was 68% at Pioneer ACOs, compared to 55% in adult diabetic patients in 10 managed care plans across seven states from 2000 to 2001. Similarly, the median rate for low density lipoprotein (LDL) control among diabetic beneficiaries was 57% in the Pioneer ACOs, compared to 48% among adult diabetic patients among the managed care plans from 2000 to 2001.

Overall, the Pioneer ACOs exceeded the published performance of fee-for-service Medicare for 15 clinical quality measures in which there were data to make comparisons. Another seven measures didn’t have comparable data in the published literature, according to the CMS.

The results are encouraging, especially for a new program, said Blair Childs, senior vice president of public affairs for the Premier health care alliance.

"The fact that these improvements were achieved, so quickly, is a real testament to the participating health systems, all of whom stepped up to assume significant risk and make major investments in ACO infrastructure, health information technology, governance, and care delivery models," Mr. Childs said. "In many cases, participating Pioneers had to take a ‘leap of faith,’ and the fact that so many goals were reached is helpful in terms of building the evidence base to support this new model of care as an effective way to improve quality and reduce costs."

The CMS also announced that nine of the ACOs will be leaving the Pioneer program. Of those, two are leaving the program completely while seven have notified the CMS that they intend to apply to the Medicare Shared Savings Program, a different ACO model with less aggressive risk sharing.

The University of Michigan is one of the seven organizations that will be moving out of the Pioneer ACO model and into the Medicare Shared Savings Program. Officials at the university said they are seeking to move to a program that will have simpler administrative requirements but will allow them to continue participation in the ACO environment.

"We remain firmly committed to the concept of improving health care and containing cost growth via the population health model that drives all ACOs," Dr. David Spahlinger, executive director of the University of Michigan Medical School’s Faculty Group Practice, said in a statement.

 

 

Conversely, the Phoenix-based Banner Health Network plans to stay in the program and is already recruiting new physicians for the third year of the program, which begins in 2014.

"Through our experience, we believe the value-based Pioneer ACO model has merit, and that it has the potential to diminish the predominance of fee-for-service plans in government and private sectors," Chuck Lehn, CEO of the Banner Health Network, said in a statement. "It is the best solution at this time for creating sustainability for the Medicare program, and could be the basis for historic change in the U.S. health care industry."

The departure of nine ACOs from the Pioneer model isn’t bad news for the program, Mr. Childs said. "In our view, this is an organic shift, and one that should be expected."

Mr. Childs predicted that even those ACOs that chose to leave the program completely will continue to experiment with the model with private payers.

"Remember that providers have made tremendous investments in getting their ACOs off the ground and they will want and need to continue to leverage these investments, most likely in a setting that offers more favorable terms that are more amenable to their operations and local patient populations," he said. "In our view, the churn out of Pioneer and into other flavors of ACO payment is more about an individual organization’s appetite for risk than it is a statement about the program."

[email protected]

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In the first year of Medicare’s most aggressive test of the accountable care organization model, less than half of participating organizations cut costs enough to share the savings with the government, though all slowed overall costs and improved quality across the-board.

Of the 32 Pioneer ACOs, 13 generated enough savings in 2012 to share in the earnings with the Medicare program, though only two generated shared losses, according to first-year results released by Medicare July 16.

Overall, the successful ACOs took home about $76 million in shared savings, while Medicare earned nearly $33 million from shared savings and about $4 million from shared losses.

The Pioneers were also successful in lowering the overall cost growth for the 669,000 Medicare beneficiaries associated with their ACOs. Costs for those beneficiaries grew by 0.3% in 2012 compared with 0.8% for similar beneficiaries during the same time period.

Mr. Blair Childs

"If you want evidence of bending the cost curve, that’s a clear win," said Rob Lazerow, practice manager at The Advisory Board Company, a consulting firm specializing in health care.

The Pioneer ACO model, launched January 2012 under the Affordable Care Act, is a 3-year program that incentivizes health care systems to improve care and coordination to save money. Successful systems share in the savings; unsuccessful ones share in the losses.

To share in the savings, the Pioneer ACOs must meet quality standards and generate a minimum savings rate between 1% and 2.7% to account for normal variation in Medicare spending. The shared savings are determined by comparing the ACO’s performance to a benchmark, which is based on Medicare’s past spending for the group of patients associated with the ACO.

During the third year of the program, Pioneer ACOs that have achieved savings during the first 2 years can opt to move to a population-based payment model where they would receive a per-beneficiary per month payment to replace some or all of their Medicare fee-for-service payments.

In this first year, decreased hospital admissions and readmissions were partly responsible for the savings, according to officials at the Centers for Medicare and Medicaid Services. In terms of readmissions, 25 of the 32 Pioneer ACOs generated lower risk-adjusted readmission rates for their beneficiaries compared to the benchmark rate for all Medicare fee-for-service beneficiaries.

The Pioneer ACOs also outperformed other managed care populations on hypertension and cholesterol control. The median rate for hypertension control for diabetic beneficiaries was 68% at Pioneer ACOs, compared to 55% in adult diabetic patients in 10 managed care plans across seven states from 2000 to 2001. Similarly, the median rate for low density lipoprotein (LDL) control among diabetic beneficiaries was 57% in the Pioneer ACOs, compared to 48% among adult diabetic patients among the managed care plans from 2000 to 2001.

Overall, the Pioneer ACOs exceeded the published performance of fee-for-service Medicare for 15 clinical quality measures in which there were data to make comparisons. Another seven measures didn’t have comparable data in the published literature, according to the CMS.

The results are encouraging, especially for a new program, said Blair Childs, senior vice president of public affairs for the Premier health care alliance.

"The fact that these improvements were achieved, so quickly, is a real testament to the participating health systems, all of whom stepped up to assume significant risk and make major investments in ACO infrastructure, health information technology, governance, and care delivery models," Mr. Childs said. "In many cases, participating Pioneers had to take a ‘leap of faith,’ and the fact that so many goals were reached is helpful in terms of building the evidence base to support this new model of care as an effective way to improve quality and reduce costs."

The CMS also announced that nine of the ACOs will be leaving the Pioneer program. Of those, two are leaving the program completely while seven have notified the CMS that they intend to apply to the Medicare Shared Savings Program, a different ACO model with less aggressive risk sharing.

The University of Michigan is one of the seven organizations that will be moving out of the Pioneer ACO model and into the Medicare Shared Savings Program. Officials at the university said they are seeking to move to a program that will have simpler administrative requirements but will allow them to continue participation in the ACO environment.

"We remain firmly committed to the concept of improving health care and containing cost growth via the population health model that drives all ACOs," Dr. David Spahlinger, executive director of the University of Michigan Medical School’s Faculty Group Practice, said in a statement.

 

 

Conversely, the Phoenix-based Banner Health Network plans to stay in the program and is already recruiting new physicians for the third year of the program, which begins in 2014.

"Through our experience, we believe the value-based Pioneer ACO model has merit, and that it has the potential to diminish the predominance of fee-for-service plans in government and private sectors," Chuck Lehn, CEO of the Banner Health Network, said in a statement. "It is the best solution at this time for creating sustainability for the Medicare program, and could be the basis for historic change in the U.S. health care industry."

The departure of nine ACOs from the Pioneer model isn’t bad news for the program, Mr. Childs said. "In our view, this is an organic shift, and one that should be expected."

Mr. Childs predicted that even those ACOs that chose to leave the program completely will continue to experiment with the model with private payers.

"Remember that providers have made tremendous investments in getting their ACOs off the ground and they will want and need to continue to leverage these investments, most likely in a setting that offers more favorable terms that are more amenable to their operations and local patient populations," he said. "In our view, the churn out of Pioneer and into other flavors of ACO payment is more about an individual organization’s appetite for risk than it is a statement about the program."

[email protected]

In the first year of Medicare’s most aggressive test of the accountable care organization model, less than half of participating organizations cut costs enough to share the savings with the government, though all slowed overall costs and improved quality across the-board.

Of the 32 Pioneer ACOs, 13 generated enough savings in 2012 to share in the earnings with the Medicare program, though only two generated shared losses, according to first-year results released by Medicare July 16.

Overall, the successful ACOs took home about $76 million in shared savings, while Medicare earned nearly $33 million from shared savings and about $4 million from shared losses.

The Pioneers were also successful in lowering the overall cost growth for the 669,000 Medicare beneficiaries associated with their ACOs. Costs for those beneficiaries grew by 0.3% in 2012 compared with 0.8% for similar beneficiaries during the same time period.

Mr. Blair Childs

"If you want evidence of bending the cost curve, that’s a clear win," said Rob Lazerow, practice manager at The Advisory Board Company, a consulting firm specializing in health care.

The Pioneer ACO model, launched January 2012 under the Affordable Care Act, is a 3-year program that incentivizes health care systems to improve care and coordination to save money. Successful systems share in the savings; unsuccessful ones share in the losses.

To share in the savings, the Pioneer ACOs must meet quality standards and generate a minimum savings rate between 1% and 2.7% to account for normal variation in Medicare spending. The shared savings are determined by comparing the ACO’s performance to a benchmark, which is based on Medicare’s past spending for the group of patients associated with the ACO.

During the third year of the program, Pioneer ACOs that have achieved savings during the first 2 years can opt to move to a population-based payment model where they would receive a per-beneficiary per month payment to replace some or all of their Medicare fee-for-service payments.

In this first year, decreased hospital admissions and readmissions were partly responsible for the savings, according to officials at the Centers for Medicare and Medicaid Services. In terms of readmissions, 25 of the 32 Pioneer ACOs generated lower risk-adjusted readmission rates for their beneficiaries compared to the benchmark rate for all Medicare fee-for-service beneficiaries.

The Pioneer ACOs also outperformed other managed care populations on hypertension and cholesterol control. The median rate for hypertension control for diabetic beneficiaries was 68% at Pioneer ACOs, compared to 55% in adult diabetic patients in 10 managed care plans across seven states from 2000 to 2001. Similarly, the median rate for low density lipoprotein (LDL) control among diabetic beneficiaries was 57% in the Pioneer ACOs, compared to 48% among adult diabetic patients among the managed care plans from 2000 to 2001.

Overall, the Pioneer ACOs exceeded the published performance of fee-for-service Medicare for 15 clinical quality measures in which there were data to make comparisons. Another seven measures didn’t have comparable data in the published literature, according to the CMS.

The results are encouraging, especially for a new program, said Blair Childs, senior vice president of public affairs for the Premier health care alliance.

"The fact that these improvements were achieved, so quickly, is a real testament to the participating health systems, all of whom stepped up to assume significant risk and make major investments in ACO infrastructure, health information technology, governance, and care delivery models," Mr. Childs said. "In many cases, participating Pioneers had to take a ‘leap of faith,’ and the fact that so many goals were reached is helpful in terms of building the evidence base to support this new model of care as an effective way to improve quality and reduce costs."

The CMS also announced that nine of the ACOs will be leaving the Pioneer program. Of those, two are leaving the program completely while seven have notified the CMS that they intend to apply to the Medicare Shared Savings Program, a different ACO model with less aggressive risk sharing.

The University of Michigan is one of the seven organizations that will be moving out of the Pioneer ACO model and into the Medicare Shared Savings Program. Officials at the university said they are seeking to move to a program that will have simpler administrative requirements but will allow them to continue participation in the ACO environment.

"We remain firmly committed to the concept of improving health care and containing cost growth via the population health model that drives all ACOs," Dr. David Spahlinger, executive director of the University of Michigan Medical School’s Faculty Group Practice, said in a statement.

 

 

Conversely, the Phoenix-based Banner Health Network plans to stay in the program and is already recruiting new physicians for the third year of the program, which begins in 2014.

"Through our experience, we believe the value-based Pioneer ACO model has merit, and that it has the potential to diminish the predominance of fee-for-service plans in government and private sectors," Chuck Lehn, CEO of the Banner Health Network, said in a statement. "It is the best solution at this time for creating sustainability for the Medicare program, and could be the basis for historic change in the U.S. health care industry."

The departure of nine ACOs from the Pioneer model isn’t bad news for the program, Mr. Childs said. "In our view, this is an organic shift, and one that should be expected."

Mr. Childs predicted that even those ACOs that chose to leave the program completely will continue to experiment with the model with private payers.

"Remember that providers have made tremendous investments in getting their ACOs off the ground and they will want and need to continue to leverage these investments, most likely in a setting that offers more favorable terms that are more amenable to their operations and local patient populations," he said. "In our view, the churn out of Pioneer and into other flavors of ACO payment is more about an individual organization’s appetite for risk than it is a statement about the program."

[email protected]

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CMS bundles payments to outpatient departments, adds quality measures

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Medicare officials are seeking to package more hospital outpatient department services into a single payment while also beefing up quality reporting programs in hospitals and ambulatory surgical centers.

The plans are part of the 2014 proposed rule for the Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System, announced July 8 and to be published in the Federal Register on July 19.

Overall, officials at the Centers for Medicare and Medicaid Services (CMS) are proposing a 1.8% payment increase for outpatient departments in 2014. But the agency wants to change the way these hospital departments are paid by bundling more services into a single payment.

Currently, the CMS offers a single payment for a variety of services including anesthesia, surgical supplies, imaging processing services, and implantable biologicals. The proposed rule would add seven new categories of services to that package.

The categories include:

• Drugs, biologicals, and radiopharmaceuticals that function as supplies when used in a diagnostic test or procedure.

• Drugs and biologicals that function as supplies or devices when used in a surgical procedure.

• Certain clinical diagnostic laboratory tests.

• Procedures described by add-on codes.

• Ancillary services such as chest x-rays that are assigned the status indicator "X."

• Diagnostic tests on the bypass list.

• Device removal procedures.

The CMS will continue to pay separately for these types of services if they are reported alone on a claim.

Medicare will also continue to pay the average sales price plus 6% for non-pass-through drugs and biologicals that are paid separately under the prospective payment system.

In a change that would have a major impact on hospital emergency departments, the CMS is also seeking to streamline payment for outpatient visit codes. In the rule, the CMS is proposing to replace the current five levels of outpatient visit codes with three Level II Healthcare Common Procedure Coding System (HCPCS) codes representing a single level of payment. A Level II HCPCS code would be available for each type of visit: clinic, type A ED, and type B ED. Rates for the new codes will be based on the total mean costs of the Level 1 through 5 visit codes from 2012 claims data, according to the proposal.

"By collapsing the current five levels of codes to one level, the CMS believes this proposal will remove incentives hospitals may have to provide medically unnecessary services and expend additional, unnecessary resources to achieve a higher level of visit payment," the agency wrote in a fact sheet on the proposal. CMS officials also predicted that the change would reduce administration burden and be able to be easily adopted by hospitals.

The proposed rule would also expand Medicare’s quality reporting programs. The agency is proposing to add five new measures to the Hospital Outpatient Quality Reporting Program.

The new measures include influenza vaccination coverage among health care workers, complications within 30 days following cataract surgery requiring additional procedures, improvement in a patient’s visual function within 90 days after cataract surgery, appropriate follow-up interval for normal colonoscopy in average-risk patients, and colonoscopy interval for patients with a history of adenomatous polyps.

Data collection on the new measures would begin in January 2014, but payments would not be affected until 2016.

Agency officials also want to remove two measures from the program because they are overly burdensome on providers. They propose eliminating the use of the measure on "transition record with specified elements received by discharged ED patients" and a cardiac rehabilitation measure on "patient referral from an outpatient setting."

Ambulatory surgery centers will also be asked to report more quality information next year. The CMS is proposing to add four new measures to the ASC Quality Reporting Program, which are similar to those being proposed for the Hospital Outpatient Quality Reporting Program.

The measures include complications within 30 days following cataract surgery requiring additional procedures, improvement in a patient’s visual function within 90 days after cataract surgery, appropriate follow-up interval for normal colonoscopy in average-risk patients, and colonoscopy interval for patients with a history of adenomatous polyps. The data will be collected in 2014 to determine payments in 2016.

The CMS will accept public comment on the rule until Sept. 6, and a final regulation is expected to be published by November.

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Medicare officials are seeking to package more hospital outpatient department services into a single payment while also beefing up quality reporting programs in hospitals and ambulatory surgical centers.

The plans are part of the 2014 proposed rule for the Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System, announced July 8 and to be published in the Federal Register on July 19.

Overall, officials at the Centers for Medicare and Medicaid Services (CMS) are proposing a 1.8% payment increase for outpatient departments in 2014. But the agency wants to change the way these hospital departments are paid by bundling more services into a single payment.

Currently, the CMS offers a single payment for a variety of services including anesthesia, surgical supplies, imaging processing services, and implantable biologicals. The proposed rule would add seven new categories of services to that package.

The categories include:

• Drugs, biologicals, and radiopharmaceuticals that function as supplies when used in a diagnostic test or procedure.

• Drugs and biologicals that function as supplies or devices when used in a surgical procedure.

• Certain clinical diagnostic laboratory tests.

• Procedures described by add-on codes.

• Ancillary services such as chest x-rays that are assigned the status indicator "X."

• Diagnostic tests on the bypass list.

• Device removal procedures.

The CMS will continue to pay separately for these types of services if they are reported alone on a claim.

Medicare will also continue to pay the average sales price plus 6% for non-pass-through drugs and biologicals that are paid separately under the prospective payment system.

In a change that would have a major impact on hospital emergency departments, the CMS is also seeking to streamline payment for outpatient visit codes. In the rule, the CMS is proposing to replace the current five levels of outpatient visit codes with three Level II Healthcare Common Procedure Coding System (HCPCS) codes representing a single level of payment. A Level II HCPCS code would be available for each type of visit: clinic, type A ED, and type B ED. Rates for the new codes will be based on the total mean costs of the Level 1 through 5 visit codes from 2012 claims data, according to the proposal.

"By collapsing the current five levels of codes to one level, the CMS believes this proposal will remove incentives hospitals may have to provide medically unnecessary services and expend additional, unnecessary resources to achieve a higher level of visit payment," the agency wrote in a fact sheet on the proposal. CMS officials also predicted that the change would reduce administration burden and be able to be easily adopted by hospitals.

The proposed rule would also expand Medicare’s quality reporting programs. The agency is proposing to add five new measures to the Hospital Outpatient Quality Reporting Program.

The new measures include influenza vaccination coverage among health care workers, complications within 30 days following cataract surgery requiring additional procedures, improvement in a patient’s visual function within 90 days after cataract surgery, appropriate follow-up interval for normal colonoscopy in average-risk patients, and colonoscopy interval for patients with a history of adenomatous polyps.

Data collection on the new measures would begin in January 2014, but payments would not be affected until 2016.

Agency officials also want to remove two measures from the program because they are overly burdensome on providers. They propose eliminating the use of the measure on "transition record with specified elements received by discharged ED patients" and a cardiac rehabilitation measure on "patient referral from an outpatient setting."

Ambulatory surgery centers will also be asked to report more quality information next year. The CMS is proposing to add four new measures to the ASC Quality Reporting Program, which are similar to those being proposed for the Hospital Outpatient Quality Reporting Program.

The measures include complications within 30 days following cataract surgery requiring additional procedures, improvement in a patient’s visual function within 90 days after cataract surgery, appropriate follow-up interval for normal colonoscopy in average-risk patients, and colonoscopy interval for patients with a history of adenomatous polyps. The data will be collected in 2014 to determine payments in 2016.

The CMS will accept public comment on the rule until Sept. 6, and a final regulation is expected to be published by November.

[email protected]

Medicare officials are seeking to package more hospital outpatient department services into a single payment while also beefing up quality reporting programs in hospitals and ambulatory surgical centers.

The plans are part of the 2014 proposed rule for the Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System, announced July 8 and to be published in the Federal Register on July 19.

Overall, officials at the Centers for Medicare and Medicaid Services (CMS) are proposing a 1.8% payment increase for outpatient departments in 2014. But the agency wants to change the way these hospital departments are paid by bundling more services into a single payment.

Currently, the CMS offers a single payment for a variety of services including anesthesia, surgical supplies, imaging processing services, and implantable biologicals. The proposed rule would add seven new categories of services to that package.

The categories include:

• Drugs, biologicals, and radiopharmaceuticals that function as supplies when used in a diagnostic test or procedure.

• Drugs and biologicals that function as supplies or devices when used in a surgical procedure.

• Certain clinical diagnostic laboratory tests.

• Procedures described by add-on codes.

• Ancillary services such as chest x-rays that are assigned the status indicator "X."

• Diagnostic tests on the bypass list.

• Device removal procedures.

The CMS will continue to pay separately for these types of services if they are reported alone on a claim.

Medicare will also continue to pay the average sales price plus 6% for non-pass-through drugs and biologicals that are paid separately under the prospective payment system.

In a change that would have a major impact on hospital emergency departments, the CMS is also seeking to streamline payment for outpatient visit codes. In the rule, the CMS is proposing to replace the current five levels of outpatient visit codes with three Level II Healthcare Common Procedure Coding System (HCPCS) codes representing a single level of payment. A Level II HCPCS code would be available for each type of visit: clinic, type A ED, and type B ED. Rates for the new codes will be based on the total mean costs of the Level 1 through 5 visit codes from 2012 claims data, according to the proposal.

"By collapsing the current five levels of codes to one level, the CMS believes this proposal will remove incentives hospitals may have to provide medically unnecessary services and expend additional, unnecessary resources to achieve a higher level of visit payment," the agency wrote in a fact sheet on the proposal. CMS officials also predicted that the change would reduce administration burden and be able to be easily adopted by hospitals.

The proposed rule would also expand Medicare’s quality reporting programs. The agency is proposing to add five new measures to the Hospital Outpatient Quality Reporting Program.

The new measures include influenza vaccination coverage among health care workers, complications within 30 days following cataract surgery requiring additional procedures, improvement in a patient’s visual function within 90 days after cataract surgery, appropriate follow-up interval for normal colonoscopy in average-risk patients, and colonoscopy interval for patients with a history of adenomatous polyps.

Data collection on the new measures would begin in January 2014, but payments would not be affected until 2016.

Agency officials also want to remove two measures from the program because they are overly burdensome on providers. They propose eliminating the use of the measure on "transition record with specified elements received by discharged ED patients" and a cardiac rehabilitation measure on "patient referral from an outpatient setting."

Ambulatory surgery centers will also be asked to report more quality information next year. The CMS is proposing to add four new measures to the ASC Quality Reporting Program, which are similar to those being proposed for the Hospital Outpatient Quality Reporting Program.

The measures include complications within 30 days following cataract surgery requiring additional procedures, improvement in a patient’s visual function within 90 days after cataract surgery, appropriate follow-up interval for normal colonoscopy in average-risk patients, and colonoscopy interval for patients with a history of adenomatous polyps. The data will be collected in 2014 to determine payments in 2016.

The CMS will accept public comment on the rule until Sept. 6, and a final regulation is expected to be published by November.

[email protected]

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Mammas, don't let your babies grow up to be doctors

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Mammas, don't let your babies grow up to be doctors

When country singer Ed Bruce released "Mammas, Don’t Let Your Babies Grow Up to be Cowboys" in 1975, he suggested that they should consider becoming doctors instead, but if a new national survey of doctors is to be believed, that’s not such a good career move either.

The survey, conducted by the Georgia-based staffing company Jackson Healthcare, found that 59% of physicians would be unlikely to encourage a young person to become a doctor. The findings are based on the responses of 3,456 physicians who completed e-mailed surveys between March 7 and April 1, 2013.

Mary Ellen Schneider/IMNG Medical Media
A new survey found 59% of physicians would be unlikely to encourage a young person to become a doctor.

Their dissatisfaction with medical practice is reflected in the career satisfaction numbers in the survey. Only 20% of physicians said that they were very satisfied in their work, while 39% were somewhat satisfied and 42% were somewhat or very dissatisfied.

The satisfied ones tended to be those employed by a hospital or working at a physician-owned practice where they had no ownership stake, according to the survey.

Satisfied doctors reported that they worked 11 hours a day or less and were supported by nurse practitioners or physician assistants.

In contrast, dissatisfied doctors tended to own their practices, work as locum tenens physicians, or work for a hospital-owned practice. They also worked longer hours and had few physician extenders.

Maybe the next generation will take Ed Bruce’s other suggested career path and become lawyers.

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When country singer Ed Bruce released "Mammas, Don’t Let Your Babies Grow Up to be Cowboys" in 1975, he suggested that they should consider becoming doctors instead, but if a new national survey of doctors is to be believed, that’s not such a good career move either.

The survey, conducted by the Georgia-based staffing company Jackson Healthcare, found that 59% of physicians would be unlikely to encourage a young person to become a doctor. The findings are based on the responses of 3,456 physicians who completed e-mailed surveys between March 7 and April 1, 2013.

Mary Ellen Schneider/IMNG Medical Media
A new survey found 59% of physicians would be unlikely to encourage a young person to become a doctor.

Their dissatisfaction with medical practice is reflected in the career satisfaction numbers in the survey. Only 20% of physicians said that they were very satisfied in their work, while 39% were somewhat satisfied and 42% were somewhat or very dissatisfied.

The satisfied ones tended to be those employed by a hospital or working at a physician-owned practice where they had no ownership stake, according to the survey.

Satisfied doctors reported that they worked 11 hours a day or less and were supported by nurse practitioners or physician assistants.

In contrast, dissatisfied doctors tended to own their practices, work as locum tenens physicians, or work for a hospital-owned practice. They also worked longer hours and had few physician extenders.

Maybe the next generation will take Ed Bruce’s other suggested career path and become lawyers.

[email protected]

When country singer Ed Bruce released "Mammas, Don’t Let Your Babies Grow Up to be Cowboys" in 1975, he suggested that they should consider becoming doctors instead, but if a new national survey of doctors is to be believed, that’s not such a good career move either.

The survey, conducted by the Georgia-based staffing company Jackson Healthcare, found that 59% of physicians would be unlikely to encourage a young person to become a doctor. The findings are based on the responses of 3,456 physicians who completed e-mailed surveys between March 7 and April 1, 2013.

Mary Ellen Schneider/IMNG Medical Media
A new survey found 59% of physicians would be unlikely to encourage a young person to become a doctor.

Their dissatisfaction with medical practice is reflected in the career satisfaction numbers in the survey. Only 20% of physicians said that they were very satisfied in their work, while 39% were somewhat satisfied and 42% were somewhat or very dissatisfied.

The satisfied ones tended to be those employed by a hospital or working at a physician-owned practice where they had no ownership stake, according to the survey.

Satisfied doctors reported that they worked 11 hours a day or less and were supported by nurse practitioners or physician assistants.

In contrast, dissatisfied doctors tended to own their practices, work as locum tenens physicians, or work for a hospital-owned practice. They also worked longer hours and had few physician extenders.

Maybe the next generation will take Ed Bruce’s other suggested career path and become lawyers.

[email protected]

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2014 Medicare fee proposal ponders pay for non-face-to-face work

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2014 Medicare fee proposal ponders pay for non-face-to-face work

In a move away from the traditional visit-based payment system, officials at the Centers for Medicare and Medicaid Services are considering paying physicians for their non-face-to-face work in chronic disease management.

The proposal, which would be a boon for primary care physicians, would create two new G-codes for the non-–face-to-face care management services for Medicare patients with two or more significant chronic conditions.

The services would include physician development and revision of a care plan, communication with other treating physicians and health providers, as well as medication management. CMS is proposing to establish two G-codes for establishing a plan of care and for providing care management over 90-day periods.

Physicians could use the codes if their patients have had either Medicare’s Annual Wellness Visit or an Initial Preventive Physician Examination. CMS also plans to establish some practice standards to go along with the codes, such as requiring the use an electronic health record at the time of service.

The new codes would go into effect Jan. 1, 2015.

Currently, Medicare only pays for primary care management that occurs during an office visit. However, last year the agency established codes for transitional care management services for patients moving from a hospital or a skilled nursing facility to home, which included some non–face-to-face activities. The transitional care codes went into effect in January 2013.

The new codes are one of several policy changes being floated as part of the proposed 2014 Medicare Physician Fee Schedule. The proposed rule will be published in the Federal Register on July 19. CMS will accept public comment on the proposal until Sept. 6 and a final rule is expected in November.

The rule also serves as a reminder that in addition to payment changes proposed by CMS, physicians currently face a 24.4% across-the-board pay cut in 2015 due to the Sustainable Growth Rate (SGR) formula. Congressional action is required to avoid the steep pay cut. Members of Congress are currently drafting legislation that would permanently eliminate the SGR formula but it is unclear if the bill would be voted on this year.

Dr. Jeffrey Cain, president of the American Academy of Family Physicians, praised the CMS proposal for complex chronic care management, but said the agency can only make so much progress on payment reform within the current system.

"In light of the SGR’s mandate that CMS slash Medicare physician payment by 24.4%, these incremental increases do nothing to sustain primary medical care, much less build the primary care physician workforce," he said in a statement. "The SGR-required payment cut shines a bright light on the need for Congress to replace this dysfunctional system."

The fee schedule proposal also offers more specifics for rolling out the physician value-based payment modifier, an Affordable Care Act program to will pay physicians based on both the quality and cost of the care they provide to Medicare beneficiaries. The program is being phased in over time but will apply to all physicians by Jan. 1, 2017.

Since the program is "budget neutral," higher payments for some physicians mean pay cuts for others. Under the program, physician groups could see a payment cut of between 1% and 2% in 2016 based on their performance on quality and cost.

The latest fee schedule proposal sets out an implementation schedule for the value modifier program. Physician groups with 100 or more eligible professionals will be subject to the modifier starting in 2015. In 2016, the program will apply to physician groups of 10 or more. However, Medicare officials will begin measuring their performance on cost and quality in 2014 to determine the payments in 2016. The expansion of the program to groups of 10 or more will mean that nearly 60% of physicians will be affected by the modifier in 2016, according to CMS.

The remainder of physicians will see their payments affected by the modifier in 2017, based on performance during 2015.

Physicians can see how they are performing on cost and quality through annual Quality and Resource Use Reports produced by CMS. The agency will be providing these reports to groups of 25 or more eligible professionals in September. CMS said they expect to provide the reports to physician groups of all sizes in 2014.

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In a move away from the traditional visit-based payment system, officials at the Centers for Medicare and Medicaid Services are considering paying physicians for their non-face-to-face work in chronic disease management.

The proposal, which would be a boon for primary care physicians, would create two new G-codes for the non-–face-to-face care management services for Medicare patients with two or more significant chronic conditions.

The services would include physician development and revision of a care plan, communication with other treating physicians and health providers, as well as medication management. CMS is proposing to establish two G-codes for establishing a plan of care and for providing care management over 90-day periods.

Physicians could use the codes if their patients have had either Medicare’s Annual Wellness Visit or an Initial Preventive Physician Examination. CMS also plans to establish some practice standards to go along with the codes, such as requiring the use an electronic health record at the time of service.

The new codes would go into effect Jan. 1, 2015.

Currently, Medicare only pays for primary care management that occurs during an office visit. However, last year the agency established codes for transitional care management services for patients moving from a hospital or a skilled nursing facility to home, which included some non–face-to-face activities. The transitional care codes went into effect in January 2013.

The new codes are one of several policy changes being floated as part of the proposed 2014 Medicare Physician Fee Schedule. The proposed rule will be published in the Federal Register on July 19. CMS will accept public comment on the proposal until Sept. 6 and a final rule is expected in November.

The rule also serves as a reminder that in addition to payment changes proposed by CMS, physicians currently face a 24.4% across-the-board pay cut in 2015 due to the Sustainable Growth Rate (SGR) formula. Congressional action is required to avoid the steep pay cut. Members of Congress are currently drafting legislation that would permanently eliminate the SGR formula but it is unclear if the bill would be voted on this year.

Dr. Jeffrey Cain, president of the American Academy of Family Physicians, praised the CMS proposal for complex chronic care management, but said the agency can only make so much progress on payment reform within the current system.

"In light of the SGR’s mandate that CMS slash Medicare physician payment by 24.4%, these incremental increases do nothing to sustain primary medical care, much less build the primary care physician workforce," he said in a statement. "The SGR-required payment cut shines a bright light on the need for Congress to replace this dysfunctional system."

The fee schedule proposal also offers more specifics for rolling out the physician value-based payment modifier, an Affordable Care Act program to will pay physicians based on both the quality and cost of the care they provide to Medicare beneficiaries. The program is being phased in over time but will apply to all physicians by Jan. 1, 2017.

Since the program is "budget neutral," higher payments for some physicians mean pay cuts for others. Under the program, physician groups could see a payment cut of between 1% and 2% in 2016 based on their performance on quality and cost.

The latest fee schedule proposal sets out an implementation schedule for the value modifier program. Physician groups with 100 or more eligible professionals will be subject to the modifier starting in 2015. In 2016, the program will apply to physician groups of 10 or more. However, Medicare officials will begin measuring their performance on cost and quality in 2014 to determine the payments in 2016. The expansion of the program to groups of 10 or more will mean that nearly 60% of physicians will be affected by the modifier in 2016, according to CMS.

The remainder of physicians will see their payments affected by the modifier in 2017, based on performance during 2015.

Physicians can see how they are performing on cost and quality through annual Quality and Resource Use Reports produced by CMS. The agency will be providing these reports to groups of 25 or more eligible professionals in September. CMS said they expect to provide the reports to physician groups of all sizes in 2014.

[email protected]

In a move away from the traditional visit-based payment system, officials at the Centers for Medicare and Medicaid Services are considering paying physicians for their non-face-to-face work in chronic disease management.

The proposal, which would be a boon for primary care physicians, would create two new G-codes for the non-–face-to-face care management services for Medicare patients with two or more significant chronic conditions.

The services would include physician development and revision of a care plan, communication with other treating physicians and health providers, as well as medication management. CMS is proposing to establish two G-codes for establishing a plan of care and for providing care management over 90-day periods.

Physicians could use the codes if their patients have had either Medicare’s Annual Wellness Visit or an Initial Preventive Physician Examination. CMS also plans to establish some practice standards to go along with the codes, such as requiring the use an electronic health record at the time of service.

The new codes would go into effect Jan. 1, 2015.

Currently, Medicare only pays for primary care management that occurs during an office visit. However, last year the agency established codes for transitional care management services for patients moving from a hospital or a skilled nursing facility to home, which included some non–face-to-face activities. The transitional care codes went into effect in January 2013.

The new codes are one of several policy changes being floated as part of the proposed 2014 Medicare Physician Fee Schedule. The proposed rule will be published in the Federal Register on July 19. CMS will accept public comment on the proposal until Sept. 6 and a final rule is expected in November.

The rule also serves as a reminder that in addition to payment changes proposed by CMS, physicians currently face a 24.4% across-the-board pay cut in 2015 due to the Sustainable Growth Rate (SGR) formula. Congressional action is required to avoid the steep pay cut. Members of Congress are currently drafting legislation that would permanently eliminate the SGR formula but it is unclear if the bill would be voted on this year.

Dr. Jeffrey Cain, president of the American Academy of Family Physicians, praised the CMS proposal for complex chronic care management, but said the agency can only make so much progress on payment reform within the current system.

"In light of the SGR’s mandate that CMS slash Medicare physician payment by 24.4%, these incremental increases do nothing to sustain primary medical care, much less build the primary care physician workforce," he said in a statement. "The SGR-required payment cut shines a bright light on the need for Congress to replace this dysfunctional system."

The fee schedule proposal also offers more specifics for rolling out the physician value-based payment modifier, an Affordable Care Act program to will pay physicians based on both the quality and cost of the care they provide to Medicare beneficiaries. The program is being phased in over time but will apply to all physicians by Jan. 1, 2017.

Since the program is "budget neutral," higher payments for some physicians mean pay cuts for others. Under the program, physician groups could see a payment cut of between 1% and 2% in 2016 based on their performance on quality and cost.

The latest fee schedule proposal sets out an implementation schedule for the value modifier program. Physician groups with 100 or more eligible professionals will be subject to the modifier starting in 2015. In 2016, the program will apply to physician groups of 10 or more. However, Medicare officials will begin measuring their performance on cost and quality in 2014 to determine the payments in 2016. The expansion of the program to groups of 10 or more will mean that nearly 60% of physicians will be affected by the modifier in 2016, according to CMS.

The remainder of physicians will see their payments affected by the modifier in 2017, based on performance during 2015.

Physicians can see how they are performing on cost and quality through annual Quality and Resource Use Reports produced by CMS. The agency will be providing these reports to groups of 25 or more eligible professionals in September. CMS said they expect to provide the reports to physician groups of all sizes in 2014.

[email protected]

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ACA employer mandate delayed 1 year

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Employers will have until January 2015 – an extra year – to comply with the Affordable Care Act’s employer mandate, a key provision of the law.

Under the health reform law, employers with more than 50 full-time workers are required to provide health care coverage for those workers or pay a penalty. The U.S. Treasury Department announced July 2 that it will not require employers to report on health care coverage until 2015 and therefore will not penalize those who do not comply with the law.

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The U.S. Treasury Department announced July 2 that it will not require employers to report on health care coverage until 2015.

The delay was billed by the Obama administration as a chance to simplify the reporting requirements.

"We have heard concerns about the complexity of the requirements and the need for more time to implement them effectively," Mark J. Mazur, Treasury’s assistant secretary for tax policy, wrote on the agency’s website. "We recognize that the vast majority of businesses that will need to do this reporting already provide health insurance to their workers, and we want to make sure it is easy for others to do so. We have listened to your feedback. And we are taking action."

The administration will offer proposed regulations on the insurance reporting requirements this summer. Officials plan to encourage employers to report voluntarily in 2014. "Real-world testing of reporting systems in 2014 will contribute to a smoother transition to full implementation in 2015," Mr. Mazur wrote.

The announcement created a firestorm on Capitol Hill, where ACA opponents said the move was an admission that the health reform law is bad for business and will cost jobs.

"We have all heard the warnings, and a 1-year delay does nothing to fix the law’s fundamental flaws," Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce Committee, said in a statement. "This law will never be ready for prime time, and sadly, the administration’s acknowledgement that it still needs yet another year clearly disrupts everyone’s ability to determine what is best for them and their business."

The delay offers relief for businesses, but it does nothing for individuals because the law requires them to have health insurance on Jan. 1, 2014, said Sarah Swinehart, spokeswoman for the House Ways and Means Committee.

"The Obama administration’s decision to give corporate America a free pass on the employer mandate while continuing to force average, everyday Americans to abide by the law is deeply disturbing," she said. "The administration’s decision is an admission that this law is a failure and that we still need to lower the cost of health care for all Americans, which this job-killing law fails to do."

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Employers will have until January 2015 – an extra year – to comply with the Affordable Care Act’s employer mandate, a key provision of the law.

Under the health reform law, employers with more than 50 full-time workers are required to provide health care coverage for those workers or pay a penalty. The U.S. Treasury Department announced July 2 that it will not require employers to report on health care coverage until 2015 and therefore will not penalize those who do not comply with the law.

iStockphoto.com
The U.S. Treasury Department announced July 2 that it will not require employers to report on health care coverage until 2015.

The delay was billed by the Obama administration as a chance to simplify the reporting requirements.

"We have heard concerns about the complexity of the requirements and the need for more time to implement them effectively," Mark J. Mazur, Treasury’s assistant secretary for tax policy, wrote on the agency’s website. "We recognize that the vast majority of businesses that will need to do this reporting already provide health insurance to their workers, and we want to make sure it is easy for others to do so. We have listened to your feedback. And we are taking action."

The administration will offer proposed regulations on the insurance reporting requirements this summer. Officials plan to encourage employers to report voluntarily in 2014. "Real-world testing of reporting systems in 2014 will contribute to a smoother transition to full implementation in 2015," Mr. Mazur wrote.

The announcement created a firestorm on Capitol Hill, where ACA opponents said the move was an admission that the health reform law is bad for business and will cost jobs.

"We have all heard the warnings, and a 1-year delay does nothing to fix the law’s fundamental flaws," Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce Committee, said in a statement. "This law will never be ready for prime time, and sadly, the administration’s acknowledgement that it still needs yet another year clearly disrupts everyone’s ability to determine what is best for them and their business."

The delay offers relief for businesses, but it does nothing for individuals because the law requires them to have health insurance on Jan. 1, 2014, said Sarah Swinehart, spokeswoman for the House Ways and Means Committee.

"The Obama administration’s decision to give corporate America a free pass on the employer mandate while continuing to force average, everyday Americans to abide by the law is deeply disturbing," she said. "The administration’s decision is an admission that this law is a failure and that we still need to lower the cost of health care for all Americans, which this job-killing law fails to do."

[email protected]

Employers will have until January 2015 – an extra year – to comply with the Affordable Care Act’s employer mandate, a key provision of the law.

Under the health reform law, employers with more than 50 full-time workers are required to provide health care coverage for those workers or pay a penalty. The U.S. Treasury Department announced July 2 that it will not require employers to report on health care coverage until 2015 and therefore will not penalize those who do not comply with the law.

iStockphoto.com
The U.S. Treasury Department announced July 2 that it will not require employers to report on health care coverage until 2015.

The delay was billed by the Obama administration as a chance to simplify the reporting requirements.

"We have heard concerns about the complexity of the requirements and the need for more time to implement them effectively," Mark J. Mazur, Treasury’s assistant secretary for tax policy, wrote on the agency’s website. "We recognize that the vast majority of businesses that will need to do this reporting already provide health insurance to their workers, and we want to make sure it is easy for others to do so. We have listened to your feedback. And we are taking action."

The administration will offer proposed regulations on the insurance reporting requirements this summer. Officials plan to encourage employers to report voluntarily in 2014. "Real-world testing of reporting systems in 2014 will contribute to a smoother transition to full implementation in 2015," Mr. Mazur wrote.

The announcement created a firestorm on Capitol Hill, where ACA opponents said the move was an admission that the health reform law is bad for business and will cost jobs.

"We have all heard the warnings, and a 1-year delay does nothing to fix the law’s fundamental flaws," Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce Committee, said in a statement. "This law will never be ready for prime time, and sadly, the administration’s acknowledgement that it still needs yet another year clearly disrupts everyone’s ability to determine what is best for them and their business."

The delay offers relief for businesses, but it does nothing for individuals because the law requires them to have health insurance on Jan. 1, 2014, said Sarah Swinehart, spokeswoman for the House Ways and Means Committee.

"The Obama administration’s decision to give corporate America a free pass on the employer mandate while continuing to force average, everyday Americans to abide by the law is deeply disturbing," she said. "The administration’s decision is an admission that this law is a failure and that we still need to lower the cost of health care for all Americans, which this job-killing law fails to do."

[email protected]

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