Doctors seek halt on meaningful use stage 2 penalties

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Doctors seek halt on meaningful use stage 2 penalties

The Medical Group Management Association wants an indefinite hold on penalties to be levied on physicians who cannot move on to the next stage of meaningful use of electronic health records.

In an Aug. 21 letter to the Health and Human Services (HHS) department, Dr. Susan Turney, MGMA president and chief executive officer, said that physicians who have already met requirements for stage 1 meaningful use should not be penalized if they can’t meet the requirements for stage 2.

Dr. Susan Turney

Physicians have been receiving incentive payments to become meaningful users of EHRs under the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. Those payments continue through 2014. But stage 2 starts in 2014, and physicians will be penalized in 2015 if they can’t meet the goals.

Dr. Turney noted that while there are 2,200 products and 1,400 complete EHRs that are certified by the government for stage 1, so far, there are only 75 products and 21 complete EHRs that are certified for stage 2.

That dearth of certified technology does not give physicians enough time to upgrade their systems or acquire new technology to allow them to be ready to participate in stage 2, Dr. Turney said.

Physicians not only are waiting on vendors to upgrade their products, but have to consider whether they can afford to invest in new technology. And, if they do, staff will have to be trained, which can take a year or more, she noted.

In addition to indefinitely delaying penalties on physicians who have achieved stage 1 but not stage 2, the MGMA recommended that HHS also extend the reporting period for stage 2 for at least a year. "This extra year would provide additional time for vendors to upgrade their software, certify for the stage 2 criteria, and install the products," Dr. Turney wrote.

HHS also should extend the reporting period for stage 1 so that providers who have attested for stage 1 and whose EHR has not been recertified by January 2015 can continue to report on stage 1 during 2014.

The MGMA is also concerned about the stage 2 criteria that would require physicians to give at least 5% of their patients the ability to view, download, and transmit their health information online within 4 days of it being posted. That requirement should be closely monitored and potentially adjusted, according to the MGMA letter.

The MGMA represents 22,500 leaders at 13,200 organizations that in turn employ or are affiliated with 280,000 physicians.

aault@frontlinemedcom.com

On Twitter @aliciaault

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The Medical Group Management Association wants an indefinite hold on penalties to be levied on physicians who cannot move on to the next stage of meaningful use of electronic health records.

In an Aug. 21 letter to the Health and Human Services (HHS) department, Dr. Susan Turney, MGMA president and chief executive officer, said that physicians who have already met requirements for stage 1 meaningful use should not be penalized if they can’t meet the requirements for stage 2.

Dr. Susan Turney

Physicians have been receiving incentive payments to become meaningful users of EHRs under the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. Those payments continue through 2014. But stage 2 starts in 2014, and physicians will be penalized in 2015 if they can’t meet the goals.

Dr. Turney noted that while there are 2,200 products and 1,400 complete EHRs that are certified by the government for stage 1, so far, there are only 75 products and 21 complete EHRs that are certified for stage 2.

That dearth of certified technology does not give physicians enough time to upgrade their systems or acquire new technology to allow them to be ready to participate in stage 2, Dr. Turney said.

Physicians not only are waiting on vendors to upgrade their products, but have to consider whether they can afford to invest in new technology. And, if they do, staff will have to be trained, which can take a year or more, she noted.

In addition to indefinitely delaying penalties on physicians who have achieved stage 1 but not stage 2, the MGMA recommended that HHS also extend the reporting period for stage 2 for at least a year. "This extra year would provide additional time for vendors to upgrade their software, certify for the stage 2 criteria, and install the products," Dr. Turney wrote.

HHS also should extend the reporting period for stage 1 so that providers who have attested for stage 1 and whose EHR has not been recertified by January 2015 can continue to report on stage 1 during 2014.

The MGMA is also concerned about the stage 2 criteria that would require physicians to give at least 5% of their patients the ability to view, download, and transmit their health information online within 4 days of it being posted. That requirement should be closely monitored and potentially adjusted, according to the MGMA letter.

The MGMA represents 22,500 leaders at 13,200 organizations that in turn employ or are affiliated with 280,000 physicians.

aault@frontlinemedcom.com

On Twitter @aliciaault

The Medical Group Management Association wants an indefinite hold on penalties to be levied on physicians who cannot move on to the next stage of meaningful use of electronic health records.

In an Aug. 21 letter to the Health and Human Services (HHS) department, Dr. Susan Turney, MGMA president and chief executive officer, said that physicians who have already met requirements for stage 1 meaningful use should not be penalized if they can’t meet the requirements for stage 2.

Dr. Susan Turney

Physicians have been receiving incentive payments to become meaningful users of EHRs under the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. Those payments continue through 2014. But stage 2 starts in 2014, and physicians will be penalized in 2015 if they can’t meet the goals.

Dr. Turney noted that while there are 2,200 products and 1,400 complete EHRs that are certified by the government for stage 1, so far, there are only 75 products and 21 complete EHRs that are certified for stage 2.

That dearth of certified technology does not give physicians enough time to upgrade their systems or acquire new technology to allow them to be ready to participate in stage 2, Dr. Turney said.

Physicians not only are waiting on vendors to upgrade their products, but have to consider whether they can afford to invest in new technology. And, if they do, staff will have to be trained, which can take a year or more, she noted.

In addition to indefinitely delaying penalties on physicians who have achieved stage 1 but not stage 2, the MGMA recommended that HHS also extend the reporting period for stage 2 for at least a year. "This extra year would provide additional time for vendors to upgrade their software, certify for the stage 2 criteria, and install the products," Dr. Turney wrote.

HHS also should extend the reporting period for stage 1 so that providers who have attested for stage 1 and whose EHR has not been recertified by January 2015 can continue to report on stage 1 during 2014.

The MGMA is also concerned about the stage 2 criteria that would require physicians to give at least 5% of their patients the ability to view, download, and transmit their health information online within 4 days of it being posted. That requirement should be closely monitored and potentially adjusted, according to the MGMA letter.

The MGMA represents 22,500 leaders at 13,200 organizations that in turn employ or are affiliated with 280,000 physicians.

aault@frontlinemedcom.com

On Twitter @aliciaault

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House committee unanimously passes SGR replacement

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The demise of the Medicare Sustainable Growth Rate formula is a step closer to reality as the House Energy and Commerce Committee voted unanimously July 31 in favor of legislation that would remove the formula.

Both Democrats and Republicans on the committee supported the Medicare Patient Access and Quality Improvement Act of 2013 in a 51-0 vote. The legislation, H.R. 2810, was authored by Rep. Michael Burgess (R-Tex.), and developed with input from physician organizations.

If enacted, the legislation would replace the SGR with a 0.5% payment increase for physicians from 2014 through 2018. It would continue to support fee-for-service medicine, but also encourage the formation of new delivery models and reward reporting of quality data.

Alicia Ault/IMNG Medical Media
Rep. Michael Burgess

"In harnessing the ideas of the medical profession, and working as a team with Energy and Commerce Democrats as well as Ways and Means Republicans, we have crafted a policy that will not only get out of committee but has the merits to make it to the president’s desk," Rep. Fred Upton (R-Mich.), chairman of the Energy and Commerce Committee, said in a statement.

Rep. Henry Waxman (D-Calif.), the committee’s ranking minority member, said, "What is obvious today is that we have a bipartisan commitment to try to solve this problem. And that when we decide to work together, we can achieve positive results." He also noted that "in more than a decade of saying something needs to be done, I’m pleased that this committee is the first to act to bring this issue to the forefront."

The American College of Physicians said it was mostly pleased with the legislation and its progress. In addition to rewarding physician efficiency, "the bill promises to accelerate the growth of patient-centered medical homes, an innovative primary care delivery model that has been shown to improve outcomes and lower the costs of care for patients across the country," said Dr. Molly Cooke, ACP president, in a statement.

The college "looks forward to continuing to work with the House and Senate on a bipartisan basis to get legislation enacted this year that includes these and other key elements of the House Energy and Commerce Committee bill, plus additional improvements needed to accelerate the movement toward high-value, patient-centered health care."

The American Medical Association and the American Academy of Family Physicians also support the legislation. When the bill was approved by the Energy and Commerce Health Subcommittee, the AAFP said it was disappointed that the bill did not have higher payments for primary care.

During those deliberations, the AMA, AAFP, ACP, and some state medical societies also told the committee that a provision addressing misvalued codes could end up cutting physician pay. They’ve asked the committee to consider an amendment that would remove the misvalued code provisions from the bill; such an amendment was not considered by the committee.

The introduction of the legislation also represents several months of collaboration among physician stakeholders like the American Gastroenterological Association and the congressional committees. The AGA was pleased that the committee worked with the physician community and incorporated many of our suggestions into the legislation. The AGA, and the Alliance of Specialty Medicine, conveyed our views to the committee and believe that the legislation moves physicians in the right direction and gives physicians opportunity to develop new payment models and quality indicators meaningful to their specialty.

The legislation still has a long path to passage. The House Ways and Means Committee and the Senate Finance Committee have also been working on legislation to replace the SGR. And so far, legislators in both houses have not addressed how to pay for an SGR fix.

Several Energy and Commerce Committee members acknowledged the looming financial reality during deliberations.

"One of the largest hurdles to overcome will be how to pay for the cost associated with fixing the SGR," said Rep. Eliot Engel (D-N.Y.). He urged his colleagues to continue the spirit of bipartisanship when figuring out the cost of replacement.

"We know that the work is not done," said Rep. Phil Gingrey (R-Ga.). "Any fiscally responsible bill in today’s budgetary environment must be paid for. I look forward to finding offsets that do not impact the practice of medicine but instead focus on good governance and combating waste," said the congressman, who is also an ob.gyn.

That work will likely come in September, when Congress returns from its summer recess.

aault@frontlinemedcom.com

On Twitter @aliciaault

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The demise of the Medicare Sustainable Growth Rate formula is a step closer to reality as the House Energy and Commerce Committee voted unanimously July 31 in favor of legislation that would remove the formula.

Both Democrats and Republicans on the committee supported the Medicare Patient Access and Quality Improvement Act of 2013 in a 51-0 vote. The legislation, H.R. 2810, was authored by Rep. Michael Burgess (R-Tex.), and developed with input from physician organizations.

If enacted, the legislation would replace the SGR with a 0.5% payment increase for physicians from 2014 through 2018. It would continue to support fee-for-service medicine, but also encourage the formation of new delivery models and reward reporting of quality data.

Alicia Ault/IMNG Medical Media
Rep. Michael Burgess

"In harnessing the ideas of the medical profession, and working as a team with Energy and Commerce Democrats as well as Ways and Means Republicans, we have crafted a policy that will not only get out of committee but has the merits to make it to the president’s desk," Rep. Fred Upton (R-Mich.), chairman of the Energy and Commerce Committee, said in a statement.

Rep. Henry Waxman (D-Calif.), the committee’s ranking minority member, said, "What is obvious today is that we have a bipartisan commitment to try to solve this problem. And that when we decide to work together, we can achieve positive results." He also noted that "in more than a decade of saying something needs to be done, I’m pleased that this committee is the first to act to bring this issue to the forefront."

The American College of Physicians said it was mostly pleased with the legislation and its progress. In addition to rewarding physician efficiency, "the bill promises to accelerate the growth of patient-centered medical homes, an innovative primary care delivery model that has been shown to improve outcomes and lower the costs of care for patients across the country," said Dr. Molly Cooke, ACP president, in a statement.

The college "looks forward to continuing to work with the House and Senate on a bipartisan basis to get legislation enacted this year that includes these and other key elements of the House Energy and Commerce Committee bill, plus additional improvements needed to accelerate the movement toward high-value, patient-centered health care."

The American Medical Association and the American Academy of Family Physicians also support the legislation. When the bill was approved by the Energy and Commerce Health Subcommittee, the AAFP said it was disappointed that the bill did not have higher payments for primary care.

During those deliberations, the AMA, AAFP, ACP, and some state medical societies also told the committee that a provision addressing misvalued codes could end up cutting physician pay. They’ve asked the committee to consider an amendment that would remove the misvalued code provisions from the bill; such an amendment was not considered by the committee.

The introduction of the legislation also represents several months of collaboration among physician stakeholders like the American Gastroenterological Association and the congressional committees. The AGA was pleased that the committee worked with the physician community and incorporated many of our suggestions into the legislation. The AGA, and the Alliance of Specialty Medicine, conveyed our views to the committee and believe that the legislation moves physicians in the right direction and gives physicians opportunity to develop new payment models and quality indicators meaningful to their specialty.

The legislation still has a long path to passage. The House Ways and Means Committee and the Senate Finance Committee have also been working on legislation to replace the SGR. And so far, legislators in both houses have not addressed how to pay for an SGR fix.

Several Energy and Commerce Committee members acknowledged the looming financial reality during deliberations.

"One of the largest hurdles to overcome will be how to pay for the cost associated with fixing the SGR," said Rep. Eliot Engel (D-N.Y.). He urged his colleagues to continue the spirit of bipartisanship when figuring out the cost of replacement.

"We know that the work is not done," said Rep. Phil Gingrey (R-Ga.). "Any fiscally responsible bill in today’s budgetary environment must be paid for. I look forward to finding offsets that do not impact the practice of medicine but instead focus on good governance and combating waste," said the congressman, who is also an ob.gyn.

That work will likely come in September, when Congress returns from its summer recess.

aault@frontlinemedcom.com

On Twitter @aliciaault

The demise of the Medicare Sustainable Growth Rate formula is a step closer to reality as the House Energy and Commerce Committee voted unanimously July 31 in favor of legislation that would remove the formula.

Both Democrats and Republicans on the committee supported the Medicare Patient Access and Quality Improvement Act of 2013 in a 51-0 vote. The legislation, H.R. 2810, was authored by Rep. Michael Burgess (R-Tex.), and developed with input from physician organizations.

If enacted, the legislation would replace the SGR with a 0.5% payment increase for physicians from 2014 through 2018. It would continue to support fee-for-service medicine, but also encourage the formation of new delivery models and reward reporting of quality data.

Alicia Ault/IMNG Medical Media
Rep. Michael Burgess

"In harnessing the ideas of the medical profession, and working as a team with Energy and Commerce Democrats as well as Ways and Means Republicans, we have crafted a policy that will not only get out of committee but has the merits to make it to the president’s desk," Rep. Fred Upton (R-Mich.), chairman of the Energy and Commerce Committee, said in a statement.

Rep. Henry Waxman (D-Calif.), the committee’s ranking minority member, said, "What is obvious today is that we have a bipartisan commitment to try to solve this problem. And that when we decide to work together, we can achieve positive results." He also noted that "in more than a decade of saying something needs to be done, I’m pleased that this committee is the first to act to bring this issue to the forefront."

The American College of Physicians said it was mostly pleased with the legislation and its progress. In addition to rewarding physician efficiency, "the bill promises to accelerate the growth of patient-centered medical homes, an innovative primary care delivery model that has been shown to improve outcomes and lower the costs of care for patients across the country," said Dr. Molly Cooke, ACP president, in a statement.

The college "looks forward to continuing to work with the House and Senate on a bipartisan basis to get legislation enacted this year that includes these and other key elements of the House Energy and Commerce Committee bill, plus additional improvements needed to accelerate the movement toward high-value, patient-centered health care."

The American Medical Association and the American Academy of Family Physicians also support the legislation. When the bill was approved by the Energy and Commerce Health Subcommittee, the AAFP said it was disappointed that the bill did not have higher payments for primary care.

During those deliberations, the AMA, AAFP, ACP, and some state medical societies also told the committee that a provision addressing misvalued codes could end up cutting physician pay. They’ve asked the committee to consider an amendment that would remove the misvalued code provisions from the bill; such an amendment was not considered by the committee.

The introduction of the legislation also represents several months of collaboration among physician stakeholders like the American Gastroenterological Association and the congressional committees. The AGA was pleased that the committee worked with the physician community and incorporated many of our suggestions into the legislation. The AGA, and the Alliance of Specialty Medicine, conveyed our views to the committee and believe that the legislation moves physicians in the right direction and gives physicians opportunity to develop new payment models and quality indicators meaningful to their specialty.

The legislation still has a long path to passage. The House Ways and Means Committee and the Senate Finance Committee have also been working on legislation to replace the SGR. And so far, legislators in both houses have not addressed how to pay for an SGR fix.

Several Energy and Commerce Committee members acknowledged the looming financial reality during deliberations.

"One of the largest hurdles to overcome will be how to pay for the cost associated with fixing the SGR," said Rep. Eliot Engel (D-N.Y.). He urged his colleagues to continue the spirit of bipartisanship when figuring out the cost of replacement.

"We know that the work is not done," said Rep. Phil Gingrey (R-Ga.). "Any fiscally responsible bill in today’s budgetary environment must be paid for. I look forward to finding offsets that do not impact the practice of medicine but instead focus on good governance and combating waste," said the congressman, who is also an ob.gyn.

That work will likely come in September, when Congress returns from its summer recess.

aault@frontlinemedcom.com

On Twitter @aliciaault

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Money is key barrier to health insurance for young adults

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Money is key barrier to health insurance for young adults

Affordability, not perceived lack of need, is the major barrier to health insurance coverage for many young adults, according to a survey from the Commonwealth Fund.

"There is a stereotype that young adults believe they are ‘invincible’ and don’t want or need health insurance," Commonwealth Fund vice president Sara Collins, the study’s lead author, said at a briefing. "This survey shows that is a myth. A typical uninsured young adult is from a low- or middle-income family and works a low-wage job. In general, young adults value health insurance but cannot afford it."

Fewer 19- to-25-year-olds are uninsured this year – 34% vs. 43% in 2011 – mostly due to Affordable Care Act provisions that allow them to stay on their parents’ insurance plans until age 26.

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In general, young adults value health insurance but cannot afford it, said Commonwealth Fund vice president Sara Collins.

However, these young adults have little overall awareness of the health insurance exchanges and options they will offer. At the time of the survey (March 2013), only 27% of young adults knew health insurance exchanges would open Oct. 1.

The survey, which compared results against a 2011 survey, also found that in states that are not expanding their Medicaid programs, low-income young adults may fall through the coverage cracks.

When offered coverage through an employer, 67% of young adults surveyed said they signed up. Among the third who did not, 36% were covered by their parents’ policy, 22% said it was too expensive, 19% were covered by a spouse or partner’s insurance, 4% had purchased coverage on their own, and 13% had other reasons. Only 5% said they did not want or need insurance; the remainder did not answer.

These young adults are viewed as key to making the ACA’s health insurance exchanges work. Generally healthier, they will help spread risk and keep premiums lower for all participants in the exchanges.

But the Commonwealth Fund survey found that states and the federal government have much work ahead of them to increase knowledge of exchanges in this age group, especially among those who have been recently uninsured or who have lower incomes.

Seventy-nine percent of those with incomes below 133% of the federal poverty line responded that they had not heard of the health insurance exchanges. The exchanges will be required to offer coverage to people with incomes up to that level, and subsidies will be available for buyers who are at 100%-400% of the poverty line.

The Commonwealth Fund estimated that 82% of young adults who have spent some time being uninsured would be eligible for those subsidies.

The Commonwealth Fund Health Insurance Tracking Survey of Young Adults was conducted by an online research firm in 2011 and 2013, among a representative sample of young adults. In 2011, 3,438 adults aged 19-29 were randomly sampled; 1,863 responded (54%). In 2013, 3,530 young adults were surveyed; 1,885 responded (53.4%). Just over 1,000 responded in both years.

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On Twitter @aliciaault

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Affordability, not perceived lack of need, is the major barrier to health insurance coverage for many young adults, according to a survey from the Commonwealth Fund.

"There is a stereotype that young adults believe they are ‘invincible’ and don’t want or need health insurance," Commonwealth Fund vice president Sara Collins, the study’s lead author, said at a briefing. "This survey shows that is a myth. A typical uninsured young adult is from a low- or middle-income family and works a low-wage job. In general, young adults value health insurance but cannot afford it."

Fewer 19- to-25-year-olds are uninsured this year – 34% vs. 43% in 2011 – mostly due to Affordable Care Act provisions that allow them to stay on their parents’ insurance plans until age 26.

Thinkstockphotos.com
In general, young adults value health insurance but cannot afford it, said Commonwealth Fund vice president Sara Collins.

However, these young adults have little overall awareness of the health insurance exchanges and options they will offer. At the time of the survey (March 2013), only 27% of young adults knew health insurance exchanges would open Oct. 1.

The survey, which compared results against a 2011 survey, also found that in states that are not expanding their Medicaid programs, low-income young adults may fall through the coverage cracks.

When offered coverage through an employer, 67% of young adults surveyed said they signed up. Among the third who did not, 36% were covered by their parents’ policy, 22% said it was too expensive, 19% were covered by a spouse or partner’s insurance, 4% had purchased coverage on their own, and 13% had other reasons. Only 5% said they did not want or need insurance; the remainder did not answer.

These young adults are viewed as key to making the ACA’s health insurance exchanges work. Generally healthier, they will help spread risk and keep premiums lower for all participants in the exchanges.

But the Commonwealth Fund survey found that states and the federal government have much work ahead of them to increase knowledge of exchanges in this age group, especially among those who have been recently uninsured or who have lower incomes.

Seventy-nine percent of those with incomes below 133% of the federal poverty line responded that they had not heard of the health insurance exchanges. The exchanges will be required to offer coverage to people with incomes up to that level, and subsidies will be available for buyers who are at 100%-400% of the poverty line.

The Commonwealth Fund estimated that 82% of young adults who have spent some time being uninsured would be eligible for those subsidies.

The Commonwealth Fund Health Insurance Tracking Survey of Young Adults was conducted by an online research firm in 2011 and 2013, among a representative sample of young adults. In 2011, 3,438 adults aged 19-29 were randomly sampled; 1,863 responded (54%). In 2013, 3,530 young adults were surveyed; 1,885 responded (53.4%). Just over 1,000 responded in both years.

aault@frontlinemedcom.com

On Twitter @aliciaault

Affordability, not perceived lack of need, is the major barrier to health insurance coverage for many young adults, according to a survey from the Commonwealth Fund.

"There is a stereotype that young adults believe they are ‘invincible’ and don’t want or need health insurance," Commonwealth Fund vice president Sara Collins, the study’s lead author, said at a briefing. "This survey shows that is a myth. A typical uninsured young adult is from a low- or middle-income family and works a low-wage job. In general, young adults value health insurance but cannot afford it."

Fewer 19- to-25-year-olds are uninsured this year – 34% vs. 43% in 2011 – mostly due to Affordable Care Act provisions that allow them to stay on their parents’ insurance plans until age 26.

Thinkstockphotos.com
In general, young adults value health insurance but cannot afford it, said Commonwealth Fund vice president Sara Collins.

However, these young adults have little overall awareness of the health insurance exchanges and options they will offer. At the time of the survey (March 2013), only 27% of young adults knew health insurance exchanges would open Oct. 1.

The survey, which compared results against a 2011 survey, also found that in states that are not expanding their Medicaid programs, low-income young adults may fall through the coverage cracks.

When offered coverage through an employer, 67% of young adults surveyed said they signed up. Among the third who did not, 36% were covered by their parents’ policy, 22% said it was too expensive, 19% were covered by a spouse or partner’s insurance, 4% had purchased coverage on their own, and 13% had other reasons. Only 5% said they did not want or need insurance; the remainder did not answer.

These young adults are viewed as key to making the ACA’s health insurance exchanges work. Generally healthier, they will help spread risk and keep premiums lower for all participants in the exchanges.

But the Commonwealth Fund survey found that states and the federal government have much work ahead of them to increase knowledge of exchanges in this age group, especially among those who have been recently uninsured or who have lower incomes.

Seventy-nine percent of those with incomes below 133% of the federal poverty line responded that they had not heard of the health insurance exchanges. The exchanges will be required to offer coverage to people with incomes up to that level, and subsidies will be available for buyers who are at 100%-400% of the poverty line.

The Commonwealth Fund estimated that 82% of young adults who have spent some time being uninsured would be eligible for those subsidies.

The Commonwealth Fund Health Insurance Tracking Survey of Young Adults was conducted by an online research firm in 2011 and 2013, among a representative sample of young adults. In 2011, 3,438 adults aged 19-29 were randomly sampled; 1,863 responded (54%). In 2013, 3,530 young adults were surveyed; 1,885 responded (53.4%). Just over 1,000 responded in both years.

aault@frontlinemedcom.com

On Twitter @aliciaault

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Sunshine apps track industry payments

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Two new smartphone apps aim to help log drug, device, and diagnostic manufacturer payments to doctors and health care providers, as called for by the Affordable Care Act.

To promote transparency in relationships between providers and industry, the ACA requires that manufacturers track and report payments for consulting, honoraria, and more.

Centers for Medicare & Medicaid Services
A new mobile app for physicians – Open Payments for Physicians – is designed to help doctors keep tabs on all their transactions in real time.

Originally known as the Sunshine Act, the effort is now called the Open Payments Program by the Centers for Medicare and Medicaid Services (CMS).

While physicians are not required to inventory anything of value they receive from manufacturers, CMS and many medical professional societies advise that they do so.

The app for physicians – Open Payments for Physicians – is designed to help doctors keep tabs on all their transactions in real time. Users can manually enter all the information regarding a particular transaction, for example, the receipt of a grant payment or a gift that’s worth more than $10.

The app is free and can be downloaded from the iTunes App Store or from Google Play.

CMS also created an app for industry representatives to use (Open Payments for Industry).

Industry users and physician users can exchange information with their apps. By using a built-in QR (quick response) code reader, the manufacturer can transfer a record of a transaction to the physician for review, according to the agency.

In a blog post, CMS Program Integrity Director Dr. Peter Budetti said the agency’s "foray into mobile technology is about providing user-friendly tools for doctors, manufacturers, and others in the health care industry to use in working with us to implement the law in a smart way."

The idea is that physicians can use the records contained in the app to compare what’s reported by manufacturers to CMS. There is a 45-day lag between when the data are reported to CMS and posted publicly. Physicians have that window to challenge the reports before they are posted on the Open Payments website. Corrections can be made later, but the erroneous data will likely stay public for awhile.

The first year of the program will be a little bit more forgiving. Data collected beginning Aug. 1 won’t be publicly reported until September 2014.

The apps can’t be used to directly transfer data to CMS, said the agency, which added that although it developed the apps, it will not "validate the accuracy of data stored in the apps, nor will it be responsible for protecting data stored in the apps."

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Two new smartphone apps aim to help log drug, device, and diagnostic manufacturer payments to doctors and health care providers, as called for by the Affordable Care Act.

To promote transparency in relationships between providers and industry, the ACA requires that manufacturers track and report payments for consulting, honoraria, and more.

Centers for Medicare & Medicaid Services
A new mobile app for physicians – Open Payments for Physicians – is designed to help doctors keep tabs on all their transactions in real time.

Originally known as the Sunshine Act, the effort is now called the Open Payments Program by the Centers for Medicare and Medicaid Services (CMS).

While physicians are not required to inventory anything of value they receive from manufacturers, CMS and many medical professional societies advise that they do so.

The app for physicians – Open Payments for Physicians – is designed to help doctors keep tabs on all their transactions in real time. Users can manually enter all the information regarding a particular transaction, for example, the receipt of a grant payment or a gift that’s worth more than $10.

The app is free and can be downloaded from the iTunes App Store or from Google Play.

CMS also created an app for industry representatives to use (Open Payments for Industry).

Industry users and physician users can exchange information with their apps. By using a built-in QR (quick response) code reader, the manufacturer can transfer a record of a transaction to the physician for review, according to the agency.

In a blog post, CMS Program Integrity Director Dr. Peter Budetti said the agency’s "foray into mobile technology is about providing user-friendly tools for doctors, manufacturers, and others in the health care industry to use in working with us to implement the law in a smart way."

The idea is that physicians can use the records contained in the app to compare what’s reported by manufacturers to CMS. There is a 45-day lag between when the data are reported to CMS and posted publicly. Physicians have that window to challenge the reports before they are posted on the Open Payments website. Corrections can be made later, but the erroneous data will likely stay public for awhile.

The first year of the program will be a little bit more forgiving. Data collected beginning Aug. 1 won’t be publicly reported until September 2014.

The apps can’t be used to directly transfer data to CMS, said the agency, which added that although it developed the apps, it will not "validate the accuracy of data stored in the apps, nor will it be responsible for protecting data stored in the apps."

aault@frontlinemedcom.com

On Twitter @aliciaault

Two new smartphone apps aim to help log drug, device, and diagnostic manufacturer payments to doctors and health care providers, as called for by the Affordable Care Act.

To promote transparency in relationships between providers and industry, the ACA requires that manufacturers track and report payments for consulting, honoraria, and more.

Centers for Medicare & Medicaid Services
A new mobile app for physicians – Open Payments for Physicians – is designed to help doctors keep tabs on all their transactions in real time.

Originally known as the Sunshine Act, the effort is now called the Open Payments Program by the Centers for Medicare and Medicaid Services (CMS).

While physicians are not required to inventory anything of value they receive from manufacturers, CMS and many medical professional societies advise that they do so.

The app for physicians – Open Payments for Physicians – is designed to help doctors keep tabs on all their transactions in real time. Users can manually enter all the information regarding a particular transaction, for example, the receipt of a grant payment or a gift that’s worth more than $10.

The app is free and can be downloaded from the iTunes App Store or from Google Play.

CMS also created an app for industry representatives to use (Open Payments for Industry).

Industry users and physician users can exchange information with their apps. By using a built-in QR (quick response) code reader, the manufacturer can transfer a record of a transaction to the physician for review, according to the agency.

In a blog post, CMS Program Integrity Director Dr. Peter Budetti said the agency’s "foray into mobile technology is about providing user-friendly tools for doctors, manufacturers, and others in the health care industry to use in working with us to implement the law in a smart way."

The idea is that physicians can use the records contained in the app to compare what’s reported by manufacturers to CMS. There is a 45-day lag between when the data are reported to CMS and posted publicly. Physicians have that window to challenge the reports before they are posted on the Open Payments website. Corrections can be made later, but the erroneous data will likely stay public for awhile.

The first year of the program will be a little bit more forgiving. Data collected beginning Aug. 1 won’t be publicly reported until September 2014.

The apps can’t be used to directly transfer data to CMS, said the agency, which added that although it developed the apps, it will not "validate the accuracy of data stored in the apps, nor will it be responsible for protecting data stored in the apps."

aault@frontlinemedcom.com

On Twitter @aliciaault

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Cost of health insurance moderates, but workers pay more

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The rise in the cost of employer-sponsored health insurance has ameliorated in the past year, continuing a flattening trend, but patients continue to be asked to pay a bigger share.

That’s the conclusion of the 13th annual survey of nonfederal private and public employers with three or more workers conducted by the Kaiser Family Foundation and the Health Research & Educational Trust, and published Aug. 20 in the journal Health Affairs (doi: 10.1377/hlthaff.2013.0644).

Kaiser and HRET estimate that in 2013, 149 million nonelderly people receive coverage through employer-sponsored insurance, with 57% of U.S. firms offering health benefits – a statistically insignificant change from 61% in 2012 and 60% in 2011. But smaller companies and those with many low-wage workers do not offer benefits as frequently.

In 2013, the average annual premiums for employer-sponsored health insurance rose 5% to $5,884 for single coverage and 4% to $16,351 for family coverage from 2012. This continues the pattern seen over the past few years, with relatively small premium increases.

Workers on average pay 18% of the premium for single coverage and 29% for family coverage, again, similar to the two previous years. "We are in a prolonged period of moderation in premiums, which should create some breathing room for the private sector to try to reduce costs without cutting back benefits for workers," said Kaiser President and CEO Drew Altman, in a statement.

But workers are still struggling to cover health costs. During the same period (2012-2013), wages increased 1.8% and inflation increased 1.1%. And since 2003, the average premium for family coverage has increased 80%, and the average worker contribution has risen 89%.

Employers continue to cost-shift. Seventy-eight percent of covered workers have a deductible, with the average for single coverage running about $1,100 (largely unchanged from 2012). But big deductibles are getting to be more common. Firms with less than 200 employees generally charged more than $1,000, and the number doing that rose from 49% of all such firms in 2012 to 58% in 2013.

Three-quarters of workers have a fixed copayment for office visits with primary care physicians and specialists. That copay averages $23 for primary care and $35 for specialty care for in-network physicians. Out-of-network amounts were not covered in the survey, but Kaiser assumes that patients bear a greater cost for those visits. About 20% of workers pay a percent of the visit (coinsurance) for primary care and the same amount for specialty care. They pay an average 18% of the visit.

The survey found that preferred provider organization (PPO) plans are the most common, enrolling 57% of covered workers in 2013. High-deductible health plans, also known as catastrophic plans, are the next most popular, with 20% of covered workers. Deductibles in those plans range from around $2,000 for single coverage to $4,000 for family coverage, with some much higher.

Only 14% of workers are enrolled in health maintenance organizations (HMOs), 9% in a point-of-service (POS) plan, and less than 1% in a conventional fee-for-service plan. High-deductible plans have grown exponentially since first coming on the scene – going from 8% in 2009 to 17% in 2011 – but have plateaued in the last few years, according to the report.

Also of interest to physicians:

• 23% of employers offering benefits have high performance or tiered networks in their largest health plan. The programs help steer patients to providers who have been identified as being more efficient or giving higher-quality care.

• 56% cover services provided by retail health clinics. Among firms covering services in these settings, 17% provide a financial incentive to receive services in a retail clinic instead of a physician’s office.

• Almost all employers with more than 200 workers and most smaller employers offer at least one wellness program. The majority offer at least one of the following in 2013: weight loss programs, gym membership discounts or on-site exercise facilities, biometric screening, smoking cessation, personal health coaching, health and nutrition education, web-based resources, flu shots or vaccinations, employee assistance programs (EAPs), or a wellness newsletter. Thirty-six percent of large firms and 8% of smaller firms offer employees a financial incentive to participate.

The growth in wellness programs "will be an important issue to watch next year, as employers will have more flexibility and could ask workers to pay more because of their lifestyles and health conditions," said Kaiser Vice President Gary Claxton, the study’s lead investigator and director of the Foundation’s Health Care Marketplace Project.

Mr. Claxton and his colleagues found that an increasing number of employees are likely to be subject to the Affordable Care Act’s various provisions. Thirty-six percent of covered workers are in "grandfathered" plans – that is, they are exempt from the law – down from 48% in 2012 and 56% in 2011.

 

 

The authors reported no disclosures.

aault@frontlinemedcom.com

On Twitter @aliciaault

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The rise in the cost of employer-sponsored health insurance has ameliorated in the past year, continuing a flattening trend, but patients continue to be asked to pay a bigger share.

That’s the conclusion of the 13th annual survey of nonfederal private and public employers with three or more workers conducted by the Kaiser Family Foundation and the Health Research & Educational Trust, and published Aug. 20 in the journal Health Affairs (doi: 10.1377/hlthaff.2013.0644).

Kaiser and HRET estimate that in 2013, 149 million nonelderly people receive coverage through employer-sponsored insurance, with 57% of U.S. firms offering health benefits – a statistically insignificant change from 61% in 2012 and 60% in 2011. But smaller companies and those with many low-wage workers do not offer benefits as frequently.

In 2013, the average annual premiums for employer-sponsored health insurance rose 5% to $5,884 for single coverage and 4% to $16,351 for family coverage from 2012. This continues the pattern seen over the past few years, with relatively small premium increases.

Workers on average pay 18% of the premium for single coverage and 29% for family coverage, again, similar to the two previous years. "We are in a prolonged period of moderation in premiums, which should create some breathing room for the private sector to try to reduce costs without cutting back benefits for workers," said Kaiser President and CEO Drew Altman, in a statement.

But workers are still struggling to cover health costs. During the same period (2012-2013), wages increased 1.8% and inflation increased 1.1%. And since 2003, the average premium for family coverage has increased 80%, and the average worker contribution has risen 89%.

Employers continue to cost-shift. Seventy-eight percent of covered workers have a deductible, with the average for single coverage running about $1,100 (largely unchanged from 2012). But big deductibles are getting to be more common. Firms with less than 200 employees generally charged more than $1,000, and the number doing that rose from 49% of all such firms in 2012 to 58% in 2013.

Three-quarters of workers have a fixed copayment for office visits with primary care physicians and specialists. That copay averages $23 for primary care and $35 for specialty care for in-network physicians. Out-of-network amounts were not covered in the survey, but Kaiser assumes that patients bear a greater cost for those visits. About 20% of workers pay a percent of the visit (coinsurance) for primary care and the same amount for specialty care. They pay an average 18% of the visit.

The survey found that preferred provider organization (PPO) plans are the most common, enrolling 57% of covered workers in 2013. High-deductible health plans, also known as catastrophic plans, are the next most popular, with 20% of covered workers. Deductibles in those plans range from around $2,000 for single coverage to $4,000 for family coverage, with some much higher.

Only 14% of workers are enrolled in health maintenance organizations (HMOs), 9% in a point-of-service (POS) plan, and less than 1% in a conventional fee-for-service plan. High-deductible plans have grown exponentially since first coming on the scene – going from 8% in 2009 to 17% in 2011 – but have plateaued in the last few years, according to the report.

Also of interest to physicians:

• 23% of employers offering benefits have high performance or tiered networks in their largest health plan. The programs help steer patients to providers who have been identified as being more efficient or giving higher-quality care.

• 56% cover services provided by retail health clinics. Among firms covering services in these settings, 17% provide a financial incentive to receive services in a retail clinic instead of a physician’s office.

• Almost all employers with more than 200 workers and most smaller employers offer at least one wellness program. The majority offer at least one of the following in 2013: weight loss programs, gym membership discounts or on-site exercise facilities, biometric screening, smoking cessation, personal health coaching, health and nutrition education, web-based resources, flu shots or vaccinations, employee assistance programs (EAPs), or a wellness newsletter. Thirty-six percent of large firms and 8% of smaller firms offer employees a financial incentive to participate.

The growth in wellness programs "will be an important issue to watch next year, as employers will have more flexibility and could ask workers to pay more because of their lifestyles and health conditions," said Kaiser Vice President Gary Claxton, the study’s lead investigator and director of the Foundation’s Health Care Marketplace Project.

Mr. Claxton and his colleagues found that an increasing number of employees are likely to be subject to the Affordable Care Act’s various provisions. Thirty-six percent of covered workers are in "grandfathered" plans – that is, they are exempt from the law – down from 48% in 2012 and 56% in 2011.

 

 

The authors reported no disclosures.

aault@frontlinemedcom.com

On Twitter @aliciaault

The rise in the cost of employer-sponsored health insurance has ameliorated in the past year, continuing a flattening trend, but patients continue to be asked to pay a bigger share.

That’s the conclusion of the 13th annual survey of nonfederal private and public employers with three or more workers conducted by the Kaiser Family Foundation and the Health Research & Educational Trust, and published Aug. 20 in the journal Health Affairs (doi: 10.1377/hlthaff.2013.0644).

Kaiser and HRET estimate that in 2013, 149 million nonelderly people receive coverage through employer-sponsored insurance, with 57% of U.S. firms offering health benefits – a statistically insignificant change from 61% in 2012 and 60% in 2011. But smaller companies and those with many low-wage workers do not offer benefits as frequently.

In 2013, the average annual premiums for employer-sponsored health insurance rose 5% to $5,884 for single coverage and 4% to $16,351 for family coverage from 2012. This continues the pattern seen over the past few years, with relatively small premium increases.

Workers on average pay 18% of the premium for single coverage and 29% for family coverage, again, similar to the two previous years. "We are in a prolonged period of moderation in premiums, which should create some breathing room for the private sector to try to reduce costs without cutting back benefits for workers," said Kaiser President and CEO Drew Altman, in a statement.

But workers are still struggling to cover health costs. During the same period (2012-2013), wages increased 1.8% and inflation increased 1.1%. And since 2003, the average premium for family coverage has increased 80%, and the average worker contribution has risen 89%.

Employers continue to cost-shift. Seventy-eight percent of covered workers have a deductible, with the average for single coverage running about $1,100 (largely unchanged from 2012). But big deductibles are getting to be more common. Firms with less than 200 employees generally charged more than $1,000, and the number doing that rose from 49% of all such firms in 2012 to 58% in 2013.

Three-quarters of workers have a fixed copayment for office visits with primary care physicians and specialists. That copay averages $23 for primary care and $35 for specialty care for in-network physicians. Out-of-network amounts were not covered in the survey, but Kaiser assumes that patients bear a greater cost for those visits. About 20% of workers pay a percent of the visit (coinsurance) for primary care and the same amount for specialty care. They pay an average 18% of the visit.

The survey found that preferred provider organization (PPO) plans are the most common, enrolling 57% of covered workers in 2013. High-deductible health plans, also known as catastrophic plans, are the next most popular, with 20% of covered workers. Deductibles in those plans range from around $2,000 for single coverage to $4,000 for family coverage, with some much higher.

Only 14% of workers are enrolled in health maintenance organizations (HMOs), 9% in a point-of-service (POS) plan, and less than 1% in a conventional fee-for-service plan. High-deductible plans have grown exponentially since first coming on the scene – going from 8% in 2009 to 17% in 2011 – but have plateaued in the last few years, according to the report.

Also of interest to physicians:

• 23% of employers offering benefits have high performance or tiered networks in their largest health plan. The programs help steer patients to providers who have been identified as being more efficient or giving higher-quality care.

• 56% cover services provided by retail health clinics. Among firms covering services in these settings, 17% provide a financial incentive to receive services in a retail clinic instead of a physician’s office.

• Almost all employers with more than 200 workers and most smaller employers offer at least one wellness program. The majority offer at least one of the following in 2013: weight loss programs, gym membership discounts or on-site exercise facilities, biometric screening, smoking cessation, personal health coaching, health and nutrition education, web-based resources, flu shots or vaccinations, employee assistance programs (EAPs), or a wellness newsletter. Thirty-six percent of large firms and 8% of smaller firms offer employees a financial incentive to participate.

The growth in wellness programs "will be an important issue to watch next year, as employers will have more flexibility and could ask workers to pay more because of their lifestyles and health conditions," said Kaiser Vice President Gary Claxton, the study’s lead investigator and director of the Foundation’s Health Care Marketplace Project.

Mr. Claxton and his colleagues found that an increasing number of employees are likely to be subject to the Affordable Care Act’s various provisions. Thirty-six percent of covered workers are in "grandfathered" plans – that is, they are exempt from the law – down from 48% in 2012 and 56% in 2011.

 

 

The authors reported no disclosures.

aault@frontlinemedcom.com

On Twitter @aliciaault

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Major finding: Employer-sponsored health insurance premiums rose 4% for family coverage and 5% for single coverage in 2013; deductibles, coinsurance, and other out-of-pocket costs also continued to rise for workers.

Data source: Survey of more than 2,000 nonfederal private and public employers with three or more workers.

Disclosures: The authors reported no disclosures.

Tofacitinib rapidly improves RA signs and symptoms

Reassuring study, but leaves questions
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Tofacitinib rapidly improves RA signs and symptoms

Response rates for rheumatoid arthritis patients taking either 5 mg or 10 mg twice-daily of the oral Janus kinase inhibitor tofacitinib were at least 20% greater after 6 months than for those who started on placebo and switched to the therapy, according to a new study.

Lead investigator Dr. Joel Kremer and his colleagues concluded that tofacitinib (Xeljanz) – when taken in combination with a nonbiologic disease-modifying antirheumatic drug (DMARD) – rapidly reduced the signs and symptoms of RA and improved physical functioning. But, they added, since the majority of patients in their study were taking methotrexate, extrapolating the results to other nonbiologic DMARDs should be done with caution.

Dr. Joel Kremer

They also noted that this trial supported findings in previous studies that tofacitinib works well with methotrexate. One such study was published in the Lancet and was also funded by Pfizer (Lancet 2013 [doi:10.1016/S0140-6736(12)61424-X]).

In the trial, paid for by Pfizer and conducted at 114 centers in 19 countries, 792 patients were randomly assigned 4:4:1:1 to twice-daily treatment with 5 mg of tofacitinib; 10 mg of tofacitinib; or placebo. The study was published Aug. 19 in the Annals of Internal Medicine.

At 3 months, placebo patients who did not respond were blindly switched to the 5-mg or 10-mg dose. Patients taking tofacitinib who did not respond at 3 months continued on the same dose. After 6 months, all patients still on placebo were switched blindly to either the 5-mg or 10-mg dose.

At 6 months, the response rates – defined as 20% improvement in the tender or painful and swollen joint count at three months (ACR20) – were 21% greater for patients taking 5 mg, and 26% greater for patients taking 10 mg, when compared with patients who had been on placebo for 3 months and then switched to one of the two doses.

There was a significantly greater improvement (P less than .001) at 3 months in the Health Assessment Questionnaire Disability Index (HAQ-DI) for patients in the treatment arms, and more of those patients had a Disease Activity Score for 28 joints (DAS28-4) of less than 2.6 at 6 months than did the placebo groups.

Patients were enrolled if they were aged 18 years or older and had a rheumatoid arthritis diagnosis consistent with the 1987 American College of Rheumatology criteria, and an inadequate response to treatment with one or more nonbiologic or biologic DMARDs. They were also required to continue treatment with one or more nonbiologic DMARDs throughout the study. Those taking methotrexate had to have been receiving it for at least 4 months and at stable dosing over at least 6 weeks before the study start. Low-dose, oral corticosteroid therapy was also allowed.

Exclusion criteria included previous treatment with lymphocyte-depleting therapies within a year of the study start; a depressed hemoglobin, hematocrit, leukocyte, or platelet count; or a history of autoimmune rheumatic disease or most cancers. Patients were also excluded if they had experienced an infection requiring hospitalization or intravenous antibiotics within 6 months of baseline, oral antibiotics within 2 weeks of baseline, or infection with herpes zoster, hepatitis B or C, or HIV.

Only 651 (82%) of the 792 patients enrolled completed the study. The mean age across the four treatment groups was 51-53 years old, and at least three-quarters of the participants were female. Two-thirds to 73% of patients continued to take background DMARDs during the study, and at least a quarter received two or more DMARDs. Methotrexate was the most frequently prescribed DMARD.

At 3 months, half of the placebo patients did not have a response and were then switched to either 5 mg (38 patients) or 10 mg (40 patients) of tofacitinib. In the treatment group at 3 months, 80 (26%) patients taking 5 mg and 58 (18%) patients taking 10 mg had no response. A total of 27% of those taking placebo had a response according to the ACR20 criteria.

The authors reported statistically significant response rates for ACR20 and ACR50 by the second week for both treatment arms. DAS28-4, DAS28-4 less than 2.6, and Functional Assessment of Chronic Illness Therapy-Fatigue response rates also were statistically significant over time for the tofacitinib treatment groups when compared with placebo.

The authors reported a higher adverse event and serious adverse event rate for patients on placebo, but a higher discontinuation rate for those taking tofacitinib.

Over a year, the adverse event rate was 172/100 patient-years for tofacitinib 5 mg, 176 for the 10 mg group, and 342 for the placebo-to-tofacitinib groups. The most common adverse events in the tofacitinib groups were upper respiratory tract infections and nasopharyngitis. The discontinuation rate from adverse events was 5.4/100 patient-years for placebo, 6.2 for the 5-mg group, and 9.7 for the 10-mg group.

 

 

The authors reported four treatment-related opportunistic infections: disseminated herpes zoster, cryptococcal pneumonia, and two cases of pulmonary tuberculosis. There were four deaths during the study, but only one, respiratory failure, was deemed to be treatment related.

The trial’s Cardiovascular Safety Endpoint Adjudication Committee determined that three patients had events that were notable: a transient ischemic attack in a patient taking 5 mg, a cerebrovascular accident in a patient taking 5 mg, and heart failure in a patient taking 10 mg who eventually died.

In patients taking tofacitinib, the authors also reported decreases in mean neutrophil counts at 3 months and increases in high- and low-density lipoprotein levels that were sustained at 12 months after baseline.

These results have not impressed the European Medicines Agency. In July, the EMA’s Committee for Medicinal Products for Human Use (CHMP) reaffirmed an opinion issued in April that tofacitinib’s benefits did not outweigh its risks. The CHMP recommended against approval of the drug. Pfizer said in a release that it is evaluating the opinion and "will determine next steps to resubmit" its approval application.

Dr. Kremer is the founder and president of the Consortium of Rheumatology Researchers of America (CORRONA) registry, which receives funding from Pfizer. He received a research grant from Pfizer to conduct the study and has been a consultant to Pfizer for the development of tofacitinib. Several other authors reported receiving grants from Pfizer and performing consultant work to Pfizer in relation to the trial. Other authors are Pfizer employees.

aault@frontlinemedcom.com

On Twitter @aliciaault

Body

Dr. Kremer and his associates' report is a good study that will reassure rheumatologists that it is possible to use tofacitinib with nonbiologic DMARDs. It also reinforces that the dose of tofacitinib that is approved in North America is too low for many patients. There is a nice dose response for DAS28 remission (placebo, 2.6%; tofacitinib, 5 mg twice daily, 8.5%; tofacitinib 10 mg twice daily, 12.5%) and HAQ-DI (-0.16, -0.44, and -0.53, respectively). This was less the case for the ACR20 responses (30.8%, 52.1%, and 56.6%, respectively), but even here there is some trend toward a dose response.

On the other hand, there are some aspects of this study that could be clearer. The patients themselves had long disease duration and relatively high disease activity, so it is not clear that the results apply to all patients. Furthermore, about 10% of patients were on biologics prior to entering the study, and it is not clear how long those biologics had actually been stopped. (The inclusion criteria were not very clear on this aspect.) The patients were allowed on more than one DMARD, and it would have been good to know the breakdown of responses by the number of concomitant DMARDs. Also, nearly 60% of the patients were on corticosteroids, and there is no discussion of the effect of this drug on response or toxicity. Finally, the breakdown of patients was about 20% on placebo initially, compared with 80% on initial tofacitinib, thus introducing the possibility of an unbalanced early response.

The bottom line is that this article is generally reassuring and allows rheumatologists to use tofacitinib more broadly. It reinforces the need for sufficient data to allow higher doses of drugs to be approved in the United States, but, like many studies, leaves many questions (especially on how to consider combinations and corticosteroids) and does not allow the degree of generalization that would have been ideal.

Daniel E. Furst, M.D., is the Carl M. Pearson Professor of Rheumatology at the at the University of California, Los Angeles. He has been a consultant to Pfizer and has received travel support and meals from the company. He has also been a consultant to or received grant support from other pharmaceutical companies marketing drugs for rheumatoid arthritis, including Abbott, Amgen, and Bristol-Myers Squibb.

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Body

Dr. Kremer and his associates' report is a good study that will reassure rheumatologists that it is possible to use tofacitinib with nonbiologic DMARDs. It also reinforces that the dose of tofacitinib that is approved in North America is too low for many patients. There is a nice dose response for DAS28 remission (placebo, 2.6%; tofacitinib, 5 mg twice daily, 8.5%; tofacitinib 10 mg twice daily, 12.5%) and HAQ-DI (-0.16, -0.44, and -0.53, respectively). This was less the case for the ACR20 responses (30.8%, 52.1%, and 56.6%, respectively), but even here there is some trend toward a dose response.

On the other hand, there are some aspects of this study that could be clearer. The patients themselves had long disease duration and relatively high disease activity, so it is not clear that the results apply to all patients. Furthermore, about 10% of patients were on biologics prior to entering the study, and it is not clear how long those biologics had actually been stopped. (The inclusion criteria were not very clear on this aspect.) The patients were allowed on more than one DMARD, and it would have been good to know the breakdown of responses by the number of concomitant DMARDs. Also, nearly 60% of the patients were on corticosteroids, and there is no discussion of the effect of this drug on response or toxicity. Finally, the breakdown of patients was about 20% on placebo initially, compared with 80% on initial tofacitinib, thus introducing the possibility of an unbalanced early response.

The bottom line is that this article is generally reassuring and allows rheumatologists to use tofacitinib more broadly. It reinforces the need for sufficient data to allow higher doses of drugs to be approved in the United States, but, like many studies, leaves many questions (especially on how to consider combinations and corticosteroids) and does not allow the degree of generalization that would have been ideal.

Daniel E. Furst, M.D., is the Carl M. Pearson Professor of Rheumatology at the at the University of California, Los Angeles. He has been a consultant to Pfizer and has received travel support and meals from the company. He has also been a consultant to or received grant support from other pharmaceutical companies marketing drugs for rheumatoid arthritis, including Abbott, Amgen, and Bristol-Myers Squibb.

Body

Dr. Kremer and his associates' report is a good study that will reassure rheumatologists that it is possible to use tofacitinib with nonbiologic DMARDs. It also reinforces that the dose of tofacitinib that is approved in North America is too low for many patients. There is a nice dose response for DAS28 remission (placebo, 2.6%; tofacitinib, 5 mg twice daily, 8.5%; tofacitinib 10 mg twice daily, 12.5%) and HAQ-DI (-0.16, -0.44, and -0.53, respectively). This was less the case for the ACR20 responses (30.8%, 52.1%, and 56.6%, respectively), but even here there is some trend toward a dose response.

On the other hand, there are some aspects of this study that could be clearer. The patients themselves had long disease duration and relatively high disease activity, so it is not clear that the results apply to all patients. Furthermore, about 10% of patients were on biologics prior to entering the study, and it is not clear how long those biologics had actually been stopped. (The inclusion criteria were not very clear on this aspect.) The patients were allowed on more than one DMARD, and it would have been good to know the breakdown of responses by the number of concomitant DMARDs. Also, nearly 60% of the patients were on corticosteroids, and there is no discussion of the effect of this drug on response or toxicity. Finally, the breakdown of patients was about 20% on placebo initially, compared with 80% on initial tofacitinib, thus introducing the possibility of an unbalanced early response.

The bottom line is that this article is generally reassuring and allows rheumatologists to use tofacitinib more broadly. It reinforces the need for sufficient data to allow higher doses of drugs to be approved in the United States, but, like many studies, leaves many questions (especially on how to consider combinations and corticosteroids) and does not allow the degree of generalization that would have been ideal.

Daniel E. Furst, M.D., is the Carl M. Pearson Professor of Rheumatology at the at the University of California, Los Angeles. He has been a consultant to Pfizer and has received travel support and meals from the company. He has also been a consultant to or received grant support from other pharmaceutical companies marketing drugs for rheumatoid arthritis, including Abbott, Amgen, and Bristol-Myers Squibb.

Title
Reassuring study, but leaves questions
Reassuring study, but leaves questions

Response rates for rheumatoid arthritis patients taking either 5 mg or 10 mg twice-daily of the oral Janus kinase inhibitor tofacitinib were at least 20% greater after 6 months than for those who started on placebo and switched to the therapy, according to a new study.

Lead investigator Dr. Joel Kremer and his colleagues concluded that tofacitinib (Xeljanz) – when taken in combination with a nonbiologic disease-modifying antirheumatic drug (DMARD) – rapidly reduced the signs and symptoms of RA and improved physical functioning. But, they added, since the majority of patients in their study were taking methotrexate, extrapolating the results to other nonbiologic DMARDs should be done with caution.

Dr. Joel Kremer

They also noted that this trial supported findings in previous studies that tofacitinib works well with methotrexate. One such study was published in the Lancet and was also funded by Pfizer (Lancet 2013 [doi:10.1016/S0140-6736(12)61424-X]).

In the trial, paid for by Pfizer and conducted at 114 centers in 19 countries, 792 patients were randomly assigned 4:4:1:1 to twice-daily treatment with 5 mg of tofacitinib; 10 mg of tofacitinib; or placebo. The study was published Aug. 19 in the Annals of Internal Medicine.

At 3 months, placebo patients who did not respond were blindly switched to the 5-mg or 10-mg dose. Patients taking tofacitinib who did not respond at 3 months continued on the same dose. After 6 months, all patients still on placebo were switched blindly to either the 5-mg or 10-mg dose.

At 6 months, the response rates – defined as 20% improvement in the tender or painful and swollen joint count at three months (ACR20) – were 21% greater for patients taking 5 mg, and 26% greater for patients taking 10 mg, when compared with patients who had been on placebo for 3 months and then switched to one of the two doses.

There was a significantly greater improvement (P less than .001) at 3 months in the Health Assessment Questionnaire Disability Index (HAQ-DI) for patients in the treatment arms, and more of those patients had a Disease Activity Score for 28 joints (DAS28-4) of less than 2.6 at 6 months than did the placebo groups.

Patients were enrolled if they were aged 18 years or older and had a rheumatoid arthritis diagnosis consistent with the 1987 American College of Rheumatology criteria, and an inadequate response to treatment with one or more nonbiologic or biologic DMARDs. They were also required to continue treatment with one or more nonbiologic DMARDs throughout the study. Those taking methotrexate had to have been receiving it for at least 4 months and at stable dosing over at least 6 weeks before the study start. Low-dose, oral corticosteroid therapy was also allowed.

Exclusion criteria included previous treatment with lymphocyte-depleting therapies within a year of the study start; a depressed hemoglobin, hematocrit, leukocyte, or platelet count; or a history of autoimmune rheumatic disease or most cancers. Patients were also excluded if they had experienced an infection requiring hospitalization or intravenous antibiotics within 6 months of baseline, oral antibiotics within 2 weeks of baseline, or infection with herpes zoster, hepatitis B or C, or HIV.

Only 651 (82%) of the 792 patients enrolled completed the study. The mean age across the four treatment groups was 51-53 years old, and at least three-quarters of the participants were female. Two-thirds to 73% of patients continued to take background DMARDs during the study, and at least a quarter received two or more DMARDs. Methotrexate was the most frequently prescribed DMARD.

At 3 months, half of the placebo patients did not have a response and were then switched to either 5 mg (38 patients) or 10 mg (40 patients) of tofacitinib. In the treatment group at 3 months, 80 (26%) patients taking 5 mg and 58 (18%) patients taking 10 mg had no response. A total of 27% of those taking placebo had a response according to the ACR20 criteria.

The authors reported statistically significant response rates for ACR20 and ACR50 by the second week for both treatment arms. DAS28-4, DAS28-4 less than 2.6, and Functional Assessment of Chronic Illness Therapy-Fatigue response rates also were statistically significant over time for the tofacitinib treatment groups when compared with placebo.

The authors reported a higher adverse event and serious adverse event rate for patients on placebo, but a higher discontinuation rate for those taking tofacitinib.

Over a year, the adverse event rate was 172/100 patient-years for tofacitinib 5 mg, 176 for the 10 mg group, and 342 for the placebo-to-tofacitinib groups. The most common adverse events in the tofacitinib groups were upper respiratory tract infections and nasopharyngitis. The discontinuation rate from adverse events was 5.4/100 patient-years for placebo, 6.2 for the 5-mg group, and 9.7 for the 10-mg group.

 

 

The authors reported four treatment-related opportunistic infections: disseminated herpes zoster, cryptococcal pneumonia, and two cases of pulmonary tuberculosis. There were four deaths during the study, but only one, respiratory failure, was deemed to be treatment related.

The trial’s Cardiovascular Safety Endpoint Adjudication Committee determined that three patients had events that were notable: a transient ischemic attack in a patient taking 5 mg, a cerebrovascular accident in a patient taking 5 mg, and heart failure in a patient taking 10 mg who eventually died.

In patients taking tofacitinib, the authors also reported decreases in mean neutrophil counts at 3 months and increases in high- and low-density lipoprotein levels that were sustained at 12 months after baseline.

These results have not impressed the European Medicines Agency. In July, the EMA’s Committee for Medicinal Products for Human Use (CHMP) reaffirmed an opinion issued in April that tofacitinib’s benefits did not outweigh its risks. The CHMP recommended against approval of the drug. Pfizer said in a release that it is evaluating the opinion and "will determine next steps to resubmit" its approval application.

Dr. Kremer is the founder and president of the Consortium of Rheumatology Researchers of America (CORRONA) registry, which receives funding from Pfizer. He received a research grant from Pfizer to conduct the study and has been a consultant to Pfizer for the development of tofacitinib. Several other authors reported receiving grants from Pfizer and performing consultant work to Pfizer in relation to the trial. Other authors are Pfizer employees.

aault@frontlinemedcom.com

On Twitter @aliciaault

Response rates for rheumatoid arthritis patients taking either 5 mg or 10 mg twice-daily of the oral Janus kinase inhibitor tofacitinib were at least 20% greater after 6 months than for those who started on placebo and switched to the therapy, according to a new study.

Lead investigator Dr. Joel Kremer and his colleagues concluded that tofacitinib (Xeljanz) – when taken in combination with a nonbiologic disease-modifying antirheumatic drug (DMARD) – rapidly reduced the signs and symptoms of RA and improved physical functioning. But, they added, since the majority of patients in their study were taking methotrexate, extrapolating the results to other nonbiologic DMARDs should be done with caution.

Dr. Joel Kremer

They also noted that this trial supported findings in previous studies that tofacitinib works well with methotrexate. One such study was published in the Lancet and was also funded by Pfizer (Lancet 2013 [doi:10.1016/S0140-6736(12)61424-X]).

In the trial, paid for by Pfizer and conducted at 114 centers in 19 countries, 792 patients were randomly assigned 4:4:1:1 to twice-daily treatment with 5 mg of tofacitinib; 10 mg of tofacitinib; or placebo. The study was published Aug. 19 in the Annals of Internal Medicine.

At 3 months, placebo patients who did not respond were blindly switched to the 5-mg or 10-mg dose. Patients taking tofacitinib who did not respond at 3 months continued on the same dose. After 6 months, all patients still on placebo were switched blindly to either the 5-mg or 10-mg dose.

At 6 months, the response rates – defined as 20% improvement in the tender or painful and swollen joint count at three months (ACR20) – were 21% greater for patients taking 5 mg, and 26% greater for patients taking 10 mg, when compared with patients who had been on placebo for 3 months and then switched to one of the two doses.

There was a significantly greater improvement (P less than .001) at 3 months in the Health Assessment Questionnaire Disability Index (HAQ-DI) for patients in the treatment arms, and more of those patients had a Disease Activity Score for 28 joints (DAS28-4) of less than 2.6 at 6 months than did the placebo groups.

Patients were enrolled if they were aged 18 years or older and had a rheumatoid arthritis diagnosis consistent with the 1987 American College of Rheumatology criteria, and an inadequate response to treatment with one or more nonbiologic or biologic DMARDs. They were also required to continue treatment with one or more nonbiologic DMARDs throughout the study. Those taking methotrexate had to have been receiving it for at least 4 months and at stable dosing over at least 6 weeks before the study start. Low-dose, oral corticosteroid therapy was also allowed.

Exclusion criteria included previous treatment with lymphocyte-depleting therapies within a year of the study start; a depressed hemoglobin, hematocrit, leukocyte, or platelet count; or a history of autoimmune rheumatic disease or most cancers. Patients were also excluded if they had experienced an infection requiring hospitalization or intravenous antibiotics within 6 months of baseline, oral antibiotics within 2 weeks of baseline, or infection with herpes zoster, hepatitis B or C, or HIV.

Only 651 (82%) of the 792 patients enrolled completed the study. The mean age across the four treatment groups was 51-53 years old, and at least three-quarters of the participants were female. Two-thirds to 73% of patients continued to take background DMARDs during the study, and at least a quarter received two or more DMARDs. Methotrexate was the most frequently prescribed DMARD.

At 3 months, half of the placebo patients did not have a response and were then switched to either 5 mg (38 patients) or 10 mg (40 patients) of tofacitinib. In the treatment group at 3 months, 80 (26%) patients taking 5 mg and 58 (18%) patients taking 10 mg had no response. A total of 27% of those taking placebo had a response according to the ACR20 criteria.

The authors reported statistically significant response rates for ACR20 and ACR50 by the second week for both treatment arms. DAS28-4, DAS28-4 less than 2.6, and Functional Assessment of Chronic Illness Therapy-Fatigue response rates also were statistically significant over time for the tofacitinib treatment groups when compared with placebo.

The authors reported a higher adverse event and serious adverse event rate for patients on placebo, but a higher discontinuation rate for those taking tofacitinib.

Over a year, the adverse event rate was 172/100 patient-years for tofacitinib 5 mg, 176 for the 10 mg group, and 342 for the placebo-to-tofacitinib groups. The most common adverse events in the tofacitinib groups were upper respiratory tract infections and nasopharyngitis. The discontinuation rate from adverse events was 5.4/100 patient-years for placebo, 6.2 for the 5-mg group, and 9.7 for the 10-mg group.

 

 

The authors reported four treatment-related opportunistic infections: disseminated herpes zoster, cryptococcal pneumonia, and two cases of pulmonary tuberculosis. There were four deaths during the study, but only one, respiratory failure, was deemed to be treatment related.

The trial’s Cardiovascular Safety Endpoint Adjudication Committee determined that three patients had events that were notable: a transient ischemic attack in a patient taking 5 mg, a cerebrovascular accident in a patient taking 5 mg, and heart failure in a patient taking 10 mg who eventually died.

In patients taking tofacitinib, the authors also reported decreases in mean neutrophil counts at 3 months and increases in high- and low-density lipoprotein levels that were sustained at 12 months after baseline.

These results have not impressed the European Medicines Agency. In July, the EMA’s Committee for Medicinal Products for Human Use (CHMP) reaffirmed an opinion issued in April that tofacitinib’s benefits did not outweigh its risks. The CHMP recommended against approval of the drug. Pfizer said in a release that it is evaluating the opinion and "will determine next steps to resubmit" its approval application.

Dr. Kremer is the founder and president of the Consortium of Rheumatology Researchers of America (CORRONA) registry, which receives funding from Pfizer. He received a research grant from Pfizer to conduct the study and has been a consultant to Pfizer for the development of tofacitinib. Several other authors reported receiving grants from Pfizer and performing consultant work to Pfizer in relation to the trial. Other authors are Pfizer employees.

aault@frontlinemedcom.com

On Twitter @aliciaault

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Major finding: ACR20 response rates were 21% greater in the 5 mg twice-daily tofacitinib arm and 26% greater in the 10 mg twice-daily arm, when compared with a combined placebo arm.

Data source: A 1-year, double-blind, 792-patient study, conducted in 114 centers in 19 countries.

Disclosures: The study was funded by Pfizer. Dr. Kremer is the founder and president of the Consortium of Rheumatology Researchers of North America. (CORRONA) registry, which receives funding from Pfizer. He received a research grant from Pfizer to conduct the study and has been a consultant to Pfizer for the development of tofacitinib. Several other authors reported receiving grants from Pfizer and performing consultant work to Pfizer in relation to the trial. Other authors are Pfizer employees.

FDA requires stronger peripheral neuropathy warning for quinolones

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FDA requires stronger peripheral neuropathy warning for quinolones

The Food and Drug Administration is requiring a stronger warning about the potential for peripheral neuropathy with fluoroquinolone antibiotics that are taken orally or by injection.

The warning does not apply to topical formulations, which have not been associated with neuropathy. Drug labels and patient medication guides must be updated, said the agency.

The potential for neuropathy was first added to the labels of all drugs in the class in 2004. The new warning was necessary because "the potential rapid onset and risk of permanence were not adequately described" in the 2004 label iteration, the FDA noted.

Before requiring new warnings, the FDA reviewed its Adverse Event Reporting System (FAERS, formerly known as AERS) database. The agency found that cases of fluoroquinolone-associated peripheral neuropathy with an outcome of "disability" had been reported to the AERS database between January 2003 and August 2012, although the FDA did not say how many cases it found. The reports indicated a rapid onset of peripheral neuropathy, often within a few days of starting the quinolone. Some cases reported neuropathy that continued for a year, even though the medication had been stopped.

The database was not able to show whether neuropathy was permanent, however, because it is designed to collect spontaneous reports.

The FDA said it had not been able to identify any risk factors for the development of peripheral neuropathy. But the onset of the condition seemed to have no correlation with the patient’s age or how long they took the antibiotic.

The updated warnings apply to all approved fluoroquinolones: levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive).

According to the FDA, 23 million outpatients were prescribed an oral quinolone in 2011. A total of 70% received ciprofloxacin; 28% were prescribed levofloxacin; and 9% were given moxifloxacin. Gemifloxacin, ofloxacin, and norfloxacin each accounted for less than 1% of those patients in 2011.

There were 3.8 million inpatients who received an injectable quinolone in 2011. The most-prescribed was levofloxacin, accounting for 63% of prescriptions, followed by ciprofloxacin (28%) and moxifloxacin (13%).

The agency recommended that patients who develop neuropathy symptoms stop taking the quinolone and be treated with a different antibiotic, unless the benefit outweighs the risk. Patients taking the medications who develop symptoms are urged to tell their physician immediately.

aault@frontlinemedcom.com

On Twitter @aliciaault

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The Food and Drug Administration is requiring a stronger warning about the potential for peripheral neuropathy with fluoroquinolone antibiotics that are taken orally or by injection.

The warning does not apply to topical formulations, which have not been associated with neuropathy. Drug labels and patient medication guides must be updated, said the agency.

The potential for neuropathy was first added to the labels of all drugs in the class in 2004. The new warning was necessary because "the potential rapid onset and risk of permanence were not adequately described" in the 2004 label iteration, the FDA noted.

Before requiring new warnings, the FDA reviewed its Adverse Event Reporting System (FAERS, formerly known as AERS) database. The agency found that cases of fluoroquinolone-associated peripheral neuropathy with an outcome of "disability" had been reported to the AERS database between January 2003 and August 2012, although the FDA did not say how many cases it found. The reports indicated a rapid onset of peripheral neuropathy, often within a few days of starting the quinolone. Some cases reported neuropathy that continued for a year, even though the medication had been stopped.

The database was not able to show whether neuropathy was permanent, however, because it is designed to collect spontaneous reports.

The FDA said it had not been able to identify any risk factors for the development of peripheral neuropathy. But the onset of the condition seemed to have no correlation with the patient’s age or how long they took the antibiotic.

The updated warnings apply to all approved fluoroquinolones: levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive).

According to the FDA, 23 million outpatients were prescribed an oral quinolone in 2011. A total of 70% received ciprofloxacin; 28% were prescribed levofloxacin; and 9% were given moxifloxacin. Gemifloxacin, ofloxacin, and norfloxacin each accounted for less than 1% of those patients in 2011.

There were 3.8 million inpatients who received an injectable quinolone in 2011. The most-prescribed was levofloxacin, accounting for 63% of prescriptions, followed by ciprofloxacin (28%) and moxifloxacin (13%).

The agency recommended that patients who develop neuropathy symptoms stop taking the quinolone and be treated with a different antibiotic, unless the benefit outweighs the risk. Patients taking the medications who develop symptoms are urged to tell their physician immediately.

aault@frontlinemedcom.com

On Twitter @aliciaault

The Food and Drug Administration is requiring a stronger warning about the potential for peripheral neuropathy with fluoroquinolone antibiotics that are taken orally or by injection.

The warning does not apply to topical formulations, which have not been associated with neuropathy. Drug labels and patient medication guides must be updated, said the agency.

The potential for neuropathy was first added to the labels of all drugs in the class in 2004. The new warning was necessary because "the potential rapid onset and risk of permanence were not adequately described" in the 2004 label iteration, the FDA noted.

Before requiring new warnings, the FDA reviewed its Adverse Event Reporting System (FAERS, formerly known as AERS) database. The agency found that cases of fluoroquinolone-associated peripheral neuropathy with an outcome of "disability" had been reported to the AERS database between January 2003 and August 2012, although the FDA did not say how many cases it found. The reports indicated a rapid onset of peripheral neuropathy, often within a few days of starting the quinolone. Some cases reported neuropathy that continued for a year, even though the medication had been stopped.

The database was not able to show whether neuropathy was permanent, however, because it is designed to collect spontaneous reports.

The FDA said it had not been able to identify any risk factors for the development of peripheral neuropathy. But the onset of the condition seemed to have no correlation with the patient’s age or how long they took the antibiotic.

The updated warnings apply to all approved fluoroquinolones: levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive).

According to the FDA, 23 million outpatients were prescribed an oral quinolone in 2011. A total of 70% received ciprofloxacin; 28% were prescribed levofloxacin; and 9% were given moxifloxacin. Gemifloxacin, ofloxacin, and norfloxacin each accounted for less than 1% of those patients in 2011.

There were 3.8 million inpatients who received an injectable quinolone in 2011. The most-prescribed was levofloxacin, accounting for 63% of prescriptions, followed by ciprofloxacin (28%) and moxifloxacin (13%).

The agency recommended that patients who develop neuropathy symptoms stop taking the quinolone and be treated with a different antibiotic, unless the benefit outweighs the risk. Patients taking the medications who develop symptoms are urged to tell their physician immediately.

aault@frontlinemedcom.com

On Twitter @aliciaault

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Medicare pay values procedures over cognitive services

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Medicare pay values procedures over cognitive services

Medicare pays three to five times more per hour for two common procedures than it does for evaluation and management services, according to a new study, and that imbalance may help push physicians away from primary care careers.

Dr. Christine A. Sinsky, an internist in Dubuque, Iowa, and Dr. David C. Dugdale, of the division of general internal medicine at the University of Washington, Seattle, decided to delve into the disparities between pay for primary care and procedures, hypothesizing that the gap is helping tilt the health system toward an emphasis on procedural over cognitive care.

Their findings were published online Aug. 12 in JAMA Internal Medicine (doi: 10.1001/jamainternmed.2013.9257).

After reviewing their data, the authors squarely blame the American Medical Association’s Relative Value Scale Update Committee (RUC) and Medicare for creating incentives that reward procedures over complex management of chronic illness.

The study authors compared hourly revenue for a physician performing cognitive services (CPT code 99214) to the hourly revenue generated by a physician performing either screening colonoscopy (G code 0121) or cataract extraction (CPT code 66984). They chose these codes because they are among Medicare’s most billed codes. The 99214 code ranks second, cataract extraction is fourth, and colonoscopy is 36th.

The authors focused on the work-specific relative value unit (wRVU), saying that it most accurately reflected the amount of time physicians put into a visit or procedure.

They found that doctors billing the evaluation and management (E&M) code of 99214 received hourly revenue of $87. Screening colonoscopy, on the other hand, generated hourly revenue of $320, and cataract extraction generated $423 per hour.

These wages did not correspond to time spent on services, or intensity, said Dr. Sinsky and Dr. Dugdale.

The Centers for Medicare and Medicaid Services (CMS) requires physicians to spend 25 minutes face-to-face with the patient to be reimbursed for the 99214 code. There are no such requirements for procedural codes. Using reports in the literature, the authors estimated that a colonoscopy takes 13.5 minutes, and a cataract extraction takes 14 minutes.

However, the AMA’s RUC used vastly different times when it set the wRVU for both cognitive services and procedures, the authors said. According to their research, the RUC estimates that 99214 requires 40 minutes, a colonoscopy 75 minutes, and a cataract extraction 84 minutes. That results in hourly revenue of $77, $100, and $121, respectively – much less of a gap than what Dr. Sinsky and Dr. Dugdale found.

The researchers offered two explanations for the discrepancy between the RUC’s calculations and their own determinations.

First, primary care physicians are vastly underrepresented on the RUC, making up 16% of the voting members despite making up half of the U.S. physician population. The relative imbalance of primary care representation has been a source of ire for family physicians and internists.

Second, "the RUC method uses self-reported times for services in which the purpose of the survey (to establish payment rates) is known to the respondents who stand to benefit by inflated estimates," the study authors noted.

Dr. Sinsky and Dr. Dugdale said that their estimates may be conservative, because physicians who bill for cognitive services generally do a lot of work between appointments that is not reimbursed. Even if they can’t exactly quantify the gap, it is there, they said.

"Our model demonstrates that an ophthalmologist will receive more revenue from Medicare for four cataract extractions, typically requiring 1-2 hours of time, than a PCP [primary care physician] will receive for an entire day of delivering complex care for chronic illness to Medicare patients," they wrote.

Overall, the reimbursement gap is "a major contributor to the decline in the number of physicians choosing primary care careers," the researchers noted. And it likely also helps fuel the ongoing growth in "expensive procedural care," they added.

That "is worthy of further evaluation," concluded Dr. Sinsky and Dr. Dugdale.

Dr. Sinsky and Dr. Dugdale reported no conflicts of interest.

aault@frontlinemedcom.com

On Twitter @aliciaault

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Medicare pays three to five times more per hour for two common procedures than it does for evaluation and management services, according to a new study, and that imbalance may help push physicians away from primary care careers.

Dr. Christine A. Sinsky, an internist in Dubuque, Iowa, and Dr. David C. Dugdale, of the division of general internal medicine at the University of Washington, Seattle, decided to delve into the disparities between pay for primary care and procedures, hypothesizing that the gap is helping tilt the health system toward an emphasis on procedural over cognitive care.

Their findings were published online Aug. 12 in JAMA Internal Medicine (doi: 10.1001/jamainternmed.2013.9257).

After reviewing their data, the authors squarely blame the American Medical Association’s Relative Value Scale Update Committee (RUC) and Medicare for creating incentives that reward procedures over complex management of chronic illness.

The study authors compared hourly revenue for a physician performing cognitive services (CPT code 99214) to the hourly revenue generated by a physician performing either screening colonoscopy (G code 0121) or cataract extraction (CPT code 66984). They chose these codes because they are among Medicare’s most billed codes. The 99214 code ranks second, cataract extraction is fourth, and colonoscopy is 36th.

The authors focused on the work-specific relative value unit (wRVU), saying that it most accurately reflected the amount of time physicians put into a visit or procedure.

They found that doctors billing the evaluation and management (E&M) code of 99214 received hourly revenue of $87. Screening colonoscopy, on the other hand, generated hourly revenue of $320, and cataract extraction generated $423 per hour.

These wages did not correspond to time spent on services, or intensity, said Dr. Sinsky and Dr. Dugdale.

The Centers for Medicare and Medicaid Services (CMS) requires physicians to spend 25 minutes face-to-face with the patient to be reimbursed for the 99214 code. There are no such requirements for procedural codes. Using reports in the literature, the authors estimated that a colonoscopy takes 13.5 minutes, and a cataract extraction takes 14 minutes.

However, the AMA’s RUC used vastly different times when it set the wRVU for both cognitive services and procedures, the authors said. According to their research, the RUC estimates that 99214 requires 40 minutes, a colonoscopy 75 minutes, and a cataract extraction 84 minutes. That results in hourly revenue of $77, $100, and $121, respectively – much less of a gap than what Dr. Sinsky and Dr. Dugdale found.

The researchers offered two explanations for the discrepancy between the RUC’s calculations and their own determinations.

First, primary care physicians are vastly underrepresented on the RUC, making up 16% of the voting members despite making up half of the U.S. physician population. The relative imbalance of primary care representation has been a source of ire for family physicians and internists.

Second, "the RUC method uses self-reported times for services in which the purpose of the survey (to establish payment rates) is known to the respondents who stand to benefit by inflated estimates," the study authors noted.

Dr. Sinsky and Dr. Dugdale said that their estimates may be conservative, because physicians who bill for cognitive services generally do a lot of work between appointments that is not reimbursed. Even if they can’t exactly quantify the gap, it is there, they said.

"Our model demonstrates that an ophthalmologist will receive more revenue from Medicare for four cataract extractions, typically requiring 1-2 hours of time, than a PCP [primary care physician] will receive for an entire day of delivering complex care for chronic illness to Medicare patients," they wrote.

Overall, the reimbursement gap is "a major contributor to the decline in the number of physicians choosing primary care careers," the researchers noted. And it likely also helps fuel the ongoing growth in "expensive procedural care," they added.

That "is worthy of further evaluation," concluded Dr. Sinsky and Dr. Dugdale.

Dr. Sinsky and Dr. Dugdale reported no conflicts of interest.

aault@frontlinemedcom.com

On Twitter @aliciaault

Medicare pays three to five times more per hour for two common procedures than it does for evaluation and management services, according to a new study, and that imbalance may help push physicians away from primary care careers.

Dr. Christine A. Sinsky, an internist in Dubuque, Iowa, and Dr. David C. Dugdale, of the division of general internal medicine at the University of Washington, Seattle, decided to delve into the disparities between pay for primary care and procedures, hypothesizing that the gap is helping tilt the health system toward an emphasis on procedural over cognitive care.

Their findings were published online Aug. 12 in JAMA Internal Medicine (doi: 10.1001/jamainternmed.2013.9257).

After reviewing their data, the authors squarely blame the American Medical Association’s Relative Value Scale Update Committee (RUC) and Medicare for creating incentives that reward procedures over complex management of chronic illness.

The study authors compared hourly revenue for a physician performing cognitive services (CPT code 99214) to the hourly revenue generated by a physician performing either screening colonoscopy (G code 0121) or cataract extraction (CPT code 66984). They chose these codes because they are among Medicare’s most billed codes. The 99214 code ranks second, cataract extraction is fourth, and colonoscopy is 36th.

The authors focused on the work-specific relative value unit (wRVU), saying that it most accurately reflected the amount of time physicians put into a visit or procedure.

They found that doctors billing the evaluation and management (E&M) code of 99214 received hourly revenue of $87. Screening colonoscopy, on the other hand, generated hourly revenue of $320, and cataract extraction generated $423 per hour.

These wages did not correspond to time spent on services, or intensity, said Dr. Sinsky and Dr. Dugdale.

The Centers for Medicare and Medicaid Services (CMS) requires physicians to spend 25 minutes face-to-face with the patient to be reimbursed for the 99214 code. There are no such requirements for procedural codes. Using reports in the literature, the authors estimated that a colonoscopy takes 13.5 minutes, and a cataract extraction takes 14 minutes.

However, the AMA’s RUC used vastly different times when it set the wRVU for both cognitive services and procedures, the authors said. According to their research, the RUC estimates that 99214 requires 40 minutes, a colonoscopy 75 minutes, and a cataract extraction 84 minutes. That results in hourly revenue of $77, $100, and $121, respectively – much less of a gap than what Dr. Sinsky and Dr. Dugdale found.

The researchers offered two explanations for the discrepancy between the RUC’s calculations and their own determinations.

First, primary care physicians are vastly underrepresented on the RUC, making up 16% of the voting members despite making up half of the U.S. physician population. The relative imbalance of primary care representation has been a source of ire for family physicians and internists.

Second, "the RUC method uses self-reported times for services in which the purpose of the survey (to establish payment rates) is known to the respondents who stand to benefit by inflated estimates," the study authors noted.

Dr. Sinsky and Dr. Dugdale said that their estimates may be conservative, because physicians who bill for cognitive services generally do a lot of work between appointments that is not reimbursed. Even if they can’t exactly quantify the gap, it is there, they said.

"Our model demonstrates that an ophthalmologist will receive more revenue from Medicare for four cataract extractions, typically requiring 1-2 hours of time, than a PCP [primary care physician] will receive for an entire day of delivering complex care for chronic illness to Medicare patients," they wrote.

Overall, the reimbursement gap is "a major contributor to the decline in the number of physicians choosing primary care careers," the researchers noted. And it likely also helps fuel the ongoing growth in "expensive procedural care," they added.

That "is worthy of further evaluation," concluded Dr. Sinsky and Dr. Dugdale.

Dr. Sinsky and Dr. Dugdale reported no conflicts of interest.

aault@frontlinemedcom.com

On Twitter @aliciaault

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Major finding: Two common specialty procedures can generate more revenue in 1-2 hours than a primary care physician receives for an entire day’s work.

Data source: An observational study that used work relative value units to compare pay for an evaluation and management code, screening colonoscopy, and cataract extraction.

Disclosures: Dr. Sinsky and Dr. Dugdale reported no conflicts of interest.

House committee unanimously passes SGR replacement

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House committee unanimously passes SGR replacement

The demise of the Medicare Sustainable Growth Rate formula is a step closer to reality as the House Energy and Commerce Committee voted unanimously July 31 in favor of legislation that would remove the formula.

Both Democrats and Republicans on the committee supported the Medicare Patient Access and Quality Improvement Act of 2013 in a 51-0 vote. The legislation, H.R. 2810, was authored by Rep. Michael Burgess (R-Tex.), and developed with input from physician organizations.

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Rep. Michael Burgess

If enacted, the legislation would replace the SGR with a 0.5% payment increase for physicians from 2014 through 2018. It would continue to support fee-for-service medicine, but also encourage the formation of new delivery models and reward reporting of quality data.

"In harnessing the ideas of the medical profession, and working as a team with Energy and Commerce Democrats as well as Ways and Means Republicans, we have crafted a policy that will not only get out of committee but has the merits to make it to the president’s desk," Rep. Fred Upton (R-Mich.), chairman of the Energy and Commerce Committee, said in a statement.

Rep. Henry Waxman (D-Calif.), the committee’s ranking minority member, said, "What is obvious today is that we have a bipartisan commitment to try to solve this problem. And that when we decide to work together, we can achieve positive results." He also noted that "in more than a decade of saying something needs to be done, I’m pleased that this committee is the first to act to bring this issue to the forefront."

The American College of Physicians said it was mostly pleased with the legislation and its progress. In addition to rewarding physician efficiency, "the bill promises to accelerate the growth of patient-centered medical homes, an innovative primary care delivery model that has been shown to improve outcomes and lower the costs of care for patients across the country," said Dr. Molly Cooke, ACP president, in a statement.

The college "looks forward to continuing to work with the House and Senate on a bipartisan basis to get legislation enacted this year that includes these and other key elements of the House Energy and Commerce Committee bill, plus additional improvements needed to accelerate the movement toward high-value, patient-centered health care."

The American Medical Association and the American Academy of Family Physicians also support the legislation. When the bill was approved by the Energy and Commerce Health Subcommittee, the AAFP said it was disappointed that the bill did not have higher payments for primary care.

During those deliberations, the AMA, AAFP, ACP, and some state medical societies also told the committee that a provision addressing misvalued codes could end up cutting physician pay. They’ve asked the committee to consider an amendment that would remove the misvalued code provisions from the bill; such an amendment was not considered by the committee.

The legislation still has a long path to passage. The House Ways and Means Committee and the Senate Finance Committee have also been working on legislation to replace the SGR. And so far, legislators in both houses have not addressed how to pay for an SGR fix.

Several Energy and Commerce Committee members acknowledged the looming financial reality during deliberations.

"One of the largest hurdles to overcome will be how to pay for the cost associated with fixing the SGR," said Rep. Eliot Engel (D-N.Y.). He urged his colleagues to continue the spirit of bipartisanship when figuring out the cost of replacement.

"We know that the work is not done," said Rep. Phil Gingrey (R-Ga.). "Any fiscally responsible bill in today’s budgetary environment must be paid for. I look forward to finding offsets that do not impact the practice of medicine but instead focus on good governance and combating waste," said the congressman, who is also an ob.gyn.

That work will likely come in September, when Congress returns from its summer recess.

aault@frontlinemedcom.com On Twitter @aliciaault

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The demise of the Medicare Sustainable Growth Rate formula is a step closer to reality as the House Energy and Commerce Committee voted unanimously July 31 in favor of legislation that would remove the formula.

Both Democrats and Republicans on the committee supported the Medicare Patient Access and Quality Improvement Act of 2013 in a 51-0 vote. The legislation, H.R. 2810, was authored by Rep. Michael Burgess (R-Tex.), and developed with input from physician organizations.

Alicia Ault/IMNG Medical Media
Rep. Michael Burgess

If enacted, the legislation would replace the SGR with a 0.5% payment increase for physicians from 2014 through 2018. It would continue to support fee-for-service medicine, but also encourage the formation of new delivery models and reward reporting of quality data.

"In harnessing the ideas of the medical profession, and working as a team with Energy and Commerce Democrats as well as Ways and Means Republicans, we have crafted a policy that will not only get out of committee but has the merits to make it to the president’s desk," Rep. Fred Upton (R-Mich.), chairman of the Energy and Commerce Committee, said in a statement.

Rep. Henry Waxman (D-Calif.), the committee’s ranking minority member, said, "What is obvious today is that we have a bipartisan commitment to try to solve this problem. And that when we decide to work together, we can achieve positive results." He also noted that "in more than a decade of saying something needs to be done, I’m pleased that this committee is the first to act to bring this issue to the forefront."

The American College of Physicians said it was mostly pleased with the legislation and its progress. In addition to rewarding physician efficiency, "the bill promises to accelerate the growth of patient-centered medical homes, an innovative primary care delivery model that has been shown to improve outcomes and lower the costs of care for patients across the country," said Dr. Molly Cooke, ACP president, in a statement.

The college "looks forward to continuing to work with the House and Senate on a bipartisan basis to get legislation enacted this year that includes these and other key elements of the House Energy and Commerce Committee bill, plus additional improvements needed to accelerate the movement toward high-value, patient-centered health care."

The American Medical Association and the American Academy of Family Physicians also support the legislation. When the bill was approved by the Energy and Commerce Health Subcommittee, the AAFP said it was disappointed that the bill did not have higher payments for primary care.

During those deliberations, the AMA, AAFP, ACP, and some state medical societies also told the committee that a provision addressing misvalued codes could end up cutting physician pay. They’ve asked the committee to consider an amendment that would remove the misvalued code provisions from the bill; such an amendment was not considered by the committee.

The legislation still has a long path to passage. The House Ways and Means Committee and the Senate Finance Committee have also been working on legislation to replace the SGR. And so far, legislators in both houses have not addressed how to pay for an SGR fix.

Several Energy and Commerce Committee members acknowledged the looming financial reality during deliberations.

"One of the largest hurdles to overcome will be how to pay for the cost associated with fixing the SGR," said Rep. Eliot Engel (D-N.Y.). He urged his colleagues to continue the spirit of bipartisanship when figuring out the cost of replacement.

"We know that the work is not done," said Rep. Phil Gingrey (R-Ga.). "Any fiscally responsible bill in today’s budgetary environment must be paid for. I look forward to finding offsets that do not impact the practice of medicine but instead focus on good governance and combating waste," said the congressman, who is also an ob.gyn.

That work will likely come in September, when Congress returns from its summer recess.

aault@frontlinemedcom.com On Twitter @aliciaault

The demise of the Medicare Sustainable Growth Rate formula is a step closer to reality as the House Energy and Commerce Committee voted unanimously July 31 in favor of legislation that would remove the formula.

Both Democrats and Republicans on the committee supported the Medicare Patient Access and Quality Improvement Act of 2013 in a 51-0 vote. The legislation, H.R. 2810, was authored by Rep. Michael Burgess (R-Tex.), and developed with input from physician organizations.

Alicia Ault/IMNG Medical Media
Rep. Michael Burgess

If enacted, the legislation would replace the SGR with a 0.5% payment increase for physicians from 2014 through 2018. It would continue to support fee-for-service medicine, but also encourage the formation of new delivery models and reward reporting of quality data.

"In harnessing the ideas of the medical profession, and working as a team with Energy and Commerce Democrats as well as Ways and Means Republicans, we have crafted a policy that will not only get out of committee but has the merits to make it to the president’s desk," Rep. Fred Upton (R-Mich.), chairman of the Energy and Commerce Committee, said in a statement.

Rep. Henry Waxman (D-Calif.), the committee’s ranking minority member, said, "What is obvious today is that we have a bipartisan commitment to try to solve this problem. And that when we decide to work together, we can achieve positive results." He also noted that "in more than a decade of saying something needs to be done, I’m pleased that this committee is the first to act to bring this issue to the forefront."

The American College of Physicians said it was mostly pleased with the legislation and its progress. In addition to rewarding physician efficiency, "the bill promises to accelerate the growth of patient-centered medical homes, an innovative primary care delivery model that has been shown to improve outcomes and lower the costs of care for patients across the country," said Dr. Molly Cooke, ACP president, in a statement.

The college "looks forward to continuing to work with the House and Senate on a bipartisan basis to get legislation enacted this year that includes these and other key elements of the House Energy and Commerce Committee bill, plus additional improvements needed to accelerate the movement toward high-value, patient-centered health care."

The American Medical Association and the American Academy of Family Physicians also support the legislation. When the bill was approved by the Energy and Commerce Health Subcommittee, the AAFP said it was disappointed that the bill did not have higher payments for primary care.

During those deliberations, the AMA, AAFP, ACP, and some state medical societies also told the committee that a provision addressing misvalued codes could end up cutting physician pay. They’ve asked the committee to consider an amendment that would remove the misvalued code provisions from the bill; such an amendment was not considered by the committee.

The legislation still has a long path to passage. The House Ways and Means Committee and the Senate Finance Committee have also been working on legislation to replace the SGR. And so far, legislators in both houses have not addressed how to pay for an SGR fix.

Several Energy and Commerce Committee members acknowledged the looming financial reality during deliberations.

"One of the largest hurdles to overcome will be how to pay for the cost associated with fixing the SGR," said Rep. Eliot Engel (D-N.Y.). He urged his colleagues to continue the spirit of bipartisanship when figuring out the cost of replacement.

"We know that the work is not done," said Rep. Phil Gingrey (R-Ga.). "Any fiscally responsible bill in today’s budgetary environment must be paid for. I look forward to finding offsets that do not impact the practice of medicine but instead focus on good governance and combating waste," said the congressman, who is also an ob.gyn.

That work will likely come in September, when Congress returns from its summer recess.

aault@frontlinemedcom.com On Twitter @aliciaault

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GAO: In-house pathology is a conflict

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Physicians may be profiting by referring pathology services on biopsies to in-house labs or to pathology labs where they have an ownership stake, according to a report from the Government Accountability Office released July 16.

The agency found that three specialties – dermatology, gastroenterology, and urology – accounted for 90% of the self-referrals in 2010. Dermatologists alone accounted for half of those self-referrals.

The practice is costing Medicare millions and resulting in excess treatments, according to the report. The agency estimated that overall in 2010, self-referring providers likely referred 918,000 more pathology services than did physicians referring to labs in which they did not have a stake. The extra tests cost Medicare about $69 million out of a total $1.28 billion tab paid to physicians, pathologists, and labs in that year.

Overall, from 2004 to 2010, "the number of self-referred anatomic pathology services more than doubled, growing from 1.06 million services to about 2.26 million services, while non–self-referred services grew about 38%, from about 5.64 million services to about 7.77 million services," according to the report.

Self-referring providers include those who have an ownership stake in a clinical lab, but more commonly, those who prepare and/or evaluate specimens in their practices.

Referrals were highest for physicians in the year after they began to self-refer, suggesting that referrals were driven by financial incentives, not by any change in clinical practice or by any demographic change, according to the GAO.

Calling these physicians "switchers," the GAO found a 24% increase in referrals for pathology services among dermatologists who self-referred in 2010, compared to only a 0.3% increase for those who sent biopsy specimens elsewhere.

The GAO conducted its investigation at the request of Rep. Henry A. Waxman (D-Calif.), Rep. Sander Levin (D-Mich.), Sen. Max Baucus (D-Mont.), and Sen. Chuck Grassley (R-Iowa).

"The analysis suggests that financial incentives for self-referring providers is likely a major factor driving the increase in referrals for these services," Rep. Waxman said in a joint statement from the legislators.

"As Congress looks to rein in unnecessary spending, my colleagues and I should explore this area in greater depth," he said.

Sen. Grassley added, "Federal policy should drive doctors to make decisions based on quality of care, not financial relationships. The taxpayers shouldn’t have to pay for services that aren’t medically necessary."

The GAO suggested that the Centers for Medicare and Medicaid Services should require providers to state on claims whether a service was self-referred, and that the agency should limit payment so that physicians aren’t rewarded for higher numbers of specimens per biopsy.

In comments to the GAO on the report, the American Academy of Dermatology Association said that it agreed that the CMS should develop a way to ensure the appropriateness of biopsy procedures. But the AADA expressed concern about limitations on financial incentives, saying that dermatologists should be encouraged to perform biopsies. The AADA also said that dermatologists should be allowed to prepare and review their own specimens "because they receive considerable training as part of their education."

aault@frontlinemedcom.com

On Twitter @aliciaault

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Physicians may be profiting by referring pathology services on biopsies to in-house labs or to pathology labs where they have an ownership stake, according to a report from the Government Accountability Office released July 16.

The agency found that three specialties – dermatology, gastroenterology, and urology – accounted for 90% of the self-referrals in 2010. Dermatologists alone accounted for half of those self-referrals.

The practice is costing Medicare millions and resulting in excess treatments, according to the report. The agency estimated that overall in 2010, self-referring providers likely referred 918,000 more pathology services than did physicians referring to labs in which they did not have a stake. The extra tests cost Medicare about $69 million out of a total $1.28 billion tab paid to physicians, pathologists, and labs in that year.

Overall, from 2004 to 2010, "the number of self-referred anatomic pathology services more than doubled, growing from 1.06 million services to about 2.26 million services, while non–self-referred services grew about 38%, from about 5.64 million services to about 7.77 million services," according to the report.

Self-referring providers include those who have an ownership stake in a clinical lab, but more commonly, those who prepare and/or evaluate specimens in their practices.

Referrals were highest for physicians in the year after they began to self-refer, suggesting that referrals were driven by financial incentives, not by any change in clinical practice or by any demographic change, according to the GAO.

Calling these physicians "switchers," the GAO found a 24% increase in referrals for pathology services among dermatologists who self-referred in 2010, compared to only a 0.3% increase for those who sent biopsy specimens elsewhere.

The GAO conducted its investigation at the request of Rep. Henry A. Waxman (D-Calif.), Rep. Sander Levin (D-Mich.), Sen. Max Baucus (D-Mont.), and Sen. Chuck Grassley (R-Iowa).

"The analysis suggests that financial incentives for self-referring providers is likely a major factor driving the increase in referrals for these services," Rep. Waxman said in a joint statement from the legislators.

"As Congress looks to rein in unnecessary spending, my colleagues and I should explore this area in greater depth," he said.

Sen. Grassley added, "Federal policy should drive doctors to make decisions based on quality of care, not financial relationships. The taxpayers shouldn’t have to pay for services that aren’t medically necessary."

The GAO suggested that the Centers for Medicare and Medicaid Services should require providers to state on claims whether a service was self-referred, and that the agency should limit payment so that physicians aren’t rewarded for higher numbers of specimens per biopsy.

In comments to the GAO on the report, the American Academy of Dermatology Association said that it agreed that the CMS should develop a way to ensure the appropriateness of biopsy procedures. But the AADA expressed concern about limitations on financial incentives, saying that dermatologists should be encouraged to perform biopsies. The AADA also said that dermatologists should be allowed to prepare and review their own specimens "because they receive considerable training as part of their education."

aault@frontlinemedcom.com

On Twitter @aliciaault

Physicians may be profiting by referring pathology services on biopsies to in-house labs or to pathology labs where they have an ownership stake, according to a report from the Government Accountability Office released July 16.

The agency found that three specialties – dermatology, gastroenterology, and urology – accounted for 90% of the self-referrals in 2010. Dermatologists alone accounted for half of those self-referrals.

The practice is costing Medicare millions and resulting in excess treatments, according to the report. The agency estimated that overall in 2010, self-referring providers likely referred 918,000 more pathology services than did physicians referring to labs in which they did not have a stake. The extra tests cost Medicare about $69 million out of a total $1.28 billion tab paid to physicians, pathologists, and labs in that year.

Overall, from 2004 to 2010, "the number of self-referred anatomic pathology services more than doubled, growing from 1.06 million services to about 2.26 million services, while non–self-referred services grew about 38%, from about 5.64 million services to about 7.77 million services," according to the report.

Self-referring providers include those who have an ownership stake in a clinical lab, but more commonly, those who prepare and/or evaluate specimens in their practices.

Referrals were highest for physicians in the year after they began to self-refer, suggesting that referrals were driven by financial incentives, not by any change in clinical practice or by any demographic change, according to the GAO.

Calling these physicians "switchers," the GAO found a 24% increase in referrals for pathology services among dermatologists who self-referred in 2010, compared to only a 0.3% increase for those who sent biopsy specimens elsewhere.

The GAO conducted its investigation at the request of Rep. Henry A. Waxman (D-Calif.), Rep. Sander Levin (D-Mich.), Sen. Max Baucus (D-Mont.), and Sen. Chuck Grassley (R-Iowa).

"The analysis suggests that financial incentives for self-referring providers is likely a major factor driving the increase in referrals for these services," Rep. Waxman said in a joint statement from the legislators.

"As Congress looks to rein in unnecessary spending, my colleagues and I should explore this area in greater depth," he said.

Sen. Grassley added, "Federal policy should drive doctors to make decisions based on quality of care, not financial relationships. The taxpayers shouldn’t have to pay for services that aren’t medically necessary."

The GAO suggested that the Centers for Medicare and Medicaid Services should require providers to state on claims whether a service was self-referred, and that the agency should limit payment so that physicians aren’t rewarded for higher numbers of specimens per biopsy.

In comments to the GAO on the report, the American Academy of Dermatology Association said that it agreed that the CMS should develop a way to ensure the appropriateness of biopsy procedures. But the AADA expressed concern about limitations on financial incentives, saying that dermatologists should be encouraged to perform biopsies. The AADA also said that dermatologists should be allowed to prepare and review their own specimens "because they receive considerable training as part of their education."

aault@frontlinemedcom.com

On Twitter @aliciaault

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