Alicia Ault

WASHINGTON –A bill with bipartisan sponsors has been introduced in the U.S. House of Representatives to permanently repeal Medicare’s Sustainable Growth Rate formula.

Rep. Joe Heck (R-Nev.) and Rep. Allyson Schwartz (D-Penn.) unveiled their proposal at a briefing with reporters on Feb. 6. They were surrounded by supporters, including representatives from the American College of Physicians, the American Academy of Family Physicians, the American College of Osteopathic Family Physicians, and the National Coalition on Health Care.

In addition to repealing the SGR, the bill also "stabilizes the current payment system for physicians," said Rep. Schwartz, who added that it also "aggressively" tests new payment and delivery models and rewards high value, high quality health care.

Rep. Schwartz and Rep. Heck, an osteopathic physician trained in emergency medicine, also introduced the bill in the last Congress. But both said that they think that legislators are primed to act, in part because of the struggle to reduce health care spending and the deficit.

If the SGR is not replaced or repealed by the end of the year, physicians will see a 27% reduction in pay beginning in January 2014. Each year the cuts are delayed merely adds more on to the final tally for fixing the formula, noted Rep. Heck. The Congressional Budget Office estimated in its latest economic outlook released on Feb. 5 that it would cost about $138 billion to permanently repeal the SGR. That’s less than the $245 billion in previous CBO estimates.

"The time right now is perfect to finally pass this legislation," said Rep. Heck.

"I think the imminent process of sequestration may add a little urgency to reform because across the board cuts are not going to get us where we need to go," said John Rother, president and CEO of the National Coalition on Health Care, an umbrella group representing medical societies, businesses, unions, health care providers, religious associations, insurers, and consumers. "And the alternative here is smarter and much more oriented toward value, and it provides a very practical and beneficial alternative to the kind of meat-axe approaches in sequestration," Mr. Rother said.

Physician groups said they are hopeful that the proposal has legs this year. Dr. Carla H. Ginsburg, AGAF, chair of the Public Affairs and Advocacy Committee for the AGA said, "The AGA applauds Rep. Schwartz and [Rep.] Heck for offering a bipartisan plan to address the broken Medicare physician payment system and transition physicians into a system that rewards physicians for improved quality and efficiency....However, we are concerned about any proposal that penalizes physicians who remain in a fee-for-service model. It is important to recognize the variations in practices and diversity both geographically and in size of practice and to provide physicians with options of delivery models that may work best for them. "

Dr. Chuck Cutler, chair-elect of the ACP Board of Regents, said that "the stability that this bill brings to the marketplace and to our practice is particularly encouraging." He also said that the ACP was happy that the bill would maintain 2013 payment levels through the end of 2014 and then provide "positive and predictable updates" through 2019.

That is especially important as physicians test out new delivery and payment models, said Dr. Cutler.

From 2015 to 2018, the bill calls for annual increases of 2.5% for primary care, preventive, and care-coordination services. All other physicians would get a 0.5% increase for the 4-year period.

By 2019, physicians who continue to use a volume-drive fee-for-service model would get a smaller increase than would those who have transitioned to new models.

In addition to the groups who participated in the briefing, the bill also is supported by the American College of Obstetricians and Gynecologists, the Society of Hospital Medicine, the American College of Rheumatology, the American College of Cardiology, the American Academy of Neurology, and the American Academy of Pediatrics.

a.ault@elsevier.com

On Twitter @aliciaault

WASHINGTON –A bill with bipartisan sponsors has been introduced in the U.S. House of Representatives to permanently repeal Medicare’s Sustainable Growth Rate formula.

Rep. Joe Heck (R-Nev.) and Rep. Allyson Schwartz (D-Penn.) unveiled their proposal at a briefing with reporters on Feb. 6. They were surrounded by supporters, including representatives from the American College of Physicians, the American Academy of Family Physicians, the American College of Osteopathic Family Physicians, and the National Coalition on Health Care.

In addition to repealing the SGR, the bill also "stabilizes the current payment system for physicians," said Rep. Schwartz, who added that it also "aggressively" tests new payment and delivery models and rewards high value, high quality health care.

Rep. Schwartz and Rep. Heck, an osteopathic physician trained in emergency medicine, also introduced the bill in the last Congress. But both said that they think that legislators are primed to act, in part because of the struggle to reduce health care spending and the deficit.

If the SGR is not replaced or repealed by the end of the year, physicians will see a 27% reduction in pay beginning in January 2014. Each year the cuts are delayed merely adds more on to the final tally for fixing the formula, noted Rep. Heck. The Congressional Budget Office estimated in its latest economic outlook released on Feb. 5 that it would cost about $138 billion to permanently repeal the SGR. That’s less than the $245 billion in previous CBO estimates.

"The time right now is perfect to finally pass this legislation," said Rep. Heck.

"I think the imminent process of sequestration may add a little urgency to reform because across the board cuts are not going to get us where we need to go," said John Rother, president and CEO of the National Coalition on Health Care, an umbrella group representing medical societies, businesses, unions, health care providers, religious associations, insurers, and consumers. "And the alternative here is smarter and much more oriented toward value, and it provides a very practical and beneficial alternative to the kind of meat-axe approaches in sequestration," Mr. Rother said.

Physician groups said they are hopeful that the proposal has legs this year. Dr. Carla H. Ginsburg, AGAF, chair of the Public Affairs and Advocacy Committee for the AGA said, "The AGA applauds Rep. Schwartz and [Rep.] Heck for offering a bipartisan plan to address the broken Medicare physician payment system and transition physicians into a system that rewards physicians for improved quality and efficiency....However, we are concerned about any proposal that penalizes physicians who remain in a fee-for-service model. It is important to recognize the variations in practices and diversity both geographically and in size of practice and to provide physicians with options of delivery models that may work best for them. "

Dr. Chuck Cutler, chair-elect of the ACP Board of Regents, said that "the stability that this bill brings to the marketplace and to our practice is particularly encouraging." He also said that the ACP was happy that the bill would maintain 2013 payment levels through the end of 2014 and then provide "positive and predictable updates" through 2019.

That is especially important as physicians test out new delivery and payment models, said Dr. Cutler.

From 2015 to 2018, the bill calls for annual increases of 2.5% for primary care, preventive, and care-coordination services. All other physicians would get a 0.5% increase for the 4-year period.

By 2019, physicians who continue to use a volume-drive fee-for-service model would get a smaller increase than would those who have transitioned to new models.

In addition to the groups who participated in the briefing, the bill also is supported by the American College of Obstetricians and Gynecologists, the Society of Hospital Medicine, the American College of Rheumatology, the American College of Cardiology, the American Academy of Neurology, and the American Academy of Pediatrics.

a.ault@elsevier.com

On Twitter @aliciaault

WASHINGTON –A bill with bipartisan sponsors has been introduced in the U.S. House of Representatives to permanently repeal Medicare’s Sustainable Growth Rate formula.

Rep. Joe Heck (R-Nev.) and Rep. Allyson Schwartz (D-Penn.) unveiled their proposal at a briefing with reporters on Feb. 6. They were surrounded by supporters, including representatives from the American College of Physicians, the American Academy of Family Physicians, the American College of Osteopathic Family Physicians, and the National Coalition on Health Care.

In addition to repealing the SGR, the bill also "stabilizes the current payment system for physicians," said Rep. Schwartz, who added that it also "aggressively" tests new payment and delivery models and rewards high value, high quality health care.

Rep. Schwartz and Rep. Heck, an osteopathic physician trained in emergency medicine, also introduced the bill in the last Congress. But both said that they think that legislators are primed to act, in part because of the struggle to reduce health care spending and the deficit.

If the SGR is not replaced or repealed by the end of the year, physicians will see a 27% reduction in pay beginning in January 2014. Each year the cuts are delayed merely adds more on to the final tally for fixing the formula, noted Rep. Heck. The Congressional Budget Office estimated in its latest economic outlook released on Feb. 5 that it would cost about $138 billion to permanently repeal the SGR. That’s less than the $245 billion in previous CBO estimates.

"The time right now is perfect to finally pass this legislation," said Rep. Heck.

"I think the imminent process of sequestration may add a little urgency to reform because across the board cuts are not going to get us where we need to go," said John Rother, president and CEO of the National Coalition on Health Care, an umbrella group representing medical societies, businesses, unions, health care providers, religious associations, insurers, and consumers. "And the alternative here is smarter and much more oriented toward value, and it provides a very practical and beneficial alternative to the kind of meat-axe approaches in sequestration," Mr. Rother said.

Physician groups said they are hopeful that the proposal has legs this year. Dr. Carla H. Ginsburg, AGAF, chair of the Public Affairs and Advocacy Committee for the AGA said, "The AGA applauds Rep. Schwartz and [Rep.] Heck for offering a bipartisan plan to address the broken Medicare physician payment system and transition physicians into a system that rewards physicians for improved quality and efficiency....However, we are concerned about any proposal that penalizes physicians who remain in a fee-for-service model. It is important to recognize the variations in practices and diversity both geographically and in size of practice and to provide physicians with options of delivery models that may work best for them. "

Dr. Chuck Cutler, chair-elect of the ACP Board of Regents, said that "the stability that this bill brings to the marketplace and to our practice is particularly encouraging." He also said that the ACP was happy that the bill would maintain 2013 payment levels through the end of 2014 and then provide "positive and predictable updates" through 2019.

That is especially important as physicians test out new delivery and payment models, said Dr. Cutler.

From 2015 to 2018, the bill calls for annual increases of 2.5% for primary care, preventive, and care-coordination services. All other physicians would get a 0.5% increase for the 4-year period.

By 2019, physicians who continue to use a volume-drive fee-for-service model would get a smaller increase than would those who have transitioned to new models.

In addition to the groups who participated in the briefing, the bill also is supported by the American College of Obstetricians and Gynecologists, the Society of Hospital Medicine, the American College of Rheumatology, the American College of Cardiology, the American Academy of Neurology, and the American Academy of Pediatrics.

a.ault@elsevier.com

On Twitter @aliciaault

WASHINGTON -- A bill with bipartisan sponsors has been introduced in the U.S. House of Representatives to permanently repeal Medicare's Sustainable Growth Rate formula.

Rep. Joe Heck (R-Nev.) and Rep. Allyson Schwartz (D-Penn.) unveiled their proposal at a briefing with reporters on Feb. 6. They were surrounded by supporters, including representatives from the American College of Physicians, the American Academy of Family Physicians, the American College of Osteopathic Family Physicians, and the National Coalition on Health Care.

In addition to repealing the SGR, the bill also "stabilizes the current payment system for physicians, and it institutes measures to ensure access to primary care with increased updates for primary care physicians in the short term," said Rep. Schwartz, who added that it also "aggressively" tests new payment and delivery models and rewards high value, high quality health care.

Rep. Schwartz and Rep. Heck, an osteopathic physician trained in emergency medicine, also introduced the bill in the last Congress. But both said that they think that legislators are primed to act, in part because of the struggle to reduce health care spending and the deficit.

If the SGR is not replaced or repealed by the end of the year, physicians will see a 27% reduction in pay beginning in January 2014. Each year the cuts are delayed merely adds more on to the final tally for fixing the formula, noted Rep. Heck. The Congressional Budget Office estimated in its latest economic outlook released on Feb. 5 that it would cost about $138 billion to permanently repeal the SGR. That's less than the $245 billion in previous CBO estimates.

"The time right now is perfect to finally pass this legislation," said Rep. Heck.

"I think the imminent process of sequestration may add a little urgency to reform because across the board cuts are not going to get us where we need to go," said John Rother, president and CEO of the National Coalition on Health Care, an umbrella group representing medical societies, businesses, unions, health care providers, religious associations, insurers, and consumers. "And the alternative here is smarter and much more oriented toward value, and it provides a very practical and beneficial alternative to the kind of meat-axe approaches in sequestration," Mr. Rother said.

Physician groups said they are hopeful that the proposal has legs this year.

The constant uncertainty about whether SGR cuts will occur "undermines the family doctor's ability to continue to keep doors open and to invest in their practices," said Dr. Jeffrey Cain, president of the AAFP. He praised the Heck-Schwartz bill, which had not been officially introduced in the House at press time, saying that it would put an end to "the annual question of whether physicians can continue to afford to practice in Medicare," and that it also "stabilizes the Medicare cost system and provides solutions that are based on successful and proven methods that can improve quality and incent value."

Dr. Chuck Cutler, chair-elect of the ACP Board of Regents, said that "the stability that this bill brings to the marketplace and to our practice is particularly encouraging." He also said that the ACP was happy that the bill would maintain 2013 payment levels through the end of 2014 and then provide "positive and predictable updates" through 2019.

That is especially important as physicians test out new delivery and payment models, said Dr. Cutler.

From 2015 to 2018, the bill calls for annual increases of 2.5% for primary care, preventive, and care-coordination services. All other physicians would get a 0.5% increase for the 4-year period.

By 2019, physicians who continue to use a volume-drive fee-for-service model would get a smaller increase than would those who have transitioned to new models.

In addition to the groups who participated in the briefing, the bill also is supported by the American College of Obstetricians and Gynecologists, the Society of Hospital Medicine, the American College of Rheumatology, the American College of Cardiology, the American Academy of Neurology, and the American Academy of Pediatrics.

a.ault@elsevier.com

On Twitter @aliciaault

WASHINGTON -- A bill with bipartisan sponsors has been introduced in the U.S. House of Representatives to permanently repeal Medicare's Sustainable Growth Rate formula.

Rep. Joe Heck (R-Nev.) and Rep. Allyson Schwartz (D-Penn.) unveiled their proposal at a briefing with reporters on Feb. 6. They were surrounded by supporters, including representatives from the American College of Physicians, the American Academy of Family Physicians, the American College of Osteopathic Family Physicians, and the National Coalition on Health Care.

In addition to repealing the SGR, the bill also "stabilizes the current payment system for physicians, and it institutes measures to ensure access to primary care with increased updates for primary care physicians in the short term," said Rep. Schwartz, who added that it also "aggressively" tests new payment and delivery models and rewards high value, high quality health care.

Rep. Schwartz and Rep. Heck, an osteopathic physician trained in emergency medicine, also introduced the bill in the last Congress. But both said that they think that legislators are primed to act, in part because of the struggle to reduce health care spending and the deficit.

If the SGR is not replaced or repealed by the end of the year, physicians will see a 27% reduction in pay beginning in January 2014. Each year the cuts are delayed merely adds more on to the final tally for fixing the formula, noted Rep. Heck. The Congressional Budget Office estimated in its latest economic outlook released on Feb. 5 that it would cost about $138 billion to permanently repeal the SGR. That's less than the $245 billion in previous CBO estimates.

"The time right now is perfect to finally pass this legislation," said Rep. Heck.

"I think the imminent process of sequestration may add a little urgency to reform because across the board cuts are not going to get us where we need to go," said John Rother, president and CEO of the National Coalition on Health Care, an umbrella group representing medical societies, businesses, unions, health care providers, religious associations, insurers, and consumers. "And the alternative here is smarter and much more oriented toward value, and it provides a very practical and beneficial alternative to the kind of meat-axe approaches in sequestration," Mr. Rother said.

Physician groups said they are hopeful that the proposal has legs this year.

The constant uncertainty about whether SGR cuts will occur "undermines the family doctor's ability to continue to keep doors open and to invest in their practices," said Dr. Jeffrey Cain, president of the AAFP. He praised the Heck-Schwartz bill, which had not been officially introduced in the House at press time, saying that it would put an end to "the annual question of whether physicians can continue to afford to practice in Medicare," and that it also "stabilizes the Medicare cost system and provides solutions that are based on successful and proven methods that can improve quality and incent value."

Dr. Chuck Cutler, chair-elect of the ACP Board of Regents, said that "the stability that this bill brings to the marketplace and to our practice is particularly encouraging." He also said that the ACP was happy that the bill would maintain 2013 payment levels through the end of 2014 and then provide "positive and predictable updates" through 2019.

That is especially important as physicians test out new delivery and payment models, said Dr. Cutler.

From 2015 to 2018, the bill calls for annual increases of 2.5% for primary care, preventive, and care-coordination services. All other physicians would get a 0.5% increase for the 4-year period.

By 2019, physicians who continue to use a volume-drive fee-for-service model would get a smaller increase than would those who have transitioned to new models.

In addition to the groups who participated in the briefing, the bill also is supported by the American College of Obstetricians and Gynecologists, the Society of Hospital Medicine, the American College of Rheumatology, the American College of Cardiology, the American Academy of Neurology, and the American Academy of Pediatrics.

a.ault@elsevier.com

On Twitter @aliciaault

WASHINGTON -- A bill with bipartisan sponsors has been introduced in the U.S. House of Representatives to permanently repeal Medicare's Sustainable Growth Rate formula.

Rep. Joe Heck (R-Nev.) and Rep. Allyson Schwartz (D-Penn.) unveiled their proposal at a briefing with reporters on Feb. 6. They were surrounded by supporters, including representatives from the American College of Physicians, the American Academy of Family Physicians, the American College of Osteopathic Family Physicians, and the National Coalition on Health Care.

In addition to repealing the SGR, the bill also "stabilizes the current payment system for physicians, and it institutes measures to ensure access to primary care with increased updates for primary care physicians in the short term," said Rep. Schwartz, who added that it also "aggressively" tests new payment and delivery models and rewards high value, high quality health care.

Rep. Schwartz and Rep. Heck, an osteopathic physician trained in emergency medicine, also introduced the bill in the last Congress. But both said that they think that legislators are primed to act, in part because of the struggle to reduce health care spending and the deficit.

If the SGR is not replaced or repealed by the end of the year, physicians will see a 27% reduction in pay beginning in January 2014. Each year the cuts are delayed merely adds more on to the final tally for fixing the formula, noted Rep. Heck. The Congressional Budget Office estimated in its latest economic outlook released on Feb. 5 that it would cost about $138 billion to permanently repeal the SGR. That's less than the $245 billion in previous CBO estimates.

"The time right now is perfect to finally pass this legislation," said Rep. Heck.

"I think the imminent process of sequestration may add a little urgency to reform because across the board cuts are not going to get us where we need to go," said John Rother, president and CEO of the National Coalition on Health Care, an umbrella group representing medical societies, businesses, unions, health care providers, religious associations, insurers, and consumers. "And the alternative here is smarter and much more oriented toward value, and it provides a very practical and beneficial alternative to the kind of meat-axe approaches in sequestration," Mr. Rother said.

Physician groups said they are hopeful that the proposal has legs this year.

The constant uncertainty about whether SGR cuts will occur "undermines the family doctor's ability to continue to keep doors open and to invest in their practices," said Dr. Jeffrey Cain, president of the AAFP. He praised the Heck-Schwartz bill, which had not been officially introduced in the House at press time, saying that it would put an end to "the annual question of whether physicians can continue to afford to practice in Medicare," and that it also "stabilizes the Medicare cost system and provides solutions that are based on successful and proven methods that can improve quality and incent value."

Dr. Chuck Cutler, chair-elect of the ACP Board of Regents, said that "the stability that this bill brings to the marketplace and to our practice is particularly encouraging." He also said that the ACP was happy that the bill would maintain 2013 payment levels through the end of 2014 and then provide "positive and predictable updates" through 2019.

That is especially important as physicians test out new delivery and payment models, said Dr. Cutler.

From 2015 to 2018, the bill calls for annual increases of 2.5% for primary care, preventive, and care-coordination services. All other physicians would get a 0.5% increase for the 4-year period.

By 2019, physicians who continue to use a volume-drive fee-for-service model would get a smaller increase than would those who have transitioned to new models.

In addition to the groups who participated in the briefing, the bill also is supported by the American College of Obstetricians and Gynecologists, the Society of Hospital Medicine, the American College of Rheumatology, the American College of Cardiology, the American Academy of Neurology, and the American Academy of Pediatrics.

a.ault@elsevier.com

On Twitter @aliciaault

An increase in Medicaid pay for physicians providing primary care services scheduled for Jan. 1 will not start flowing into practices until at least April 1.

Under the Affordable Care Act, physicians providing certain primary care services to Medicaid patients will be paid at the higher Medicare rate in 2013 and 2014. However, regulations to implement these provisions of the ACA were not issued until last November.

©claudiobaba/iStockPhoto.com

That late date did not allow states enough time to complete all the necessary paperwork to start paying physicians at the higher rate, according to Matt Salo, executive director of the National Association of Medicaid Directors.

"I’m betting most states won’t get money flowing until March 31 or so – the end of the quarter – but that it will be retroactive to January 1," Mr. Salo said in an interview.

The Centers for Medicare and Medicaid Services (CMS) gave states until Mar. 31 to submit a plan amendment outlining how they will pay physicians the new rates. States also must work out how to verify physician eligibility, which could delay even further the pay increase.

"This is a very complex issue, and the eligibility attestation is just one of a host of challenges we’ll need to figure out between now and then," Mr. Salo said.

Doctors have registered their concern in letters to the National Association of Medicaid Directors and the National Governors Association.

"We urge states to take the necessary steps to implement the primary care payment increase by filing the required state plan amendment with CMS as soon as possible," according to a letter signed by the American Medical Association, the American Academy of Family Physicians (AAFP), the American College of Physicians, the American Academy of Pediatrics, and the American Osteopathic Association.

The organizations also said that state Medicaid programs should reach out to physicians to let them know they might be eligible for the increased pay, even those who have not previously participated in Medicaid. "This will maximize physician participation," according to the letter.

Mr. Salo said that these concerns were echoed in a letter he received from the Medical Group Management Association.

"We are hearing concerns from our members, who have inquired about the increased payments with their state Medicaid agency, that many Medicaid customer service representatives or agency staff members say they are unaware that this increased payment exists and have no further information to provide," wrote Dr. Susan Turney, president and CEO of the MGMA.

She, too, said that state Medicaid agencies should get the word out to physicians that they will be able to seek an increase in pay.

According to the law, doctors who are board certified by the American Board of Medical Specialties, the American Osteopathic Association, and the American Board of Physician Specialties will receive Medicare rates for evaluation and management (E&M) codes between 99201 and 99499 and vaccine administration codes 90460, 90461, 90471, 90472, 90473, and 90474. The codes also cover hospital observation and consultation for inpatient services provided by nonadmitting physicians, emergency department services, and critical care services.

Emergency physicians and obstetricians cannot, however, be compensated at the Medicare level for services under Medicaid.

According to the AAFP, certain other E&M codes not normally paid by Medicare will also be covered, including new patient/initial comprehensive preventive medicine codes 99381-99387; risk factor and behavioral intervention codes 99401-99404, 99408, 99409, 99411, 99412, 99420 and 99429; and E&M/non face-to-face physician service codes 99441-99444, among others.

If a state Medicaid program does not currently pay for those services, it will not be covered under the new rates, according to the AAFP.

Physicians likely will have to prove either that they are board certified in an eligible specialty or subspecialty and/or that 60% of their Medicaid claims for the prior year were for the E&M codes specified, according to the American College of Physicians. CMS has compiled a list of frequently asked questions on the higher rate on its website.

CMS estimated in November that some $5.6 billion in additional money would go to physicians in 2013 and $5.7 billion additional in 2014.

While many physicians may not have counted on that money starting to come in on Jan. 1, "everyone would have liked that," Dr. Reid Blackwelder, president-elect of the AAFP, said in an interview.

"We fully expect most states to be up and running probably sometime in the next 3-6 months, with payments being retroactive," he said.

The AAFP is telling its members that "if you’re already seeing Medicaid patients, keep doing that," Dr. Blackwelder said. "We know that providing preventive services and increasing access to care are one of the most important ways of decreasing overall health costs."

ault@elsevier.com On Twitter @aliciaault

An increase in Medicaid pay for physicians providing primary care services scheduled for Jan. 1 will not start flowing into practices until at least April 1.

Under the Affordable Care Act, physicians providing certain primary care services to Medicaid patients will be paid at the higher Medicare rate in 2013 and 2014. However, regulations to implement these provisions of the ACA were not issued until last November.

©claudiobaba/iStockPhoto.com

That late date did not allow states enough time to complete all the necessary paperwork to start paying physicians at the higher rate, according to Matt Salo, executive director of the National Association of Medicaid Directors.

"I’m betting most states won’t get money flowing until March 31 or so – the end of the quarter – but that it will be retroactive to January 1," Mr. Salo said in an interview.

The Centers for Medicare and Medicaid Services (CMS) gave states until Mar. 31 to submit a plan amendment outlining how they will pay physicians the new rates. States also must work out how to verify physician eligibility, which could delay even further the pay increase.

"This is a very complex issue, and the eligibility attestation is just one of a host of challenges we’ll need to figure out between now and then," Mr. Salo said.

Doctors have registered their concern in letters to the National Association of Medicaid Directors and the National Governors Association.

"We urge states to take the necessary steps to implement the primary care payment increase by filing the required state plan amendment with CMS as soon as possible," according to a letter signed by the American Medical Association, the American Academy of Family Physicians (AAFP), the American College of Physicians, the American Academy of Pediatrics, and the American Osteopathic Association.

The organizations also said that state Medicaid programs should reach out to physicians to let them know they might be eligible for the increased pay, even those who have not previously participated in Medicaid. "This will maximize physician participation," according to the letter.

Mr. Salo said that these concerns were echoed in a letter he received from the Medical Group Management Association.

"We are hearing concerns from our members, who have inquired about the increased payments with their state Medicaid agency, that many Medicaid customer service representatives or agency staff members say they are unaware that this increased payment exists and have no further information to provide," wrote Dr. Susan Turney, president and CEO of the MGMA.

She, too, said that state Medicaid agencies should get the word out to physicians that they will be able to seek an increase in pay.

According to the law, doctors who are board certified by the American Board of Medical Specialties, the American Osteopathic Association, and the American Board of Physician Specialties will receive Medicare rates for evaluation and management (E&M) codes between 99201 and 99499 and vaccine administration codes 90460, 90461, 90471, 90472, 90473, and 90474. The codes also cover hospital observation and consultation for inpatient services provided by nonadmitting physicians, emergency department services, and critical care services.

Emergency physicians and obstetricians cannot, however, be compensated at the Medicare level for services under Medicaid.

According to the AAFP, certain other E&M codes not normally paid by Medicare will also be covered, including new patient/initial comprehensive preventive medicine codes 99381-99387; risk factor and behavioral intervention codes 99401-99404, 99408, 99409, 99411, 99412, 99420 and 99429; and E&M/non face-to-face physician service codes 99441-99444, among others.

If a state Medicaid program does not currently pay for those services, it will not be covered under the new rates, according to the AAFP.

Physicians likely will have to prove either that they are board certified in an eligible specialty or subspecialty and/or that 60% of their Medicaid claims for the prior year were for the E&M codes specified, according to the American College of Physicians. CMS has compiled a list of frequently asked questions on the higher rate on its website.

CMS estimated in November that some $5.6 billion in additional money would go to physicians in 2013 and $5.7 billion additional in 2014.

While many physicians may not have counted on that money starting to come in on Jan. 1, "everyone would have liked that," Dr. Reid Blackwelder, president-elect of the AAFP, said in an interview.

"We fully expect most states to be up and running probably sometime in the next 3-6 months, with payments being retroactive," he said.

The AAFP is telling its members that "if you’re already seeing Medicaid patients, keep doing that," Dr. Blackwelder said. "We know that providing preventive services and increasing access to care are one of the most important ways of decreasing overall health costs."

ault@elsevier.com On Twitter @aliciaault

An increase in Medicaid pay for physicians providing primary care services scheduled for Jan. 1 will not start flowing into practices until at least April 1.

Under the Affordable Care Act, physicians providing certain primary care services to Medicaid patients will be paid at the higher Medicare rate in 2013 and 2014. However, regulations to implement these provisions of the ACA were not issued until last November.

©claudiobaba/iStockPhoto.com

That late date did not allow states enough time to complete all the necessary paperwork to start paying physicians at the higher rate, according to Matt Salo, executive director of the National Association of Medicaid Directors.

"I’m betting most states won’t get money flowing until March 31 or so – the end of the quarter – but that it will be retroactive to January 1," Mr. Salo said in an interview.

The Centers for Medicare and Medicaid Services (CMS) gave states until Mar. 31 to submit a plan amendment outlining how they will pay physicians the new rates. States also must work out how to verify physician eligibility, which could delay even further the pay increase.

"This is a very complex issue, and the eligibility attestation is just one of a host of challenges we’ll need to figure out between now and then," Mr. Salo said.

Doctors have registered their concern in letters to the National Association of Medicaid Directors and the National Governors Association.

"We urge states to take the necessary steps to implement the primary care payment increase by filing the required state plan amendment with CMS as soon as possible," according to a letter signed by the American Medical Association, the American Academy of Family Physicians (AAFP), the American College of Physicians, the American Academy of Pediatrics, and the American Osteopathic Association.

The organizations also said that state Medicaid programs should reach out to physicians to let them know they might be eligible for the increased pay, even those who have not previously participated in Medicaid. "This will maximize physician participation," according to the letter.

Mr. Salo said that these concerns were echoed in a letter he received from the Medical Group Management Association.

"We are hearing concerns from our members, who have inquired about the increased payments with their state Medicaid agency, that many Medicaid customer service representatives or agency staff members say they are unaware that this increased payment exists and have no further information to provide," wrote Dr. Susan Turney, president and CEO of the MGMA.

She, too, said that state Medicaid agencies should get the word out to physicians that they will be able to seek an increase in pay.

According to the law, doctors who are board certified by the American Board of Medical Specialties, the American Osteopathic Association, and the American Board of Physician Specialties will receive Medicare rates for evaluation and management (E&M) codes between 99201 and 99499 and vaccine administration codes 90460, 90461, 90471, 90472, 90473, and 90474. The codes also cover hospital observation and consultation for inpatient services provided by nonadmitting physicians, emergency department services, and critical care services.

Emergency physicians and obstetricians cannot, however, be compensated at the Medicare level for services under Medicaid.

According to the AAFP, certain other E&M codes not normally paid by Medicare will also be covered, including new patient/initial comprehensive preventive medicine codes 99381-99387; risk factor and behavioral intervention codes 99401-99404, 99408, 99409, 99411, 99412, 99420 and 99429; and E&M/non face-to-face physician service codes 99441-99444, among others.

If a state Medicaid program does not currently pay for those services, it will not be covered under the new rates, according to the AAFP.

Physicians likely will have to prove either that they are board certified in an eligible specialty or subspecialty and/or that 60% of their Medicaid claims for the prior year were for the E&M codes specified, according to the American College of Physicians. CMS has compiled a list of frequently asked questions on the higher rate on its website.

CMS estimated in November that some $5.6 billion in additional money would go to physicians in 2013 and $5.7 billion additional in 2014.

While many physicians may not have counted on that money starting to come in on Jan. 1, "everyone would have liked that," Dr. Reid Blackwelder, president-elect of the AAFP, said in an interview.

"We fully expect most states to be up and running probably sometime in the next 3-6 months, with payments being retroactive," he said.

The AAFP is telling its members that "if you’re already seeing Medicaid patients, keep doing that," Dr. Blackwelder said. "We know that providing preventive services and increasing access to care are one of the most important ways of decreasing overall health costs."

ault@elsevier.com On Twitter @aliciaault

NEW ORLEANS – Use of photo-aging software helped persuade young people to stop smoking in a small Australian study.

Oksana Burford, a lecturer and doctoral candidate in the School of Pharmacy at Curtin University in Perth, Western Australia, said that she and her colleagues were hoping to find a way to motivate young smokers to quit, as they are generally resistant to most messages. Previous studies have shown, however, that young people do respond to graphic imagery, she said at the annual meeting of the North American Primary Care Research Group.

Ms. Burford decided to test a software program that would show teens and young adults how they would look in their 50s and 60s if they continued to smoke. She used face-aging software – called April – which is marketed by Toronto-based Aprilage Inc.

That company was started in 1998 to help develop the software, which was created for an exhibit at the Ontario Science Center. The Roswell Park Cancer Institute in Buffalo, N.Y., also was very involved in developing the first version of April, and it has been used by many antismoking and substance abuse programs around the world, according to the company.

The photo-aging program is available to clinicians who want to use it in their offices, and individuals also can use the program on the web by visiting http://www.ageme.com/.

Ms. Burford conducted a randomized controlled study at eight pharmacy sites around Western Australia, targeting young smokers. About 1,500 were screened and 213 were deemed eligible for study. In the end, 160 participated – 80 in the control group and 80 in the intervention group. The participants were smokers, aged 18-30, and they had to give informed consent and be available for 6 months of telephone follow-up.

All participants were asked to complete a baseline questionnaire: 56 (70%) in the control group and 48 (60%) in the intervention group completed the form. All received a self-care guide on smoking. For the intervention group, Ms. Burford took a photo of each, downloaded it onto her laptop, and then showed them what they would look like as a smoker or a nonsmoker at age 55. They also were given the photo-aging results to have at home.

Ms. Burford and her colleagues followed up with all subjects by phone at 1, 3, and 6 months.

At 6 months, only 5 of the 80 people in the control group self-reported as nonsmokers. Only 1 of the 5 agreed to a breath test to confirm whether they had actually quit. Just 11 of the 22 in the intervention group who said they had quit agreed to the confirmatory test.

The researchers calculated a Fagerstrom score for all the participants at baseline and at 6 months. Most clinicians use a modified, six-question Fagerstrom quiz, which is a measure of physical dependence on nicotine. The higher the score, the more intense the dependence.

For the control group, 11 moved to a lower category (14%), 68 (85%) had no change, and 1 (1%) moved to a higher category. For the intervention group, 41 (51%) moved to a lower category (this was significant, with a P value of .0001), 39 (49%) had no change, and none moved to a higher group.

The researchers assumed that subjects who did not return follow-up calls continued to smoke, Ms. Burford said. Overall, one in seven smokers quit after viewing their photo-aged selves. Ms. Burford concluded that the software program is an effective motivator in getting young people to quit, but she noted some limitations of the study, including the lack of blinding for participants and researchers and the low number of breath-test verifications in the control group.

Ms. Burford reported no conflicts.

a.ault@elsevier.com

On Twitter @aliciaault

NEW ORLEANS – Use of photo-aging software helped persuade young people to stop smoking in a small Australian study.

Oksana Burford, a lecturer and doctoral candidate in the School of Pharmacy at Curtin University in Perth, Western Australia, said that she and her colleagues were hoping to find a way to motivate young smokers to quit, as they are generally resistant to most messages. Previous studies have shown, however, that young people do respond to graphic imagery, she said at the annual meeting of the North American Primary Care Research Group.

Ms. Burford decided to test a software program that would show teens and young adults how they would look in their 50s and 60s if they continued to smoke. She used face-aging software – called April – which is marketed by Toronto-based Aprilage Inc.

That company was started in 1998 to help develop the software, which was created for an exhibit at the Ontario Science Center. The Roswell Park Cancer Institute in Buffalo, N.Y., also was very involved in developing the first version of April, and it has been used by many antismoking and substance abuse programs around the world, according to the company.

The photo-aging program is available to clinicians who want to use it in their offices, and individuals also can use the program on the web by visiting http://www.ageme.com/.

Ms. Burford conducted a randomized controlled study at eight pharmacy sites around Western Australia, targeting young smokers. About 1,500 were screened and 213 were deemed eligible for study. In the end, 160 participated – 80 in the control group and 80 in the intervention group. The participants were smokers, aged 18-30, and they had to give informed consent and be available for 6 months of telephone follow-up.

All participants were asked to complete a baseline questionnaire: 56 (70%) in the control group and 48 (60%) in the intervention group completed the form. All received a self-care guide on smoking. For the intervention group, Ms. Burford took a photo of each, downloaded it onto her laptop, and then showed them what they would look like as a smoker or a nonsmoker at age 55. They also were given the photo-aging results to have at home.

Ms. Burford and her colleagues followed up with all subjects by phone at 1, 3, and 6 months.

At 6 months, only 5 of the 80 people in the control group self-reported as nonsmokers. Only 1 of the 5 agreed to a breath test to confirm whether they had actually quit. Just 11 of the 22 in the intervention group who said they had quit agreed to the confirmatory test.

The researchers calculated a Fagerstrom score for all the participants at baseline and at 6 months. Most clinicians use a modified, six-question Fagerstrom quiz, which is a measure of physical dependence on nicotine. The higher the score, the more intense the dependence.

For the control group, 11 moved to a lower category (14%), 68 (85%) had no change, and 1 (1%) moved to a higher category. For the intervention group, 41 (51%) moved to a lower category (this was significant, with a P value of .0001), 39 (49%) had no change, and none moved to a higher group.

The researchers assumed that subjects who did not return follow-up calls continued to smoke, Ms. Burford said. Overall, one in seven smokers quit after viewing their photo-aged selves. Ms. Burford concluded that the software program is an effective motivator in getting young people to quit, but she noted some limitations of the study, including the lack of blinding for participants and researchers and the low number of breath-test verifications in the control group.

Ms. Burford reported no conflicts.

a.ault@elsevier.com

On Twitter @aliciaault

NEW ORLEANS – Use of photo-aging software helped persuade young people to stop smoking in a small Australian study.

Oksana Burford, a lecturer and doctoral candidate in the School of Pharmacy at Curtin University in Perth, Western Australia, said that she and her colleagues were hoping to find a way to motivate young smokers to quit, as they are generally resistant to most messages. Previous studies have shown, however, that young people do respond to graphic imagery, she said at the annual meeting of the North American Primary Care Research Group.

Ms. Burford decided to test a software program that would show teens and young adults how they would look in their 50s and 60s if they continued to smoke. She used face-aging software – called April – which is marketed by Toronto-based Aprilage Inc.

That company was started in 1998 to help develop the software, which was created for an exhibit at the Ontario Science Center. The Roswell Park Cancer Institute in Buffalo, N.Y., also was very involved in developing the first version of April, and it has been used by many antismoking and substance abuse programs around the world, according to the company.

The photo-aging program is available to clinicians who want to use it in their offices, and individuals also can use the program on the web by visiting http://www.ageme.com/.

Ms. Burford conducted a randomized controlled study at eight pharmacy sites around Western Australia, targeting young smokers. About 1,500 were screened and 213 were deemed eligible for study. In the end, 160 participated – 80 in the control group and 80 in the intervention group. The participants were smokers, aged 18-30, and they had to give informed consent and be available for 6 months of telephone follow-up.

All participants were asked to complete a baseline questionnaire: 56 (70%) in the control group and 48 (60%) in the intervention group completed the form. All received a self-care guide on smoking. For the intervention group, Ms. Burford took a photo of each, downloaded it onto her laptop, and then showed them what they would look like as a smoker or a nonsmoker at age 55. They also were given the photo-aging results to have at home.

Ms. Burford and her colleagues followed up with all subjects by phone at 1, 3, and 6 months.

At 6 months, only 5 of the 80 people in the control group self-reported as nonsmokers. Only 1 of the 5 agreed to a breath test to confirm whether they had actually quit. Just 11 of the 22 in the intervention group who said they had quit agreed to the confirmatory test.

The researchers calculated a Fagerstrom score for all the participants at baseline and at 6 months. Most clinicians use a modified, six-question Fagerstrom quiz, which is a measure of physical dependence on nicotine. The higher the score, the more intense the dependence.

For the control group, 11 moved to a lower category (14%), 68 (85%) had no change, and 1 (1%) moved to a higher category. For the intervention group, 41 (51%) moved to a lower category (this was significant, with a P value of .0001), 39 (49%) had no change, and none moved to a higher group.

The researchers assumed that subjects who did not return follow-up calls continued to smoke, Ms. Burford said. Overall, one in seven smokers quit after viewing their photo-aged selves. Ms. Burford concluded that the software program is an effective motivator in getting young people to quit, but she noted some limitations of the study, including the lack of blinding for participants and researchers and the low number of breath-test verifications in the control group.

Ms. Burford reported no conflicts.

a.ault@elsevier.com

On Twitter @aliciaault

After several years of reviews and rejections, the dipeptidyl peptidase IV inhibitor alogliptin has finally been approved by the Food and Drug Administration.

The FDA approved three versions of the product: as a single agent (Nesina); in combination with metformin (Kazano); and, in combination with pioglitazone (Oseni). All are indicated for treatment of type 2 diabetes in combination with diet and exercise.

Alogliptin is designed to slow the inactivation of incretin hormones GLP-1 (glucagonlike peptide–1) and GIP (glucose-dependent insulinotropic peptide), according to the drug’s maker, Takeda Pharmaceutical Company Ltd. Oseni is the first product approved in the United States that includes a DPP-4 inhibitor and a thiazolidinedione in a single tablet, the company said.

That unique combination may be of interest to clinicians, said Dr. Paul Jellinger, professor of clinical medicine at the University of Miami, Division of Endocrinology. First, a one-pill combination offers convenience for patients. And, the combination of a DPP-4 inhibitor and a TZD robustly drops hemoglobin A_1C and also makes physiologic sense since they work by two different mechanisms, added Dr. Jellinger.

He notes that in carefully selected patients, pioglitazone is useful to reverse or diminish insulin resistance and also to treat and minimize the appearance of fatty liver. “The same patient that you would think of using pioglitazone for is probably an ideal candidate for a combination of pioglitazone and a DPP-4 inhibitor like alogliptin,” said Dr. Jellinger, who practices at The Center for Diabetes & Endocrine Care in Hollywood, Florida.

Patients should be monitored for pioglitazone side effects such as heart failure, weight gain, edema, and more rarely, small bone fractures, he said. They should also be screened for bladder cancer several times yearly.Alogliptin is the fourth DPP-4 inhibitor to win FDA approval. Merck’s sitagliptin (Januvia) is the market leader; the others in the class are saxagliptin (Onglyza, marketed by AstraZeneca and Bristol-Myers Squibb) and linagliptin (Tradjenta, marketed by Boehringer Ingelheim and Lilly).

These approvals are 5 years in the making. Takeda submitted an application for the drug in 2008, but was tripped up by several developments. First, shortly after concerns were raised in 2007 about a link between rosiglitazone (Avandia) and an increased risk of myocardial infarction, the FDA in 2008 began requiring all diabetes therapies to demonstrate cardiovascular safety. Takeda had to restart its clinical development to incorporate trials with cardiovascular endpoints. The company subsequently received two requests – one for alogliptin as a single agent and another for the combination with pioglitazone – for more information, because of safety concerns.

As a result, the agency’s approval for each product is a mixed bag, with each carrying different warnings and requirements.

The single agent, Nesina, showed in more than 14 trials that it reduced hemoglobin A_1c by 0.4-0.6 percentage points compared with placebo over 26 weeks. It will be available in 6.25-mg, 12.5-mg, and 25-mg tablets. But the agency is requiring five postmarketing studies for alogliptin as a single agent: an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions; and three pediatric studies under the Pediatric Research Equity Act (PREA), including a dose-finding study and two safety and efficacy studies, one with Nesina as a monotherapy and one with Nesina and metformin.

The metformin combination, Kazano, reduced HbA_1c by 1.1 percentage points more than Nesina, and 0.5 percentage points more than metformin alone in four clinical trials. The two dosages are 12.5 mg alogliptin/500 mg metformin and 12.5 mg/1,000 mg. The FDA is requiring two postmarketing studies for Kazano: a program to monitor for liver abnormalities, serious pancreatitis, and severe hypersensitivity reactions; and a pediatric safety and efficacy study. Kazano will carry a boxed warning for lactic acidosis.

Oseni, the alogliptin/pioglitazone combination, in six fixed-dose formulations (5 mg/15 mg, 25 mg/30 mg, 25 mg/45 mg, 12.5 mg/15 mg, 12.5 mg/30 mg, and 12.5 mg/45 mg), reduced HbA_1c by 0.4-0.9 percentage points more than alogliptin alone, and 0.4-0.6 percentage points better than pioglitazone alone in studies. Takeda will have to conduct a postmarketing study on liver abnormalities, pancreatitis, and hypersensitivity reactions for Oseni, as well. The drug will have a boxed warning for heart failure.

Both Oseni and Nesina are approved in Japan, but those are the only other global approvals for the products.

Although there has been some concern with all diabetes therapeutics and cardiovascular safety, a recent meta-analysis showed that DPP-4 inhibitors may substantially reduce the risk of major cardiovascular events. The study, funded by Bristol-Myers Squibb and AstraZeneca, was reported at the annual scientific sessions of the American Heart Association in late November.

a.ault@elsevier.com

Twitter @aliciaault

After several years of reviews and rejections, the dipeptidyl peptidase IV inhibitor alogliptin has finally been approved by the Food and Drug Administration.

The FDA approved three versions of the product: as a single agent (Nesina); in combination with metformin (Kazano); and, in combination with pioglitazone (Oseni). All are indicated for treatment of type 2 diabetes in combination with diet and exercise.

Alogliptin is designed to slow the inactivation of incretin hormones GLP-1 (glucagonlike peptide–1) and GIP (glucose-dependent insulinotropic peptide), according to the drug’s maker, Takeda Pharmaceutical Company Ltd. Oseni is the first product approved in the United States that includes a DPP-4 inhibitor and a thiazolidinedione in a single tablet, the company said.

That unique combination may be of interest to clinicians, said Dr. Paul Jellinger, professor of clinical medicine at the University of Miami, Division of Endocrinology. First, a one-pill combination offers convenience for patients. And, the combination of a DPP-4 inhibitor and a TZD robustly drops hemoglobin A_1C and also makes physiologic sense since they work by two different mechanisms, added Dr. Jellinger.

He notes that in carefully selected patients, pioglitazone is useful to reverse or diminish insulin resistance and also to treat and minimize the appearance of fatty liver. “The same patient that you would think of using pioglitazone for is probably an ideal candidate for a combination of pioglitazone and a DPP-4 inhibitor like alogliptin,” said Dr. Jellinger, who practices at The Center for Diabetes & Endocrine Care in Hollywood, Florida.

Patients should be monitored for pioglitazone side effects such as heart failure, weight gain, edema, and more rarely, small bone fractures, he said. They should also be screened for bladder cancer several times yearly.Alogliptin is the fourth DPP-4 inhibitor to win FDA approval. Merck’s sitagliptin (Januvia) is the market leader; the others in the class are saxagliptin (Onglyza, marketed by AstraZeneca and Bristol-Myers Squibb) and linagliptin (Tradjenta, marketed by Boehringer Ingelheim and Lilly).

These approvals are 5 years in the making. Takeda submitted an application for the drug in 2008, but was tripped up by several developments. First, shortly after concerns were raised in 2007 about a link between rosiglitazone (Avandia) and an increased risk of myocardial infarction, the FDA in 2008 began requiring all diabetes therapies to demonstrate cardiovascular safety. Takeda had to restart its clinical development to incorporate trials with cardiovascular endpoints. The company subsequently received two requests – one for alogliptin as a single agent and another for the combination with pioglitazone – for more information, because of safety concerns.

As a result, the agency’s approval for each product is a mixed bag, with each carrying different warnings and requirements.

The single agent, Nesina, showed in more than 14 trials that it reduced hemoglobin A_1c by 0.4-0.6 percentage points compared with placebo over 26 weeks. It will be available in 6.25-mg, 12.5-mg, and 25-mg tablets. But the agency is requiring five postmarketing studies for alogliptin as a single agent: an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions; and three pediatric studies under the Pediatric Research Equity Act (PREA), including a dose-finding study and two safety and efficacy studies, one with Nesina as a monotherapy and one with Nesina and metformin.

The metformin combination, Kazano, reduced HbA_1c by 1.1 percentage points more than Nesina, and 0.5 percentage points more than metformin alone in four clinical trials. The two dosages are 12.5 mg alogliptin/500 mg metformin and 12.5 mg/1,000 mg. The FDA is requiring two postmarketing studies for Kazano: a program to monitor for liver abnormalities, serious pancreatitis, and severe hypersensitivity reactions; and a pediatric safety and efficacy study. Kazano will carry a boxed warning for lactic acidosis.

Oseni, the alogliptin/pioglitazone combination, in six fixed-dose formulations (5 mg/15 mg, 25 mg/30 mg, 25 mg/45 mg, 12.5 mg/15 mg, 12.5 mg/30 mg, and 12.5 mg/45 mg), reduced HbA_1c by 0.4-0.9 percentage points more than alogliptin alone, and 0.4-0.6 percentage points better than pioglitazone alone in studies. Takeda will have to conduct a postmarketing study on liver abnormalities, pancreatitis, and hypersensitivity reactions for Oseni, as well. The drug will have a boxed warning for heart failure.

Both Oseni and Nesina are approved in Japan, but those are the only other global approvals for the products.

Although there has been some concern with all diabetes therapeutics and cardiovascular safety, a recent meta-analysis showed that DPP-4 inhibitors may substantially reduce the risk of major cardiovascular events. The study, funded by Bristol-Myers Squibb and AstraZeneca, was reported at the annual scientific sessions of the American Heart Association in late November.

a.ault@elsevier.com

Twitter @aliciaault

After several years of reviews and rejections, the dipeptidyl peptidase IV inhibitor alogliptin has finally been approved by the Food and Drug Administration.

The FDA approved three versions of the product: as a single agent (Nesina); in combination with metformin (Kazano); and, in combination with pioglitazone (Oseni). All are indicated for treatment of type 2 diabetes in combination with diet and exercise.

Alogliptin is designed to slow the inactivation of incretin hormones GLP-1 (glucagonlike peptide–1) and GIP (glucose-dependent insulinotropic peptide), according to the drug’s maker, Takeda Pharmaceutical Company Ltd. Oseni is the first product approved in the United States that includes a DPP-4 inhibitor and a thiazolidinedione in a single tablet, the company said.

That unique combination may be of interest to clinicians, said Dr. Paul Jellinger, professor of clinical medicine at the University of Miami, Division of Endocrinology. First, a one-pill combination offers convenience for patients. And, the combination of a DPP-4 inhibitor and a TZD robustly drops hemoglobin A_1C and also makes physiologic sense since they work by two different mechanisms, added Dr. Jellinger.

He notes that in carefully selected patients, pioglitazone is useful to reverse or diminish insulin resistance and also to treat and minimize the appearance of fatty liver. “The same patient that you would think of using pioglitazone for is probably an ideal candidate for a combination of pioglitazone and a DPP-4 inhibitor like alogliptin,” said Dr. Jellinger, who practices at The Center for Diabetes & Endocrine Care in Hollywood, Florida.

Patients should be monitored for pioglitazone side effects such as heart failure, weight gain, edema, and more rarely, small bone fractures, he said. They should also be screened for bladder cancer several times yearly.Alogliptin is the fourth DPP-4 inhibitor to win FDA approval. Merck’s sitagliptin (Januvia) is the market leader; the others in the class are saxagliptin (Onglyza, marketed by AstraZeneca and Bristol-Myers Squibb) and linagliptin (Tradjenta, marketed by Boehringer Ingelheim and Lilly).

These approvals are 5 years in the making. Takeda submitted an application for the drug in 2008, but was tripped up by several developments. First, shortly after concerns were raised in 2007 about a link between rosiglitazone (Avandia) and an increased risk of myocardial infarction, the FDA in 2008 began requiring all diabetes therapies to demonstrate cardiovascular safety. Takeda had to restart its clinical development to incorporate trials with cardiovascular endpoints. The company subsequently received two requests – one for alogliptin as a single agent and another for the combination with pioglitazone – for more information, because of safety concerns.

As a result, the agency’s approval for each product is a mixed bag, with each carrying different warnings and requirements.

The single agent, Nesina, showed in more than 14 trials that it reduced hemoglobin A_1c by 0.4-0.6 percentage points compared with placebo over 26 weeks. It will be available in 6.25-mg, 12.5-mg, and 25-mg tablets. But the agency is requiring five postmarketing studies for alogliptin as a single agent: an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions; and three pediatric studies under the Pediatric Research Equity Act (PREA), including a dose-finding study and two safety and efficacy studies, one with Nesina as a monotherapy and one with Nesina and metformin.

The metformin combination, Kazano, reduced HbA_1c by 1.1 percentage points more than Nesina, and 0.5 percentage points more than metformin alone in four clinical trials. The two dosages are 12.5 mg alogliptin/500 mg metformin and 12.5 mg/1,000 mg. The FDA is requiring two postmarketing studies for Kazano: a program to monitor for liver abnormalities, serious pancreatitis, and severe hypersensitivity reactions; and a pediatric safety and efficacy study. Kazano will carry a boxed warning for lactic acidosis.

Oseni, the alogliptin/pioglitazone combination, in six fixed-dose formulations (5 mg/15 mg, 25 mg/30 mg, 25 mg/45 mg, 12.5 mg/15 mg, 12.5 mg/30 mg, and 12.5 mg/45 mg), reduced HbA_1c by 0.4-0.9 percentage points more than alogliptin alone, and 0.4-0.6 percentage points better than pioglitazone alone in studies. Takeda will have to conduct a postmarketing study on liver abnormalities, pancreatitis, and hypersensitivity reactions for Oseni, as well. The drug will have a boxed warning for heart failure.

Both Oseni and Nesina are approved in Japan, but those are the only other global approvals for the products.

Although there has been some concern with all diabetes therapeutics and cardiovascular safety, a recent meta-analysis showed that DPP-4 inhibitors may substantially reduce the risk of major cardiovascular events. The study, funded by Bristol-Myers Squibb and AstraZeneca, was reported at the annual scientific sessions of the American Heart Association in late November.

a.ault@elsevier.com

Twitter @aliciaault

Bevacizumab is now approved by the Food and Drug Administration for use in combination with fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy for metastatic colorectal cancer in patients whose disease has progressed on a first-line bevacizumab-containing regimen.

The agency based its approval on results from the 820-patient ML18147 study, funded by Genentech, which markets bevacizumab as Avastin. In that trial, median overall survival for those who received the bevacizumab combination in the first and second line was 11.2 months, compared with 9.8 months for those who had combinations that did not contain bevacizumab. The median progression-free survival was 5.7 months for those receiving the combination with bevacizumab, compared with 4.1 months for the others.

The results of ML18147 were presented at the 2012 American Society of Clinical Oncology annual meeting.

"The majority of people diagnosed with metastatic colorectal cancer receive Avastin plus chemotherapy as their initial treatment," said Dr. Hal Barron, chief medical officer and head of Global Product Development for Genentech, in a statement. "These people now have the option to continue with Avastin plus a new chemotherapy after their cancer worsens, which may help them live longer than changing to the new chemotherapy alone."

The Food and Drug Administration (FDA) said that the safety data from the ML18147 study were similar to bevacizumab’s known safety profile, especially in previous trials of metastatic colorectal cancer.

Genentech noted that this is the third approval for bevacizumab in that disease that is based on improved overall survival. The drug is approved in Europe in combination with fluoropyrimidine-based chemotherapy in metastatic carcinoma of the colon or rectum.

According to the FDA, patients receiving bevacizumab in combination with fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy after progression on a first-line bevacizumab-containing regimen should receive 5 mg/kg administered every 2 weeks or 7.5 mg/kg administered every 3 weeks as a 60-minute intravenous infusion.

Full prescribing information is available here.

a.ault@elsevier.com

On Twitter @aliciaault

Bevacizumab is now approved by the Food and Drug Administration for use in combination with fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy for metastatic colorectal cancer in patients whose disease has progressed on a first-line bevacizumab-containing regimen.

The agency based its approval on results from the 820-patient ML18147 study, funded by Genentech, which markets bevacizumab as Avastin. In that trial, median overall survival for those who received the bevacizumab combination in the first and second line was 11.2 months, compared with 9.8 months for those who had combinations that did not contain bevacizumab. The median progression-free survival was 5.7 months for those receiving the combination with bevacizumab, compared with 4.1 months for the others.

The results of ML18147 were presented at the 2012 American Society of Clinical Oncology annual meeting.

"The majority of people diagnosed with metastatic colorectal cancer receive Avastin plus chemotherapy as their initial treatment," said Dr. Hal Barron, chief medical officer and head of Global Product Development for Genentech, in a statement. "These people now have the option to continue with Avastin plus a new chemotherapy after their cancer worsens, which may help them live longer than changing to the new chemotherapy alone."

The Food and Drug Administration (FDA) said that the safety data from the ML18147 study were similar to bevacizumab’s known safety profile, especially in previous trials of metastatic colorectal cancer.

Genentech noted that this is the third approval for bevacizumab in that disease that is based on improved overall survival. The drug is approved in Europe in combination with fluoropyrimidine-based chemotherapy in metastatic carcinoma of the colon or rectum.

According to the FDA, patients receiving bevacizumab in combination with fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy after progression on a first-line bevacizumab-containing regimen should receive 5 mg/kg administered every 2 weeks or 7.5 mg/kg administered every 3 weeks as a 60-minute intravenous infusion.

Full prescribing information is available here.

a.ault@elsevier.com

On Twitter @aliciaault

Bevacizumab is now approved by the Food and Drug Administration for use in combination with fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy for metastatic colorectal cancer in patients whose disease has progressed on a first-line bevacizumab-containing regimen.

The agency based its approval on results from the 820-patient ML18147 study, funded by Genentech, which markets bevacizumab as Avastin. In that trial, median overall survival for those who received the bevacizumab combination in the first and second line was 11.2 months, compared with 9.8 months for those who had combinations that did not contain bevacizumab. The median progression-free survival was 5.7 months for those receiving the combination with bevacizumab, compared with 4.1 months for the others.

The results of ML18147 were presented at the 2012 American Society of Clinical Oncology annual meeting.

"The majority of people diagnosed with metastatic colorectal cancer receive Avastin plus chemotherapy as their initial treatment," said Dr. Hal Barron, chief medical officer and head of Global Product Development for Genentech, in a statement. "These people now have the option to continue with Avastin plus a new chemotherapy after their cancer worsens, which may help them live longer than changing to the new chemotherapy alone."

The Food and Drug Administration (FDA) said that the safety data from the ML18147 study were similar to bevacizumab’s known safety profile, especially in previous trials of metastatic colorectal cancer.

Genentech noted that this is the third approval for bevacizumab in that disease that is based on improved overall survival. The drug is approved in Europe in combination with fluoropyrimidine-based chemotherapy in metastatic carcinoma of the colon or rectum.

According to the FDA, patients receiving bevacizumab in combination with fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy after progression on a first-line bevacizumab-containing regimen should receive 5 mg/kg administered every 2 weeks or 7.5 mg/kg administered every 3 weeks as a 60-minute intravenous infusion.

Full prescribing information is available here.

a.ault@elsevier.com

On Twitter @aliciaault

Cancer deaths have declined 20% since 1991, which means there were 1.2 million fewer deaths from cancer in 2009, according to the American Cancer Society.

The overall cancer death rate decreased from 215 per 100,000 in 1991 to 173 per 100,000 in 2009. Death rates declined more sharply for cancers of the lung and prostate in men, for breast cancers in women, and for colon and rectal cancers for men and women. The ACS attributes the drops to decreases in smoking and improvements in early detection and treatment.

The most common causes of cancer death in Americans, accounting for 50% of cancer deaths, are cancers of the lung and bronchus, prostate, and colorectum in men; and cancers of the lung and bronchus, breast, and colorectum in women. This year, there will be 1.6 million cancer cases and 580,350 cancer deaths; lung cancers will account for 25% of cancer deaths in men and women this year, according to estimates from the ACS.

The mortality figures and incidence data are contained in two reports: Cancer Facts & Figures 2013 and Cancer Statistics 2013, both published in CA: A Cancer Journal for Clinicians. (doi:10.3322/caac.21166). The reports were published online on Jan. 18.

Incidence rates are on the decline for most cancers with the exception of melanoma, and liver, thyroid and pancreatic cancer.

Dr. Daniel M. Siegel, president of the American Academy of Dermatology, said in a statement that a rising incidence of melanoma "is particularly concerning because skin cancer can often be easily prevented and detected." Dr. Siegel said that the AAD and its members "are actively working to reduce the incidence of skin cancer and change society’s attitudes and behaviors toward sun exposure and tanning."

Death rates from pancreatic cancer have increased over the last decade, due to what the ACS called "a lack progress in primary prevention, early diagnosis, and treatment of this cancer." The ACS report included a special section devoted to updated information on the occurrence and treatment of pancreatic cancer. Most patients with pancreatic cancer die within a year of diagnosis; the 5-year survival rate is 6%.

The ACS also noted that the disparity in cancer outcomes based on ethnicity and income, "particularly [among] those diagnosed with colorectal or breast cancer where earlier detection and better treatments are credited for the improving trends," said John R. Seffrin, Ph.D., chief executive officer of the ACS, in a statement. "We can and must close this gap so that people are not punished for having the misfortune of being born poor and disadvantaged."

The 5-year survival rate in 2002-2008 for white women with breast cancer, for instance, was 92%, whereas for black women, it was 78%. For colon cancer, the 5-year survival rate was 66% for whites, but 55% for blacks.

a.ault@elsevier.com

On Twitter @aliciaault

Cancer deaths have declined 20% since 1991, which means there were 1.2 million fewer deaths from cancer in 2009, according to the American Cancer Society.

The overall cancer death rate decreased from 215 per 100,000 in 1991 to 173 per 100,000 in 2009. Death rates declined more sharply for cancers of the lung and prostate in men, for breast cancers in women, and for colon and rectal cancers for men and women. The ACS attributes the drops to decreases in smoking and improvements in early detection and treatment.

The most common causes of cancer death in Americans, accounting for 50% of cancer deaths, are cancers of the lung and bronchus, prostate, and colorectum in men; and cancers of the lung and bronchus, breast, and colorectum in women. This year, there will be 1.6 million cancer cases and 580,350 cancer deaths; lung cancers will account for 25% of cancer deaths in men and women this year, according to estimates from the ACS.

The mortality figures and incidence data are contained in two reports: Cancer Facts & Figures 2013 and Cancer Statistics 2013, both published in CA: A Cancer Journal for Clinicians. (doi:10.3322/caac.21166). The reports were published online on Jan. 18.

Incidence rates are on the decline for most cancers with the exception of melanoma, and liver, thyroid and pancreatic cancer.

Dr. Daniel M. Siegel, president of the American Academy of Dermatology, said in a statement that a rising incidence of melanoma "is particularly concerning because skin cancer can often be easily prevented and detected." Dr. Siegel said that the AAD and its members "are actively working to reduce the incidence of skin cancer and change society’s attitudes and behaviors toward sun exposure and tanning."

Death rates from pancreatic cancer have increased over the last decade, due to what the ACS called "a lack progress in primary prevention, early diagnosis, and treatment of this cancer." The ACS report included a special section devoted to updated information on the occurrence and treatment of pancreatic cancer. Most patients with pancreatic cancer die within a year of diagnosis; the 5-year survival rate is 6%.

The ACS also noted that the disparity in cancer outcomes based on ethnicity and income, "particularly [among] those diagnosed with colorectal or breast cancer where earlier detection and better treatments are credited for the improving trends," said John R. Seffrin, Ph.D., chief executive officer of the ACS, in a statement. "We can and must close this gap so that people are not punished for having the misfortune of being born poor and disadvantaged."

The 5-year survival rate in 2002-2008 for white women with breast cancer, for instance, was 92%, whereas for black women, it was 78%. For colon cancer, the 5-year survival rate was 66% for whites, but 55% for blacks.

a.ault@elsevier.com

On Twitter @aliciaault

Cancer deaths have declined 20% since 1991, which means there were 1.2 million fewer deaths from cancer in 2009, according to the American Cancer Society.

The overall cancer death rate decreased from 215 per 100,000 in 1991 to 173 per 100,000 in 2009. Death rates declined more sharply for cancers of the lung and prostate in men, for breast cancers in women, and for colon and rectal cancers for men and women. The ACS attributes the drops to decreases in smoking and improvements in early detection and treatment.

The most common causes of cancer death in Americans, accounting for 50% of cancer deaths, are cancers of the lung and bronchus, prostate, and colorectum in men; and cancers of the lung and bronchus, breast, and colorectum in women. This year, there will be 1.6 million cancer cases and 580,350 cancer deaths; lung cancers will account for 25% of cancer deaths in men and women this year, according to estimates from the ACS.

The mortality figures and incidence data are contained in two reports: Cancer Facts & Figures 2013 and Cancer Statistics 2013, both published in CA: A Cancer Journal for Clinicians. (doi:10.3322/caac.21166). The reports were published online on Jan. 18.

Incidence rates are on the decline for most cancers with the exception of melanoma, and liver, thyroid and pancreatic cancer.

Dr. Daniel M. Siegel, president of the American Academy of Dermatology, said in a statement that a rising incidence of melanoma "is particularly concerning because skin cancer can often be easily prevented and detected." Dr. Siegel said that the AAD and its members "are actively working to reduce the incidence of skin cancer and change society’s attitudes and behaviors toward sun exposure and tanning."

Death rates from pancreatic cancer have increased over the last decade, due to what the ACS called "a lack progress in primary prevention, early diagnosis, and treatment of this cancer." The ACS report included a special section devoted to updated information on the occurrence and treatment of pancreatic cancer. Most patients with pancreatic cancer die within a year of diagnosis; the 5-year survival rate is 6%.

The ACS also noted that the disparity in cancer outcomes based on ethnicity and income, "particularly [among] those diagnosed with colorectal or breast cancer where earlier detection and better treatments are credited for the improving trends," said John R. Seffrin, Ph.D., chief executive officer of the ACS, in a statement. "We can and must close this gap so that people are not punished for having the misfortune of being born poor and disadvantaged."

The 5-year survival rate in 2002-2008 for white women with breast cancer, for instance, was 92%, whereas for black women, it was 78%. For colon cancer, the 5-year survival rate was 66% for whites, but 55% for blacks.

a.ault@elsevier.com

On Twitter @aliciaault

The Food and Drug Administration on Jan. 18 approved Botox for patients with overactive bladder who have contraindications to or don’t respond to anticholinergics.

"Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence," Dr. Hylton V. Joffe, director of the Division of Reproductive and Urologic Products in the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement.

"With the approval of Botox [onabotulinumtoxinA], we have a new treatment option to offer these patients that has demonstrated efficacy in reducing urinary leakage and other symptoms of OAB with the effect lasting up to 6 months," Dr. Victor Nitti, vice chairman in the department of urology at NYU Langone Medical Center, said in a statement released by Botox maker Allergan.

Overactive bladder (OAB) results in an uncontrolled urge to urinate, frequent urination, and uncontrollable leakage of urine, according to the Allergan statement. About 14.7 million American adults have overactive bladder, and 3.3 million use anticholinergics; however, at least half of them stop taking the drugs within a year because of intolerance.

Botox injected into the bladder muscle relaxes the organ and increases its storage capacity, thus reducing incontinence, according to the FDA. The Botox is injected via cystoscopy.

The FDA evaluated the drug’s safety and efficacy for overactive bladder through two studies in which 1,105 patients were randomly assigned to receive injections of 100 units of Botox (20 injections of 5 units each) or placebo. At 12 weeks, patients who received Botox had 1.6 to 1.9 fewer incidents of incontinence per day, and also needed to urinate less frequently.

The treatment needs to be repeated to maintain effectiveness; the FDA recommends at least 12 weeks between injections. Side effects during trials included urinary tract infections, painful urination, and urinary retention.

Patients must take antibiotics before, during, and a few days after Botox treatment to reduce infection risk.

a.ault@elsevier.com

On Twitter @aliciaault

The Food and Drug Administration on Jan. 18 approved Botox for patients with overactive bladder who have contraindications to or don’t respond to anticholinergics.

"Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence," Dr. Hylton V. Joffe, director of the Division of Reproductive and Urologic Products in the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement.

"With the approval of Botox [onabotulinumtoxinA], we have a new treatment option to offer these patients that has demonstrated efficacy in reducing urinary leakage and other symptoms of OAB with the effect lasting up to 6 months," Dr. Victor Nitti, vice chairman in the department of urology at NYU Langone Medical Center, said in a statement released by Botox maker Allergan.

Overactive bladder (OAB) results in an uncontrolled urge to urinate, frequent urination, and uncontrollable leakage of urine, according to the Allergan statement. About 14.7 million American adults have overactive bladder, and 3.3 million use anticholinergics; however, at least half of them stop taking the drugs within a year because of intolerance.

Botox injected into the bladder muscle relaxes the organ and increases its storage capacity, thus reducing incontinence, according to the FDA. The Botox is injected via cystoscopy.

The FDA evaluated the drug’s safety and efficacy for overactive bladder through two studies in which 1,105 patients were randomly assigned to receive injections of 100 units of Botox (20 injections of 5 units each) or placebo. At 12 weeks, patients who received Botox had 1.6 to 1.9 fewer incidents of incontinence per day, and also needed to urinate less frequently.

The treatment needs to be repeated to maintain effectiveness; the FDA recommends at least 12 weeks between injections. Side effects during trials included urinary tract infections, painful urination, and urinary retention.

Patients must take antibiotics before, during, and a few days after Botox treatment to reduce infection risk.

a.ault@elsevier.com

On Twitter @aliciaault

The Food and Drug Administration on Jan. 18 approved Botox for patients with overactive bladder who have contraindications to or don’t respond to anticholinergics.

"Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence," Dr. Hylton V. Joffe, director of the Division of Reproductive and Urologic Products in the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement.

"With the approval of Botox [onabotulinumtoxinA], we have a new treatment option to offer these patients that has demonstrated efficacy in reducing urinary leakage and other symptoms of OAB with the effect lasting up to 6 months," Dr. Victor Nitti, vice chairman in the department of urology at NYU Langone Medical Center, said in a statement released by Botox maker Allergan.

Overactive bladder (OAB) results in an uncontrolled urge to urinate, frequent urination, and uncontrollable leakage of urine, according to the Allergan statement. About 14.7 million American adults have overactive bladder, and 3.3 million use anticholinergics; however, at least half of them stop taking the drugs within a year because of intolerance.

Botox injected into the bladder muscle relaxes the organ and increases its storage capacity, thus reducing incontinence, according to the FDA. The Botox is injected via cystoscopy.

The FDA evaluated the drug’s safety and efficacy for overactive bladder through two studies in which 1,105 patients were randomly assigned to receive injections of 100 units of Botox (20 injections of 5 units each) or placebo. At 12 weeks, patients who received Botox had 1.6 to 1.9 fewer incidents of incontinence per day, and also needed to urinate less frequently.

The treatment needs to be repeated to maintain effectiveness; the FDA recommends at least 12 weeks between injections. Side effects during trials included urinary tract infections, painful urination, and urinary retention.

Patients must take antibiotics before, during, and a few days after Botox treatment to reduce infection risk.

a.ault@elsevier.com

On Twitter @aliciaault

President Obama’s wide range of proposals to address gun violence in the United States included a clarification that physicians should be allowed to discuss firearm safety with their patients.

The plan states, "Doctors and other health care providers also need to be able to ask about firearms in their patients’ homes and safe storage of those firearms, especially if their patients show signs of certain mental illnesses or if they have a young child or mentally ill family member at home."

The clarification was issued in response to recent concerns that the Affordable Care Act prohibited physicians from asking about firearms in the home. That is not true, according to the White House, which also added that "the administration will issue guidance clarifying that the Affordable Care Act does not prohibit or otherwise regulate communication between doctors and patients, including about firearms."

Pete Souza/The White House

Several groups representing physicians, including the American Psychiatric Association, the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Physicians, praised the administration’s initiatives.

"We are glad that the president has clarified that doctors are not prohibited from asking their patients about guns in their homes," Dr. Dilip V. Jeste, president of the APA, said in a statement. "The APA has consistently advocated for such a position."

In a statement, the ACP said that "state governments must also do their part, by not imposing restrictions on engaging in such discussions with their patients, as some state legislatures have attempted to do."

"Family physicians need to be able to have appropriate medical conversations with our patients about gun safety, and researchers need the ability to study gun safety," said Dr. Jeffrey Cain, president of the American Academy of Family Physicians (AAFP), in a recent blog post, calling for a broader recognition of gun violence as a public health issue.

Physician organizations also said they supported the President’s executive order directing the Centers for Disease Control and Prevention to study gun violence. In his remarks, the president said, "While year after year, those who oppose even modest gun safety measures have threatened to defund scientific or medical research into the causes of gun violence, I will direct the Centers for Disease Control to go ahead and study the best ways to reduce it."

In addition, the proposal seeks $10 million from Congress for CDC to research the relationship between video games, media images, and violence, and $20 million from Congress to expand the National Violent Death Reporting System to all 50 states.

As part of the gun control package, the president also issued executive orders seeking reviews of gun locks and other safety technologies. He is asking Congress to reinstate the assault weapons ban and to limit large-capacity ammunition magazines.

Congress also will have to approve several other proposals, including $55 million for a new initiative (Project AWARE), which covers teacher training and coordination of referrals to make sure students get mental health treatment, $25 million for state-based strategies to support young adults with mental health or substance abuse issues, and $25 million for student mental health services. The president also wants Congress to provide $50 million to train 5,000 mental health professionals who can target children and young adults.

Pete Souza/The White House

The proposal also emphasized the need for parity of mental health coverage with medical and surgical health benefits, and noted that the administration intends to issue soon the final regulations for the Mental Health Parity and Addiction Equity Act of 2008. Parity will be further fleshed out under the essential benefits requirements called for by the Affordable Care Act, according to the proposal. A final rule on the essential health benefits package is expected in February.

"We are heartened that the administration plans to finalize rules governing mental health parity under the 2008 Mental Health Parity and Addiction Equity Act, the Affordable Care Act, and Medicaid," said Dr. Jeste of the APA. "We strongly urge the administration to close loopholes involving so-called ‘nonquantitative treatment limits’ and to ensure that health plans deliver a full scope of mental health services in order to comply with the law."

The ACP said that it also has long supported parity and increased access to mental health services, especially for young adults. The organization said in its statement that it "agrees on the urgency of adoption of policies that include these and other measures and is committed to being part of the change outlined by the president."

The AAP said that it was pleased that the proposals reflected recommendations the group made during a Jan. 3 meeting with the White House Task Force on Gun Violence Prevention.

In a statement, Dr. Thomas K. McInerny, AAP president said, "The AAP agrees with the President that we must improve the identification of mental illnesses through increased screening, address inadequate insurance coverage and high out-of-pocket costs that create barriers to access, strengthen the overall quality of mental health access, and improve and expand the Medicaid reimbursement policy to include mental health and developmental services."

a.ault@elsevier.com

On Twitter @aliciaault

President Obama’s wide range of proposals to address gun violence in the United States included a clarification that physicians should be allowed to discuss firearm safety with their patients.

The plan states, "Doctors and other health care providers also need to be able to ask about firearms in their patients’ homes and safe storage of those firearms, especially if their patients show signs of certain mental illnesses or if they have a young child or mentally ill family member at home."

The clarification was issued in response to recent concerns that the Affordable Care Act prohibited physicians from asking about firearms in the home. That is not true, according to the White House, which also added that "the administration will issue guidance clarifying that the Affordable Care Act does not prohibit or otherwise regulate communication between doctors and patients, including about firearms."

Pete Souza/The White House

Several groups representing physicians, including the American Psychiatric Association, the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Physicians, praised the administration’s initiatives.

"We are glad that the president has clarified that doctors are not prohibited from asking their patients about guns in their homes," Dr. Dilip V. Jeste, president of the APA, said in a statement. "The APA has consistently advocated for such a position."

In a statement, the ACP said that "state governments must also do their part, by not imposing restrictions on engaging in such discussions with their patients, as some state legislatures have attempted to do."

"Family physicians need to be able to have appropriate medical conversations with our patients about gun safety, and researchers need the ability to study gun safety," said Dr. Jeffrey Cain, president of the American Academy of Family Physicians (AAFP), in a recent blog post, calling for a broader recognition of gun violence as a public health issue.

Physician organizations also said they supported the President’s executive order directing the Centers for Disease Control and Prevention to study gun violence. In his remarks, the president said, "While year after year, those who oppose even modest gun safety measures have threatened to defund scientific or medical research into the causes of gun violence, I will direct the Centers for Disease Control to go ahead and study the best ways to reduce it."

In addition, the proposal seeks $10 million from Congress for CDC to research the relationship between video games, media images, and violence, and $20 million from Congress to expand the National Violent Death Reporting System to all 50 states.

As part of the gun control package, the president also issued executive orders seeking reviews of gun locks and other safety technologies. He is asking Congress to reinstate the assault weapons ban and to limit large-capacity ammunition magazines.

Congress also will have to approve several other proposals, including $55 million for a new initiative (Project AWARE), which covers teacher training and coordination of referrals to make sure students get mental health treatment, $25 million for state-based strategies to support young adults with mental health or substance abuse issues, and $25 million for student mental health services. The president also wants Congress to provide $50 million to train 5,000 mental health professionals who can target children and young adults.

Pete Souza/The White House

The proposal also emphasized the need for parity of mental health coverage with medical and surgical health benefits, and noted that the administration intends to issue soon the final regulations for the Mental Health Parity and Addiction Equity Act of 2008. Parity will be further fleshed out under the essential benefits requirements called for by the Affordable Care Act, according to the proposal. A final rule on the essential health benefits package is expected in February.

"We are heartened that the administration plans to finalize rules governing mental health parity under the 2008 Mental Health Parity and Addiction Equity Act, the Affordable Care Act, and Medicaid," said Dr. Jeste of the APA. "We strongly urge the administration to close loopholes involving so-called ‘nonquantitative treatment limits’ and to ensure that health plans deliver a full scope of mental health services in order to comply with the law."

The ACP said that it also has long supported parity and increased access to mental health services, especially for young adults. The organization said in its statement that it "agrees on the urgency of adoption of policies that include these and other measures and is committed to being part of the change outlined by the president."

The AAP said that it was pleased that the proposals reflected recommendations the group made during a Jan. 3 meeting with the White House Task Force on Gun Violence Prevention.

In a statement, Dr. Thomas K. McInerny, AAP president said, "The AAP agrees with the President that we must improve the identification of mental illnesses through increased screening, address inadequate insurance coverage and high out-of-pocket costs that create barriers to access, strengthen the overall quality of mental health access, and improve and expand the Medicaid reimbursement policy to include mental health and developmental services."

a.ault@elsevier.com

On Twitter @aliciaault

President Obama’s wide range of proposals to address gun violence in the United States included a clarification that physicians should be allowed to discuss firearm safety with their patients.

The plan states, "Doctors and other health care providers also need to be able to ask about firearms in their patients’ homes and safe storage of those firearms, especially if their patients show signs of certain mental illnesses or if they have a young child or mentally ill family member at home."

The clarification was issued in response to recent concerns that the Affordable Care Act prohibited physicians from asking about firearms in the home. That is not true, according to the White House, which also added that "the administration will issue guidance clarifying that the Affordable Care Act does not prohibit or otherwise regulate communication between doctors and patients, including about firearms."

Pete Souza/The White House

Several groups representing physicians, including the American Psychiatric Association, the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Physicians, praised the administration’s initiatives.

"We are glad that the president has clarified that doctors are not prohibited from asking their patients about guns in their homes," Dr. Dilip V. Jeste, president of the APA, said in a statement. "The APA has consistently advocated for such a position."

In a statement, the ACP said that "state governments must also do their part, by not imposing restrictions on engaging in such discussions with their patients, as some state legislatures have attempted to do."

"Family physicians need to be able to have appropriate medical conversations with our patients about gun safety, and researchers need the ability to study gun safety," said Dr. Jeffrey Cain, president of the American Academy of Family Physicians (AAFP), in a recent blog post, calling for a broader recognition of gun violence as a public health issue.

Physician organizations also said they supported the President’s executive order directing the Centers for Disease Control and Prevention to study gun violence. In his remarks, the president said, "While year after year, those who oppose even modest gun safety measures have threatened to defund scientific or medical research into the causes of gun violence, I will direct the Centers for Disease Control to go ahead and study the best ways to reduce it."

In addition, the proposal seeks $10 million from Congress for CDC to research the relationship between video games, media images, and violence, and $20 million from Congress to expand the National Violent Death Reporting System to all 50 states.

As part of the gun control package, the president also issued executive orders seeking reviews of gun locks and other safety technologies. He is asking Congress to reinstate the assault weapons ban and to limit large-capacity ammunition magazines.

Congress also will have to approve several other proposals, including $55 million for a new initiative (Project AWARE), which covers teacher training and coordination of referrals to make sure students get mental health treatment, $25 million for state-based strategies to support young adults with mental health or substance abuse issues, and $25 million for student mental health services. The president also wants Congress to provide $50 million to train 5,000 mental health professionals who can target children and young adults.

Pete Souza/The White House

The proposal also emphasized the need for parity of mental health coverage with medical and surgical health benefits, and noted that the administration intends to issue soon the final regulations for the Mental Health Parity and Addiction Equity Act of 2008. Parity will be further fleshed out under the essential benefits requirements called for by the Affordable Care Act, according to the proposal. A final rule on the essential health benefits package is expected in February.

"We are heartened that the administration plans to finalize rules governing mental health parity under the 2008 Mental Health Parity and Addiction Equity Act, the Affordable Care Act, and Medicaid," said Dr. Jeste of the APA. "We strongly urge the administration to close loopholes involving so-called ‘nonquantitative treatment limits’ and to ensure that health plans deliver a full scope of mental health services in order to comply with the law."

The ACP said that it also has long supported parity and increased access to mental health services, especially for young adults. The organization said in its statement that it "agrees on the urgency of adoption of policies that include these and other measures and is committed to being part of the change outlined by the president."

The AAP said that it was pleased that the proposals reflected recommendations the group made during a Jan. 3 meeting with the White House Task Force on Gun Violence Prevention.

In a statement, Dr. Thomas K. McInerny, AAP president said, "The AAP agrees with the President that we must improve the identification of mental illnesses through increased screening, address inadequate insurance coverage and high out-of-pocket costs that create barriers to access, strengthen the overall quality of mental health access, and improve and expand the Medicaid reimbursement policy to include mental health and developmental services."

a.ault@elsevier.com

On Twitter @aliciaault