Senate Passes Short-Term SGR Fix

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The United States Senate on Nov. 18 approved a 1-month extension of current Medicare physician fee rates, moving Congress one step closer to avoiding the statutory 23% reduction that is due to go into effect Dec. 1.

The Physician Payment and Therapy Relief Act of 2010 was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa). It was originally introduced in the House in July by Rep. Sander Levin (D-Mich.) and was agreed to by voice vote that month. But the Senate amended the bill Nov. 18, which means it has to go back to the House for approval.

The American College of Physicians expects the House, which has gone out on recess for the Thanksgiving holiday, to take up the bill Nov. 29 or 30, according to a spokesman for the physician organization.

The estimated cost for the 1-month extension: $1 billion over 10 years. The Senate would pay for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sens. Baucus and Grassley.

"Seniors and military families can rest assured that they will continue to have access to the doctors, treatments, and medications they need," said Sen. Baucus in a statement. "Once signed into law by the president, it will mean that seniors and military families are spared the threat of a lapse in care. The next step is moving on to finding a yearlong extension before this fix runs out."

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The United States Senate on Nov. 18 approved a 1-month extension of current Medicare physician fee rates, moving Congress one step closer to avoiding the statutory 23% reduction that is due to go into effect Dec. 1.

The Physician Payment and Therapy Relief Act of 2010 was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa). It was originally introduced in the House in July by Rep. Sander Levin (D-Mich.) and was agreed to by voice vote that month. But the Senate amended the bill Nov. 18, which means it has to go back to the House for approval.

The American College of Physicians expects the House, which has gone out on recess for the Thanksgiving holiday, to take up the bill Nov. 29 or 30, according to a spokesman for the physician organization.

The estimated cost for the 1-month extension: $1 billion over 10 years. The Senate would pay for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sens. Baucus and Grassley.

"Seniors and military families can rest assured that they will continue to have access to the doctors, treatments, and medications they need," said Sen. Baucus in a statement. "Once signed into law by the president, it will mean that seniors and military families are spared the threat of a lapse in care. The next step is moving on to finding a yearlong extension before this fix runs out."

The United States Senate on Nov. 18 approved a 1-month extension of current Medicare physician fee rates, moving Congress one step closer to avoiding the statutory 23% reduction that is due to go into effect Dec. 1.

The Physician Payment and Therapy Relief Act of 2010 was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa). It was originally introduced in the House in July by Rep. Sander Levin (D-Mich.) and was agreed to by voice vote that month. But the Senate amended the bill Nov. 18, which means it has to go back to the House for approval.

The American College of Physicians expects the House, which has gone out on recess for the Thanksgiving holiday, to take up the bill Nov. 29 or 30, according to a spokesman for the physician organization.

The estimated cost for the 1-month extension: $1 billion over 10 years. The Senate would pay for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sens. Baucus and Grassley.

"Seniors and military families can rest assured that they will continue to have access to the doctors, treatments, and medications they need," said Sen. Baucus in a statement. "Once signed into law by the president, it will mean that seniors and military families are spared the threat of a lapse in care. The next step is moving on to finding a yearlong extension before this fix runs out."

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Medicare's Berwick Makes First Appearance on the Hill

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Washington – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

Dr. Donald Berwick    

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said

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Washington – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

Dr. Donald Berwick    

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said

Washington – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

Dr. Donald Berwick    

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said

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Medicare's Berwick Makes First Appearance on the Hill

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WASHINGTON – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

    Dr. Don Berwick

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said.

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WASHINGTON – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

    Dr. Don Berwick

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said.

WASHINGTON – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

    Dr. Don Berwick

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said.

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Medicare's Berwick Makes First Appearance on the Hill

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WASHINGTON – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

    Dr. Don Berwick

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said.

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WASHINGTON – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

    Dr. Don Berwick

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said.

WASHINGTON – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

    Dr. Don Berwick

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said.

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Medicare May Be Stifled in Effective Use of Data

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The use of comparative effectiveness research would give Medicare a sophisticated tool for making coverage decisions on the basis of quality, but the federal health program's ability to use such data is hamstrung by political interests and the new health reform law, according to two researchers.

“We believe that the time is ripe for Medicare to use comparative effectiveness research to reach a new paradigm of paying equally for services that provide equivalent results,” said Dr. Steven D. Pearson, president of the Institute for Clinical and Economic Review, Boston, and Dr. Peter B. Bach of Memorial Sloan-Kettering Cancer Center, New York (Health Affairs 2010;29:1796-804).

The Obama administration is helping create a larger comparative effectiveness enterprise through some $1.1 billion that was set aside as part of the American Recovery and Reinvestment Act of 2009, and 15 experts are to guide investments and coordinate research through the Federal Coordinating Council for Comparative Effectiveness Research.

However, the council's role is limited. It will not set clinical guidelines, or establish payment rates, or tell Medicare what to cover. The Act further spelled out restrictions on how comparative effectiveness findings could be used by the federal government.

Currently, Medicare covers a drug, device, product, or service if the evidence supports its effectiveness. No comparisons are made to comparable technologies. Payment is set separately, based on arcane formulas that cover cost and maybe a small profit.

Dr. Pearson and Dr. Bach propose that Medicare instead link coverage and payment decisions at the outset. The program could still use the “reasonable and necessary” threshold in deciding when to cover a product or service. But regulators could adopt a three-tiered effectiveness scale that would let them assign differing reimbursement to each level.

For instance, a superior rating would garner the highest payment. Such a product would have the fewest side effects or offer the most effective treatment when compared with similar treatments.

Next down would be the “comparable” product or service. Payment would be slightly less than that for the superior product, as in the difference between what is paid for a brand name and a generic pharmaceutical, for example.

The lowest rating would be “insufficient evidence.” The service would be covered and reimbursed at the conventional cost plus a small profit, but the payment level would be reevaluated every 3 years.

The authors said that a 3-year time frame can act as both a carrot and a stick. Having coverage at current Medicare rates is better than not having coverage, so innovation will not be stifled. But limiting that rate to only 3 years gives manufacturers and clinicians greater incentives to conduct comparative effectiveness studies, they said.

The new payment and coverage scheme might end up restricting access to new services, but the authors said they believe the “trade-off would be justifiable” because the services being reimbursed at the lower rate would have the least amount of evidence supporting their use.

They also said that using comparative effectiveness data, although threatening to manufacturers, might actually end up encouraging the development of superior products and services. “Paying more for better results is the best way to spur the kind of innovation desired most by patients, clinicians, and payers,” they wrote.

The new approach raises conundrums, they noted. It could be difficult to rate a service if effectiveness differed across patient subgroups. And there is the question of whether previously covered services should be grandfathered in. But overall, said Dr. Pearson and Dr. Bach, using comparative effectiveness data to guide payment would benefit both Medicare and physicians, who would no longer have “perverse incentives to invest in and deliver services that add to the cost but not the quality of care.”

Dr. Pearson and Dr. Bach reported no conflicts.

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The use of comparative effectiveness research would give Medicare a sophisticated tool for making coverage decisions on the basis of quality, but the federal health program's ability to use such data is hamstrung by political interests and the new health reform law, according to two researchers.

“We believe that the time is ripe for Medicare to use comparative effectiveness research to reach a new paradigm of paying equally for services that provide equivalent results,” said Dr. Steven D. Pearson, president of the Institute for Clinical and Economic Review, Boston, and Dr. Peter B. Bach of Memorial Sloan-Kettering Cancer Center, New York (Health Affairs 2010;29:1796-804).

The Obama administration is helping create a larger comparative effectiveness enterprise through some $1.1 billion that was set aside as part of the American Recovery and Reinvestment Act of 2009, and 15 experts are to guide investments and coordinate research through the Federal Coordinating Council for Comparative Effectiveness Research.

However, the council's role is limited. It will not set clinical guidelines, or establish payment rates, or tell Medicare what to cover. The Act further spelled out restrictions on how comparative effectiveness findings could be used by the federal government.

Currently, Medicare covers a drug, device, product, or service if the evidence supports its effectiveness. No comparisons are made to comparable technologies. Payment is set separately, based on arcane formulas that cover cost and maybe a small profit.

Dr. Pearson and Dr. Bach propose that Medicare instead link coverage and payment decisions at the outset. The program could still use the “reasonable and necessary” threshold in deciding when to cover a product or service. But regulators could adopt a three-tiered effectiveness scale that would let them assign differing reimbursement to each level.

For instance, a superior rating would garner the highest payment. Such a product would have the fewest side effects or offer the most effective treatment when compared with similar treatments.

Next down would be the “comparable” product or service. Payment would be slightly less than that for the superior product, as in the difference between what is paid for a brand name and a generic pharmaceutical, for example.

The lowest rating would be “insufficient evidence.” The service would be covered and reimbursed at the conventional cost plus a small profit, but the payment level would be reevaluated every 3 years.

The authors said that a 3-year time frame can act as both a carrot and a stick. Having coverage at current Medicare rates is better than not having coverage, so innovation will not be stifled. But limiting that rate to only 3 years gives manufacturers and clinicians greater incentives to conduct comparative effectiveness studies, they said.

The new payment and coverage scheme might end up restricting access to new services, but the authors said they believe the “trade-off would be justifiable” because the services being reimbursed at the lower rate would have the least amount of evidence supporting their use.

They also said that using comparative effectiveness data, although threatening to manufacturers, might actually end up encouraging the development of superior products and services. “Paying more for better results is the best way to spur the kind of innovation desired most by patients, clinicians, and payers,” they wrote.

The new approach raises conundrums, they noted. It could be difficult to rate a service if effectiveness differed across patient subgroups. And there is the question of whether previously covered services should be grandfathered in. But overall, said Dr. Pearson and Dr. Bach, using comparative effectiveness data to guide payment would benefit both Medicare and physicians, who would no longer have “perverse incentives to invest in and deliver services that add to the cost but not the quality of care.”

Dr. Pearson and Dr. Bach reported no conflicts.

The use of comparative effectiveness research would give Medicare a sophisticated tool for making coverage decisions on the basis of quality, but the federal health program's ability to use such data is hamstrung by political interests and the new health reform law, according to two researchers.

“We believe that the time is ripe for Medicare to use comparative effectiveness research to reach a new paradigm of paying equally for services that provide equivalent results,” said Dr. Steven D. Pearson, president of the Institute for Clinical and Economic Review, Boston, and Dr. Peter B. Bach of Memorial Sloan-Kettering Cancer Center, New York (Health Affairs 2010;29:1796-804).

The Obama administration is helping create a larger comparative effectiveness enterprise through some $1.1 billion that was set aside as part of the American Recovery and Reinvestment Act of 2009, and 15 experts are to guide investments and coordinate research through the Federal Coordinating Council for Comparative Effectiveness Research.

However, the council's role is limited. It will not set clinical guidelines, or establish payment rates, or tell Medicare what to cover. The Act further spelled out restrictions on how comparative effectiveness findings could be used by the federal government.

Currently, Medicare covers a drug, device, product, or service if the evidence supports its effectiveness. No comparisons are made to comparable technologies. Payment is set separately, based on arcane formulas that cover cost and maybe a small profit.

Dr. Pearson and Dr. Bach propose that Medicare instead link coverage and payment decisions at the outset. The program could still use the “reasonable and necessary” threshold in deciding when to cover a product or service. But regulators could adopt a three-tiered effectiveness scale that would let them assign differing reimbursement to each level.

For instance, a superior rating would garner the highest payment. Such a product would have the fewest side effects or offer the most effective treatment when compared with similar treatments.

Next down would be the “comparable” product or service. Payment would be slightly less than that for the superior product, as in the difference between what is paid for a brand name and a generic pharmaceutical, for example.

The lowest rating would be “insufficient evidence.” The service would be covered and reimbursed at the conventional cost plus a small profit, but the payment level would be reevaluated every 3 years.

The authors said that a 3-year time frame can act as both a carrot and a stick. Having coverage at current Medicare rates is better than not having coverage, so innovation will not be stifled. But limiting that rate to only 3 years gives manufacturers and clinicians greater incentives to conduct comparative effectiveness studies, they said.

The new payment and coverage scheme might end up restricting access to new services, but the authors said they believe the “trade-off would be justifiable” because the services being reimbursed at the lower rate would have the least amount of evidence supporting their use.

They also said that using comparative effectiveness data, although threatening to manufacturers, might actually end up encouraging the development of superior products and services. “Paying more for better results is the best way to spur the kind of innovation desired most by patients, clinicians, and payers,” they wrote.

The new approach raises conundrums, they noted. It could be difficult to rate a service if effectiveness differed across patient subgroups. And there is the question of whether previously covered services should be grandfathered in. But overall, said Dr. Pearson and Dr. Bach, using comparative effectiveness data to guide payment would benefit both Medicare and physicians, who would no longer have “perverse incentives to invest in and deliver services that add to the cost but not the quality of care.”

Dr. Pearson and Dr. Bach reported no conflicts.

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GOP House Majority Will Roil Reform Progress

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WASHINGTON – The historic midterm election victory by Republicans does not signal the end of the Affordable Care Act, but now the law will very likely undergo the scrutiny that many in the GOP say it did not get as it made its way through Congress.

The GOP now holds a majority in the House, with 239 seats, compared with 187 for the Democrats. Republican members of the Senate are still in the minority, but the current 52-46 Democratic margin is much slimmer than before the election.

Earlier this year, House Republican leaders and Senate Minority Leader Mitch McConnell (R-Ky.) vowed to “repeal and replace” the Affordable Care Act (ACA) if they regained the majority. A Republican-led House cannot make that happen alone; the Democratic-led Senate is unlikely to pass repeal legislation, and President Obama would likely veto any bill sent to him.

At a postelection press briefing, President Obama said he welcomed GOP input. “If the Republicans have ideas for how to improve our health care system, if they want to suggest modifications that would deliver faster and more effective reform to a health care system that has been widely expensive for too many families, businesses, and certainly our federal government, I'm happy to consider some of those ideas,” he said.

But he said that the White House would not entertain a repeal debate.

Speaking at a postelection forum, Jim Slattery, a former six-term Democratic congressman from Kansas, said that he expected to see a repeal proposal. “The new Tea Party congresspeople and the leadership in the House will probably have to introduce some kind of resolution that would call for the repeal of ACA, and I think they know it's going nowhere and it's not going to happen,” said Mr. Slattery, now a lobbyist with Wiley Rein.

Mr. Slattery said that President Obama mainly has himself to blame for the Democrats' poor showing in the election and for polling data indicating that half of Americans want to repeal the ACA. The president “failed to connect the dots” with Americans on how the law would benefit them, he added.

At the same forum, Nancy Johnson, a former Republican House member from Connecticut, said that she expected to see a number of oversight and investigative hearings on the ACA.

“The one thing that has to be done [in the next Congress] is, people have to regain their confidence in government and that's not about policy, that's about process,” said Ms. Johnson, a senior public policy adviser at Baker Donelson. “Half the bill is terrific. But the other half wasn't seen, and that created suspicion.”

Congressional Republicans have said they will keep some of the insurance market reforms – such as the prohibition on denying coverage for preexisting conditions – but will seek to throw out the mandate that individuals have health insurance coverage. That is a formula for disaster for the law – and for insurance companies, wrote Henry Aaron, a senior fellow at the Brookings Institution, in a perspective article published in the New England Journal of Medicine (2010;18:1685-7). Unless most Americans are covered, insurers might be bankrupted by the reforms, he said.

“In brief, the pledge to keep insurance-market reforms without both mandated coverage and subsidies is untenable,” Mr. Aaron wrote.

Mr. Slattery agreed. “If you're going to really reform the insurance industry with the preexisting-condition reforms, we have to have a mandate of some kind,” he said.

The requirement that individuals carry insurance or pay a penalty, however, is the central issue being challenged by 20 states that are involved in a lawsuit against the federal government in the U.S. District Court in Florida. Virginia has also filed its own suit, a case that Mr. Slattery said he expected to rise to the Supreme Court.

And governors and attorneys general elected in five states also campaigned on the promise that they, too, would support overturning the mandate.

With money tight and millions of potential new Medicaid enrollees, governors from all parties may revolt against the mandate, said Ms. Johnson. States are challenging the mandate, because it imposes burdens on them that they can't fulfill, she noted.

Back on Capitol Hill, the GOP-led House will also likely look closely at the ACA-created Independent Payment Advisory Board, said Ms. Johnson. The IPAB, charged with looking at how the federal government pays physicians, hospitals, pharmaceutical companies, and other providers, would have broad powers that make many Republicans uncomfortable, she said.

In his perspective piece, Mr. Aaron wrote that that Republicans could also tinker with the ACA by cutting off funding for implementation via the appropriations process, or even try to prohibit the Health and Human Services department from writing regulations. Some of those regulations are due to come out in the next 2 months – before the start of the 112th Congress.

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WASHINGTON – The historic midterm election victory by Republicans does not signal the end of the Affordable Care Act, but now the law will very likely undergo the scrutiny that many in the GOP say it did not get as it made its way through Congress.

The GOP now holds a majority in the House, with 239 seats, compared with 187 for the Democrats. Republican members of the Senate are still in the minority, but the current 52-46 Democratic margin is much slimmer than before the election.

Earlier this year, House Republican leaders and Senate Minority Leader Mitch McConnell (R-Ky.) vowed to “repeal and replace” the Affordable Care Act (ACA) if they regained the majority. A Republican-led House cannot make that happen alone; the Democratic-led Senate is unlikely to pass repeal legislation, and President Obama would likely veto any bill sent to him.

At a postelection press briefing, President Obama said he welcomed GOP input. “If the Republicans have ideas for how to improve our health care system, if they want to suggest modifications that would deliver faster and more effective reform to a health care system that has been widely expensive for too many families, businesses, and certainly our federal government, I'm happy to consider some of those ideas,” he said.

But he said that the White House would not entertain a repeal debate.

Speaking at a postelection forum, Jim Slattery, a former six-term Democratic congressman from Kansas, said that he expected to see a repeal proposal. “The new Tea Party congresspeople and the leadership in the House will probably have to introduce some kind of resolution that would call for the repeal of ACA, and I think they know it's going nowhere and it's not going to happen,” said Mr. Slattery, now a lobbyist with Wiley Rein.

Mr. Slattery said that President Obama mainly has himself to blame for the Democrats' poor showing in the election and for polling data indicating that half of Americans want to repeal the ACA. The president “failed to connect the dots” with Americans on how the law would benefit them, he added.

At the same forum, Nancy Johnson, a former Republican House member from Connecticut, said that she expected to see a number of oversight and investigative hearings on the ACA.

“The one thing that has to be done [in the next Congress] is, people have to regain their confidence in government and that's not about policy, that's about process,” said Ms. Johnson, a senior public policy adviser at Baker Donelson. “Half the bill is terrific. But the other half wasn't seen, and that created suspicion.”

Congressional Republicans have said they will keep some of the insurance market reforms – such as the prohibition on denying coverage for preexisting conditions – but will seek to throw out the mandate that individuals have health insurance coverage. That is a formula for disaster for the law – and for insurance companies, wrote Henry Aaron, a senior fellow at the Brookings Institution, in a perspective article published in the New England Journal of Medicine (2010;18:1685-7). Unless most Americans are covered, insurers might be bankrupted by the reforms, he said.

“In brief, the pledge to keep insurance-market reforms without both mandated coverage and subsidies is untenable,” Mr. Aaron wrote.

Mr. Slattery agreed. “If you're going to really reform the insurance industry with the preexisting-condition reforms, we have to have a mandate of some kind,” he said.

The requirement that individuals carry insurance or pay a penalty, however, is the central issue being challenged by 20 states that are involved in a lawsuit against the federal government in the U.S. District Court in Florida. Virginia has also filed its own suit, a case that Mr. Slattery said he expected to rise to the Supreme Court.

And governors and attorneys general elected in five states also campaigned on the promise that they, too, would support overturning the mandate.

With money tight and millions of potential new Medicaid enrollees, governors from all parties may revolt against the mandate, said Ms. Johnson. States are challenging the mandate, because it imposes burdens on them that they can't fulfill, she noted.

Back on Capitol Hill, the GOP-led House will also likely look closely at the ACA-created Independent Payment Advisory Board, said Ms. Johnson. The IPAB, charged with looking at how the federal government pays physicians, hospitals, pharmaceutical companies, and other providers, would have broad powers that make many Republicans uncomfortable, she said.

In his perspective piece, Mr. Aaron wrote that that Republicans could also tinker with the ACA by cutting off funding for implementation via the appropriations process, or even try to prohibit the Health and Human Services department from writing regulations. Some of those regulations are due to come out in the next 2 months – before the start of the 112th Congress.

WASHINGTON – The historic midterm election victory by Republicans does not signal the end of the Affordable Care Act, but now the law will very likely undergo the scrutiny that many in the GOP say it did not get as it made its way through Congress.

The GOP now holds a majority in the House, with 239 seats, compared with 187 for the Democrats. Republican members of the Senate are still in the minority, but the current 52-46 Democratic margin is much slimmer than before the election.

Earlier this year, House Republican leaders and Senate Minority Leader Mitch McConnell (R-Ky.) vowed to “repeal and replace” the Affordable Care Act (ACA) if they regained the majority. A Republican-led House cannot make that happen alone; the Democratic-led Senate is unlikely to pass repeal legislation, and President Obama would likely veto any bill sent to him.

At a postelection press briefing, President Obama said he welcomed GOP input. “If the Republicans have ideas for how to improve our health care system, if they want to suggest modifications that would deliver faster and more effective reform to a health care system that has been widely expensive for too many families, businesses, and certainly our federal government, I'm happy to consider some of those ideas,” he said.

But he said that the White House would not entertain a repeal debate.

Speaking at a postelection forum, Jim Slattery, a former six-term Democratic congressman from Kansas, said that he expected to see a repeal proposal. “The new Tea Party congresspeople and the leadership in the House will probably have to introduce some kind of resolution that would call for the repeal of ACA, and I think they know it's going nowhere and it's not going to happen,” said Mr. Slattery, now a lobbyist with Wiley Rein.

Mr. Slattery said that President Obama mainly has himself to blame for the Democrats' poor showing in the election and for polling data indicating that half of Americans want to repeal the ACA. The president “failed to connect the dots” with Americans on how the law would benefit them, he added.

At the same forum, Nancy Johnson, a former Republican House member from Connecticut, said that she expected to see a number of oversight and investigative hearings on the ACA.

“The one thing that has to be done [in the next Congress] is, people have to regain their confidence in government and that's not about policy, that's about process,” said Ms. Johnson, a senior public policy adviser at Baker Donelson. “Half the bill is terrific. But the other half wasn't seen, and that created suspicion.”

Congressional Republicans have said they will keep some of the insurance market reforms – such as the prohibition on denying coverage for preexisting conditions – but will seek to throw out the mandate that individuals have health insurance coverage. That is a formula for disaster for the law – and for insurance companies, wrote Henry Aaron, a senior fellow at the Brookings Institution, in a perspective article published in the New England Journal of Medicine (2010;18:1685-7). Unless most Americans are covered, insurers might be bankrupted by the reforms, he said.

“In brief, the pledge to keep insurance-market reforms without both mandated coverage and subsidies is untenable,” Mr. Aaron wrote.

Mr. Slattery agreed. “If you're going to really reform the insurance industry with the preexisting-condition reforms, we have to have a mandate of some kind,” he said.

The requirement that individuals carry insurance or pay a penalty, however, is the central issue being challenged by 20 states that are involved in a lawsuit against the federal government in the U.S. District Court in Florida. Virginia has also filed its own suit, a case that Mr. Slattery said he expected to rise to the Supreme Court.

And governors and attorneys general elected in five states also campaigned on the promise that they, too, would support overturning the mandate.

With money tight and millions of potential new Medicaid enrollees, governors from all parties may revolt against the mandate, said Ms. Johnson. States are challenging the mandate, because it imposes burdens on them that they can't fulfill, she noted.

Back on Capitol Hill, the GOP-led House will also likely look closely at the ACA-created Independent Payment Advisory Board, said Ms. Johnson. The IPAB, charged with looking at how the federal government pays physicians, hospitals, pharmaceutical companies, and other providers, would have broad powers that make many Republicans uncomfortable, she said.

In his perspective piece, Mr. Aaron wrote that that Republicans could also tinker with the ACA by cutting off funding for implementation via the appropriations process, or even try to prohibit the Health and Human Services department from writing regulations. Some of those regulations are due to come out in the next 2 months – before the start of the 112th Congress.

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NCQA Seeks Comment On Draft ACO Criteria

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The National Committee for Quality Assurance has issued draft criteria to define the core capabilities of an accountable care organization.

The accountable care organization (ACO) concept is central to the health system reform envisioned by the Affordable Care Act, but what it would look like or how it would work has been variously and loosely defined. The nonprofit NCQA has stepped in to offer a set of parameters that might standardize the ACO model.

“Our goal is to help people be confident that ACOs meeting the final criteria actually can contain costs without compromising quality,” said NCQA President Margaret O'Kane in a statement.

The NCQA has been a leader in establishing quality performance measurement tools that are widely used by health care providers, insurers, and employers. The group receives funding and support from a variety of organizations, including the American College of Physicians and the American Academy of Family Physicians; insurers and pharmaceutical companies also contribute.

The organization has posted the ACO criteria on its Web site and was accepting public comments until Nov. 19.

According to the NCQA, each ACO should have core capabilities in seven categories: program structure operations; access and availability; primary care; care management; care coordination and transitions; patient rights and responsibilities; and performance reporting.

The criteria were developed by the organization's ACO task force, which was headed by Dr. Robert Margolis, CEO of the California-based HealthCare Partners Medical Group; the 18 other task force members included Dr. Duane Davis, vice president and chief medical officer of the Pennsylvania-based Geisinger Health Plan, and Dr. Nicholas Wolter, CEO of the Billings (Mont.) Clinic.

ACOs that participate in the NCQA process also will eventually report outcomes on performance measurements. That is important, Dr. Margolis said in a statement, adding that, “most potential ACOs do not have data that can be used from the start to evaluate performance.”

He added that “public feedback will help with finalizing the criteria that will start these organizations to a firm foundation.”

After the comment period closes, the task force led by Dr. Margolis will review the comments and make revisions, as appropriate, according to a spokesperson for NCQA.

The group will also align the criteria with any regulations pertaining to ACOs. The criteria will likely be made final by March 2011 and then will be released in the second quarter of 2011, the spokesperson said.

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The National Committee for Quality Assurance has issued draft criteria to define the core capabilities of an accountable care organization.

The accountable care organization (ACO) concept is central to the health system reform envisioned by the Affordable Care Act, but what it would look like or how it would work has been variously and loosely defined. The nonprofit NCQA has stepped in to offer a set of parameters that might standardize the ACO model.

“Our goal is to help people be confident that ACOs meeting the final criteria actually can contain costs without compromising quality,” said NCQA President Margaret O'Kane in a statement.

The NCQA has been a leader in establishing quality performance measurement tools that are widely used by health care providers, insurers, and employers. The group receives funding and support from a variety of organizations, including the American College of Physicians and the American Academy of Family Physicians; insurers and pharmaceutical companies also contribute.

The organization has posted the ACO criteria on its Web site and was accepting public comments until Nov. 19.

According to the NCQA, each ACO should have core capabilities in seven categories: program structure operations; access and availability; primary care; care management; care coordination and transitions; patient rights and responsibilities; and performance reporting.

The criteria were developed by the organization's ACO task force, which was headed by Dr. Robert Margolis, CEO of the California-based HealthCare Partners Medical Group; the 18 other task force members included Dr. Duane Davis, vice president and chief medical officer of the Pennsylvania-based Geisinger Health Plan, and Dr. Nicholas Wolter, CEO of the Billings (Mont.) Clinic.

ACOs that participate in the NCQA process also will eventually report outcomes on performance measurements. That is important, Dr. Margolis said in a statement, adding that, “most potential ACOs do not have data that can be used from the start to evaluate performance.”

He added that “public feedback will help with finalizing the criteria that will start these organizations to a firm foundation.”

After the comment period closes, the task force led by Dr. Margolis will review the comments and make revisions, as appropriate, according to a spokesperson for NCQA.

The group will also align the criteria with any regulations pertaining to ACOs. The criteria will likely be made final by March 2011 and then will be released in the second quarter of 2011, the spokesperson said.

The National Committee for Quality Assurance has issued draft criteria to define the core capabilities of an accountable care organization.

The accountable care organization (ACO) concept is central to the health system reform envisioned by the Affordable Care Act, but what it would look like or how it would work has been variously and loosely defined. The nonprofit NCQA has stepped in to offer a set of parameters that might standardize the ACO model.

“Our goal is to help people be confident that ACOs meeting the final criteria actually can contain costs without compromising quality,” said NCQA President Margaret O'Kane in a statement.

The NCQA has been a leader in establishing quality performance measurement tools that are widely used by health care providers, insurers, and employers. The group receives funding and support from a variety of organizations, including the American College of Physicians and the American Academy of Family Physicians; insurers and pharmaceutical companies also contribute.

The organization has posted the ACO criteria on its Web site and was accepting public comments until Nov. 19.

According to the NCQA, each ACO should have core capabilities in seven categories: program structure operations; access and availability; primary care; care management; care coordination and transitions; patient rights and responsibilities; and performance reporting.

The criteria were developed by the organization's ACO task force, which was headed by Dr. Robert Margolis, CEO of the California-based HealthCare Partners Medical Group; the 18 other task force members included Dr. Duane Davis, vice president and chief medical officer of the Pennsylvania-based Geisinger Health Plan, and Dr. Nicholas Wolter, CEO of the Billings (Mont.) Clinic.

ACOs that participate in the NCQA process also will eventually report outcomes on performance measurements. That is important, Dr. Margolis said in a statement, adding that, “most potential ACOs do not have data that can be used from the start to evaluate performance.”

He added that “public feedback will help with finalizing the criteria that will start these organizations to a firm foundation.”

After the comment period closes, the task force led by Dr. Margolis will review the comments and make revisions, as appropriate, according to a spokesperson for NCQA.

The group will also align the criteria with any regulations pertaining to ACOs. The criteria will likely be made final by March 2011 and then will be released in the second quarter of 2011, the spokesperson said.

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Medicare Clock Ticks Toward 23% Cut Dec. 1

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The Centers for Medicare and Medicaid Services this month issued its final rule governing physician fees for 2011, offering a 10% incentive payment to primary care physicians, but taking away an additional 2% across the board as a result of the statutory requirements of the sustainable growth rate formula.

Unless Congress acts, physician fees under Medicare will be cut by 23% on Dec. 1 as mandated by the SGR; just about 2% more will be cut Jan. 1, bringing the total cut for 2011 to 25%.

Although CMS Administrator Don Berwick has called for a permanent overhaul of the SGR, it was not mentioned in the materials that went out with the new rule. Instead, Dr. Berwick touted the new preventive care benefits that will be covered, and thus reimbursed, as a result of the Affordable Care Act.

Under the final rule, which implements certain ACA provisions, Medicare will pay for an annual wellness visit, “that will allow a physician and patient to develop a closer partnership to improve the patient's long-term health,” said Dr. Berwick in a statement.

“The rule will also eliminate out-of-pocket costs for most preventive services beginning Jan. 1, 2011, reducing barriers to access for many beneficiaries,” he added.

The wellness visit will be paid at the rate of a level 4 office visit for a new patient.

The ACA also provided the primary care bonus, which is separate from the fee cuts. The payment is available to family physicians, general internists, geriatricians, pediatricians, nurse practitioners, clinical nurse specialists, and physician assistants who can show that 60% or more of their Medicare allowable charges were for primary care.

The incentive payments will be made quarterly, based on the services provided in the previous quarter.

A similar 10% quarterly incentive payment will be made in 2011 to general surgeons in Health Professional Shortage Areas.

The fee schedule also implements a provision of the ACA that increases payment for two codes for dual-energy x-ray absorptiometry (DXA) for both 2010 and 2011.

However, CMS decided it would not restore consultation codes for inpatient, outpatient, or nursing facility visits. The consultation codes, which are essential to most physicians who receive referrals, were dropped by Medicare in 2010.

Instead, physicians were told to use new or established office visit codes, initial hospital care codes, or initial nursing facility care codes. At that time, CMS officials said that the codes were no longer necessary, given that the agency had reduced the paperwork burden for consultations.

The final rule for the 2011 fee schedule notes that there is no evidence to support the necessity of the codes, and that coordination of care should not be adversely affected by dropping them.

“If we become aware of such evidence in the future, we would certainly consider whether there is an appropriate policy response to promote more effective coordination of care,” according to the final rule.

The agency said there was no evidence that Medicare beneficiaries had been harmed by the loss of the codes.

However, a survey by the American Medical Association this past summer found that a fifth of physicians had stopped seeing new Medicare patients, and almost 40% were cutting back on information technology purchases because of lost revenue.

The ACA also dictated new requirements for physicians who refer patients to MRI, CT, and PET facilities in which they have an ownership interest. Now, the physician will have to disclose in writing to patients that they can receive the service elsewhere. Referring physicians will also have to provide a list of five alternatives within 25 miles of the physician's office.

Payment for imaging procedures will also be reduced. Previously, CMS reimbursed based on the assumption that equipment was used 100% of the time. That assumption has been changed to 75%.

The ACA also reduced incentives for the Physician Quality Reporting System (formerly known as the Physician Quality Reporting Initiative).

In 2011, physicians will be eligible for an incentive payment equal to 1% of the total Medicare charges during the reporting period. For 2012 through 2014, the payment drops to 0.5% of charges. After 2014, physicians who do not report data could see a 1.5% cut in Medicare fees; the penalty increases each year.

There is a carrot, though. Physicians who use a maintenance of certification program to report PQRS data will get an additional 0.5%.

The incentive payment for e-prescribing in 2011 will be 1% of charges during the calendar year. But in 2012, payments will be reduced if physicians are “not successful e-prescribers,” according to the CMS.

 

 

The final fee schedule rule will be published Nov. 29 in the Federal Register.

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The Centers for Medicare and Medicaid Services this month issued its final rule governing physician fees for 2011, offering a 10% incentive payment to primary care physicians, but taking away an additional 2% across the board as a result of the statutory requirements of the sustainable growth rate formula.

Unless Congress acts, physician fees under Medicare will be cut by 23% on Dec. 1 as mandated by the SGR; just about 2% more will be cut Jan. 1, bringing the total cut for 2011 to 25%.

Although CMS Administrator Don Berwick has called for a permanent overhaul of the SGR, it was not mentioned in the materials that went out with the new rule. Instead, Dr. Berwick touted the new preventive care benefits that will be covered, and thus reimbursed, as a result of the Affordable Care Act.

Under the final rule, which implements certain ACA provisions, Medicare will pay for an annual wellness visit, “that will allow a physician and patient to develop a closer partnership to improve the patient's long-term health,” said Dr. Berwick in a statement.

“The rule will also eliminate out-of-pocket costs for most preventive services beginning Jan. 1, 2011, reducing barriers to access for many beneficiaries,” he added.

The wellness visit will be paid at the rate of a level 4 office visit for a new patient.

The ACA also provided the primary care bonus, which is separate from the fee cuts. The payment is available to family physicians, general internists, geriatricians, pediatricians, nurse practitioners, clinical nurse specialists, and physician assistants who can show that 60% or more of their Medicare allowable charges were for primary care.

The incentive payments will be made quarterly, based on the services provided in the previous quarter.

A similar 10% quarterly incentive payment will be made in 2011 to general surgeons in Health Professional Shortage Areas.

The fee schedule also implements a provision of the ACA that increases payment for two codes for dual-energy x-ray absorptiometry (DXA) for both 2010 and 2011.

However, CMS decided it would not restore consultation codes for inpatient, outpatient, or nursing facility visits. The consultation codes, which are essential to most physicians who receive referrals, were dropped by Medicare in 2010.

Instead, physicians were told to use new or established office visit codes, initial hospital care codes, or initial nursing facility care codes. At that time, CMS officials said that the codes were no longer necessary, given that the agency had reduced the paperwork burden for consultations.

The final rule for the 2011 fee schedule notes that there is no evidence to support the necessity of the codes, and that coordination of care should not be adversely affected by dropping them.

“If we become aware of such evidence in the future, we would certainly consider whether there is an appropriate policy response to promote more effective coordination of care,” according to the final rule.

The agency said there was no evidence that Medicare beneficiaries had been harmed by the loss of the codes.

However, a survey by the American Medical Association this past summer found that a fifth of physicians had stopped seeing new Medicare patients, and almost 40% were cutting back on information technology purchases because of lost revenue.

The ACA also dictated new requirements for physicians who refer patients to MRI, CT, and PET facilities in which they have an ownership interest. Now, the physician will have to disclose in writing to patients that they can receive the service elsewhere. Referring physicians will also have to provide a list of five alternatives within 25 miles of the physician's office.

Payment for imaging procedures will also be reduced. Previously, CMS reimbursed based on the assumption that equipment was used 100% of the time. That assumption has been changed to 75%.

The ACA also reduced incentives for the Physician Quality Reporting System (formerly known as the Physician Quality Reporting Initiative).

In 2011, physicians will be eligible for an incentive payment equal to 1% of the total Medicare charges during the reporting period. For 2012 through 2014, the payment drops to 0.5% of charges. After 2014, physicians who do not report data could see a 1.5% cut in Medicare fees; the penalty increases each year.

There is a carrot, though. Physicians who use a maintenance of certification program to report PQRS data will get an additional 0.5%.

The incentive payment for e-prescribing in 2011 will be 1% of charges during the calendar year. But in 2012, payments will be reduced if physicians are “not successful e-prescribers,” according to the CMS.

 

 

The final fee schedule rule will be published Nov. 29 in the Federal Register.

The Centers for Medicare and Medicaid Services this month issued its final rule governing physician fees for 2011, offering a 10% incentive payment to primary care physicians, but taking away an additional 2% across the board as a result of the statutory requirements of the sustainable growth rate formula.

Unless Congress acts, physician fees under Medicare will be cut by 23% on Dec. 1 as mandated by the SGR; just about 2% more will be cut Jan. 1, bringing the total cut for 2011 to 25%.

Although CMS Administrator Don Berwick has called for a permanent overhaul of the SGR, it was not mentioned in the materials that went out with the new rule. Instead, Dr. Berwick touted the new preventive care benefits that will be covered, and thus reimbursed, as a result of the Affordable Care Act.

Under the final rule, which implements certain ACA provisions, Medicare will pay for an annual wellness visit, “that will allow a physician and patient to develop a closer partnership to improve the patient's long-term health,” said Dr. Berwick in a statement.

“The rule will also eliminate out-of-pocket costs for most preventive services beginning Jan. 1, 2011, reducing barriers to access for many beneficiaries,” he added.

The wellness visit will be paid at the rate of a level 4 office visit for a new patient.

The ACA also provided the primary care bonus, which is separate from the fee cuts. The payment is available to family physicians, general internists, geriatricians, pediatricians, nurse practitioners, clinical nurse specialists, and physician assistants who can show that 60% or more of their Medicare allowable charges were for primary care.

The incentive payments will be made quarterly, based on the services provided in the previous quarter.

A similar 10% quarterly incentive payment will be made in 2011 to general surgeons in Health Professional Shortage Areas.

The fee schedule also implements a provision of the ACA that increases payment for two codes for dual-energy x-ray absorptiometry (DXA) for both 2010 and 2011.

However, CMS decided it would not restore consultation codes for inpatient, outpatient, or nursing facility visits. The consultation codes, which are essential to most physicians who receive referrals, were dropped by Medicare in 2010.

Instead, physicians were told to use new or established office visit codes, initial hospital care codes, or initial nursing facility care codes. At that time, CMS officials said that the codes were no longer necessary, given that the agency had reduced the paperwork burden for consultations.

The final rule for the 2011 fee schedule notes that there is no evidence to support the necessity of the codes, and that coordination of care should not be adversely affected by dropping them.

“If we become aware of such evidence in the future, we would certainly consider whether there is an appropriate policy response to promote more effective coordination of care,” according to the final rule.

The agency said there was no evidence that Medicare beneficiaries had been harmed by the loss of the codes.

However, a survey by the American Medical Association this past summer found that a fifth of physicians had stopped seeing new Medicare patients, and almost 40% were cutting back on information technology purchases because of lost revenue.

The ACA also dictated new requirements for physicians who refer patients to MRI, CT, and PET facilities in which they have an ownership interest. Now, the physician will have to disclose in writing to patients that they can receive the service elsewhere. Referring physicians will also have to provide a list of five alternatives within 25 miles of the physician's office.

Payment for imaging procedures will also be reduced. Previously, CMS reimbursed based on the assumption that equipment was used 100% of the time. That assumption has been changed to 75%.

The ACA also reduced incentives for the Physician Quality Reporting System (formerly known as the Physician Quality Reporting Initiative).

In 2011, physicians will be eligible for an incentive payment equal to 1% of the total Medicare charges during the reporting period. For 2012 through 2014, the payment drops to 0.5% of charges. After 2014, physicians who do not report data could see a 1.5% cut in Medicare fees; the penalty increases each year.

There is a carrot, though. Physicians who use a maintenance of certification program to report PQRS data will get an additional 0.5%.

The incentive payment for e-prescribing in 2011 will be 1% of charges during the calendar year. But in 2012, payments will be reduced if physicians are “not successful e-prescribers,” according to the CMS.

 

 

The final fee schedule rule will be published Nov. 29 in the Federal Register.

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HHS Tobacco Control Strategy Includes Graphic Warnings

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The Department of Health and Human Services issued a sweeping new tobacco control strategy on Nov. 10 that would require cigarette makers to place photographs and graphic depictions of the harms of smoking prominently on the packages or in advertising.

Photo credit: courtesy of the FDA.
The FDA is seeking comments on what required warnings to include in the final rule, including comments on proposed color graphics such as the one above.    

The graphic warnings – which will be regulated by the Food and Drug Administration – were part of a proposed rule issued by the agency. They were required by the Family Smoking Prevention and Tobacco Control Act and are the centerpiece of the 66-page strategy released by HHS.

"Every day, almost 4,000 youth try a cigarette for the first time and 1,000 youth become regular, daily smokers," HHS Secretary Kathleen Sebelius said in a statement. "Today marks an important milestone in protecting our children and the health of the American public."

HHS estimates that 443,000 Americans die from tobacco-related diseases each year, with 50,000 of those deaths caused by secondhand smoke. Some 8.6 million Americans have smoking-related chronic diseases.

FDA Commissioner Margaret Hamburg said, "When this rule takes effect, the health consequences of smoking will be obvious every time someone picks up a pack of cigarettes."

The agency is going to require a disturbing photograph or cartoon graphic that takes up half a package of cigarettes or is prominently placed in an ad. The graphic would depict one of the following warnings: "Cigarettes are addictive," "Tobacco smoke can harm your children," "Cigarettes cause fatal lung disease," "Cigarettes cause cancer," "Cigarettes cause strokes and heart disease," "Smoking during pregnancy can harm your baby," "Smoking can kill you," "Tobacco smoke causes fatal lung disease in nonsmokers," and "Quitting smoking now greatly reduces serious risks to your health."

The cancer warning might have a photograph of an obviously terminally ill person in a hospital bed, or a close-up of a mouth riddled with rotting teeth and sores. The heart disease warning might have a photograph of a man clutching his chest, in the throes of a myocardial infarction.

The FDA is seeking the public’s input on which graphic depiction to use for each warning. It is accepting comments until Jan. 9, 2011. Then, the agency will select one graphic for each of the nine warnings and publish the choices in a final rule to be issued by June 22, 2011. Manufacturers would have 15 months from that time – by October 2012 – to come into compliance. If they do not comply, their product will be banned from sale in the United States.

Public health advocacy groups applauded the HHS plan and the FDA proposal. "The new warnings represent the most significant change in U.S. cigarette warnings since they were first required in 1965," Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.

The American Cancer Society Cancer Action Network said that current warnings are ineffective "because of their inability to attract attention due to their size and placement on the packaging." The group said that the proposal is important and timely. "The FDA has the opportunity to make an enormous impact on effectively informing the public of the actual harms of using tobacco products and inducing the desire to quit among users," ACSCAN said in a statement.

The HHS strategy paper recommended expanding tobacco cessation services, including Medicare and Medicaid; accelerating the adoption of smoke-free laws across the country; increasing the number of tobacco-free workplaces and campuses; and adopting evidence-based intervention strategies. Health care providers should receive enhanced incentives for offering interventions and treatments, and federal agencies should increase research into tobacco cessation strategies and treatments and surveillance and monitoring of control efforts, said the HHS strategic paper.

The HHS also called for a national media campaign to prevent kids from smoking, which Mr. Myers characterized as a critical element of tobacco control.

"The administration and Congress must now provide sufficient funding for these initiatives if they are to succeed," he said.

According to the HHS, if the agency receives funding and all of the initiatives were to go forward, the country could meet the Healthy People 2010 objective to reduce the smoking rate to 12% of American adults.

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The Department of Health and Human Services issued a sweeping new tobacco control strategy on Nov. 10 that would require cigarette makers to place photographs and graphic depictions of the harms of smoking prominently on the packages or in advertising.

Photo credit: courtesy of the FDA.
The FDA is seeking comments on what required warnings to include in the final rule, including comments on proposed color graphics such as the one above.    

The graphic warnings – which will be regulated by the Food and Drug Administration – were part of a proposed rule issued by the agency. They were required by the Family Smoking Prevention and Tobacco Control Act and are the centerpiece of the 66-page strategy released by HHS.

"Every day, almost 4,000 youth try a cigarette for the first time and 1,000 youth become regular, daily smokers," HHS Secretary Kathleen Sebelius said in a statement. "Today marks an important milestone in protecting our children and the health of the American public."

HHS estimates that 443,000 Americans die from tobacco-related diseases each year, with 50,000 of those deaths caused by secondhand smoke. Some 8.6 million Americans have smoking-related chronic diseases.

FDA Commissioner Margaret Hamburg said, "When this rule takes effect, the health consequences of smoking will be obvious every time someone picks up a pack of cigarettes."

The agency is going to require a disturbing photograph or cartoon graphic that takes up half a package of cigarettes or is prominently placed in an ad. The graphic would depict one of the following warnings: "Cigarettes are addictive," "Tobacco smoke can harm your children," "Cigarettes cause fatal lung disease," "Cigarettes cause cancer," "Cigarettes cause strokes and heart disease," "Smoking during pregnancy can harm your baby," "Smoking can kill you," "Tobacco smoke causes fatal lung disease in nonsmokers," and "Quitting smoking now greatly reduces serious risks to your health."

The cancer warning might have a photograph of an obviously terminally ill person in a hospital bed, or a close-up of a mouth riddled with rotting teeth and sores. The heart disease warning might have a photograph of a man clutching his chest, in the throes of a myocardial infarction.

The FDA is seeking the public’s input on which graphic depiction to use for each warning. It is accepting comments until Jan. 9, 2011. Then, the agency will select one graphic for each of the nine warnings and publish the choices in a final rule to be issued by June 22, 2011. Manufacturers would have 15 months from that time – by October 2012 – to come into compliance. If they do not comply, their product will be banned from sale in the United States.

Public health advocacy groups applauded the HHS plan and the FDA proposal. "The new warnings represent the most significant change in U.S. cigarette warnings since they were first required in 1965," Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.

The American Cancer Society Cancer Action Network said that current warnings are ineffective "because of their inability to attract attention due to their size and placement on the packaging." The group said that the proposal is important and timely. "The FDA has the opportunity to make an enormous impact on effectively informing the public of the actual harms of using tobacco products and inducing the desire to quit among users," ACSCAN said in a statement.

The HHS strategy paper recommended expanding tobacco cessation services, including Medicare and Medicaid; accelerating the adoption of smoke-free laws across the country; increasing the number of tobacco-free workplaces and campuses; and adopting evidence-based intervention strategies. Health care providers should receive enhanced incentives for offering interventions and treatments, and federal agencies should increase research into tobacco cessation strategies and treatments and surveillance and monitoring of control efforts, said the HHS strategic paper.

The HHS also called for a national media campaign to prevent kids from smoking, which Mr. Myers characterized as a critical element of tobacco control.

"The administration and Congress must now provide sufficient funding for these initiatives if they are to succeed," he said.

According to the HHS, if the agency receives funding and all of the initiatives were to go forward, the country could meet the Healthy People 2010 objective to reduce the smoking rate to 12% of American adults.

The Department of Health and Human Services issued a sweeping new tobacco control strategy on Nov. 10 that would require cigarette makers to place photographs and graphic depictions of the harms of smoking prominently on the packages or in advertising.

Photo credit: courtesy of the FDA.
The FDA is seeking comments on what required warnings to include in the final rule, including comments on proposed color graphics such as the one above.    

The graphic warnings – which will be regulated by the Food and Drug Administration – were part of a proposed rule issued by the agency. They were required by the Family Smoking Prevention and Tobacco Control Act and are the centerpiece of the 66-page strategy released by HHS.

"Every day, almost 4,000 youth try a cigarette for the first time and 1,000 youth become regular, daily smokers," HHS Secretary Kathleen Sebelius said in a statement. "Today marks an important milestone in protecting our children and the health of the American public."

HHS estimates that 443,000 Americans die from tobacco-related diseases each year, with 50,000 of those deaths caused by secondhand smoke. Some 8.6 million Americans have smoking-related chronic diseases.

FDA Commissioner Margaret Hamburg said, "When this rule takes effect, the health consequences of smoking will be obvious every time someone picks up a pack of cigarettes."

The agency is going to require a disturbing photograph or cartoon graphic that takes up half a package of cigarettes or is prominently placed in an ad. The graphic would depict one of the following warnings: "Cigarettes are addictive," "Tobacco smoke can harm your children," "Cigarettes cause fatal lung disease," "Cigarettes cause cancer," "Cigarettes cause strokes and heart disease," "Smoking during pregnancy can harm your baby," "Smoking can kill you," "Tobacco smoke causes fatal lung disease in nonsmokers," and "Quitting smoking now greatly reduces serious risks to your health."

The cancer warning might have a photograph of an obviously terminally ill person in a hospital bed, or a close-up of a mouth riddled with rotting teeth and sores. The heart disease warning might have a photograph of a man clutching his chest, in the throes of a myocardial infarction.

The FDA is seeking the public’s input on which graphic depiction to use for each warning. It is accepting comments until Jan. 9, 2011. Then, the agency will select one graphic for each of the nine warnings and publish the choices in a final rule to be issued by June 22, 2011. Manufacturers would have 15 months from that time – by October 2012 – to come into compliance. If they do not comply, their product will be banned from sale in the United States.

Public health advocacy groups applauded the HHS plan and the FDA proposal. "The new warnings represent the most significant change in U.S. cigarette warnings since they were first required in 1965," Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.

The American Cancer Society Cancer Action Network said that current warnings are ineffective "because of their inability to attract attention due to their size and placement on the packaging." The group said that the proposal is important and timely. "The FDA has the opportunity to make an enormous impact on effectively informing the public of the actual harms of using tobacco products and inducing the desire to quit among users," ACSCAN said in a statement.

The HHS strategy paper recommended expanding tobacco cessation services, including Medicare and Medicaid; accelerating the adoption of smoke-free laws across the country; increasing the number of tobacco-free workplaces and campuses; and adopting evidence-based intervention strategies. Health care providers should receive enhanced incentives for offering interventions and treatments, and federal agencies should increase research into tobacco cessation strategies and treatments and surveillance and monitoring of control efforts, said the HHS strategic paper.

The HHS also called for a national media campaign to prevent kids from smoking, which Mr. Myers characterized as a critical element of tobacco control.

"The administration and Congress must now provide sufficient funding for these initiatives if they are to succeed," he said.

According to the HHS, if the agency receives funding and all of the initiatives were to go forward, the country could meet the Healthy People 2010 objective to reduce the smoking rate to 12% of American adults.

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GOP Takeover of House Will Roil Reform Progress

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WASHINGTON – The historic midterm election victory by Republicans does not signal the end of the Affordable Care Act, but now the law will very likely undergo the scrutiny that many in the GOP say it did not get as it made its way through Congress.

At press time, the Republicans had gained 60 seats in the House (with 9 races still undecided) and 6 seats in the Senate (with 1 still undecided). Even without the final results, the GOP now holds a majority in the House, with 239 seats, compared with 187 for the Democrats. Republican members of the Senate are still in the minority, but the current 52-46 Democratic margin is much slimmer than before the election.

Earlier this year, House Republican leaders and Senate Minority Leader Mitch McConnell (R-Ky.) vowed to "repeal and replace" the ACA if they regained the majority. A Republican-led House will not be able to make that happen alone; the Democratic-led Senate is unlikely to pass repeal legislation, and President Obama would likely veto any bill sent to him.

But Rep. John Boehner (R-Ohio), expected to be elected speaker of the House when the 112th Congress convenes in January, has indicated that the health reform law will be challenged in his chamber.

At a postelection press briefing, President Obama said he welcomed GOP input. "If the Republicans have ideas for how to improve our health care system, if they want to suggest modifications that would deliver faster and more effective reform to a health care system that has been widely expensive for too many families, businesses, and certainly our federal government, I’m happy to consider some of those ideas," he said.

But he said that the White House would not entertain a repeal debate.

Speaking at a postelection forum, Jim Slattery, a former six-term Democratic congressman from Kansas, said that he expected to see a repeal proposal. "The new Tea Party congresspeople and the leadership in the House will probably have to introduce some kind of resolution that would call for the repeal of ACA, and I think they know it’s going nowhere and it’s not going to happen, but they’re going to have to do that probably to satisfy political demand," said Mr. Slattery, now a lobbyist with Wiley Rein.

Mr. Slattery said that President Obama mainly has himself to blame for the Democrats’ poor showing in the election and for polling data indicating that half of Americans want to repeal the ACA. The president "failed to connect the dots" with Americans on how the law would benefit them, he added.

At the same forum, Nancy Johnson, a former Republican House member from Connecticut, said that she expected to see a number of oversight and investigative hearings on the ACA.

"The one thing that has to be done [in the next Congress] is, people have to regain their confidence in government and that’s not about policy, that’s about process," said Ms. Johnson, a senior public policy adviser at Baker Donelson. "Half the bill is terrific. But the other half wasn’t seen, and that created suspicion."

Rep. Boehner and other congressional Republicans have said they will keep some of the insurance market reforms – such as the prohibition on denying coverage for preexisting conditions – but will seek to throw out the mandate that individuals have health insurance coverage. That is a formula for disaster for the law – and for insurance companies, wrote Henry Aaron, a senior fellow at the Brookings Institution, in a perspective article published in the New England Journal of Medicine (2010;18:1685-7). Unless most Americans are covered, insurers might be bankrupted by the reforms, he said.

"In brief, the pledge to keep insurance-market reforms without both mandated coverage and subsidies is untenable," Mr. Aaron wrote.

Mr. Slattery agreed. "If you’re going to really reform the insurance industry with the preexisting-condition reforms, we have to have a mandate of some kind," he said.

The requirement that individuals carry insurance or pay a penalty, however, is the central issue being challenged by 20 states that are involved in a lawsuit against the federal government in the U.S. District Court in Florida. Virginia has also filed its own suit, a case that Mr. Slattery said he expected to rise to the Supreme Court.

And governors and attorneys general elected in five states also campaigned on the promise that they, too, would support overturning the mandate.

With money tight and millions of potential new Medicaid enrollees, governors from all parties may revolt against the mandate, said Ms. Johnson. "If you look at the basis on which states are challenging the mandate, it’s in part that it abrogates the federal-state partnership because it imposes burdens they can’t fulfill."

 

 

Back on Capitol Hill, the GOP-led House will also likely take a close look at the ACA-created Independent Payment Advisory Board, said Ms. Johnson. The IPAB, charged with looking at how the federal government pays physicians, hospitals, pharmaceutical companies, and other health providers, would have broad powers that make many Republicans uncomfortable, she said.

In his perspective piece, Mr. Aaron wrote that that Republicans could also tinker with the ACA by cutting off funding for implementation via the appropriations process, or even try to prohibit the Health and Human Services department from writing regulations. Some of those regulations are due to come out in the next 2 months – before the start of the 112th Congress.

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WASHINGTON – The historic midterm election victory by Republicans does not signal the end of the Affordable Care Act, but now the law will very likely undergo the scrutiny that many in the GOP say it did not get as it made its way through Congress.

At press time, the Republicans had gained 60 seats in the House (with 9 races still undecided) and 6 seats in the Senate (with 1 still undecided). Even without the final results, the GOP now holds a majority in the House, with 239 seats, compared with 187 for the Democrats. Republican members of the Senate are still in the minority, but the current 52-46 Democratic margin is much slimmer than before the election.

Earlier this year, House Republican leaders and Senate Minority Leader Mitch McConnell (R-Ky.) vowed to "repeal and replace" the ACA if they regained the majority. A Republican-led House will not be able to make that happen alone; the Democratic-led Senate is unlikely to pass repeal legislation, and President Obama would likely veto any bill sent to him.

But Rep. John Boehner (R-Ohio), expected to be elected speaker of the House when the 112th Congress convenes in January, has indicated that the health reform law will be challenged in his chamber.

At a postelection press briefing, President Obama said he welcomed GOP input. "If the Republicans have ideas for how to improve our health care system, if they want to suggest modifications that would deliver faster and more effective reform to a health care system that has been widely expensive for too many families, businesses, and certainly our federal government, I’m happy to consider some of those ideas," he said.

But he said that the White House would not entertain a repeal debate.

Speaking at a postelection forum, Jim Slattery, a former six-term Democratic congressman from Kansas, said that he expected to see a repeal proposal. "The new Tea Party congresspeople and the leadership in the House will probably have to introduce some kind of resolution that would call for the repeal of ACA, and I think they know it’s going nowhere and it’s not going to happen, but they’re going to have to do that probably to satisfy political demand," said Mr. Slattery, now a lobbyist with Wiley Rein.

Mr. Slattery said that President Obama mainly has himself to blame for the Democrats’ poor showing in the election and for polling data indicating that half of Americans want to repeal the ACA. The president "failed to connect the dots" with Americans on how the law would benefit them, he added.

At the same forum, Nancy Johnson, a former Republican House member from Connecticut, said that she expected to see a number of oversight and investigative hearings on the ACA.

"The one thing that has to be done [in the next Congress] is, people have to regain their confidence in government and that’s not about policy, that’s about process," said Ms. Johnson, a senior public policy adviser at Baker Donelson. "Half the bill is terrific. But the other half wasn’t seen, and that created suspicion."

Rep. Boehner and other congressional Republicans have said they will keep some of the insurance market reforms – such as the prohibition on denying coverage for preexisting conditions – but will seek to throw out the mandate that individuals have health insurance coverage. That is a formula for disaster for the law – and for insurance companies, wrote Henry Aaron, a senior fellow at the Brookings Institution, in a perspective article published in the New England Journal of Medicine (2010;18:1685-7). Unless most Americans are covered, insurers might be bankrupted by the reforms, he said.

"In brief, the pledge to keep insurance-market reforms without both mandated coverage and subsidies is untenable," Mr. Aaron wrote.

Mr. Slattery agreed. "If you’re going to really reform the insurance industry with the preexisting-condition reforms, we have to have a mandate of some kind," he said.

The requirement that individuals carry insurance or pay a penalty, however, is the central issue being challenged by 20 states that are involved in a lawsuit against the federal government in the U.S. District Court in Florida. Virginia has also filed its own suit, a case that Mr. Slattery said he expected to rise to the Supreme Court.

And governors and attorneys general elected in five states also campaigned on the promise that they, too, would support overturning the mandate.

With money tight and millions of potential new Medicaid enrollees, governors from all parties may revolt against the mandate, said Ms. Johnson. "If you look at the basis on which states are challenging the mandate, it’s in part that it abrogates the federal-state partnership because it imposes burdens they can’t fulfill."

 

 

Back on Capitol Hill, the GOP-led House will also likely take a close look at the ACA-created Independent Payment Advisory Board, said Ms. Johnson. The IPAB, charged with looking at how the federal government pays physicians, hospitals, pharmaceutical companies, and other health providers, would have broad powers that make many Republicans uncomfortable, she said.

In his perspective piece, Mr. Aaron wrote that that Republicans could also tinker with the ACA by cutting off funding for implementation via the appropriations process, or even try to prohibit the Health and Human Services department from writing regulations. Some of those regulations are due to come out in the next 2 months – before the start of the 112th Congress.

WASHINGTON – The historic midterm election victory by Republicans does not signal the end of the Affordable Care Act, but now the law will very likely undergo the scrutiny that many in the GOP say it did not get as it made its way through Congress.

At press time, the Republicans had gained 60 seats in the House (with 9 races still undecided) and 6 seats in the Senate (with 1 still undecided). Even without the final results, the GOP now holds a majority in the House, with 239 seats, compared with 187 for the Democrats. Republican members of the Senate are still in the minority, but the current 52-46 Democratic margin is much slimmer than before the election.

Earlier this year, House Republican leaders and Senate Minority Leader Mitch McConnell (R-Ky.) vowed to "repeal and replace" the ACA if they regained the majority. A Republican-led House will not be able to make that happen alone; the Democratic-led Senate is unlikely to pass repeal legislation, and President Obama would likely veto any bill sent to him.

But Rep. John Boehner (R-Ohio), expected to be elected speaker of the House when the 112th Congress convenes in January, has indicated that the health reform law will be challenged in his chamber.

At a postelection press briefing, President Obama said he welcomed GOP input. "If the Republicans have ideas for how to improve our health care system, if they want to suggest modifications that would deliver faster and more effective reform to a health care system that has been widely expensive for too many families, businesses, and certainly our federal government, I’m happy to consider some of those ideas," he said.

But he said that the White House would not entertain a repeal debate.

Speaking at a postelection forum, Jim Slattery, a former six-term Democratic congressman from Kansas, said that he expected to see a repeal proposal. "The new Tea Party congresspeople and the leadership in the House will probably have to introduce some kind of resolution that would call for the repeal of ACA, and I think they know it’s going nowhere and it’s not going to happen, but they’re going to have to do that probably to satisfy political demand," said Mr. Slattery, now a lobbyist with Wiley Rein.

Mr. Slattery said that President Obama mainly has himself to blame for the Democrats’ poor showing in the election and for polling data indicating that half of Americans want to repeal the ACA. The president "failed to connect the dots" with Americans on how the law would benefit them, he added.

At the same forum, Nancy Johnson, a former Republican House member from Connecticut, said that she expected to see a number of oversight and investigative hearings on the ACA.

"The one thing that has to be done [in the next Congress] is, people have to regain their confidence in government and that’s not about policy, that’s about process," said Ms. Johnson, a senior public policy adviser at Baker Donelson. "Half the bill is terrific. But the other half wasn’t seen, and that created suspicion."

Rep. Boehner and other congressional Republicans have said they will keep some of the insurance market reforms – such as the prohibition on denying coverage for preexisting conditions – but will seek to throw out the mandate that individuals have health insurance coverage. That is a formula for disaster for the law – and for insurance companies, wrote Henry Aaron, a senior fellow at the Brookings Institution, in a perspective article published in the New England Journal of Medicine (2010;18:1685-7). Unless most Americans are covered, insurers might be bankrupted by the reforms, he said.

"In brief, the pledge to keep insurance-market reforms without both mandated coverage and subsidies is untenable," Mr. Aaron wrote.

Mr. Slattery agreed. "If you’re going to really reform the insurance industry with the preexisting-condition reforms, we have to have a mandate of some kind," he said.

The requirement that individuals carry insurance or pay a penalty, however, is the central issue being challenged by 20 states that are involved in a lawsuit against the federal government in the U.S. District Court in Florida. Virginia has also filed its own suit, a case that Mr. Slattery said he expected to rise to the Supreme Court.

And governors and attorneys general elected in five states also campaigned on the promise that they, too, would support overturning the mandate.

With money tight and millions of potential new Medicaid enrollees, governors from all parties may revolt against the mandate, said Ms. Johnson. "If you look at the basis on which states are challenging the mandate, it’s in part that it abrogates the federal-state partnership because it imposes burdens they can’t fulfill."

 

 

Back on Capitol Hill, the GOP-led House will also likely take a close look at the ACA-created Independent Payment Advisory Board, said Ms. Johnson. The IPAB, charged with looking at how the federal government pays physicians, hospitals, pharmaceutical companies, and other health providers, would have broad powers that make many Republicans uncomfortable, she said.

In his perspective piece, Mr. Aaron wrote that that Republicans could also tinker with the ACA by cutting off funding for implementation via the appropriations process, or even try to prohibit the Health and Human Services department from writing regulations. Some of those regulations are due to come out in the next 2 months – before the start of the 112th Congress.

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