Alicia Ault

Two plastic surgery professional organizations have removed a members-only webinar in the wake of complaints by an advocacy group that the program downplayed the risk of anaplastic large-cell lymphoma (ALCL) in women who have breast implants.

Public Citizens Health Research Group wrote to the Food and Drug Administration on Feb. 17 to urge the agency to take action against the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS).

The Washington-based nonprofit said that the groups held the webinar in the wake of the FDA’s Jan. 26 announcement that there were a growing number of cases of ALCL in women with implants.

Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Feb. 28 letter (pdf) to Public Citizen that it had viewed the webinar and "spoke with representatives of both organizations." Dr. Shuren added that, "They informed us of their plans to remove the webinar from their Web site."

Both organizations said that they were not instructed by the FDA to take the webinar down, but that it was a voluntary decision.

In a March 2 statement, the ASAPS said that it removed the webinar "as newer information became available a week ago." That information, according to ASAPS president Felmont F. Eaves III, is "an independent, systematic review of ALCL, which will be published in an upcoming edition of Plastic and Reconstructive Surgery."

Dr. Eaves said in an interview that the Rand Corp. conducted the review and that it is his understanding that the article will be available some time in June. For the time being, the advanced copy of the article is available only to ASAPS members.

The ASPS said in a March 2 statement, "It was never our intention to downplay the risk of a very rarely occurring cancer associated with breast implants." Rather, said the Society, "We did not want to unnecessarily alarm patients when the risk of ALCL associated with breast implants is so low."

According to Public Citizen, ASPS president Phil Haeck explained in the webinar that ALCL should not be referred to as a tumor or a malignancy, but as a "condition." Dr. Haeck said, "I would recommend that you use the same terms with your patients rather than disturb them by saying this is a cancer, this is a malignancy. The best word is this is a condition," according to Public Citizen. Dr. Haeck added, "And I think you are certainly justified, with what we know now, in downplaying the malignant potential of these."

Public Citizen also objected to the webinar telling members that "surgery was curative," for ALCL.

In his response to Public Citizen, the FDA’s Dr. Shuren said, "the FDA believes the optimal treatment regimen has not been established and that additional data collection is needed to fully understand the possible relationship between ALCL and breast implants, as well as the risk factors, optimal treatment plan, and prognosis."

The FDA is asking health care providers to report confirmed cases of ALCL. The agency also notes that ASPS and others are collaborating with the agency to develop a registry tracking ALCL and implants. ASAPS said in late January that it also is supporting the registry. Details are still being worked out.

Two plastic surgery professional organizations have removed a members-only webinar in the wake of complaints by an advocacy group that the program downplayed the risk of anaplastic large-cell lymphoma (ALCL) in women who have breast implants.

Public Citizens Health Research Group wrote to the Food and Drug Administration on Feb. 17 to urge the agency to take action against the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS).

The Washington-based nonprofit said that the groups held the webinar in the wake of the FDA’s Jan. 26 announcement that there were a growing number of cases of ALCL in women with implants.

Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Feb. 28 letter (pdf) to Public Citizen that it had viewed the webinar and "spoke with representatives of both organizations." Dr. Shuren added that, "They informed us of their plans to remove the webinar from their Web site."

Both organizations said that they were not instructed by the FDA to take the webinar down, but that it was a voluntary decision.

In a March 2 statement, the ASAPS said that it removed the webinar "as newer information became available a week ago." That information, according to ASAPS president Felmont F. Eaves III, is "an independent, systematic review of ALCL, which will be published in an upcoming edition of Plastic and Reconstructive Surgery."

Dr. Eaves said in an interview that the Rand Corp. conducted the review and that it is his understanding that the article will be available some time in June. For the time being, the advanced copy of the article is available only to ASAPS members.

The ASPS said in a March 2 statement, "It was never our intention to downplay the risk of a very rarely occurring cancer associated with breast implants." Rather, said the Society, "We did not want to unnecessarily alarm patients when the risk of ALCL associated with breast implants is so low."

According to Public Citizen, ASPS president Phil Haeck explained in the webinar that ALCL should not be referred to as a tumor or a malignancy, but as a "condition." Dr. Haeck said, "I would recommend that you use the same terms with your patients rather than disturb them by saying this is a cancer, this is a malignancy. The best word is this is a condition," according to Public Citizen. Dr. Haeck added, "And I think you are certainly justified, with what we know now, in downplaying the malignant potential of these."

Public Citizen also objected to the webinar telling members that "surgery was curative," for ALCL.

In his response to Public Citizen, the FDA’s Dr. Shuren said, "the FDA believes the optimal treatment regimen has not been established and that additional data collection is needed to fully understand the possible relationship between ALCL and breast implants, as well as the risk factors, optimal treatment plan, and prognosis."

The FDA is asking health care providers to report confirmed cases of ALCL. The agency also notes that ASPS and others are collaborating with the agency to develop a registry tracking ALCL and implants. ASAPS said in late January that it also is supporting the registry. Details are still being worked out.

Two plastic surgery professional organizations have removed a members-only webinar in the wake of complaints by an advocacy group that the program downplayed the risk of anaplastic large-cell lymphoma (ALCL) in women who have breast implants.

Public Citizens Health Research Group wrote to the Food and Drug Administration on Feb. 17 to urge the agency to take action against the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS).

The Washington-based nonprofit said that the groups held the webinar in the wake of the FDA’s Jan. 26 announcement that there were a growing number of cases of ALCL in women with implants.

Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Feb. 28 letter (pdf) to Public Citizen that it had viewed the webinar and "spoke with representatives of both organizations." Dr. Shuren added that, "They informed us of their plans to remove the webinar from their Web site."

Both organizations said that they were not instructed by the FDA to take the webinar down, but that it was a voluntary decision.

In a March 2 statement, the ASAPS said that it removed the webinar "as newer information became available a week ago." That information, according to ASAPS president Felmont F. Eaves III, is "an independent, systematic review of ALCL, which will be published in an upcoming edition of Plastic and Reconstructive Surgery."

Dr. Eaves said in an interview that the Rand Corp. conducted the review and that it is his understanding that the article will be available some time in June. For the time being, the advanced copy of the article is available only to ASAPS members.

The ASPS said in a March 2 statement, "It was never our intention to downplay the risk of a very rarely occurring cancer associated with breast implants." Rather, said the Society, "We did not want to unnecessarily alarm patients when the risk of ALCL associated with breast implants is so low."

According to Public Citizen, ASPS president Phil Haeck explained in the webinar that ALCL should not be referred to as a tumor or a malignancy, but as a "condition." Dr. Haeck said, "I would recommend that you use the same terms with your patients rather than disturb them by saying this is a cancer, this is a malignancy. The best word is this is a condition," according to Public Citizen. Dr. Haeck added, "And I think you are certainly justified, with what we know now, in downplaying the malignant potential of these."

Public Citizen also objected to the webinar telling members that "surgery was curative," for ALCL.

In his response to Public Citizen, the FDA’s Dr. Shuren said, "the FDA believes the optimal treatment regimen has not been established and that additional data collection is needed to fully understand the possible relationship between ALCL and breast implants, as well as the risk factors, optimal treatment plan, and prognosis."

The FDA is asking health care providers to report confirmed cases of ALCL. The agency also notes that ASPS and others are collaborating with the agency to develop a registry tracking ALCL and implants. ASAPS said in late January that it also is supporting the registry. Details are still being worked out.

The White House has issued a rule that would mostly overturn a regulation that was widely interpreted to allow health care providers to opt out of providing services such as contraception or abortion, or bar federal funding to those entities that did not accommodate providers' wishes to deny services.

The so-called conscience rule was issued in 2008 at the end of the Bush administration. The new regulation mostly rescinds that rule.

In issuing the new regulation, the Health and Human Services department said that it “supports clear and strong conscience protections for health care providers who are opposed to performing abortions,” and that protections that have existed for decades will continue to offer the same coverage.

The new rule will retain an enforcement mechanism set up under the 2008 regulation, but will mostly jettison the rest of it.

“Strong conscience laws make it clear that health care providers cannot be compelled to perform or assist in an abortion,” said HHS in a statement. “Many of these strong conscience laws have been in existence for more than 30 years. The rule being issued today builds on these laws by providing a clear enforcement process.”

The agency proposed rescinding the Bush rule in March 2009 and received more than 300,000 comments on the proposed rule. More than 97,000 supported a rescinding of the 2008 rule, about 187,000 opposed any revision, and the rest were of various opinions.

The rule went into effect March 18.

The White House has issued a rule that would mostly overturn a regulation that was widely interpreted to allow health care providers to opt out of providing services such as contraception or abortion, or bar federal funding to those entities that did not accommodate providers' wishes to deny services.

The so-called conscience rule was issued in 2008 at the end of the Bush administration. The new regulation mostly rescinds that rule.

In issuing the new regulation, the Health and Human Services department said that it “supports clear and strong conscience protections for health care providers who are opposed to performing abortions,” and that protections that have existed for decades will continue to offer the same coverage.

The new rule will retain an enforcement mechanism set up under the 2008 regulation, but will mostly jettison the rest of it.

“Strong conscience laws make it clear that health care providers cannot be compelled to perform or assist in an abortion,” said HHS in a statement. “Many of these strong conscience laws have been in existence for more than 30 years. The rule being issued today builds on these laws by providing a clear enforcement process.”

The agency proposed rescinding the Bush rule in March 2009 and received more than 300,000 comments on the proposed rule. More than 97,000 supported a rescinding of the 2008 rule, about 187,000 opposed any revision, and the rest were of various opinions.

The rule went into effect March 18.

The White House has issued a rule that would mostly overturn a regulation that was widely interpreted to allow health care providers to opt out of providing services such as contraception or abortion, or bar federal funding to those entities that did not accommodate providers' wishes to deny services.

The so-called conscience rule was issued in 2008 at the end of the Bush administration. The new regulation mostly rescinds that rule.

In issuing the new regulation, the Health and Human Services department said that it “supports clear and strong conscience protections for health care providers who are opposed to performing abortions,” and that protections that have existed for decades will continue to offer the same coverage.

The new rule will retain an enforcement mechanism set up under the 2008 regulation, but will mostly jettison the rest of it.

“Strong conscience laws make it clear that health care providers cannot be compelled to perform or assist in an abortion,” said HHS in a statement. “Many of these strong conscience laws have been in existence for more than 30 years. The rule being issued today builds on these laws by providing a clear enforcement process.”

The agency proposed rescinding the Bush rule in March 2009 and received more than 300,000 comments on the proposed rule. More than 97,000 supported a rescinding of the 2008 rule, about 187,000 opposed any revision, and the rest were of various opinions.

The rule went into effect March 18.

A federal judge in Florida issued a ruling on Jan. 31 that the Affordable Care Act is unconstitutional.

The ruling and the direction of his opinion were expected.

The suit was filed in March 2010 by 20 states. Another six states recently joined the suit. Two private citizens and the National Federation of Independent Business also joined the suit.

The parties challenged the law's requirement that individuals purchase health insurance and also the ACA's requirement that Medicaid eligibility be expanded to offer insurance to more Americans.

In his 78-page decision, Judge Roger Vinson of the U.S. District Court for the Northern District of Florida in Pensacola said that the individual mandate exceeds Congress' regulatory powers.

“The individual mandate falls outside the boundary of Congress' Commerce Clause authority and cannot be reconciled with a limited government of enumerated powers,” Judge Vinson wrote. “By definition, it cannot be 'proper.'”

Judge Vinson also ruled that the law in its entirety would have to be struck down, as the individual mandate could not be separated out from the ACA, in part because the legislation appeared to be built on a framework that required all the pieces for it to work.

“If…the statute is viewed as a carefully balanced and clockwork-like statutory arrangement [comprising] pieces that all work toward one primary legislative goal, and if that goal would be undermined if a central part of the legislation is found to be unconstitutional, then severability is not appropriate,” he wrote.

While the judge agreed with the plaintiffs' argument that the mandate exceeded Congress' authority, he did not agree with the proposition that the government was overreaching through its proposed Medicaid expansion.

The plaintiffs failed to provide ample evidence of the claims, Judge Vinson ruled.

As a result, “the states have little recourse to remaining the very junior partner in this partnership,” the judge wrote.

The White House characterized the ruling as outside the mainstream of judicial thinking and said that the administration would continue implementing health reform while it appeals.

During a background briefing, senior administration officials said that Judge Vinson's decision, indicating that there was no severability in this case, flew in the face of legal precedent.

And, on the White House blog, Stephanie Cutter, a senior adviser to President Obama, wrote, “This decision is at odds with decades of established Supreme Court law, which has consistently found that courts have a constitutional obligation to preserve as a much of a statute as can be preserved. As a result, the judge's decision puts all of the new benefits, cost savings, and patient protections that were included in the law at risk.”

The Department of Justice issued a statement indicating that it was still analyzing the decision, but said that “there is clear and well-established legal precedent that Congress acted within its constitutional authority in passing this law and we are confident that we will ultimately prevail on appeal.”

After the ruling, House Speaker John Boehner (R-Ohio) said in a statement that the decision “affirms the view, held by most of the states and a majority of the American people, that the federal government should not be in the business of forcing you to buy health insurance and punishing you if you don't.”

Rep. Boehner filed a friend of the court brief on behalf of the plaintiffs.

“All parties involved should request that this case be sent to the U.S. Supreme Court for a swift and fair resolution,” Rep. Boehner said in the statement.

Ron Pollack, executive director of Families USA, which filed a brief on behalf of the federal government, said in a statement, “Judge Vinson's decision is radical judicial activism run amok, and it will undoubtedly be reversed on appeal.”

Mr. Pollack added that if the decision is not reversed, “it would have devastating consequences for America's families.”

Most court watchers expect the case to end up at the Supreme Court.

A federal judge in Virginia also ruled against the insurance mandate in December; two other judges have upheld the ACA.

A federal judge in Florida issued a ruling on Jan. 31 that the Affordable Care Act is unconstitutional.

The ruling and the direction of his opinion were expected.

The suit was filed in March 2010 by 20 states. Another six states recently joined the suit. Two private citizens and the National Federation of Independent Business also joined the suit.

The parties challenged the law's requirement that individuals purchase health insurance and also the ACA's requirement that Medicaid eligibility be expanded to offer insurance to more Americans.

In his 78-page decision, Judge Roger Vinson of the U.S. District Court for the Northern District of Florida in Pensacola said that the individual mandate exceeds Congress' regulatory powers.

“The individual mandate falls outside the boundary of Congress' Commerce Clause authority and cannot be reconciled with a limited government of enumerated powers,” Judge Vinson wrote. “By definition, it cannot be 'proper.'”

Judge Vinson also ruled that the law in its entirety would have to be struck down, as the individual mandate could not be separated out from the ACA, in part because the legislation appeared to be built on a framework that required all the pieces for it to work.

“If…the statute is viewed as a carefully balanced and clockwork-like statutory arrangement [comprising] pieces that all work toward one primary legislative goal, and if that goal would be undermined if a central part of the legislation is found to be unconstitutional, then severability is not appropriate,” he wrote.

While the judge agreed with the plaintiffs' argument that the mandate exceeded Congress' authority, he did not agree with the proposition that the government was overreaching through its proposed Medicaid expansion.

The plaintiffs failed to provide ample evidence of the claims, Judge Vinson ruled.

As a result, “the states have little recourse to remaining the very junior partner in this partnership,” the judge wrote.

The White House characterized the ruling as outside the mainstream of judicial thinking and said that the administration would continue implementing health reform while it appeals.

During a background briefing, senior administration officials said that Judge Vinson's decision, indicating that there was no severability in this case, flew in the face of legal precedent.

And, on the White House blog, Stephanie Cutter, a senior adviser to President Obama, wrote, “This decision is at odds with decades of established Supreme Court law, which has consistently found that courts have a constitutional obligation to preserve as a much of a statute as can be preserved. As a result, the judge's decision puts all of the new benefits, cost savings, and patient protections that were included in the law at risk.”

The Department of Justice issued a statement indicating that it was still analyzing the decision, but said that “there is clear and well-established legal precedent that Congress acted within its constitutional authority in passing this law and we are confident that we will ultimately prevail on appeal.”

After the ruling, House Speaker John Boehner (R-Ohio) said in a statement that the decision “affirms the view, held by most of the states and a majority of the American people, that the federal government should not be in the business of forcing you to buy health insurance and punishing you if you don't.”

Rep. Boehner filed a friend of the court brief on behalf of the plaintiffs.

“All parties involved should request that this case be sent to the U.S. Supreme Court for a swift and fair resolution,” Rep. Boehner said in the statement.

Ron Pollack, executive director of Families USA, which filed a brief on behalf of the federal government, said in a statement, “Judge Vinson's decision is radical judicial activism run amok, and it will undoubtedly be reversed on appeal.”

Mr. Pollack added that if the decision is not reversed, “it would have devastating consequences for America's families.”

Most court watchers expect the case to end up at the Supreme Court.

A federal judge in Virginia also ruled against the insurance mandate in December; two other judges have upheld the ACA.

A federal judge in Florida issued a ruling on Jan. 31 that the Affordable Care Act is unconstitutional.

The ruling and the direction of his opinion were expected.

The suit was filed in March 2010 by 20 states. Another six states recently joined the suit. Two private citizens and the National Federation of Independent Business also joined the suit.

The parties challenged the law's requirement that individuals purchase health insurance and also the ACA's requirement that Medicaid eligibility be expanded to offer insurance to more Americans.

In his 78-page decision, Judge Roger Vinson of the U.S. District Court for the Northern District of Florida in Pensacola said that the individual mandate exceeds Congress' regulatory powers.

“The individual mandate falls outside the boundary of Congress' Commerce Clause authority and cannot be reconciled with a limited government of enumerated powers,” Judge Vinson wrote. “By definition, it cannot be 'proper.'”

Judge Vinson also ruled that the law in its entirety would have to be struck down, as the individual mandate could not be separated out from the ACA, in part because the legislation appeared to be built on a framework that required all the pieces for it to work.

“If…the statute is viewed as a carefully balanced and clockwork-like statutory arrangement [comprising] pieces that all work toward one primary legislative goal, and if that goal would be undermined if a central part of the legislation is found to be unconstitutional, then severability is not appropriate,” he wrote.

While the judge agreed with the plaintiffs' argument that the mandate exceeded Congress' authority, he did not agree with the proposition that the government was overreaching through its proposed Medicaid expansion.

The plaintiffs failed to provide ample evidence of the claims, Judge Vinson ruled.

As a result, “the states have little recourse to remaining the very junior partner in this partnership,” the judge wrote.

The White House characterized the ruling as outside the mainstream of judicial thinking and said that the administration would continue implementing health reform while it appeals.

During a background briefing, senior administration officials said that Judge Vinson's decision, indicating that there was no severability in this case, flew in the face of legal precedent.

And, on the White House blog, Stephanie Cutter, a senior adviser to President Obama, wrote, “This decision is at odds with decades of established Supreme Court law, which has consistently found that courts have a constitutional obligation to preserve as a much of a statute as can be preserved. As a result, the judge's decision puts all of the new benefits, cost savings, and patient protections that were included in the law at risk.”

The Department of Justice issued a statement indicating that it was still analyzing the decision, but said that “there is clear and well-established legal precedent that Congress acted within its constitutional authority in passing this law and we are confident that we will ultimately prevail on appeal.”

After the ruling, House Speaker John Boehner (R-Ohio) said in a statement that the decision “affirms the view, held by most of the states and a majority of the American people, that the federal government should not be in the business of forcing you to buy health insurance and punishing you if you don't.”

Rep. Boehner filed a friend of the court brief on behalf of the plaintiffs.

“All parties involved should request that this case be sent to the U.S. Supreme Court for a swift and fair resolution,” Rep. Boehner said in the statement.

Ron Pollack, executive director of Families USA, which filed a brief on behalf of the federal government, said in a statement, “Judge Vinson's decision is radical judicial activism run amok, and it will undoubtedly be reversed on appeal.”

Mr. Pollack added that if the decision is not reversed, “it would have devastating consequences for America's families.”

Most court watchers expect the case to end up at the Supreme Court.

A federal judge in Virginia also ruled against the insurance mandate in December; two other judges have upheld the ACA.

WASHINGTON – Multiple options exist to permanently fix the Medicare Sustainable Growth Rate formula, but each has its cost to physicians, patients, and the program, according to staff analysts for the Medicare Payment Advisory Commission.

Two options seemed to pique commissioners' interest: exempting certain providers (such as accountable care organizations) from the current SGR target but holding them accountable for other targets, and using penalties for physicians who are outliers in terms of resource use.

In the past, MedPAC has recommended setting target growth rates – and payment rates – according to particular service categories; the commission is looking in this direction again. For example, separate categories could be established for primary care, imaging, minor procedures, and anesthesia, allowing rates to more closely track volume of services. But the system might also provide incentives for physicians to order higher-volume (and more highly paid) services, according to Kevin Hayes, another MedPAC analyst.

Every year since 2002, Medicare has failed to meet the SGR targets, causing physician pay, by law, to be reduced. However, pretty much every year, and more recently, two or three times a year, Congress has stepped in to legislate a way to avoid those cuts. Cumulatively, the avoided cuts are becoming an ever-growing debt being carried on the federal ledger.

The White House's fiscal 2012 budget proposs to reduce that debt over the next 10 years, at a cost of $370 billion.

But the administration has figured out only how to pay for that fix for the first 2 years. The reality is that there's a declining pool of Medicare-specific offsets – required by law – to pay for fixing the SGR, Glenn Hackbarth, MedPAC chairman, said at the meeting.

“We're in a deteriorating situation here; we're spiraling down,” said Mr. Hackbarth. “This isn't going to get better; it's going to get worse.”

Mr. Hackbarth said that the time might be right to work out a “quid pro quo” with physicians: an end to the yearly exercise to avert the SGR cuts in exchange for a payment system that has volume constraints and rewards efficiency and improved quality, or, alternatively penalizes those who fail to meet such targets.

WASHINGTON – Multiple options exist to permanently fix the Medicare Sustainable Growth Rate formula, but each has its cost to physicians, patients, and the program, according to staff analysts for the Medicare Payment Advisory Commission.

Two options seemed to pique commissioners' interest: exempting certain providers (such as accountable care organizations) from the current SGR target but holding them accountable for other targets, and using penalties for physicians who are outliers in terms of resource use.

In the past, MedPAC has recommended setting target growth rates – and payment rates – according to particular service categories; the commission is looking in this direction again. For example, separate categories could be established for primary care, imaging, minor procedures, and anesthesia, allowing rates to more closely track volume of services. But the system might also provide incentives for physicians to order higher-volume (and more highly paid) services, according to Kevin Hayes, another MedPAC analyst.

Every year since 2002, Medicare has failed to meet the SGR targets, causing physician pay, by law, to be reduced. However, pretty much every year, and more recently, two or three times a year, Congress has stepped in to legislate a way to avoid those cuts. Cumulatively, the avoided cuts are becoming an ever-growing debt being carried on the federal ledger.

The White House's fiscal 2012 budget proposs to reduce that debt over the next 10 years, at a cost of $370 billion.

But the administration has figured out only how to pay for that fix for the first 2 years. The reality is that there's a declining pool of Medicare-specific offsets – required by law – to pay for fixing the SGR, Glenn Hackbarth, MedPAC chairman, said at the meeting.

“We're in a deteriorating situation here; we're spiraling down,” said Mr. Hackbarth. “This isn't going to get better; it's going to get worse.”

Mr. Hackbarth said that the time might be right to work out a “quid pro quo” with physicians: an end to the yearly exercise to avert the SGR cuts in exchange for a payment system that has volume constraints and rewards efficiency and improved quality, or, alternatively penalizes those who fail to meet such targets.

WASHINGTON – Multiple options exist to permanently fix the Medicare Sustainable Growth Rate formula, but each has its cost to physicians, patients, and the program, according to staff analysts for the Medicare Payment Advisory Commission.

Two options seemed to pique commissioners' interest: exempting certain providers (such as accountable care organizations) from the current SGR target but holding them accountable for other targets, and using penalties for physicians who are outliers in terms of resource use.

In the past, MedPAC has recommended setting target growth rates – and payment rates – according to particular service categories; the commission is looking in this direction again. For example, separate categories could be established for primary care, imaging, minor procedures, and anesthesia, allowing rates to more closely track volume of services. But the system might also provide incentives for physicians to order higher-volume (and more highly paid) services, according to Kevin Hayes, another MedPAC analyst.

Every year since 2002, Medicare has failed to meet the SGR targets, causing physician pay, by law, to be reduced. However, pretty much every year, and more recently, two or three times a year, Congress has stepped in to legislate a way to avoid those cuts. Cumulatively, the avoided cuts are becoming an ever-growing debt being carried on the federal ledger.

The White House's fiscal 2012 budget proposs to reduce that debt over the next 10 years, at a cost of $370 billion.

But the administration has figured out only how to pay for that fix for the first 2 years. The reality is that there's a declining pool of Medicare-specific offsets – required by law – to pay for fixing the SGR, Glenn Hackbarth, MedPAC chairman, said at the meeting.

“We're in a deteriorating situation here; we're spiraling down,” said Mr. Hackbarth. “This isn't going to get better; it's going to get worse.”

Mr. Hackbarth said that the time might be right to work out a “quid pro quo” with physicians: an end to the yearly exercise to avert the SGR cuts in exchange for a payment system that has volume constraints and rewards efficiency and improved quality, or, alternatively penalizes those who fail to meet such targets.

WASHINGTON – The American College of Physicians came out strongly against any repeal of the Affordable Care Act, and instead is calling on the White House and Congress to come to an agreement on how to tinker with the bill so that it still meets its objectives of covering more Americans, improving access, and reducing the cost of care.

At the ACP's annual State of the Nation's Health Care briefing, President J. Fred Ralston Jr. said that “a highly partisan and polarized debate over health care reform legislation regrettably has taken the country's 'eye off the ball'” of achieving the Affordable Care Act's (ACA's) multiple goals, including “ensuring a sufficient supply of primary care physicians and other specialties facing shortages.”

Dr. Ralston said that the stage is being set for a self-defeating debate that will only lead to a worsening of the nation's health care problems.

“Instead of turning away from the ACA's promise of ensuring access to affordable health insurance to nearly all Americans, the ACP believes that Congress should seek bipartisan common ground on making improvements to it, including giving states more freedom earlier to implement the coverage expansions in a way that best meets their own needs,” he said.

Bob Doherty, the ACP's senior vice president for governmental affairs and public policy, was more blunt about the unfolding political landscape, with Republicans bent on repeal and Democrats intent on preserving every bit of the law intact. Neither side will win, said Mr. Doherty.

“The law won't go away, as most Republicans hope, but restrictions on funding and enforcement could undermine its effectiveness, as many Democrats fear.”

He said it was ironic that Republicans might seek to strip funding from such programs as incentives for establishing electronic medical records, comparative effectiveness, and higher Medicare and Medicaid payments for physicians. Most of these very programs have been championed by Republicans in the past, said Mr. Doherty.

“We know that bipartisan solutions remain possible, if we can move beyond arguing about repeal, to seeking common ground to build and improve upon the Affordable Care Act,” he said.

The ACP, in its State of the Nation's Health Care report, urged the White House and Congress to give states more options to cover their residents, and to do it sooner than called for under the ACA. The physicians' group is supporting the bipartisan Empowering States to Innovate Act, a bill cosponsored by Sen. Ron Wyden (D-Ore.) and Sen. Scott Brown (R-Mass.).

The White House and Congress should also find a mutually acceptable replacement for Medicare's Sustainable Growth Rate (SGR), said Mr. Doherty. Instead of eliminating comparative effectiveness programs, Congress should embrace them as a means of reducing health care costs.

Medical liability reform is another area that is ripe for bipartisan solutions, said Mr. Doherty. President Obama supported reform in his State of the Union address and seems open to suggestions, he said.

The ACP is backing a bill that would cap noneconomic damages, even though it has little chance of making its way through Congress, Mr. Doherty said. And, the group would like to see pilots of so-called health courts, which would create a no-fault system with specially trained judges.

A key element of the ACP's wish list for the White House and Congress: a national conversation on “how to conserve and share health care resources effectively, efficiently, judiciously, and fairly, based on the evidence of their clinical effectiveness and value, and in accord with distinctive American values, including individualism,” said Mr. Doherty.

That position is more thoroughly fleshed out in a white paper released by the ACP at the briefing, “How Can Our Nation Conserve and Distribute Health Care Resources Effectively and Efficiently?”

Dr. Ralston said that the ACP believes that “this is the first time a major physician membership society has called for a national consensus on conserving and allocating health care resources and proposed a framework on how to make such decisions.”

But, he added, “to be clear, the ACP is not proposing that care be rationed.”

The idea is that physicians should have access to the best possible evidence on diagnostics and treatments, and that they should be able to share that with patients and make informed decisions about how to proceed.

The United States already limits access to services just by virtue of the fact that people do not have insurance or because insurance companies limit benefits or require cost sharing, said Dr. Ralston. Other factors that impact access are socio-economic, racial, and ethnic characteristics of patients, and the availability of physicians and facilities, said Dr. Ralston.

He said that Americans have to address the reality that spending is increasing at an unaffordable pace, and decide how best to allocate limited resources.

“We know it won't be easy,” said Dr. Ralston. “We offer our paper, though, in the fervent hope that it will lead to a nonpartisan dialogue on how best to ensure that spending on health care is sustainable and doesn't bankrupt our country.”

To read “How Can Our Nation Conserve and Distribute Health Care Resources Effectively and Efficiently?” go to www.acponline.org/advocacy/where_we_stand/policy/health_care_resources.pdf

Dr. J. Fred Ralston, Jr.: ACP has called for a national consensus on conserving and allocating health resources.

Source Courtesy Jay Mallin

WASHINGTON – The American College of Physicians came out strongly against any repeal of the Affordable Care Act, and instead is calling on the White House and Congress to come to an agreement on how to tinker with the bill so that it still meets its objectives of covering more Americans, improving access, and reducing the cost of care.

At the ACP's annual State of the Nation's Health Care briefing, President J. Fred Ralston Jr. said that “a highly partisan and polarized debate over health care reform legislation regrettably has taken the country's 'eye off the ball'” of achieving the Affordable Care Act's (ACA's) multiple goals, including “ensuring a sufficient supply of primary care physicians and other specialties facing shortages.”

Dr. Ralston said that the stage is being set for a self-defeating debate that will only lead to a worsening of the nation's health care problems.

“Instead of turning away from the ACA's promise of ensuring access to affordable health insurance to nearly all Americans, the ACP believes that Congress should seek bipartisan common ground on making improvements to it, including giving states more freedom earlier to implement the coverage expansions in a way that best meets their own needs,” he said.

Bob Doherty, the ACP's senior vice president for governmental affairs and public policy, was more blunt about the unfolding political landscape, with Republicans bent on repeal and Democrats intent on preserving every bit of the law intact. Neither side will win, said Mr. Doherty.

“The law won't go away, as most Republicans hope, but restrictions on funding and enforcement could undermine its effectiveness, as many Democrats fear.”

He said it was ironic that Republicans might seek to strip funding from such programs as incentives for establishing electronic medical records, comparative effectiveness, and higher Medicare and Medicaid payments for physicians. Most of these very programs have been championed by Republicans in the past, said Mr. Doherty.

“We know that bipartisan solutions remain possible, if we can move beyond arguing about repeal, to seeking common ground to build and improve upon the Affordable Care Act,” he said.

The ACP, in its State of the Nation's Health Care report, urged the White House and Congress to give states more options to cover their residents, and to do it sooner than called for under the ACA. The physicians' group is supporting the bipartisan Empowering States to Innovate Act, a bill cosponsored by Sen. Ron Wyden (D-Ore.) and Sen. Scott Brown (R-Mass.).

The White House and Congress should also find a mutually acceptable replacement for Medicare's Sustainable Growth Rate (SGR), said Mr. Doherty. Instead of eliminating comparative effectiveness programs, Congress should embrace them as a means of reducing health care costs.

Medical liability reform is another area that is ripe for bipartisan solutions, said Mr. Doherty. President Obama supported reform in his State of the Union address and seems open to suggestions, he said.

The ACP is backing a bill that would cap noneconomic damages, even though it has little chance of making its way through Congress, Mr. Doherty said. And, the group would like to see pilots of so-called health courts, which would create a no-fault system with specially trained judges.

A key element of the ACP's wish list for the White House and Congress: a national conversation on “how to conserve and share health care resources effectively, efficiently, judiciously, and fairly, based on the evidence of their clinical effectiveness and value, and in accord with distinctive American values, including individualism,” said Mr. Doherty.

That position is more thoroughly fleshed out in a white paper released by the ACP at the briefing, “How Can Our Nation Conserve and Distribute Health Care Resources Effectively and Efficiently?”

Dr. Ralston said that the ACP believes that “this is the first time a major physician membership society has called for a national consensus on conserving and allocating health care resources and proposed a framework on how to make such decisions.”

But, he added, “to be clear, the ACP is not proposing that care be rationed.”

The idea is that physicians should have access to the best possible evidence on diagnostics and treatments, and that they should be able to share that with patients and make informed decisions about how to proceed.

The United States already limits access to services just by virtue of the fact that people do not have insurance or because insurance companies limit benefits or require cost sharing, said Dr. Ralston. Other factors that impact access are socio-economic, racial, and ethnic characteristics of patients, and the availability of physicians and facilities, said Dr. Ralston.

He said that Americans have to address the reality that spending is increasing at an unaffordable pace, and decide how best to allocate limited resources.

“We know it won't be easy,” said Dr. Ralston. “We offer our paper, though, in the fervent hope that it will lead to a nonpartisan dialogue on how best to ensure that spending on health care is sustainable and doesn't bankrupt our country.”

To read “How Can Our Nation Conserve and Distribute Health Care Resources Effectively and Efficiently?” go to www.acponline.org/advocacy/where_we_stand/policy/health_care_resources.pdf

Dr. J. Fred Ralston, Jr.: ACP has called for a national consensus on conserving and allocating health resources.

Source Courtesy Jay Mallin

WASHINGTON – The American College of Physicians came out strongly against any repeal of the Affordable Care Act, and instead is calling on the White House and Congress to come to an agreement on how to tinker with the bill so that it still meets its objectives of covering more Americans, improving access, and reducing the cost of care.

At the ACP's annual State of the Nation's Health Care briefing, President J. Fred Ralston Jr. said that “a highly partisan and polarized debate over health care reform legislation regrettably has taken the country's 'eye off the ball'” of achieving the Affordable Care Act's (ACA's) multiple goals, including “ensuring a sufficient supply of primary care physicians and other specialties facing shortages.”

Dr. Ralston said that the stage is being set for a self-defeating debate that will only lead to a worsening of the nation's health care problems.

“Instead of turning away from the ACA's promise of ensuring access to affordable health insurance to nearly all Americans, the ACP believes that Congress should seek bipartisan common ground on making improvements to it, including giving states more freedom earlier to implement the coverage expansions in a way that best meets their own needs,” he said.

Bob Doherty, the ACP's senior vice president for governmental affairs and public policy, was more blunt about the unfolding political landscape, with Republicans bent on repeal and Democrats intent on preserving every bit of the law intact. Neither side will win, said Mr. Doherty.

“The law won't go away, as most Republicans hope, but restrictions on funding and enforcement could undermine its effectiveness, as many Democrats fear.”

He said it was ironic that Republicans might seek to strip funding from such programs as incentives for establishing electronic medical records, comparative effectiveness, and higher Medicare and Medicaid payments for physicians. Most of these very programs have been championed by Republicans in the past, said Mr. Doherty.

“We know that bipartisan solutions remain possible, if we can move beyond arguing about repeal, to seeking common ground to build and improve upon the Affordable Care Act,” he said.

The ACP, in its State of the Nation's Health Care report, urged the White House and Congress to give states more options to cover their residents, and to do it sooner than called for under the ACA. The physicians' group is supporting the bipartisan Empowering States to Innovate Act, a bill cosponsored by Sen. Ron Wyden (D-Ore.) and Sen. Scott Brown (R-Mass.).

The White House and Congress should also find a mutually acceptable replacement for Medicare's Sustainable Growth Rate (SGR), said Mr. Doherty. Instead of eliminating comparative effectiveness programs, Congress should embrace them as a means of reducing health care costs.

Medical liability reform is another area that is ripe for bipartisan solutions, said Mr. Doherty. President Obama supported reform in his State of the Union address and seems open to suggestions, he said.

The ACP is backing a bill that would cap noneconomic damages, even though it has little chance of making its way through Congress, Mr. Doherty said. And, the group would like to see pilots of so-called health courts, which would create a no-fault system with specially trained judges.

A key element of the ACP's wish list for the White House and Congress: a national conversation on “how to conserve and share health care resources effectively, efficiently, judiciously, and fairly, based on the evidence of their clinical effectiveness and value, and in accord with distinctive American values, including individualism,” said Mr. Doherty.

That position is more thoroughly fleshed out in a white paper released by the ACP at the briefing, “How Can Our Nation Conserve and Distribute Health Care Resources Effectively and Efficiently?”

Dr. Ralston said that the ACP believes that “this is the first time a major physician membership society has called for a national consensus on conserving and allocating health care resources and proposed a framework on how to make such decisions.”

But, he added, “to be clear, the ACP is not proposing that care be rationed.”

The idea is that physicians should have access to the best possible evidence on diagnostics and treatments, and that they should be able to share that with patients and make informed decisions about how to proceed.

The United States already limits access to services just by virtue of the fact that people do not have insurance or because insurance companies limit benefits or require cost sharing, said Dr. Ralston. Other factors that impact access are socio-economic, racial, and ethnic characteristics of patients, and the availability of physicians and facilities, said Dr. Ralston.

He said that Americans have to address the reality that spending is increasing at an unaffordable pace, and decide how best to allocate limited resources.

“We know it won't be easy,” said Dr. Ralston. “We offer our paper, though, in the fervent hope that it will lead to a nonpartisan dialogue on how best to ensure that spending on health care is sustainable and doesn't bankrupt our country.”

To read “How Can Our Nation Conserve and Distribute Health Care Resources Effectively and Efficiently?” go to www.acponline.org/advocacy/where_we_stand/policy/health_care_resources.pdf

Dr. J. Fred Ralston, Jr.: ACP has called for a national consensus on conserving and allocating health resources.

Source Courtesy Jay Mallin

The White House has issued a rule that would mostly overturn a regulation that was widely interpreted to allow health care providers to opt out of providing services such as contraception or abortion, or bar federal funding to those entities that did not accommodate providers' wishes to deny services.

The so-called conscience rule was issued in 2008 at the end of the George W. Bush administration. The new regulation mostly rescinds that rule.

In issuing the new regulation, the Health and Human Services department said that it “supports clear and strong conscience protections for health care providers who are opposed to performing abortions,” and that protections that have existed for decades will continue to offer the same coverage.

But, the Bush administration rule was overbroad and confusing, HHS said in the final rule published in the Federal Register. The new rule will retain an enforcement mechanism set up under the 2008 regulation, but will mostly jettison the rest of it.

“Strong conscience laws make it clear that health care providers cannot be compelled to perform or assist in an abortion,” said HHS in a statement.

“Many of these strong conscience laws have been in existence for more than 30 years. The rule being issued today builds on these laws by providing a clear enforcement process.”

The agency proposed rescinding the Bush rule in March 2009 and received more than 300,000 comments on the proposed rule, the majority of which were form letters generated by various organizations, HHS said. More than 97,000 supported a rescinding of the 2008 rule, about 187,000 opposed any revision, and the rest were of various opinions.

NARAL Pro-Choice America, which claimed to have generated more than 25,000 of the comments, applauded the change. “The language published today reaffirms the principles of protecting the doctor-patient relationship by repealing the most onerous and intrusive parts of Bush's last-minute refusal rule,” said President Nancy Keenan in a statement.

The rule goes into effect on March 18.

The White House has issued a rule that would mostly overturn a regulation that was widely interpreted to allow health care providers to opt out of providing services such as contraception or abortion, or bar federal funding to those entities that did not accommodate providers' wishes to deny services.

The so-called conscience rule was issued in 2008 at the end of the George W. Bush administration. The new regulation mostly rescinds that rule.

In issuing the new regulation, the Health and Human Services department said that it “supports clear and strong conscience protections for health care providers who are opposed to performing abortions,” and that protections that have existed for decades will continue to offer the same coverage.

But, the Bush administration rule was overbroad and confusing, HHS said in the final rule published in the Federal Register. The new rule will retain an enforcement mechanism set up under the 2008 regulation, but will mostly jettison the rest of it.

“Strong conscience laws make it clear that health care providers cannot be compelled to perform or assist in an abortion,” said HHS in a statement.

“Many of these strong conscience laws have been in existence for more than 30 years. The rule being issued today builds on these laws by providing a clear enforcement process.”

The agency proposed rescinding the Bush rule in March 2009 and received more than 300,000 comments on the proposed rule, the majority of which were form letters generated by various organizations, HHS said. More than 97,000 supported a rescinding of the 2008 rule, about 187,000 opposed any revision, and the rest were of various opinions.

NARAL Pro-Choice America, which claimed to have generated more than 25,000 of the comments, applauded the change. “The language published today reaffirms the principles of protecting the doctor-patient relationship by repealing the most onerous and intrusive parts of Bush's last-minute refusal rule,” said President Nancy Keenan in a statement.

The rule goes into effect on March 18.

The White House has issued a rule that would mostly overturn a regulation that was widely interpreted to allow health care providers to opt out of providing services such as contraception or abortion, or bar federal funding to those entities that did not accommodate providers' wishes to deny services.

The so-called conscience rule was issued in 2008 at the end of the George W. Bush administration. The new regulation mostly rescinds that rule.

In issuing the new regulation, the Health and Human Services department said that it “supports clear and strong conscience protections for health care providers who are opposed to performing abortions,” and that protections that have existed for decades will continue to offer the same coverage.

But, the Bush administration rule was overbroad and confusing, HHS said in the final rule published in the Federal Register. The new rule will retain an enforcement mechanism set up under the 2008 regulation, but will mostly jettison the rest of it.

“Strong conscience laws make it clear that health care providers cannot be compelled to perform or assist in an abortion,” said HHS in a statement.

“Many of these strong conscience laws have been in existence for more than 30 years. The rule being issued today builds on these laws by providing a clear enforcement process.”

The agency proposed rescinding the Bush rule in March 2009 and received more than 300,000 comments on the proposed rule, the majority of which were form letters generated by various organizations, HHS said. More than 97,000 supported a rescinding of the 2008 rule, about 187,000 opposed any revision, and the rest were of various opinions.

NARAL Pro-Choice America, which claimed to have generated more than 25,000 of the comments, applauded the change. “The language published today reaffirms the principles of protecting the doctor-patient relationship by repealing the most onerous and intrusive parts of Bush's last-minute refusal rule,” said President Nancy Keenan in a statement.

The rule goes into effect on March 18.

CMS May Pay for Counseling

The Centers for Medicare and Medicaid Services is studying whether to pay for lifestyle counseling of patients with hypertension, hyperlipidemia, or other cardiac risk factors. Last October, the nonprofit Partnership for Prevention asked the CMS to cover counseling for aspirin as a preventive treatment for cardiovascular disease, noting that the practice had been strongly recommended by the U.S. Preventive Services Task Force. After reviewing the available evidence, the CMS decided in early February to weigh coverage of what it calls “intensive behavioral therapy,” including aspirin and dietary counseling, to prevent heart disease.

The agency expects to make a final coverage decision in November 2011.

For More Heart Rehabilitation

Studies have shown that cardiac rehabilitation reduces morbidity and mortality, and yet only 20%–30% of eligible patients receive the service after hospital discharge for cardiovascular disease. Investigators in Canada found that they could increase participation by 45% if they automatically referred patients to rehabilitation and counseled them on its benefits.

The researchers compared four referral strategies in 2,635 patients who had coronary artery dsease and were seen at 11 hospitals in Ontario: automatic referral, a personal discussion with a nurse or peer, a combination of both, or a customary referral at the discretion of the health provider.

More than 73% of patients who received the combination strategy enrolled, whereas 29% enrolled who were referred at a provider's discretion. All patients who were referred for rehabilitation attended more than 80% of sessions. The authors, who reported no conflicts, published their findings in Archives of Internal Medicine.

Tougher Device Review Needed?

One of the two review processes that the Food and Drug Administration uses for medical devices is faulty and results in more recalls than do more stringent reviews, according to a study published on the Archives of Internal Medicine's Web site.

A team led by Diana Zuckerman, Ph.D., of the advocacy group the National Research Center for Women & Families, found that of 113 device high-risk recalls from 2005 to 2009, 80 were approved through the “510(k) process” and 21 were approved through “premarket approval,” whereas 12 had not been reviewed for various reasons.

The 510(k) category is for devices that are deemed similar to those already on the market, and are determined to involve low or moderate risk, according to the report.

In all, 35 cardiovascular devices were recalled in 2005–2009, and 23 of them had been approved under the 510(k) process.

Stricter Standards for Stroke Care

The American Heart Association and its American Stroke Association are recommending the creation of a specialized class of stroke-care centers in the United States.

Called Comprehensive Stroke Centers, they would be held to stricter standards than are current Primary Stroke Centers, which would continue to exist. For instance, the comprehensive centers would be measured by the time from hospitalization to blood vessel repair for patients with ruptured aneurysms.

“Initiatives such as primary and now comprehensive stroke center certification will greatly help us reach our 2020 goal” of reducing cardiac and stroke deaths by 20%, Dr. Ralph L. Sacco, president of the AHA, said in a statement. The recommendations were published in Stroke: Journal of the American Heart Association.

Stealth Grants to Advocacy Groups

Health advocacy groups are not routinely disclosing their financial ties to pharmaceutical companies, according to a new study.

Researchers led by Sheila Rothman, Ph.D., of Columbia University, New York, studied grants made by Eli Lilly & Co. to such groups in 2007. The company was the first drugmaker to disclose its payouts. During the first half of the year, Lilly gave $3.2 million to 161 organizations that were generally concerned with diseases that the company's products treat.

Only 25% of those organizations acknowledged getting Lilly grants on their Web sites, and none disclosed the amount. Two-thirds of the funds went to mental health groups. Only 18% of those advocacy groups identified Lilly as a corporate sponsor.

FDA Accelerates Device Reviews

The Food and Drug Administration has proposed a new, accelerated review program for what it terms breakthrough medical devices as part of a broader effort to encourage cutting-edge technologies among device manufacturers. The FDA could conduct reviews within 150 days on devices that are submitted under the new Innovation Pathway – about half the time it now takes the agency to review devices. However, enrollment in the program won't change the standards that the agency currently uses to evaluate medical devices, the FDA said.

A brain-controlled, upper-extremity prosthetic will serve as the first submission to the Innovation Pathway program, the agency said. However, the FDA also is asking for public comment on the new program and plans to hold a hearing in March before finalizing the rules.

CMS May Pay for Counseling

The Centers for Medicare and Medicaid Services is studying whether to pay for lifestyle counseling of patients with hypertension, hyperlipidemia, or other cardiac risk factors. Last October, the nonprofit Partnership for Prevention asked the CMS to cover counseling for aspirin as a preventive treatment for cardiovascular disease, noting that the practice had been strongly recommended by the U.S. Preventive Services Task Force. After reviewing the available evidence, the CMS decided in early February to weigh coverage of what it calls “intensive behavioral therapy,” including aspirin and dietary counseling, to prevent heart disease.

The agency expects to make a final coverage decision in November 2011.

For More Heart Rehabilitation

Studies have shown that cardiac rehabilitation reduces morbidity and mortality, and yet only 20%–30% of eligible patients receive the service after hospital discharge for cardiovascular disease. Investigators in Canada found that they could increase participation by 45% if they automatically referred patients to rehabilitation and counseled them on its benefits.

The researchers compared four referral strategies in 2,635 patients who had coronary artery dsease and were seen at 11 hospitals in Ontario: automatic referral, a personal discussion with a nurse or peer, a combination of both, or a customary referral at the discretion of the health provider.

More than 73% of patients who received the combination strategy enrolled, whereas 29% enrolled who were referred at a provider's discretion. All patients who were referred for rehabilitation attended more than 80% of sessions. The authors, who reported no conflicts, published their findings in Archives of Internal Medicine.

Tougher Device Review Needed?

One of the two review processes that the Food and Drug Administration uses for medical devices is faulty and results in more recalls than do more stringent reviews, according to a study published on the Archives of Internal Medicine's Web site.

A team led by Diana Zuckerman, Ph.D., of the advocacy group the National Research Center for Women & Families, found that of 113 device high-risk recalls from 2005 to 2009, 80 were approved through the “510(k) process” and 21 were approved through “premarket approval,” whereas 12 had not been reviewed for various reasons.

The 510(k) category is for devices that are deemed similar to those already on the market, and are determined to involve low or moderate risk, according to the report.

In all, 35 cardiovascular devices were recalled in 2005–2009, and 23 of them had been approved under the 510(k) process.

Stricter Standards for Stroke Care

The American Heart Association and its American Stroke Association are recommending the creation of a specialized class of stroke-care centers in the United States.

Called Comprehensive Stroke Centers, they would be held to stricter standards than are current Primary Stroke Centers, which would continue to exist. For instance, the comprehensive centers would be measured by the time from hospitalization to blood vessel repair for patients with ruptured aneurysms.

“Initiatives such as primary and now comprehensive stroke center certification will greatly help us reach our 2020 goal” of reducing cardiac and stroke deaths by 20%, Dr. Ralph L. Sacco, president of the AHA, said in a statement. The recommendations were published in Stroke: Journal of the American Heart Association.

Stealth Grants to Advocacy Groups

Health advocacy groups are not routinely disclosing their financial ties to pharmaceutical companies, according to a new study.

Researchers led by Sheila Rothman, Ph.D., of Columbia University, New York, studied grants made by Eli Lilly & Co. to such groups in 2007. The company was the first drugmaker to disclose its payouts. During the first half of the year, Lilly gave $3.2 million to 161 organizations that were generally concerned with diseases that the company's products treat.

Only 25% of those organizations acknowledged getting Lilly grants on their Web sites, and none disclosed the amount. Two-thirds of the funds went to mental health groups. Only 18% of those advocacy groups identified Lilly as a corporate sponsor.

FDA Accelerates Device Reviews

The Food and Drug Administration has proposed a new, accelerated review program for what it terms breakthrough medical devices as part of a broader effort to encourage cutting-edge technologies among device manufacturers. The FDA could conduct reviews within 150 days on devices that are submitted under the new Innovation Pathway – about half the time it now takes the agency to review devices. However, enrollment in the program won't change the standards that the agency currently uses to evaluate medical devices, the FDA said.

A brain-controlled, upper-extremity prosthetic will serve as the first submission to the Innovation Pathway program, the agency said. However, the FDA also is asking for public comment on the new program and plans to hold a hearing in March before finalizing the rules.

CMS May Pay for Counseling

The Centers for Medicare and Medicaid Services is studying whether to pay for lifestyle counseling of patients with hypertension, hyperlipidemia, or other cardiac risk factors. Last October, the nonprofit Partnership for Prevention asked the CMS to cover counseling for aspirin as a preventive treatment for cardiovascular disease, noting that the practice had been strongly recommended by the U.S. Preventive Services Task Force. After reviewing the available evidence, the CMS decided in early February to weigh coverage of what it calls “intensive behavioral therapy,” including aspirin and dietary counseling, to prevent heart disease.

The agency expects to make a final coverage decision in November 2011.

For More Heart Rehabilitation

Studies have shown that cardiac rehabilitation reduces morbidity and mortality, and yet only 20%–30% of eligible patients receive the service after hospital discharge for cardiovascular disease. Investigators in Canada found that they could increase participation by 45% if they automatically referred patients to rehabilitation and counseled them on its benefits.

The researchers compared four referral strategies in 2,635 patients who had coronary artery dsease and were seen at 11 hospitals in Ontario: automatic referral, a personal discussion with a nurse or peer, a combination of both, or a customary referral at the discretion of the health provider.

More than 73% of patients who received the combination strategy enrolled, whereas 29% enrolled who were referred at a provider's discretion. All patients who were referred for rehabilitation attended more than 80% of sessions. The authors, who reported no conflicts, published their findings in Archives of Internal Medicine.

Tougher Device Review Needed?

One of the two review processes that the Food and Drug Administration uses for medical devices is faulty and results in more recalls than do more stringent reviews, according to a study published on the Archives of Internal Medicine's Web site.

A team led by Diana Zuckerman, Ph.D., of the advocacy group the National Research Center for Women & Families, found that of 113 device high-risk recalls from 2005 to 2009, 80 were approved through the “510(k) process” and 21 were approved through “premarket approval,” whereas 12 had not been reviewed for various reasons.

The 510(k) category is for devices that are deemed similar to those already on the market, and are determined to involve low or moderate risk, according to the report.

In all, 35 cardiovascular devices were recalled in 2005–2009, and 23 of them had been approved under the 510(k) process.

Stricter Standards for Stroke Care

The American Heart Association and its American Stroke Association are recommending the creation of a specialized class of stroke-care centers in the United States.

Called Comprehensive Stroke Centers, they would be held to stricter standards than are current Primary Stroke Centers, which would continue to exist. For instance, the comprehensive centers would be measured by the time from hospitalization to blood vessel repair for patients with ruptured aneurysms.

“Initiatives such as primary and now comprehensive stroke center certification will greatly help us reach our 2020 goal” of reducing cardiac and stroke deaths by 20%, Dr. Ralph L. Sacco, president of the AHA, said in a statement. The recommendations were published in Stroke: Journal of the American Heart Association.

Stealth Grants to Advocacy Groups

Health advocacy groups are not routinely disclosing their financial ties to pharmaceutical companies, according to a new study.

Researchers led by Sheila Rothman, Ph.D., of Columbia University, New York, studied grants made by Eli Lilly & Co. to such groups in 2007. The company was the first drugmaker to disclose its payouts. During the first half of the year, Lilly gave $3.2 million to 161 organizations that were generally concerned with diseases that the company's products treat.

Only 25% of those organizations acknowledged getting Lilly grants on their Web sites, and none disclosed the amount. Two-thirds of the funds went to mental health groups. Only 18% of those advocacy groups identified Lilly as a corporate sponsor.

FDA Accelerates Device Reviews

The Food and Drug Administration has proposed a new, accelerated review program for what it terms breakthrough medical devices as part of a broader effort to encourage cutting-edge technologies among device manufacturers. The FDA could conduct reviews within 150 days on devices that are submitted under the new Innovation Pathway – about half the time it now takes the agency to review devices. However, enrollment in the program won't change the standards that the agency currently uses to evaluate medical devices, the FDA said.

A brain-controlled, upper-extremity prosthetic will serve as the first submission to the Innovation Pathway program, the agency said. However, the FDA also is asking for public comment on the new program and plans to hold a hearing in March before finalizing the rules.

WASHINGTON – The American College of Physicians came out strongly against any repeal of the Affordable Care Act, and instead is calling on the White House and Congress to come to an agreement on how to tinker with the bill so that it still meets its objectives of covering more Americans, improving access, and reducing the cost of care.

At its annual State of the Nation's Health Care briefing, ACP President J. Fred Ralston Jr. said that “a highly partisan and polarized debate over health care reform legislation regrettably has taken the country's 'eye off the ball' ” of achieving the Affordable Care Act's (ACA's) multiple goals, including “ensuring a sufficient supply of primary care physicians and other specialties facing shortages.”

Dr. Ralston said that the stage is being set for a self-defeating debate that will only lead to a worsening of the nation's health care problems.

“Instead of turning away from the ACA's promise of ensuring access to affordable health insurance to nearly all Americans, the ACP believes that Congress should seek bipartisan common ground on making improvements to it, including giving states more freedom earlier to implement the coverage expansions in a way that best meets their own needs,” he said.

Bob Doherty, the ACP's senior vice president for governmental affairs and public policy, was more blunt about the unfolding political landscape, with Republicans bent on repeal and Democrats intent on preserving every bit of the law intact. Neither side will win, said Mr. Doherty.

“The law won't go away, as most Republicans hope, but restrictions on funding and enforcement could undermine its effectiveness, as many Democrats fear.”

He said it was ironic that Republicans might seek to strip funding from such programs as incentives for establishing electronic medical records, comparative effectiveness, and higher Medicare and Medicaid payments for physicians. Most of these very programs have been championed by Republicans in the past, said Mr. Doherty.

In its report, the ACP urged the White House and Congress to give states more options to cover their residents, and to do it sooner than called for under the ACA. The physicians' group is supporting the bipartisan Empowering States to Innovate Act, a bill cosponsored by Sen. Ron Wyden (D-Ore.) and Sen. Scott Brown (R-Mass.).

The White House and Congress should also find a mutually acceptable replacement for Medicare's Sustainable Growth Rate (SGR), said Mr. Doherty. Instead of eliminating comparative effectiveness programs, Congress should embrace them as a means of reducing health care costs.

Medical liability reform is another area that is ripe for bipartisan solutions, said Mr. Doherty. President Obama supported reform in his State of the Union address and seems open to suggestions, he said. The ACP is backing a bill that would cap noneconomic damages, even though it has little chance of making its way through Congress, Mr. Doherty said. And the group would like to see pilots of so-called health courts, which would create a no-fault system with specially trained judges.

A key element of the ACP's wish list for the White House and Congress: a national conversation on “how to conserve and share health care resources effectively, efficiently, judiciously, and fairly, based on the evidence of their clinical effectiveness and value, and in accord with distinctive American values, including individualism,” said Mr. Doherty.

That position is more thoroughly fleshed out in a white paper released by the ACP at the briefing, “How Can Our Nation Conserve and Distribute Health Care Resources Effectively and Efficiently?”

Dr. Ralston said that the ACP believes that “this is the first time a major physician membership society has called for a national consensus on conserving and allocating health care resources and proposed a framework on how to make such decisions.” But, he added, “to be clear, the ACP is not proposing that care be rationed.”

The idea is that physicians should have access to the best possible evidence on diagnostics and treatments, and that they should be able to share that with patients and make informed decisions about how to proceed.

The United States already limits access to services just by virtue of the fact that people do not have insurance or because insurance companies limit benefits or require cost sharing, said Dr. Ralston. Socioeconomic, racial, and ethnic factors also affect access, he added.

He said that Americans have to address the reality that spending is increasing at an unaffordable pace, and decide how best to allocate limited resources. “We know it won't be easy,” Dr. Ralston concluded.

WASHINGTON – The American College of Physicians came out strongly against any repeal of the Affordable Care Act, and instead is calling on the White House and Congress to come to an agreement on how to tinker with the bill so that it still meets its objectives of covering more Americans, improving access, and reducing the cost of care.

At its annual State of the Nation's Health Care briefing, ACP President J. Fred Ralston Jr. said that “a highly partisan and polarized debate over health care reform legislation regrettably has taken the country's 'eye off the ball' ” of achieving the Affordable Care Act's (ACA's) multiple goals, including “ensuring a sufficient supply of primary care physicians and other specialties facing shortages.”

Dr. Ralston said that the stage is being set for a self-defeating debate that will only lead to a worsening of the nation's health care problems.

“Instead of turning away from the ACA's promise of ensuring access to affordable health insurance to nearly all Americans, the ACP believes that Congress should seek bipartisan common ground on making improvements to it, including giving states more freedom earlier to implement the coverage expansions in a way that best meets their own needs,” he said.

Bob Doherty, the ACP's senior vice president for governmental affairs and public policy, was more blunt about the unfolding political landscape, with Republicans bent on repeal and Democrats intent on preserving every bit of the law intact. Neither side will win, said Mr. Doherty.

“The law won't go away, as most Republicans hope, but restrictions on funding and enforcement could undermine its effectiveness, as many Democrats fear.”

He said it was ironic that Republicans might seek to strip funding from such programs as incentives for establishing electronic medical records, comparative effectiveness, and higher Medicare and Medicaid payments for physicians. Most of these very programs have been championed by Republicans in the past, said Mr. Doherty.

In its report, the ACP urged the White House and Congress to give states more options to cover their residents, and to do it sooner than called for under the ACA. The physicians' group is supporting the bipartisan Empowering States to Innovate Act, a bill cosponsored by Sen. Ron Wyden (D-Ore.) and Sen. Scott Brown (R-Mass.).

The White House and Congress should also find a mutually acceptable replacement for Medicare's Sustainable Growth Rate (SGR), said Mr. Doherty. Instead of eliminating comparative effectiveness programs, Congress should embrace them as a means of reducing health care costs.

Medical liability reform is another area that is ripe for bipartisan solutions, said Mr. Doherty. President Obama supported reform in his State of the Union address and seems open to suggestions, he said. The ACP is backing a bill that would cap noneconomic damages, even though it has little chance of making its way through Congress, Mr. Doherty said. And the group would like to see pilots of so-called health courts, which would create a no-fault system with specially trained judges.

A key element of the ACP's wish list for the White House and Congress: a national conversation on “how to conserve and share health care resources effectively, efficiently, judiciously, and fairly, based on the evidence of their clinical effectiveness and value, and in accord with distinctive American values, including individualism,” said Mr. Doherty.

That position is more thoroughly fleshed out in a white paper released by the ACP at the briefing, “How Can Our Nation Conserve and Distribute Health Care Resources Effectively and Efficiently?”

Dr. Ralston said that the ACP believes that “this is the first time a major physician membership society has called for a national consensus on conserving and allocating health care resources and proposed a framework on how to make such decisions.” But, he added, “to be clear, the ACP is not proposing that care be rationed.”

The idea is that physicians should have access to the best possible evidence on diagnostics and treatments, and that they should be able to share that with patients and make informed decisions about how to proceed.

The United States already limits access to services just by virtue of the fact that people do not have insurance or because insurance companies limit benefits or require cost sharing, said Dr. Ralston. Socioeconomic, racial, and ethnic factors also affect access, he added.

He said that Americans have to address the reality that spending is increasing at an unaffordable pace, and decide how best to allocate limited resources. “We know it won't be easy,” Dr. Ralston concluded.

WASHINGTON – The American College of Physicians came out strongly against any repeal of the Affordable Care Act, and instead is calling on the White House and Congress to come to an agreement on how to tinker with the bill so that it still meets its objectives of covering more Americans, improving access, and reducing the cost of care.

At its annual State of the Nation's Health Care briefing, ACP President J. Fred Ralston Jr. said that “a highly partisan and polarized debate over health care reform legislation regrettably has taken the country's 'eye off the ball' ” of achieving the Affordable Care Act's (ACA's) multiple goals, including “ensuring a sufficient supply of primary care physicians and other specialties facing shortages.”

Dr. Ralston said that the stage is being set for a self-defeating debate that will only lead to a worsening of the nation's health care problems.

“Instead of turning away from the ACA's promise of ensuring access to affordable health insurance to nearly all Americans, the ACP believes that Congress should seek bipartisan common ground on making improvements to it, including giving states more freedom earlier to implement the coverage expansions in a way that best meets their own needs,” he said.

Bob Doherty, the ACP's senior vice president for governmental affairs and public policy, was more blunt about the unfolding political landscape, with Republicans bent on repeal and Democrats intent on preserving every bit of the law intact. Neither side will win, said Mr. Doherty.

“The law won't go away, as most Republicans hope, but restrictions on funding and enforcement could undermine its effectiveness, as many Democrats fear.”

He said it was ironic that Republicans might seek to strip funding from such programs as incentives for establishing electronic medical records, comparative effectiveness, and higher Medicare and Medicaid payments for physicians. Most of these very programs have been championed by Republicans in the past, said Mr. Doherty.

In its report, the ACP urged the White House and Congress to give states more options to cover their residents, and to do it sooner than called for under the ACA. The physicians' group is supporting the bipartisan Empowering States to Innovate Act, a bill cosponsored by Sen. Ron Wyden (D-Ore.) and Sen. Scott Brown (R-Mass.).

The White House and Congress should also find a mutually acceptable replacement for Medicare's Sustainable Growth Rate (SGR), said Mr. Doherty. Instead of eliminating comparative effectiveness programs, Congress should embrace them as a means of reducing health care costs.

Medical liability reform is another area that is ripe for bipartisan solutions, said Mr. Doherty. President Obama supported reform in his State of the Union address and seems open to suggestions, he said. The ACP is backing a bill that would cap noneconomic damages, even though it has little chance of making its way through Congress, Mr. Doherty said. And the group would like to see pilots of so-called health courts, which would create a no-fault system with specially trained judges.

A key element of the ACP's wish list for the White House and Congress: a national conversation on “how to conserve and share health care resources effectively, efficiently, judiciously, and fairly, based on the evidence of their clinical effectiveness and value, and in accord with distinctive American values, including individualism,” said Mr. Doherty.

That position is more thoroughly fleshed out in a white paper released by the ACP at the briefing, “How Can Our Nation Conserve and Distribute Health Care Resources Effectively and Efficiently?”

Dr. Ralston said that the ACP believes that “this is the first time a major physician membership society has called for a national consensus on conserving and allocating health care resources and proposed a framework on how to make such decisions.” But, he added, “to be clear, the ACP is not proposing that care be rationed.”

The idea is that physicians should have access to the best possible evidence on diagnostics and treatments, and that they should be able to share that with patients and make informed decisions about how to proceed.

The United States already limits access to services just by virtue of the fact that people do not have insurance or because insurance companies limit benefits or require cost sharing, said Dr. Ralston. Socioeconomic, racial, and ethnic factors also affect access, he added.

He said that Americans have to address the reality that spending is increasing at an unaffordable pace, and decide how best to allocate limited resources. “We know it won't be easy,” Dr. Ralston concluded.

NEW ORLEANS - There were approximately 3.7 million nonmelanoma skin cancers in the United States in 2009, up almost 2% from the previous year, said Dr. Brett Coldiron.

This number marks the continuation of an upwards trend in the incidence of skin cancer, noted Dr. Coldiron, a private practice dermatologic surgeon and member of the dermatology faculty at the University of Cincinnati. He presented his preliminary 2009 data at the meeting, and noted that the vast numbers of those affected seem to indicate an epidemic.

"At this rate of increase, the total number of nonmelanoma skin cancer [NMSC] will double every 15-20 years," said Dr. Coldiron.

The data update a study he and his colleagues published last year estimating that there were 3.5 million NMSCs, affecting 2.1 million people in the United States in 2006 (Arch. Dermatol. 2010;146:283-7) . He and his colleagues estimated that the number of skin cancer procedures increased by 77% from 1992 to 2006. During this time, there was a 16% increase in procedures for NMSCs in the Medicare population.

NMSC is not a reportable disease, so there have not been good estimates for how many Americans are affected. For his initial paper, said Dr. Coldiron, "It occurred to me one day that you can't treat NMSC without a positive pathologic diagnosis, or they'll send you off to jail."

So he sought procedure data from Medicare's Fee-for-Service Physicians Claims database and the National Ambulatory Medical Care Service database. Procedures are "a pretty good proxy for the actual number of NMSCs," said Dr. Coldiron.

To get a total number of NMSCs, he and his colleagues multiplied the estimated crude number of skin cancers by the proportion of skin cancer procedure code claims associated with the ICD-9-CM diagnoses for invasive nonmelanoma cutaneous malignancy (173.0-173.9) and in situ malignancy (232.0-232.9).

Looking at trends, it appears the number of procedures have been levelling off at about a 2% rate the last few years, said Dr. Coldiron. However, the continued increase should be of concern to physicians, patients, and policy makers, he said.

The cost of treating NMSCs is around $8 billion a year, "so it's serious money," he said.

In commenting on Dr. Coldiron's findings, Dr. Darrell S. Rigel, who is a professor of dermatology and dermatologic surgery at New York University Medical Center, said that the number of NMSCs is "a surprisingly high number." Overall, skin cancer is much more common than all other cancers combined, said Dr. Rigel, adding that he had conducted studies showing that the lifetime risk of developing melanoma--invasive and in situ--now stood at 1 in 35 in the U.S.

And, more than 10,000 Americans will die from skin cancer this year. "So it is a serious public health problem," said Dr. Rigel.

For his part, Dr. Coldiron said, "We have to convince people there is an epidemic out there." In addition to increasing Medicare funding to treat NMSCs, "it's prudent and cost effective to focus on prevention," he said.

Dr. Coldiron reported no conflicts related to his talk. His study was self funded.

NEW ORLEANS - There were approximately 3.7 million nonmelanoma skin cancers in the United States in 2009, up almost 2% from the previous year, said Dr. Brett Coldiron.

This number marks the continuation of an upwards trend in the incidence of skin cancer, noted Dr. Coldiron, a private practice dermatologic surgeon and member of the dermatology faculty at the University of Cincinnati. He presented his preliminary 2009 data at the meeting, and noted that the vast numbers of those affected seem to indicate an epidemic.

"At this rate of increase, the total number of nonmelanoma skin cancer [NMSC] will double every 15-20 years," said Dr. Coldiron.

The data update a study he and his colleagues published last year estimating that there were 3.5 million NMSCs, affecting 2.1 million people in the United States in 2006 (Arch. Dermatol. 2010;146:283-7) . He and his colleagues estimated that the number of skin cancer procedures increased by 77% from 1992 to 2006. During this time, there was a 16% increase in procedures for NMSCs in the Medicare population.

NMSC is not a reportable disease, so there have not been good estimates for how many Americans are affected. For his initial paper, said Dr. Coldiron, "It occurred to me one day that you can't treat NMSC without a positive pathologic diagnosis, or they'll send you off to jail."

So he sought procedure data from Medicare's Fee-for-Service Physicians Claims database and the National Ambulatory Medical Care Service database. Procedures are "a pretty good proxy for the actual number of NMSCs," said Dr. Coldiron.

To get a total number of NMSCs, he and his colleagues multiplied the estimated crude number of skin cancers by the proportion of skin cancer procedure code claims associated with the ICD-9-CM diagnoses for invasive nonmelanoma cutaneous malignancy (173.0-173.9) and in situ malignancy (232.0-232.9).

Looking at trends, it appears the number of procedures have been levelling off at about a 2% rate the last few years, said Dr. Coldiron. However, the continued increase should be of concern to physicians, patients, and policy makers, he said.

The cost of treating NMSCs is around $8 billion a year, "so it's serious money," he said.

In commenting on Dr. Coldiron's findings, Dr. Darrell S. Rigel, who is a professor of dermatology and dermatologic surgery at New York University Medical Center, said that the number of NMSCs is "a surprisingly high number." Overall, skin cancer is much more common than all other cancers combined, said Dr. Rigel, adding that he had conducted studies showing that the lifetime risk of developing melanoma--invasive and in situ--now stood at 1 in 35 in the U.S.

And, more than 10,000 Americans will die from skin cancer this year. "So it is a serious public health problem," said Dr. Rigel.

For his part, Dr. Coldiron said, "We have to convince people there is an epidemic out there." In addition to increasing Medicare funding to treat NMSCs, "it's prudent and cost effective to focus on prevention," he said.

Dr. Coldiron reported no conflicts related to his talk. His study was self funded.

NEW ORLEANS - There were approximately 3.7 million nonmelanoma skin cancers in the United States in 2009, up almost 2% from the previous year, said Dr. Brett Coldiron.

This number marks the continuation of an upwards trend in the incidence of skin cancer, noted Dr. Coldiron, a private practice dermatologic surgeon and member of the dermatology faculty at the University of Cincinnati. He presented his preliminary 2009 data at the meeting, and noted that the vast numbers of those affected seem to indicate an epidemic.

"At this rate of increase, the total number of nonmelanoma skin cancer [NMSC] will double every 15-20 years," said Dr. Coldiron.

The data update a study he and his colleagues published last year estimating that there were 3.5 million NMSCs, affecting 2.1 million people in the United States in 2006 (Arch. Dermatol. 2010;146:283-7) . He and his colleagues estimated that the number of skin cancer procedures increased by 77% from 1992 to 2006. During this time, there was a 16% increase in procedures for NMSCs in the Medicare population.

NMSC is not a reportable disease, so there have not been good estimates for how many Americans are affected. For his initial paper, said Dr. Coldiron, "It occurred to me one day that you can't treat NMSC without a positive pathologic diagnosis, or they'll send you off to jail."

So he sought procedure data from Medicare's Fee-for-Service Physicians Claims database and the National Ambulatory Medical Care Service database. Procedures are "a pretty good proxy for the actual number of NMSCs," said Dr. Coldiron.

To get a total number of NMSCs, he and his colleagues multiplied the estimated crude number of skin cancers by the proportion of skin cancer procedure code claims associated with the ICD-9-CM diagnoses for invasive nonmelanoma cutaneous malignancy (173.0-173.9) and in situ malignancy (232.0-232.9).

Looking at trends, it appears the number of procedures have been levelling off at about a 2% rate the last few years, said Dr. Coldiron. However, the continued increase should be of concern to physicians, patients, and policy makers, he said.

The cost of treating NMSCs is around $8 billion a year, "so it's serious money," he said.

In commenting on Dr. Coldiron's findings, Dr. Darrell S. Rigel, who is a professor of dermatology and dermatologic surgery at New York University Medical Center, said that the number of NMSCs is "a surprisingly high number." Overall, skin cancer is much more common than all other cancers combined, said Dr. Rigel, adding that he had conducted studies showing that the lifetime risk of developing melanoma--invasive and in situ--now stood at 1 in 35 in the U.S.

And, more than 10,000 Americans will die from skin cancer this year. "So it is a serious public health problem," said Dr. Rigel.

For his part, Dr. Coldiron said, "We have to convince people there is an epidemic out there." In addition to increasing Medicare funding to treat NMSCs, "it's prudent and cost effective to focus on prevention," he said.

Dr. Coldiron reported no conflicts related to his talk. His study was self funded.