Alicia Ault

One day after the full ENHANCE data were presented at the ACC meeting, Sen. Chuck Grassley sent Merck & Co. and Schering-Plough Corp. executives a letter asking for the names of “key opinion leaders” who advised the companies on development and marketing of their cholesterol-lowering drug ezetimibe/simvastatin (Vytorin). The letter also called for a full accounting of payments made to these medical professionals and of how much was spent in total on advertising and marketing for Vytorin and/or ezetimibe (Zetia).

Sen. Grassley (R-Iowa) is the ranking minority member on the Senate Finance Committee, which has been investigating an alleged delay of the release of pivotal data from the ENHANCE study.

“Delaying the release of the results from the ENHANCE trial not only affected medical decisions, but also imposed financial burdens on patients as well as the federal government,” Sen. Grassley said in his letter, adding that since the trial's completion in 2006, the federal government has paid “hundreds of millions of dollars for Vytorin,” a drug which now seems to be of limited utility.

ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) showed that in patients with heterozygous familial hypercholesterolemia, a combination of ezetimibe and simvastatin was substantially more potent than simvastatin alone for reducing levels of LDL cholesterol and high-sensitivity C-reactive protein. But the combination had absolutely no advantage over the statin alone for slowing the progression of carotid atherosclerosis during 2 years of follow-up.

According to Sen. Grassley's letter, the Finance Committee staff has unearthed e-mail correspondence between Schering-Plough and Dr. John Kastelein, the ENHANCE primary investigator.

In July 2007, Dr. Kastelein wrote to a Schering-Plough executive, saying, “Is it correct that SP has decided not to present at AHA [the American Heart Association annual meeting], but to await the two other, completely unvalidated, endpoints, which analysis is going to take us straight into 2008??!!??” Dr. Kastelein added, “If this is true, SP must have taken this decision without even the semblance of decency to consult me as PI of the study. I can tell you that if this is the case, our collaboration is over. … This starts smelling like extending the publication for no other [than] political reasons and I cannot live with that.”

Just a day later, Dr. Kastelein wrote again to a Schering-Plough executive that he had been “cleared to say that ENHANCE would be presented at AHA” when he was presenting ezetimibe data at meetings he attended on behalf of the company over 6 months. “There is no reason whatsoever to include femorals; you will be seen as a company that tries to hide something and I will be perceived as being in bed with you!”

Sen. Grassley also said he was disturbed by a Merck/Schering-Plough public relations campaign, the “49 plan,” which was “designed to wine and dine doctors and convince them to prescribe Vytorin.” The campaign budget was at least $3.5 million, said Sen. Grassley, adding, “This seems like a great deal of money for free lunches and dinners.”

A Schering-Plough spokeswoman said that the letter from Sen. Grassley is one of a series the company has received from the committee. “We are cooperating fully with the committee, and we stand behind our products, as we have done nothing wrong,” Rosemarie Yancosek said in an interview.

The Iowa senator also wrote to the American College of Cardiology, saying that he was hopeful that the college was hewing to its own conflicts-of-interest policies but that he was concerned, noting that ACC had received $5 million from Merck since 2003, $1 million from Schering-Plough, and $5 million from the joint venture.

Soon after the ENHANCE data were released in January, ACC issued a statement saying that “there is no reason for patients to panic” and advising concerned patients to talk to their health care professional. ACC also said that further research was needed to determine Vytorin's usefulness. Sen. Grassley noted that in internal e-mails, both Merck and Schering-Plough officials had pointed to the ACC statement as evidence of Vytorin's effectiveness.

“It would not be unreasonable for an independent third party to conclude that the Merck and Schering-Plough payments to ACC influenced ACC's comments about Vytorin, especially now that experts are calling for doctors to use this drug only as a last resort,” Sen. Grassley said in his letter.

One day after the full ENHANCE data were presented at the ACC meeting, Sen. Chuck Grassley sent Merck & Co. and Schering-Plough Corp. executives a letter asking for the names of “key opinion leaders” who advised the companies on development and marketing of their cholesterol-lowering drug ezetimibe/simvastatin (Vytorin). The letter also called for a full accounting of payments made to these medical professionals and of how much was spent in total on advertising and marketing for Vytorin and/or ezetimibe (Zetia).

Sen. Grassley (R-Iowa) is the ranking minority member on the Senate Finance Committee, which has been investigating an alleged delay of the release of pivotal data from the ENHANCE study.

“Delaying the release of the results from the ENHANCE trial not only affected medical decisions, but also imposed financial burdens on patients as well as the federal government,” Sen. Grassley said in his letter, adding that since the trial's completion in 2006, the federal government has paid “hundreds of millions of dollars for Vytorin,” a drug which now seems to be of limited utility.

ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) showed that in patients with heterozygous familial hypercholesterolemia, a combination of ezetimibe and simvastatin was substantially more potent than simvastatin alone for reducing levels of LDL cholesterol and high-sensitivity C-reactive protein. But the combination had absolutely no advantage over the statin alone for slowing the progression of carotid atherosclerosis during 2 years of follow-up.

According to Sen. Grassley's letter, the Finance Committee staff has unearthed e-mail correspondence between Schering-Plough and Dr. John Kastelein, the ENHANCE primary investigator.

In July 2007, Dr. Kastelein wrote to a Schering-Plough executive, saying, “Is it correct that SP has decided not to present at AHA [the American Heart Association annual meeting], but to await the two other, completely unvalidated, endpoints, which analysis is going to take us straight into 2008??!!??” Dr. Kastelein added, “If this is true, SP must have taken this decision without even the semblance of decency to consult me as PI of the study. I can tell you that if this is the case, our collaboration is over. … This starts smelling like extending the publication for no other [than] political reasons and I cannot live with that.”

Just a day later, Dr. Kastelein wrote again to a Schering-Plough executive that he had been “cleared to say that ENHANCE would be presented at AHA” when he was presenting ezetimibe data at meetings he attended on behalf of the company over 6 months. “There is no reason whatsoever to include femorals; you will be seen as a company that tries to hide something and I will be perceived as being in bed with you!”

Sen. Grassley also said he was disturbed by a Merck/Schering-Plough public relations campaign, the “49 plan,” which was “designed to wine and dine doctors and convince them to prescribe Vytorin.” The campaign budget was at least $3.5 million, said Sen. Grassley, adding, “This seems like a great deal of money for free lunches and dinners.”

A Schering-Plough spokeswoman said that the letter from Sen. Grassley is one of a series the company has received from the committee. “We are cooperating fully with the committee, and we stand behind our products, as we have done nothing wrong,” Rosemarie Yancosek said in an interview.

The Iowa senator also wrote to the American College of Cardiology, saying that he was hopeful that the college was hewing to its own conflicts-of-interest policies but that he was concerned, noting that ACC had received $5 million from Merck since 2003, $1 million from Schering-Plough, and $5 million from the joint venture.

Soon after the ENHANCE data were released in January, ACC issued a statement saying that “there is no reason for patients to panic” and advising concerned patients to talk to their health care professional. ACC also said that further research was needed to determine Vytorin's usefulness. Sen. Grassley noted that in internal e-mails, both Merck and Schering-Plough officials had pointed to the ACC statement as evidence of Vytorin's effectiveness.

“It would not be unreasonable for an independent third party to conclude that the Merck and Schering-Plough payments to ACC influenced ACC's comments about Vytorin, especially now that experts are calling for doctors to use this drug only as a last resort,” Sen. Grassley said in his letter.

One day after the full ENHANCE data were presented at the ACC meeting, Sen. Chuck Grassley sent Merck & Co. and Schering-Plough Corp. executives a letter asking for the names of “key opinion leaders” who advised the companies on development and marketing of their cholesterol-lowering drug ezetimibe/simvastatin (Vytorin). The letter also called for a full accounting of payments made to these medical professionals and of how much was spent in total on advertising and marketing for Vytorin and/or ezetimibe (Zetia).

Sen. Grassley (R-Iowa) is the ranking minority member on the Senate Finance Committee, which has been investigating an alleged delay of the release of pivotal data from the ENHANCE study.

“Delaying the release of the results from the ENHANCE trial not only affected medical decisions, but also imposed financial burdens on patients as well as the federal government,” Sen. Grassley said in his letter, adding that since the trial's completion in 2006, the federal government has paid “hundreds of millions of dollars for Vytorin,” a drug which now seems to be of limited utility.

ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) showed that in patients with heterozygous familial hypercholesterolemia, a combination of ezetimibe and simvastatin was substantially more potent than simvastatin alone for reducing levels of LDL cholesterol and high-sensitivity C-reactive protein. But the combination had absolutely no advantage over the statin alone for slowing the progression of carotid atherosclerosis during 2 years of follow-up.

According to Sen. Grassley's letter, the Finance Committee staff has unearthed e-mail correspondence between Schering-Plough and Dr. John Kastelein, the ENHANCE primary investigator.

In July 2007, Dr. Kastelein wrote to a Schering-Plough executive, saying, “Is it correct that SP has decided not to present at AHA [the American Heart Association annual meeting], but to await the two other, completely unvalidated, endpoints, which analysis is going to take us straight into 2008??!!??” Dr. Kastelein added, “If this is true, SP must have taken this decision without even the semblance of decency to consult me as PI of the study. I can tell you that if this is the case, our collaboration is over. … This starts smelling like extending the publication for no other [than] political reasons and I cannot live with that.”

Just a day later, Dr. Kastelein wrote again to a Schering-Plough executive that he had been “cleared to say that ENHANCE would be presented at AHA” when he was presenting ezetimibe data at meetings he attended on behalf of the company over 6 months. “There is no reason whatsoever to include femorals; you will be seen as a company that tries to hide something and I will be perceived as being in bed with you!”

Sen. Grassley also said he was disturbed by a Merck/Schering-Plough public relations campaign, the “49 plan,” which was “designed to wine and dine doctors and convince them to prescribe Vytorin.” The campaign budget was at least $3.5 million, said Sen. Grassley, adding, “This seems like a great deal of money for free lunches and dinners.”

A Schering-Plough spokeswoman said that the letter from Sen. Grassley is one of a series the company has received from the committee. “We are cooperating fully with the committee, and we stand behind our products, as we have done nothing wrong,” Rosemarie Yancosek said in an interview.

The Iowa senator also wrote to the American College of Cardiology, saying that he was hopeful that the college was hewing to its own conflicts-of-interest policies but that he was concerned, noting that ACC had received $5 million from Merck since 2003, $1 million from Schering-Plough, and $5 million from the joint venture.

Soon after the ENHANCE data were released in January, ACC issued a statement saying that “there is no reason for patients to panic” and advising concerned patients to talk to their health care professional. ACC also said that further research was needed to determine Vytorin's usefulness. Sen. Grassley noted that in internal e-mails, both Merck and Schering-Plough officials had pointed to the ACC statement as evidence of Vytorin's effectiveness.

“It would not be unreasonable for an independent third party to conclude that the Merck and Schering-Plough payments to ACC influenced ACC's comments about Vytorin, especially now that experts are calling for doctors to use this drug only as a last resort,” Sen. Grassley said in his letter.

WASHINGTON — The explosive growth of hospitalists has caught the notice of the Medicare Payment Advisory Commission, which advises Congress on cost, quality, and access issues affecting the federal health program.

The number of hospitalists has nearly doubled in the last 5 years and will rise to 24,000 in 2008, according to information presented by MedPAC staff at a recent meeting. Citing figures from the Society for Hospital Medicine, the staff said that 40% of Medicare beneficiaries will receive care from a hospitalist by 2010, which is double the current number.

The MedPAC staff and some of the commissioners expressed concern that the explosion of hospitalist care could increase Medicare's overall spending. According to the staff, hospitalists are usually compensated through a combination of fixed salary and volume-based bonus incentives.

Those volume-based incentives may be driving hospitalists to admit and consult more often, said Zach Gaumer, a MedPAC staff member—and currently, he continued, Medicare's payment system rewards volume, not quality and efficiency.

Hospitalists have shown that they can "create measurable efficiency gains," he said, citing a study that showed that patients treated by hospitalists had a shorter length of stay and lower costs than those who were looked after by a general internist or family physician (N. Engl. J. Med. 2007;357:2589–600). There seemed to be no impact, however, on mortality or readmissions, said Mr. Gaumer.

The consistent presence of a hospitalist, however, may improve patient safety and lead to quicker adoption of process-improvement initiatives, he added.

On balance, the collaboration between hospitals and physicians can be a plus for providers and patients, said MedPAC staff member Ann Mutti.

The commission should aim for Medicare incentives that encourage appropriate care and the right mix of care, she said.

WASHINGTON — The explosive growth of hospitalists has caught the notice of the Medicare Payment Advisory Commission, which advises Congress on cost, quality, and access issues affecting the federal health program.

The number of hospitalists has nearly doubled in the last 5 years and will rise to 24,000 in 2008, according to information presented by MedPAC staff at a recent meeting. Citing figures from the Society for Hospital Medicine, the staff said that 40% of Medicare beneficiaries will receive care from a hospitalist by 2010, which is double the current number.

The MedPAC staff and some of the commissioners expressed concern that the explosion of hospitalist care could increase Medicare's overall spending. According to the staff, hospitalists are usually compensated through a combination of fixed salary and volume-based bonus incentives.

Those volume-based incentives may be driving hospitalists to admit and consult more often, said Zach Gaumer, a MedPAC staff member—and currently, he continued, Medicare's payment system rewards volume, not quality and efficiency.

Hospitalists have shown that they can "create measurable efficiency gains," he said, citing a study that showed that patients treated by hospitalists had a shorter length of stay and lower costs than those who were looked after by a general internist or family physician (N. Engl. J. Med. 2007;357:2589–600). There seemed to be no impact, however, on mortality or readmissions, said Mr. Gaumer.

The consistent presence of a hospitalist, however, may improve patient safety and lead to quicker adoption of process-improvement initiatives, he added.

On balance, the collaboration between hospitals and physicians can be a plus for providers and patients, said MedPAC staff member Ann Mutti.

The commission should aim for Medicare incentives that encourage appropriate care and the right mix of care, she said.

WASHINGTON — The explosive growth of hospitalists has caught the notice of the Medicare Payment Advisory Commission, which advises Congress on cost, quality, and access issues affecting the federal health program.

The number of hospitalists has nearly doubled in the last 5 years and will rise to 24,000 in 2008, according to information presented by MedPAC staff at a recent meeting. Citing figures from the Society for Hospital Medicine, the staff said that 40% of Medicare beneficiaries will receive care from a hospitalist by 2010, which is double the current number.

The MedPAC staff and some of the commissioners expressed concern that the explosion of hospitalist care could increase Medicare's overall spending. According to the staff, hospitalists are usually compensated through a combination of fixed salary and volume-based bonus incentives.

Those volume-based incentives may be driving hospitalists to admit and consult more often, said Zach Gaumer, a MedPAC staff member—and currently, he continued, Medicare's payment system rewards volume, not quality and efficiency.

Hospitalists have shown that they can "create measurable efficiency gains," he said, citing a study that showed that patients treated by hospitalists had a shorter length of stay and lower costs than those who were looked after by a general internist or family physician (N. Engl. J. Med. 2007;357:2589–600). There seemed to be no impact, however, on mortality or readmissions, said Mr. Gaumer.

The consistent presence of a hospitalist, however, may improve patient safety and lead to quicker adoption of process-improvement initiatives, he added.

On balance, the collaboration between hospitals and physicians can be a plus for providers and patients, said MedPAC staff member Ann Mutti.

The commission should aim for Medicare incentives that encourage appropriate care and the right mix of care, she said.

The federal government's portrayal of enrollment growth in the State Children's Health Insurance Program in 2007 is disingenuous and somewhat misleading, advocates for children's programs said.

According to the Centers for Medicare and Medicaid Services, 7.1 million children were enrolled in the program (SCHIP) in 2007, up from 6.7 million in 2006.

"While we are pleased that SCHIP continues to grow, we must do more to reach those at the lowest income levels who still need this coverage," Mike Leavitt, Health and Human Services secretary, said in a statement. "Toward that end, we will continue to work with Congress on the reauthorization of this vital program."

That comment is "disingenuous," Dr. Steve Wegner, chairman of the child health funding committee at the American Academy of Pediatrics, said in an interview. He noted that President Bush vetoed a compromise agreement to reauthorize SCHIP not once, but twice, in 2007.

"The administration did everything possible to stand in the way of the reauthorization," Jenny Sullivan, a health policy analyst with Families USA, said in an interview.

SCHIP was finally given a reprieve, with Congress passing, and the president signing, a funding extension through March 2009. But the program still has not been formally reauthorized.

And, said Ms. Sullivan and Dr. Wegner, many millions more children would have been covered in 2007 if the reauthorization had been approved when it was first taken up early in the year.

CMS spokeswoman Mary Kahn said that it was not accurate to imply that the Bush administration did not want to continue the SCHIP program. The administration did, however, want to fund it at a lower level, she said in an interview.

Also in the HHS statement, Kerry Weems, CMS acting administrator, said, "We continue to work with states to [ensure] that as many eligible, uninsured children as possible are enrolled in SCHIP and Medicaid."

Dr. Wegner took exception to that statement as well, noting that a CMS directive issued in August 2007 has effectively prevented states from expanding eligibility. The CMS said it would limit states' ability to expand coverage to children in families who had incomes at 250% of the poverty level or above. Ms. Sullivan said that the directive had, in many cases, reversed expansion plans previously approved by the CMS.

Twenty-three states are expected to be affected by the directive, according to the Kaiser Family Foundation. Nine already cover children in families with incomes above 250%, and 13 states had received approval to expand eligibility at or above that level. In addition, Washington was covering children at the 250% level and had gotten approval to raise that cap.

The directive is consistent with the administration's belief that every effort should be made to enroll 95% of children eligible at the lowest income levels before expanding it to those who are in higher-income families, said Ms. Kahn.

The increase in SCHIP enrollment was not unusually high for the program, said Ms. Sullivan. And, she said, U.S. Census Bureau figures indicate that the overall number of uninsured children actually increased in the last 2 years.

There are approximately 9 million uninsured children in the United States, according to a Families USA analysis. Both Ms. Sullivan and Dr. Wegner said they expect that number to grow in the current year, as states face harsh budget realities.

A much larger number of children are covered under traditional Medicaid programs—about 28 million in 2005, according to Kaiser—but their coverage is also being threatened because of a series of CMS regulations taking effect this year. Rep. John Dingell (D-Mich.) and Rep. Tim Murphy (R-Penn.) introduced a bill in March (H.R. 5613) that would place a 1-year moratorium on seven of those regulations. According to estimates they cite from the Congressional Budget Office, the regulations could translate to $20 billion in cuts to Medicaid over the next 5 years.

The National Governors Association, the National Association of State Medicaid Directors, and the American Public Human Services Association, have all expressed their opposition to the regulations in letters to HHS.

The federal government's portrayal of enrollment growth in the State Children's Health Insurance Program in 2007 is disingenuous and somewhat misleading, advocates for children's programs said.

According to the Centers for Medicare and Medicaid Services, 7.1 million children were enrolled in the program (SCHIP) in 2007, up from 6.7 million in 2006.

"While we are pleased that SCHIP continues to grow, we must do more to reach those at the lowest income levels who still need this coverage," Mike Leavitt, Health and Human Services secretary, said in a statement. "Toward that end, we will continue to work with Congress on the reauthorization of this vital program."

That comment is "disingenuous," Dr. Steve Wegner, chairman of the child health funding committee at the American Academy of Pediatrics, said in an interview. He noted that President Bush vetoed a compromise agreement to reauthorize SCHIP not once, but twice, in 2007.

"The administration did everything possible to stand in the way of the reauthorization," Jenny Sullivan, a health policy analyst with Families USA, said in an interview.

SCHIP was finally given a reprieve, with Congress passing, and the president signing, a funding extension through March 2009. But the program still has not been formally reauthorized.

And, said Ms. Sullivan and Dr. Wegner, many millions more children would have been covered in 2007 if the reauthorization had been approved when it was first taken up early in the year.

CMS spokeswoman Mary Kahn said that it was not accurate to imply that the Bush administration did not want to continue the SCHIP program. The administration did, however, want to fund it at a lower level, she said in an interview.

Also in the HHS statement, Kerry Weems, CMS acting administrator, said, "We continue to work with states to [ensure] that as many eligible, uninsured children as possible are enrolled in SCHIP and Medicaid."

Dr. Wegner took exception to that statement as well, noting that a CMS directive issued in August 2007 has effectively prevented states from expanding eligibility. The CMS said it would limit states' ability to expand coverage to children in families who had incomes at 250% of the poverty level or above. Ms. Sullivan said that the directive had, in many cases, reversed expansion plans previously approved by the CMS.

Twenty-three states are expected to be affected by the directive, according to the Kaiser Family Foundation. Nine already cover children in families with incomes above 250%, and 13 states had received approval to expand eligibility at or above that level. In addition, Washington was covering children at the 250% level and had gotten approval to raise that cap.

The directive is consistent with the administration's belief that every effort should be made to enroll 95% of children eligible at the lowest income levels before expanding it to those who are in higher-income families, said Ms. Kahn.

The increase in SCHIP enrollment was not unusually high for the program, said Ms. Sullivan. And, she said, U.S. Census Bureau figures indicate that the overall number of uninsured children actually increased in the last 2 years.

There are approximately 9 million uninsured children in the United States, according to a Families USA analysis. Both Ms. Sullivan and Dr. Wegner said they expect that number to grow in the current year, as states face harsh budget realities.

A much larger number of children are covered under traditional Medicaid programs—about 28 million in 2005, according to Kaiser—but their coverage is also being threatened because of a series of CMS regulations taking effect this year. Rep. John Dingell (D-Mich.) and Rep. Tim Murphy (R-Penn.) introduced a bill in March (H.R. 5613) that would place a 1-year moratorium on seven of those regulations. According to estimates they cite from the Congressional Budget Office, the regulations could translate to $20 billion in cuts to Medicaid over the next 5 years.

The National Governors Association, the National Association of State Medicaid Directors, and the American Public Human Services Association, have all expressed their opposition to the regulations in letters to HHS.

The federal government's portrayal of enrollment growth in the State Children's Health Insurance Program in 2007 is disingenuous and somewhat misleading, advocates for children's programs said.

According to the Centers for Medicare and Medicaid Services, 7.1 million children were enrolled in the program (SCHIP) in 2007, up from 6.7 million in 2006.

"While we are pleased that SCHIP continues to grow, we must do more to reach those at the lowest income levels who still need this coverage," Mike Leavitt, Health and Human Services secretary, said in a statement. "Toward that end, we will continue to work with Congress on the reauthorization of this vital program."

That comment is "disingenuous," Dr. Steve Wegner, chairman of the child health funding committee at the American Academy of Pediatrics, said in an interview. He noted that President Bush vetoed a compromise agreement to reauthorize SCHIP not once, but twice, in 2007.

"The administration did everything possible to stand in the way of the reauthorization," Jenny Sullivan, a health policy analyst with Families USA, said in an interview.

SCHIP was finally given a reprieve, with Congress passing, and the president signing, a funding extension through March 2009. But the program still has not been formally reauthorized.

And, said Ms. Sullivan and Dr. Wegner, many millions more children would have been covered in 2007 if the reauthorization had been approved when it was first taken up early in the year.

CMS spokeswoman Mary Kahn said that it was not accurate to imply that the Bush administration did not want to continue the SCHIP program. The administration did, however, want to fund it at a lower level, she said in an interview.

Also in the HHS statement, Kerry Weems, CMS acting administrator, said, "We continue to work with states to [ensure] that as many eligible, uninsured children as possible are enrolled in SCHIP and Medicaid."

Dr. Wegner took exception to that statement as well, noting that a CMS directive issued in August 2007 has effectively prevented states from expanding eligibility. The CMS said it would limit states' ability to expand coverage to children in families who had incomes at 250% of the poverty level or above. Ms. Sullivan said that the directive had, in many cases, reversed expansion plans previously approved by the CMS.

Twenty-three states are expected to be affected by the directive, according to the Kaiser Family Foundation. Nine already cover children in families with incomes above 250%, and 13 states had received approval to expand eligibility at or above that level. In addition, Washington was covering children at the 250% level and had gotten approval to raise that cap.

The directive is consistent with the administration's belief that every effort should be made to enroll 95% of children eligible at the lowest income levels before expanding it to those who are in higher-income families, said Ms. Kahn.

The increase in SCHIP enrollment was not unusually high for the program, said Ms. Sullivan. And, she said, U.S. Census Bureau figures indicate that the overall number of uninsured children actually increased in the last 2 years.

There are approximately 9 million uninsured children in the United States, according to a Families USA analysis. Both Ms. Sullivan and Dr. Wegner said they expect that number to grow in the current year, as states face harsh budget realities.

A much larger number of children are covered under traditional Medicaid programs—about 28 million in 2005, according to Kaiser—but their coverage is also being threatened because of a series of CMS regulations taking effect this year. Rep. John Dingell (D-Mich.) and Rep. Tim Murphy (R-Penn.) introduced a bill in March (H.R. 5613) that would place a 1-year moratorium on seven of those regulations. According to estimates they cite from the Congressional Budget Office, the regulations could translate to $20 billion in cuts to Medicaid over the next 5 years.

The National Governors Association, the National Association of State Medicaid Directors, and the American Public Human Services Association, have all expressed their opposition to the regulations in letters to HHS.

Market Swing to Noninjectables?

The number of botulinum toxin injections in 2007 far exceeded any other cosmetic procedure—surgical or nonsurgical—according to the American Society for Aesthetic Plastic Surgery's annual accounting of Americans' cosmetic predilections. However, the 2.7 million Botox injections were slightly down from 2006, when 3.1 million procedures were performed. The number of hyaluronic acid injections also dropped slightly to 1.4 million, as did injections of collagen and polyactate (Sculptra). Injections of calcium hydroxylapatite (Radiesse) increased by 55% to 119,000. And there was rapid uptake of noninjectables: Fraxel (167,000 procedures), IPL (647,000), and noninvasive tightening (258,000). Laser hair removal was still popular, at 1.4 million procedures, as was microdermabrasion (829,000 procedures). By comparison, the top surgical procedure—liposuction—was performed about 450,000 times. There's been a continued trend away from surgery. In 2007, nonsurgical procedures were 82% of the total cosmetic procedures. The sweet spot is the 35- to 50-year-old demographic, which accounted for 46% of all cosmetic procedures (surgical and nonsurgical). Women accounted for 91% of the total.

NSF-Gadolinium Cases Centralized

Discovery for 66 suits alleging that gadolinium-based contrast led to nephrogenic systemic fibrosis (NSF) has been consolidated in a federal court in Ohio. The plaintiffs allege that the gadolinium-based contrast agent used during magnetic resonance imaging led to NSF. NSF has occurred only in patients with preexisting renal compromise. The Food and Drug Administration has issued several warnings about gadolinium and NSF; in May 2007, the agency requested new black box warnings about the risk of NSF for the five products on the market. The discovery process for the product liability suits is now consolidated as multidistrict litigation 1909 in the U.S. District Court, Northern District of Ohio.

QLT to Divest Aczone

Vancouver, B.C.-based QLT Inc. said in mid-March that it would divest its acne therapy Aczone. The company made the announcement in the wake of the Food and Drug Administration's decision to remove a requirement for glucose-6-phosphate dehydrogenase screening and blood monitoring for users. The FDA decision was based on results of a postmarketing study submitted by the manufacturer. Aczone (dapsone 5% aqueous gel) was approved in July 2005. QLT owns worldwide marketing rights, but says it will now divest the product, as planned. "Management believed in the product and took the necessary steps to address the FDA's needs, ultimately dramatically enhancing the value of Aczone," said QLT CEO Bob Butchofsky in a statement.

Judge Rules for Journals

A federal judge in Chicago last month ruled that JAMA and the Archives of Internal Medicine do not need to release documents related to the confidential peer review process for studies on cyclooxygenase-2 inhibitors. Attorneys for drugmaker Pfizer Inc. had issued subpoenas last year to obtain all documents relating to the decision to accept or reject manuscripts, copies of rejected manuscripts, the identities of peer reviewers and their comments, and editors' comments regarding manuscripts, peer review, and publication decisions. But U.S. District Court Judge Arlander Keys of the Northern District of Illinois ruled that the journals can keep the documents confidential. "It is not unreasonable to believe that compelling production of peer review documents would compromise the process," Judge Keys wrote. Dr. Catherine DeAngelis, JAMA's editor-in-chief, and JAMA's editorial counsel, Joseph Thornton, wrote in an online editorial released March 24 that the ruling supports the confidential peer review process. "For months, JAMA and [Archives of Internal Medicine] consistently argued that the sanctity of the confidential peer review process should not be violated," they wrote. "JAMA and our Archives journals have historically and deliberately kept unpublished manuscripts and peer review comments confidential. This promise to reviewers and authors allows the peer review process to work in an unrestrained environment." A federal judge in Boston has not yet ruled on a similar request by Pfizer to force the release of documents from the New England Journal of Medicine.

Trouble Paying for Rx

Four in 10 Americans—and half those regularly taking at least one medication—reported that they have trouble paying for drugs, skip prescriptions, or cut pills because of the cost of their prescriptions, a poll jointly conducted by USA Today, the Kaiser Family Foundation, and the Harvard School of Public Health showed. People were most likely to report one of those three issues if they lack drug coverage, if they have low incomes, or if they take four or more drugs regularly. The survey found that while the public values the products drug companies produce, they do not like what they charge and are suspicious of their motivation. Nearly 80% of Americans said that the cost of prescription drugs is unreasonable, and about 70% said pharmaceutical companies are too concerned about making profits and not concerned enough about helping people. But at the same time, the public overwhelmingly believes that recent advances in prescription drugs provide benefits, the survey found.

Market Swing to Noninjectables?

The number of botulinum toxin injections in 2007 far exceeded any other cosmetic procedure—surgical or nonsurgical—according to the American Society for Aesthetic Plastic Surgery's annual accounting of Americans' cosmetic predilections. However, the 2.7 million Botox injections were slightly down from 2006, when 3.1 million procedures were performed. The number of hyaluronic acid injections also dropped slightly to 1.4 million, as did injections of collagen and polyactate (Sculptra). Injections of calcium hydroxylapatite (Radiesse) increased by 55% to 119,000. And there was rapid uptake of noninjectables: Fraxel (167,000 procedures), IPL (647,000), and noninvasive tightening (258,000). Laser hair removal was still popular, at 1.4 million procedures, as was microdermabrasion (829,000 procedures). By comparison, the top surgical procedure—liposuction—was performed about 450,000 times. There's been a continued trend away from surgery. In 2007, nonsurgical procedures were 82% of the total cosmetic procedures. The sweet spot is the 35- to 50-year-old demographic, which accounted for 46% of all cosmetic procedures (surgical and nonsurgical). Women accounted for 91% of the total.

NSF-Gadolinium Cases Centralized

Discovery for 66 suits alleging that gadolinium-based contrast led to nephrogenic systemic fibrosis (NSF) has been consolidated in a federal court in Ohio. The plaintiffs allege that the gadolinium-based contrast agent used during magnetic resonance imaging led to NSF. NSF has occurred only in patients with preexisting renal compromise. The Food and Drug Administration has issued several warnings about gadolinium and NSF; in May 2007, the agency requested new black box warnings about the risk of NSF for the five products on the market. The discovery process for the product liability suits is now consolidated as multidistrict litigation 1909 in the U.S. District Court, Northern District of Ohio.

QLT to Divest Aczone

Vancouver, B.C.-based QLT Inc. said in mid-March that it would divest its acne therapy Aczone. The company made the announcement in the wake of the Food and Drug Administration's decision to remove a requirement for glucose-6-phosphate dehydrogenase screening and blood monitoring for users. The FDA decision was based on results of a postmarketing study submitted by the manufacturer. Aczone (dapsone 5% aqueous gel) was approved in July 2005. QLT owns worldwide marketing rights, but says it will now divest the product, as planned. "Management believed in the product and took the necessary steps to address the FDA's needs, ultimately dramatically enhancing the value of Aczone," said QLT CEO Bob Butchofsky in a statement.

Judge Rules for Journals

A federal judge in Chicago last month ruled that JAMA and the Archives of Internal Medicine do not need to release documents related to the confidential peer review process for studies on cyclooxygenase-2 inhibitors. Attorneys for drugmaker Pfizer Inc. had issued subpoenas last year to obtain all documents relating to the decision to accept or reject manuscripts, copies of rejected manuscripts, the identities of peer reviewers and their comments, and editors' comments regarding manuscripts, peer review, and publication decisions. But U.S. District Court Judge Arlander Keys of the Northern District of Illinois ruled that the journals can keep the documents confidential. "It is not unreasonable to believe that compelling production of peer review documents would compromise the process," Judge Keys wrote. Dr. Catherine DeAngelis, JAMA's editor-in-chief, and JAMA's editorial counsel, Joseph Thornton, wrote in an online editorial released March 24 that the ruling supports the confidential peer review process. "For months, JAMA and [Archives of Internal Medicine] consistently argued that the sanctity of the confidential peer review process should not be violated," they wrote. "JAMA and our Archives journals have historically and deliberately kept unpublished manuscripts and peer review comments confidential. This promise to reviewers and authors allows the peer review process to work in an unrestrained environment." A federal judge in Boston has not yet ruled on a similar request by Pfizer to force the release of documents from the New England Journal of Medicine.

Trouble Paying for Rx

Four in 10 Americans—and half those regularly taking at least one medication—reported that they have trouble paying for drugs, skip prescriptions, or cut pills because of the cost of their prescriptions, a poll jointly conducted by USA Today, the Kaiser Family Foundation, and the Harvard School of Public Health showed. People were most likely to report one of those three issues if they lack drug coverage, if they have low incomes, or if they take four or more drugs regularly. The survey found that while the public values the products drug companies produce, they do not like what they charge and are suspicious of their motivation. Nearly 80% of Americans said that the cost of prescription drugs is unreasonable, and about 70% said pharmaceutical companies are too concerned about making profits and not concerned enough about helping people. But at the same time, the public overwhelmingly believes that recent advances in prescription drugs provide benefits, the survey found.

Market Swing to Noninjectables?

The number of botulinum toxin injections in 2007 far exceeded any other cosmetic procedure—surgical or nonsurgical—according to the American Society for Aesthetic Plastic Surgery's annual accounting of Americans' cosmetic predilections. However, the 2.7 million Botox injections were slightly down from 2006, when 3.1 million procedures were performed. The number of hyaluronic acid injections also dropped slightly to 1.4 million, as did injections of collagen and polyactate (Sculptra). Injections of calcium hydroxylapatite (Radiesse) increased by 55% to 119,000. And there was rapid uptake of noninjectables: Fraxel (167,000 procedures), IPL (647,000), and noninvasive tightening (258,000). Laser hair removal was still popular, at 1.4 million procedures, as was microdermabrasion (829,000 procedures). By comparison, the top surgical procedure—liposuction—was performed about 450,000 times. There's been a continued trend away from surgery. In 2007, nonsurgical procedures were 82% of the total cosmetic procedures. The sweet spot is the 35- to 50-year-old demographic, which accounted for 46% of all cosmetic procedures (surgical and nonsurgical). Women accounted for 91% of the total.

NSF-Gadolinium Cases Centralized

Discovery for 66 suits alleging that gadolinium-based contrast led to nephrogenic systemic fibrosis (NSF) has been consolidated in a federal court in Ohio. The plaintiffs allege that the gadolinium-based contrast agent used during magnetic resonance imaging led to NSF. NSF has occurred only in patients with preexisting renal compromise. The Food and Drug Administration has issued several warnings about gadolinium and NSF; in May 2007, the agency requested new black box warnings about the risk of NSF for the five products on the market. The discovery process for the product liability suits is now consolidated as multidistrict litigation 1909 in the U.S. District Court, Northern District of Ohio.

QLT to Divest Aczone

Vancouver, B.C.-based QLT Inc. said in mid-March that it would divest its acne therapy Aczone. The company made the announcement in the wake of the Food and Drug Administration's decision to remove a requirement for glucose-6-phosphate dehydrogenase screening and blood monitoring for users. The FDA decision was based on results of a postmarketing study submitted by the manufacturer. Aczone (dapsone 5% aqueous gel) was approved in July 2005. QLT owns worldwide marketing rights, but says it will now divest the product, as planned. "Management believed in the product and took the necessary steps to address the FDA's needs, ultimately dramatically enhancing the value of Aczone," said QLT CEO Bob Butchofsky in a statement.

Judge Rules for Journals

A federal judge in Chicago last month ruled that JAMA and the Archives of Internal Medicine do not need to release documents related to the confidential peer review process for studies on cyclooxygenase-2 inhibitors. Attorneys for drugmaker Pfizer Inc. had issued subpoenas last year to obtain all documents relating to the decision to accept or reject manuscripts, copies of rejected manuscripts, the identities of peer reviewers and their comments, and editors' comments regarding manuscripts, peer review, and publication decisions. But U.S. District Court Judge Arlander Keys of the Northern District of Illinois ruled that the journals can keep the documents confidential. "It is not unreasonable to believe that compelling production of peer review documents would compromise the process," Judge Keys wrote. Dr. Catherine DeAngelis, JAMA's editor-in-chief, and JAMA's editorial counsel, Joseph Thornton, wrote in an online editorial released March 24 that the ruling supports the confidential peer review process. "For months, JAMA and [Archives of Internal Medicine] consistently argued that the sanctity of the confidential peer review process should not be violated," they wrote. "JAMA and our Archives journals have historically and deliberately kept unpublished manuscripts and peer review comments confidential. This promise to reviewers and authors allows the peer review process to work in an unrestrained environment." A federal judge in Boston has not yet ruled on a similar request by Pfizer to force the release of documents from the New England Journal of Medicine.

Trouble Paying for Rx

Four in 10 Americans—and half those regularly taking at least one medication—reported that they have trouble paying for drugs, skip prescriptions, or cut pills because of the cost of their prescriptions, a poll jointly conducted by USA Today, the Kaiser Family Foundation, and the Harvard School of Public Health showed. People were most likely to report one of those three issues if they lack drug coverage, if they have low incomes, or if they take four or more drugs regularly. The survey found that while the public values the products drug companies produce, they do not like what they charge and are suspicious of their motivation. Nearly 80% of Americans said that the cost of prescription drugs is unreasonable, and about 70% said pharmaceutical companies are too concerned about making profits and not concerned enough about helping people. But at the same time, the public overwhelmingly believes that recent advances in prescription drugs provide benefits, the survey found.

WASHINGTON — Several members of Congress who spoke at a medical specialty conference said they were hopeful that their colleagues would enact legislation quickly to increase physician fees for at least 18 months.

The current legislation, enacted at the end of last year, is due to expire in June. The 6-month fix was a slap in the face to physicians, said Rep. Mike Burgess (R-Tex.).

“What an insult,” said Rep. Burgess, who is an ob.gyn. He introduced a bill last month to reset the sustainable growth rate formula baseline to the year of 2007 and to eliminate it in 2010. The bill, H.R. 5545, would also improve incentives for e-prescribing and for participation in the Physicians Quality Reporting Initiative. At press time, the bill had no cosponsors. It had been referred to the House Ways and Means Committee and the House Energy and Commerce Committee.

Rep. Bart Gordon (R-Tenn.), a senior member of the Energy and Commerce Health Subcommittee, said he was hopeful that corrective legislation would be passed, including a fee increase through 2009. By then, there will be a new president and a new Congress, providing a fresh perspective on how to get away from the sustainable growth rate target that's been ruling Medicare physician pay, he said at the meeting sponsored by the American Academy of Otolaryngology-Head and Neck Surgery.

The Ways and Means Health Subcommittee chairman, Rep. Pete Stark (D-Calif.), seemed less sanguine about quick action this year. However, he pointed out that the Senate had promised to have a bill by April. The most likely scenario is a reimbursement fix that follows the Medicare Payment Advisory Commission's recommendation of a 1%–2% increase over the next few years, he said.

The next 4–6 years will be incredibly exciting for the health reform movement, Rep. Stark said.

Rep. Tom Price (R-Ga.), a physician and fellow of the American College of Surgeons, agreed with Rep. Stark that the next few years would be significant.

“The next few years will be pivotal to the future of American medicine,” Rep. Price told meeting attendees.

He introduced a bill in mid-February (H.R. 5445) to increase physician fees by 1% for the remainder of 2008, and 1.8% for 2009.

That bill was referred to the Ways and Means Committee and to the Energy and Commerce Committee. At press time, the bill had approximately two dozen cosponsors.

WASHINGTON — Several members of Congress who spoke at a medical specialty conference said they were hopeful that their colleagues would enact legislation quickly to increase physician fees for at least 18 months.

The current legislation, enacted at the end of last year, is due to expire in June. The 6-month fix was a slap in the face to physicians, said Rep. Mike Burgess (R-Tex.).

“What an insult,” said Rep. Burgess, who is an ob.gyn. He introduced a bill last month to reset the sustainable growth rate formula baseline to the year of 2007 and to eliminate it in 2010. The bill, H.R. 5545, would also improve incentives for e-prescribing and for participation in the Physicians Quality Reporting Initiative. At press time, the bill had no cosponsors. It had been referred to the House Ways and Means Committee and the House Energy and Commerce Committee.

Rep. Bart Gordon (R-Tenn.), a senior member of the Energy and Commerce Health Subcommittee, said he was hopeful that corrective legislation would be passed, including a fee increase through 2009. By then, there will be a new president and a new Congress, providing a fresh perspective on how to get away from the sustainable growth rate target that's been ruling Medicare physician pay, he said at the meeting sponsored by the American Academy of Otolaryngology-Head and Neck Surgery.

The Ways and Means Health Subcommittee chairman, Rep. Pete Stark (D-Calif.), seemed less sanguine about quick action this year. However, he pointed out that the Senate had promised to have a bill by April. The most likely scenario is a reimbursement fix that follows the Medicare Payment Advisory Commission's recommendation of a 1%–2% increase over the next few years, he said.

The next 4–6 years will be incredibly exciting for the health reform movement, Rep. Stark said.

Rep. Tom Price (R-Ga.), a physician and fellow of the American College of Surgeons, agreed with Rep. Stark that the next few years would be significant.

“The next few years will be pivotal to the future of American medicine,” Rep. Price told meeting attendees.

He introduced a bill in mid-February (H.R. 5445) to increase physician fees by 1% for the remainder of 2008, and 1.8% for 2009.

That bill was referred to the Ways and Means Committee and to the Energy and Commerce Committee. At press time, the bill had approximately two dozen cosponsors.

WASHINGTON — Several members of Congress who spoke at a medical specialty conference said they were hopeful that their colleagues would enact legislation quickly to increase physician fees for at least 18 months.

The current legislation, enacted at the end of last year, is due to expire in June. The 6-month fix was a slap in the face to physicians, said Rep. Mike Burgess (R-Tex.).

“What an insult,” said Rep. Burgess, who is an ob.gyn. He introduced a bill last month to reset the sustainable growth rate formula baseline to the year of 2007 and to eliminate it in 2010. The bill, H.R. 5545, would also improve incentives for e-prescribing and for participation in the Physicians Quality Reporting Initiative. At press time, the bill had no cosponsors. It had been referred to the House Ways and Means Committee and the House Energy and Commerce Committee.

Rep. Bart Gordon (R-Tenn.), a senior member of the Energy and Commerce Health Subcommittee, said he was hopeful that corrective legislation would be passed, including a fee increase through 2009. By then, there will be a new president and a new Congress, providing a fresh perspective on how to get away from the sustainable growth rate target that's been ruling Medicare physician pay, he said at the meeting sponsored by the American Academy of Otolaryngology-Head and Neck Surgery.

The Ways and Means Health Subcommittee chairman, Rep. Pete Stark (D-Calif.), seemed less sanguine about quick action this year. However, he pointed out that the Senate had promised to have a bill by April. The most likely scenario is a reimbursement fix that follows the Medicare Payment Advisory Commission's recommendation of a 1%–2% increase over the next few years, he said.

The next 4–6 years will be incredibly exciting for the health reform movement, Rep. Stark said.

Rep. Tom Price (R-Ga.), a physician and fellow of the American College of Surgeons, agreed with Rep. Stark that the next few years would be significant.

“The next few years will be pivotal to the future of American medicine,” Rep. Price told meeting attendees.

He introduced a bill in mid-February (H.R. 5445) to increase physician fees by 1% for the remainder of 2008, and 1.8% for 2009.

That bill was referred to the Ways and Means Committee and to the Energy and Commerce Committee. At press time, the bill had approximately two dozen cosponsors.

WASHINGTON — Saying that primary care is undervalued, the Medicare Payment Advisory Commission might recommend that Congress increase payment for primary care and pilot test a medical home program.

MedPAC met in March to discuss various issues affecting cost, access, and quality of the Medicare program. At that meeting, a majority of the 16 commissioners present supported three draft recommendations to adjust the Medicare fee schedule upward for primary care and to start a medical home pilot.

If a majority supports the final recommendations at the commission's next meeting, they will be included in MedPAC's subsequent report to Congress, due in June.

More than most people in the United States, Medicare beneficiaries rely on primary care physicians, said MedPAC staff member Christina Boccuti at the March meeting. Primary care has proven to be more efficient and less costly, noted Ms. Boccuti.

Thus, the federal health program should find a way to encourage use of primary care and to reward primary care physicians, especially because the field is becoming less attractive, with fewer medical school graduates seeking family practice or primary care residencies, and more internists choosing to sub-subspecialize, she said.

Currently, primary care physicians are being paid only a fraction of their true value, said Ms. Boccuti.

In part, the shortfall is because the fee schedule that favors medical specialties over primary care, and relative values are updated only every 5 years, which tends to magnify the difference in efficiency gains between technology-dependent specialties and primary care.

If primary care physicians were more justly rewarded, they could invest in health information technology and other infrastructure needed to establish medical homes, said Ms. Boccuti.

MedPAC commissioners agreed that the playing field needs to be leveled and suggested some options. Congress could make a budget-neutral adjustment to the fee schedule to increase the payment for primary care, and ask the Medicare program to more closely identify who is considered a primary care physician.

“You could look at this as us trying to make up for the past failures” of the relative value-setting process, said MedPAC Chairman Glenn Hackbarth. The increase would be a reward for the value primary care delivers to the health care system, he said. “My own view is that ultimately, we need to be about recognizing value,” said Mr. Hackbarth, a health care consultant from Bend, Ore.

Dr. Nicholas Wolter, a commissioner and physician at the Billings Clinic in Montana, said that he would like to see an increase, even if it were not “budget neutral.” The investment in primary care would likely drive down overall Medicare spending, said Dr. Wolter.

Commissioners also expressed support for a medical home pilot program. To participate, a physician or a practice would have to demonstrate certain essential capabilities.

Although there is currently an ongoing medical home demonstration project being funded by Medicare, a pilot will bring more timely results, said Mr. Hackbarth, who explained that the difference is more than just semantic.

Pilots tend to be large in scale, with concrete parameters for participation and outcomes. If a pilot is successful, Medicare can simply expand the program, rather than have to go back to Congress to seek authority for a new regulation, he said.

“I think we need to accelerate the process to find good ideas that work,” Mr. Hackbarth said.

WASHINGTON — Saying that primary care is undervalued, the Medicare Payment Advisory Commission might recommend that Congress increase payment for primary care and pilot test a medical home program.

MedPAC met in March to discuss various issues affecting cost, access, and quality of the Medicare program. At that meeting, a majority of the 16 commissioners present supported three draft recommendations to adjust the Medicare fee schedule upward for primary care and to start a medical home pilot.

If a majority supports the final recommendations at the commission's next meeting, they will be included in MedPAC's subsequent report to Congress, due in June.

More than most people in the United States, Medicare beneficiaries rely on primary care physicians, said MedPAC staff member Christina Boccuti at the March meeting. Primary care has proven to be more efficient and less costly, noted Ms. Boccuti.

Thus, the federal health program should find a way to encourage use of primary care and to reward primary care physicians, especially because the field is becoming less attractive, with fewer medical school graduates seeking family practice or primary care residencies, and more internists choosing to sub-subspecialize, she said.

Currently, primary care physicians are being paid only a fraction of their true value, said Ms. Boccuti.

In part, the shortfall is because the fee schedule that favors medical specialties over primary care, and relative values are updated only every 5 years, which tends to magnify the difference in efficiency gains between technology-dependent specialties and primary care.

If primary care physicians were more justly rewarded, they could invest in health information technology and other infrastructure needed to establish medical homes, said Ms. Boccuti.

MedPAC commissioners agreed that the playing field needs to be leveled and suggested some options. Congress could make a budget-neutral adjustment to the fee schedule to increase the payment for primary care, and ask the Medicare program to more closely identify who is considered a primary care physician.

“You could look at this as us trying to make up for the past failures” of the relative value-setting process, said MedPAC Chairman Glenn Hackbarth. The increase would be a reward for the value primary care delivers to the health care system, he said. “My own view is that ultimately, we need to be about recognizing value,” said Mr. Hackbarth, a health care consultant from Bend, Ore.

Dr. Nicholas Wolter, a commissioner and physician at the Billings Clinic in Montana, said that he would like to see an increase, even if it were not “budget neutral.” The investment in primary care would likely drive down overall Medicare spending, said Dr. Wolter.

Commissioners also expressed support for a medical home pilot program. To participate, a physician or a practice would have to demonstrate certain essential capabilities.

Although there is currently an ongoing medical home demonstration project being funded by Medicare, a pilot will bring more timely results, said Mr. Hackbarth, who explained that the difference is more than just semantic.

Pilots tend to be large in scale, with concrete parameters for participation and outcomes. If a pilot is successful, Medicare can simply expand the program, rather than have to go back to Congress to seek authority for a new regulation, he said.

“I think we need to accelerate the process to find good ideas that work,” Mr. Hackbarth said.

WASHINGTON — Saying that primary care is undervalued, the Medicare Payment Advisory Commission might recommend that Congress increase payment for primary care and pilot test a medical home program.

MedPAC met in March to discuss various issues affecting cost, access, and quality of the Medicare program. At that meeting, a majority of the 16 commissioners present supported three draft recommendations to adjust the Medicare fee schedule upward for primary care and to start a medical home pilot.

If a majority supports the final recommendations at the commission's next meeting, they will be included in MedPAC's subsequent report to Congress, due in June.

More than most people in the United States, Medicare beneficiaries rely on primary care physicians, said MedPAC staff member Christina Boccuti at the March meeting. Primary care has proven to be more efficient and less costly, noted Ms. Boccuti.

Thus, the federal health program should find a way to encourage use of primary care and to reward primary care physicians, especially because the field is becoming less attractive, with fewer medical school graduates seeking family practice or primary care residencies, and more internists choosing to sub-subspecialize, she said.

Currently, primary care physicians are being paid only a fraction of their true value, said Ms. Boccuti.

In part, the shortfall is because the fee schedule that favors medical specialties over primary care, and relative values are updated only every 5 years, which tends to magnify the difference in efficiency gains between technology-dependent specialties and primary care.

If primary care physicians were more justly rewarded, they could invest in health information technology and other infrastructure needed to establish medical homes, said Ms. Boccuti.

MedPAC commissioners agreed that the playing field needs to be leveled and suggested some options. Congress could make a budget-neutral adjustment to the fee schedule to increase the payment for primary care, and ask the Medicare program to more closely identify who is considered a primary care physician.

“You could look at this as us trying to make up for the past failures” of the relative value-setting process, said MedPAC Chairman Glenn Hackbarth. The increase would be a reward for the value primary care delivers to the health care system, he said. “My own view is that ultimately, we need to be about recognizing value,” said Mr. Hackbarth, a health care consultant from Bend, Ore.

Dr. Nicholas Wolter, a commissioner and physician at the Billings Clinic in Montana, said that he would like to see an increase, even if it were not “budget neutral.” The investment in primary care would likely drive down overall Medicare spending, said Dr. Wolter.

Commissioners also expressed support for a medical home pilot program. To participate, a physician or a practice would have to demonstrate certain essential capabilities.

Although there is currently an ongoing medical home demonstration project being funded by Medicare, a pilot will bring more timely results, said Mr. Hackbarth, who explained that the difference is more than just semantic.

Pilots tend to be large in scale, with concrete parameters for participation and outcomes. If a pilot is successful, Medicare can simply expand the program, rather than have to go back to Congress to seek authority for a new regulation, he said.

“I think we need to accelerate the process to find good ideas that work,” Mr. Hackbarth said.

The risk of death from cancer may be increased in patients prescribed becaplermin (Regranex) more than three times, according to statement by the Food and Drug Administration issued last month.

Becaplermin is made by Johnson & Johnson's Ethicon division and is used to treat diabetic leg and foot ulcers. It was approved in 1997.

In a posting on its Web site, the agency said it recently was informed of a study—an analysis of a health insurance database—that found an increase in the number of cancer deaths in patients taking becaplermin. The database contained information on adult patients with diabetes who had no history of cancer. The authors compared patients taking becaplermin with those who did not. There were more cancer deaths in those prescribed the drug three or more times. It is not clear whether there was an increase in new cancer cases, said the FDA.

Johnson & Johnson had already been monitoring a potential cancer link, as becaplermin, a recombinant form of human platelet-derived growth factor, inherently had the potential to accelerate disease. Growth factors cause cells to divide more rapidly, said the FDA.

A long-term safety study completed by Johnson & Johnson in 2001 found more cancer in patients prescribed the drug.

The agency said patients should not stop taking the drug. Instead, “the risk of using Regranex should be weighed against the benefit for each individual patient.” The agency has not yet decided whether the new data will lead to any labeling changes.

The risk of death from cancer may be increased in patients prescribed becaplermin (Regranex) more than three times, according to statement by the Food and Drug Administration issued last month.

Becaplermin is made by Johnson & Johnson's Ethicon division and is used to treat diabetic leg and foot ulcers. It was approved in 1997.

In a posting on its Web site, the agency said it recently was informed of a study—an analysis of a health insurance database—that found an increase in the number of cancer deaths in patients taking becaplermin. The database contained information on adult patients with diabetes who had no history of cancer. The authors compared patients taking becaplermin with those who did not. There were more cancer deaths in those prescribed the drug three or more times. It is not clear whether there was an increase in new cancer cases, said the FDA.

Johnson & Johnson had already been monitoring a potential cancer link, as becaplermin, a recombinant form of human platelet-derived growth factor, inherently had the potential to accelerate disease. Growth factors cause cells to divide more rapidly, said the FDA.

A long-term safety study completed by Johnson & Johnson in 2001 found more cancer in patients prescribed the drug.

The agency said patients should not stop taking the drug. Instead, “the risk of using Regranex should be weighed against the benefit for each individual patient.” The agency has not yet decided whether the new data will lead to any labeling changes.

The risk of death from cancer may be increased in patients prescribed becaplermin (Regranex) more than three times, according to statement by the Food and Drug Administration issued last month.

Becaplermin is made by Johnson & Johnson's Ethicon division and is used to treat diabetic leg and foot ulcers. It was approved in 1997.

In a posting on its Web site, the agency said it recently was informed of a study—an analysis of a health insurance database—that found an increase in the number of cancer deaths in patients taking becaplermin. The database contained information on adult patients with diabetes who had no history of cancer. The authors compared patients taking becaplermin with those who did not. There were more cancer deaths in those prescribed the drug three or more times. It is not clear whether there was an increase in new cancer cases, said the FDA.

Johnson & Johnson had already been monitoring a potential cancer link, as becaplermin, a recombinant form of human platelet-derived growth factor, inherently had the potential to accelerate disease. Growth factors cause cells to divide more rapidly, said the FDA.

A long-term safety study completed by Johnson & Johnson in 2001 found more cancer in patients prescribed the drug.

The agency said patients should not stop taking the drug. Instead, “the risk of using Regranex should be weighed against the benefit for each individual patient.” The agency has not yet decided whether the new data will lead to any labeling changes.

WASHINGTON — With health care expenses accounting for the single largest expense in their budget, states are increasingly looking for solutions from within, not from the federal government, according to an annual accounting of state legislative trends compiled by the Blue Cross and Blue Shield Association.

“Health care spending represented nearly one-third of total state expenditures last fiscal year,” commented Susan Laudicina, who is BCBSA director for state research and policy, during a briefing for reporters.

As the economy weakens, health care costs will continue to rise, while tax revenues will fall, she noted.

“The challenge for state lawmakers is how to avoid cutting existing programs like Medicaid and the State Children's Health Insurance Program while also finding new ways to cover the uninsured and contain costs,” Ms. Laudicina said.

About half of the state legislatures debated establishing universal coverage or expansion programs for children in fiscal 2007.

Mandates requiring individuals to buy insurance were introduced in 12 states but failed, largely because such mandates are controversial, she said.

Connecticut and New York expanded eligibility for SCHIP to 400% of the federal poverty level and seven other states raised eligibility to 300%, but those efforts are threatened by a rule change issued by the U.S. Department of Health and Human Services last August that ostensibly caps eligibility at 250% of the federal poverty level.

Eight states—Connecticut, Indiana, Kansas, Louisiana, Maryland, New York, Texas, and Washington—created programs that use public funds to subsidize private employer-sponsored health insurance in order to make it available to Medicaid-eligible workers.

In addition, “transparency” initiatives—which are proposals requiring hospitals (and, in some cases, physicians) to publicly share information on adverse events, quality data, and pricing—are gaining ground.

Transparency bills were enacted in Arkansas, Delaware, Georgia, Indiana, Minnesota, New Jersey, Oregon, Pennsylvania, Texas, and Washington.

WASHINGTON — With health care expenses accounting for the single largest expense in their budget, states are increasingly looking for solutions from within, not from the federal government, according to an annual accounting of state legislative trends compiled by the Blue Cross and Blue Shield Association.

“Health care spending represented nearly one-third of total state expenditures last fiscal year,” commented Susan Laudicina, who is BCBSA director for state research and policy, during a briefing for reporters.

As the economy weakens, health care costs will continue to rise, while tax revenues will fall, she noted.

“The challenge for state lawmakers is how to avoid cutting existing programs like Medicaid and the State Children's Health Insurance Program while also finding new ways to cover the uninsured and contain costs,” Ms. Laudicina said.

About half of the state legislatures debated establishing universal coverage or expansion programs for children in fiscal 2007.

Mandates requiring individuals to buy insurance were introduced in 12 states but failed, largely because such mandates are controversial, she said.

Connecticut and New York expanded eligibility for SCHIP to 400% of the federal poverty level and seven other states raised eligibility to 300%, but those efforts are threatened by a rule change issued by the U.S. Department of Health and Human Services last August that ostensibly caps eligibility at 250% of the federal poverty level.

Eight states—Connecticut, Indiana, Kansas, Louisiana, Maryland, New York, Texas, and Washington—created programs that use public funds to subsidize private employer-sponsored health insurance in order to make it available to Medicaid-eligible workers.

In addition, “transparency” initiatives—which are proposals requiring hospitals (and, in some cases, physicians) to publicly share information on adverse events, quality data, and pricing—are gaining ground.

Transparency bills were enacted in Arkansas, Delaware, Georgia, Indiana, Minnesota, New Jersey, Oregon, Pennsylvania, Texas, and Washington.

WASHINGTON — With health care expenses accounting for the single largest expense in their budget, states are increasingly looking for solutions from within, not from the federal government, according to an annual accounting of state legislative trends compiled by the Blue Cross and Blue Shield Association.

“Health care spending represented nearly one-third of total state expenditures last fiscal year,” commented Susan Laudicina, who is BCBSA director for state research and policy, during a briefing for reporters.

As the economy weakens, health care costs will continue to rise, while tax revenues will fall, she noted.

“The challenge for state lawmakers is how to avoid cutting existing programs like Medicaid and the State Children's Health Insurance Program while also finding new ways to cover the uninsured and contain costs,” Ms. Laudicina said.

About half of the state legislatures debated establishing universal coverage or expansion programs for children in fiscal 2007.

Mandates requiring individuals to buy insurance were introduced in 12 states but failed, largely because such mandates are controversial, she said.

Connecticut and New York expanded eligibility for SCHIP to 400% of the federal poverty level and seven other states raised eligibility to 300%, but those efforts are threatened by a rule change issued by the U.S. Department of Health and Human Services last August that ostensibly caps eligibility at 250% of the federal poverty level.

Eight states—Connecticut, Indiana, Kansas, Louisiana, Maryland, New York, Texas, and Washington—created programs that use public funds to subsidize private employer-sponsored health insurance in order to make it available to Medicaid-eligible workers.

In addition, “transparency” initiatives—which are proposals requiring hospitals (and, in some cases, physicians) to publicly share information on adverse events, quality data, and pricing—are gaining ground.

Transparency bills were enacted in Arkansas, Delaware, Georgia, Indiana, Minnesota, New Jersey, Oregon, Pennsylvania, Texas, and Washington.

WASHINGTON — With Congress scrambling to avert a physician fee cut in July, it appears once again that Medicare Advantage is being eyed as funding source by Democrats but as sacrosanct by Republicans, setting the stage for several months of political wrangling.

It also may portend a repeat of last year's battle, one that ended with President Bush refusing to sign a legislative package that restored physician reimbursement but slashed Medicare Advantage payments.

The debate played out at a March hearing of the House Ways and Means Committee's Subcommittee on Health where recommendations from the Medicare Payment Advisory Commission's (MedPAC) recent report to Congress were discussed, including a bid for Congress to increase physician fees by 1.5% in 2008 and 2009.

MedPAC said it supported Medicare Advantage (MA) plans—which let beneficiaries receive coverage from private plans such as HMOs and PPOs, and from private fee-for-service insurers. MedPAC also made the case that, for the third year in a row, the MA plans are overpaid relative to traditional fee-for-service (FFS) Medicare.

MedPAC Chairman Glenn Hackbarth told the subcommittee that the commission estimates that Medicare has paid the plans $10 billion more than it would have under traditional FFS for each of the last 3 years. Overall, MA plans will be paid 13% more than conventional Medicare providers in 2008, a 1% uptick from 2007.

The profit potential in those plans has fueled a rush into the market and a 101% increase in enrollment from 2006 to 2007, according to MedPAC. Coordinated care, such as HMOs and PPOs, saw an 8% enrollment increase, although those plans still account for the largest group (20%) of beneficiaries in an MA.

MA plans, with their added benefits, are increasingly attractive to beneficiaries, so MedPAC is concerned about the growth of high-cost FFS plans, said Mr. Hackbarth.

The plans are rewarded for their costs, and there is no penalty for poor quality, he said. “Payment policy is a powerful signal of what we value,” Mr. Hackbarth said. He added that MedPAC “supports financial neutrality” between payment rates for the FFS and the MA programs. He noted that about half of overpayments to MA plans are going to insurers' bottom lines.

That fact has not been lost on the subcommittee chairman, Pete Stark (D-Calif.), who has held hearings questioning the value and integrity of the MA plans. Republicans defended the MA program, however.

Rep. Dave Camp (R-Mich.) intensely questioned Mr. Hackbarth, eliciting the admission that MA plans had been successful in rural areas. Rep. Sam Johnson (R-Tenn.) added, “my seniors have asked me not to mess with their Medicare Advantage plans.” At one point, he accused the MedPAC chairman of saying the government is a more efficient insurer than the private sector. Mr. Hackbarth disagreed and clarified his position. “The problem with this payment system is we are rewarding inefficient private plans,” he said.

WASHINGTON — With Congress scrambling to avert a physician fee cut in July, it appears once again that Medicare Advantage is being eyed as funding source by Democrats but as sacrosanct by Republicans, setting the stage for several months of political wrangling.

It also may portend a repeat of last year's battle, one that ended with President Bush refusing to sign a legislative package that restored physician reimbursement but slashed Medicare Advantage payments.

The debate played out at a March hearing of the House Ways and Means Committee's Subcommittee on Health where recommendations from the Medicare Payment Advisory Commission's (MedPAC) recent report to Congress were discussed, including a bid for Congress to increase physician fees by 1.5% in 2008 and 2009.

MedPAC said it supported Medicare Advantage (MA) plans—which let beneficiaries receive coverage from private plans such as HMOs and PPOs, and from private fee-for-service insurers. MedPAC also made the case that, for the third year in a row, the MA plans are overpaid relative to traditional fee-for-service (FFS) Medicare.

MedPAC Chairman Glenn Hackbarth told the subcommittee that the commission estimates that Medicare has paid the plans $10 billion more than it would have under traditional FFS for each of the last 3 years. Overall, MA plans will be paid 13% more than conventional Medicare providers in 2008, a 1% uptick from 2007.

The profit potential in those plans has fueled a rush into the market and a 101% increase in enrollment from 2006 to 2007, according to MedPAC. Coordinated care, such as HMOs and PPOs, saw an 8% enrollment increase, although those plans still account for the largest group (20%) of beneficiaries in an MA.

MA plans, with their added benefits, are increasingly attractive to beneficiaries, so MedPAC is concerned about the growth of high-cost FFS plans, said Mr. Hackbarth.

The plans are rewarded for their costs, and there is no penalty for poor quality, he said. “Payment policy is a powerful signal of what we value,” Mr. Hackbarth said. He added that MedPAC “supports financial neutrality” between payment rates for the FFS and the MA programs. He noted that about half of overpayments to MA plans are going to insurers' bottom lines.

That fact has not been lost on the subcommittee chairman, Pete Stark (D-Calif.), who has held hearings questioning the value and integrity of the MA plans. Republicans defended the MA program, however.

Rep. Dave Camp (R-Mich.) intensely questioned Mr. Hackbarth, eliciting the admission that MA plans had been successful in rural areas. Rep. Sam Johnson (R-Tenn.) added, “my seniors have asked me not to mess with their Medicare Advantage plans.” At one point, he accused the MedPAC chairman of saying the government is a more efficient insurer than the private sector. Mr. Hackbarth disagreed and clarified his position. “The problem with this payment system is we are rewarding inefficient private plans,” he said.

WASHINGTON — With Congress scrambling to avert a physician fee cut in July, it appears once again that Medicare Advantage is being eyed as funding source by Democrats but as sacrosanct by Republicans, setting the stage for several months of political wrangling.

It also may portend a repeat of last year's battle, one that ended with President Bush refusing to sign a legislative package that restored physician reimbursement but slashed Medicare Advantage payments.

The debate played out at a March hearing of the House Ways and Means Committee's Subcommittee on Health where recommendations from the Medicare Payment Advisory Commission's (MedPAC) recent report to Congress were discussed, including a bid for Congress to increase physician fees by 1.5% in 2008 and 2009.

MedPAC said it supported Medicare Advantage (MA) plans—which let beneficiaries receive coverage from private plans such as HMOs and PPOs, and from private fee-for-service insurers. MedPAC also made the case that, for the third year in a row, the MA plans are overpaid relative to traditional fee-for-service (FFS) Medicare.

MedPAC Chairman Glenn Hackbarth told the subcommittee that the commission estimates that Medicare has paid the plans $10 billion more than it would have under traditional FFS for each of the last 3 years. Overall, MA plans will be paid 13% more than conventional Medicare providers in 2008, a 1% uptick from 2007.

The profit potential in those plans has fueled a rush into the market and a 101% increase in enrollment from 2006 to 2007, according to MedPAC. Coordinated care, such as HMOs and PPOs, saw an 8% enrollment increase, although those plans still account for the largest group (20%) of beneficiaries in an MA.

MA plans, with their added benefits, are increasingly attractive to beneficiaries, so MedPAC is concerned about the growth of high-cost FFS plans, said Mr. Hackbarth.

The plans are rewarded for their costs, and there is no penalty for poor quality, he said. “Payment policy is a powerful signal of what we value,” Mr. Hackbarth said. He added that MedPAC “supports financial neutrality” between payment rates for the FFS and the MA programs. He noted that about half of overpayments to MA plans are going to insurers' bottom lines.

That fact has not been lost on the subcommittee chairman, Pete Stark (D-Calif.), who has held hearings questioning the value and integrity of the MA plans. Republicans defended the MA program, however.

Rep. Dave Camp (R-Mich.) intensely questioned Mr. Hackbarth, eliciting the admission that MA plans had been successful in rural areas. Rep. Sam Johnson (R-Tenn.) added, “my seniors have asked me not to mess with their Medicare Advantage plans.” At one point, he accused the MedPAC chairman of saying the government is a more efficient insurer than the private sector. Mr. Hackbarth disagreed and clarified his position. “The problem with this payment system is we are rewarding inefficient private plans,” he said.

The federal government's portrayal of enrollment growth in the State Children's Health Insurance Program in 2007 is disingenuous and somewhat misleading, advocates for children's programs said.

According to the Centers for Medicare and Medicaid Services, 7.1 million children were enrolled in the program (SCHIP) in 2007, up from 6.7 million in 2006.

“While we are pleased that SCHIP continues to grow, we must do more to reach those at the lowest income levels who still need this coverage,” Mike Leavitt, Health and Human Services secretary, said in a statement. “Toward that end, we will continue to work with Congress on the reauthorization of this vital program.”

That comment is “disingenuous,” Dr. Steve Wegner, chairman of the child health funding committee at the American Academy of Pediatrics, said in an interview. He noted that President Bush vetoed a compromise agreement to reauthorize SCHIP not once, but twice, in 2007.

“The administration did everything possible to stand in the way of the reauthorization,” Jenny Sullivan, a health policy analyst with Families USA, said in an interview.

SCHIP was finally given a reprieve, with Congress passing, and the president signing, a funding extension through March 2009. But the program still has not been formally reauthorized. And, said Ms. Sullivan and Dr. Wegner, many millions more children would have been covered in 2007 if the reauthorization had been approved when it was first taken up early in the year.

CMS spokeswoman Mary Kahn said that it was not accurate to imply that the Bush administration did not want to continue the SCHIP program. The administration did, however, want to fund it at a lower level, she said in an interview.

Also in the HHS statement, Kerry Weems, CMS acting administrator, said, “We continue to work with states to [ensure] that as many eligible, uninsured children as possible are enrolled in SCHIP and Medicaid.”

Dr. Wegner took exception to that statement as well, noting that a CMS directive issued in August 2007 has effectively prevented states from expanding eligibility. The CMS said it would limit states' ability to expand coverage to children in families who had incomes at 250% of the poverty level or above. Ms. Sullivan said that the directive had, in many cases, reversed expansion plans previously approved by the CMS.

Twenty-three states are expected to be affected by the directive, according to the Kaiser Family Foundation. Nine already cover children in families with incomes above 250%, and 13 states had received approval to expand eligibility at or above that level. In addition, Washington was covering children at the 250% level and had gotten approval to raise that cap.

The directive is consistent with the administration's belief that every effort should be made to enroll 95% of children eligible at the lowest income levels before expanding it to those who are in higher-income families, said Ms. Kahn.

The increase in SCHIP enrollment was not unusually high for the program, said Ms. Sullivan. And, she said, U.S. Census Bureau figures indicate that the overall number of uninsured children actually increased in the last 2 years.

There are approximately 9 million uninsured children in the United States, according to a Families USA analysis. Both Ms. Sullivan and Dr. Wegner said they expect that number to grow in the current year.

A much larger number of children are covered under traditional Medicaid programs—about 28 million in 2005, according to Kaiser—but their coverage is also being threatened because of a series of CMS regulations taking effect this year. Rep. John Dingell (D-Mich.) and Rep. Tim Murphy (R-Penn.) introduced a bill in March (H.R. 5613) that would place a 1-year moratorium on seven of those regulations.

Looking ahead into next year, the picture grows even dimmer. For fiscal 2009, President Bush proposed increasing SCHIP funding by $19.7 billion (added to the current baseline of $25 billion) through 2013. That is much less than the $35 billion that was authorized in the two legislative packages vetoed by the President last year.

'We must do more to reach those at the lowest income levels who still need this coverage.' MR. LEAVITT

The federal government's portrayal of enrollment growth in the State Children's Health Insurance Program in 2007 is disingenuous and somewhat misleading, advocates for children's programs said.

According to the Centers for Medicare and Medicaid Services, 7.1 million children were enrolled in the program (SCHIP) in 2007, up from 6.7 million in 2006.

“While we are pleased that SCHIP continues to grow, we must do more to reach those at the lowest income levels who still need this coverage,” Mike Leavitt, Health and Human Services secretary, said in a statement. “Toward that end, we will continue to work with Congress on the reauthorization of this vital program.”

That comment is “disingenuous,” Dr. Steve Wegner, chairman of the child health funding committee at the American Academy of Pediatrics, said in an interview. He noted that President Bush vetoed a compromise agreement to reauthorize SCHIP not once, but twice, in 2007.

“The administration did everything possible to stand in the way of the reauthorization,” Jenny Sullivan, a health policy analyst with Families USA, said in an interview.

SCHIP was finally given a reprieve, with Congress passing, and the president signing, a funding extension through March 2009. But the program still has not been formally reauthorized. And, said Ms. Sullivan and Dr. Wegner, many millions more children would have been covered in 2007 if the reauthorization had been approved when it was first taken up early in the year.

CMS spokeswoman Mary Kahn said that it was not accurate to imply that the Bush administration did not want to continue the SCHIP program. The administration did, however, want to fund it at a lower level, she said in an interview.

Also in the HHS statement, Kerry Weems, CMS acting administrator, said, “We continue to work with states to [ensure] that as many eligible, uninsured children as possible are enrolled in SCHIP and Medicaid.”

Dr. Wegner took exception to that statement as well, noting that a CMS directive issued in August 2007 has effectively prevented states from expanding eligibility. The CMS said it would limit states' ability to expand coverage to children in families who had incomes at 250% of the poverty level or above. Ms. Sullivan said that the directive had, in many cases, reversed expansion plans previously approved by the CMS.

Twenty-three states are expected to be affected by the directive, according to the Kaiser Family Foundation. Nine already cover children in families with incomes above 250%, and 13 states had received approval to expand eligibility at or above that level. In addition, Washington was covering children at the 250% level and had gotten approval to raise that cap.

The directive is consistent with the administration's belief that every effort should be made to enroll 95% of children eligible at the lowest income levels before expanding it to those who are in higher-income families, said Ms. Kahn.

The increase in SCHIP enrollment was not unusually high for the program, said Ms. Sullivan. And, she said, U.S. Census Bureau figures indicate that the overall number of uninsured children actually increased in the last 2 years.

There are approximately 9 million uninsured children in the United States, according to a Families USA analysis. Both Ms. Sullivan and Dr. Wegner said they expect that number to grow in the current year.

A much larger number of children are covered under traditional Medicaid programs—about 28 million in 2005, according to Kaiser—but their coverage is also being threatened because of a series of CMS regulations taking effect this year. Rep. John Dingell (D-Mich.) and Rep. Tim Murphy (R-Penn.) introduced a bill in March (H.R. 5613) that would place a 1-year moratorium on seven of those regulations.

Looking ahead into next year, the picture grows even dimmer. For fiscal 2009, President Bush proposed increasing SCHIP funding by $19.7 billion (added to the current baseline of $25 billion) through 2013. That is much less than the $35 billion that was authorized in the two legislative packages vetoed by the President last year.

'We must do more to reach those at the lowest income levels who still need this coverage.' MR. LEAVITT

The federal government's portrayal of enrollment growth in the State Children's Health Insurance Program in 2007 is disingenuous and somewhat misleading, advocates for children's programs said.

According to the Centers for Medicare and Medicaid Services, 7.1 million children were enrolled in the program (SCHIP) in 2007, up from 6.7 million in 2006.

“While we are pleased that SCHIP continues to grow, we must do more to reach those at the lowest income levels who still need this coverage,” Mike Leavitt, Health and Human Services secretary, said in a statement. “Toward that end, we will continue to work with Congress on the reauthorization of this vital program.”

That comment is “disingenuous,” Dr. Steve Wegner, chairman of the child health funding committee at the American Academy of Pediatrics, said in an interview. He noted that President Bush vetoed a compromise agreement to reauthorize SCHIP not once, but twice, in 2007.

“The administration did everything possible to stand in the way of the reauthorization,” Jenny Sullivan, a health policy analyst with Families USA, said in an interview.

SCHIP was finally given a reprieve, with Congress passing, and the president signing, a funding extension through March 2009. But the program still has not been formally reauthorized. And, said Ms. Sullivan and Dr. Wegner, many millions more children would have been covered in 2007 if the reauthorization had been approved when it was first taken up early in the year.

CMS spokeswoman Mary Kahn said that it was not accurate to imply that the Bush administration did not want to continue the SCHIP program. The administration did, however, want to fund it at a lower level, she said in an interview.

Also in the HHS statement, Kerry Weems, CMS acting administrator, said, “We continue to work with states to [ensure] that as many eligible, uninsured children as possible are enrolled in SCHIP and Medicaid.”

Dr. Wegner took exception to that statement as well, noting that a CMS directive issued in August 2007 has effectively prevented states from expanding eligibility. The CMS said it would limit states' ability to expand coverage to children in families who had incomes at 250% of the poverty level or above. Ms. Sullivan said that the directive had, in many cases, reversed expansion plans previously approved by the CMS.

Twenty-three states are expected to be affected by the directive, according to the Kaiser Family Foundation. Nine already cover children in families with incomes above 250%, and 13 states had received approval to expand eligibility at or above that level. In addition, Washington was covering children at the 250% level and had gotten approval to raise that cap.

The directive is consistent with the administration's belief that every effort should be made to enroll 95% of children eligible at the lowest income levels before expanding it to those who are in higher-income families, said Ms. Kahn.

The increase in SCHIP enrollment was not unusually high for the program, said Ms. Sullivan. And, she said, U.S. Census Bureau figures indicate that the overall number of uninsured children actually increased in the last 2 years.

There are approximately 9 million uninsured children in the United States, according to a Families USA analysis. Both Ms. Sullivan and Dr. Wegner said they expect that number to grow in the current year.

A much larger number of children are covered under traditional Medicaid programs—about 28 million in 2005, according to Kaiser—but their coverage is also being threatened because of a series of CMS regulations taking effect this year. Rep. John Dingell (D-Mich.) and Rep. Tim Murphy (R-Penn.) introduced a bill in March (H.R. 5613) that would place a 1-year moratorium on seven of those regulations.

Looking ahead into next year, the picture grows even dimmer. For fiscal 2009, President Bush proposed increasing SCHIP funding by $19.7 billion (added to the current baseline of $25 billion) through 2013. That is much less than the $35 billion that was authorized in the two legislative packages vetoed by the President last year.

'We must do more to reach those at the lowest income levels who still need this coverage.' MR. LEAVITT