Debate Continues Over Early Cognition Screening

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WASHINGTON – Some Alzheimer's disease-related groups–but not all–are stepping up calls for earlier and more frequent cognition screening, citing an aging population increasingly at risk for dementia.

The disease affects 1 in 10 people older than age 65 years, and almost half of those older than age 85 years, according to the Alzheimer's Foundation of America. It is the seventh leading cause of death in the United States.

A cognition screen can establish a baseline, and be used to prompt referrals to clinicians who can pinpoint the cause of memory loss or loss of executive functioning, Eric J. Hall, CEO of the New York-based AFA, said in an interview.

Knowing of an Alzheimer's diagnosis early in the disease progression helps patients and families prepare, and early intervention can improve quality of life, he said.

The AFA has been seeking coverage of cognition screening as part of the “Welcome to Medicare” exam. The exam is offered during the first 6 months of Medicare Part B coverage; beneficiaries pay 20% of the cost, if they've met the deductible. If they have not met the deductible, they may be liable for the exam's entire cost.

To add cognition screening would require an act of Congress, according to a spokesperson at the Centers for Medicare and Medicaid Services.

The AFA's call for early screening and coverage was echoed by a group of experts convened by Pfizer Inc. and Eisai Inc., who issued a consensus statement in November. Pfizer and Eisai manufacture Aricept (donepezil), an Alzheimer's drug.

In the consensus document, the Alzheimer's Disease Screening Discussion Group urged all adults aged 65 years and older to seek cognition screening during a physical exam. Screening should be conducted on those with a strong family history of the disease or those who are concerned about memory problems, as well as on anyone admitted to an assisted-living or long-term care facility, said the seven-member panel.

Two of the panelists are paid speakers for Pfizer: Paul Solomon, Ph.D., who is clinical director of the memory clinic at Williams College, Williamstown, Mass., and Dr. Barry W. Rovner, who serves as director of clinical Alzheimer's disease research at Jefferson Medical College, Philadelphia.

At a briefing on the consensus document, Dr. Solomon said there are a number of validated cognition screening tools that can be used by practitioners, including the Mini-Mental State Examination, verbal fluency test, and clock-drawing test. “A delay in diagnosis can undermine Alzheimer's patients and their families in [their] ability to plan financially, socially, emotionally, and medically for the future,” he said.

Dr. Rovner called for more training during medical school and residency on the importance of cognition screening, and for more education programs to target primary care physicians and the public.

Patients aren't talking with physicians about memory loss, according to an AFA survey of 1,902 people who participated in the organization's National Memory Screening Day in 2006. Of the survey respondents, 97% had never been given a memory test.

Of those surveyed, 80% said they had visited a primary care physician within the last 6 months, but fewer than 10% of those with self-identified memory problems had talked about them with their doctor.

The 2007 National Memory Screening Day was held in mid-November at 2,000 sites in 46 states, including 1,100 Kmart pharmacies. The AFA is supported by drug company grants and private donations. Memory Screening Day participants are given access to a special Web site that contains education materials and three cognition tests recommended by the AFA's Memory Screening Advisory Board.

The Chicago-based Alzheimer's Association does not see the wisdom of such health fair-type screening events, William Thies, Ph.D., vice president of medical and scientific relations, said in an interview. Patients may not get enough encouragement to talk with their physicians, and the tests used for screening are often not sensitive or specific enough, thus potentially leading to false-negative or false-positive results, he said.

“But we know it's a good thing for people to talk to their physicians about any memory concerns they have,” Dr. Thies said, adding that the Alzheimer's Association encourages physicians to conduct more “cognitive surveillance.”

Once a dialogue has started, physicians can determine whether the patient is just worried or if diagnostics are necessary, Dr. Thies said.

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WASHINGTON – Some Alzheimer's disease-related groups–but not all–are stepping up calls for earlier and more frequent cognition screening, citing an aging population increasingly at risk for dementia.

The disease affects 1 in 10 people older than age 65 years, and almost half of those older than age 85 years, according to the Alzheimer's Foundation of America. It is the seventh leading cause of death in the United States.

A cognition screen can establish a baseline, and be used to prompt referrals to clinicians who can pinpoint the cause of memory loss or loss of executive functioning, Eric J. Hall, CEO of the New York-based AFA, said in an interview.

Knowing of an Alzheimer's diagnosis early in the disease progression helps patients and families prepare, and early intervention can improve quality of life, he said.

The AFA has been seeking coverage of cognition screening as part of the “Welcome to Medicare” exam. The exam is offered during the first 6 months of Medicare Part B coverage; beneficiaries pay 20% of the cost, if they've met the deductible. If they have not met the deductible, they may be liable for the exam's entire cost.

To add cognition screening would require an act of Congress, according to a spokesperson at the Centers for Medicare and Medicaid Services.

The AFA's call for early screening and coverage was echoed by a group of experts convened by Pfizer Inc. and Eisai Inc., who issued a consensus statement in November. Pfizer and Eisai manufacture Aricept (donepezil), an Alzheimer's drug.

In the consensus document, the Alzheimer's Disease Screening Discussion Group urged all adults aged 65 years and older to seek cognition screening during a physical exam. Screening should be conducted on those with a strong family history of the disease or those who are concerned about memory problems, as well as on anyone admitted to an assisted-living or long-term care facility, said the seven-member panel.

Two of the panelists are paid speakers for Pfizer: Paul Solomon, Ph.D., who is clinical director of the memory clinic at Williams College, Williamstown, Mass., and Dr. Barry W. Rovner, who serves as director of clinical Alzheimer's disease research at Jefferson Medical College, Philadelphia.

At a briefing on the consensus document, Dr. Solomon said there are a number of validated cognition screening tools that can be used by practitioners, including the Mini-Mental State Examination, verbal fluency test, and clock-drawing test. “A delay in diagnosis can undermine Alzheimer's patients and their families in [their] ability to plan financially, socially, emotionally, and medically for the future,” he said.

Dr. Rovner called for more training during medical school and residency on the importance of cognition screening, and for more education programs to target primary care physicians and the public.

Patients aren't talking with physicians about memory loss, according to an AFA survey of 1,902 people who participated in the organization's National Memory Screening Day in 2006. Of the survey respondents, 97% had never been given a memory test.

Of those surveyed, 80% said they had visited a primary care physician within the last 6 months, but fewer than 10% of those with self-identified memory problems had talked about them with their doctor.

The 2007 National Memory Screening Day was held in mid-November at 2,000 sites in 46 states, including 1,100 Kmart pharmacies. The AFA is supported by drug company grants and private donations. Memory Screening Day participants are given access to a special Web site that contains education materials and three cognition tests recommended by the AFA's Memory Screening Advisory Board.

The Chicago-based Alzheimer's Association does not see the wisdom of such health fair-type screening events, William Thies, Ph.D., vice president of medical and scientific relations, said in an interview. Patients may not get enough encouragement to talk with their physicians, and the tests used for screening are often not sensitive or specific enough, thus potentially leading to false-negative or false-positive results, he said.

“But we know it's a good thing for people to talk to their physicians about any memory concerns they have,” Dr. Thies said, adding that the Alzheimer's Association encourages physicians to conduct more “cognitive surveillance.”

Once a dialogue has started, physicians can determine whether the patient is just worried or if diagnostics are necessary, Dr. Thies said.

WASHINGTON – Some Alzheimer's disease-related groups–but not all–are stepping up calls for earlier and more frequent cognition screening, citing an aging population increasingly at risk for dementia.

The disease affects 1 in 10 people older than age 65 years, and almost half of those older than age 85 years, according to the Alzheimer's Foundation of America. It is the seventh leading cause of death in the United States.

A cognition screen can establish a baseline, and be used to prompt referrals to clinicians who can pinpoint the cause of memory loss or loss of executive functioning, Eric J. Hall, CEO of the New York-based AFA, said in an interview.

Knowing of an Alzheimer's diagnosis early in the disease progression helps patients and families prepare, and early intervention can improve quality of life, he said.

The AFA has been seeking coverage of cognition screening as part of the “Welcome to Medicare” exam. The exam is offered during the first 6 months of Medicare Part B coverage; beneficiaries pay 20% of the cost, if they've met the deductible. If they have not met the deductible, they may be liable for the exam's entire cost.

To add cognition screening would require an act of Congress, according to a spokesperson at the Centers for Medicare and Medicaid Services.

The AFA's call for early screening and coverage was echoed by a group of experts convened by Pfizer Inc. and Eisai Inc., who issued a consensus statement in November. Pfizer and Eisai manufacture Aricept (donepezil), an Alzheimer's drug.

In the consensus document, the Alzheimer's Disease Screening Discussion Group urged all adults aged 65 years and older to seek cognition screening during a physical exam. Screening should be conducted on those with a strong family history of the disease or those who are concerned about memory problems, as well as on anyone admitted to an assisted-living or long-term care facility, said the seven-member panel.

Two of the panelists are paid speakers for Pfizer: Paul Solomon, Ph.D., who is clinical director of the memory clinic at Williams College, Williamstown, Mass., and Dr. Barry W. Rovner, who serves as director of clinical Alzheimer's disease research at Jefferson Medical College, Philadelphia.

At a briefing on the consensus document, Dr. Solomon said there are a number of validated cognition screening tools that can be used by practitioners, including the Mini-Mental State Examination, verbal fluency test, and clock-drawing test. “A delay in diagnosis can undermine Alzheimer's patients and their families in [their] ability to plan financially, socially, emotionally, and medically for the future,” he said.

Dr. Rovner called for more training during medical school and residency on the importance of cognition screening, and for more education programs to target primary care physicians and the public.

Patients aren't talking with physicians about memory loss, according to an AFA survey of 1,902 people who participated in the organization's National Memory Screening Day in 2006. Of the survey respondents, 97% had never been given a memory test.

Of those surveyed, 80% said they had visited a primary care physician within the last 6 months, but fewer than 10% of those with self-identified memory problems had talked about them with their doctor.

The 2007 National Memory Screening Day was held in mid-November at 2,000 sites in 46 states, including 1,100 Kmart pharmacies. The AFA is supported by drug company grants and private donations. Memory Screening Day participants are given access to a special Web site that contains education materials and three cognition tests recommended by the AFA's Memory Screening Advisory Board.

The Chicago-based Alzheimer's Association does not see the wisdom of such health fair-type screening events, William Thies, Ph.D., vice president of medical and scientific relations, said in an interview. Patients may not get enough encouragement to talk with their physicians, and the tests used for screening are often not sensitive or specific enough, thus potentially leading to false-negative or false-positive results, he said.

“But we know it's a good thing for people to talk to their physicians about any memory concerns they have,” Dr. Thies said, adding that the Alzheimer's Association encourages physicians to conduct more “cognitive surveillance.”

Once a dialogue has started, physicians can determine whether the patient is just worried or if diagnostics are necessary, Dr. Thies said.

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MedPAC Recommends 1.1% Fee Increase for 2009

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MedPAC Recommends 1.1% Fee Increase for 2009

WASHINGTON — The Medicare Payment Advisory Commission has voted to recommend that Congress increase the fees that physicians receive from Medicare by 1.1% in 2009.

The recommendation will be included in MedPAC's final report to Congress next month but was discussed and voted on at a panel meeting in January.

The panel believes that physician fees should not be cut, said MedPAC Chairman Glenn M. Hackbarth. “That's a very important message for us to convey to Congress.”

Before the vote, Mr. Hackbarth said the commission struggled each year to come up with the right numbers.

“We try to zero in on the most appropriate update,” he said, adding that information on cost reports, physicians' access to capital, and beneficiaries' access to physician services all go into that calculation.

MedPAC staff member John Richardson told commissioners that it appears that most physicians continue to accept new Medicare patients, but there has been an increase in beneficiaries who said they had trouble finding a new primary care physician, according to a MedPAC survey.

In 2006, 24% said they had trouble; by 2007, 30% of beneficiaries reported difficulty.

Medicare fees also are staying fairly steady as a percentage of private insurance fees, said Mr. Richardson. In 2005, Medicare paid 83% of what private insurers did, and in 2006, that had slipped slightly to 81%.

In December, Congress passed and the President signed a last-minute fix to the 2008 fee schedule, granting a 6-month, 0.5% increase for 2008. The fee increase, which included incentives for rural physicians, will cost about $3.1 billion, Mr. Richardson said.

Under current law, Medicare will cut physician fees by 5.5% in 2009. But when fees are renegotiated in July, the 2009 update could change.

MedPAC recommended that fees be increased in 2009 by the projected change in input prices (2.6%) minus the expected growth in productivity (1.5%), for a 1.1% increase. The cost: about $2 billion.

The commission projected that spending would increase by another $8 billion out to 2011.

The commission also urged Congress to set up a system to measure and report physician resource use.

The reporting should be confidential for 2 years.

After that, the Centers for Medicare and Medicaid Services should establish a new payment system that takes into account both resource use and quality measures.

Dr. Ronald D. Castellanos, a physician in a group practice in Port Charlotte, Fla. and a MedPAC commissioner, said a recommendation for an increase was better than a cut, but that the 1.1% “doesn't keep up with our costs.”

Dr. Castellanos said that physicians would not look happily on the recommended update.

“Quite honestly, it's insulting,” he said. “The update is a blunt tool for trying to constrain costs,” said Dr. Castellanos, who voted against the update.

Dr. Nicholas Wolter, a commissioner who practices at a clinic in Billings, Mont., also said that he was not comfortable with the recommendation.

“Unless we start focusing on other tactics, we're not going to get a handle on costs,” Dr. Wolter commented.

Mr. Hackbarth noted that the panel's recommendation should not be taken to mean that the commission believes that everything is fine with the reimbursement system.

But, he added, the problems with Medicare threatened beneficiaries, taxpayers, and even his children's future.

Solutions should not be focused only on physicians, said Mr. Hackbarth, adding, “it's way bigger than that.”

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WASHINGTON — The Medicare Payment Advisory Commission has voted to recommend that Congress increase the fees that physicians receive from Medicare by 1.1% in 2009.

The recommendation will be included in MedPAC's final report to Congress next month but was discussed and voted on at a panel meeting in January.

The panel believes that physician fees should not be cut, said MedPAC Chairman Glenn M. Hackbarth. “That's a very important message for us to convey to Congress.”

Before the vote, Mr. Hackbarth said the commission struggled each year to come up with the right numbers.

“We try to zero in on the most appropriate update,” he said, adding that information on cost reports, physicians' access to capital, and beneficiaries' access to physician services all go into that calculation.

MedPAC staff member John Richardson told commissioners that it appears that most physicians continue to accept new Medicare patients, but there has been an increase in beneficiaries who said they had trouble finding a new primary care physician, according to a MedPAC survey.

In 2006, 24% said they had trouble; by 2007, 30% of beneficiaries reported difficulty.

Medicare fees also are staying fairly steady as a percentage of private insurance fees, said Mr. Richardson. In 2005, Medicare paid 83% of what private insurers did, and in 2006, that had slipped slightly to 81%.

In December, Congress passed and the President signed a last-minute fix to the 2008 fee schedule, granting a 6-month, 0.5% increase for 2008. The fee increase, which included incentives for rural physicians, will cost about $3.1 billion, Mr. Richardson said.

Under current law, Medicare will cut physician fees by 5.5% in 2009. But when fees are renegotiated in July, the 2009 update could change.

MedPAC recommended that fees be increased in 2009 by the projected change in input prices (2.6%) minus the expected growth in productivity (1.5%), for a 1.1% increase. The cost: about $2 billion.

The commission projected that spending would increase by another $8 billion out to 2011.

The commission also urged Congress to set up a system to measure and report physician resource use.

The reporting should be confidential for 2 years.

After that, the Centers for Medicare and Medicaid Services should establish a new payment system that takes into account both resource use and quality measures.

Dr. Ronald D. Castellanos, a physician in a group practice in Port Charlotte, Fla. and a MedPAC commissioner, said a recommendation for an increase was better than a cut, but that the 1.1% “doesn't keep up with our costs.”

Dr. Castellanos said that physicians would not look happily on the recommended update.

“Quite honestly, it's insulting,” he said. “The update is a blunt tool for trying to constrain costs,” said Dr. Castellanos, who voted against the update.

Dr. Nicholas Wolter, a commissioner who practices at a clinic in Billings, Mont., also said that he was not comfortable with the recommendation.

“Unless we start focusing on other tactics, we're not going to get a handle on costs,” Dr. Wolter commented.

Mr. Hackbarth noted that the panel's recommendation should not be taken to mean that the commission believes that everything is fine with the reimbursement system.

But, he added, the problems with Medicare threatened beneficiaries, taxpayers, and even his children's future.

Solutions should not be focused only on physicians, said Mr. Hackbarth, adding, “it's way bigger than that.”

WASHINGTON — The Medicare Payment Advisory Commission has voted to recommend that Congress increase the fees that physicians receive from Medicare by 1.1% in 2009.

The recommendation will be included in MedPAC's final report to Congress next month but was discussed and voted on at a panel meeting in January.

The panel believes that physician fees should not be cut, said MedPAC Chairman Glenn M. Hackbarth. “That's a very important message for us to convey to Congress.”

Before the vote, Mr. Hackbarth said the commission struggled each year to come up with the right numbers.

“We try to zero in on the most appropriate update,” he said, adding that information on cost reports, physicians' access to capital, and beneficiaries' access to physician services all go into that calculation.

MedPAC staff member John Richardson told commissioners that it appears that most physicians continue to accept new Medicare patients, but there has been an increase in beneficiaries who said they had trouble finding a new primary care physician, according to a MedPAC survey.

In 2006, 24% said they had trouble; by 2007, 30% of beneficiaries reported difficulty.

Medicare fees also are staying fairly steady as a percentage of private insurance fees, said Mr. Richardson. In 2005, Medicare paid 83% of what private insurers did, and in 2006, that had slipped slightly to 81%.

In December, Congress passed and the President signed a last-minute fix to the 2008 fee schedule, granting a 6-month, 0.5% increase for 2008. The fee increase, which included incentives for rural physicians, will cost about $3.1 billion, Mr. Richardson said.

Under current law, Medicare will cut physician fees by 5.5% in 2009. But when fees are renegotiated in July, the 2009 update could change.

MedPAC recommended that fees be increased in 2009 by the projected change in input prices (2.6%) minus the expected growth in productivity (1.5%), for a 1.1% increase. The cost: about $2 billion.

The commission projected that spending would increase by another $8 billion out to 2011.

The commission also urged Congress to set up a system to measure and report physician resource use.

The reporting should be confidential for 2 years.

After that, the Centers for Medicare and Medicaid Services should establish a new payment system that takes into account both resource use and quality measures.

Dr. Ronald D. Castellanos, a physician in a group practice in Port Charlotte, Fla. and a MedPAC commissioner, said a recommendation for an increase was better than a cut, but that the 1.1% “doesn't keep up with our costs.”

Dr. Castellanos said that physicians would not look happily on the recommended update.

“Quite honestly, it's insulting,” he said. “The update is a blunt tool for trying to constrain costs,” said Dr. Castellanos, who voted against the update.

Dr. Nicholas Wolter, a commissioner who practices at a clinic in Billings, Mont., also said that he was not comfortable with the recommendation.

“Unless we start focusing on other tactics, we're not going to get a handle on costs,” Dr. Wolter commented.

Mr. Hackbarth noted that the panel's recommendation should not be taken to mean that the commission believes that everything is fine with the reimbursement system.

But, he added, the problems with Medicare threatened beneficiaries, taxpayers, and even his children's future.

Solutions should not be focused only on physicians, said Mr. Hackbarth, adding, “it's way bigger than that.”

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Drug Utilization Boosts Nation's Health Tab

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Drug Utilization Boosts Nation's Health Tab

WASHINGTON — The nation spent $2 trillion, or $7,000 per person, on health care in 2006. While that was only a small increase from the previous year, America's prescription drug tab increased by 8.5%, fueled largely by the new Medicare Part D drug benefit.

Health spending as a share of the nation's gross domestic product continues to rise, hitting 16% in 2006.

Total spending on physician and clinical services grew 5.9% to $448 billion, the slowest rate of growth since 1999. Physician pay crawled almost to a halt, largely because of the freeze in Medicare's reimbursement rates in 2006. Private insurers seemed to have followed suit, said Cathy Cowan, an economist at the Centers for Medicare and Medicaid Services. Cowan, a coauthor of an annual analysis of the nation's health spending, spoke at a briefing on the report, which was published in the January/February issue of Health Affairs.

Medicare had the fastest rate of growth since 1981, according to the report. Spending increased 19% in 2006 to $401 billion, driven largely by the prescription drug benefit and the cost of administration for that benefit and for Medicare Advantage, a managed care program.

Medicaid spending dropped for the first time since the program began in 1965. The 0.9% decrease was largely due to Medicaid enrollees who were shifted into Medicare for their prescription drugs.

Overall drug spending grew 8.5% in 2006—a far cry from the double-digit increases seen in the late 1990s, but still an increase from the 5.8% rise in spending in 2005. Half of the 2006 increase was due to greater utilization, not surprising given that about 23 million Medicare beneficiaries took advantage of the new benefit. Prescription prices increased by only a little over 3%, according to an annual analysis by actuaries at the Centers for Medicare and Medicaid Services.

The change in the drug rebate picture also contributed to rising drug costs. Under Medicaid, states received an average 30% rebate from drugmakers. Medicare, however, got only about 5% from manufacturers for the millions of beneficiaries who shifted out of Medicaid.

Medicare spent $41 billion on Part D in 2006, with $35 billion for drug purchases and $6 billion for administration and "net cost of insurance"—that is, the cost of subsidizing premiums for low-income beneficiaries and costs for transferring beneficiaries into private plans. Medicare paid for 18% of all retail drugs, compared with only 2% in 2005.

The largest increase in drug utilization came from beneficiaries using the Part D benefit. But there was also increased drug use due to new indications for existing drugs, growth in several therapeutic classes, and rising use of specialty drugs such as injectable biologics for rheumatoid arthritis and multiple sclerosis, and anemia drugs for oncology. Hypnotics saw the largest rise in use of any drug class.

The authors said the data they had at hand and their analysis did not allow them to determine whether the prescription drug benefit had increased or lowered overall health care spending. "Sooner or later, somebody's going to do a dynamite study and figure this out," said Richard Foster, the chief actuary at CMS.

Mr. Foster told reporters that the study showed that the "overall cost of prescription drugs has changed very little as a result of Part D."

A study by Consumers Union, however, seemed to refute that claim. (See box.)

Drug Prices Up Too: Consumers Union

Government economists have concluded that the Medicare Part D prescription drug benefit did not affect the price of pharmaceuticals in 2006, the program's first full year, but Consumers Union has issued another in a series of studies charging that drug prices are indeed rising.

Each month since December 2005, the consumer advocacy group has tracked the prices of five drugs commonly used by Medicare beneficiaries in a single ZIP code in each of five states—California, New York, Illinois, Florida, and Texas. The data are taken directly from Medicare.gov. According to Consumers Union, the data show that the majority of private insurers have consistently raised prices, sometimes at 2–3 times the rate of inflation.

Medicare beneficiaries might be bearing the brunt of price increases, especially because they usually are liable for a percentage of the drug's price as a copayment. "We're seeing a lot of inflation," said Consumers Union Senior Policy Analyst Bill Vaughan in an interview.

The group also found that prices generally rise the most from December to January—after a beneficiary has locked into a plan for the upcoming year. The average increase for the five drugs as a package (Lipitor, Celebrex, Zoloft, nifedipine ER, and Altace) was $369 from December 2007 to January 2008, according to Consumers Union.

 

 

"Most of these Medicare drug plans are increasing costs [at] double or triple the rate of inflation, which really torpedoes the insurance industry's claim that they are getting the best deal for seniors," said Mr. Vaughan. "These continual price hikes are Exhibit A for Congress to give renewed attention to negotiating drug prices on behalf of America's taxpayers and seniors."

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WASHINGTON — The nation spent $2 trillion, or $7,000 per person, on health care in 2006. While that was only a small increase from the previous year, America's prescription drug tab increased by 8.5%, fueled largely by the new Medicare Part D drug benefit.

Health spending as a share of the nation's gross domestic product continues to rise, hitting 16% in 2006.

Total spending on physician and clinical services grew 5.9% to $448 billion, the slowest rate of growth since 1999. Physician pay crawled almost to a halt, largely because of the freeze in Medicare's reimbursement rates in 2006. Private insurers seemed to have followed suit, said Cathy Cowan, an economist at the Centers for Medicare and Medicaid Services. Cowan, a coauthor of an annual analysis of the nation's health spending, spoke at a briefing on the report, which was published in the January/February issue of Health Affairs.

Medicare had the fastest rate of growth since 1981, according to the report. Spending increased 19% in 2006 to $401 billion, driven largely by the prescription drug benefit and the cost of administration for that benefit and for Medicare Advantage, a managed care program.

Medicaid spending dropped for the first time since the program began in 1965. The 0.9% decrease was largely due to Medicaid enrollees who were shifted into Medicare for their prescription drugs.

Overall drug spending grew 8.5% in 2006—a far cry from the double-digit increases seen in the late 1990s, but still an increase from the 5.8% rise in spending in 2005. Half of the 2006 increase was due to greater utilization, not surprising given that about 23 million Medicare beneficiaries took advantage of the new benefit. Prescription prices increased by only a little over 3%, according to an annual analysis by actuaries at the Centers for Medicare and Medicaid Services.

The change in the drug rebate picture also contributed to rising drug costs. Under Medicaid, states received an average 30% rebate from drugmakers. Medicare, however, got only about 5% from manufacturers for the millions of beneficiaries who shifted out of Medicaid.

Medicare spent $41 billion on Part D in 2006, with $35 billion for drug purchases and $6 billion for administration and "net cost of insurance"—that is, the cost of subsidizing premiums for low-income beneficiaries and costs for transferring beneficiaries into private plans. Medicare paid for 18% of all retail drugs, compared with only 2% in 2005.

The largest increase in drug utilization came from beneficiaries using the Part D benefit. But there was also increased drug use due to new indications for existing drugs, growth in several therapeutic classes, and rising use of specialty drugs such as injectable biologics for rheumatoid arthritis and multiple sclerosis, and anemia drugs for oncology. Hypnotics saw the largest rise in use of any drug class.

The authors said the data they had at hand and their analysis did not allow them to determine whether the prescription drug benefit had increased or lowered overall health care spending. "Sooner or later, somebody's going to do a dynamite study and figure this out," said Richard Foster, the chief actuary at CMS.

Mr. Foster told reporters that the study showed that the "overall cost of prescription drugs has changed very little as a result of Part D."

A study by Consumers Union, however, seemed to refute that claim. (See box.)

Drug Prices Up Too: Consumers Union

Government economists have concluded that the Medicare Part D prescription drug benefit did not affect the price of pharmaceuticals in 2006, the program's first full year, but Consumers Union has issued another in a series of studies charging that drug prices are indeed rising.

Each month since December 2005, the consumer advocacy group has tracked the prices of five drugs commonly used by Medicare beneficiaries in a single ZIP code in each of five states—California, New York, Illinois, Florida, and Texas. The data are taken directly from Medicare.gov. According to Consumers Union, the data show that the majority of private insurers have consistently raised prices, sometimes at 2–3 times the rate of inflation.

Medicare beneficiaries might be bearing the brunt of price increases, especially because they usually are liable for a percentage of the drug's price as a copayment. "We're seeing a lot of inflation," said Consumers Union Senior Policy Analyst Bill Vaughan in an interview.

The group also found that prices generally rise the most from December to January—after a beneficiary has locked into a plan for the upcoming year. The average increase for the five drugs as a package (Lipitor, Celebrex, Zoloft, nifedipine ER, and Altace) was $369 from December 2007 to January 2008, according to Consumers Union.

 

 

"Most of these Medicare drug plans are increasing costs [at] double or triple the rate of inflation, which really torpedoes the insurance industry's claim that they are getting the best deal for seniors," said Mr. Vaughan. "These continual price hikes are Exhibit A for Congress to give renewed attention to negotiating drug prices on behalf of America's taxpayers and seniors."

WASHINGTON — The nation spent $2 trillion, or $7,000 per person, on health care in 2006. While that was only a small increase from the previous year, America's prescription drug tab increased by 8.5%, fueled largely by the new Medicare Part D drug benefit.

Health spending as a share of the nation's gross domestic product continues to rise, hitting 16% in 2006.

Total spending on physician and clinical services grew 5.9% to $448 billion, the slowest rate of growth since 1999. Physician pay crawled almost to a halt, largely because of the freeze in Medicare's reimbursement rates in 2006. Private insurers seemed to have followed suit, said Cathy Cowan, an economist at the Centers for Medicare and Medicaid Services. Cowan, a coauthor of an annual analysis of the nation's health spending, spoke at a briefing on the report, which was published in the January/February issue of Health Affairs.

Medicare had the fastest rate of growth since 1981, according to the report. Spending increased 19% in 2006 to $401 billion, driven largely by the prescription drug benefit and the cost of administration for that benefit and for Medicare Advantage, a managed care program.

Medicaid spending dropped for the first time since the program began in 1965. The 0.9% decrease was largely due to Medicaid enrollees who were shifted into Medicare for their prescription drugs.

Overall drug spending grew 8.5% in 2006—a far cry from the double-digit increases seen in the late 1990s, but still an increase from the 5.8% rise in spending in 2005. Half of the 2006 increase was due to greater utilization, not surprising given that about 23 million Medicare beneficiaries took advantage of the new benefit. Prescription prices increased by only a little over 3%, according to an annual analysis by actuaries at the Centers for Medicare and Medicaid Services.

The change in the drug rebate picture also contributed to rising drug costs. Under Medicaid, states received an average 30% rebate from drugmakers. Medicare, however, got only about 5% from manufacturers for the millions of beneficiaries who shifted out of Medicaid.

Medicare spent $41 billion on Part D in 2006, with $35 billion for drug purchases and $6 billion for administration and "net cost of insurance"—that is, the cost of subsidizing premiums for low-income beneficiaries and costs for transferring beneficiaries into private plans. Medicare paid for 18% of all retail drugs, compared with only 2% in 2005.

The largest increase in drug utilization came from beneficiaries using the Part D benefit. But there was also increased drug use due to new indications for existing drugs, growth in several therapeutic classes, and rising use of specialty drugs such as injectable biologics for rheumatoid arthritis and multiple sclerosis, and anemia drugs for oncology. Hypnotics saw the largest rise in use of any drug class.

The authors said the data they had at hand and their analysis did not allow them to determine whether the prescription drug benefit had increased or lowered overall health care spending. "Sooner or later, somebody's going to do a dynamite study and figure this out," said Richard Foster, the chief actuary at CMS.

Mr. Foster told reporters that the study showed that the "overall cost of prescription drugs has changed very little as a result of Part D."

A study by Consumers Union, however, seemed to refute that claim. (See box.)

Drug Prices Up Too: Consumers Union

Government economists have concluded that the Medicare Part D prescription drug benefit did not affect the price of pharmaceuticals in 2006, the program's first full year, but Consumers Union has issued another in a series of studies charging that drug prices are indeed rising.

Each month since December 2005, the consumer advocacy group has tracked the prices of five drugs commonly used by Medicare beneficiaries in a single ZIP code in each of five states—California, New York, Illinois, Florida, and Texas. The data are taken directly from Medicare.gov. According to Consumers Union, the data show that the majority of private insurers have consistently raised prices, sometimes at 2–3 times the rate of inflation.

Medicare beneficiaries might be bearing the brunt of price increases, especially because they usually are liable for a percentage of the drug's price as a copayment. "We're seeing a lot of inflation," said Consumers Union Senior Policy Analyst Bill Vaughan in an interview.

The group also found that prices generally rise the most from December to January—after a beneficiary has locked into a plan for the upcoming year. The average increase for the five drugs as a package (Lipitor, Celebrex, Zoloft, nifedipine ER, and Altace) was $369 from December 2007 to January 2008, according to Consumers Union.

 

 

"Most of these Medicare drug plans are increasing costs [at] double or triple the rate of inflation, which really torpedoes the insurance industry's claim that they are getting the best deal for seniors," said Mr. Vaughan. "These continual price hikes are Exhibit A for Congress to give renewed attention to negotiating drug prices on behalf of America's taxpayers and seniors."

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Spa Regulations Coming to Mass.

The Massachusetts Board of Registration in Medicine will issue a report next month outlining potential regulatory and statutory changes, and new policies and guidelines for medical spas, according to a board spokesman. The report will be the culmination of a year's worth of work by a medical spa task force. In 2006, the state legislature directed the board to look into how medical spas are monitored and regulated. Massachusetts may be the first state to have taken a comprehensive look at spas. Other state medical boards are eagerly awaiting the task force report, according to the board spokesman. When it is completed, the report will be posted at

www.massmedboard.org/public/med_spa.shtm

Mesotherapy Chain Closes

Fig., a St. Louis-based chain of spas offering mesotherapy, closed 17 of its 18 facilities in mid-December. Only an independently owned and operated center in Costa Mesa, Calif., remains open. According to the chain, formerly known as Advanced LipoDissolve, they had received an eight-figure influx of capital in September from the Larchmont, N.Y., office of Bessemer Venture Partners. At press time, postings on Fig.'s Web site reported that executives planned to file for bankruptcy and eventually reorganize.

FDA Investigating Tattoo Ink

The Food and Drug Administration is investigating the safety of inks and dyes used in tattooing and permanent makeup. In an article written for consumers and posted on FDA's Web site in December, agency officials said that continuing reports of reactions to ink prompted the launch of a study. The agency's National Center for Toxicological Research now is looking into the chemical composition of inks and how they are metabolized, short- and long-term safety of pigments used in tattoo inks, and how inks might change when the body is exposed to light. Some research has already shown that some pigment migrates to the lymph nodes, according to the FDA. The article can be found at

www.fda.gov/consumer/features/tattoos120607.html

Warning on Bioidentical Hormones

The FDA is warning seven pharmacy operations that their claims regarding bioidentical hormone therapy (HT) products are not supported by medical evidence and are considered false and misleading. The pharmacy operations compound hormone therapy drugs that contain estriol as well as progesterone and estrogen. Compounded drugs are not reviewed by the FDA for safety and effectiveness; in addition, no drug product containing estriol has been approved by the FDA. The agency said the pharmacy operations improperly claim that these drugs are superior to FDA-approved HT drugs and prevent or treat diseases, including Alzheimer's disease, stroke, and cancer. More information is available at

www.fda.gov/cder/pharmcomp/default.htm

Minn. Mercury Ban Goes Into Effect

A Minnesota ban on the use of mercury in over-the-counter pharmaceuticals, cosmetics, toiletries, fragrances, and a host of other household and medical products, including thermometers and barometers, went into effect on Jan. 1. The law, signed last May by Gov. Tim Pawlenty, a Republican, is aimed at reducing mercury exposure. Mercury is often added to cosmetics as a preservative. Retailers who knowingly sell cosmetics that contain mercury are liable for fines of up to $700, and manufacturers could be penalized as much as $10,000 for failing to disclose mercury on any product label.

Tanner Subtypes Identified

Physicians can more effectively target messages about the risks of indoor tanning if they first determine a tanner's behavior pattern, researchers from East Tennessee State University and Pennsylvania State University have found. They identified four tanning subtypes: special event, spontaneous or mood, mixed, and regular year-round tanning. They drew their conclusions from a sample of 168 women randomly selected from a larger study of indoor tanning behavior among female students at East Tennessee State. Participants were asked to assess their tanning frequency during the previous 3, 6, and 12 months, and to project their intentions over the next year. The researchers found statistically significant differences among participants in attitudes, social norms, partner preference, and belief that tanning relieves stress, and on four tanning dependence scales. Event tanners (53% of the sample) tanned the least, and scored lowest on attitudes, social norms, and tanning dependence measures; year-round tanners (12%) scored highest and started earliest. The study was funded by grants from the American Cancer Society and the National Cancer Institute. It was published in the December issue of the Archives of Dermatology.

Scant Number of New Approvals

The FDA approved only 17 new chemical entities (NCEs) in 2007, the lowest number since 2002. This comes on the heels of 2 previous years with only 18 NCE approvals each. NCEs are unique products. Those approved in 2007 included two HIV therapies; four oncology products; two antihypertensives; one antibiotic; and one NME each to treat Parkinson's disease, pulmonary hypertension, impetigo, acromegaly, attention-deficit hyperactivity disorder, and phenylketonuria. An imaging agent and injection to prevent blood volume loss during surgery also were approved, as were a handful of biologics, an influenza vaccine, and an avian flu vaccine.

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Spa Regulations Coming to Mass.

The Massachusetts Board of Registration in Medicine will issue a report next month outlining potential regulatory and statutory changes, and new policies and guidelines for medical spas, according to a board spokesman. The report will be the culmination of a year's worth of work by a medical spa task force. In 2006, the state legislature directed the board to look into how medical spas are monitored and regulated. Massachusetts may be the first state to have taken a comprehensive look at spas. Other state medical boards are eagerly awaiting the task force report, according to the board spokesman. When it is completed, the report will be posted at

www.massmedboard.org/public/med_spa.shtm

Mesotherapy Chain Closes

Fig., a St. Louis-based chain of spas offering mesotherapy, closed 17 of its 18 facilities in mid-December. Only an independently owned and operated center in Costa Mesa, Calif., remains open. According to the chain, formerly known as Advanced LipoDissolve, they had received an eight-figure influx of capital in September from the Larchmont, N.Y., office of Bessemer Venture Partners. At press time, postings on Fig.'s Web site reported that executives planned to file for bankruptcy and eventually reorganize.

FDA Investigating Tattoo Ink

The Food and Drug Administration is investigating the safety of inks and dyes used in tattooing and permanent makeup. In an article written for consumers and posted on FDA's Web site in December, agency officials said that continuing reports of reactions to ink prompted the launch of a study. The agency's National Center for Toxicological Research now is looking into the chemical composition of inks and how they are metabolized, short- and long-term safety of pigments used in tattoo inks, and how inks might change when the body is exposed to light. Some research has already shown that some pigment migrates to the lymph nodes, according to the FDA. The article can be found at

www.fda.gov/consumer/features/tattoos120607.html

Warning on Bioidentical Hormones

The FDA is warning seven pharmacy operations that their claims regarding bioidentical hormone therapy (HT) products are not supported by medical evidence and are considered false and misleading. The pharmacy operations compound hormone therapy drugs that contain estriol as well as progesterone and estrogen. Compounded drugs are not reviewed by the FDA for safety and effectiveness; in addition, no drug product containing estriol has been approved by the FDA. The agency said the pharmacy operations improperly claim that these drugs are superior to FDA-approved HT drugs and prevent or treat diseases, including Alzheimer's disease, stroke, and cancer. More information is available at

www.fda.gov/cder/pharmcomp/default.htm

Minn. Mercury Ban Goes Into Effect

A Minnesota ban on the use of mercury in over-the-counter pharmaceuticals, cosmetics, toiletries, fragrances, and a host of other household and medical products, including thermometers and barometers, went into effect on Jan. 1. The law, signed last May by Gov. Tim Pawlenty, a Republican, is aimed at reducing mercury exposure. Mercury is often added to cosmetics as a preservative. Retailers who knowingly sell cosmetics that contain mercury are liable for fines of up to $700, and manufacturers could be penalized as much as $10,000 for failing to disclose mercury on any product label.

Tanner Subtypes Identified

Physicians can more effectively target messages about the risks of indoor tanning if they first determine a tanner's behavior pattern, researchers from East Tennessee State University and Pennsylvania State University have found. They identified four tanning subtypes: special event, spontaneous or mood, mixed, and regular year-round tanning. They drew their conclusions from a sample of 168 women randomly selected from a larger study of indoor tanning behavior among female students at East Tennessee State. Participants were asked to assess their tanning frequency during the previous 3, 6, and 12 months, and to project their intentions over the next year. The researchers found statistically significant differences among participants in attitudes, social norms, partner preference, and belief that tanning relieves stress, and on four tanning dependence scales. Event tanners (53% of the sample) tanned the least, and scored lowest on attitudes, social norms, and tanning dependence measures; year-round tanners (12%) scored highest and started earliest. The study was funded by grants from the American Cancer Society and the National Cancer Institute. It was published in the December issue of the Archives of Dermatology.

Scant Number of New Approvals

The FDA approved only 17 new chemical entities (NCEs) in 2007, the lowest number since 2002. This comes on the heels of 2 previous years with only 18 NCE approvals each. NCEs are unique products. Those approved in 2007 included two HIV therapies; four oncology products; two antihypertensives; one antibiotic; and one NME each to treat Parkinson's disease, pulmonary hypertension, impetigo, acromegaly, attention-deficit hyperactivity disorder, and phenylketonuria. An imaging agent and injection to prevent blood volume loss during surgery also were approved, as were a handful of biologics, an influenza vaccine, and an avian flu vaccine.

Spa Regulations Coming to Mass.

The Massachusetts Board of Registration in Medicine will issue a report next month outlining potential regulatory and statutory changes, and new policies and guidelines for medical spas, according to a board spokesman. The report will be the culmination of a year's worth of work by a medical spa task force. In 2006, the state legislature directed the board to look into how medical spas are monitored and regulated. Massachusetts may be the first state to have taken a comprehensive look at spas. Other state medical boards are eagerly awaiting the task force report, according to the board spokesman. When it is completed, the report will be posted at

www.massmedboard.org/public/med_spa.shtm

Mesotherapy Chain Closes

Fig., a St. Louis-based chain of spas offering mesotherapy, closed 17 of its 18 facilities in mid-December. Only an independently owned and operated center in Costa Mesa, Calif., remains open. According to the chain, formerly known as Advanced LipoDissolve, they had received an eight-figure influx of capital in September from the Larchmont, N.Y., office of Bessemer Venture Partners. At press time, postings on Fig.'s Web site reported that executives planned to file for bankruptcy and eventually reorganize.

FDA Investigating Tattoo Ink

The Food and Drug Administration is investigating the safety of inks and dyes used in tattooing and permanent makeup. In an article written for consumers and posted on FDA's Web site in December, agency officials said that continuing reports of reactions to ink prompted the launch of a study. The agency's National Center for Toxicological Research now is looking into the chemical composition of inks and how they are metabolized, short- and long-term safety of pigments used in tattoo inks, and how inks might change when the body is exposed to light. Some research has already shown that some pigment migrates to the lymph nodes, according to the FDA. The article can be found at

www.fda.gov/consumer/features/tattoos120607.html

Warning on Bioidentical Hormones

The FDA is warning seven pharmacy operations that their claims regarding bioidentical hormone therapy (HT) products are not supported by medical evidence and are considered false and misleading. The pharmacy operations compound hormone therapy drugs that contain estriol as well as progesterone and estrogen. Compounded drugs are not reviewed by the FDA for safety and effectiveness; in addition, no drug product containing estriol has been approved by the FDA. The agency said the pharmacy operations improperly claim that these drugs are superior to FDA-approved HT drugs and prevent or treat diseases, including Alzheimer's disease, stroke, and cancer. More information is available at

www.fda.gov/cder/pharmcomp/default.htm

Minn. Mercury Ban Goes Into Effect

A Minnesota ban on the use of mercury in over-the-counter pharmaceuticals, cosmetics, toiletries, fragrances, and a host of other household and medical products, including thermometers and barometers, went into effect on Jan. 1. The law, signed last May by Gov. Tim Pawlenty, a Republican, is aimed at reducing mercury exposure. Mercury is often added to cosmetics as a preservative. Retailers who knowingly sell cosmetics that contain mercury are liable for fines of up to $700, and manufacturers could be penalized as much as $10,000 for failing to disclose mercury on any product label.

Tanner Subtypes Identified

Physicians can more effectively target messages about the risks of indoor tanning if they first determine a tanner's behavior pattern, researchers from East Tennessee State University and Pennsylvania State University have found. They identified four tanning subtypes: special event, spontaneous or mood, mixed, and regular year-round tanning. They drew their conclusions from a sample of 168 women randomly selected from a larger study of indoor tanning behavior among female students at East Tennessee State. Participants were asked to assess their tanning frequency during the previous 3, 6, and 12 months, and to project their intentions over the next year. The researchers found statistically significant differences among participants in attitudes, social norms, partner preference, and belief that tanning relieves stress, and on four tanning dependence scales. Event tanners (53% of the sample) tanned the least, and scored lowest on attitudes, social norms, and tanning dependence measures; year-round tanners (12%) scored highest and started earliest. The study was funded by grants from the American Cancer Society and the National Cancer Institute. It was published in the December issue of the Archives of Dermatology.

Scant Number of New Approvals

The FDA approved only 17 new chemical entities (NCEs) in 2007, the lowest number since 2002. This comes on the heels of 2 previous years with only 18 NCE approvals each. NCEs are unique products. Those approved in 2007 included two HIV therapies; four oncology products; two antihypertensives; one antibiotic; and one NME each to treat Parkinson's disease, pulmonary hypertension, impetigo, acromegaly, attention-deficit hyperactivity disorder, and phenylketonuria. An imaging agent and injection to prevent blood volume loss during surgery also were approved, as were a handful of biologics, an influenza vaccine, and an avian flu vaccine.

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MedPAC Recommends 1.1% Fee Increase for Physicians in 2009

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WASHINGTON — The Medicare Payment Advisory Commission has voted to recommend that Congress increase Medicare physician fees by 1.1% in 2009.

The recommendation will be included in MedPAC's final report to Congress this month.

The panel believes that physician fees should not be cut, said MedPAC Chairman Glenn M. Hackbarth. "That's a very important message for us to convey to Congress."

Before the vote, Mr. Hackbarth said the commission struggled each year to come up with the right numbers. "We try to zero in on the most appropriate update," he said, adding that cost reports, physicians' access to capital, and beneficiaries' access to physician services all go into that calculation.

MedPAC staff member John Richardson told commissioners that it appears that most physicians continue to accept new Medicare patients, but there has been an increase in beneficiaries who said they had trouble finding a new primary care physician, according to a MedPAC survey. In 2006, 24% said they had trouble; by 2007, 30% of beneficiaries reported difficulty.

Medicare fees also are staying fairly steady as a percentage of private insurance fees, said Mr. Richardson. In 2005, Medicare paid 83% of what private insurers did, and in 2006, that had slipped slightly to 81%.

In December, Congress passed and the President signed a last-minute fix to the 2008 fee schedule, granting a 6-month, 0.5% increase for 2008. The fee increase, which included incentives for rural physicians, will cost about $3.1 billion, Mr. Richardson said.

Under current law, Medicare will cut physician fees by 5.5% in 2009. But when fees are renegotiated in July, the 2009 update could change.

MedPAC recommended that fees be increased in 2009 by the projected change in input prices (2.6%) minus the expected growth in productivity (1.5%), for a 1.1% increase. The cost: about $2 billion. The commission projected that spending would increase by another $8 billion out to 2011.

The commission also urged Congress to set up a system to measure and report physician resource use. The reporting should be confidential for 2 years. After that, the Centers for Medicare and Medicaid Services should establish a new payment system that takes into account both resource use and quality measures.

Dr. Ronald D. Castellanos, a physician in a group practice in Port Charlotte, Fla. and a MedPAC commissioner, said a recommendation for an increase was better than a cut, but that the 1.1% "doesn't keep up with our costs." Dr. Castellanos said that physicians would not look happily on the recommended update.

"Quite honestly, it's insulting," he said. "The update is a blunt tool for trying to constrain costs," said Dr. Castellanos.

Dr. Nicholas Wolter, a commissioner who practices at a clinic in Billings, Mont., also said that he was not comfortable with the recommendation. "Unless we start focusing on other tactics, we're not going to get a handle on costs," he said.

Mr. Hackbarth said the panel's recommendation should not be taken to mean that the commission believed that everything was fine with the reimbursement system. But, he added, the problems with Medicare threatened beneficiaries, taxpayers, and even his children's future. Solutions should not be focused only on physicians, said Mr. Hackbarth, adding, "it's way bigger than that."

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WASHINGTON — The Medicare Payment Advisory Commission has voted to recommend that Congress increase Medicare physician fees by 1.1% in 2009.

The recommendation will be included in MedPAC's final report to Congress this month.

The panel believes that physician fees should not be cut, said MedPAC Chairman Glenn M. Hackbarth. "That's a very important message for us to convey to Congress."

Before the vote, Mr. Hackbarth said the commission struggled each year to come up with the right numbers. "We try to zero in on the most appropriate update," he said, adding that cost reports, physicians' access to capital, and beneficiaries' access to physician services all go into that calculation.

MedPAC staff member John Richardson told commissioners that it appears that most physicians continue to accept new Medicare patients, but there has been an increase in beneficiaries who said they had trouble finding a new primary care physician, according to a MedPAC survey. In 2006, 24% said they had trouble; by 2007, 30% of beneficiaries reported difficulty.

Medicare fees also are staying fairly steady as a percentage of private insurance fees, said Mr. Richardson. In 2005, Medicare paid 83% of what private insurers did, and in 2006, that had slipped slightly to 81%.

In December, Congress passed and the President signed a last-minute fix to the 2008 fee schedule, granting a 6-month, 0.5% increase for 2008. The fee increase, which included incentives for rural physicians, will cost about $3.1 billion, Mr. Richardson said.

Under current law, Medicare will cut physician fees by 5.5% in 2009. But when fees are renegotiated in July, the 2009 update could change.

MedPAC recommended that fees be increased in 2009 by the projected change in input prices (2.6%) minus the expected growth in productivity (1.5%), for a 1.1% increase. The cost: about $2 billion. The commission projected that spending would increase by another $8 billion out to 2011.

The commission also urged Congress to set up a system to measure and report physician resource use. The reporting should be confidential for 2 years. After that, the Centers for Medicare and Medicaid Services should establish a new payment system that takes into account both resource use and quality measures.

Dr. Ronald D. Castellanos, a physician in a group practice in Port Charlotte, Fla. and a MedPAC commissioner, said a recommendation for an increase was better than a cut, but that the 1.1% "doesn't keep up with our costs." Dr. Castellanos said that physicians would not look happily on the recommended update.

"Quite honestly, it's insulting," he said. "The update is a blunt tool for trying to constrain costs," said Dr. Castellanos.

Dr. Nicholas Wolter, a commissioner who practices at a clinic in Billings, Mont., also said that he was not comfortable with the recommendation. "Unless we start focusing on other tactics, we're not going to get a handle on costs," he said.

Mr. Hackbarth said the panel's recommendation should not be taken to mean that the commission believed that everything was fine with the reimbursement system. But, he added, the problems with Medicare threatened beneficiaries, taxpayers, and even his children's future. Solutions should not be focused only on physicians, said Mr. Hackbarth, adding, "it's way bigger than that."

WASHINGTON — The Medicare Payment Advisory Commission has voted to recommend that Congress increase Medicare physician fees by 1.1% in 2009.

The recommendation will be included in MedPAC's final report to Congress this month.

The panel believes that physician fees should not be cut, said MedPAC Chairman Glenn M. Hackbarth. "That's a very important message for us to convey to Congress."

Before the vote, Mr. Hackbarth said the commission struggled each year to come up with the right numbers. "We try to zero in on the most appropriate update," he said, adding that cost reports, physicians' access to capital, and beneficiaries' access to physician services all go into that calculation.

MedPAC staff member John Richardson told commissioners that it appears that most physicians continue to accept new Medicare patients, but there has been an increase in beneficiaries who said they had trouble finding a new primary care physician, according to a MedPAC survey. In 2006, 24% said they had trouble; by 2007, 30% of beneficiaries reported difficulty.

Medicare fees also are staying fairly steady as a percentage of private insurance fees, said Mr. Richardson. In 2005, Medicare paid 83% of what private insurers did, and in 2006, that had slipped slightly to 81%.

In December, Congress passed and the President signed a last-minute fix to the 2008 fee schedule, granting a 6-month, 0.5% increase for 2008. The fee increase, which included incentives for rural physicians, will cost about $3.1 billion, Mr. Richardson said.

Under current law, Medicare will cut physician fees by 5.5% in 2009. But when fees are renegotiated in July, the 2009 update could change.

MedPAC recommended that fees be increased in 2009 by the projected change in input prices (2.6%) minus the expected growth in productivity (1.5%), for a 1.1% increase. The cost: about $2 billion. The commission projected that spending would increase by another $8 billion out to 2011.

The commission also urged Congress to set up a system to measure and report physician resource use. The reporting should be confidential for 2 years. After that, the Centers for Medicare and Medicaid Services should establish a new payment system that takes into account both resource use and quality measures.

Dr. Ronald D. Castellanos, a physician in a group practice in Port Charlotte, Fla. and a MedPAC commissioner, said a recommendation for an increase was better than a cut, but that the 1.1% "doesn't keep up with our costs." Dr. Castellanos said that physicians would not look happily on the recommended update.

"Quite honestly, it's insulting," he said. "The update is a blunt tool for trying to constrain costs," said Dr. Castellanos.

Dr. Nicholas Wolter, a commissioner who practices at a clinic in Billings, Mont., also said that he was not comfortable with the recommendation. "Unless we start focusing on other tactics, we're not going to get a handle on costs," he said.

Mr. Hackbarth said the panel's recommendation should not be taken to mean that the commission believed that everything was fine with the reimbursement system. But, he added, the problems with Medicare threatened beneficiaries, taxpayers, and even his children's future. Solutions should not be focused only on physicians, said Mr. Hackbarth, adding, "it's way bigger than that."

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In Stopgap Move, Congress Extends SCHIP Until 2009

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After months of debate and two presidential vetoes, Congress has voted to extend the State Children's Health Insurance Program to April 2009.

President Bush signed the legislation on December 29th. The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.

Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.

The showdown ended in late December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats had sought to broaden SCHIP to cover 10 million children.

And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.

Democrats and child advocates were relieved that the program was at least extended temporarily, but many expressed concern about SCHIP's future.

“Today we passed a package that puts a band-aid on Medicare and buys just a little more time for families currently relying on SCHIP to keep their children healthy,” Rep. Charles B. Rangel (D-N.Y.) said in a statement. “My concern with this legislation is not what's in it, but what's not in it.”

House Speaker Nancy Pelosi issued a statement noting that the bill “does not make headway in reducing the number of uninsured.”

Some Republicans weren't happy, either. Sen. Charles Grassley (R-Iowa) said that although the original bill was passed unanimously in the Senate, he knew that the bill fell short of what many in Congress were hoping for. “I do hope we can do more when we come back next year,” he said in a statement.

The SCHIP package that was passed did not—as Democrats had preferred—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.

States must meet that target by August 2008. In a briefing with reporters, Acting CMS Administrator Kerry Weems said that at least two states, Vermont and Massachusetts, will soon meet the goal. Currently, there is no set enforcement plan, he said. The CMS would likely look at each state individually to determine whether it was meeting the directive, Mr. Weems said.

In a conference call with reporters, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a Washington think tank, said the directive could have a huge impact on enrollment. Fourteen states cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level. Thus, the SCHIP bill “was not a maintenance of the current situation but backwards progress,” he said.

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After months of debate and two presidential vetoes, Congress has voted to extend the State Children's Health Insurance Program to April 2009.

President Bush signed the legislation on December 29th. The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.

Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.

The showdown ended in late December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats had sought to broaden SCHIP to cover 10 million children.

And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.

Democrats and child advocates were relieved that the program was at least extended temporarily, but many expressed concern about SCHIP's future.

“Today we passed a package that puts a band-aid on Medicare and buys just a little more time for families currently relying on SCHIP to keep their children healthy,” Rep. Charles B. Rangel (D-N.Y.) said in a statement. “My concern with this legislation is not what's in it, but what's not in it.”

House Speaker Nancy Pelosi issued a statement noting that the bill “does not make headway in reducing the number of uninsured.”

Some Republicans weren't happy, either. Sen. Charles Grassley (R-Iowa) said that although the original bill was passed unanimously in the Senate, he knew that the bill fell short of what many in Congress were hoping for. “I do hope we can do more when we come back next year,” he said in a statement.

The SCHIP package that was passed did not—as Democrats had preferred—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.

States must meet that target by August 2008. In a briefing with reporters, Acting CMS Administrator Kerry Weems said that at least two states, Vermont and Massachusetts, will soon meet the goal. Currently, there is no set enforcement plan, he said. The CMS would likely look at each state individually to determine whether it was meeting the directive, Mr. Weems said.

In a conference call with reporters, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a Washington think tank, said the directive could have a huge impact on enrollment. Fourteen states cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level. Thus, the SCHIP bill “was not a maintenance of the current situation but backwards progress,” he said.

After months of debate and two presidential vetoes, Congress has voted to extend the State Children's Health Insurance Program to April 2009.

President Bush signed the legislation on December 29th. The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.

Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.

The showdown ended in late December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats had sought to broaden SCHIP to cover 10 million children.

And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.

Democrats and child advocates were relieved that the program was at least extended temporarily, but many expressed concern about SCHIP's future.

“Today we passed a package that puts a band-aid on Medicare and buys just a little more time for families currently relying on SCHIP to keep their children healthy,” Rep. Charles B. Rangel (D-N.Y.) said in a statement. “My concern with this legislation is not what's in it, but what's not in it.”

House Speaker Nancy Pelosi issued a statement noting that the bill “does not make headway in reducing the number of uninsured.”

Some Republicans weren't happy, either. Sen. Charles Grassley (R-Iowa) said that although the original bill was passed unanimously in the Senate, he knew that the bill fell short of what many in Congress were hoping for. “I do hope we can do more when we come back next year,” he said in a statement.

The SCHIP package that was passed did not—as Democrats had preferred—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.

States must meet that target by August 2008. In a briefing with reporters, Acting CMS Administrator Kerry Weems said that at least two states, Vermont and Massachusetts, will soon meet the goal. Currently, there is no set enforcement plan, he said. The CMS would likely look at each state individually to determine whether it was meeting the directive, Mr. Weems said.

In a conference call with reporters, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a Washington think tank, said the directive could have a huge impact on enrollment. Fourteen states cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level. Thus, the SCHIP bill “was not a maintenance of the current situation but backwards progress,” he said.

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SCHIP Gets Extension to April 2009

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After months of debate and two presidential vetoes, Congress voted to extend the State Children's Health Insurance Program to April 2009. President Bush signed the legislation on Dec. 29.

The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.

Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.

The showdown ended in late December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats have sought to broaden SCHIP to cover 10 million children.

And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.

Democrats and child advocates were relieved that the program was at least extended temporarily, but many expressed concern about SCHIP's future. House Speaker Nancy Pelosi issued a statement noting that the bill “does not make headway in reducing the number of uninsured.”

Sen. Charles Grassley (R-Iowa) said that although the original bill was passed unanimously in the Senate, he knew that the bill fell short of what many in Congress were hoping for.

The SCHIP package did not—as Democrats wanted—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.

States must meet that target by August 2008. Fourteen states already cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level.

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After months of debate and two presidential vetoes, Congress voted to extend the State Children's Health Insurance Program to April 2009. President Bush signed the legislation on Dec. 29.

The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.

Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.

The showdown ended in late December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats have sought to broaden SCHIP to cover 10 million children.

And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.

Democrats and child advocates were relieved that the program was at least extended temporarily, but many expressed concern about SCHIP's future. House Speaker Nancy Pelosi issued a statement noting that the bill “does not make headway in reducing the number of uninsured.”

Sen. Charles Grassley (R-Iowa) said that although the original bill was passed unanimously in the Senate, he knew that the bill fell short of what many in Congress were hoping for.

The SCHIP package did not—as Democrats wanted—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.

States must meet that target by August 2008. Fourteen states already cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level.

After months of debate and two presidential vetoes, Congress voted to extend the State Children's Health Insurance Program to April 2009. President Bush signed the legislation on Dec. 29.

The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.

Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.

The showdown ended in late December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats have sought to broaden SCHIP to cover 10 million children.

And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.

Democrats and child advocates were relieved that the program was at least extended temporarily, but many expressed concern about SCHIP's future. House Speaker Nancy Pelosi issued a statement noting that the bill “does not make headway in reducing the number of uninsured.”

Sen. Charles Grassley (R-Iowa) said that although the original bill was passed unanimously in the Senate, he knew that the bill fell short of what many in Congress were hoping for.

The SCHIP package did not—as Democrats wanted—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.

States must meet that target by August 2008. Fourteen states already cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level.

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FDA Sets New Conflict-of-Interest Rules for Advisory Panels

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The Food and Drug Administration said it wants to require more public disclosure of advisory committee members' conflicts of interest and the information will be available on a new and improved Web site.

The agency also said it will also post more data in advance of upcoming meetings.

The changes were announced in November in a draft guidance, which does not carry the weight of a rule, but is generally followed by most companies that have products regulated by the FDA. A draft guidance represents the agency's “current thinking on the topic.”

According to the FDA, the new emphasis on disclosure is a response to recommendations made by the Institute of Medicine in its 2006 report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The draft guidance will apply to all members of the 31 current advisory panels. Committee members are either government employees or outsiders who are designated as special government employees. The FDA will ask panelists to state publicly the type, nature, and magnitude of any “disqualifying financial interests.”

Panel members will be required to complete a waiver request when they have a financial conflict. As part of that document, they'll list the nature of the interest (for instance, whether it's a stock holding, or if they've been a paid consultant or an expert witness); whether the conflicting relationship is with the sponsor or a competitor; and the value of the remuneration, up to $50,000. At least 15 days before an advisory committee meeting, any disclosures from panelists will be posted on the Web site, along with the agency's waiver decision. Currently, waivers may or may not be posted a few days in advance of a committee meeting, and are read aloud at the start of the proceedings.

Critics have charged that panel reviews of products have become less rigorous because so many committee members have conflicts of interest. Essentially, the panels are biased in favor of approval, critics contend.

The National Research Center for Women and Families, a consumer advocacy group, issued a report in 2006 showing that advisory panels backed approval for 76% of new drugs and 82% of new medical devices, and that 96% of those products were later approved by the FDA.

The new guidance “focuses on disclosure, not on change,” Diana Zuckerman, Ph.D., president of the National Research Center, said in an interview. “Although disclosure is nice, it doesn't solve the problems.”

A recent report that was commissioned by the FDA concluded that creating conflict-free panels would require higher recruiting and screening costs, and would take much more time than the current process, potentially delaying important decisions.

Eastern Research Group, a consulting firm in Lexington, Mass., studied 16 advisory committee meetings that involved 124 panel members. Of the 124, 32 (26%) required waivers for at least one meeting. Almost the same number required waivers for multiple meetings. An equal number of standing members and consumer representatives required waivers (29%). More than half of patient representatives required waivers.

Dr. Zuckerman questioned the study's validity, noting that the consulting company used literature searches to form the basis of its conclusions on panelists' conflicts. The FDA would be more proactive in searching for conflict-free advisers, she said.

She was in favor of the FDA's proposed new voting procedures. The agency said that it wanted to have simultaneous votes. Currently, committees often have panelists vote individually, one by one. That can influence the votes of successive voting members.

Even with this reform, Dr. Zuckerman said she was not satisfied. “I do actually think it's mostly a sham process,” she said. “I don't believe that these are independent scientific advisory committees.”

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The Food and Drug Administration said it wants to require more public disclosure of advisory committee members' conflicts of interest and the information will be available on a new and improved Web site.

The agency also said it will also post more data in advance of upcoming meetings.

The changes were announced in November in a draft guidance, which does not carry the weight of a rule, but is generally followed by most companies that have products regulated by the FDA. A draft guidance represents the agency's “current thinking on the topic.”

According to the FDA, the new emphasis on disclosure is a response to recommendations made by the Institute of Medicine in its 2006 report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The draft guidance will apply to all members of the 31 current advisory panels. Committee members are either government employees or outsiders who are designated as special government employees. The FDA will ask panelists to state publicly the type, nature, and magnitude of any “disqualifying financial interests.”

Panel members will be required to complete a waiver request when they have a financial conflict. As part of that document, they'll list the nature of the interest (for instance, whether it's a stock holding, or if they've been a paid consultant or an expert witness); whether the conflicting relationship is with the sponsor or a competitor; and the value of the remuneration, up to $50,000. At least 15 days before an advisory committee meeting, any disclosures from panelists will be posted on the Web site, along with the agency's waiver decision. Currently, waivers may or may not be posted a few days in advance of a committee meeting, and are read aloud at the start of the proceedings.

Critics have charged that panel reviews of products have become less rigorous because so many committee members have conflicts of interest. Essentially, the panels are biased in favor of approval, critics contend.

The National Research Center for Women and Families, a consumer advocacy group, issued a report in 2006 showing that advisory panels backed approval for 76% of new drugs and 82% of new medical devices, and that 96% of those products were later approved by the FDA.

The new guidance “focuses on disclosure, not on change,” Diana Zuckerman, Ph.D., president of the National Research Center, said in an interview. “Although disclosure is nice, it doesn't solve the problems.”

A recent report that was commissioned by the FDA concluded that creating conflict-free panels would require higher recruiting and screening costs, and would take much more time than the current process, potentially delaying important decisions.

Eastern Research Group, a consulting firm in Lexington, Mass., studied 16 advisory committee meetings that involved 124 panel members. Of the 124, 32 (26%) required waivers for at least one meeting. Almost the same number required waivers for multiple meetings. An equal number of standing members and consumer representatives required waivers (29%). More than half of patient representatives required waivers.

Dr. Zuckerman questioned the study's validity, noting that the consulting company used literature searches to form the basis of its conclusions on panelists' conflicts. The FDA would be more proactive in searching for conflict-free advisers, she said.

She was in favor of the FDA's proposed new voting procedures. The agency said that it wanted to have simultaneous votes. Currently, committees often have panelists vote individually, one by one. That can influence the votes of successive voting members.

Even with this reform, Dr. Zuckerman said she was not satisfied. “I do actually think it's mostly a sham process,” she said. “I don't believe that these are independent scientific advisory committees.”

The Food and Drug Administration said it wants to require more public disclosure of advisory committee members' conflicts of interest and the information will be available on a new and improved Web site.

The agency also said it will also post more data in advance of upcoming meetings.

The changes were announced in November in a draft guidance, which does not carry the weight of a rule, but is generally followed by most companies that have products regulated by the FDA. A draft guidance represents the agency's “current thinking on the topic.”

According to the FDA, the new emphasis on disclosure is a response to recommendations made by the Institute of Medicine in its 2006 report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The draft guidance will apply to all members of the 31 current advisory panels. Committee members are either government employees or outsiders who are designated as special government employees. The FDA will ask panelists to state publicly the type, nature, and magnitude of any “disqualifying financial interests.”

Panel members will be required to complete a waiver request when they have a financial conflict. As part of that document, they'll list the nature of the interest (for instance, whether it's a stock holding, or if they've been a paid consultant or an expert witness); whether the conflicting relationship is with the sponsor or a competitor; and the value of the remuneration, up to $50,000. At least 15 days before an advisory committee meeting, any disclosures from panelists will be posted on the Web site, along with the agency's waiver decision. Currently, waivers may or may not be posted a few days in advance of a committee meeting, and are read aloud at the start of the proceedings.

Critics have charged that panel reviews of products have become less rigorous because so many committee members have conflicts of interest. Essentially, the panels are biased in favor of approval, critics contend.

The National Research Center for Women and Families, a consumer advocacy group, issued a report in 2006 showing that advisory panels backed approval for 76% of new drugs and 82% of new medical devices, and that 96% of those products were later approved by the FDA.

The new guidance “focuses on disclosure, not on change,” Diana Zuckerman, Ph.D., president of the National Research Center, said in an interview. “Although disclosure is nice, it doesn't solve the problems.”

A recent report that was commissioned by the FDA concluded that creating conflict-free panels would require higher recruiting and screening costs, and would take much more time than the current process, potentially delaying important decisions.

Eastern Research Group, a consulting firm in Lexington, Mass., studied 16 advisory committee meetings that involved 124 panel members. Of the 124, 32 (26%) required waivers for at least one meeting. Almost the same number required waivers for multiple meetings. An equal number of standing members and consumer representatives required waivers (29%). More than half of patient representatives required waivers.

Dr. Zuckerman questioned the study's validity, noting that the consulting company used literature searches to form the basis of its conclusions on panelists' conflicts. The FDA would be more proactive in searching for conflict-free advisers, she said.

She was in favor of the FDA's proposed new voting procedures. The agency said that it wanted to have simultaneous votes. Currently, committees often have panelists vote individually, one by one. That can influence the votes of successive voting members.

Even with this reform, Dr. Zuckerman said she was not satisfied. “I do actually think it's mostly a sham process,” she said. “I don't believe that these are independent scientific advisory committees.”

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E-Prescribing Standards Are Proposed for Medicare Use

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The U.S. Health and Human Services Department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.

The proposal was issued last month; comments are being accepted through mid-January.

E-prescribing is not required for participation in the Medicare Part D drug benefit.

But under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—the law that established the benefit—drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.

Some organizations have pushed for required e-prescribing for Medicare participation.

The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort. The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.

The American Health Information Community has also urged the HHS to require e-prescribing for Medicare.

The American Medical Association and other groups oppose a mandate.

“From a practical side, a mandate would be premature,” Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, said in an interview.

“We can see the benefits of it, but we can't ignore that there are costs involved,” she added.

The final e-prescribing standards are expected to be issued by April 1, 2008.

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The U.S. Health and Human Services Department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.

The proposal was issued last month; comments are being accepted through mid-January.

E-prescribing is not required for participation in the Medicare Part D drug benefit.

But under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—the law that established the benefit—drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.

Some organizations have pushed for required e-prescribing for Medicare participation.

The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort. The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.

The American Health Information Community has also urged the HHS to require e-prescribing for Medicare.

The American Medical Association and other groups oppose a mandate.

“From a practical side, a mandate would be premature,” Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, said in an interview.

“We can see the benefits of it, but we can't ignore that there are costs involved,” she added.

The final e-prescribing standards are expected to be issued by April 1, 2008.

The U.S. Health and Human Services Department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.

The proposal was issued last month; comments are being accepted through mid-January.

E-prescribing is not required for participation in the Medicare Part D drug benefit.

But under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—the law that established the benefit—drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.

Some organizations have pushed for required e-prescribing for Medicare participation.

The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort. The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.

The American Health Information Community has also urged the HHS to require e-prescribing for Medicare.

The American Medical Association and other groups oppose a mandate.

“From a practical side, a mandate would be premature,” Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, said in an interview.

“We can see the benefits of it, but we can't ignore that there are costs involved,” she added.

The final e-prescribing standards are expected to be issued by April 1, 2008.

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Care Quality Rises, Driven by Public Reporting

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WASHINGTON — Thousands of lives are being saved each year as health plans and physicians more closely follow quality measures such as giving β-blockers after a heart attack, managing hypertension and hypercholesterolemia, and controlling hemoglobin A1c levels, according to the latest report card from the National Committee for Quality Assurance.

And, plans that report publicly on these measures deliver higher quality care, said NCQA president Margaret O'Kane in a briefing.

The NCQA's recently released report card shows that commercial and Medicaid plans that publicly disclose NCQA-tracked quality measures perform anywhere from half a percent to 16% better than plans that do not disclose their data.

However, even with some notable successes, some of the gains—such as in controlling blood sugar—are starting to plateau, said Ms. O'Kane. And, there are still gaps in quality between top-performing and average health plans. Thousands more lives could be saved if the laggards did as well as the top performers in the NCQA database, she said.

The report is based on data that are voluntarily submitted to the NCQA, which also accredits health plans. In 2006, 767 organizations—626 managed care plans covering private patients and Medicare and Medicaid enrollees, and 83 commercial and 58 Medicare PPO plans—submitted data using the NCQA's Healthcare Effectiveness Data and Information Set (HEDIS) .

Much of the data come from claims, but some also come from chart reviews. None of them are adjusted for severity-of-illness, socioeconomic, or other factors.

Approximately 84 million Americans were enrolled in plans that used HEDIS measures to report to the NCQA in 2006. Although that is a big number, at least 100 million Americans are in health plans that do not report quality data, and some 47 million have no insurance, said Ms. O'Kane. The quality picture is completely dark for the uninsured, she said.

But for those plans that did report, the news was good. Overall, commercial plans improved performance in 30 of 44 HEDIS measures where a trend could be discerned, Medicaid plans notched increases in 34 of 43 “trendable” measures, and Medicare plans achieved increase only on 7 of 21 trendable measures.

Among the biggest successes was that 98% of commercial plans, 94% of Medicare, and 88% of Medicaid plans reported prescribing a β-blocker upon discharge after acute myocardial infarction. Over the last 6 years, β-blocker treatment has saved an estimated 4,400–5,600 lives, said Ms. O'Kane.

Given the high prescribing rates, the NCQA will no longer track this measure. Instead, the organization will collect data on how many patients still receive β-blockers 6 months after discharge—currently, only about 74% in commercial plans and 70% for Medicare and Medicaid.

Childhood immunization rates are also at all-time highs, at about 80% for commercial plans and 73% for Medicaid plans for the recommended series of vaccinations.

There has been “stalling” in some of the older HEDIS measures, however, said Ms. O'Kane. Baseline screening for HbA1c has plateaued at 88% in commercial plans and is down slightly for Medicare and Medicaid, at 87% and 78%, respectively.

Cholesterol screening and control of total cholesterol is also trending flat or down. The NCQA has no explanation for the leveling off, said Ms. O'Kane.

Adherence to mental health measures—which are already abysmally low—has also been flat for almost a decade. For instance, only 20% of commercial, 21% of Medicaid, and 11% of Medicare plans are meeting the benchmark of treating newly diagnosed depression patients with an antidepressant and following up with at least three visits within the 12-week acute treatment phase. These rates have stayed virtually the same since 1998.

Similarly, patients who have been hospitalized for a mental illness are not getting quality care, said Ms. O'Kane. Only 57% of patients in commercial plans, 37% of those in a Medicare plan, and 39% of those in a Medicaid plan had a follow-up within a week of hospitalization. Rates improved somewhat a month out, to 75%, 55%, and 58%. Studies have shown that follow-up care decreases the risk of repeat hospitalizations and improves adherence, according to the NCQA.

The low follow-up rates are “a national disgrace,” said Ms. O'Kane, adding that for anyone to be “out 30 days with no one checking on you is unacceptable.”

Several new HEDIS measures are in place for 2007, including tracking of potentially harmful drug-disease interactions in the elderly.

And, for the first time, health plans are being asked to report on their use of resources in treating various conditions. In 2007, they were diabetes, asthma, and low back pain. In 2008, chronic obstructive pulmonary disease, hypertension, and cardiovascular disease have been added. These conditions account for 60% of health care spending, said Ms. O'Kane.

 

 

The data will be used to determine the variations in resource use among health plans.

Coupled with the HEDIS quality measures, the NCQA will eventually be able to rate which plans give the best quality care for the least amount of money, said Ms. O'Kane.

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WASHINGTON — Thousands of lives are being saved each year as health plans and physicians more closely follow quality measures such as giving β-blockers after a heart attack, managing hypertension and hypercholesterolemia, and controlling hemoglobin A1c levels, according to the latest report card from the National Committee for Quality Assurance.

And, plans that report publicly on these measures deliver higher quality care, said NCQA president Margaret O'Kane in a briefing.

The NCQA's recently released report card shows that commercial and Medicaid plans that publicly disclose NCQA-tracked quality measures perform anywhere from half a percent to 16% better than plans that do not disclose their data.

However, even with some notable successes, some of the gains—such as in controlling blood sugar—are starting to plateau, said Ms. O'Kane. And, there are still gaps in quality between top-performing and average health plans. Thousands more lives could be saved if the laggards did as well as the top performers in the NCQA database, she said.

The report is based on data that are voluntarily submitted to the NCQA, which also accredits health plans. In 2006, 767 organizations—626 managed care plans covering private patients and Medicare and Medicaid enrollees, and 83 commercial and 58 Medicare PPO plans—submitted data using the NCQA's Healthcare Effectiveness Data and Information Set (HEDIS) .

Much of the data come from claims, but some also come from chart reviews. None of them are adjusted for severity-of-illness, socioeconomic, or other factors.

Approximately 84 million Americans were enrolled in plans that used HEDIS measures to report to the NCQA in 2006. Although that is a big number, at least 100 million Americans are in health plans that do not report quality data, and some 47 million have no insurance, said Ms. O'Kane. The quality picture is completely dark for the uninsured, she said.

But for those plans that did report, the news was good. Overall, commercial plans improved performance in 30 of 44 HEDIS measures where a trend could be discerned, Medicaid plans notched increases in 34 of 43 “trendable” measures, and Medicare plans achieved increase only on 7 of 21 trendable measures.

Among the biggest successes was that 98% of commercial plans, 94% of Medicare, and 88% of Medicaid plans reported prescribing a β-blocker upon discharge after acute myocardial infarction. Over the last 6 years, β-blocker treatment has saved an estimated 4,400–5,600 lives, said Ms. O'Kane.

Given the high prescribing rates, the NCQA will no longer track this measure. Instead, the organization will collect data on how many patients still receive β-blockers 6 months after discharge—currently, only about 74% in commercial plans and 70% for Medicare and Medicaid.

Childhood immunization rates are also at all-time highs, at about 80% for commercial plans and 73% for Medicaid plans for the recommended series of vaccinations.

There has been “stalling” in some of the older HEDIS measures, however, said Ms. O'Kane. Baseline screening for HbA1c has plateaued at 88% in commercial plans and is down slightly for Medicare and Medicaid, at 87% and 78%, respectively.

Cholesterol screening and control of total cholesterol is also trending flat or down. The NCQA has no explanation for the leveling off, said Ms. O'Kane.

Adherence to mental health measures—which are already abysmally low—has also been flat for almost a decade. For instance, only 20% of commercial, 21% of Medicaid, and 11% of Medicare plans are meeting the benchmark of treating newly diagnosed depression patients with an antidepressant and following up with at least three visits within the 12-week acute treatment phase. These rates have stayed virtually the same since 1998.

Similarly, patients who have been hospitalized for a mental illness are not getting quality care, said Ms. O'Kane. Only 57% of patients in commercial plans, 37% of those in a Medicare plan, and 39% of those in a Medicaid plan had a follow-up within a week of hospitalization. Rates improved somewhat a month out, to 75%, 55%, and 58%. Studies have shown that follow-up care decreases the risk of repeat hospitalizations and improves adherence, according to the NCQA.

The low follow-up rates are “a national disgrace,” said Ms. O'Kane, adding that for anyone to be “out 30 days with no one checking on you is unacceptable.”

Several new HEDIS measures are in place for 2007, including tracking of potentially harmful drug-disease interactions in the elderly.

And, for the first time, health plans are being asked to report on their use of resources in treating various conditions. In 2007, they were diabetes, asthma, and low back pain. In 2008, chronic obstructive pulmonary disease, hypertension, and cardiovascular disease have been added. These conditions account for 60% of health care spending, said Ms. O'Kane.

 

 

The data will be used to determine the variations in resource use among health plans.

Coupled with the HEDIS quality measures, the NCQA will eventually be able to rate which plans give the best quality care for the least amount of money, said Ms. O'Kane.

WASHINGTON — Thousands of lives are being saved each year as health plans and physicians more closely follow quality measures such as giving β-blockers after a heart attack, managing hypertension and hypercholesterolemia, and controlling hemoglobin A1c levels, according to the latest report card from the National Committee for Quality Assurance.

And, plans that report publicly on these measures deliver higher quality care, said NCQA president Margaret O'Kane in a briefing.

The NCQA's recently released report card shows that commercial and Medicaid plans that publicly disclose NCQA-tracked quality measures perform anywhere from half a percent to 16% better than plans that do not disclose their data.

However, even with some notable successes, some of the gains—such as in controlling blood sugar—are starting to plateau, said Ms. O'Kane. And, there are still gaps in quality between top-performing and average health plans. Thousands more lives could be saved if the laggards did as well as the top performers in the NCQA database, she said.

The report is based on data that are voluntarily submitted to the NCQA, which also accredits health plans. In 2006, 767 organizations—626 managed care plans covering private patients and Medicare and Medicaid enrollees, and 83 commercial and 58 Medicare PPO plans—submitted data using the NCQA's Healthcare Effectiveness Data and Information Set (HEDIS) .

Much of the data come from claims, but some also come from chart reviews. None of them are adjusted for severity-of-illness, socioeconomic, or other factors.

Approximately 84 million Americans were enrolled in plans that used HEDIS measures to report to the NCQA in 2006. Although that is a big number, at least 100 million Americans are in health plans that do not report quality data, and some 47 million have no insurance, said Ms. O'Kane. The quality picture is completely dark for the uninsured, she said.

But for those plans that did report, the news was good. Overall, commercial plans improved performance in 30 of 44 HEDIS measures where a trend could be discerned, Medicaid plans notched increases in 34 of 43 “trendable” measures, and Medicare plans achieved increase only on 7 of 21 trendable measures.

Among the biggest successes was that 98% of commercial plans, 94% of Medicare, and 88% of Medicaid plans reported prescribing a β-blocker upon discharge after acute myocardial infarction. Over the last 6 years, β-blocker treatment has saved an estimated 4,400–5,600 lives, said Ms. O'Kane.

Given the high prescribing rates, the NCQA will no longer track this measure. Instead, the organization will collect data on how many patients still receive β-blockers 6 months after discharge—currently, only about 74% in commercial plans and 70% for Medicare and Medicaid.

Childhood immunization rates are also at all-time highs, at about 80% for commercial plans and 73% for Medicaid plans for the recommended series of vaccinations.

There has been “stalling” in some of the older HEDIS measures, however, said Ms. O'Kane. Baseline screening for HbA1c has plateaued at 88% in commercial plans and is down slightly for Medicare and Medicaid, at 87% and 78%, respectively.

Cholesterol screening and control of total cholesterol is also trending flat or down. The NCQA has no explanation for the leveling off, said Ms. O'Kane.

Adherence to mental health measures—which are already abysmally low—has also been flat for almost a decade. For instance, only 20% of commercial, 21% of Medicaid, and 11% of Medicare plans are meeting the benchmark of treating newly diagnosed depression patients with an antidepressant and following up with at least three visits within the 12-week acute treatment phase. These rates have stayed virtually the same since 1998.

Similarly, patients who have been hospitalized for a mental illness are not getting quality care, said Ms. O'Kane. Only 57% of patients in commercial plans, 37% of those in a Medicare plan, and 39% of those in a Medicaid plan had a follow-up within a week of hospitalization. Rates improved somewhat a month out, to 75%, 55%, and 58%. Studies have shown that follow-up care decreases the risk of repeat hospitalizations and improves adherence, according to the NCQA.

The low follow-up rates are “a national disgrace,” said Ms. O'Kane, adding that for anyone to be “out 30 days with no one checking on you is unacceptable.”

Several new HEDIS measures are in place for 2007, including tracking of potentially harmful drug-disease interactions in the elderly.

And, for the first time, health plans are being asked to report on their use of resources in treating various conditions. In 2007, they were diabetes, asthma, and low back pain. In 2008, chronic obstructive pulmonary disease, hypertension, and cardiovascular disease have been added. These conditions account for 60% of health care spending, said Ms. O'Kane.

 

 

The data will be used to determine the variations in resource use among health plans.

Coupled with the HEDIS quality measures, the NCQA will eventually be able to rate which plans give the best quality care for the least amount of money, said Ms. O'Kane.

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