Alicia Ault

After months of debate and two presidential vetoes, Congress has successfully 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 when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough funds to keep SCHIP enrollment at 2007 levels—about 6 million children and adults—through March 31, 2009. Democrats had sought 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 the program was 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 the bill “does not make headway in reducing the number of uninsured.”

Some Republicans weren't happy, either. Sen. Charles Grassley (R-Iowa) said although the original bill was passed unanimously in the Senate, he knew it 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, Acting CMS Administrator Kerry Weems said at least two states, Vermont and Massachusetts, will soon meet the goal. Currently, there is no enforcement plan, he said.

In a conference call with reporters, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a liberal-leaning think tank in Washington, said that the directive could have a huge impact on enrollment. Fourteen states already 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 successfully 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 when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough funds to keep SCHIP enrollment at 2007 levels—about 6 million children and adults—through March 31, 2009. Democrats had sought 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 the program was 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 the bill “does not make headway in reducing the number of uninsured.”

Some Republicans weren't happy, either. Sen. Charles Grassley (R-Iowa) said although the original bill was passed unanimously in the Senate, he knew it 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, Acting CMS Administrator Kerry Weems said at least two states, Vermont and Massachusetts, will soon meet the goal. Currently, there is no enforcement plan, he said.

In a conference call with reporters, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a liberal-leaning think tank in Washington, said that the directive could have a huge impact on enrollment. Fourteen states already 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 successfully 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 when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough funds to keep SCHIP enrollment at 2007 levels—about 6 million children and adults—through March 31, 2009. Democrats had sought 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 the program was 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 the bill “does not make headway in reducing the number of uninsured.”

Some Republicans weren't happy, either. Sen. Charles Grassley (R-Iowa) said although the original bill was passed unanimously in the Senate, he knew it 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, Acting CMS Administrator Kerry Weems said at least two states, Vermont and Massachusetts, will soon meet the goal. Currently, there is no enforcement plan, he said.

In a conference call with reporters, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a liberal-leaning think tank in Washington, said that the directive could have a huge impact on enrollment. Fourteen states already 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.

In a reversal, the Drug Enforcement Administration will now allow physicians to write up to three prescriptions for a 90-day supply of schedule II controlled substances.

The final rule, published in November, is viewed as a victory by pain medicine specialists, said Dr. B. Todd Sitzman, American Academy of Pain Medicine president and director of advanced pain therapy at the Forrest General Hospital's cancer center in Hattiesburg, Miss.

“It's an indication that [DEA officials] have listened to pain physicians and to the pain patient community,” he said in an interview.

The rule overturns an interim policy that prohibited the dispensing of multiple prescriptions at a single office visit and clarifies the DEA's expectations, said Dr. Sitzman.

Under the new policy, physicians may write prescriptions labeled “do not fill until,” with a preset date. This means patients can get a new prescription every 30 days, for 3 months, without having to return to the physician's office.

The prescriptions do not qualify as refills. They still must be taken to a pharmacy to be filled. DEA also said that the 90-day limit is the maximum according to its interpretation of congressional intent and the statute covering schedule II controlled substances.

In the rule, the DEA addressed several areas of concern to prescribing physicians.

The agency said it “wishes to dispel the mistaken notion among a small number of medical professionals that the agency has embarked on a campaign to 'target' physicians who prescribe controlled substances for the treatment of pain (or that physicians must curb their legitimate prescribing of pain medications to avoid legal liability).”

The agency noted that in any given year, fewer than 1 in 10,000 physicians lose their controlled substance registration because of a DEA investigation.

But, added the agency, the rule does not alter longstanding state and federal requirements that controlled substances can only be prescribed, administered or dispensed for a legitimate medical purpose by a physician acting in the usual course of professional practice.

The changes were first proposed in 2006, when the DEA was asked by commenters to issue specific guidance on how a clinician could assess pain, when a physician should prescribe an opioid, or how to use opioids.

But the agency said it would not do so, noting it does not regulate the practice of medicine and these topics are better addressed by professional organizations, medical schools, and postgraduate medical training.

Dr. Sitzman said the lack of strict guidelines is a positive thing.

Other organizations were also heartened by the rule change. In a statement, Dr. Rebecca Patchin, an American Medical Association board member, said the change “will give patients better access to the prescription drugs they need and continue to minimize the risks controlled substances pose to public health and safety.”

In a reversal, the Drug Enforcement Administration will now allow physicians to write up to three prescriptions for a 90-day supply of schedule II controlled substances.

The final rule, published in November, is viewed as a victory by pain medicine specialists, said Dr. B. Todd Sitzman, American Academy of Pain Medicine president and director of advanced pain therapy at the Forrest General Hospital's cancer center in Hattiesburg, Miss.

“It's an indication that [DEA officials] have listened to pain physicians and to the pain patient community,” he said in an interview.

The rule overturns an interim policy that prohibited the dispensing of multiple prescriptions at a single office visit and clarifies the DEA's expectations, said Dr. Sitzman.

Under the new policy, physicians may write prescriptions labeled “do not fill until,” with a preset date. This means patients can get a new prescription every 30 days, for 3 months, without having to return to the physician's office.

The prescriptions do not qualify as refills. They still must be taken to a pharmacy to be filled. DEA also said that the 90-day limit is the maximum according to its interpretation of congressional intent and the statute covering schedule II controlled substances.

In the rule, the DEA addressed several areas of concern to prescribing physicians.

The agency said it “wishes to dispel the mistaken notion among a small number of medical professionals that the agency has embarked on a campaign to 'target' physicians who prescribe controlled substances for the treatment of pain (or that physicians must curb their legitimate prescribing of pain medications to avoid legal liability).”

The agency noted that in any given year, fewer than 1 in 10,000 physicians lose their controlled substance registration because of a DEA investigation.

But, added the agency, the rule does not alter longstanding state and federal requirements that controlled substances can only be prescribed, administered or dispensed for a legitimate medical purpose by a physician acting in the usual course of professional practice.

The changes were first proposed in 2006, when the DEA was asked by commenters to issue specific guidance on how a clinician could assess pain, when a physician should prescribe an opioid, or how to use opioids.

But the agency said it would not do so, noting it does not regulate the practice of medicine and these topics are better addressed by professional organizations, medical schools, and postgraduate medical training.

Dr. Sitzman said the lack of strict guidelines is a positive thing.

Other organizations were also heartened by the rule change. In a statement, Dr. Rebecca Patchin, an American Medical Association board member, said the change “will give patients better access to the prescription drugs they need and continue to minimize the risks controlled substances pose to public health and safety.”

In a reversal, the Drug Enforcement Administration will now allow physicians to write up to three prescriptions for a 90-day supply of schedule II controlled substances.

The final rule, published in November, is viewed as a victory by pain medicine specialists, said Dr. B. Todd Sitzman, American Academy of Pain Medicine president and director of advanced pain therapy at the Forrest General Hospital's cancer center in Hattiesburg, Miss.

“It's an indication that [DEA officials] have listened to pain physicians and to the pain patient community,” he said in an interview.

The rule overturns an interim policy that prohibited the dispensing of multiple prescriptions at a single office visit and clarifies the DEA's expectations, said Dr. Sitzman.

Under the new policy, physicians may write prescriptions labeled “do not fill until,” with a preset date. This means patients can get a new prescription every 30 days, for 3 months, without having to return to the physician's office.

The prescriptions do not qualify as refills. They still must be taken to a pharmacy to be filled. DEA also said that the 90-day limit is the maximum according to its interpretation of congressional intent and the statute covering schedule II controlled substances.

In the rule, the DEA addressed several areas of concern to prescribing physicians.

The agency said it “wishes to dispel the mistaken notion among a small number of medical professionals that the agency has embarked on a campaign to 'target' physicians who prescribe controlled substances for the treatment of pain (or that physicians must curb their legitimate prescribing of pain medications to avoid legal liability).”

The agency noted that in any given year, fewer than 1 in 10,000 physicians lose their controlled substance registration because of a DEA investigation.

But, added the agency, the rule does not alter longstanding state and federal requirements that controlled substances can only be prescribed, administered or dispensed for a legitimate medical purpose by a physician acting in the usual course of professional practice.

The changes were first proposed in 2006, when the DEA was asked by commenters to issue specific guidance on how a clinician could assess pain, when a physician should prescribe an opioid, or how to use opioids.

But the agency said it would not do so, noting it does not regulate the practice of medicine and these topics are better addressed by professional organizations, medical schools, and postgraduate medical training.

Dr. Sitzman said the lack of strict guidelines is a positive thing.

Other organizations were also heartened by the rule change. In a statement, Dr. Rebecca Patchin, an American Medical Association board member, said the change “will give patients better access to the prescription drugs they need and continue to minimize the risks controlled substances pose to public health and safety.”

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

President Bush signed the legislation on December 29th. The law containing the SCHIP extension 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 resolutions that kept the entire federal government funded until December while lawmakers and President Bush wrangled over a 5-year reauthorization. The showdown ended in December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress allocated enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats sought to cover 10 million children.

“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,” Rep. Charles B. Rangel (D-N.Y.) said in a statement.

Also in a statement, House Speaker Nancy Pelosi said the bill “does not make headway in reducing the number of uninsured.” Sen. Charles Grassley (R-Iowa) said although the original bill was passed unanimously in the Senate, he knew it fell short of what many in Congress were hoping for.

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 proving that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure 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 at least two states, Vermont and Massachusetts, will soon meet the goal.

In a conference call, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a liberal-leaning think tank in Washington, said the directive could have a huge impact on enrollment. Fourteen states already 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 successfully voted to extend the State Children's Health Insurance Program to April 2009.

President Bush signed the legislation on December 29th. The law containing the SCHIP extension 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 resolutions that kept the entire federal government funded until December while lawmakers and President Bush wrangled over a 5-year reauthorization. The showdown ended in December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress allocated enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats sought to cover 10 million children.

“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,” Rep. Charles B. Rangel (D-N.Y.) said in a statement.

Also in a statement, House Speaker Nancy Pelosi said the bill “does not make headway in reducing the number of uninsured.” Sen. Charles Grassley (R-Iowa) said although the original bill was passed unanimously in the Senate, he knew it fell short of what many in Congress were hoping for.

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 proving that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure 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 at least two states, Vermont and Massachusetts, will soon meet the goal.

In a conference call, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a liberal-leaning think tank in Washington, said the directive could have a huge impact on enrollment. Fourteen states already 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 successfully voted to extend the State Children's Health Insurance Program to April 2009.

President Bush signed the legislation on December 29th. The law containing the SCHIP extension 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 resolutions that kept the entire federal government funded until December while lawmakers and President Bush wrangled over a 5-year reauthorization. The showdown ended in December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress allocated enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats sought to cover 10 million children.

“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,” Rep. Charles B. Rangel (D-N.Y.) said in a statement.

Also in a statement, House Speaker Nancy Pelosi said the bill “does not make headway in reducing the number of uninsured.” Sen. Charles Grassley (R-Iowa) said although the original bill was passed unanimously in the Senate, he knew it fell short of what many in Congress were hoping for.

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 proving that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure 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 at least two states, Vermont and Massachusetts, will soon meet the goal.

In a conference call, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a liberal-leaning think tank in Washington, said the directive could have a huge impact on enrollment. Fourteen states already 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.

The 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 November 16; 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,” said Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, 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 should be issued by April 1, 2008.

The 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 November 16; 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,” said Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, 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 should be issued by April 1, 2008.

The 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 November 16; 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,” said Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, 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 should be issued by April 1, 2008.

The 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, and the final e-prescribing standards should be issued by April 1.

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, 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 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.”

The 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, and the final e-prescribing standards should be issued by April 1.

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, 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 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.”

The 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, and the final e-prescribing standards should be issued by April 1.

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, 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 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.”

Practice Revenues Down, Costs Up

In 2006, the total revenue per full-time equivalent physician declined by 0.72% for cardiologists, while operating costs per FTE increased by 3% to $538,135, according to the recently published Medical Group Management Association cost survey. Operating costs are increasing largely because of a rise in practice overhead. The median total operating cost as a percentage of revenue has increased 12% since 2000, said MGMA. Sixty-nine percent of practices had total revenues of $10 million or above; the biggest slice, 21% of practices, had revenues of $10-$15 million. Sixty percent operated at a profit and 35% operated at a loss; 4% broke even. According to the survey, to which 94 cardiology and thoracic surgery practices responded, 51% of cardiovascular practices still keep paper medical records; 39% have electronic health records, 9% use a document-imaging management system, and 1% employ another method. A large majority of practices offered ultrasound in the office, but most did not offer in-office cardiac MRI, computed tomography, or peripheral vascular CT.

America's Cholesterol on Target

Americans have met the Healthy People 2010 goal of a serum total cholesterol level of 200 mg/dL or less, according to the Centers for Disease Control and Prevention's National Center for Health Statistics. Using data from the National Health and Nutrition Examination Survey (NHANES), CDC determined that the age-adjusted mean total cholesterol level for adults over age 20 years was 199 mg/dL in 2005–2006, which is a drop from 204 mg/dL in 1999–2000. The decline was primarily in men over age 40 years and women over age 60 years; there wasn't much change for other age and sex groups during that time period, according to the CDC. However, women over age 60 years had higher cholesterol levels than men their age, and higher than any other group.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands put upon it and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor-in-chief of the journal Science, in a statement.

FDA Sets User Fees for DTC Ads

The FDA is charging drug companies about $40,000 to review each of their direct-to-consumer television advertisements, according to a notice issued by the agency in December. Last September, Congress authorized FDA to create a user-fee program for the advisory review of DTC prescription-drug television advertisements. The program is voluntary; drug sponsors can choose whether to seek FDA advisory review of their ads before broadcast. However, if they seek review by the agency, they must pay the fee. The $41,390 fee established for fiscal year 2008 is based on the number of ads slated for review and is expected to generate $6.25 million in total revenues during the first year of the program.

Agency's Approval Plan Flawed

The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the agency in a Nov. 30 letter to reconsider its draft guidance. “[It] would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said. He asked the FDA for detailed information on development of the new policy.

Practice Revenues Down, Costs Up

In 2006, the total revenue per full-time equivalent physician declined by 0.72% for cardiologists, while operating costs per FTE increased by 3% to $538,135, according to the recently published Medical Group Management Association cost survey. Operating costs are increasing largely because of a rise in practice overhead. The median total operating cost as a percentage of revenue has increased 12% since 2000, said MGMA. Sixty-nine percent of practices had total revenues of $10 million or above; the biggest slice, 21% of practices, had revenues of $10-$15 million. Sixty percent operated at a profit and 35% operated at a loss; 4% broke even. According to the survey, to which 94 cardiology and thoracic surgery practices responded, 51% of cardiovascular practices still keep paper medical records; 39% have electronic health records, 9% use a document-imaging management system, and 1% employ another method. A large majority of practices offered ultrasound in the office, but most did not offer in-office cardiac MRI, computed tomography, or peripheral vascular CT.

America's Cholesterol on Target

Americans have met the Healthy People 2010 goal of a serum total cholesterol level of 200 mg/dL or less, according to the Centers for Disease Control and Prevention's National Center for Health Statistics. Using data from the National Health and Nutrition Examination Survey (NHANES), CDC determined that the age-adjusted mean total cholesterol level for adults over age 20 years was 199 mg/dL in 2005–2006, which is a drop from 204 mg/dL in 1999–2000. The decline was primarily in men over age 40 years and women over age 60 years; there wasn't much change for other age and sex groups during that time period, according to the CDC. However, women over age 60 years had higher cholesterol levels than men their age, and higher than any other group.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands put upon it and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor-in-chief of the journal Science, in a statement.

FDA Sets User Fees for DTC Ads

The FDA is charging drug companies about $40,000 to review each of their direct-to-consumer television advertisements, according to a notice issued by the agency in December. Last September, Congress authorized FDA to create a user-fee program for the advisory review of DTC prescription-drug television advertisements. The program is voluntary; drug sponsors can choose whether to seek FDA advisory review of their ads before broadcast. However, if they seek review by the agency, they must pay the fee. The $41,390 fee established for fiscal year 2008 is based on the number of ads slated for review and is expected to generate $6.25 million in total revenues during the first year of the program.

Agency's Approval Plan Flawed

The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the agency in a Nov. 30 letter to reconsider its draft guidance. “[It] would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said. He asked the FDA for detailed information on development of the new policy.

Practice Revenues Down, Costs Up

In 2006, the total revenue per full-time equivalent physician declined by 0.72% for cardiologists, while operating costs per FTE increased by 3% to $538,135, according to the recently published Medical Group Management Association cost survey. Operating costs are increasing largely because of a rise in practice overhead. The median total operating cost as a percentage of revenue has increased 12% since 2000, said MGMA. Sixty-nine percent of practices had total revenues of $10 million or above; the biggest slice, 21% of practices, had revenues of $10-$15 million. Sixty percent operated at a profit and 35% operated at a loss; 4% broke even. According to the survey, to which 94 cardiology and thoracic surgery practices responded, 51% of cardiovascular practices still keep paper medical records; 39% have electronic health records, 9% use a document-imaging management system, and 1% employ another method. A large majority of practices offered ultrasound in the office, but most did not offer in-office cardiac MRI, computed tomography, or peripheral vascular CT.

America's Cholesterol on Target

Americans have met the Healthy People 2010 goal of a serum total cholesterol level of 200 mg/dL or less, according to the Centers for Disease Control and Prevention's National Center for Health Statistics. Using data from the National Health and Nutrition Examination Survey (NHANES), CDC determined that the age-adjusted mean total cholesterol level for adults over age 20 years was 199 mg/dL in 2005–2006, which is a drop from 204 mg/dL in 1999–2000. The decline was primarily in men over age 40 years and women over age 60 years; there wasn't much change for other age and sex groups during that time period, according to the CDC. However, women over age 60 years had higher cholesterol levels than men their age, and higher than any other group.

FDA Can't Fulfill Mission

Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands put upon it and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor-in-chief of the journal Science, in a statement.

FDA Sets User Fees for DTC Ads

The FDA is charging drug companies about $40,000 to review each of their direct-to-consumer television advertisements, according to a notice issued by the agency in December. Last September, Congress authorized FDA to create a user-fee program for the advisory review of DTC prescription-drug television advertisements. The program is voluntary; drug sponsors can choose whether to seek FDA advisory review of their ads before broadcast. However, if they seek review by the agency, they must pay the fee. The $41,390 fee established for fiscal year 2008 is based on the number of ads slated for review and is expected to generate $6.25 million in total revenues during the first year of the program.

Agency's Approval Plan Flawed

The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the agency in a Nov. 30 letter to reconsider its draft guidance. “[It] would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said. He asked the FDA for detailed information on development of the new policy.

FDA Warning on Effexor

The Food and Drug Administration has warned Wyeth Pharmaceuticals that a journal ad for Effexor XR (venlafaxine) was misleading because it overstated the drug's efficacy, made unsubstantiated superiority claims, and minimized its risks. Effexor XR is approved for major depressive disorder. The ad suggested that patients who did not respond to other antidepressants could be successfully treated with Effexor XR; that superiority has not been demonstrated through substantial evidence or clinical experience, said the FDA. Wyeth also said that Effexor was used in 20 million patients; that is misleading because it is not an accurate tally of unique users, said the agency. “Falsely inflating the number of people treated with Effexor XR may mislead consumers and healthcare providers into inferring greater efficacy and safety than would be warranted by the actual numbers,” wrote the FDA.

Psych Disorders = More Drug Use

Men who have a psychiatric diagnosis tend to have higher rates of daily substance abuse, compared with peers who do not have a co-occurring diagnosis, according to a survey of men admitted to hospitals in 2005. The DASIS (Drug and Alcohol Services Information System) Report compiled data from 544,800 male hospital admissions in 26 states in 2005. Of those, 86,500 (16%) were for admission with co-occurring substance use and psychiatric disorders. Daily use of alcohol, cocaine, marijuana, and stimulants, were higher for those with a codiagnosis. These men also were more likely to report abuse of multiple substances, and to have started using alcohol or drugs before age 13 years. The DASIS Report is produced by the Substance Abuse and Mental Health Services Administration, and its most recent report was issued in mid-December. Copies can be found at

www.oas.samhsa.gov

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. “Health, United States, 2007” is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people between the ages of 18 and 64 years reported that they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care. Ten percent of 45- to 64-year-olds did not have a usual source of care. The report highlighted some other age-specific data as well. For instance, about 70% of men and more than 80% of women over age 75 either had hypertension or were taking antihypertensives in 2001–2004, compared with about 35% of adults aged 45–54. And about 20% of 16- to 17-year-olds, and more than 40% of 18- to 25-year-olds reported binge alcohol use in 2005; 20% of the latter age group reported illicit drug use in the previous month.

FDA Can't Fulfill Mission

Three members of the FDA Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor in chief of the journal Science, in a statement.

Agency's Approval Plan Flawed

FDA is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the FDA in a Nov. 30 letter to reconsider its draft guidance, which the congressman said was close to being finalized. “The draft guidance that I have obtained would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” Rep. Waxman said. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices.” He asked the FDA to provide detailed information on the development of the new policy and how it would address his concerns.

FDA Warning on Effexor

The Food and Drug Administration has warned Wyeth Pharmaceuticals that a journal ad for Effexor XR (venlafaxine) was misleading because it overstated the drug's efficacy, made unsubstantiated superiority claims, and minimized its risks. Effexor XR is approved for major depressive disorder. The ad suggested that patients who did not respond to other antidepressants could be successfully treated with Effexor XR; that superiority has not been demonstrated through substantial evidence or clinical experience, said the FDA. Wyeth also said that Effexor was used in 20 million patients; that is misleading because it is not an accurate tally of unique users, said the agency. “Falsely inflating the number of people treated with Effexor XR may mislead consumers and healthcare providers into inferring greater efficacy and safety than would be warranted by the actual numbers,” wrote the FDA.

Psych Disorders = More Drug Use

Men who have a psychiatric diagnosis tend to have higher rates of daily substance abuse, compared with peers who do not have a co-occurring diagnosis, according to a survey of men admitted to hospitals in 2005. The DASIS (Drug and Alcohol Services Information System) Report compiled data from 544,800 male hospital admissions in 26 states in 2005. Of those, 86,500 (16%) were for admission with co-occurring substance use and psychiatric disorders. Daily use of alcohol, cocaine, marijuana, and stimulants, were higher for those with a codiagnosis. These men also were more likely to report abuse of multiple substances, and to have started using alcohol or drugs before age 13 years. The DASIS Report is produced by the Substance Abuse and Mental Health Services Administration, and its most recent report was issued in mid-December. Copies can be found at

www.oas.samhsa.gov

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. “Health, United States, 2007” is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people between the ages of 18 and 64 years reported that they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care. Ten percent of 45- to 64-year-olds did not have a usual source of care. The report highlighted some other age-specific data as well. For instance, about 70% of men and more than 80% of women over age 75 either had hypertension or were taking antihypertensives in 2001–2004, compared with about 35% of adults aged 45–54. And about 20% of 16- to 17-year-olds, and more than 40% of 18- to 25-year-olds reported binge alcohol use in 2005; 20% of the latter age group reported illicit drug use in the previous month.

FDA Can't Fulfill Mission

Three members of the FDA Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor in chief of the journal Science, in a statement.

Agency's Approval Plan Flawed

FDA is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the FDA in a Nov. 30 letter to reconsider its draft guidance, which the congressman said was close to being finalized. “The draft guidance that I have obtained would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” Rep. Waxman said. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices.” He asked the FDA to provide detailed information on the development of the new policy and how it would address his concerns.

FDA Warning on Effexor

The Food and Drug Administration has warned Wyeth Pharmaceuticals that a journal ad for Effexor XR (venlafaxine) was misleading because it overstated the drug's efficacy, made unsubstantiated superiority claims, and minimized its risks. Effexor XR is approved for major depressive disorder. The ad suggested that patients who did not respond to other antidepressants could be successfully treated with Effexor XR; that superiority has not been demonstrated through substantial evidence or clinical experience, said the FDA. Wyeth also said that Effexor was used in 20 million patients; that is misleading because it is not an accurate tally of unique users, said the agency. “Falsely inflating the number of people treated with Effexor XR may mislead consumers and healthcare providers into inferring greater efficacy and safety than would be warranted by the actual numbers,” wrote the FDA.

Psych Disorders = More Drug Use

Men who have a psychiatric diagnosis tend to have higher rates of daily substance abuse, compared with peers who do not have a co-occurring diagnosis, according to a survey of men admitted to hospitals in 2005. The DASIS (Drug and Alcohol Services Information System) Report compiled data from 544,800 male hospital admissions in 26 states in 2005. Of those, 86,500 (16%) were for admission with co-occurring substance use and psychiatric disorders. Daily use of alcohol, cocaine, marijuana, and stimulants, were higher for those with a codiagnosis. These men also were more likely to report abuse of multiple substances, and to have started using alcohol or drugs before age 13 years. The DASIS Report is produced by the Substance Abuse and Mental Health Services Administration, and its most recent report was issued in mid-December. Copies can be found at

www.oas.samhsa.gov

Access Reduced by Cost

Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. “Health, United States, 2007” is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people between the ages of 18 and 64 years reported that they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care. Ten percent of 45- to 64-year-olds did not have a usual source of care. The report highlighted some other age-specific data as well. For instance, about 70% of men and more than 80% of women over age 75 either had hypertension or were taking antihypertensives in 2001–2004, compared with about 35% of adults aged 45–54. And about 20% of 16- to 17-year-olds, and more than 40% of 18- to 25-year-olds reported binge alcohol use in 2005; 20% of the latter age group reported illicit drug use in the previous month.

FDA Can't Fulfill Mission

Three members of the FDA Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor in chief of the journal Science, in a statement.

Agency's Approval Plan Flawed

FDA is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the FDA in a Nov. 30 letter to reconsider its draft guidance, which the congressman said was close to being finalized. “The draft guidance that I have obtained would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” Rep. Waxman said. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices.” He asked the FDA to provide detailed information on the development of the new policy and how it would address his concerns.

WASHINGTON – The Food and Drug Administration has no immediate plans to seek establishment of a new, behind-the-counter class of drugs, agency officials said at the conclusion of a day-long meeting on the topic in November.

FDA Deputy Commissioner for Policy Dr. Randall Lutter told reporters that he realized that by holding the meeting the agency had likely raised expectations that it would take action. But, he said, the FDA was merely soliciting views and comments on which, if any, pharmaceuticals might be moved to a special status by which they could be dispensed directly by a pharmacist after counseling, but without a physician's prescription.

The agency accepted comments until Nov. 28, and would decide afterward “whether additional action is appropriate,” said Dr. Lutter. He added that the FDA had no specific timetable in mind.

This is the fourth time the FDA has broached the idea of following the lead of several other nations, including Canada and the United Kingdom, by creating a third class of drugs.

At the public meeting, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, contended that the agency's latest foray had been “precipitated by drug companies who make statins and want to switch them to [over-the-counter].”

Merck & Co. has sought permission to sell lovastatin (Mevacor) over the counter in the United States. An FDA panel was due to review that request on Dec. 13.

Dr. Lutter said, however, that agency officials convened the meeting “on our own initiative,” and not at the behest of any drug maker. The agency decided to take another look at BTC (behind the counter) drugs because consumers increasingly are involved in their own health care and frequently use the Internet not just to access information, but also to buy products without a physician's advice or counsel, Dr. Lutter said.

A BTC class of drugs might be one way both to empower consumers and to ensure that they get safe and effective medications, he said.

Not surprisingly, pharmacists who spoke at the meeting were in favor of creating a new BTC class, while physicians were opposed. There was a mixed response from consumer advocates.

Joseph Cranston, Ph.D., a pharmacist and director of science, research, and technology for the American Medical Association, said that the AMA opposes creation of a BTC class. The FDA does not have the statutory authority to create such a class, he said, adding, “thus, it is perplexing that this meeting is even being held today.”

Dr. Cranston said that the AMA was concerned that insurers might require use of BTC medications before covering prescription medications, and that it wasn't clear if moving drugs behind the counter would increase or decrease access or costs.

Also, pharmacists do not have the training to make the same types of patient management decisions as physicians, he said.

The National Community Pharmacists Association said that BTC drugs could reduce consumer health care costs, increase patient convenience, and perhaps add yet another avenue to track postmarket drug safety. An early November survey of its membership found that 97% of members were in favor of the new BTC class, according to Stephen L. Giroux, who serves as NCPA president.

Dr. Giroux also cited polling data that showed that patients would support a BTC category.

Michael Moné, director of regulatory compliance for Medicine Shoppe International and a member of the American Pharmacists Association (APhA) board of trustees, said that having a BTC class of drugs would benefit consumers and public health. “With increased access to medications, combined with a pharmacist intervention, a patient is less likely to go untreated or incorrectly treated, and therefore is less likely to deal with more advanced symptoms or the adverse effects of inappropriate usage,” he said.

All pharmacy groups that presented at the meeting said that if BTC were to become a reality, standard protocols for dispensing and counseling should be established, and that pharmacists should be reimbursed for their services.

Some consumer advocacy groups expressed concern that insurers not only would not reimburse pharmacists, but that they would also drop coverage altogether of products that were moved behind the counter. Laurie Tansman of Mount Sinai Medical Center, New York, said that diabetes patients who could get oral agents BTC might forego hard lifestyle changes and perhaps skip needed physician visits.

The Consumer Healthcare Products Association, whose members make OTC products, argued against creation of a new class, saying that consumers were well served by the current two-class system. OTC switches have mostly been a success, said David C. Spangler, CHPA senior vice president for policy and international affairs.

George Quesnelle, president of GlaxoSmithKline Consumer Healthcare, echoed the CHPA position. GSK makes and markets Nicorette. Mr. Quesnelle said significantly more people have quit smoking since nicotine replacement products were moved OTC.

This idea was 'precipitated by drug companies' that want to switch statins to OTC status. DR. WOLFE

WASHINGTON – The Food and Drug Administration has no immediate plans to seek establishment of a new, behind-the-counter class of drugs, agency officials said at the conclusion of a day-long meeting on the topic in November.

FDA Deputy Commissioner for Policy Dr. Randall Lutter told reporters that he realized that by holding the meeting the agency had likely raised expectations that it would take action. But, he said, the FDA was merely soliciting views and comments on which, if any, pharmaceuticals might be moved to a special status by which they could be dispensed directly by a pharmacist after counseling, but without a physician's prescription.

The agency accepted comments until Nov. 28, and would decide afterward “whether additional action is appropriate,” said Dr. Lutter. He added that the FDA had no specific timetable in mind.

This is the fourth time the FDA has broached the idea of following the lead of several other nations, including Canada and the United Kingdom, by creating a third class of drugs.

At the public meeting, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, contended that the agency's latest foray had been “precipitated by drug companies who make statins and want to switch them to [over-the-counter].”

Merck & Co. has sought permission to sell lovastatin (Mevacor) over the counter in the United States. An FDA panel was due to review that request on Dec. 13.

Dr. Lutter said, however, that agency officials convened the meeting “on our own initiative,” and not at the behest of any drug maker. The agency decided to take another look at BTC (behind the counter) drugs because consumers increasingly are involved in their own health care and frequently use the Internet not just to access information, but also to buy products without a physician's advice or counsel, Dr. Lutter said.

A BTC class of drugs might be one way both to empower consumers and to ensure that they get safe and effective medications, he said.

Not surprisingly, pharmacists who spoke at the meeting were in favor of creating a new BTC class, while physicians were opposed. There was a mixed response from consumer advocates.

Joseph Cranston, Ph.D., a pharmacist and director of science, research, and technology for the American Medical Association, said that the AMA opposes creation of a BTC class. The FDA does not have the statutory authority to create such a class, he said, adding, “thus, it is perplexing that this meeting is even being held today.”

Dr. Cranston said that the AMA was concerned that insurers might require use of BTC medications before covering prescription medications, and that it wasn't clear if moving drugs behind the counter would increase or decrease access or costs.

Also, pharmacists do not have the training to make the same types of patient management decisions as physicians, he said.

The National Community Pharmacists Association said that BTC drugs could reduce consumer health care costs, increase patient convenience, and perhaps add yet another avenue to track postmarket drug safety. An early November survey of its membership found that 97% of members were in favor of the new BTC class, according to Stephen L. Giroux, who serves as NCPA president.

Dr. Giroux also cited polling data that showed that patients would support a BTC category.

Michael Moné, director of regulatory compliance for Medicine Shoppe International and a member of the American Pharmacists Association (APhA) board of trustees, said that having a BTC class of drugs would benefit consumers and public health. “With increased access to medications, combined with a pharmacist intervention, a patient is less likely to go untreated or incorrectly treated, and therefore is less likely to deal with more advanced symptoms or the adverse effects of inappropriate usage,” he said.

All pharmacy groups that presented at the meeting said that if BTC were to become a reality, standard protocols for dispensing and counseling should be established, and that pharmacists should be reimbursed for their services.

Some consumer advocacy groups expressed concern that insurers not only would not reimburse pharmacists, but that they would also drop coverage altogether of products that were moved behind the counter. Laurie Tansman of Mount Sinai Medical Center, New York, said that diabetes patients who could get oral agents BTC might forego hard lifestyle changes and perhaps skip needed physician visits.

The Consumer Healthcare Products Association, whose members make OTC products, argued against creation of a new class, saying that consumers were well served by the current two-class system. OTC switches have mostly been a success, said David C. Spangler, CHPA senior vice president for policy and international affairs.

George Quesnelle, president of GlaxoSmithKline Consumer Healthcare, echoed the CHPA position. GSK makes and markets Nicorette. Mr. Quesnelle said significantly more people have quit smoking since nicotine replacement products were moved OTC.

This idea was 'precipitated by drug companies' that want to switch statins to OTC status. DR. WOLFE

WASHINGTON – The Food and Drug Administration has no immediate plans to seek establishment of a new, behind-the-counter class of drugs, agency officials said at the conclusion of a day-long meeting on the topic in November.

FDA Deputy Commissioner for Policy Dr. Randall Lutter told reporters that he realized that by holding the meeting the agency had likely raised expectations that it would take action. But, he said, the FDA was merely soliciting views and comments on which, if any, pharmaceuticals might be moved to a special status by which they could be dispensed directly by a pharmacist after counseling, but without a physician's prescription.

The agency accepted comments until Nov. 28, and would decide afterward “whether additional action is appropriate,” said Dr. Lutter. He added that the FDA had no specific timetable in mind.

This is the fourth time the FDA has broached the idea of following the lead of several other nations, including Canada and the United Kingdom, by creating a third class of drugs.

At the public meeting, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, contended that the agency's latest foray had been “precipitated by drug companies who make statins and want to switch them to [over-the-counter].”

Merck & Co. has sought permission to sell lovastatin (Mevacor) over the counter in the United States. An FDA panel was due to review that request on Dec. 13.

Dr. Lutter said, however, that agency officials convened the meeting “on our own initiative,” and not at the behest of any drug maker. The agency decided to take another look at BTC (behind the counter) drugs because consumers increasingly are involved in their own health care and frequently use the Internet not just to access information, but also to buy products without a physician's advice or counsel, Dr. Lutter said.

A BTC class of drugs might be one way both to empower consumers and to ensure that they get safe and effective medications, he said.

Not surprisingly, pharmacists who spoke at the meeting were in favor of creating a new BTC class, while physicians were opposed. There was a mixed response from consumer advocates.

Joseph Cranston, Ph.D., a pharmacist and director of science, research, and technology for the American Medical Association, said that the AMA opposes creation of a BTC class. The FDA does not have the statutory authority to create such a class, he said, adding, “thus, it is perplexing that this meeting is even being held today.”

Dr. Cranston said that the AMA was concerned that insurers might require use of BTC medications before covering prescription medications, and that it wasn't clear if moving drugs behind the counter would increase or decrease access or costs.

Also, pharmacists do not have the training to make the same types of patient management decisions as physicians, he said.

The National Community Pharmacists Association said that BTC drugs could reduce consumer health care costs, increase patient convenience, and perhaps add yet another avenue to track postmarket drug safety. An early November survey of its membership found that 97% of members were in favor of the new BTC class, according to Stephen L. Giroux, who serves as NCPA president.

Dr. Giroux also cited polling data that showed that patients would support a BTC category.

Michael Moné, director of regulatory compliance for Medicine Shoppe International and a member of the American Pharmacists Association (APhA) board of trustees, said that having a BTC class of drugs would benefit consumers and public health. “With increased access to medications, combined with a pharmacist intervention, a patient is less likely to go untreated or incorrectly treated, and therefore is less likely to deal with more advanced symptoms or the adverse effects of inappropriate usage,” he said.

All pharmacy groups that presented at the meeting said that if BTC were to become a reality, standard protocols for dispensing and counseling should be established, and that pharmacists should be reimbursed for their services.

Some consumer advocacy groups expressed concern that insurers not only would not reimburse pharmacists, but that they would also drop coverage altogether of products that were moved behind the counter. Laurie Tansman of Mount Sinai Medical Center, New York, said that diabetes patients who could get oral agents BTC might forego hard lifestyle changes and perhaps skip needed physician visits.

The Consumer Healthcare Products Association, whose members make OTC products, argued against creation of a new class, saying that consumers were well served by the current two-class system. OTC switches have mostly been a success, said David C. Spangler, CHPA senior vice president for policy and international affairs.

George Quesnelle, president of GlaxoSmithKline Consumer Healthcare, echoed the CHPA position. GSK makes and markets Nicorette. Mr. Quesnelle said significantly more people have quit smoking since nicotine replacement products were moved OTC.

This idea was 'precipitated by drug companies' that want to switch statins to OTC status. DR. WOLFE

WASHINGTON — The National Committee for Quality Assurance in 2008 will begin reporting in earnest on how many myocardial infarction patients are receiving β-blockers 6 months after hospital discharge, as recommended by the American Heart Association and the American College of Cardiology.

The organization announced last September that it would no longer collect data on how many acute MI patients receive β-blockers within a week of hospital discharge.

First collected in 1996, that measure—an element of the Healthcare Effectiveness Data and Information Set (HEDIS)—was “retired” because so many patients are now meeting the benchmark, said NCQA president Margaret O'Kane at a briefing.

Of privately insured patients older than 35 years who had survived a heart attack, 98% were prescribed a β-blocker upon discharge in 2006, according to the most recent NCQA State of Health Care Quality report.

Postdischarge β-blockers were prescribed to 94% of Medicare managed care patients and 88% of Medicaid managed care patients in 2006.

When the measure was first reported, only “two-thirds of U.S. patients who survived acute myocardial infarction received β-blockers; today, nearly all do,” according to Dr. Thomas H. Lee, cochair of the NCQA Committee on Performance Measurement. “At least when it comes to this intervention, the U.S. health care system has become reliable” he said (N. Engl. J. Med. 2007;357:1175–7).

Thus, NCQA decided it would no longer collect this information. The organization decided to “evolve” the β-blocker measure by setting the bar higher, and began asking for the data in 2005, Ms. O'Kane said in an interview.

In the latest report, only 68% of Medicaid patients, 70% of Medicare patients, and 72% of privately insured patients were still taking β-blockers 6 months after an MI. There's a huge amount of variability among plans. Ms. O'Kane said she believes that putting more scrutiny on the 6-month measure is appropriate and will improve results.

Dr. James Dove, president of the American College of Cardiology, agreed that the 6-month measure was important—probably more important than whether patients were receiving β-blockers immediately after discharge.

Most post-MI care is done on an outpatient basis, Dr. Dove said in an interview. Plus, “the data suggest that most people who are on a β-blocker at 6 months got it at discharge,” he said, adding that the new measure will capture both the immediate postdischarge data and the picture at 6 months. Dr. Dove practices at Prairie Cardiovascular Consultants in Springfield, Ill.

It will be a challenge to both health plans and physicians to improve compliance rates, he said. Electronic health records could help; health plans could use the systems to send reminders, for instance, Dr. Dove said.

Patient compliance, however, is one of the biggest hurdles. Patients might not take medications for a variety of reasons—cost, forgetfulness, fears about side effects, or because they feel better, he said.

“It's our obligation as we see the patient to reinforce why they need to take the medication,” Dr. Dove said.

WASHINGTON — The National Committee for Quality Assurance in 2008 will begin reporting in earnest on how many myocardial infarction patients are receiving β-blockers 6 months after hospital discharge, as recommended by the American Heart Association and the American College of Cardiology.

The organization announced last September that it would no longer collect data on how many acute MI patients receive β-blockers within a week of hospital discharge.

First collected in 1996, that measure—an element of the Healthcare Effectiveness Data and Information Set (HEDIS)—was “retired” because so many patients are now meeting the benchmark, said NCQA president Margaret O'Kane at a briefing.

Of privately insured patients older than 35 years who had survived a heart attack, 98% were prescribed a β-blocker upon discharge in 2006, according to the most recent NCQA State of Health Care Quality report.

Postdischarge β-blockers were prescribed to 94% of Medicare managed care patients and 88% of Medicaid managed care patients in 2006.

When the measure was first reported, only “two-thirds of U.S. patients who survived acute myocardial infarction received β-blockers; today, nearly all do,” according to Dr. Thomas H. Lee, cochair of the NCQA Committee on Performance Measurement. “At least when it comes to this intervention, the U.S. health care system has become reliable” he said (N. Engl. J. Med. 2007;357:1175–7).

Thus, NCQA decided it would no longer collect this information. The organization decided to “evolve” the β-blocker measure by setting the bar higher, and began asking for the data in 2005, Ms. O'Kane said in an interview.

In the latest report, only 68% of Medicaid patients, 70% of Medicare patients, and 72% of privately insured patients were still taking β-blockers 6 months after an MI. There's a huge amount of variability among plans. Ms. O'Kane said she believes that putting more scrutiny on the 6-month measure is appropriate and will improve results.

Dr. James Dove, president of the American College of Cardiology, agreed that the 6-month measure was important—probably more important than whether patients were receiving β-blockers immediately after discharge.

Most post-MI care is done on an outpatient basis, Dr. Dove said in an interview. Plus, “the data suggest that most people who are on a β-blocker at 6 months got it at discharge,” he said, adding that the new measure will capture both the immediate postdischarge data and the picture at 6 months. Dr. Dove practices at Prairie Cardiovascular Consultants in Springfield, Ill.

It will be a challenge to both health plans and physicians to improve compliance rates, he said. Electronic health records could help; health plans could use the systems to send reminders, for instance, Dr. Dove said.

Patient compliance, however, is one of the biggest hurdles. Patients might not take medications for a variety of reasons—cost, forgetfulness, fears about side effects, or because they feel better, he said.

“It's our obligation as we see the patient to reinforce why they need to take the medication,” Dr. Dove said.

WASHINGTON — The National Committee for Quality Assurance in 2008 will begin reporting in earnest on how many myocardial infarction patients are receiving β-blockers 6 months after hospital discharge, as recommended by the American Heart Association and the American College of Cardiology.

The organization announced last September that it would no longer collect data on how many acute MI patients receive β-blockers within a week of hospital discharge.

First collected in 1996, that measure—an element of the Healthcare Effectiveness Data and Information Set (HEDIS)—was “retired” because so many patients are now meeting the benchmark, said NCQA president Margaret O'Kane at a briefing.

Of privately insured patients older than 35 years who had survived a heart attack, 98% were prescribed a β-blocker upon discharge in 2006, according to the most recent NCQA State of Health Care Quality report.

Postdischarge β-blockers were prescribed to 94% of Medicare managed care patients and 88% of Medicaid managed care patients in 2006.

When the measure was first reported, only “two-thirds of U.S. patients who survived acute myocardial infarction received β-blockers; today, nearly all do,” according to Dr. Thomas H. Lee, cochair of the NCQA Committee on Performance Measurement. “At least when it comes to this intervention, the U.S. health care system has become reliable” he said (N. Engl. J. Med. 2007;357:1175–7).

Thus, NCQA decided it would no longer collect this information. The organization decided to “evolve” the β-blocker measure by setting the bar higher, and began asking for the data in 2005, Ms. O'Kane said in an interview.

In the latest report, only 68% of Medicaid patients, 70% of Medicare patients, and 72% of privately insured patients were still taking β-blockers 6 months after an MI. There's a huge amount of variability among plans. Ms. O'Kane said she believes that putting more scrutiny on the 6-month measure is appropriate and will improve results.

Dr. James Dove, president of the American College of Cardiology, agreed that the 6-month measure was important—probably more important than whether patients were receiving β-blockers immediately after discharge.

Most post-MI care is done on an outpatient basis, Dr. Dove said in an interview. Plus, “the data suggest that most people who are on a β-blocker at 6 months got it at discharge,” he said, adding that the new measure will capture both the immediate postdischarge data and the picture at 6 months. Dr. Dove practices at Prairie Cardiovascular Consultants in Springfield, Ill.

It will be a challenge to both health plans and physicians to improve compliance rates, he said. Electronic health records could help; health plans could use the systems to send reminders, for instance, Dr. Dove said.

Patient compliance, however, is one of the biggest hurdles. Patients might not take medications for a variety of reasons—cost, forgetfulness, fears about side effects, or because they feel better, he said.

“It's our obligation as we see the patient to reinforce why they need to take the medication,” Dr. Dove said.

Participants in several hospital and physician-related quality organizations are sanguine that almost $16 million in grants from the Robert Wood Johnson Foundation will hasten development of national cost and quality measures, as well as acceptance of those measures.

The foundation awarded $8.7 million to the Engelberg Center for Health Care Reform at the Washington-based Brookings Institution, $4.2 million to the America's Health Insurance Plans (AHIP) Foundation, and another $3 million to various other groups to identify potential cost measures.

The project will be coordinated by Dr. Mark McClellan, the former commissioner of the Food and Drug Administration and former administrator of the Centers for Medicare and Medicaid Services, who now directs the Engelberg Center.

The grants will help "fill in the gaps" of the work being done by the Quality Alliance Steering Committee (QASC), said Susan Pisano, a spokeswoman for the AHIP Foundation. The steering committee is an amalgam of the Hospital Quality Alliance and the AQA, bringing together hospital and physician concerns.

"By bringing all stakeholders in the health care system together, this new project is an important step in accelerating the current slow pace of improvement in health care quality," said Dr. Carolyn Clancy, director of the Agency for Health Care Research and Quality, and cochair of the QASC, in a statement.

The RWJ Foundation's backing also serves as recognition that the steering committee's efforts are worthwhile, said Dr. Frank Opelka, vice chancellor of clinical affairs at the Louisiana State University Health Sciences Center, and the American College of Surgeons' representative on the QASC.

Established in 2006, the steering committee's principal members include: the RWJ Foundation, the American Medical Association, the American College of Physicians, the Association of American Medical Colleges, the Federation of American Hospitals, Blue Cross/Blue Shield, the American Hospital Association, the Society of Thoracic Surgeons, AHIP, the AFL-CIO, the National Partnership for Women and Families, the National Business Coalition on Health, the Pacific Business Group on Health, General Motors, Honeywell, Boeing, Exxon Mobil, the Joint Commission, the AHRQ, the Centers for Medicare and Medicaid Services, the National Quality Forum (NQF), and the National Committee for Quality Assurance.

The group will use performance measures that have been developed and endorsed by the NQF and AQA, but will use them in conjunction with a new database being developed by AHIP. The data will be collected from private plans and Medicare—all from claims—and aggregated into a practice-wide and a nationwide picture, said Ms. Pisano. The database means that reports back to physicians will "provide a more comprehensive view of their practices," she said. Instead of getting a report from one plan on all that plan's patients, and another from another plan, it will be a report that cuts across all insurers.

The bigger picture is important because it will give physicians the information they need to evaluate their performance across an entire practice, not just a single encounter, said Dr. John Tooker, executive vice president and CEO of the American College of Physicians.

It also will make for more accurate reporting, he said, noting that with a larger sample, there should be fewer outlier patients to skew a physician's rating.

The RWJ Foundation grants will also support the development of cost measures that will look at how physicians and hospitals use resources and compare them with national data. Initially, measures will be developed for 20 common conditions.

Both the quality and cost data will also eventually be shared with consumers.

Participants in several hospital and physician-related quality organizations are sanguine that almost $16 million in grants from the Robert Wood Johnson Foundation will hasten development of national cost and quality measures, as well as acceptance of those measures.

The foundation awarded $8.7 million to the Engelberg Center for Health Care Reform at the Washington-based Brookings Institution, $4.2 million to the America's Health Insurance Plans (AHIP) Foundation, and another $3 million to various other groups to identify potential cost measures.

The project will be coordinated by Dr. Mark McClellan, the former commissioner of the Food and Drug Administration and former administrator of the Centers for Medicare and Medicaid Services, who now directs the Engelberg Center.

The grants will help "fill in the gaps" of the work being done by the Quality Alliance Steering Committee (QASC), said Susan Pisano, a spokeswoman for the AHIP Foundation. The steering committee is an amalgam of the Hospital Quality Alliance and the AQA, bringing together hospital and physician concerns.

"By bringing all stakeholders in the health care system together, this new project is an important step in accelerating the current slow pace of improvement in health care quality," said Dr. Carolyn Clancy, director of the Agency for Health Care Research and Quality, and cochair of the QASC, in a statement.

The RWJ Foundation's backing also serves as recognition that the steering committee's efforts are worthwhile, said Dr. Frank Opelka, vice chancellor of clinical affairs at the Louisiana State University Health Sciences Center, and the American College of Surgeons' representative on the QASC.

Established in 2006, the steering committee's principal members include: the RWJ Foundation, the American Medical Association, the American College of Physicians, the Association of American Medical Colleges, the Federation of American Hospitals, Blue Cross/Blue Shield, the American Hospital Association, the Society of Thoracic Surgeons, AHIP, the AFL-CIO, the National Partnership for Women and Families, the National Business Coalition on Health, the Pacific Business Group on Health, General Motors, Honeywell, Boeing, Exxon Mobil, the Joint Commission, the AHRQ, the Centers for Medicare and Medicaid Services, the National Quality Forum (NQF), and the National Committee for Quality Assurance.

The group will use performance measures that have been developed and endorsed by the NQF and AQA, but will use them in conjunction with a new database being developed by AHIP. The data will be collected from private plans and Medicare—all from claims—and aggregated into a practice-wide and a nationwide picture, said Ms. Pisano. The database means that reports back to physicians will "provide a more comprehensive view of their practices," she said. Instead of getting a report from one plan on all that plan's patients, and another from another plan, it will be a report that cuts across all insurers.

The bigger picture is important because it will give physicians the information they need to evaluate their performance across an entire practice, not just a single encounter, said Dr. John Tooker, executive vice president and CEO of the American College of Physicians.

It also will make for more accurate reporting, he said, noting that with a larger sample, there should be fewer outlier patients to skew a physician's rating.

The RWJ Foundation grants will also support the development of cost measures that will look at how physicians and hospitals use resources and compare them with national data. Initially, measures will be developed for 20 common conditions.

Both the quality and cost data will also eventually be shared with consumers.

Participants in several hospital and physician-related quality organizations are sanguine that almost $16 million in grants from the Robert Wood Johnson Foundation will hasten development of national cost and quality measures, as well as acceptance of those measures.

The foundation awarded $8.7 million to the Engelberg Center for Health Care Reform at the Washington-based Brookings Institution, $4.2 million to the America's Health Insurance Plans (AHIP) Foundation, and another $3 million to various other groups to identify potential cost measures.

The project will be coordinated by Dr. Mark McClellan, the former commissioner of the Food and Drug Administration and former administrator of the Centers for Medicare and Medicaid Services, who now directs the Engelberg Center.

The grants will help "fill in the gaps" of the work being done by the Quality Alliance Steering Committee (QASC), said Susan Pisano, a spokeswoman for the AHIP Foundation. The steering committee is an amalgam of the Hospital Quality Alliance and the AQA, bringing together hospital and physician concerns.

"By bringing all stakeholders in the health care system together, this new project is an important step in accelerating the current slow pace of improvement in health care quality," said Dr. Carolyn Clancy, director of the Agency for Health Care Research and Quality, and cochair of the QASC, in a statement.

The RWJ Foundation's backing also serves as recognition that the steering committee's efforts are worthwhile, said Dr. Frank Opelka, vice chancellor of clinical affairs at the Louisiana State University Health Sciences Center, and the American College of Surgeons' representative on the QASC.

Established in 2006, the steering committee's principal members include: the RWJ Foundation, the American Medical Association, the American College of Physicians, the Association of American Medical Colleges, the Federation of American Hospitals, Blue Cross/Blue Shield, the American Hospital Association, the Society of Thoracic Surgeons, AHIP, the AFL-CIO, the National Partnership for Women and Families, the National Business Coalition on Health, the Pacific Business Group on Health, General Motors, Honeywell, Boeing, Exxon Mobil, the Joint Commission, the AHRQ, the Centers for Medicare and Medicaid Services, the National Quality Forum (NQF), and the National Committee for Quality Assurance.

The group will use performance measures that have been developed and endorsed by the NQF and AQA, but will use them in conjunction with a new database being developed by AHIP. The data will be collected from private plans and Medicare—all from claims—and aggregated into a practice-wide and a nationwide picture, said Ms. Pisano. The database means that reports back to physicians will "provide a more comprehensive view of their practices," she said. Instead of getting a report from one plan on all that plan's patients, and another from another plan, it will be a report that cuts across all insurers.

The bigger picture is important because it will give physicians the information they need to evaluate their performance across an entire practice, not just a single encounter, said Dr. John Tooker, executive vice president and CEO of the American College of Physicians.

It also will make for more accurate reporting, he said, noting that with a larger sample, there should be fewer outlier patients to skew a physician's rating.

The RWJ Foundation grants will also support the development of cost measures that will look at how physicians and hospitals use resources and compare them with national data. Initially, measures will be developed for 20 common conditions.

Both the quality and cost data will also eventually be shared with consumers.