Alicia Ault

WASHINGTON — As a Senate panel opened debate on reauthorization of the State Children's Health Insurance Program, legislators had doubts about expanding coverage to an estimated 9 million children who are eligible but who have not yet been enrolled.

SCHIP is due to expire on Sept. 30, but most states have been straining in the last few years to pay for children already covered by the program, several witnesses said at a meeting of the Senate Finance Committee.

Members of the committee also acknowledged that reality.

"Congress has simply not given [SCHIP] enough funds to meet the current demand for services," said committee chair Max Baucus (D-Mont.), who estimated that the program would need $12 billion to $15 billion over the next 5 years to maintain current coverage and $45 billion to bring all eligible children into SCHIP.

A last-minute deal signed into law at the end of 2006 allocated $271 million to cover anticipated shortfalls for a dozen or so states, but at least 14 more states will run out of SCHIP funds for fiscal 2007 if Congress does not enact another bailout by mid-May, said Sen. Baucus.

In 2007, states will spend an estimated $6.3 billion on SCHIP, but only $5 billion has been allotted, said Cindy Mann, executive director of the Georgetown University Center for Children and Families. Without an influx of federal cash, 37 states will run out of funds this year, Ms. Mann testified to the Finance Committee.

As of fiscal 2005, SCHIP had 6 million enrollees, according to a Government Accountability Office (GAO) report released at the Finance Committee hearing. Enrollment grew fastest during the early years of the program and leveled off more recently.

Georgia Gov. Sonny Perdue testified that there has been no slowing of enrollment in his state, with an average 19% per month increase since June 2005. About 273,000 children are covered in Georgia, making it the fourth-largest SCHIP program in the country, he said. The Centers for Medicare and Medicaid Services had projected that only 130,000 children were eligible in Georgia, he said.

But, because of SCHIP rules, states that cover more children end up receiving a smaller allotment for the following year. "The successful implementation of SCHIP in any state automatically undermines maintaining funding to keep these kids enrolled in the program," Gov. Perdue testified, arguing for a change in the SCHIP funding formula.

Some senators questioned whether states' flexibility should be reined in, saying that some initiatives might be diluting the program's intent—to cover low-income children.

Generally, federal law allows states to cover children in families with incomes up to 200% of the poverty level or 50 percentage points above the Medicaid eligibility standard as of 1997. According to the GAO report, seven states were covering families with incomes at 300% of the poverty level or higher. Thirty-nine states require some cost sharing by families, but 11 states charge no premiums or copayments.

Fifteen states cover adults—generally parents of Medicaid- or SCHIP-eligible children, pregnant women, or childless adults. The Health and Human Services department has granted waivers for those states, said Kathryn G. Allen, director of health care at the GAO.

Sen. Charles Grassley (R-Iowa), ranking minority member of the Finance Committee, said he was interested in giving states more flexibility but was not happy about extending coverage to adults.

"The issue is whether SCHIP funds used to cover adults has drained resources targeted by Congress for kids," said Sen. Grassley. "The 'C' stands for children. There is no 'A' in SCHIP."

Sen. Orrin Hatch (R-Utah) also questioned how states had been allowed to extend SCHIP benefits to adults.

"We have to question whether these waivers have been properly approved," said Sen. Hatch.

Ms. Mann counseled senators to keep adult coverage in perspective, noting that only 600,000 of the 6 million SCHIP enrollees are adults, and that it has been shown that when parents and children have health insurance, the whole family benefits.

WASHINGTON — As a Senate panel opened debate on reauthorization of the State Children's Health Insurance Program, legislators had doubts about expanding coverage to an estimated 9 million children who are eligible but who have not yet been enrolled.

SCHIP is due to expire on Sept. 30, but most states have been straining in the last few years to pay for children already covered by the program, several witnesses said at a meeting of the Senate Finance Committee.

Members of the committee also acknowledged that reality.

"Congress has simply not given [SCHIP] enough funds to meet the current demand for services," said committee chair Max Baucus (D-Mont.), who estimated that the program would need $12 billion to $15 billion over the next 5 years to maintain current coverage and $45 billion to bring all eligible children into SCHIP.

A last-minute deal signed into law at the end of 2006 allocated $271 million to cover anticipated shortfalls for a dozen or so states, but at least 14 more states will run out of SCHIP funds for fiscal 2007 if Congress does not enact another bailout by mid-May, said Sen. Baucus.

In 2007, states will spend an estimated $6.3 billion on SCHIP, but only $5 billion has been allotted, said Cindy Mann, executive director of the Georgetown University Center for Children and Families. Without an influx of federal cash, 37 states will run out of funds this year, Ms. Mann testified to the Finance Committee.

As of fiscal 2005, SCHIP had 6 million enrollees, according to a Government Accountability Office (GAO) report released at the Finance Committee hearing. Enrollment grew fastest during the early years of the program and leveled off more recently.

Georgia Gov. Sonny Perdue testified that there has been no slowing of enrollment in his state, with an average 19% per month increase since June 2005. About 273,000 children are covered in Georgia, making it the fourth-largest SCHIP program in the country, he said. The Centers for Medicare and Medicaid Services had projected that only 130,000 children were eligible in Georgia, he said.

But, because of SCHIP rules, states that cover more children end up receiving a smaller allotment for the following year. "The successful implementation of SCHIP in any state automatically undermines maintaining funding to keep these kids enrolled in the program," Gov. Perdue testified, arguing for a change in the SCHIP funding formula.

Some senators questioned whether states' flexibility should be reined in, saying that some initiatives might be diluting the program's intent—to cover low-income children.

Generally, federal law allows states to cover children in families with incomes up to 200% of the poverty level or 50 percentage points above the Medicaid eligibility standard as of 1997. According to the GAO report, seven states were covering families with incomes at 300% of the poverty level or higher. Thirty-nine states require some cost sharing by families, but 11 states charge no premiums or copayments.

Fifteen states cover adults—generally parents of Medicaid- or SCHIP-eligible children, pregnant women, or childless adults. The Health and Human Services department has granted waivers for those states, said Kathryn G. Allen, director of health care at the GAO.

Sen. Charles Grassley (R-Iowa), ranking minority member of the Finance Committee, said he was interested in giving states more flexibility but was not happy about extending coverage to adults.

"The issue is whether SCHIP funds used to cover adults has drained resources targeted by Congress for kids," said Sen. Grassley. "The 'C' stands for children. There is no 'A' in SCHIP."

Sen. Orrin Hatch (R-Utah) also questioned how states had been allowed to extend SCHIP benefits to adults.

"We have to question whether these waivers have been properly approved," said Sen. Hatch.

Ms. Mann counseled senators to keep adult coverage in perspective, noting that only 600,000 of the 6 million SCHIP enrollees are adults, and that it has been shown that when parents and children have health insurance, the whole family benefits.

WASHINGTON — As a Senate panel opened debate on reauthorization of the State Children's Health Insurance Program, legislators had doubts about expanding coverage to an estimated 9 million children who are eligible but who have not yet been enrolled.

SCHIP is due to expire on Sept. 30, but most states have been straining in the last few years to pay for children already covered by the program, several witnesses said at a meeting of the Senate Finance Committee.

Members of the committee also acknowledged that reality.

"Congress has simply not given [SCHIP] enough funds to meet the current demand for services," said committee chair Max Baucus (D-Mont.), who estimated that the program would need $12 billion to $15 billion over the next 5 years to maintain current coverage and $45 billion to bring all eligible children into SCHIP.

A last-minute deal signed into law at the end of 2006 allocated $271 million to cover anticipated shortfalls for a dozen or so states, but at least 14 more states will run out of SCHIP funds for fiscal 2007 if Congress does not enact another bailout by mid-May, said Sen. Baucus.

In 2007, states will spend an estimated $6.3 billion on SCHIP, but only $5 billion has been allotted, said Cindy Mann, executive director of the Georgetown University Center for Children and Families. Without an influx of federal cash, 37 states will run out of funds this year, Ms. Mann testified to the Finance Committee.

As of fiscal 2005, SCHIP had 6 million enrollees, according to a Government Accountability Office (GAO) report released at the Finance Committee hearing. Enrollment grew fastest during the early years of the program and leveled off more recently.

Georgia Gov. Sonny Perdue testified that there has been no slowing of enrollment in his state, with an average 19% per month increase since June 2005. About 273,000 children are covered in Georgia, making it the fourth-largest SCHIP program in the country, he said. The Centers for Medicare and Medicaid Services had projected that only 130,000 children were eligible in Georgia, he said.

But, because of SCHIP rules, states that cover more children end up receiving a smaller allotment for the following year. "The successful implementation of SCHIP in any state automatically undermines maintaining funding to keep these kids enrolled in the program," Gov. Perdue testified, arguing for a change in the SCHIP funding formula.

Some senators questioned whether states' flexibility should be reined in, saying that some initiatives might be diluting the program's intent—to cover low-income children.

Generally, federal law allows states to cover children in families with incomes up to 200% of the poverty level or 50 percentage points above the Medicaid eligibility standard as of 1997. According to the GAO report, seven states were covering families with incomes at 300% of the poverty level or higher. Thirty-nine states require some cost sharing by families, but 11 states charge no premiums or copayments.

Fifteen states cover adults—generally parents of Medicaid- or SCHIP-eligible children, pregnant women, or childless adults. The Health and Human Services department has granted waivers for those states, said Kathryn G. Allen, director of health care at the GAO.

Sen. Charles Grassley (R-Iowa), ranking minority member of the Finance Committee, said he was interested in giving states more flexibility but was not happy about extending coverage to adults.

"The issue is whether SCHIP funds used to cover adults has drained resources targeted by Congress for kids," said Sen. Grassley. "The 'C' stands for children. There is no 'A' in SCHIP."

Sen. Orrin Hatch (R-Utah) also questioned how states had been allowed to extend SCHIP benefits to adults.

"We have to question whether these waivers have been properly approved," said Sen. Hatch.

Ms. Mann counseled senators to keep adult coverage in perspective, noting that only 600,000 of the 6 million SCHIP enrollees are adults, and that it has been shown that when parents and children have health insurance, the whole family benefits.

Specific Measures for PVRP

Beginning this year, dermatologists will have an opportunity to directly participate in the Physicians Voluntary Reporting Program with the Centers for Medicare and Medicaid Services. Three dermatology-specific measures are included for 2007, Dr. Stephen Stone, president of the American Academy of Dermatology, said at the academy's annual meeting. Dermatologists who wish to participate in the program will be asked to submit data to the CMS on three melanoma-related components: patient medical history, complete physical examination, and counseling on skin self-examination. Both G codes and CPT II codes will be available for these measures, said Dr. Stone. The G codes are temporary and will be used until all data can be submitted electronically.

State Victories in 2006

At the AAD meeting, Dr. Stone also enumerated several legislative and regulatory victories for dermatologists at the state government level. In Wisconsin, dermatologists worked with plastic surgeons to defeat a proposal that would allow aestheticians to expand their scope of practice to include performance of chemical peels under remote supervision. The final rule restricted the providers to performing chemical exfoliation only, not medical grade peels, said Dr. Stone. This year, the AAD is fending off encroachment by nondermatologists in a number of states including Georgia, Mississippi, Missouri, New York, Oklahoma, Texas, Virginia, and Wisconsin, he said. In New Jersey, dermatologists, plastic surgeons, ophthalmologists, and other physicians worked together to repeal a 6% gross receipts tax on cosmetic procedures that went into effect in 2004. The repeal bill passed both houses of the New Jersey legislature and is awaiting the governor's signature, Dr. Stone said. There was one defeat. Pathologists in Missouri successfully secured passage of a law that allowed them to directly bill patients. Dr. Stone urged AAD members to get involved in government affairs at all levels. "The more representation we have, the more influence we will have," he said.

Derms Don't Get No Respect

In what seems to be a yearly effort, the AAD is launching an ad campaign to boost dermatologists' profile as specialists. "The public is confused about who really has the expertise [to provide skin care] and they are getting misleading messages," Dr. Stone said at the AAD meeting. "Unless the public understands the distinction between a dermatologist and nondermatologist, this problem will continue to grow," he added. Therefore, the academy will run a national print advertising campaign "that conveys the essence of the specialty" in the March issue of six national magazines, including Prevention, Real Simple, Redbook, and O: The Oprah Magazine. The ads ask: "There are thousands of reasons to see a dermatologist, what's yours?" and end by telling consumers, "Trust the expert care of a board-certified dermatologist." Dr. Stone said the ad "communicates our message in an assertive but nonthreatening way."

FDA's $2 Billion Budget

The Bush administration is requesting $2.1 billion for the Food and Drug Administration in fiscal 2008, a 5% increase from the previous year's request. The agency still has not received its final appropriation for fiscal 2007, so the exact amount it will receive for that year is not known yet. The budget includes $444 million in user fees from industry, including a new program to charge generic drug makers fees to review their products. The agency estimates that generic companies will contribute $16 million in fiscal 2008. In a statement, Generic Pharmaceutical Association CEO Kathleen Jaeger said the decision to seek user fees "will not bring generic medicines to consumers faster as long as brand companies are still permitted to use tactics that delay market entry." The budget also includes $11 million for improving drug safety (this does not include user fee funds that will also go to that effort) and $7 million to boost medical device safety and to speed up device review. The agency also is requesting $13 million to move about 1,300 employees of the Center for Devices and Radiological Health to offices at the FDA's new White Oak, Md., campus. The FDA has been gradually moving its operations to the new facilities. The Washington-based consumer-, patient- and industry-supported Coalition for a Stronger FDA said the budget did not go far enough. It is seeking at least $175 million more, including greater increases for food, drug, and medical device safety.

Medicare Generic Drug Use Rises

The CMS says that generic drugs accounted for 60% of the prescriptions dispensed to people who receive benefits through either Part D or Medicare Advantage plans for the first three-quarters of 2006. Generic drug use among Part D enrollees is 13% higher than for Americans who receive benefits through private payers, said the CMS. The agency said that in 2006, generics accounted for 53% of prescriptions dispensed to privately insured Americans. Greater use of generics will translate into lower costs for the Part D program and possibly expanded coverage for beneficiaries, according to the CMS. "We will continue to promote generics where they are available as an important strategy to keep the new drug benefit affordable over the long term," CMS Acting Administrator Leslie Norwalk said in a statement.

Specific Measures for PVRP

Beginning this year, dermatologists will have an opportunity to directly participate in the Physicians Voluntary Reporting Program with the Centers for Medicare and Medicaid Services. Three dermatology-specific measures are included for 2007, Dr. Stephen Stone, president of the American Academy of Dermatology, said at the academy's annual meeting. Dermatologists who wish to participate in the program will be asked to submit data to the CMS on three melanoma-related components: patient medical history, complete physical examination, and counseling on skin self-examination. Both G codes and CPT II codes will be available for these measures, said Dr. Stone. The G codes are temporary and will be used until all data can be submitted electronically.

State Victories in 2006

At the AAD meeting, Dr. Stone also enumerated several legislative and regulatory victories for dermatologists at the state government level. In Wisconsin, dermatologists worked with plastic surgeons to defeat a proposal that would allow aestheticians to expand their scope of practice to include performance of chemical peels under remote supervision. The final rule restricted the providers to performing chemical exfoliation only, not medical grade peels, said Dr. Stone. This year, the AAD is fending off encroachment by nondermatologists in a number of states including Georgia, Mississippi, Missouri, New York, Oklahoma, Texas, Virginia, and Wisconsin, he said. In New Jersey, dermatologists, plastic surgeons, ophthalmologists, and other physicians worked together to repeal a 6% gross receipts tax on cosmetic procedures that went into effect in 2004. The repeal bill passed both houses of the New Jersey legislature and is awaiting the governor's signature, Dr. Stone said. There was one defeat. Pathologists in Missouri successfully secured passage of a law that allowed them to directly bill patients. Dr. Stone urged AAD members to get involved in government affairs at all levels. "The more representation we have, the more influence we will have," he said.

Derms Don't Get No Respect

In what seems to be a yearly effort, the AAD is launching an ad campaign to boost dermatologists' profile as specialists. "The public is confused about who really has the expertise [to provide skin care] and they are getting misleading messages," Dr. Stone said at the AAD meeting. "Unless the public understands the distinction between a dermatologist and nondermatologist, this problem will continue to grow," he added. Therefore, the academy will run a national print advertising campaign "that conveys the essence of the specialty" in the March issue of six national magazines, including Prevention, Real Simple, Redbook, and O: The Oprah Magazine. The ads ask: "There are thousands of reasons to see a dermatologist, what's yours?" and end by telling consumers, "Trust the expert care of a board-certified dermatologist." Dr. Stone said the ad "communicates our message in an assertive but nonthreatening way."

FDA's $2 Billion Budget

The Bush administration is requesting $2.1 billion for the Food and Drug Administration in fiscal 2008, a 5% increase from the previous year's request. The agency still has not received its final appropriation for fiscal 2007, so the exact amount it will receive for that year is not known yet. The budget includes $444 million in user fees from industry, including a new program to charge generic drug makers fees to review their products. The agency estimates that generic companies will contribute $16 million in fiscal 2008. In a statement, Generic Pharmaceutical Association CEO Kathleen Jaeger said the decision to seek user fees "will not bring generic medicines to consumers faster as long as brand companies are still permitted to use tactics that delay market entry." The budget also includes $11 million for improving drug safety (this does not include user fee funds that will also go to that effort) and $7 million to boost medical device safety and to speed up device review. The agency also is requesting $13 million to move about 1,300 employees of the Center for Devices and Radiological Health to offices at the FDA's new White Oak, Md., campus. The FDA has been gradually moving its operations to the new facilities. The Washington-based consumer-, patient- and industry-supported Coalition for a Stronger FDA said the budget did not go far enough. It is seeking at least $175 million more, including greater increases for food, drug, and medical device safety.

Medicare Generic Drug Use Rises

The CMS says that generic drugs accounted for 60% of the prescriptions dispensed to people who receive benefits through either Part D or Medicare Advantage plans for the first three-quarters of 2006. Generic drug use among Part D enrollees is 13% higher than for Americans who receive benefits through private payers, said the CMS. The agency said that in 2006, generics accounted for 53% of prescriptions dispensed to privately insured Americans. Greater use of generics will translate into lower costs for the Part D program and possibly expanded coverage for beneficiaries, according to the CMS. "We will continue to promote generics where they are available as an important strategy to keep the new drug benefit affordable over the long term," CMS Acting Administrator Leslie Norwalk said in a statement.

Specific Measures for PVRP

Beginning this year, dermatologists will have an opportunity to directly participate in the Physicians Voluntary Reporting Program with the Centers for Medicare and Medicaid Services. Three dermatology-specific measures are included for 2007, Dr. Stephen Stone, president of the American Academy of Dermatology, said at the academy's annual meeting. Dermatologists who wish to participate in the program will be asked to submit data to the CMS on three melanoma-related components: patient medical history, complete physical examination, and counseling on skin self-examination. Both G codes and CPT II codes will be available for these measures, said Dr. Stone. The G codes are temporary and will be used until all data can be submitted electronically.

State Victories in 2006

At the AAD meeting, Dr. Stone also enumerated several legislative and regulatory victories for dermatologists at the state government level. In Wisconsin, dermatologists worked with plastic surgeons to defeat a proposal that would allow aestheticians to expand their scope of practice to include performance of chemical peels under remote supervision. The final rule restricted the providers to performing chemical exfoliation only, not medical grade peels, said Dr. Stone. This year, the AAD is fending off encroachment by nondermatologists in a number of states including Georgia, Mississippi, Missouri, New York, Oklahoma, Texas, Virginia, and Wisconsin, he said. In New Jersey, dermatologists, plastic surgeons, ophthalmologists, and other physicians worked together to repeal a 6% gross receipts tax on cosmetic procedures that went into effect in 2004. The repeal bill passed both houses of the New Jersey legislature and is awaiting the governor's signature, Dr. Stone said. There was one defeat. Pathologists in Missouri successfully secured passage of a law that allowed them to directly bill patients. Dr. Stone urged AAD members to get involved in government affairs at all levels. "The more representation we have, the more influence we will have," he said.

Derms Don't Get No Respect

In what seems to be a yearly effort, the AAD is launching an ad campaign to boost dermatologists' profile as specialists. "The public is confused about who really has the expertise [to provide skin care] and they are getting misleading messages," Dr. Stone said at the AAD meeting. "Unless the public understands the distinction between a dermatologist and nondermatologist, this problem will continue to grow," he added. Therefore, the academy will run a national print advertising campaign "that conveys the essence of the specialty" in the March issue of six national magazines, including Prevention, Real Simple, Redbook, and O: The Oprah Magazine. The ads ask: "There are thousands of reasons to see a dermatologist, what's yours?" and end by telling consumers, "Trust the expert care of a board-certified dermatologist." Dr. Stone said the ad "communicates our message in an assertive but nonthreatening way."

FDA's $2 Billion Budget

The Bush administration is requesting $2.1 billion for the Food and Drug Administration in fiscal 2008, a 5% increase from the previous year's request. The agency still has not received its final appropriation for fiscal 2007, so the exact amount it will receive for that year is not known yet. The budget includes $444 million in user fees from industry, including a new program to charge generic drug makers fees to review their products. The agency estimates that generic companies will contribute $16 million in fiscal 2008. In a statement, Generic Pharmaceutical Association CEO Kathleen Jaeger said the decision to seek user fees "will not bring generic medicines to consumers faster as long as brand companies are still permitted to use tactics that delay market entry." The budget also includes $11 million for improving drug safety (this does not include user fee funds that will also go to that effort) and $7 million to boost medical device safety and to speed up device review. The agency also is requesting $13 million to move about 1,300 employees of the Center for Devices and Radiological Health to offices at the FDA's new White Oak, Md., campus. The FDA has been gradually moving its operations to the new facilities. The Washington-based consumer-, patient- and industry-supported Coalition for a Stronger FDA said the budget did not go far enough. It is seeking at least $175 million more, including greater increases for food, drug, and medical device safety.

Medicare Generic Drug Use Rises

The CMS says that generic drugs accounted for 60% of the prescriptions dispensed to people who receive benefits through either Part D or Medicare Advantage plans for the first three-quarters of 2006. Generic drug use among Part D enrollees is 13% higher than for Americans who receive benefits through private payers, said the CMS. The agency said that in 2006, generics accounted for 53% of prescriptions dispensed to privately insured Americans. Greater use of generics will translate into lower costs for the Part D program and possibly expanded coverage for beneficiaries, according to the CMS. "We will continue to promote generics where they are available as an important strategy to keep the new drug benefit affordable over the long term," CMS Acting Administrator Leslie Norwalk said in a statement.

WASHINGTON — The American Academy of Dermatology will soon start giving its official imprimatur to sunscreen products that it deems worthy, outgoing AAD President Stephen Stone said at the academy's annual meeting.

Two sunscreens, both made by Johnson & Johnson's consumer products division, will bear the AAD logo, with the words "Seal of Recognition" underneath, Dr. Stone said in his plenary address.

According to a company spokeswoman, the products are Aveeno Continuous Protection Sunblock Lotion, SPF 55, and Aveeno Baby Continuous Protection Sunblock Lotion, SPF 55.

Johnson & Johnson and other manufacturers that meet the AAD's selection criteria also will be allowed to use one of two statements. The first is "The American Academy of Dermatology recognizes this product for its sun-protection benefit."

The second statement is somewhat longer: "The American Academy of Dermatology (AAD) recognizes that proper and regular use of sunscreens with Sun Protection Factor (SPF) 15 or higher and broad-spectrum (UVA/UVB) protection, along with wearing sun-protective clothing and seeking shade, will help protect against sunburn and may reduce long-term damage to the skin caused by sun exposure."

To receive both the seal and the statement of support, sunscreen makers will pay the AAD a $10,000 application fee and a $10,000 annual fee. The sunscreens must offer broad-spectrum (UVA/UVB) protection and a sun protection factor of 15 or higher. They also have to provide evidence of water and sweat resistance and phototoxicity/stability.

The AAD Web site will include a list of products that have received the seal of recognition. Sunscreen makers can link their product's Web page to the AAD page that gives all the details on the program.

Dr. Stone said the program "will help consumers make educated choices when purchasing sunscreen products and help maintain the public perception of dermatologists as the leading experts in skin cancer prevention."

The seal of recognition program came into being after surveys showed that 86% of AAD members believe it would help consumers make better choices, said an AAD spokeswoman.

It was approved by the AAD board at its summer meeting in July.

Any funds left over after administration of the program will be applied to the academy's Skin Cancer Reduction: Intervention Plan for Tomorrow (SCRIPT) program, said Dr. Stone. That program aims to markedly reduce skin cancer incidence and mortality over the next 10–30 years.

WASHINGTON — The American Academy of Dermatology will soon start giving its official imprimatur to sunscreen products that it deems worthy, outgoing AAD President Stephen Stone said at the academy's annual meeting.

Two sunscreens, both made by Johnson & Johnson's consumer products division, will bear the AAD logo, with the words "Seal of Recognition" underneath, Dr. Stone said in his plenary address.

According to a company spokeswoman, the products are Aveeno Continuous Protection Sunblock Lotion, SPF 55, and Aveeno Baby Continuous Protection Sunblock Lotion, SPF 55.

Johnson & Johnson and other manufacturers that meet the AAD's selection criteria also will be allowed to use one of two statements. The first is "The American Academy of Dermatology recognizes this product for its sun-protection benefit."

The second statement is somewhat longer: "The American Academy of Dermatology (AAD) recognizes that proper and regular use of sunscreens with Sun Protection Factor (SPF) 15 or higher and broad-spectrum (UVA/UVB) protection, along with wearing sun-protective clothing and seeking shade, will help protect against sunburn and may reduce long-term damage to the skin caused by sun exposure."

To receive both the seal and the statement of support, sunscreen makers will pay the AAD a $10,000 application fee and a $10,000 annual fee. The sunscreens must offer broad-spectrum (UVA/UVB) protection and a sun protection factor of 15 or higher. They also have to provide evidence of water and sweat resistance and phototoxicity/stability.

The AAD Web site will include a list of products that have received the seal of recognition. Sunscreen makers can link their product's Web page to the AAD page that gives all the details on the program.

Dr. Stone said the program "will help consumers make educated choices when purchasing sunscreen products and help maintain the public perception of dermatologists as the leading experts in skin cancer prevention."

The seal of recognition program came into being after surveys showed that 86% of AAD members believe it would help consumers make better choices, said an AAD spokeswoman.

It was approved by the AAD board at its summer meeting in July.

Any funds left over after administration of the program will be applied to the academy's Skin Cancer Reduction: Intervention Plan for Tomorrow (SCRIPT) program, said Dr. Stone. That program aims to markedly reduce skin cancer incidence and mortality over the next 10–30 years.

WASHINGTON — The American Academy of Dermatology will soon start giving its official imprimatur to sunscreen products that it deems worthy, outgoing AAD President Stephen Stone said at the academy's annual meeting.

Two sunscreens, both made by Johnson & Johnson's consumer products division, will bear the AAD logo, with the words "Seal of Recognition" underneath, Dr. Stone said in his plenary address.

According to a company spokeswoman, the products are Aveeno Continuous Protection Sunblock Lotion, SPF 55, and Aveeno Baby Continuous Protection Sunblock Lotion, SPF 55.

Johnson & Johnson and other manufacturers that meet the AAD's selection criteria also will be allowed to use one of two statements. The first is "The American Academy of Dermatology recognizes this product for its sun-protection benefit."

The second statement is somewhat longer: "The American Academy of Dermatology (AAD) recognizes that proper and regular use of sunscreens with Sun Protection Factor (SPF) 15 or higher and broad-spectrum (UVA/UVB) protection, along with wearing sun-protective clothing and seeking shade, will help protect against sunburn and may reduce long-term damage to the skin caused by sun exposure."

To receive both the seal and the statement of support, sunscreen makers will pay the AAD a $10,000 application fee and a $10,000 annual fee. The sunscreens must offer broad-spectrum (UVA/UVB) protection and a sun protection factor of 15 or higher. They also have to provide evidence of water and sweat resistance and phototoxicity/stability.

The AAD Web site will include a list of products that have received the seal of recognition. Sunscreen makers can link their product's Web page to the AAD page that gives all the details on the program.

Dr. Stone said the program "will help consumers make educated choices when purchasing sunscreen products and help maintain the public perception of dermatologists as the leading experts in skin cancer prevention."

The seal of recognition program came into being after surveys showed that 86% of AAD members believe it would help consumers make better choices, said an AAD spokeswoman.

It was approved by the AAD board at its summer meeting in July.

Any funds left over after administration of the program will be applied to the academy's Skin Cancer Reduction: Intervention Plan for Tomorrow (SCRIPT) program, said Dr. Stone. That program aims to markedly reduce skin cancer incidence and mortality over the next 10–30 years.

The Food and Drug Administration has proposed greatly increasing the fees its drug division collects from pharmaceutical manufacturers, saying that current fees collected under the Prescription Drug User Fee Act have not kept pace with inflation or the agency's growing workload.

Most of the additional money would be used to upgrade the agency's postmarketing drug safety monitoring. The FDA also is proposing to create a separate program to collect fees from companies that want their direct-to-consumer television ads reviewed by the agency.

The FDA published its proposals in the Federal Register in January and collected comments on them at a public meeting this month. The final proposal will be sent to Congress later this year, said Jane Axelrad, associate director for policy at the Center for Drug Evaluation and Research (CDER), in a teleconference sponsored by the FDA.

Time is of the essence as PDUFA, first enacted in 1992 and reauthorized in 5-year increments, is due to expire Sept. 30.

Under PDUFA, the FDA charges prescription drugmakers a set fee to review the safety and efficacy of products submitted under a new drug application. In return, the agency has to meet deadlines for review and approval.

The law has helped the FDA reduce review times and increase its postmarketing oversight, said Dr. Steven K. Galson, CDER director, during the teleconference.

Under the new proposal, FDA seeks to collect $393 million annually, $87 million more than it currently takes in each year. Drug user fees account for about half of CDER's budget, said Dr. Galson, adding that he could not say whether that would hold true going forward, since the agency has not yet received its appropriation for fiscal 2007 or a budget for fiscal 2008.

However, Ms. Axelrad said that drug user fees represent an increasing proportion of CDER's budget.

Public Citizen's Health Research Group criticized that trend, saying that the agency should not receive so much of its funding from the industry it regulates.

“The FDA's crucial drug regulatory functions are too important to be tainted and compromised by direct funding from the very companies whose drugs the agency reviews for safety,” Dr. Sidney Wolfe, director of the health group, said in a statement.

The biotechnology and pharmaceutical industries praised the FDA proposal.

“The PDUFA recommendations announced today are a win-win,” said Jim Greenwood, president of the Biotechnology Industry Organization, in a statement. “If enacted, they will help enhance and improve drug safety while providing resources to continue to enable efficient and comprehensive review of new drugs.”

The largest portion of the increase, $29 million, would be devoted to postmarketing safety. With those funds, the agency said it could hire 82 new employees, and acquire the best tools and databases for improving the detection and analysis of safety signals. The agency also will institute new programs to reduce medication errors, in response to an Institute of Medicine report issued in September 2006 calling for drug safety improvements at the agency.

Some $20 million would go to cover expenses incurred in the last few years to facilitate drug makers' requests for formal meetings about their products. Sheila Mullin, FDA assistant commissioner for planning, said that in fiscal 2005, the agency held 1,800 formal meetings at manufacturers' request.

About $4 million would be devoted to improving information technology for drug reviews, with the goal of moving to “an all-electronic environment,” according to the FDA proposal.

“Reviewing data electronically helps to improve the efficiency of the drug approval process and expedites getting important new drugs to the patients who need them,” said Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, in a statement.

The agency is proposing to create a new user fee program solely to fund the review of direct-to-consumer television ads. Currently, companies can voluntarily submit their ads for review, but the FDA has not been able to keep up with the growing workload, said Dr. Galson.

The FDA anticipates charging $6 million in the first year of the program, which would subsidize the hiring of 27 new employees. Another $6 million would be collected for a reserve fund, to cope with unanticipated increases in volume of advertisements.

FDA regulatory functions are too important to be compromised by direct funding from companies. DR. WOLFE

The Food and Drug Administration has proposed greatly increasing the fees its drug division collects from pharmaceutical manufacturers, saying that current fees collected under the Prescription Drug User Fee Act have not kept pace with inflation or the agency's growing workload.

Most of the additional money would be used to upgrade the agency's postmarketing drug safety monitoring. The FDA also is proposing to create a separate program to collect fees from companies that want their direct-to-consumer television ads reviewed by the agency.

The FDA published its proposals in the Federal Register in January and collected comments on them at a public meeting this month. The final proposal will be sent to Congress later this year, said Jane Axelrad, associate director for policy at the Center for Drug Evaluation and Research (CDER), in a teleconference sponsored by the FDA.

Time is of the essence as PDUFA, first enacted in 1992 and reauthorized in 5-year increments, is due to expire Sept. 30.

Under PDUFA, the FDA charges prescription drugmakers a set fee to review the safety and efficacy of products submitted under a new drug application. In return, the agency has to meet deadlines for review and approval.

The law has helped the FDA reduce review times and increase its postmarketing oversight, said Dr. Steven K. Galson, CDER director, during the teleconference.

Under the new proposal, FDA seeks to collect $393 million annually, $87 million more than it currently takes in each year. Drug user fees account for about half of CDER's budget, said Dr. Galson, adding that he could not say whether that would hold true going forward, since the agency has not yet received its appropriation for fiscal 2007 or a budget for fiscal 2008.

However, Ms. Axelrad said that drug user fees represent an increasing proportion of CDER's budget.

Public Citizen's Health Research Group criticized that trend, saying that the agency should not receive so much of its funding from the industry it regulates.

“The FDA's crucial drug regulatory functions are too important to be tainted and compromised by direct funding from the very companies whose drugs the agency reviews for safety,” Dr. Sidney Wolfe, director of the health group, said in a statement.

The biotechnology and pharmaceutical industries praised the FDA proposal.

“The PDUFA recommendations announced today are a win-win,” said Jim Greenwood, president of the Biotechnology Industry Organization, in a statement. “If enacted, they will help enhance and improve drug safety while providing resources to continue to enable efficient and comprehensive review of new drugs.”

The largest portion of the increase, $29 million, would be devoted to postmarketing safety. With those funds, the agency said it could hire 82 new employees, and acquire the best tools and databases for improving the detection and analysis of safety signals. The agency also will institute new programs to reduce medication errors, in response to an Institute of Medicine report issued in September 2006 calling for drug safety improvements at the agency.

Some $20 million would go to cover expenses incurred in the last few years to facilitate drug makers' requests for formal meetings about their products. Sheila Mullin, FDA assistant commissioner for planning, said that in fiscal 2005, the agency held 1,800 formal meetings at manufacturers' request.

About $4 million would be devoted to improving information technology for drug reviews, with the goal of moving to “an all-electronic environment,” according to the FDA proposal.

“Reviewing data electronically helps to improve the efficiency of the drug approval process and expedites getting important new drugs to the patients who need them,” said Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, in a statement.

The agency is proposing to create a new user fee program solely to fund the review of direct-to-consumer television ads. Currently, companies can voluntarily submit their ads for review, but the FDA has not been able to keep up with the growing workload, said Dr. Galson.

The FDA anticipates charging $6 million in the first year of the program, which would subsidize the hiring of 27 new employees. Another $6 million would be collected for a reserve fund, to cope with unanticipated increases in volume of advertisements.

FDA regulatory functions are too important to be compromised by direct funding from companies. DR. WOLFE

The Food and Drug Administration has proposed greatly increasing the fees its drug division collects from pharmaceutical manufacturers, saying that current fees collected under the Prescription Drug User Fee Act have not kept pace with inflation or the agency's growing workload.

Most of the additional money would be used to upgrade the agency's postmarketing drug safety monitoring. The FDA also is proposing to create a separate program to collect fees from companies that want their direct-to-consumer television ads reviewed by the agency.

The FDA published its proposals in the Federal Register in January and collected comments on them at a public meeting this month. The final proposal will be sent to Congress later this year, said Jane Axelrad, associate director for policy at the Center for Drug Evaluation and Research (CDER), in a teleconference sponsored by the FDA.

Time is of the essence as PDUFA, first enacted in 1992 and reauthorized in 5-year increments, is due to expire Sept. 30.

Under PDUFA, the FDA charges prescription drugmakers a set fee to review the safety and efficacy of products submitted under a new drug application. In return, the agency has to meet deadlines for review and approval.

The law has helped the FDA reduce review times and increase its postmarketing oversight, said Dr. Steven K. Galson, CDER director, during the teleconference.

Under the new proposal, FDA seeks to collect $393 million annually, $87 million more than it currently takes in each year. Drug user fees account for about half of CDER's budget, said Dr. Galson, adding that he could not say whether that would hold true going forward, since the agency has not yet received its appropriation for fiscal 2007 or a budget for fiscal 2008.

However, Ms. Axelrad said that drug user fees represent an increasing proportion of CDER's budget.

Public Citizen's Health Research Group criticized that trend, saying that the agency should not receive so much of its funding from the industry it regulates.

“The FDA's crucial drug regulatory functions are too important to be tainted and compromised by direct funding from the very companies whose drugs the agency reviews for safety,” Dr. Sidney Wolfe, director of the health group, said in a statement.

The biotechnology and pharmaceutical industries praised the FDA proposal.

“The PDUFA recommendations announced today are a win-win,” said Jim Greenwood, president of the Biotechnology Industry Organization, in a statement. “If enacted, they will help enhance and improve drug safety while providing resources to continue to enable efficient and comprehensive review of new drugs.”

The largest portion of the increase, $29 million, would be devoted to postmarketing safety. With those funds, the agency said it could hire 82 new employees, and acquire the best tools and databases for improving the detection and analysis of safety signals. The agency also will institute new programs to reduce medication errors, in response to an Institute of Medicine report issued in September 2006 calling for drug safety improvements at the agency.

Some $20 million would go to cover expenses incurred in the last few years to facilitate drug makers' requests for formal meetings about their products. Sheila Mullin, FDA assistant commissioner for planning, said that in fiscal 2005, the agency held 1,800 formal meetings at manufacturers' request.

About $4 million would be devoted to improving information technology for drug reviews, with the goal of moving to “an all-electronic environment,” according to the FDA proposal.

“Reviewing data electronically helps to improve the efficiency of the drug approval process and expedites getting important new drugs to the patients who need them,” said Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, in a statement.

The agency is proposing to create a new user fee program solely to fund the review of direct-to-consumer television ads. Currently, companies can voluntarily submit their ads for review, but the FDA has not been able to keep up with the growing workload, said Dr. Galson.

The FDA anticipates charging $6 million in the first year of the program, which would subsidize the hiring of 27 new employees. Another $6 million would be collected for a reserve fund, to cope with unanticipated increases in volume of advertisements.

FDA regulatory functions are too important to be compromised by direct funding from companies. DR. WOLFE

Missed Opportunities for Prevention

Two new reports from the Agency for Healthcare Research and Quality find that physicians often miss opportunities to offer patients preventive and counseling services. It is the fourth consecutive year in which AHRQ has compiled data on 40 core quality measures for the National Healthcare Quality Report. Among the agency's findings: Only 52% of adults reported undergoing recommended colorectal cancer screening, and fewer than half of obese adults reported that they had received diet counseling. Only 48% of patients with diabetes received blood sugar screens or foot and eye exams. The overall quality of care improved by almost 8% in hospitals, but by only 3% in ambulatory settings and by 1% in nursing homes and home health settings, according to AHRQ. The agency attributed quality improvement in hospitals to initiatives established by the Centers for Medicare and Medicaid Services. In a separate study—the National Healthcare Disparities Report—AHRQ found that blacks received poorer quality care than did whites in 73% of the core measures. Furthermore, Hispanics received poorer quality of care in 77% of the measures, and low-income people in 77% of the measures.

Drug Ads Play On Emotions

A new study shows that prescription drug advertising on television is rarely educational, and mostly uses emotional appeals to entice consumers. Dominick Frosch, Ph.D., of the University of California, Los Angeles, and colleagues analyzed ads shown during prime time and evening news hours over 4 consecutive weeks on four major broadcast networks. The sample included ads for 7 of the top 10 best-selling prescription drugs for 2004, and included reminder ads (the “ask your doctor” ads, which do not have to be factual) and product claim ads (which must include product risks). A positive emotional appeal—such as a character who's happy after taking the product—was used by 95% of the claim ads and 100% of the reminder ads. The claim ads did provide some educational information, such as detailing how to use the drug or enumerating some of the potential risks and benefits, said the authors. But, they concluded, direct-to-consumer advertising “often presents best-case scenarios that can distort and inflate consumers' expectations about what prescription drugs can accomplish.” Their analysis appeared in the January/February issue of the Annals of Family Medicine. In an editorial accompanying the study, former Food and Drug Commissioner David Kessler said that “although none of these findings are surprising, they should be disturbing.”

Back Pain Program to Begin

Physicians and chiropractors who provide high-quality back pain care will soon be able to be recognized under a program sponsored by the National Committee for Quality Assurance (NCQA). The program will identify physicians and chiropractors who follow 16 evidence-based criteria, including performing a thorough patient assessment, offering recommendations for appropriate physical activity, and avoiding unnecessary imaging. Criteria also include patient education and shared decision making about surgery and alternatives with the patient. “How back pain is treated varies tremendously from practice to practice, [such that] where you go for your care is as important as what is causing your problem,” NCQA President Margaret E. O'Kane, said in a statement. The program was designed with input from experts in orthopedics, neurosurgery, primary care, and public health, as well as from health plans and employers. NCQA will begin accepting applications for the program in April.

Antidepressant Side Effects Vary

Second-generation antidepressants generally have similar rates of effectiveness but have variable side effects, according to an AHRQ analysis. On average, about 61% of patients will experience at least one side effect from taking a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI), according to the analysis. However, the type of side effect varies by drug. For example, the SNRI venlafaxine (Effexor) is associated with more reports of nausea and vomiting than are SSRIs, according to AHRQ. The antidepressant trazodone (Desyrel), on the other hand, is associated with higher rates of somnolence than are some similar drugs. Researchers at AHRQ analyzed 293 published studies to compare the risks and benefits of second-generation antidepressants in the treatment of major depressive disorder, dysthymia, and subsyndromal depression. “Second-generation antidepressants provide hope for many of the millions of Americans who struggle with depression,” Dr. Carolyn Clancy, AHRQ director, said in a statement. “But often, trying to find the right drug is trial and error, and in many cases relief is temporary or comes with serious side effects. It's clear we need more evidence to help patients and their doctors make the best choices.” The study is available at

http://effectivehealthcare.ahrq.gov

New Medical School to Open

The Touro College of Osteopathic Medicine will open this fall in New York's Harlem neighborhood. The new school's mission is to serve minorities in the area, and school officials also plan to recruit medical students from among minority populations. The new facility is in the final stages of construction and is expected to be completed in April. School officials have already received 800 applications for the first class of 125 students. Officials also plan to hire 40 full-time faculty and 100 part-time faculty, as well as 200 physicians from New York City-area hospitals as adjunct faculty members.

Missed Opportunities for Prevention

Two new reports from the Agency for Healthcare Research and Quality find that physicians often miss opportunities to offer patients preventive and counseling services. It is the fourth consecutive year in which AHRQ has compiled data on 40 core quality measures for the National Healthcare Quality Report. Among the agency's findings: Only 52% of adults reported undergoing recommended colorectal cancer screening, and fewer than half of obese adults reported that they had received diet counseling. Only 48% of patients with diabetes received blood sugar screens or foot and eye exams. The overall quality of care improved by almost 8% in hospitals, but by only 3% in ambulatory settings and by 1% in nursing homes and home health settings, according to AHRQ. The agency attributed quality improvement in hospitals to initiatives established by the Centers for Medicare and Medicaid Services. In a separate study—the National Healthcare Disparities Report—AHRQ found that blacks received poorer quality care than did whites in 73% of the core measures. Furthermore, Hispanics received poorer quality of care in 77% of the measures, and low-income people in 77% of the measures.

Drug Ads Play On Emotions

A new study shows that prescription drug advertising on television is rarely educational, and mostly uses emotional appeals to entice consumers. Dominick Frosch, Ph.D., of the University of California, Los Angeles, and colleagues analyzed ads shown during prime time and evening news hours over 4 consecutive weeks on four major broadcast networks. The sample included ads for 7 of the top 10 best-selling prescription drugs for 2004, and included reminder ads (the “ask your doctor” ads, which do not have to be factual) and product claim ads (which must include product risks). A positive emotional appeal—such as a character who's happy after taking the product—was used by 95% of the claim ads and 100% of the reminder ads. The claim ads did provide some educational information, such as detailing how to use the drug or enumerating some of the potential risks and benefits, said the authors. But, they concluded, direct-to-consumer advertising “often presents best-case scenarios that can distort and inflate consumers' expectations about what prescription drugs can accomplish.” Their analysis appeared in the January/February issue of the Annals of Family Medicine. In an editorial accompanying the study, former Food and Drug Commissioner David Kessler said that “although none of these findings are surprising, they should be disturbing.”

Back Pain Program to Begin

Physicians and chiropractors who provide high-quality back pain care will soon be able to be recognized under a program sponsored by the National Committee for Quality Assurance (NCQA). The program will identify physicians and chiropractors who follow 16 evidence-based criteria, including performing a thorough patient assessment, offering recommendations for appropriate physical activity, and avoiding unnecessary imaging. Criteria also include patient education and shared decision making about surgery and alternatives with the patient. “How back pain is treated varies tremendously from practice to practice, [such that] where you go for your care is as important as what is causing your problem,” NCQA President Margaret E. O'Kane, said in a statement. The program was designed with input from experts in orthopedics, neurosurgery, primary care, and public health, as well as from health plans and employers. NCQA will begin accepting applications for the program in April.

Antidepressant Side Effects Vary

Second-generation antidepressants generally have similar rates of effectiveness but have variable side effects, according to an AHRQ analysis. On average, about 61% of patients will experience at least one side effect from taking a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI), according to the analysis. However, the type of side effect varies by drug. For example, the SNRI venlafaxine (Effexor) is associated with more reports of nausea and vomiting than are SSRIs, according to AHRQ. The antidepressant trazodone (Desyrel), on the other hand, is associated with higher rates of somnolence than are some similar drugs. Researchers at AHRQ analyzed 293 published studies to compare the risks and benefits of second-generation antidepressants in the treatment of major depressive disorder, dysthymia, and subsyndromal depression. “Second-generation antidepressants provide hope for many of the millions of Americans who struggle with depression,” Dr. Carolyn Clancy, AHRQ director, said in a statement. “But often, trying to find the right drug is trial and error, and in many cases relief is temporary or comes with serious side effects. It's clear we need more evidence to help patients and their doctors make the best choices.” The study is available at

http://effectivehealthcare.ahrq.gov

New Medical School to Open

The Touro College of Osteopathic Medicine will open this fall in New York's Harlem neighborhood. The new school's mission is to serve minorities in the area, and school officials also plan to recruit medical students from among minority populations. The new facility is in the final stages of construction and is expected to be completed in April. School officials have already received 800 applications for the first class of 125 students. Officials also plan to hire 40 full-time faculty and 100 part-time faculty, as well as 200 physicians from New York City-area hospitals as adjunct faculty members.

Missed Opportunities for Prevention

Two new reports from the Agency for Healthcare Research and Quality find that physicians often miss opportunities to offer patients preventive and counseling services. It is the fourth consecutive year in which AHRQ has compiled data on 40 core quality measures for the National Healthcare Quality Report. Among the agency's findings: Only 52% of adults reported undergoing recommended colorectal cancer screening, and fewer than half of obese adults reported that they had received diet counseling. Only 48% of patients with diabetes received blood sugar screens or foot and eye exams. The overall quality of care improved by almost 8% in hospitals, but by only 3% in ambulatory settings and by 1% in nursing homes and home health settings, according to AHRQ. The agency attributed quality improvement in hospitals to initiatives established by the Centers for Medicare and Medicaid Services. In a separate study—the National Healthcare Disparities Report—AHRQ found that blacks received poorer quality care than did whites in 73% of the core measures. Furthermore, Hispanics received poorer quality of care in 77% of the measures, and low-income people in 77% of the measures.

Drug Ads Play On Emotions

A new study shows that prescription drug advertising on television is rarely educational, and mostly uses emotional appeals to entice consumers. Dominick Frosch, Ph.D., of the University of California, Los Angeles, and colleagues analyzed ads shown during prime time and evening news hours over 4 consecutive weeks on four major broadcast networks. The sample included ads for 7 of the top 10 best-selling prescription drugs for 2004, and included reminder ads (the “ask your doctor” ads, which do not have to be factual) and product claim ads (which must include product risks). A positive emotional appeal—such as a character who's happy after taking the product—was used by 95% of the claim ads and 100% of the reminder ads. The claim ads did provide some educational information, such as detailing how to use the drug or enumerating some of the potential risks and benefits, said the authors. But, they concluded, direct-to-consumer advertising “often presents best-case scenarios that can distort and inflate consumers' expectations about what prescription drugs can accomplish.” Their analysis appeared in the January/February issue of the Annals of Family Medicine. In an editorial accompanying the study, former Food and Drug Commissioner David Kessler said that “although none of these findings are surprising, they should be disturbing.”

Back Pain Program to Begin

Physicians and chiropractors who provide high-quality back pain care will soon be able to be recognized under a program sponsored by the National Committee for Quality Assurance (NCQA). The program will identify physicians and chiropractors who follow 16 evidence-based criteria, including performing a thorough patient assessment, offering recommendations for appropriate physical activity, and avoiding unnecessary imaging. Criteria also include patient education and shared decision making about surgery and alternatives with the patient. “How back pain is treated varies tremendously from practice to practice, [such that] where you go for your care is as important as what is causing your problem,” NCQA President Margaret E. O'Kane, said in a statement. The program was designed with input from experts in orthopedics, neurosurgery, primary care, and public health, as well as from health plans and employers. NCQA will begin accepting applications for the program in April.

Antidepressant Side Effects Vary

Second-generation antidepressants generally have similar rates of effectiveness but have variable side effects, according to an AHRQ analysis. On average, about 61% of patients will experience at least one side effect from taking a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI), according to the analysis. However, the type of side effect varies by drug. For example, the SNRI venlafaxine (Effexor) is associated with more reports of nausea and vomiting than are SSRIs, according to AHRQ. The antidepressant trazodone (Desyrel), on the other hand, is associated with higher rates of somnolence than are some similar drugs. Researchers at AHRQ analyzed 293 published studies to compare the risks and benefits of second-generation antidepressants in the treatment of major depressive disorder, dysthymia, and subsyndromal depression. “Second-generation antidepressants provide hope for many of the millions of Americans who struggle with depression,” Dr. Carolyn Clancy, AHRQ director, said in a statement. “But often, trying to find the right drug is trial and error, and in many cases relief is temporary or comes with serious side effects. It's clear we need more evidence to help patients and their doctors make the best choices.” The study is available at

http://effectivehealthcare.ahrq.gov

New Medical School to Open

The Touro College of Osteopathic Medicine will open this fall in New York's Harlem neighborhood. The new school's mission is to serve minorities in the area, and school officials also plan to recruit medical students from among minority populations. The new facility is in the final stages of construction and is expected to be completed in April. School officials have already received 800 applications for the first class of 125 students. Officials also plan to hire 40 full-time faculty and 100 part-time faculty, as well as 200 physicians from New York City-area hospitals as adjunct faculty members.

The Food and Drug Administration has announced that it will beef up oversight of prescription drug safety, with a particular focus on risks and benefits after a product has been launched into the marketplace.

The initiatives were announced in January in a long-awaited response to last September's Institute of Medicine critique of pharmaceutic safety monitoring practices at the agency.

The agency said it had reviewed the IOM's 25 recommendations and would focus its efforts on three major areas:

▸ Strengthening the science used during product reviews and finding new tools to detect safety issues from preclinical testing through postmarketing.

▸ Improving communications, especially about risk, to patients, physicians, and other interested parties.

▸ Improving management practices.

The IOM criticized an agency culture that it saw as too concentrated on drug approval at the expense of product safety.

Some of the FDA initiatives are already underway. Others were published in the Federal Register as part of recommendations for the reauthorization of the Prescription Drug User Fee Act. Under the next PDUFA law, which, if enacted would begin in fiscal 2008, the FDA aims to collect $29 million from drug makers over 5 years specifically for postmarketing safety programs.

Key among the new initiatives announced in late January is a “report card” on the postmarketing safety of new molecular entities. The FDA has proposed a pilot feasibility study this year. These periodic, regularly scheduled reports would encompass data from the Adverse Events Reporting System (AERS), epidemiologic studies, postmarketing clinical trials, and from “mining” of various other databases. The first report would come 18 months after a drug's launch. The goal of this effort is “to identify potential safety concerns early in the product life cycle,” the agency said.

It also proposed sharing data more often with other agencies, and said it was already collaborating with the Agency for Health Care Quality and Research, the Centers for Disease Control and Prevention, and the Veterans Affairs department. The VA will provide real-world data on how its patients use pharmaceuticals and medical devices.

To address criticism that the FDA has not done a good job of communicating what it knows about a drug's risks and on a timely basis, the agency is putting together a new advisory committee. The IOM panel had thought it would take new legislation to establish a risk communications committee, but the agency said it could—and would—move quickly to establish such a panel.

The FDA also said it would hold a public meeting in early March to explore the creation of a nationwide public-private medical product safety network. The agency envisions a network that would let both health care providers and regulators rapidly collect and exchange information about adverse events—and would do so at the point of care to help providers make better-informed treatment decisions.

American Medical Association board member Dr. Edward Langston said the AMA generally supported the proposals. “The AMA agrees that the approaches used to communicate information to patients about the risks associated with drug products need significant improvement,” said Dr. Langston in a statement.

Long-time FDA critics in Congress, however, said the agency had not gone far enough.

“[The report] provides important recommendations for administrative action, but only legislation can give the FDA the tools it needs to ensure that the agency is the gold standard for safety,” said Sen. Edward M. Kennedy (D-Mass.), who, along with Sen. Michael Enzi (R-Wyo.) soon will introduce a bill to further overhaul the FDA's postmarketing safety program.

Sen. Christopher J. Dodd (D-Conn.) said that he and Sen. Chuck Grassley (R-Iowa) were also introducing a bill that would “revamp and prioritize the postmarket surveillance process within the Food and Drug Administration.” That bill, called the Food and Drug Administration Safety Act, would establish a Center for Postmarket Evaluation and Research for Drugs and Biologics. The center would report directly to the FDA commissioner.

“Congress will act on FDA-related legislation this year, and meaningful structural reforms to the agency need to be a part of what Congress does with regard to drug safety,” said Sen. Grassley in a statement.

The Food and Drug Administration has announced that it will beef up oversight of prescription drug safety, with a particular focus on risks and benefits after a product has been launched into the marketplace.

The initiatives were announced in January in a long-awaited response to last September's Institute of Medicine critique of pharmaceutic safety monitoring practices at the agency.

The agency said it had reviewed the IOM's 25 recommendations and would focus its efforts on three major areas:

▸ Strengthening the science used during product reviews and finding new tools to detect safety issues from preclinical testing through postmarketing.

▸ Improving communications, especially about risk, to patients, physicians, and other interested parties.

▸ Improving management practices.

The IOM criticized an agency culture that it saw as too concentrated on drug approval at the expense of product safety.

Some of the FDA initiatives are already underway. Others were published in the Federal Register as part of recommendations for the reauthorization of the Prescription Drug User Fee Act. Under the next PDUFA law, which, if enacted would begin in fiscal 2008, the FDA aims to collect $29 million from drug makers over 5 years specifically for postmarketing safety programs.

Key among the new initiatives announced in late January is a “report card” on the postmarketing safety of new molecular entities. The FDA has proposed a pilot feasibility study this year. These periodic, regularly scheduled reports would encompass data from the Adverse Events Reporting System (AERS), epidemiologic studies, postmarketing clinical trials, and from “mining” of various other databases. The first report would come 18 months after a drug's launch. The goal of this effort is “to identify potential safety concerns early in the product life cycle,” the agency said.

It also proposed sharing data more often with other agencies, and said it was already collaborating with the Agency for Health Care Quality and Research, the Centers for Disease Control and Prevention, and the Veterans Affairs department. The VA will provide real-world data on how its patients use pharmaceuticals and medical devices.

To address criticism that the FDA has not done a good job of communicating what it knows about a drug's risks and on a timely basis, the agency is putting together a new advisory committee. The IOM panel had thought it would take new legislation to establish a risk communications committee, but the agency said it could—and would—move quickly to establish such a panel.

The FDA also said it would hold a public meeting in early March to explore the creation of a nationwide public-private medical product safety network. The agency envisions a network that would let both health care providers and regulators rapidly collect and exchange information about adverse events—and would do so at the point of care to help providers make better-informed treatment decisions.

American Medical Association board member Dr. Edward Langston said the AMA generally supported the proposals. “The AMA agrees that the approaches used to communicate information to patients about the risks associated with drug products need significant improvement,” said Dr. Langston in a statement.

Long-time FDA critics in Congress, however, said the agency had not gone far enough.

“[The report] provides important recommendations for administrative action, but only legislation can give the FDA the tools it needs to ensure that the agency is the gold standard for safety,” said Sen. Edward M. Kennedy (D-Mass.), who, along with Sen. Michael Enzi (R-Wyo.) soon will introduce a bill to further overhaul the FDA's postmarketing safety program.

Sen. Christopher J. Dodd (D-Conn.) said that he and Sen. Chuck Grassley (R-Iowa) were also introducing a bill that would “revamp and prioritize the postmarket surveillance process within the Food and Drug Administration.” That bill, called the Food and Drug Administration Safety Act, would establish a Center for Postmarket Evaluation and Research for Drugs and Biologics. The center would report directly to the FDA commissioner.

“Congress will act on FDA-related legislation this year, and meaningful structural reforms to the agency need to be a part of what Congress does with regard to drug safety,” said Sen. Grassley in a statement.

The Food and Drug Administration has announced that it will beef up oversight of prescription drug safety, with a particular focus on risks and benefits after a product has been launched into the marketplace.

The initiatives were announced in January in a long-awaited response to last September's Institute of Medicine critique of pharmaceutic safety monitoring practices at the agency.

The agency said it had reviewed the IOM's 25 recommendations and would focus its efforts on three major areas:

▸ Strengthening the science used during product reviews and finding new tools to detect safety issues from preclinical testing through postmarketing.

▸ Improving communications, especially about risk, to patients, physicians, and other interested parties.

▸ Improving management practices.

The IOM criticized an agency culture that it saw as too concentrated on drug approval at the expense of product safety.

Some of the FDA initiatives are already underway. Others were published in the Federal Register as part of recommendations for the reauthorization of the Prescription Drug User Fee Act. Under the next PDUFA law, which, if enacted would begin in fiscal 2008, the FDA aims to collect $29 million from drug makers over 5 years specifically for postmarketing safety programs.

Key among the new initiatives announced in late January is a “report card” on the postmarketing safety of new molecular entities. The FDA has proposed a pilot feasibility study this year. These periodic, regularly scheduled reports would encompass data from the Adverse Events Reporting System (AERS), epidemiologic studies, postmarketing clinical trials, and from “mining” of various other databases. The first report would come 18 months after a drug's launch. The goal of this effort is “to identify potential safety concerns early in the product life cycle,” the agency said.

It also proposed sharing data more often with other agencies, and said it was already collaborating with the Agency for Health Care Quality and Research, the Centers for Disease Control and Prevention, and the Veterans Affairs department. The VA will provide real-world data on how its patients use pharmaceuticals and medical devices.

To address criticism that the FDA has not done a good job of communicating what it knows about a drug's risks and on a timely basis, the agency is putting together a new advisory committee. The IOM panel had thought it would take new legislation to establish a risk communications committee, but the agency said it could—and would—move quickly to establish such a panel.

The FDA also said it would hold a public meeting in early March to explore the creation of a nationwide public-private medical product safety network. The agency envisions a network that would let both health care providers and regulators rapidly collect and exchange information about adverse events—and would do so at the point of care to help providers make better-informed treatment decisions.

American Medical Association board member Dr. Edward Langston said the AMA generally supported the proposals. “The AMA agrees that the approaches used to communicate information to patients about the risks associated with drug products need significant improvement,” said Dr. Langston in a statement.

Long-time FDA critics in Congress, however, said the agency had not gone far enough.

“[The report] provides important recommendations for administrative action, but only legislation can give the FDA the tools it needs to ensure that the agency is the gold standard for safety,” said Sen. Edward M. Kennedy (D-Mass.), who, along with Sen. Michael Enzi (R-Wyo.) soon will introduce a bill to further overhaul the FDA's postmarketing safety program.

Sen. Christopher J. Dodd (D-Conn.) said that he and Sen. Chuck Grassley (R-Iowa) were also introducing a bill that would “revamp and prioritize the postmarket surveillance process within the Food and Drug Administration.” That bill, called the Food and Drug Administration Safety Act, would establish a Center for Postmarket Evaluation and Research for Drugs and Biologics. The center would report directly to the FDA commissioner.

“Congress will act on FDA-related legislation this year, and meaningful structural reforms to the agency need to be a part of what Congress does with regard to drug safety,” said Sen. Grassley in a statement.

NEW ORLEANS — Mortality rates after trauma are three times higher in octogenarians than in septuagenarians, according to an analysis of a trauma registry from a South Carolina hospital presented at the annual meeting of the American Association for the Surgery of Trauma.

Most of the literature suggests that mortality increases with age, but data on trauma outcomes for older patients are limited, said Dr. Robert Palmer of the Greenville (S.C.) Hospital System.

Dr. Palmer and his colleagues aimed to quantify morbidity, mortality, and disposition of cases in patients aged 70–79 and 80–90 years. They reviewed the hospital's trauma registry for the period 2002–2005 and identified 277 patients aged 70–79 and 230 patients over age 80. The group in their 70s represented 7% of all trauma cases, and the over-80 group represented 6% of the cases. Falls accounted for just over half of the trauma in the 70-year-olds and for 80% in the 80-year-olds.

There was no statistically significant difference in the Glasgow Coma Score or Revised Trauma Score (RTS) between the two groups.

There were 16 deaths in the 70s group and 40 in the over-80 group. Head injury was the main cause of death. There was no correlation between the number or types of comorbidities in the two groups and mortality. When mortality was broken down by age and RTS, there were no differences between the groups except for those who had an RTS of 11. Only 11% of the 70- to 79-year-olds died with an RTS of 11, compared with 68% of those over age 80. The fact that some patients had a Do Not Resuscitate order may have changed mortality rates, which were 31% and 42%, respectively, in the 70–79 and over-80 groups with DNR orders.

NEW ORLEANS — Mortality rates after trauma are three times higher in octogenarians than in septuagenarians, according to an analysis of a trauma registry from a South Carolina hospital presented at the annual meeting of the American Association for the Surgery of Trauma.

Most of the literature suggests that mortality increases with age, but data on trauma outcomes for older patients are limited, said Dr. Robert Palmer of the Greenville (S.C.) Hospital System.

Dr. Palmer and his colleagues aimed to quantify morbidity, mortality, and disposition of cases in patients aged 70–79 and 80–90 years. They reviewed the hospital's trauma registry for the period 2002–2005 and identified 277 patients aged 70–79 and 230 patients over age 80. The group in their 70s represented 7% of all trauma cases, and the over-80 group represented 6% of the cases. Falls accounted for just over half of the trauma in the 70-year-olds and for 80% in the 80-year-olds.

There was no statistically significant difference in the Glasgow Coma Score or Revised Trauma Score (RTS) between the two groups.

There were 16 deaths in the 70s group and 40 in the over-80 group. Head injury was the main cause of death. There was no correlation between the number or types of comorbidities in the two groups and mortality. When mortality was broken down by age and RTS, there were no differences between the groups except for those who had an RTS of 11. Only 11% of the 70- to 79-year-olds died with an RTS of 11, compared with 68% of those over age 80. The fact that some patients had a Do Not Resuscitate order may have changed mortality rates, which were 31% and 42%, respectively, in the 70–79 and over-80 groups with DNR orders.

NEW ORLEANS — Mortality rates after trauma are three times higher in octogenarians than in septuagenarians, according to an analysis of a trauma registry from a South Carolina hospital presented at the annual meeting of the American Association for the Surgery of Trauma.

Most of the literature suggests that mortality increases with age, but data on trauma outcomes for older patients are limited, said Dr. Robert Palmer of the Greenville (S.C.) Hospital System.

Dr. Palmer and his colleagues aimed to quantify morbidity, mortality, and disposition of cases in patients aged 70–79 and 80–90 years. They reviewed the hospital's trauma registry for the period 2002–2005 and identified 277 patients aged 70–79 and 230 patients over age 80. The group in their 70s represented 7% of all trauma cases, and the over-80 group represented 6% of the cases. Falls accounted for just over half of the trauma in the 70-year-olds and for 80% in the 80-year-olds.

There was no statistically significant difference in the Glasgow Coma Score or Revised Trauma Score (RTS) between the two groups.

There were 16 deaths in the 70s group and 40 in the over-80 group. Head injury was the main cause of death. There was no correlation between the number or types of comorbidities in the two groups and mortality. When mortality was broken down by age and RTS, there were no differences between the groups except for those who had an RTS of 11. Only 11% of the 70- to 79-year-olds died with an RTS of 11, compared with 68% of those over age 80. The fact that some patients had a Do Not Resuscitate order may have changed mortality rates, which were 31% and 42%, respectively, in the 70–79 and over-80 groups with DNR orders.

Overall health spending growth for 2005 hit the lowest level since 1999, largely because of a continuing slowdown in retail prescription drug sales and an increased use of generic drugs, according to a report issued by the Centers for Medicare and Medicaid Services in January.

The CMS report, the official government tally, found that overall, health care spending grew 6.9% in 2005, compared with 7.2% in 2004 and 8.1% in 2003.

“It is unclear whether this is temporary or indicative of a longer-term trend,” lead author Aaron Catlin, a CMS economist, said in a statement.

Even with the slowdown, the United States spent slightly more per capita in 2005–$6,697 per person—than in 2004, when expenditures were $6,322 per person. The percentage of personal income devoted to health care also rose. Out-of-pocket spending grew from $235 billion in 2004 to $249 billion in 2005, with prescription drugs accounting for 20%.

Total spending in 2005 hit $2 trillion, according to CMS (Health Affairs 2007; 26:142–53; Health Affairs 2007;26:249–57).

Medicare was the biggest spender, accounting for $342 billion of the $2 trillion total, not including the Part D drug benefit, which began in 2006. Medicaid spent $311 billion in 2005, a 7.2% increase from the previous year. But that growth rate was on par with 2004, when spending rose 7.5%.

Cost-containment efforts by Medicaid helped hold down the nation's overall drug bill, according to the report. Medicaid drug spending grew only 2.8% in 2005. The nation's total drug tab in 2005 was $200 billion, an increase of 5.8% over the previous year, when drug spending rose 8.6%.

Most drugs—about 73%–were covered by private sources in 2005. Private spending grew only 6%, down from 7.2% in 2004. Drug price increases remained stable from 2004 to 2005, at about 3.5% overall and 6% for brand names.

The pharmacy benefit management industry helped keep a lid on spending, with industry tools such as formularies, rebates, generic drugs, and mail service being used by both private and public payers. “PBMs have played a huge role in helping to drive prescription drug trends to an historic low,” said Mark Merritt, Pharmaceutical Care Management Association president.

Increasing use of multitiered drug formularies—which require consumers to pay more for higher-cost medicines—also contributed to the drug spending slowdown.

Spending on physician and clinical services hit $421 billion in 2005, making it the second biggest category, after hospitals. That was a 7% increase from 2004, when spending rose 7.4%. Medicare spent 9.5% more on physician services in 2005, a slight decline from the 10.4% growth in 2004.

Hospital spending grew about 8% in 2005 and 2004, hitting $611 billion.

The fastest growing component was home health care, rising 11% in 2005 to $47.5 billion. At least three-quarters of home care is covered by public payers.

Spending for nursing home care grew 6% in 2005 to $121 billion, more than the previous year's 4%. Medicaid is the largest payer, funding 44% of nursing home care, but its expenditures increased by only 4% in 2005, compared with Medicare's 12% rise.

Growth in the cost of health insurance premiums also declined. In 2005, premiums increased 6.6%, compared with 7.9% in 2004. It was the third consecutive year that premium increases dropped.

However, employees are still paying more for health care through higher coinsurance, deductibles, and out-of-pocket costs.

ELSEVIER GLOBAL MEDICAL NEWS

Overall health spending growth for 2005 hit the lowest level since 1999, largely because of a continuing slowdown in retail prescription drug sales and an increased use of generic drugs, according to a report issued by the Centers for Medicare and Medicaid Services in January.

The CMS report, the official government tally, found that overall, health care spending grew 6.9% in 2005, compared with 7.2% in 2004 and 8.1% in 2003.

“It is unclear whether this is temporary or indicative of a longer-term trend,” lead author Aaron Catlin, a CMS economist, said in a statement.

Even with the slowdown, the United States spent slightly more per capita in 2005–$6,697 per person—than in 2004, when expenditures were $6,322 per person. The percentage of personal income devoted to health care also rose. Out-of-pocket spending grew from $235 billion in 2004 to $249 billion in 2005, with prescription drugs accounting for 20%.

Total spending in 2005 hit $2 trillion, according to CMS (Health Affairs 2007; 26:142–53; Health Affairs 2007;26:249–57).

Medicare was the biggest spender, accounting for $342 billion of the $2 trillion total, not including the Part D drug benefit, which began in 2006. Medicaid spent $311 billion in 2005, a 7.2% increase from the previous year. But that growth rate was on par with 2004, when spending rose 7.5%.

Cost-containment efforts by Medicaid helped hold down the nation's overall drug bill, according to the report. Medicaid drug spending grew only 2.8% in 2005. The nation's total drug tab in 2005 was $200 billion, an increase of 5.8% over the previous year, when drug spending rose 8.6%.

Most drugs—about 73%–were covered by private sources in 2005. Private spending grew only 6%, down from 7.2% in 2004. Drug price increases remained stable from 2004 to 2005, at about 3.5% overall and 6% for brand names.

The pharmacy benefit management industry helped keep a lid on spending, with industry tools such as formularies, rebates, generic drugs, and mail service being used by both private and public payers. “PBMs have played a huge role in helping to drive prescription drug trends to an historic low,” said Mark Merritt, Pharmaceutical Care Management Association president.

Increasing use of multitiered drug formularies—which require consumers to pay more for higher-cost medicines—also contributed to the drug spending slowdown.

Spending on physician and clinical services hit $421 billion in 2005, making it the second biggest category, after hospitals. That was a 7% increase from 2004, when spending rose 7.4%. Medicare spent 9.5% more on physician services in 2005, a slight decline from the 10.4% growth in 2004.

Hospital spending grew about 8% in 2005 and 2004, hitting $611 billion.

The fastest growing component was home health care, rising 11% in 2005 to $47.5 billion. At least three-quarters of home care is covered by public payers.

Spending for nursing home care grew 6% in 2005 to $121 billion, more than the previous year's 4%. Medicaid is the largest payer, funding 44% of nursing home care, but its expenditures increased by only 4% in 2005, compared with Medicare's 12% rise.

Growth in the cost of health insurance premiums also declined. In 2005, premiums increased 6.6%, compared with 7.9% in 2004. It was the third consecutive year that premium increases dropped.

However, employees are still paying more for health care through higher coinsurance, deductibles, and out-of-pocket costs.

ELSEVIER GLOBAL MEDICAL NEWS

Overall health spending growth for 2005 hit the lowest level since 1999, largely because of a continuing slowdown in retail prescription drug sales and an increased use of generic drugs, according to a report issued by the Centers for Medicare and Medicaid Services in January.

The CMS report, the official government tally, found that overall, health care spending grew 6.9% in 2005, compared with 7.2% in 2004 and 8.1% in 2003.

“It is unclear whether this is temporary or indicative of a longer-term trend,” lead author Aaron Catlin, a CMS economist, said in a statement.

Even with the slowdown, the United States spent slightly more per capita in 2005–$6,697 per person—than in 2004, when expenditures were $6,322 per person. The percentage of personal income devoted to health care also rose. Out-of-pocket spending grew from $235 billion in 2004 to $249 billion in 2005, with prescription drugs accounting for 20%.

Total spending in 2005 hit $2 trillion, according to CMS (Health Affairs 2007; 26:142–53; Health Affairs 2007;26:249–57).

Medicare was the biggest spender, accounting for $342 billion of the $2 trillion total, not including the Part D drug benefit, which began in 2006. Medicaid spent $311 billion in 2005, a 7.2% increase from the previous year. But that growth rate was on par with 2004, when spending rose 7.5%.

Cost-containment efforts by Medicaid helped hold down the nation's overall drug bill, according to the report. Medicaid drug spending grew only 2.8% in 2005. The nation's total drug tab in 2005 was $200 billion, an increase of 5.8% over the previous year, when drug spending rose 8.6%.

Most drugs—about 73%–were covered by private sources in 2005. Private spending grew only 6%, down from 7.2% in 2004. Drug price increases remained stable from 2004 to 2005, at about 3.5% overall and 6% for brand names.

The pharmacy benefit management industry helped keep a lid on spending, with industry tools such as formularies, rebates, generic drugs, and mail service being used by both private and public payers. “PBMs have played a huge role in helping to drive prescription drug trends to an historic low,” said Mark Merritt, Pharmaceutical Care Management Association president.

Increasing use of multitiered drug formularies—which require consumers to pay more for higher-cost medicines—also contributed to the drug spending slowdown.

Spending on physician and clinical services hit $421 billion in 2005, making it the second biggest category, after hospitals. That was a 7% increase from 2004, when spending rose 7.4%. Medicare spent 9.5% more on physician services in 2005, a slight decline from the 10.4% growth in 2004.

Hospital spending grew about 8% in 2005 and 2004, hitting $611 billion.

The fastest growing component was home health care, rising 11% in 2005 to $47.5 billion. At least three-quarters of home care is covered by public payers.

Spending for nursing home care grew 6% in 2005 to $121 billion, more than the previous year's 4%. Medicaid is the largest payer, funding 44% of nursing home care, but its expenditures increased by only 4% in 2005, compared with Medicare's 12% rise.

Growth in the cost of health insurance premiums also declined. In 2005, premiums increased 6.6%, compared with 7.9% in 2004. It was the third consecutive year that premium increases dropped.

However, employees are still paying more for health care through higher coinsurance, deductibles, and out-of-pocket costs.

ELSEVIER GLOBAL MEDICAL NEWS

Missed Opportunities for Prevention

Two new reports from the Agency for Healthcare Research and Quality find that physicians often miss opportunities to offer preventive and counseling services. It is the fourth consecutive year in which AHRQ has compiled data on 40 core quality measures for the National Healthcare Quality Report. Among the agency's findings: Only 52% of adults reported undergoing recommended colorectal cancer screening, and fewer than half of obese adults reported receiving diet counseling. Only 48% of patients with diabetes received blood sugar screens or foot and eye exams. The overall quality of care improved by almost 8% in hospitals, but by only 3% in ambulatory settings and by 1% in nursing homes and home health settings, according to AHRQ. The agency attributed quality improvement in hospitals to initiatives established by the Centers for Medicare and Medicaid Services. In a separate study—the National Healthcare Disparities Report—AHRQ found that blacks received poorer quality care than did whites in 73% of the core measures. Furthermore, Hispanics received poorer quality of care in 77% of the measures, and low-income people in 77% of the measures.

Drug Ads Play on Emotions

A new study shows that prescription drug advertising on television is rarely educational, and mostly uses emotional appeals to entice consumers. Dominick Frosch, Ph.D., of the University of California, Los Angeles, and colleagues analyzed ads shown during prime time and evening news hours over 4 consecutive weeks on four major broadcast networks. The sample included ads for 7 of the top 10 best-selling prescription drugs for 2004, and included reminder ads (the “ask your doctor” ads, which do not have to be factual) and product claim ads (which must include product risks). A positive emotional appeal—such as a character who's happy after taking the product—was used by 95% of the claim ads and 100% of the reminder ads. The claim ads did provide some educational information, such as detailing how to use the drug or enumerating some of the potential risks and benefits, the authors said. But, they concluded, direct-to-consumer advertising “often presents best-case scenarios that can distort and inflate consumers' expectations about what prescription drugs can accomplish.” Their analysis appeared in the January/February issue of the Annals of Family Medicine. Former Food and Drug Commissioner David Kessler said in an accompanying editorial that “although none of these findings are surprising, they should be disturbing.”

Back Pain Program to Begin

Physicians and chiropractors who provide high-quality back pain care will soon be able to be recognized under a program sponsored by the National Committee for Quality Assurance (NCQA). The program will identify physicians and chiropractors who follow 16 evidence-based criteria, including performing a thorough patient assessment, offering recommendations for appropriate physical activity, and avoiding unnecessary imaging. Criteria also include patient education and shared decision making about surgery and alternatives with the patient. “How back pain is treated varies tremendously from practice to practice, [such that] where you go for your care is as important as what is causing your problem,” NCQA President Margaret E. O'Kane said in a statement. The program was designed with input from experts in orthopedics, neurosurgery, primary care, and public health, as well as from health plans and employers. NCQA will begin accepting applications for the program in April.

Antidepressant Side Effects Vary

Second-generation antidepressants generally have similar rates of effectiveness but have variable side effects, according to an AHRQ analysis. On average, about 61% of patients will experience at least one side effect from taking a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI), according to the analysis. However, the type of side effect varies by drug. For example, the SNRI venlafaxine (Effexor) is associated with more reports of nausea and vomiting than are SSRIs, according to AHRQ. The antidepressant trazodone (Desyrel), on the other hand, is associated with higher rates of somnolence than are some similar drugs. Researchers at AHRQ analyzed 293 published studies to compare the risks and benefits of second-generation antidepressants in the treatment of major depressive disorder, dysthymia, and subsyndromal depression. “Second-generation antidepressants provide hope for many of the millions of Americans who struggle with depression,” Dr. Carolyn Clancy, AHRQ director, said in a statement. “But often, trying to find the right drug is trial and error, and in many cases relief is temporary or comes with serious side effects. It's clear we need more evidence to help patients and their doctors make the best choices.” The study is available at

http://effectivehealthcare.ahrq.gov

New Medical School to Open

The Touro College of Osteopathic Medicine will open this fall in New York's Harlem neighborhood. The new school's mission is to serve minorities in the area, and school officials also plan to recruit medical students from among minority populations. The new facility is in the final stages of construction and is expected to be completed in April. School officials have already received 800 applications for the first class of 125 students. Officials also plan to hire 40 full-time faculty and 100 part-time faculty, as well as 200 physicians from New York City-area hospitals as adjunct faculty members.

Missed Opportunities for Prevention

Two new reports from the Agency for Healthcare Research and Quality find that physicians often miss opportunities to offer preventive and counseling services. It is the fourth consecutive year in which AHRQ has compiled data on 40 core quality measures for the National Healthcare Quality Report. Among the agency's findings: Only 52% of adults reported undergoing recommended colorectal cancer screening, and fewer than half of obese adults reported receiving diet counseling. Only 48% of patients with diabetes received blood sugar screens or foot and eye exams. The overall quality of care improved by almost 8% in hospitals, but by only 3% in ambulatory settings and by 1% in nursing homes and home health settings, according to AHRQ. The agency attributed quality improvement in hospitals to initiatives established by the Centers for Medicare and Medicaid Services. In a separate study—the National Healthcare Disparities Report—AHRQ found that blacks received poorer quality care than did whites in 73% of the core measures. Furthermore, Hispanics received poorer quality of care in 77% of the measures, and low-income people in 77% of the measures.

Drug Ads Play on Emotions

A new study shows that prescription drug advertising on television is rarely educational, and mostly uses emotional appeals to entice consumers. Dominick Frosch, Ph.D., of the University of California, Los Angeles, and colleagues analyzed ads shown during prime time and evening news hours over 4 consecutive weeks on four major broadcast networks. The sample included ads for 7 of the top 10 best-selling prescription drugs for 2004, and included reminder ads (the “ask your doctor” ads, which do not have to be factual) and product claim ads (which must include product risks). A positive emotional appeal—such as a character who's happy after taking the product—was used by 95% of the claim ads and 100% of the reminder ads. The claim ads did provide some educational information, such as detailing how to use the drug or enumerating some of the potential risks and benefits, the authors said. But, they concluded, direct-to-consumer advertising “often presents best-case scenarios that can distort and inflate consumers' expectations about what prescription drugs can accomplish.” Their analysis appeared in the January/February issue of the Annals of Family Medicine. Former Food and Drug Commissioner David Kessler said in an accompanying editorial that “although none of these findings are surprising, they should be disturbing.”

Back Pain Program to Begin

Physicians and chiropractors who provide high-quality back pain care will soon be able to be recognized under a program sponsored by the National Committee for Quality Assurance (NCQA). The program will identify physicians and chiropractors who follow 16 evidence-based criteria, including performing a thorough patient assessment, offering recommendations for appropriate physical activity, and avoiding unnecessary imaging. Criteria also include patient education and shared decision making about surgery and alternatives with the patient. “How back pain is treated varies tremendously from practice to practice, [such that] where you go for your care is as important as what is causing your problem,” NCQA President Margaret E. O'Kane said in a statement. The program was designed with input from experts in orthopedics, neurosurgery, primary care, and public health, as well as from health plans and employers. NCQA will begin accepting applications for the program in April.

Antidepressant Side Effects Vary

Second-generation antidepressants generally have similar rates of effectiveness but have variable side effects, according to an AHRQ analysis. On average, about 61% of patients will experience at least one side effect from taking a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI), according to the analysis. However, the type of side effect varies by drug. For example, the SNRI venlafaxine (Effexor) is associated with more reports of nausea and vomiting than are SSRIs, according to AHRQ. The antidepressant trazodone (Desyrel), on the other hand, is associated with higher rates of somnolence than are some similar drugs. Researchers at AHRQ analyzed 293 published studies to compare the risks and benefits of second-generation antidepressants in the treatment of major depressive disorder, dysthymia, and subsyndromal depression. “Second-generation antidepressants provide hope for many of the millions of Americans who struggle with depression,” Dr. Carolyn Clancy, AHRQ director, said in a statement. “But often, trying to find the right drug is trial and error, and in many cases relief is temporary or comes with serious side effects. It's clear we need more evidence to help patients and their doctors make the best choices.” The study is available at

http://effectivehealthcare.ahrq.gov

New Medical School to Open

The Touro College of Osteopathic Medicine will open this fall in New York's Harlem neighborhood. The new school's mission is to serve minorities in the area, and school officials also plan to recruit medical students from among minority populations. The new facility is in the final stages of construction and is expected to be completed in April. School officials have already received 800 applications for the first class of 125 students. Officials also plan to hire 40 full-time faculty and 100 part-time faculty, as well as 200 physicians from New York City-area hospitals as adjunct faculty members.

Missed Opportunities for Prevention

Two new reports from the Agency for Healthcare Research and Quality find that physicians often miss opportunities to offer preventive and counseling services. It is the fourth consecutive year in which AHRQ has compiled data on 40 core quality measures for the National Healthcare Quality Report. Among the agency's findings: Only 52% of adults reported undergoing recommended colorectal cancer screening, and fewer than half of obese adults reported receiving diet counseling. Only 48% of patients with diabetes received blood sugar screens or foot and eye exams. The overall quality of care improved by almost 8% in hospitals, but by only 3% in ambulatory settings and by 1% in nursing homes and home health settings, according to AHRQ. The agency attributed quality improvement in hospitals to initiatives established by the Centers for Medicare and Medicaid Services. In a separate study—the National Healthcare Disparities Report—AHRQ found that blacks received poorer quality care than did whites in 73% of the core measures. Furthermore, Hispanics received poorer quality of care in 77% of the measures, and low-income people in 77% of the measures.

Drug Ads Play on Emotions

A new study shows that prescription drug advertising on television is rarely educational, and mostly uses emotional appeals to entice consumers. Dominick Frosch, Ph.D., of the University of California, Los Angeles, and colleagues analyzed ads shown during prime time and evening news hours over 4 consecutive weeks on four major broadcast networks. The sample included ads for 7 of the top 10 best-selling prescription drugs for 2004, and included reminder ads (the “ask your doctor” ads, which do not have to be factual) and product claim ads (which must include product risks). A positive emotional appeal—such as a character who's happy after taking the product—was used by 95% of the claim ads and 100% of the reminder ads. The claim ads did provide some educational information, such as detailing how to use the drug or enumerating some of the potential risks and benefits, the authors said. But, they concluded, direct-to-consumer advertising “often presents best-case scenarios that can distort and inflate consumers' expectations about what prescription drugs can accomplish.” Their analysis appeared in the January/February issue of the Annals of Family Medicine. Former Food and Drug Commissioner David Kessler said in an accompanying editorial that “although none of these findings are surprising, they should be disturbing.”

Back Pain Program to Begin

Physicians and chiropractors who provide high-quality back pain care will soon be able to be recognized under a program sponsored by the National Committee for Quality Assurance (NCQA). The program will identify physicians and chiropractors who follow 16 evidence-based criteria, including performing a thorough patient assessment, offering recommendations for appropriate physical activity, and avoiding unnecessary imaging. Criteria also include patient education and shared decision making about surgery and alternatives with the patient. “How back pain is treated varies tremendously from practice to practice, [such that] where you go for your care is as important as what is causing your problem,” NCQA President Margaret E. O'Kane said in a statement. The program was designed with input from experts in orthopedics, neurosurgery, primary care, and public health, as well as from health plans and employers. NCQA will begin accepting applications for the program in April.

Antidepressant Side Effects Vary

Second-generation antidepressants generally have similar rates of effectiveness but have variable side effects, according to an AHRQ analysis. On average, about 61% of patients will experience at least one side effect from taking a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI), according to the analysis. However, the type of side effect varies by drug. For example, the SNRI venlafaxine (Effexor) is associated with more reports of nausea and vomiting than are SSRIs, according to AHRQ. The antidepressant trazodone (Desyrel), on the other hand, is associated with higher rates of somnolence than are some similar drugs. Researchers at AHRQ analyzed 293 published studies to compare the risks and benefits of second-generation antidepressants in the treatment of major depressive disorder, dysthymia, and subsyndromal depression. “Second-generation antidepressants provide hope for many of the millions of Americans who struggle with depression,” Dr. Carolyn Clancy, AHRQ director, said in a statement. “But often, trying to find the right drug is trial and error, and in many cases relief is temporary or comes with serious side effects. It's clear we need more evidence to help patients and their doctors make the best choices.” The study is available at

http://effectivehealthcare.ahrq.gov

New Medical School to Open

The Touro College of Osteopathic Medicine will open this fall in New York's Harlem neighborhood. The new school's mission is to serve minorities in the area, and school officials also plan to recruit medical students from among minority populations. The new facility is in the final stages of construction and is expected to be completed in April. School officials have already received 800 applications for the first class of 125 students. Officials also plan to hire 40 full-time faculty and 100 part-time faculty, as well as 200 physicians from New York City-area hospitals as adjunct faculty members.

Overall health spending growth for 2005 hit the lowest level since 1999, largely because of a continuing slowdown in retail prescription drug sales and an increased use of generic drugs, according to a report issued by the Centers for Medicare and Medicaid Services in January.

The CMS report, the official government tally, found that overall, health care spending grew 6.9% in 2005, compared with 7.2% in 2004 and 8.1% in 2003.

“It is unclear whether this is temporary or indicative of a longer-term trend,” lead author Aaron Catlin, a CMS economist, said in a statement.

Even with the slowdown, the United States spent slightly more per capita in 2005–$6,697 per person—than in 2004, when the total was $6,322 per person.

The percentage of personal income devoted to health care is rising as well. Out-of-pocket spending grew from $235 billion in 2004 to $249 billion in 2005, with prescription drugs accounting for 20% of that expense.

Total spending in 2005 hit $2 trillion, according to the CMS (Health Affairs 2007;26:142–53, and Health Affairs 2007;26:249–57).

Medicare was the biggest spender, accounting for $342 billion of the $2 trillion total.

The figure does not include the Part D drug benefit, which did not begin until 2006. Medicaid spent $311 billion in 2005, a 7.2% increase from the previous year. But that growth rate was on par with 2004, when spending rose 7.5%.

Cost-containment efforts by the Medicaid program helped hold down the nation's overall drug bill, according to the report. For Medicaid, drug spending grew only 2.8% in 2005. The nation's total drug tab in 2005 was $200 billion, an increase of 5.8% over the previous year, when drug spending rose 8.6%.

Most drugs—about 73%–-were covered by private sources in 2005. Private spending grew only 6%, down from 7.2% in 2004. Drug price increases remained stable from 2004 to 2005, at about 3.5% overall and 6% for brand names.

The pharmacy benefit management industry took credit for helping to keep a lid on spending, noting that industry tools such as formularies, rebates, generic drugs, and mail-service are being used by both private and public payers.

“PBMs have played a huge role in helping to drive prescription drug trends to an historic low,” Mark Merritt, president of the Pharmaceutical Care Management Association, said in a statement.

Both CMS and America's Health Insurance Plans said that increasing use of multitiered drug formularies—which require consumers to pay more for higher-cost medicines—also contributed to the slowdown in drug spending.

Spending on physician and clinical services hit $421 billion in 2005, which made it the second biggest category of spending, after hospitals. That represented a 7% increase from 2004, when spending rose 7.4%. Medicare, however, spent 9.5% more on physician services in 2005, which was a slight decline from the 10.4% growth in 2004.

Hospital spending grew about 8% in 2005 and 2004, hitting $611 billion.

The fastest growing component of health spending was freestanding home health care, rising 11% in 2005 to $47.5 billion. At least three-quarters of home care is covered by public payers.

Spending for nursing home care grew 6% in 2005 to $121 billion. That was a larger increase than in the previous year, when spending rose 4%. Though Medicaid is the largest payer, accounting for 44% of funding for nursing home care, its expenditures increased by only 4% in 2005, compared with Medicare's 12% rise.

Growth in the cost of health insurance premiums also declined. In 2005, premiums increased 6.6%, compared with 7.9% in 2004. It was the third consecutive year that premium increases dropped.

However, the CMS researchers noted that employees are still paying more for their health care through higher coinsurance and deductibles and other out-of-pocket costs.

Consumers are taking a big hit on health costs, agreed Karen Davis, president of the Commonwealth Fund, a private nonpartisan foundation that is working toward a health system that offers better quality and more access.

“Even the slower spending growth of 6.9% continues to outpace inflation and growth in wages for the average worker in the United States,” Ms. Davis said in a statement.

ELSEVIER GLOBAL MEDICAL NEWS

Overall health spending growth for 2005 hit the lowest level since 1999, largely because of a continuing slowdown in retail prescription drug sales and an increased use of generic drugs, according to a report issued by the Centers for Medicare and Medicaid Services in January.

The CMS report, the official government tally, found that overall, health care spending grew 6.9% in 2005, compared with 7.2% in 2004 and 8.1% in 2003.

“It is unclear whether this is temporary or indicative of a longer-term trend,” lead author Aaron Catlin, a CMS economist, said in a statement.

Even with the slowdown, the United States spent slightly more per capita in 2005–$6,697 per person—than in 2004, when the total was $6,322 per person.

The percentage of personal income devoted to health care is rising as well. Out-of-pocket spending grew from $235 billion in 2004 to $249 billion in 2005, with prescription drugs accounting for 20% of that expense.

Total spending in 2005 hit $2 trillion, according to the CMS (Health Affairs 2007;26:142–53, and Health Affairs 2007;26:249–57).

Medicare was the biggest spender, accounting for $342 billion of the $2 trillion total.

The figure does not include the Part D drug benefit, which did not begin until 2006. Medicaid spent $311 billion in 2005, a 7.2% increase from the previous year. But that growth rate was on par with 2004, when spending rose 7.5%.

Cost-containment efforts by the Medicaid program helped hold down the nation's overall drug bill, according to the report. For Medicaid, drug spending grew only 2.8% in 2005. The nation's total drug tab in 2005 was $200 billion, an increase of 5.8% over the previous year, when drug spending rose 8.6%.

Most drugs—about 73%–-were covered by private sources in 2005. Private spending grew only 6%, down from 7.2% in 2004. Drug price increases remained stable from 2004 to 2005, at about 3.5% overall and 6% for brand names.

The pharmacy benefit management industry took credit for helping to keep a lid on spending, noting that industry tools such as formularies, rebates, generic drugs, and mail-service are being used by both private and public payers.

“PBMs have played a huge role in helping to drive prescription drug trends to an historic low,” Mark Merritt, president of the Pharmaceutical Care Management Association, said in a statement.

Both CMS and America's Health Insurance Plans said that increasing use of multitiered drug formularies—which require consumers to pay more for higher-cost medicines—also contributed to the slowdown in drug spending.

Spending on physician and clinical services hit $421 billion in 2005, which made it the second biggest category of spending, after hospitals. That represented a 7% increase from 2004, when spending rose 7.4%. Medicare, however, spent 9.5% more on physician services in 2005, which was a slight decline from the 10.4% growth in 2004.

Hospital spending grew about 8% in 2005 and 2004, hitting $611 billion.

The fastest growing component of health spending was freestanding home health care, rising 11% in 2005 to $47.5 billion. At least three-quarters of home care is covered by public payers.

Spending for nursing home care grew 6% in 2005 to $121 billion. That was a larger increase than in the previous year, when spending rose 4%. Though Medicaid is the largest payer, accounting for 44% of funding for nursing home care, its expenditures increased by only 4% in 2005, compared with Medicare's 12% rise.

Growth in the cost of health insurance premiums also declined. In 2005, premiums increased 6.6%, compared with 7.9% in 2004. It was the third consecutive year that premium increases dropped.

However, the CMS researchers noted that employees are still paying more for their health care through higher coinsurance and deductibles and other out-of-pocket costs.

Consumers are taking a big hit on health costs, agreed Karen Davis, president of the Commonwealth Fund, a private nonpartisan foundation that is working toward a health system that offers better quality and more access.

“Even the slower spending growth of 6.9% continues to outpace inflation and growth in wages for the average worker in the United States,” Ms. Davis said in a statement.

ELSEVIER GLOBAL MEDICAL NEWS

Overall health spending growth for 2005 hit the lowest level since 1999, largely because of a continuing slowdown in retail prescription drug sales and an increased use of generic drugs, according to a report issued by the Centers for Medicare and Medicaid Services in January.

The CMS report, the official government tally, found that overall, health care spending grew 6.9% in 2005, compared with 7.2% in 2004 and 8.1% in 2003.

“It is unclear whether this is temporary or indicative of a longer-term trend,” lead author Aaron Catlin, a CMS economist, said in a statement.

Even with the slowdown, the United States spent slightly more per capita in 2005–$6,697 per person—than in 2004, when the total was $6,322 per person.

The percentage of personal income devoted to health care is rising as well. Out-of-pocket spending grew from $235 billion in 2004 to $249 billion in 2005, with prescription drugs accounting for 20% of that expense.

Total spending in 2005 hit $2 trillion, according to the CMS (Health Affairs 2007;26:142–53, and Health Affairs 2007;26:249–57).

Medicare was the biggest spender, accounting for $342 billion of the $2 trillion total.

The figure does not include the Part D drug benefit, which did not begin until 2006. Medicaid spent $311 billion in 2005, a 7.2% increase from the previous year. But that growth rate was on par with 2004, when spending rose 7.5%.

Cost-containment efforts by the Medicaid program helped hold down the nation's overall drug bill, according to the report. For Medicaid, drug spending grew only 2.8% in 2005. The nation's total drug tab in 2005 was $200 billion, an increase of 5.8% over the previous year, when drug spending rose 8.6%.

Most drugs—about 73%–-were covered by private sources in 2005. Private spending grew only 6%, down from 7.2% in 2004. Drug price increases remained stable from 2004 to 2005, at about 3.5% overall and 6% for brand names.

The pharmacy benefit management industry took credit for helping to keep a lid on spending, noting that industry tools such as formularies, rebates, generic drugs, and mail-service are being used by both private and public payers.

“PBMs have played a huge role in helping to drive prescription drug trends to an historic low,” Mark Merritt, president of the Pharmaceutical Care Management Association, said in a statement.

Both CMS and America's Health Insurance Plans said that increasing use of multitiered drug formularies—which require consumers to pay more for higher-cost medicines—also contributed to the slowdown in drug spending.

Spending on physician and clinical services hit $421 billion in 2005, which made it the second biggest category of spending, after hospitals. That represented a 7% increase from 2004, when spending rose 7.4%. Medicare, however, spent 9.5% more on physician services in 2005, which was a slight decline from the 10.4% growth in 2004.

Hospital spending grew about 8% in 2005 and 2004, hitting $611 billion.

The fastest growing component of health spending was freestanding home health care, rising 11% in 2005 to $47.5 billion. At least three-quarters of home care is covered by public payers.

Spending for nursing home care grew 6% in 2005 to $121 billion. That was a larger increase than in the previous year, when spending rose 4%. Though Medicaid is the largest payer, accounting for 44% of funding for nursing home care, its expenditures increased by only 4% in 2005, compared with Medicare's 12% rise.

Growth in the cost of health insurance premiums also declined. In 2005, premiums increased 6.6%, compared with 7.9% in 2004. It was the third consecutive year that premium increases dropped.

However, the CMS researchers noted that employees are still paying more for their health care through higher coinsurance and deductibles and other out-of-pocket costs.

Consumers are taking a big hit on health costs, agreed Karen Davis, president of the Commonwealth Fund, a private nonpartisan foundation that is working toward a health system that offers better quality and more access.

“Even the slower spending growth of 6.9% continues to outpace inflation and growth in wages for the average worker in the United States,” Ms. Davis said in a statement.

ELSEVIER GLOBAL MEDICAL NEWS