Mary Ellen Schneider

WASHINGTON — Physicians should continue to control access to outpatient physical therapy for Medicare beneficiaries, according to the Medicare Payment Advisory Commission.

In a report to Congress, MedPAC recommended that Medicare keep in place its current policy of using physicians as gatekeepers to accessing physical therapy.

Under current law, Medicare beneficiaries must be referred by a physician to receive physical therapy services; the physician must review a written plan of care every 30 days. The Medicare Modernization Act required MedPAC to examine the idea of allowing Medicare beneficiaries to have direct access to these services.

But MedPAC commissioners were reluctant to recommend removing the restrictions because so many Medicare beneficiaries have multiple and chronic health conditions. “Without these physician requirements, the medical appropriateness of starting or continuing physical therapy services would be more uncertain,” the MedPAC commissioners said in their report.

And current requirements do not appear to impair access for most beneficiaries. In 2003, 85% of beneficiaries reported no problem getting physical therapy services, commission consultant Carol Carter said at a MedPAC meeting last November. These restrictions are also the only way Medicare can curb unnecessary use, she said.

But MedPAC recommended that additional steps should be taken to make the current restrictions more effective. For example, there is a need for more provider education about Medicare coverage rules, both for physicians making the referrals and for physical therapists.

WASHINGTON — Physicians should continue to control access to outpatient physical therapy for Medicare beneficiaries, according to the Medicare Payment Advisory Commission.

In a report to Congress, MedPAC recommended that Medicare keep in place its current policy of using physicians as gatekeepers to accessing physical therapy.

Under current law, Medicare beneficiaries must be referred by a physician to receive physical therapy services; the physician must review a written plan of care every 30 days. The Medicare Modernization Act required MedPAC to examine the idea of allowing Medicare beneficiaries to have direct access to these services.

But MedPAC commissioners were reluctant to recommend removing the restrictions because so many Medicare beneficiaries have multiple and chronic health conditions. “Without these physician requirements, the medical appropriateness of starting or continuing physical therapy services would be more uncertain,” the MedPAC commissioners said in their report.

And current requirements do not appear to impair access for most beneficiaries. In 2003, 85% of beneficiaries reported no problem getting physical therapy services, commission consultant Carol Carter said at a MedPAC meeting last November. These restrictions are also the only way Medicare can curb unnecessary use, she said.

But MedPAC recommended that additional steps should be taken to make the current restrictions more effective. For example, there is a need for more provider education about Medicare coverage rules, both for physicians making the referrals and for physical therapists.

WASHINGTON — Physicians should continue to control access to outpatient physical therapy for Medicare beneficiaries, according to the Medicare Payment Advisory Commission.

In a report to Congress, MedPAC recommended that Medicare keep in place its current policy of using physicians as gatekeepers to accessing physical therapy.

Under current law, Medicare beneficiaries must be referred by a physician to receive physical therapy services; the physician must review a written plan of care every 30 days. The Medicare Modernization Act required MedPAC to examine the idea of allowing Medicare beneficiaries to have direct access to these services.

But MedPAC commissioners were reluctant to recommend removing the restrictions because so many Medicare beneficiaries have multiple and chronic health conditions. “Without these physician requirements, the medical appropriateness of starting or continuing physical therapy services would be more uncertain,” the MedPAC commissioners said in their report.

And current requirements do not appear to impair access for most beneficiaries. In 2003, 85% of beneficiaries reported no problem getting physical therapy services, commission consultant Carol Carter said at a MedPAC meeting last November. These restrictions are also the only way Medicare can curb unnecessary use, she said.

But MedPAC recommended that additional steps should be taken to make the current restrictions more effective. For example, there is a need for more provider education about Medicare coverage rules, both for physicians making the referrals and for physical therapists.

A limited, commercial program that would import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as being extraordinarily difficult and costly to implement safely.

It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

“Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections,” according to the secretaries. “These drugs must have the same level of safety and effectiveness as FDA-approved products.”

In the letter, Bush administration officials outlined the requirements of such a system. For example, it should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are mostly likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could pose increased safety risks in an importation program, such as controlled substances or drugs that require refrigeration during shipping.

And the program must avoid “anticompetitive provisions” including “forced sale” clauses and other types of price controls.

The letter also warns Congress that if its members pass legislation that stifles competition or fails to address safety concerns, the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet this criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position on drug importation. The group said that it supports importation of prescription drugs by wholesalers and pharmacies, provided that the drugs have been FDA approved and are part of a closed distribution chain. AMA does not support personal importation via the Internet until patient safety can be ensured.

“Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled,” AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation.

“Millions of American obtain prescription medicines from Canada and other countries every year and do so safety,” Sen. Dorgan said in a statement. “The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market, just because they can.”

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act.

The law includes a provision that would allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report on prescription drug importation is available online at www.hhs.gov/importtaskforce

A limited, commercial program that would import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as being extraordinarily difficult and costly to implement safely.

It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

“Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections,” according to the secretaries. “These drugs must have the same level of safety and effectiveness as FDA-approved products.”

In the letter, Bush administration officials outlined the requirements of such a system. For example, it should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are mostly likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could pose increased safety risks in an importation program, such as controlled substances or drugs that require refrigeration during shipping.

And the program must avoid “anticompetitive provisions” including “forced sale” clauses and other types of price controls.

The letter also warns Congress that if its members pass legislation that stifles competition or fails to address safety concerns, the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet this criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position on drug importation. The group said that it supports importation of prescription drugs by wholesalers and pharmacies, provided that the drugs have been FDA approved and are part of a closed distribution chain. AMA does not support personal importation via the Internet until patient safety can be ensured.

“Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled,” AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation.

“Millions of American obtain prescription medicines from Canada and other countries every year and do so safety,” Sen. Dorgan said in a statement. “The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market, just because they can.”

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act.

The law includes a provision that would allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report on prescription drug importation is available online at www.hhs.gov/importtaskforce

A limited, commercial program that would import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as being extraordinarily difficult and costly to implement safely.

It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

“Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections,” according to the secretaries. “These drugs must have the same level of safety and effectiveness as FDA-approved products.”

In the letter, Bush administration officials outlined the requirements of such a system. For example, it should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are mostly likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could pose increased safety risks in an importation program, such as controlled substances or drugs that require refrigeration during shipping.

And the program must avoid “anticompetitive provisions” including “forced sale” clauses and other types of price controls.

The letter also warns Congress that if its members pass legislation that stifles competition or fails to address safety concerns, the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet this criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position on drug importation. The group said that it supports importation of prescription drugs by wholesalers and pharmacies, provided that the drugs have been FDA approved and are part of a closed distribution chain. AMA does not support personal importation via the Internet until patient safety can be ensured.

“Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled,” AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation.

“Millions of American obtain prescription medicines from Canada and other countries every year and do so safety,” Sen. Dorgan said in a statement. “The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market, just because they can.”

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act.

The law includes a provision that would allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report on prescription drug importation is available online at www.hhs.gov/importtaskforce

A limited commercial program to import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as being extraordinarily difficult and costly to implement safely. It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

"Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections," according to the secretaries. "These drugs must have the same level of safety and effectiveness as FDA-approved products."

In the letter, Bush administration officials outlined the requirements of such a system. It should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are mostly likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could pose increased safety risks in an importation program, such as controlled substances or drugs that require refrigeration during shipping. And the program must avoid "anticompetitive provisions" including "forced sale" clauses and other types of price controls.

If Congress passes legislation that stifles competition or fails to address safety concerns, the letter warns that the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet this criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position on drug importation. The AMA supports importation of prescription drugs by wholesalers and pharmacies, provided the drugs have been FDA approved and are part of a closed distribution chain. The AMA does not support personal importation via the Internet until patient safety can be assured.

"Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled," AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation.

"Millions of Americans obtain prescription medicines from Canada and other countries every year and do so safety," Sen. Dorgan said in a statement. "The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market."

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act. The law includes a provision that would allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report is available online at www.hhs.gov/importtaskforce

A limited commercial program to import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as being extraordinarily difficult and costly to implement safely. It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

"Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections," according to the secretaries. "These drugs must have the same level of safety and effectiveness as FDA-approved products."

In the letter, Bush administration officials outlined the requirements of such a system. It should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are mostly likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could pose increased safety risks in an importation program, such as controlled substances or drugs that require refrigeration during shipping. And the program must avoid "anticompetitive provisions" including "forced sale" clauses and other types of price controls.

If Congress passes legislation that stifles competition or fails to address safety concerns, the letter warns that the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet this criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position on drug importation. The AMA supports importation of prescription drugs by wholesalers and pharmacies, provided the drugs have been FDA approved and are part of a closed distribution chain. The AMA does not support personal importation via the Internet until patient safety can be assured.

"Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled," AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation.

"Millions of Americans obtain prescription medicines from Canada and other countries every year and do so safety," Sen. Dorgan said in a statement. "The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market."

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act. The law includes a provision that would allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report is available online at www.hhs.gov/importtaskforce

A limited commercial program to import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as being extraordinarily difficult and costly to implement safely. It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

"Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections," according to the secretaries. "These drugs must have the same level of safety and effectiveness as FDA-approved products."

In the letter, Bush administration officials outlined the requirements of such a system. It should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are mostly likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could pose increased safety risks in an importation program, such as controlled substances or drugs that require refrigeration during shipping. And the program must avoid "anticompetitive provisions" including "forced sale" clauses and other types of price controls.

If Congress passes legislation that stifles competition or fails to address safety concerns, the letter warns that the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet this criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position on drug importation. The AMA supports importation of prescription drugs by wholesalers and pharmacies, provided the drugs have been FDA approved and are part of a closed distribution chain. The AMA does not support personal importation via the Internet until patient safety can be assured.

"Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled," AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation.

"Millions of Americans obtain prescription medicines from Canada and other countries every year and do so safety," Sen. Dorgan said in a statement. "The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market."

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act. The law includes a provision that would allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report is available online at www.hhs.gov/importtaskforce

The standard-setting group U.S. Pharmacopeia has established 146 unique therapeutic categories and pharmacologic classes to guide the establishment of formularies under the new Medicare Part D prescription drug benefit.

The model guidelines created by USP will serve as a voluntary framework for health plans and prescription drug plans as they create drug plan formularies for Medicare, as established by the Medicare Modernization Act of 2003.

"The model guidelines are not a formulary," Roger L. Williams, M.D., USP executive vice president and CEO and chair of the group's Model Guidelines Expert Committee, said in a press teleconference.

In addition to the categories and classes created by USP, the group also created a separate listing of formulary key drug types to help the Centers for Medicare and Medicaid Services assess the comprehensiveness of proposed formularies.

Under proposed Medicare regulations, plans that follow the model guidelines would need to offer at least two drugs in each therapeutic category and pharmacologic class. USP has also recommended that CMS require plans to offer at least one drug from the list of formulary key drug types or have a clinical or scientific rationale for excluding the drugs.

CMS officials will use the guidelines to help evaluate proposed formularies.

The USP issued draft guidelines last August that were criticized by physician groups and patient advocates as leaving too many critical drugs in a third category, where coverage would not be required.

The final guidelines include a new therapeutic category for inflammatory bowel disease agents and a new pharmacologic class for proton pump inhibitors. Other changes to the model guidelines include additional antidementia drugs and expanded dermatologic agents.

Dr. Williams said he hopes all parties will see this as "workable compromise."

The American Academy of Dermatology had raised concerns last year that the draft guidelines did not adequately cover combination therapies for chronic conditions such as psoriasis and psoriatic arthritis, for example. At press time, the group was still reviewing the final guidelines.

The American College of Rheumatology (ACR) applauded USP's efforts in putting together the model guidelines and called it a good place to start. But much will depend upon how CMS decides to use the guidelines, said Pam Ferraro, a regulatory analyst for ACR.

Many of the drugs of interest to rheumatologists, such as tumor necrosis factor inhibitors, were not included as either therapeutic categories or pharmacologic classes but were part of USP's list of formulary key drug types. ACR officials want to see drug plans cover the medications in this third category and make them available at affordable prices, Ms. Ferraro said.

The National Mental Health Association (NMHA) warned that the USP guidelines ignored recommendations from the mental health field not to group older medications with newer therapies. Since these medications are lumped together, health plans could choose to cover only the older, less expensive drugs. But NMHA president and CEO Michael M. Faenza said that his group is encouraged that CMS plans to consider widely accepted treatment guidelines for mental health when reviewing formularies.

But America's Health Insurance Plans (AHIP) praised the USP's final document.

"The final model continues to provide needed flexibility by not expanding the number of categories and classes previously proposed," said Karen Ignagni, AHIP president and CEO. "The direction that CMS is clearly taking supports the building of effective private plan strategies to make the Part D benefit clinically appropriate and affordable for Medicare beneficiaries."

Officials at the Pharmaceutical Research and Manufacturers of America, which has supported access to a broad array of treatments, were still reviewing the document at press time.

The standard-setting group U.S. Pharmacopeia has established 146 unique therapeutic categories and pharmacologic classes to guide the establishment of formularies under the new Medicare Part D prescription drug benefit.

The model guidelines created by USP will serve as a voluntary framework for health plans and prescription drug plans as they create drug plan formularies for Medicare, as established by the Medicare Modernization Act of 2003.

"The model guidelines are not a formulary," Roger L. Williams, M.D., USP executive vice president and CEO and chair of the group's Model Guidelines Expert Committee, said in a press teleconference.

In addition to the categories and classes created by USP, the group also created a separate listing of formulary key drug types to help the Centers for Medicare and Medicaid Services assess the comprehensiveness of proposed formularies.

Under proposed Medicare regulations, plans that follow the model guidelines would need to offer at least two drugs in each therapeutic category and pharmacologic class. USP has also recommended that CMS require plans to offer at least one drug from the list of formulary key drug types or have a clinical or scientific rationale for excluding the drugs.

CMS officials will use the guidelines to help evaluate proposed formularies.

The USP issued draft guidelines last August that were criticized by physician groups and patient advocates as leaving too many critical drugs in a third category, where coverage would not be required.

The final guidelines include a new therapeutic category for inflammatory bowel disease agents and a new pharmacologic class for proton pump inhibitors. Other changes to the model guidelines include additional antidementia drugs and expanded dermatologic agents.

Dr. Williams said he hopes all parties will see this as "workable compromise."

The American Academy of Dermatology had raised concerns last year that the draft guidelines did not adequately cover combination therapies for chronic conditions such as psoriasis and psoriatic arthritis, for example. At press time, the group was still reviewing the final guidelines.

The American College of Rheumatology (ACR) applauded USP's efforts in putting together the model guidelines and called it a good place to start. But much will depend upon how CMS decides to use the guidelines, said Pam Ferraro, a regulatory analyst for ACR.

Many of the drugs of interest to rheumatologists, such as tumor necrosis factor inhibitors, were not included as either therapeutic categories or pharmacologic classes but were part of USP's list of formulary key drug types. ACR officials want to see drug plans cover the medications in this third category and make them available at affordable prices, Ms. Ferraro said.

The National Mental Health Association (NMHA) warned that the USP guidelines ignored recommendations from the mental health field not to group older medications with newer therapies. Since these medications are lumped together, health plans could choose to cover only the older, less expensive drugs. But NMHA president and CEO Michael M. Faenza said that his group is encouraged that CMS plans to consider widely accepted treatment guidelines for mental health when reviewing formularies.

But America's Health Insurance Plans (AHIP) praised the USP's final document.

"The final model continues to provide needed flexibility by not expanding the number of categories and classes previously proposed," said Karen Ignagni, AHIP president and CEO. "The direction that CMS is clearly taking supports the building of effective private plan strategies to make the Part D benefit clinically appropriate and affordable for Medicare beneficiaries."

Officials at the Pharmaceutical Research and Manufacturers of America, which has supported access to a broad array of treatments, were still reviewing the document at press time.

The standard-setting group U.S. Pharmacopeia has established 146 unique therapeutic categories and pharmacologic classes to guide the establishment of formularies under the new Medicare Part D prescription drug benefit.

The model guidelines created by USP will serve as a voluntary framework for health plans and prescription drug plans as they create drug plan formularies for Medicare, as established by the Medicare Modernization Act of 2003.

"The model guidelines are not a formulary," Roger L. Williams, M.D., USP executive vice president and CEO and chair of the group's Model Guidelines Expert Committee, said in a press teleconference.

In addition to the categories and classes created by USP, the group also created a separate listing of formulary key drug types to help the Centers for Medicare and Medicaid Services assess the comprehensiveness of proposed formularies.

Under proposed Medicare regulations, plans that follow the model guidelines would need to offer at least two drugs in each therapeutic category and pharmacologic class. USP has also recommended that CMS require plans to offer at least one drug from the list of formulary key drug types or have a clinical or scientific rationale for excluding the drugs.

CMS officials will use the guidelines to help evaluate proposed formularies.

The USP issued draft guidelines last August that were criticized by physician groups and patient advocates as leaving too many critical drugs in a third category, where coverage would not be required.

The final guidelines include a new therapeutic category for inflammatory bowel disease agents and a new pharmacologic class for proton pump inhibitors. Other changes to the model guidelines include additional antidementia drugs and expanded dermatologic agents.

Dr. Williams said he hopes all parties will see this as "workable compromise."

The American Academy of Dermatology had raised concerns last year that the draft guidelines did not adequately cover combination therapies for chronic conditions such as psoriasis and psoriatic arthritis, for example. At press time, the group was still reviewing the final guidelines.

The American College of Rheumatology (ACR) applauded USP's efforts in putting together the model guidelines and called it a good place to start. But much will depend upon how CMS decides to use the guidelines, said Pam Ferraro, a regulatory analyst for ACR.

Many of the drugs of interest to rheumatologists, such as tumor necrosis factor inhibitors, were not included as either therapeutic categories or pharmacologic classes but were part of USP's list of formulary key drug types. ACR officials want to see drug plans cover the medications in this third category and make them available at affordable prices, Ms. Ferraro said.

The National Mental Health Association (NMHA) warned that the USP guidelines ignored recommendations from the mental health field not to group older medications with newer therapies. Since these medications are lumped together, health plans could choose to cover only the older, less expensive drugs. But NMHA president and CEO Michael M. Faenza said that his group is encouraged that CMS plans to consider widely accepted treatment guidelines for mental health when reviewing formularies.

But America's Health Insurance Plans (AHIP) praised the USP's final document.

"The final model continues to provide needed flexibility by not expanding the number of categories and classes previously proposed," said Karen Ignagni, AHIP president and CEO. "The direction that CMS is clearly taking supports the building of effective private plan strategies to make the Part D benefit clinically appropriate and affordable for Medicare beneficiaries."

Officials at the Pharmaceutical Research and Manufacturers of America, which has supported access to a broad array of treatments, were still reviewing the document at press time.

Office-Based Surgery

A recent study points to the use of general anesthesia as being a more significant factor in patient injury in cosmetic surgeries than whether the procedure is performed in a physician's office or a surgical facility, according to the American Society for Dermatologic Surgery. The study, published in the December 2004 issue of Dermatologic Surgery, finds that patients who undergo cosmetic procedures under general anesthesia are at a greater risk of complication and death than those who had procedures with local anesthesia. The study is based on analysis of 3 years of data from Florida, a state that has the highest reporting of adverse incidents from in-office surgical procedures in the country. These findings conflict with a 2003 study published in the Archives of Surgery that found that deaths and adverse events are more likely in the physician's office than in an ambulatory surgery center. "Office-based surgery is safe and effective when performed by a properly trained physician with the appropriate procedure and level of anesthesia," Gary Monheit, M.D., president-elect of the American Society for Dermatologic Surgery said in a statement. "The real concern is that patients who undergo cosmetic procedures are often unaware of all the risks involved, including where to have the surgery and which types of anesthesia are available."

Medical Spa Trend

Medical spas, a phenomenon that was popular in 2004, will continue to thrive this year, according to an analysis from Spa Finder, a spa marketing and publishing company. The group lists the medical spa as one of the Top 10 spa trends to watch in 2005. These spas are becoming popular places for executive physicals, health and wellness programs, and cosmetic dermatology and dentistry treatments. Spa Finder predicts that these facilities will continue to earn the respect of the medical community as physicians embrace alternative therapies and cosmetic procedures.

Smallpox Vaccine Stockpile

The United States has pledged 20 million doses of smallpox vaccine toward the global stockpile managed by the World Health Organization (WHO). The vaccine doses will physically remain in the U.S. Strategic National Stockpile but will be available for use by the WHO in the event of an emergency. The global stockpile is designed to help those countries, especially those in the developing world, that have no smallpox vaccine and are not prepared to respond to an outbreak of the disease. The global stockpile will only be used if at least one case of smallpox is confirmed in the human population. U.S. government officials have been urging the creation of a WHO Smallpox Vaccine Bank, which would create a physical stockpile of vaccine in Geneva and a virtual global stockpile of pledged vaccine stocks around the world.

Computer Entries Lead to Errors

Automation isn't necessarily a foolproof way to improve patient safety and reduce medical errors, a report from the United States Pharmacopeia (USP) found. Computer entry errors were the fourth leading cause of medication errors according to MEDMARX, USP's national medication error reporting system. These errors have steadily increased and represent about 12% of all MEDMARX records from 1999 through 2003. Performance deficits—wherein an otherwise qualified physician makes a mistake—were the most frequently reported cause of errors. Distractions were the leading contributing factor, accounting for almost 57% of errors associated with computer entry. The report provided an analysis of 235,159 medication errors voluntarily reported by 570 hospitals and health care facilities nationwide.

Improper Payments Increase

Medicare made approximately $20 billion in improper payments in fiscal year 2004, a report from the Centers for Medicare and Medicaid Services has found. The sum included $900 million in underpayments to providers due to errors made by insurers and $20.8 billion in overpayments made to providers. Medicare hopes to cut the rate of erroneous payments by more than half, to 4%, in 2008 by conducting more extensive payment reviews and by implementing other quality control measures. "We have made significant strides in how we measure the error rate in Medicare payments, and that will enable us to do even more to bring it down," commented Mark McClellan, M.D., CMS administrator. "We have much better data that will help us pinpoint problems and allow us to work with the Medicare contractors and providers to make sure claims are submitted and paid properly."

Patients Turn to CAM

Discouraged by the high cost of conventional treatments, 6 million Americans turned to alternative medicines in the past year to treat conditions such as depression and chronic pain, the Center for Studying Health System Change reported. People using these approaches to save money are often uninsured and usually lack a medical home. While the price is right, these alternative treatments "may be of questionable value," said HSC President Paul Ginsburg, Ph.D. About 63% of the respondents said they used herbal remedies, yet two of the most popular remedies—St. John's wort and kava—have been known to cause serious side effects. In more than half these cases, a conventional medical professional was unaware of a patient using an alternative treatment. The study was based on the 2002 National Health Interview Survey, a government survey that includes information on 31,000 adults.

Office-Based Surgery

A recent study points to the use of general anesthesia as being a more significant factor in patient injury in cosmetic surgeries than whether the procedure is performed in a physician's office or a surgical facility, according to the American Society for Dermatologic Surgery. The study, published in the December 2004 issue of Dermatologic Surgery, finds that patients who undergo cosmetic procedures under general anesthesia are at a greater risk of complication and death than those who had procedures with local anesthesia. The study is based on analysis of 3 years of data from Florida, a state that has the highest reporting of adverse incidents from in-office surgical procedures in the country. These findings conflict with a 2003 study published in the Archives of Surgery that found that deaths and adverse events are more likely in the physician's office than in an ambulatory surgery center. "Office-based surgery is safe and effective when performed by a properly trained physician with the appropriate procedure and level of anesthesia," Gary Monheit, M.D., president-elect of the American Society for Dermatologic Surgery said in a statement. "The real concern is that patients who undergo cosmetic procedures are often unaware of all the risks involved, including where to have the surgery and which types of anesthesia are available."

Medical Spa Trend

Medical spas, a phenomenon that was popular in 2004, will continue to thrive this year, according to an analysis from Spa Finder, a spa marketing and publishing company. The group lists the medical spa as one of the Top 10 spa trends to watch in 2005. These spas are becoming popular places for executive physicals, health and wellness programs, and cosmetic dermatology and dentistry treatments. Spa Finder predicts that these facilities will continue to earn the respect of the medical community as physicians embrace alternative therapies and cosmetic procedures.

Smallpox Vaccine Stockpile

The United States has pledged 20 million doses of smallpox vaccine toward the global stockpile managed by the World Health Organization (WHO). The vaccine doses will physically remain in the U.S. Strategic National Stockpile but will be available for use by the WHO in the event of an emergency. The global stockpile is designed to help those countries, especially those in the developing world, that have no smallpox vaccine and are not prepared to respond to an outbreak of the disease. The global stockpile will only be used if at least one case of smallpox is confirmed in the human population. U.S. government officials have been urging the creation of a WHO Smallpox Vaccine Bank, which would create a physical stockpile of vaccine in Geneva and a virtual global stockpile of pledged vaccine stocks around the world.

Computer Entries Lead to Errors

Automation isn't necessarily a foolproof way to improve patient safety and reduce medical errors, a report from the United States Pharmacopeia (USP) found. Computer entry errors were the fourth leading cause of medication errors according to MEDMARX, USP's national medication error reporting system. These errors have steadily increased and represent about 12% of all MEDMARX records from 1999 through 2003. Performance deficits—wherein an otherwise qualified physician makes a mistake—were the most frequently reported cause of errors. Distractions were the leading contributing factor, accounting for almost 57% of errors associated with computer entry. The report provided an analysis of 235,159 medication errors voluntarily reported by 570 hospitals and health care facilities nationwide.

Improper Payments Increase

Medicare made approximately $20 billion in improper payments in fiscal year 2004, a report from the Centers for Medicare and Medicaid Services has found. The sum included $900 million in underpayments to providers due to errors made by insurers and $20.8 billion in overpayments made to providers. Medicare hopes to cut the rate of erroneous payments by more than half, to 4%, in 2008 by conducting more extensive payment reviews and by implementing other quality control measures. "We have made significant strides in how we measure the error rate in Medicare payments, and that will enable us to do even more to bring it down," commented Mark McClellan, M.D., CMS administrator. "We have much better data that will help us pinpoint problems and allow us to work with the Medicare contractors and providers to make sure claims are submitted and paid properly."

Patients Turn to CAM

Discouraged by the high cost of conventional treatments, 6 million Americans turned to alternative medicines in the past year to treat conditions such as depression and chronic pain, the Center for Studying Health System Change reported. People using these approaches to save money are often uninsured and usually lack a medical home. While the price is right, these alternative treatments "may be of questionable value," said HSC President Paul Ginsburg, Ph.D. About 63% of the respondents said they used herbal remedies, yet two of the most popular remedies—St. John's wort and kava—have been known to cause serious side effects. In more than half these cases, a conventional medical professional was unaware of a patient using an alternative treatment. The study was based on the 2002 National Health Interview Survey, a government survey that includes information on 31,000 adults.

Office-Based Surgery

A recent study points to the use of general anesthesia as being a more significant factor in patient injury in cosmetic surgeries than whether the procedure is performed in a physician's office or a surgical facility, according to the American Society for Dermatologic Surgery. The study, published in the December 2004 issue of Dermatologic Surgery, finds that patients who undergo cosmetic procedures under general anesthesia are at a greater risk of complication and death than those who had procedures with local anesthesia. The study is based on analysis of 3 years of data from Florida, a state that has the highest reporting of adverse incidents from in-office surgical procedures in the country. These findings conflict with a 2003 study published in the Archives of Surgery that found that deaths and adverse events are more likely in the physician's office than in an ambulatory surgery center. "Office-based surgery is safe and effective when performed by a properly trained physician with the appropriate procedure and level of anesthesia," Gary Monheit, M.D., president-elect of the American Society for Dermatologic Surgery said in a statement. "The real concern is that patients who undergo cosmetic procedures are often unaware of all the risks involved, including where to have the surgery and which types of anesthesia are available."

Medical Spa Trend

Medical spas, a phenomenon that was popular in 2004, will continue to thrive this year, according to an analysis from Spa Finder, a spa marketing and publishing company. The group lists the medical spa as one of the Top 10 spa trends to watch in 2005. These spas are becoming popular places for executive physicals, health and wellness programs, and cosmetic dermatology and dentistry treatments. Spa Finder predicts that these facilities will continue to earn the respect of the medical community as physicians embrace alternative therapies and cosmetic procedures.

Smallpox Vaccine Stockpile

The United States has pledged 20 million doses of smallpox vaccine toward the global stockpile managed by the World Health Organization (WHO). The vaccine doses will physically remain in the U.S. Strategic National Stockpile but will be available for use by the WHO in the event of an emergency. The global stockpile is designed to help those countries, especially those in the developing world, that have no smallpox vaccine and are not prepared to respond to an outbreak of the disease. The global stockpile will only be used if at least one case of smallpox is confirmed in the human population. U.S. government officials have been urging the creation of a WHO Smallpox Vaccine Bank, which would create a physical stockpile of vaccine in Geneva and a virtual global stockpile of pledged vaccine stocks around the world.

Computer Entries Lead to Errors

Automation isn't necessarily a foolproof way to improve patient safety and reduce medical errors, a report from the United States Pharmacopeia (USP) found. Computer entry errors were the fourth leading cause of medication errors according to MEDMARX, USP's national medication error reporting system. These errors have steadily increased and represent about 12% of all MEDMARX records from 1999 through 2003. Performance deficits—wherein an otherwise qualified physician makes a mistake—were the most frequently reported cause of errors. Distractions were the leading contributing factor, accounting for almost 57% of errors associated with computer entry. The report provided an analysis of 235,159 medication errors voluntarily reported by 570 hospitals and health care facilities nationwide.

Improper Payments Increase

Medicare made approximately $20 billion in improper payments in fiscal year 2004, a report from the Centers for Medicare and Medicaid Services has found. The sum included $900 million in underpayments to providers due to errors made by insurers and $20.8 billion in overpayments made to providers. Medicare hopes to cut the rate of erroneous payments by more than half, to 4%, in 2008 by conducting more extensive payment reviews and by implementing other quality control measures. "We have made significant strides in how we measure the error rate in Medicare payments, and that will enable us to do even more to bring it down," commented Mark McClellan, M.D., CMS administrator. "We have much better data that will help us pinpoint problems and allow us to work with the Medicare contractors and providers to make sure claims are submitted and paid properly."

Patients Turn to CAM

Discouraged by the high cost of conventional treatments, 6 million Americans turned to alternative medicines in the past year to treat conditions such as depression and chronic pain, the Center for Studying Health System Change reported. People using these approaches to save money are often uninsured and usually lack a medical home. While the price is right, these alternative treatments "may be of questionable value," said HSC President Paul Ginsburg, Ph.D. About 63% of the respondents said they used herbal remedies, yet two of the most popular remedies—St. John's wort and kava—have been known to cause serious side effects. In more than half these cases, a conventional medical professional was unaware of a patient using an alternative treatment. The study was based on the 2002 National Health Interview Survey, a government survey that includes information on 31,000 adults.

Challenging the Refusal Clause

A group representing family planning clinics across the country is challenging a clause in Fiscal Year 2005 spending legislation that withholds federal funds from government agencies that discriminate against insurers or providers for failing to provide abortion services. The National Family Planning and Reproductive Health Association filed a lawsuit last month claiming that the refusal clause in the legislation has the potential to curb access to reproductive health care information and services. The group is seeking a temporary restraining order and a preliminary injunction to stop enforcement of the law. The new provision violates federal regulation of the Title X family planning program, which requires all institutions receiving Title X funding to provide referrals for abortion services to women who request that information, according to the lawsuit. “No individual provider in this country is required to perform abortions against his or her will,” Judith DeSarno, president and CEO of the National Family Planning and Reproductive Health Association said in a statement. But Cathy Cleaver Ruse, director of planning and information for the U.S. Conference of Catholic Bishops' Secretariat for Pro-Life Activities, said the lawsuit would force Catholic and other health providers with moral objections into providing abortions.

Teens Delaying Sexual Activity

Sexual activity among younger teenagers declined significantly between 1995 and 2002, while use of contraception increased, according to a study by the Centers for Disease Control and Prevention. Among never-married girls aged 15-17 years, 30% of those surveyed in 2002 had ever had intercourse, compared with 38% in 1995. Among boys the same age, the percentage dropped from 43% in 1995 to 31% in 2002. The numbers were more mixed among teens aged 18-19; the percentage of boys in that group who had ever had sex dropped from 75% to 64%, but the percentage among the girls actually went from 68% to 69%. More than three-quarters used contraception when they began having intercourse. “More teenagers are avoiding or postponing sexual activity, which can lead to sexually transmitted diseases, unwanted pregnancy, or emotional and societal responsibilities for which they are not prepared,” the Health and Human Services Department said in a statement.

Patients Turn to CAM

Six million Americans turned to alternative medicines in the past year to treat conditions such as depression and chronic pain, the Center for Studying Health System Change reported. People using these approaches to save money are often uninsured and usually lack a medical home. While the price is right, these alternatives “may be of questionable value,” said HSC President Paul Ginsburg, Ph.D. About 63% of the respondents said they used herbal remedies, yet two of the most popular remedies—St. John's wort and kava—have been known to cause serious side effects. In more than half these cases, a conventional medical professional was unaware of a patient using an alternative treatment. The study was based on the 2002 National Health Interview Survey, which included information on 31,000 adults.

Mixed Messages on Sex

Some adults are concerned that providing teens with information about abstinence and contraception sends a mixed message that encourages them to have sex, but most adults (51%) and more than two-thirds of teens (68%) disagree, according to a recent survey. The National Campaign to Prevent Teen Pregnancy sponsored the nationally representative survey of 1,000 teens aged 12-19 years, and 1,014 adults 20 years and older. The survey also found that teens are less critical of their school-based sex education program than adults are. About 26% of adults would give their child's sex education class an A or B, while nearly 60% of teens would do so.

Closed Claims Analysis

The American Society of Anesthesiologists has been using closed insurance claims to track trends in medical errors and design patient safety strategies, Frederick W. Cheney, M.D., director of the group's Closed Claims Project said at a meeting on patient safety and medical liability sponsored by the Joint Commission on Accreditation of Healthcare Organizations. Information from the project, which began in 1985, has been used to create standards of practice and practice guidelines. Since the project was launched in 1985, the inflation-adjusted median payment for a malpractice claim involving anesthesia has dropped from $220,875 to $72,500 in 1999. But there are drawbacks to the use of closed claims, such as the 5-year time lag involved, Dr. Cheney said. Multi-institutional injury specific registries and access to open claims could improve the analysis in the future, he said.

Challenging the Refusal Clause

A group representing family planning clinics across the country is challenging a clause in Fiscal Year 2005 spending legislation that withholds federal funds from government agencies that discriminate against insurers or providers for failing to provide abortion services. The National Family Planning and Reproductive Health Association filed a lawsuit last month claiming that the refusal clause in the legislation has the potential to curb access to reproductive health care information and services. The group is seeking a temporary restraining order and a preliminary injunction to stop enforcement of the law. The new provision violates federal regulation of the Title X family planning program, which requires all institutions receiving Title X funding to provide referrals for abortion services to women who request that information, according to the lawsuit. “No individual provider in this country is required to perform abortions against his or her will,” Judith DeSarno, president and CEO of the National Family Planning and Reproductive Health Association said in a statement. But Cathy Cleaver Ruse, director of planning and information for the U.S. Conference of Catholic Bishops' Secretariat for Pro-Life Activities, said the lawsuit would force Catholic and other health providers with moral objections into providing abortions.

Teens Delaying Sexual Activity

Sexual activity among younger teenagers declined significantly between 1995 and 2002, while use of contraception increased, according to a study by the Centers for Disease Control and Prevention. Among never-married girls aged 15-17 years, 30% of those surveyed in 2002 had ever had intercourse, compared with 38% in 1995. Among boys the same age, the percentage dropped from 43% in 1995 to 31% in 2002. The numbers were more mixed among teens aged 18-19; the percentage of boys in that group who had ever had sex dropped from 75% to 64%, but the percentage among the girls actually went from 68% to 69%. More than three-quarters used contraception when they began having intercourse. “More teenagers are avoiding or postponing sexual activity, which can lead to sexually transmitted diseases, unwanted pregnancy, or emotional and societal responsibilities for which they are not prepared,” the Health and Human Services Department said in a statement.

Patients Turn to CAM

Six million Americans turned to alternative medicines in the past year to treat conditions such as depression and chronic pain, the Center for Studying Health System Change reported. People using these approaches to save money are often uninsured and usually lack a medical home. While the price is right, these alternatives “may be of questionable value,” said HSC President Paul Ginsburg, Ph.D. About 63% of the respondents said they used herbal remedies, yet two of the most popular remedies—St. John's wort and kava—have been known to cause serious side effects. In more than half these cases, a conventional medical professional was unaware of a patient using an alternative treatment. The study was based on the 2002 National Health Interview Survey, which included information on 31,000 adults.

Mixed Messages on Sex

Some adults are concerned that providing teens with information about abstinence and contraception sends a mixed message that encourages them to have sex, but most adults (51%) and more than two-thirds of teens (68%) disagree, according to a recent survey. The National Campaign to Prevent Teen Pregnancy sponsored the nationally representative survey of 1,000 teens aged 12-19 years, and 1,014 adults 20 years and older. The survey also found that teens are less critical of their school-based sex education program than adults are. About 26% of adults would give their child's sex education class an A or B, while nearly 60% of teens would do so.

Closed Claims Analysis

The American Society of Anesthesiologists has been using closed insurance claims to track trends in medical errors and design patient safety strategies, Frederick W. Cheney, M.D., director of the group's Closed Claims Project said at a meeting on patient safety and medical liability sponsored by the Joint Commission on Accreditation of Healthcare Organizations. Information from the project, which began in 1985, has been used to create standards of practice and practice guidelines. Since the project was launched in 1985, the inflation-adjusted median payment for a malpractice claim involving anesthesia has dropped from $220,875 to $72,500 in 1999. But there are drawbacks to the use of closed claims, such as the 5-year time lag involved, Dr. Cheney said. Multi-institutional injury specific registries and access to open claims could improve the analysis in the future, he said.

Challenging the Refusal Clause

A group representing family planning clinics across the country is challenging a clause in Fiscal Year 2005 spending legislation that withholds federal funds from government agencies that discriminate against insurers or providers for failing to provide abortion services. The National Family Planning and Reproductive Health Association filed a lawsuit last month claiming that the refusal clause in the legislation has the potential to curb access to reproductive health care information and services. The group is seeking a temporary restraining order and a preliminary injunction to stop enforcement of the law. The new provision violates federal regulation of the Title X family planning program, which requires all institutions receiving Title X funding to provide referrals for abortion services to women who request that information, according to the lawsuit. “No individual provider in this country is required to perform abortions against his or her will,” Judith DeSarno, president and CEO of the National Family Planning and Reproductive Health Association said in a statement. But Cathy Cleaver Ruse, director of planning and information for the U.S. Conference of Catholic Bishops' Secretariat for Pro-Life Activities, said the lawsuit would force Catholic and other health providers with moral objections into providing abortions.

Teens Delaying Sexual Activity

Sexual activity among younger teenagers declined significantly between 1995 and 2002, while use of contraception increased, according to a study by the Centers for Disease Control and Prevention. Among never-married girls aged 15-17 years, 30% of those surveyed in 2002 had ever had intercourse, compared with 38% in 1995. Among boys the same age, the percentage dropped from 43% in 1995 to 31% in 2002. The numbers were more mixed among teens aged 18-19; the percentage of boys in that group who had ever had sex dropped from 75% to 64%, but the percentage among the girls actually went from 68% to 69%. More than three-quarters used contraception when they began having intercourse. “More teenagers are avoiding or postponing sexual activity, which can lead to sexually transmitted diseases, unwanted pregnancy, or emotional and societal responsibilities for which they are not prepared,” the Health and Human Services Department said in a statement.

Patients Turn to CAM

Six million Americans turned to alternative medicines in the past year to treat conditions such as depression and chronic pain, the Center for Studying Health System Change reported. People using these approaches to save money are often uninsured and usually lack a medical home. While the price is right, these alternatives “may be of questionable value,” said HSC President Paul Ginsburg, Ph.D. About 63% of the respondents said they used herbal remedies, yet two of the most popular remedies—St. John's wort and kava—have been known to cause serious side effects. In more than half these cases, a conventional medical professional was unaware of a patient using an alternative treatment. The study was based on the 2002 National Health Interview Survey, which included information on 31,000 adults.

Mixed Messages on Sex

Some adults are concerned that providing teens with information about abstinence and contraception sends a mixed message that encourages them to have sex, but most adults (51%) and more than two-thirds of teens (68%) disagree, according to a recent survey. The National Campaign to Prevent Teen Pregnancy sponsored the nationally representative survey of 1,000 teens aged 12-19 years, and 1,014 adults 20 years and older. The survey also found that teens are less critical of their school-based sex education program than adults are. About 26% of adults would give their child's sex education class an A or B, while nearly 60% of teens would do so.

Closed Claims Analysis

The American Society of Anesthesiologists has been using closed insurance claims to track trends in medical errors and design patient safety strategies, Frederick W. Cheney, M.D., director of the group's Closed Claims Project said at a meeting on patient safety and medical liability sponsored by the Joint Commission on Accreditation of Healthcare Organizations. Information from the project, which began in 1985, has been used to create standards of practice and practice guidelines. Since the project was launched in 1985, the inflation-adjusted median payment for a malpractice claim involving anesthesia has dropped from $220,875 to $72,500 in 1999. But there are drawbacks to the use of closed claims, such as the 5-year time lag involved, Dr. Cheney said. Multi-institutional injury specific registries and access to open claims could improve the analysis in the future, he said.

While medical liability and health care reform remain the top issues for many physicians this year, of particular urgency is a fix to Medicare's flawed payment formula, which threatens cuts of up to 5% in 2006 and cumulative cuts of 30% through 2012.

“It's certainly one of our top priorities for the coming legislative year,” Paul Speidell, government affairs representative for the Medical Group Management Association (MGMA), told this newspaper. Health information technology and other capital investments “are all thrown into question for the physician practice community when you're looking at cuts that major,” he said.

The issue should generate widespread interest, as “every member of Congress has physicians and Medicare beneficiaries in their district,” Mr. Speidell said. All of the physician groups who spoke with this newspaper detailed grassroots and other efforts to get Congress to avert the cuts.

The Medicare physician fee schedule “is a likely subject for our committees and it's possible we'll do hearings” on the issue this year, although no specific agenda has been discussed, Jon Tripp, deputy communications director with the Energy and Commerce Committee, said in an interview.

An ideal scenario would be to scrap the sustainable growth rate (SGR), a component in the physician pay formula that determines each year's update, and to “look toward a vision of paying for performance and rewarding quality,” a Senate aide told this newspaper.

That approach comes with a high price tag: The Congressional Budget Office estimates it would cost $95 billion to replace the SGR. Exploring that option “really all depends on what the budget outlook is for this year,” the aide said.

No matter what the cost, the fix needs to be done, Robert Doherty, senior vice president for governmental affairs and public policy with the American College of Physicians, said in an interview. “The cost of fixing this may be high, but the reason it's high is because the hole is so deep—and we didn't dig that hole. All we're asking is to fill in that hole so we're breaking even.”

The budget situation is clearly the biggest obstacle, Mr. Doherty said. “If the deficit wasn't bad as it is, it wouldn't be that difficult.”

While no one can predict whether Congress will pursue a permanent fix or a temporary reprieve as they've done in the past, physicians would gain more credibility if Congress didn't focus solely on fixing the SGR, Mr. Doherty said. “We need to engage in other reforms to the physician payments system to make it more functional for the physician, payer, and patient,” he said. For example, medical organizations could talk to Congress about integrating a pay-for-performance component into Medicare, he said.

Malpractice reform is on the top of President Bush's health care agenda and will likely take precedence over the public health safety net and other health care reforms in 2005. Several physician groups and the administration have long advocated a $250,000 cap on noneconomic damages as part of a reform package.

The hurdle ahead is getting the Senate to approve such a bill, Matt Salo, director of the health and human services committee with the National Governors Association, told this newspaper. “Ultimately, you need 60 votes in the Senate to get a bill through. While the Republican margin is a little larger after the elections, it's not 60,” Mr. Salo said.

Passage of the bill is possible, provided that all 55 Republicans in the Senate vote for it, Mr. Doherty said. “We'd also need to win over five Democrats to override a filibuster.” Achieving liability reform “would be a real test of the president's political capital. This is an uphill battle, but these battles have been won before.”

Physicians will have to decide which is more important: their desire for a Medicare payment increase or their desire for medical liability reform, a Republican House staff member said at a meeting sponsored by the American Bar Association.

“They've got two competing interests,” he said. And while some physician groups may pursue liability reform on the assumption that Congress is probably going to pass the payment increase anyway, that isn't necessarily the case, the aide told this newspaper.

Physicians are also holding their breath on the expected transition from the International Classification of Diseases, 9th Revision (ICD-9)—the current diagnosis and inpatient procedure classification system—to the 10th revision (ICD-10).

An upgrade had been recommended on the premise that the ICD-9 was too antiquated to address the need for accurate health care billing in today's technology-driven environment. But physician groups remain concerned that ICD-10 has the potential to drive up costs and add new hassles to physician practice.

The Department of Health and Human Services may issue a proposed rule in 2005, although it's questionable that regulators are looking for more feedback at this point, Robert M. Tennant, MGMA's senior policy advisor for health informatics, said in an interview. Such a notice would more likely be designed “to give us a heads-up, rather than ask questions” that could lead to changes in the rule, he said.

Physicians would prefer a staggered implementation date, Mr. Tennant said. In addition, “we would like health plans to be compliant first, so physician practices could have time to get their systems upgraded and complete their testing and staff training,” he said. The goal is to make sure the transition is cost effective and causes as little disruption to the industry as possible, he said.

The new year also brings new leadership to the federal health bureaucracy. At press time, President Bush named Michael O. Leavitt as his pick to lead HHS. Mr. Leavitt served as the administrator of the Environmental Protection Agency in the president's first administration and was previously governor of Utah. Mr. Leavitt must be confirmed by the Senate before assuming his new duties.

At the Centers for Medicare and Medicaid Services, much effort will be focused this year on getting ready to launch the new Medicare prescription drug benefit just 1 year from now.

This year will be the final year for the drug discount cards that were instituted as a bridge to Medicare drug coverage. The lessons of the drug card should prompt Congress to simplify the Part D drug benefit, said Robert M. Hayes, president of the Medicare Rights Center. But conventional wisdom is that Congress won't do anything to address it this year, and will wait until next year to address problems.

Congress should act to ensure that there is one clear Medicare-run drug plan in every region of the country and that Medicare automatically enrolls low-income seniors. Also, Congress should standardize the benefit packages, he said.

A lot of beneficiary education will be needed this year, said John Rother, director of policy and strategy at AARP (formerly the American Association of Retired Persons), especially since the choices will be different across the country.

Medicare officials need to simplify the sign-up process and make sure that there aren't too many choices for beneficiaries, which was one of the major problems with the drug cards, Mr. Rother said.

Joyce Frieden, Jennifer Silverman, and Mary Ellen Schneider contributed to this report.

ACOG Focuses On Liability Reform

Liability reform continues to top the agenda for the American College of Obstetricians and Gynecologists, said President Vivian M. Dickerson, M.D. “We've got probably a better chance of seeing something happen [this year],” she said.

But despite the shifts in the makeup of the Senate this year, ACOG does not believe that the physician community has enough votes to stop a filibuster, she said.

Tort reform that includes a $250,000 cap on noneconomic damages remains the group's first choice for reform, Dr. Dickerson said, but it is willing to consider the range of policy options, including insurance reforms and a medical court.

A cap on noneconomic damages is still a proven solution, she said, but ACOG is willing to consider other options that could decrease insurance premiums.

In addition, ACOG officials plan to work this year on addressing the lack of insurance coverage and access to care, which is especially severe among women. They will also be monitoring coverage of contraception. And the group remains committed to seeing the Food and Drug Administration approve over-the-counter use for emergency contraception across the board, Dr. Dickerson said.

More Doctors in the House—and Senate

Physicians are heading to Capitol Hill this month and not just to lobby. Below are the results of last year's House and Senate races in which a physician ran for office.

House of Representatives

Arkansas, 2nd District:

Florida, 15th District:

Georgia, 6th District: Tom Price, M.D. (R), was unopposed

Georgia, 11th District:

Illinois, 15th District: David Gill, M.D. (D), lost to

Louisiana, 3rd District: Kevin Chiasson, M.D. (R), lost to Charles Melancon (D)

Louisiana, 7th District: Charles Boustany, Jr., M.D. (R), defeated Willie Mount (D)

Michigan, 7th District: Joseph Schwarz, M.D. (R), defeated Sharon Renier (D)

New Jersey, 3rd District: Herb Conaway, M.D. (D), lost to

New York, 24th District: David Walrath, M.D. (Conservative Party), lost to

North Carolina, 12th District: Ada M. Fisher, M.D. (R), lost to

Pennsylvania, 13th District: Melissa Brown, M.D. (R), lost to Allyson Schwartz (D)

Pennsylvania, 18th District: Mark Boles, M.D. (D), lost to

Texas, 14th District:

Texas, 26th District:

Washington, 7th District:

Senate

Kentucky: Dan Mongiardo, M.D. (D), lost to

New York: Marilyn O'Grady, M.D. (Conservative Party), lost to

Oklahoma: Tom Coburn, M.D. (R), defeated Brad Carson (D)

While medical liability and health care reform remain the top issues for many physicians this year, of particular urgency is a fix to Medicare's flawed payment formula, which threatens cuts of up to 5% in 2006 and cumulative cuts of 30% through 2012.

“It's certainly one of our top priorities for the coming legislative year,” Paul Speidell, government affairs representative for the Medical Group Management Association (MGMA), told this newspaper. Health information technology and other capital investments “are all thrown into question for the physician practice community when you're looking at cuts that major,” he said.

The issue should generate widespread interest, as “every member of Congress has physicians and Medicare beneficiaries in their district,” Mr. Speidell said. All of the physician groups who spoke with this newspaper detailed grassroots and other efforts to get Congress to avert the cuts.

The Medicare physician fee schedule “is a likely subject for our committees and it's possible we'll do hearings” on the issue this year, although no specific agenda has been discussed, Jon Tripp, deputy communications director with the Energy and Commerce Committee, said in an interview.

An ideal scenario would be to scrap the sustainable growth rate (SGR), a component in the physician pay formula that determines each year's update, and to “look toward a vision of paying for performance and rewarding quality,” a Senate aide told this newspaper.

That approach comes with a high price tag: The Congressional Budget Office estimates it would cost $95 billion to replace the SGR. Exploring that option “really all depends on what the budget outlook is for this year,” the aide said.

No matter what the cost, the fix needs to be done, Robert Doherty, senior vice president for governmental affairs and public policy with the American College of Physicians, said in an interview. “The cost of fixing this may be high, but the reason it's high is because the hole is so deep—and we didn't dig that hole. All we're asking is to fill in that hole so we're breaking even.”

The budget situation is clearly the biggest obstacle, Mr. Doherty said. “If the deficit wasn't bad as it is, it wouldn't be that difficult.”

While no one can predict whether Congress will pursue a permanent fix or a temporary reprieve as they've done in the past, physicians would gain more credibility if Congress didn't focus solely on fixing the SGR, Mr. Doherty said. “We need to engage in other reforms to the physician payments system to make it more functional for the physician, payer, and patient,” he said. For example, medical organizations could talk to Congress about integrating a pay-for-performance component into Medicare, he said.

Malpractice reform is on the top of President Bush's health care agenda and will likely take precedence over the public health safety net and other health care reforms in 2005. Several physician groups and the administration have long advocated a $250,000 cap on noneconomic damages as part of a reform package.

The hurdle ahead is getting the Senate to approve such a bill, Matt Salo, director of the health and human services committee with the National Governors Association, told this newspaper. “Ultimately, you need 60 votes in the Senate to get a bill through. While the Republican margin is a little larger after the elections, it's not 60,” Mr. Salo said.

Passage of the bill is possible, provided that all 55 Republicans in the Senate vote for it, Mr. Doherty said. “We'd also need to win over five Democrats to override a filibuster.” Achieving liability reform “would be a real test of the president's political capital. This is an uphill battle, but these battles have been won before.”

Physicians will have to decide which is more important: their desire for a Medicare payment increase or their desire for medical liability reform, a Republican House staff member said at a meeting sponsored by the American Bar Association.

“They've got two competing interests,” he said. And while some physician groups may pursue liability reform on the assumption that Congress is probably going to pass the payment increase anyway, that isn't necessarily the case, the aide told this newspaper.

Physicians are also holding their breath on the expected transition from the International Classification of Diseases, 9th Revision (ICD-9)—the current diagnosis and inpatient procedure classification system—to the 10th revision (ICD-10).

An upgrade had been recommended on the premise that the ICD-9 was too antiquated to address the need for accurate health care billing in today's technology-driven environment. But physician groups remain concerned that ICD-10 has the potential to drive up costs and add new hassles to physician practice.

The Department of Health and Human Services may issue a proposed rule in 2005, although it's questionable that regulators are looking for more feedback at this point, Robert M. Tennant, MGMA's senior policy advisor for health informatics, said in an interview. Such a notice would more likely be designed “to give us a heads-up, rather than ask questions” that could lead to changes in the rule, he said.

Physicians would prefer a staggered implementation date, Mr. Tennant said. In addition, “we would like health plans to be compliant first, so physician practices could have time to get their systems upgraded and complete their testing and staff training,” he said. The goal is to make sure the transition is cost effective and causes as little disruption to the industry as possible, he said.

The new year also brings new leadership to the federal health bureaucracy. At press time, President Bush named Michael O. Leavitt as his pick to lead HHS. Mr. Leavitt served as the administrator of the Environmental Protection Agency in the president's first administration and was previously governor of Utah. Mr. Leavitt must be confirmed by the Senate before assuming his new duties.

At the Centers for Medicare and Medicaid Services, much effort will be focused this year on getting ready to launch the new Medicare prescription drug benefit just 1 year from now.

This year will be the final year for the drug discount cards that were instituted as a bridge to Medicare drug coverage. The lessons of the drug card should prompt Congress to simplify the Part D drug benefit, said Robert M. Hayes, president of the Medicare Rights Center. But conventional wisdom is that Congress won't do anything to address it this year, and will wait until next year to address problems.

Congress should act to ensure that there is one clear Medicare-run drug plan in every region of the country and that Medicare automatically enrolls low-income seniors. Also, Congress should standardize the benefit packages, he said.

A lot of beneficiary education will be needed this year, said John Rother, director of policy and strategy at AARP (formerly the American Association of Retired Persons), especially since the choices will be different across the country.

Medicare officials need to simplify the sign-up process and make sure that there aren't too many choices for beneficiaries, which was one of the major problems with the drug cards, Mr. Rother said.

Joyce Frieden, Jennifer Silverman, and Mary Ellen Schneider contributed to this report.

ACOG Focuses On Liability Reform

Liability reform continues to top the agenda for the American College of Obstetricians and Gynecologists, said President Vivian M. Dickerson, M.D. “We've got probably a better chance of seeing something happen [this year],” she said.

But despite the shifts in the makeup of the Senate this year, ACOG does not believe that the physician community has enough votes to stop a filibuster, she said.

Tort reform that includes a $250,000 cap on noneconomic damages remains the group's first choice for reform, Dr. Dickerson said, but it is willing to consider the range of policy options, including insurance reforms and a medical court.

A cap on noneconomic damages is still a proven solution, she said, but ACOG is willing to consider other options that could decrease insurance premiums.

In addition, ACOG officials plan to work this year on addressing the lack of insurance coverage and access to care, which is especially severe among women. They will also be monitoring coverage of contraception. And the group remains committed to seeing the Food and Drug Administration approve over-the-counter use for emergency contraception across the board, Dr. Dickerson said.

More Doctors in the House—and Senate

Physicians are heading to Capitol Hill this month and not just to lobby. Below are the results of last year's House and Senate races in which a physician ran for office.

House of Representatives

Arkansas, 2nd District:

Florida, 15th District:

Georgia, 6th District: Tom Price, M.D. (R), was unopposed

Georgia, 11th District:

Illinois, 15th District: David Gill, M.D. (D), lost to

Louisiana, 3rd District: Kevin Chiasson, M.D. (R), lost to Charles Melancon (D)

Louisiana, 7th District: Charles Boustany, Jr., M.D. (R), defeated Willie Mount (D)

Michigan, 7th District: Joseph Schwarz, M.D. (R), defeated Sharon Renier (D)

New Jersey, 3rd District: Herb Conaway, M.D. (D), lost to

New York, 24th District: David Walrath, M.D. (Conservative Party), lost to

North Carolina, 12th District: Ada M. Fisher, M.D. (R), lost to

Pennsylvania, 13th District: Melissa Brown, M.D. (R), lost to Allyson Schwartz (D)

Pennsylvania, 18th District: Mark Boles, M.D. (D), lost to

Texas, 14th District:

Texas, 26th District:

Washington, 7th District:

Senate

Kentucky: Dan Mongiardo, M.D. (D), lost to

New York: Marilyn O'Grady, M.D. (Conservative Party), lost to

Oklahoma: Tom Coburn, M.D. (R), defeated Brad Carson (D)

While medical liability and health care reform remain the top issues for many physicians this year, of particular urgency is a fix to Medicare's flawed payment formula, which threatens cuts of up to 5% in 2006 and cumulative cuts of 30% through 2012.

“It's certainly one of our top priorities for the coming legislative year,” Paul Speidell, government affairs representative for the Medical Group Management Association (MGMA), told this newspaper. Health information technology and other capital investments “are all thrown into question for the physician practice community when you're looking at cuts that major,” he said.

The issue should generate widespread interest, as “every member of Congress has physicians and Medicare beneficiaries in their district,” Mr. Speidell said. All of the physician groups who spoke with this newspaper detailed grassroots and other efforts to get Congress to avert the cuts.

The Medicare physician fee schedule “is a likely subject for our committees and it's possible we'll do hearings” on the issue this year, although no specific agenda has been discussed, Jon Tripp, deputy communications director with the Energy and Commerce Committee, said in an interview.

An ideal scenario would be to scrap the sustainable growth rate (SGR), a component in the physician pay formula that determines each year's update, and to “look toward a vision of paying for performance and rewarding quality,” a Senate aide told this newspaper.

That approach comes with a high price tag: The Congressional Budget Office estimates it would cost $95 billion to replace the SGR. Exploring that option “really all depends on what the budget outlook is for this year,” the aide said.

No matter what the cost, the fix needs to be done, Robert Doherty, senior vice president for governmental affairs and public policy with the American College of Physicians, said in an interview. “The cost of fixing this may be high, but the reason it's high is because the hole is so deep—and we didn't dig that hole. All we're asking is to fill in that hole so we're breaking even.”

The budget situation is clearly the biggest obstacle, Mr. Doherty said. “If the deficit wasn't bad as it is, it wouldn't be that difficult.”

While no one can predict whether Congress will pursue a permanent fix or a temporary reprieve as they've done in the past, physicians would gain more credibility if Congress didn't focus solely on fixing the SGR, Mr. Doherty said. “We need to engage in other reforms to the physician payments system to make it more functional for the physician, payer, and patient,” he said. For example, medical organizations could talk to Congress about integrating a pay-for-performance component into Medicare, he said.

Malpractice reform is on the top of President Bush's health care agenda and will likely take precedence over the public health safety net and other health care reforms in 2005. Several physician groups and the administration have long advocated a $250,000 cap on noneconomic damages as part of a reform package.

The hurdle ahead is getting the Senate to approve such a bill, Matt Salo, director of the health and human services committee with the National Governors Association, told this newspaper. “Ultimately, you need 60 votes in the Senate to get a bill through. While the Republican margin is a little larger after the elections, it's not 60,” Mr. Salo said.

Passage of the bill is possible, provided that all 55 Republicans in the Senate vote for it, Mr. Doherty said. “We'd also need to win over five Democrats to override a filibuster.” Achieving liability reform “would be a real test of the president's political capital. This is an uphill battle, but these battles have been won before.”

Physicians will have to decide which is more important: their desire for a Medicare payment increase or their desire for medical liability reform, a Republican House staff member said at a meeting sponsored by the American Bar Association.

“They've got two competing interests,” he said. And while some physician groups may pursue liability reform on the assumption that Congress is probably going to pass the payment increase anyway, that isn't necessarily the case, the aide told this newspaper.

Physicians are also holding their breath on the expected transition from the International Classification of Diseases, 9th Revision (ICD-9)—the current diagnosis and inpatient procedure classification system—to the 10th revision (ICD-10).

An upgrade had been recommended on the premise that the ICD-9 was too antiquated to address the need for accurate health care billing in today's technology-driven environment. But physician groups remain concerned that ICD-10 has the potential to drive up costs and add new hassles to physician practice.

The Department of Health and Human Services may issue a proposed rule in 2005, although it's questionable that regulators are looking for more feedback at this point, Robert M. Tennant, MGMA's senior policy advisor for health informatics, said in an interview. Such a notice would more likely be designed “to give us a heads-up, rather than ask questions” that could lead to changes in the rule, he said.

Physicians would prefer a staggered implementation date, Mr. Tennant said. In addition, “we would like health plans to be compliant first, so physician practices could have time to get their systems upgraded and complete their testing and staff training,” he said. The goal is to make sure the transition is cost effective and causes as little disruption to the industry as possible, he said.

The new year also brings new leadership to the federal health bureaucracy. At press time, President Bush named Michael O. Leavitt as his pick to lead HHS. Mr. Leavitt served as the administrator of the Environmental Protection Agency in the president's first administration and was previously governor of Utah. Mr. Leavitt must be confirmed by the Senate before assuming his new duties.

At the Centers for Medicare and Medicaid Services, much effort will be focused this year on getting ready to launch the new Medicare prescription drug benefit just 1 year from now.

This year will be the final year for the drug discount cards that were instituted as a bridge to Medicare drug coverage. The lessons of the drug card should prompt Congress to simplify the Part D drug benefit, said Robert M. Hayes, president of the Medicare Rights Center. But conventional wisdom is that Congress won't do anything to address it this year, and will wait until next year to address problems.

Congress should act to ensure that there is one clear Medicare-run drug plan in every region of the country and that Medicare automatically enrolls low-income seniors. Also, Congress should standardize the benefit packages, he said.

A lot of beneficiary education will be needed this year, said John Rother, director of policy and strategy at AARP (formerly the American Association of Retired Persons), especially since the choices will be different across the country.

Medicare officials need to simplify the sign-up process and make sure that there aren't too many choices for beneficiaries, which was one of the major problems with the drug cards, Mr. Rother said.

Joyce Frieden, Jennifer Silverman, and Mary Ellen Schneider contributed to this report.

ACOG Focuses On Liability Reform

Liability reform continues to top the agenda for the American College of Obstetricians and Gynecologists, said President Vivian M. Dickerson, M.D. “We've got probably a better chance of seeing something happen [this year],” she said.

But despite the shifts in the makeup of the Senate this year, ACOG does not believe that the physician community has enough votes to stop a filibuster, she said.

Tort reform that includes a $250,000 cap on noneconomic damages remains the group's first choice for reform, Dr. Dickerson said, but it is willing to consider the range of policy options, including insurance reforms and a medical court.

A cap on noneconomic damages is still a proven solution, she said, but ACOG is willing to consider other options that could decrease insurance premiums.

In addition, ACOG officials plan to work this year on addressing the lack of insurance coverage and access to care, which is especially severe among women. They will also be monitoring coverage of contraception. And the group remains committed to seeing the Food and Drug Administration approve over-the-counter use for emergency contraception across the board, Dr. Dickerson said.

More Doctors in the House—and Senate

Physicians are heading to Capitol Hill this month and not just to lobby. Below are the results of last year's House and Senate races in which a physician ran for office.

House of Representatives

Arkansas, 2nd District:

Florida, 15th District:

Georgia, 6th District: Tom Price, M.D. (R), was unopposed

Georgia, 11th District:

Illinois, 15th District: David Gill, M.D. (D), lost to

Louisiana, 3rd District: Kevin Chiasson, M.D. (R), lost to Charles Melancon (D)

Louisiana, 7th District: Charles Boustany, Jr., M.D. (R), defeated Willie Mount (D)

Michigan, 7th District: Joseph Schwarz, M.D. (R), defeated Sharon Renier (D)

New Jersey, 3rd District: Herb Conaway, M.D. (D), lost to

New York, 24th District: David Walrath, M.D. (Conservative Party), lost to

North Carolina, 12th District: Ada M. Fisher, M.D. (R), lost to

Pennsylvania, 13th District: Melissa Brown, M.D. (R), lost to Allyson Schwartz (D)

Pennsylvania, 18th District: Mark Boles, M.D. (D), lost to

Texas, 14th District:

Texas, 26th District:

Washington, 7th District:

Senate

Kentucky: Dan Mongiardo, M.D. (D), lost to

New York: Marilyn O'Grady, M.D. (Conservative Party), lost to

Oklahoma: Tom Coburn, M.D. (R), defeated Brad Carson (D)

WASHINGTON — The Medicare Payment Advisory Commission is considering redistributing 1%-2% of Medicare physician payments to physicians who demonstrate quality based on certain performance measures.

But what measures to use, how to obtain the quality information, and whether to base payments on performance by individual physicians or group practices is still up in the air.

Linking an even greater portion of physician pay to quality might be necessary to make the plan viable, Arnold Milstein, M.D., who is a member of the commission, said at a recent commission meeting.

Private-sector experiences indicate that in order for physicians to put a high priority on quality measures, payments need to be more than 10%, Dr. Milstein said, compared with the current 5%-10% on table from insurers.

“I also agree that we should put more and more of the payment at risk,” said Ralph W. Muller, a MedPAC member and CEO of the University of Pennsylvania Health System.

Over 3-5 years, Medicare should increase the amount of the payment that is at risk, he said.

“We've now seen 30 years of evidence that the payment system drives behavior more powerfully than almost everything else. So if you want quality to be a bigger part of the agenda, as we are suggesting it should be, then more and more of the payment system in fact has to be tied to quality,” Mr. Muller said at the meeting.

But taking 1%-2% of Medicare physician payment and redistributing it based on quality may have a much bigger impact than larger payments from private insurers because of the larger average share of Medicare patients in many physician practices, said Glenn Hackbarth, who is the chairman of MedPAC and also an independent consultant from Bend, Ore.

“The 1%-2% is a starting point,” Mr. Hackbarth said, “not necessary an end point.”

It would be better to start out at a lower level of payments as Medicare officials figure out the best measures to use, but keep the door open to increasing the amount of payments linked to quality over time, Mr. Hackbarth said.

Alan R. Nelson, M.D., who is both a MedPAC member and an internist, cautioned that the commission members should be careful about pay for performance.

“We have to be aware as we proceed with this of unintended consequences that could end up in worse patient care, rather than better patient care,” Dr. Nelson said.

Although that's not a factor in the majority of situations, some unintended consequences possibly could occur, he noted.

For example, linking quality payments in the area of avoidable hospitalizations could create a disincentive. It can be difficult for physicians to decide how far to go in managing a patient's care successfully at home or if the patient needs to go into the hospital, according to Dr. Nelson, but if there is a financial incentive to keep patients at home, it could create a greater risk for patients.

Pay for performance also leaves the door open to “cherry picking” of patients, Dr. Nelson said. For example, a physician may choose not to provide care to a patient who smokes, because that patient would hurt the physician's quality numbers.

The commission should also exercise caution in how it chooses to collect data, according to Dr. Nelson.

If Medicare is going to collect quality data using methods that impose an additional administrative burden on physicians, that time should be reimbursed. Physicians want to do a good job, he said, but they won't embrace unfunded mandates, he said.

WASHINGTON — The Medicare Payment Advisory Commission is considering redistributing 1%-2% of Medicare physician payments to physicians who demonstrate quality based on certain performance measures.

But what measures to use, how to obtain the quality information, and whether to base payments on performance by individual physicians or group practices is still up in the air.

Linking an even greater portion of physician pay to quality might be necessary to make the plan viable, Arnold Milstein, M.D., who is a member of the commission, said at a recent commission meeting.

Private-sector experiences indicate that in order for physicians to put a high priority on quality measures, payments need to be more than 10%, Dr. Milstein said, compared with the current 5%-10% on table from insurers.

“I also agree that we should put more and more of the payment at risk,” said Ralph W. Muller, a MedPAC member and CEO of the University of Pennsylvania Health System.

Over 3-5 years, Medicare should increase the amount of the payment that is at risk, he said.

“We've now seen 30 years of evidence that the payment system drives behavior more powerfully than almost everything else. So if you want quality to be a bigger part of the agenda, as we are suggesting it should be, then more and more of the payment system in fact has to be tied to quality,” Mr. Muller said at the meeting.

But taking 1%-2% of Medicare physician payment and redistributing it based on quality may have a much bigger impact than larger payments from private insurers because of the larger average share of Medicare patients in many physician practices, said Glenn Hackbarth, who is the chairman of MedPAC and also an independent consultant from Bend, Ore.

“The 1%-2% is a starting point,” Mr. Hackbarth said, “not necessary an end point.”

It would be better to start out at a lower level of payments as Medicare officials figure out the best measures to use, but keep the door open to increasing the amount of payments linked to quality over time, Mr. Hackbarth said.

Alan R. Nelson, M.D., who is both a MedPAC member and an internist, cautioned that the commission members should be careful about pay for performance.

“We have to be aware as we proceed with this of unintended consequences that could end up in worse patient care, rather than better patient care,” Dr. Nelson said.

Although that's not a factor in the majority of situations, some unintended consequences possibly could occur, he noted.

For example, linking quality payments in the area of avoidable hospitalizations could create a disincentive. It can be difficult for physicians to decide how far to go in managing a patient's care successfully at home or if the patient needs to go into the hospital, according to Dr. Nelson, but if there is a financial incentive to keep patients at home, it could create a greater risk for patients.

Pay for performance also leaves the door open to “cherry picking” of patients, Dr. Nelson said. For example, a physician may choose not to provide care to a patient who smokes, because that patient would hurt the physician's quality numbers.

The commission should also exercise caution in how it chooses to collect data, according to Dr. Nelson.

If Medicare is going to collect quality data using methods that impose an additional administrative burden on physicians, that time should be reimbursed. Physicians want to do a good job, he said, but they won't embrace unfunded mandates, he said.

WASHINGTON — The Medicare Payment Advisory Commission is considering redistributing 1%-2% of Medicare physician payments to physicians who demonstrate quality based on certain performance measures.

But what measures to use, how to obtain the quality information, and whether to base payments on performance by individual physicians or group practices is still up in the air.

Linking an even greater portion of physician pay to quality might be necessary to make the plan viable, Arnold Milstein, M.D., who is a member of the commission, said at a recent commission meeting.

Private-sector experiences indicate that in order for physicians to put a high priority on quality measures, payments need to be more than 10%, Dr. Milstein said, compared with the current 5%-10% on table from insurers.

“I also agree that we should put more and more of the payment at risk,” said Ralph W. Muller, a MedPAC member and CEO of the University of Pennsylvania Health System.

Over 3-5 years, Medicare should increase the amount of the payment that is at risk, he said.

“We've now seen 30 years of evidence that the payment system drives behavior more powerfully than almost everything else. So if you want quality to be a bigger part of the agenda, as we are suggesting it should be, then more and more of the payment system in fact has to be tied to quality,” Mr. Muller said at the meeting.

But taking 1%-2% of Medicare physician payment and redistributing it based on quality may have a much bigger impact than larger payments from private insurers because of the larger average share of Medicare patients in many physician practices, said Glenn Hackbarth, who is the chairman of MedPAC and also an independent consultant from Bend, Ore.

“The 1%-2% is a starting point,” Mr. Hackbarth said, “not necessary an end point.”

It would be better to start out at a lower level of payments as Medicare officials figure out the best measures to use, but keep the door open to increasing the amount of payments linked to quality over time, Mr. Hackbarth said.

Alan R. Nelson, M.D., who is both a MedPAC member and an internist, cautioned that the commission members should be careful about pay for performance.

“We have to be aware as we proceed with this of unintended consequences that could end up in worse patient care, rather than better patient care,” Dr. Nelson said.

Although that's not a factor in the majority of situations, some unintended consequences possibly could occur, he noted.

For example, linking quality payments in the area of avoidable hospitalizations could create a disincentive. It can be difficult for physicians to decide how far to go in managing a patient's care successfully at home or if the patient needs to go into the hospital, according to Dr. Nelson, but if there is a financial incentive to keep patients at home, it could create a greater risk for patients.

Pay for performance also leaves the door open to “cherry picking” of patients, Dr. Nelson said. For example, a physician may choose not to provide care to a patient who smokes, because that patient would hurt the physician's quality numbers.

The commission should also exercise caution in how it chooses to collect data, according to Dr. Nelson.

If Medicare is going to collect quality data using methods that impose an additional administrative burden on physicians, that time should be reimbursed. Physicians want to do a good job, he said, but they won't embrace unfunded mandates, he said.

More than 4 years ago, Raymond M. Pomm, M.D., started to see a pattern of disruptive behavior occurring in physicians across Florida, where he is the medical director for the state's Impaired Professionals Program.

Hospitals were reporting a range of inappropriate and disruptive behaviors, from yelling to berating nurses in front of other staffers to physical violence. But the behavior didn't fit any patterns typically associated with psychiatric disorders such as bipolar disorder or substance abuse, he said, so he searched the country for a person or program that could help to change the behavior. “It became a real dilemma,” Dr. Pomm said.

Then in 2002, Eva Ritvo, M.D., a psychiatrist, and Larry Harmon, Ph.D., a psychologist, stepped forward with a unique approach. They started the Physicians Development Program, which provides a complete psychiatric, psychological, and workplace evaluation of potentially disruptive physicians, offers referrals to local treatment, and monitors behavior to chart improvement.

“We really try to tailor the program to the individual doctor,” said Dr. Ritvo of the department of psychiatry and behavioral sciences at the University of Miami and chair of the department of psychiatry at Mount Sinai Medical Center in Miami Beach.

They also use the Physicians' Universal Leadership Skills Survey Enhancement (PULSE) tool to evaluate and monitor physician behavior. The survey was developed by asking a variety of health care professionals what their colleagues do at work that motivates them to perform at their best, and what disrupts or discourages them.

When a physician agrees to go through the program, Dr. Harmon sends the survey to nurses, physician colleagues, and hospital leadership to find out how the individual physician behaves.

This feedback gives the physician some insight into how he or she is viewed by colleagues. This is a “magic moment” in the program, said Dr. Harmon, chair of the ethics advisory board of the Florida Psychological Association.

The physicians, along with hospital administrators, choose the people who will complete the survey. “This is not mental health treatment, this is physician development,” Dr. Harmon said.

Seeing this report usually turns around the behavior, Dr. Harmon said. Once the behavior is pointed out in a structured, objective way by a neutral third party, the findings are seen as credible and have an impact on the doctor.

The feedback report allows Dr. Harmon to constructively confront the doctor's lack of insight, he said. Physicians do not notice their disruptive impact on others until they see the collective voice of their team members reflected in the report.

It's also the best way to find out if a physician isn't being disruptive, but may be a political target at the hospital.

After the survey is shown to the physician, Dr. Harmon conducts a follow-up survey to chart the physician's progress.

So far, all of the physicians who have been through the program have improved their behavior, he said.

About 42 physicians have completed the program since its inception in 2002. They come from around the country and from various specialties, Dr. Ritvo said.

“Typically, our physicians are not what you'd expect,” she said.

These physicians usually don't see their behavior as inappropriate and will say that they are just trying to get the best care for their patients. And they are usually excellent doctors but they are operating under a lot of stress and generally have some type of personality disorder involving obsessive behavior and control issues. “We see a lot of perfectionism,” said Dr. Ritvo said, who, in the future, hopes to focus more on prevention and be able to offer physicians a chance to assess their behavior before they are reported for inappropriate behavior.

The Physicians Development Program isn't just for disruptive physicians, Dr. Harmon said. It can also be used by groups of physicians who want to provide confidential feedback about how they are impacting their staff and colleagues.

“It gives physicians a chance to see themselves as others see them, and maybe for the first time,” he said.

Prevention is key, Dr. Pomm said. Hospitals should conduct ongoing assessments of personnel and work environments and offer help to employees, he said.

State medical boards are also in a position to help physicians get help before a disciplinary action is necessary, said James N. Thompson, M.D., president and CEO of the Federation of State Medical Boards.

Developing a nonpunitive way to identify physicians who are heading toward trouble would serve the public, reduce disciplinary actions, and keep physicians in practice longer, Dr. Thompson said.

Behavior Checklist For Physicians

So how do you avoid becoming a disruptive physician? Dr. Ritvo and Dr. Harmon have put together some tips on how to ensure that your behavior is appropriate:

▸ Periodically ask staff, supervisors, and colleagues how you are doing with “teamwork.”

▸ Let your staff know when they are doing a good job.

▸ Praise in public; reprimand in private.

▸ Reprimand the mistake, not the person.

▸ Foster positive and open communication with staff.

▸ Beware of sarcasm, tone of voice, and body language.

▸ Set clear and realistic goals for yourself and your staff and make sure the goals are communicated effectively.

▸ Develop stress reducing techniques.

▸ Humor can be an effective way to cope, but remember what is funny to one person may be offensive to another.

▸ Avoid all sexual comments at the office.

▸ Avoid excessive work hours.

▸ Add balance to your life.

▸ Seek help when needed.

More than 4 years ago, Raymond M. Pomm, M.D., started to see a pattern of disruptive behavior occurring in physicians across Florida, where he is the medical director for the state's Impaired Professionals Program.

Hospitals were reporting a range of inappropriate and disruptive behaviors, from yelling to berating nurses in front of other staffers to physical violence. But the behavior didn't fit any patterns typically associated with psychiatric disorders such as bipolar disorder or substance abuse, he said, so he searched the country for a person or program that could help to change the behavior. “It became a real dilemma,” Dr. Pomm said.

Then in 2002, Eva Ritvo, M.D., a psychiatrist, and Larry Harmon, Ph.D., a psychologist, stepped forward with a unique approach. They started the Physicians Development Program, which provides a complete psychiatric, psychological, and workplace evaluation of potentially disruptive physicians, offers referrals to local treatment, and monitors behavior to chart improvement.

“We really try to tailor the program to the individual doctor,” said Dr. Ritvo of the department of psychiatry and behavioral sciences at the University of Miami and chair of the department of psychiatry at Mount Sinai Medical Center in Miami Beach.

They also use the Physicians' Universal Leadership Skills Survey Enhancement (PULSE) tool to evaluate and monitor physician behavior. The survey was developed by asking a variety of health care professionals what their colleagues do at work that motivates them to perform at their best, and what disrupts or discourages them.

When a physician agrees to go through the program, Dr. Harmon sends the survey to nurses, physician colleagues, and hospital leadership to find out how the individual physician behaves.

This feedback gives the physician some insight into how he or she is viewed by colleagues. This is a “magic moment” in the program, said Dr. Harmon, chair of the ethics advisory board of the Florida Psychological Association.

The physicians, along with hospital administrators, choose the people who will complete the survey. “This is not mental health treatment, this is physician development,” Dr. Harmon said.

Seeing this report usually turns around the behavior, Dr. Harmon said. Once the behavior is pointed out in a structured, objective way by a neutral third party, the findings are seen as credible and have an impact on the doctor.

The feedback report allows Dr. Harmon to constructively confront the doctor's lack of insight, he said. Physicians do not notice their disruptive impact on others until they see the collective voice of their team members reflected in the report.

It's also the best way to find out if a physician isn't being disruptive, but may be a political target at the hospital.

After the survey is shown to the physician, Dr. Harmon conducts a follow-up survey to chart the physician's progress.

So far, all of the physicians who have been through the program have improved their behavior, he said.

About 42 physicians have completed the program since its inception in 2002. They come from around the country and from various specialties, Dr. Ritvo said.

“Typically, our physicians are not what you'd expect,” she said.

These physicians usually don't see their behavior as inappropriate and will say that they are just trying to get the best care for their patients. And they are usually excellent doctors but they are operating under a lot of stress and generally have some type of personality disorder involving obsessive behavior and control issues. “We see a lot of perfectionism,” said Dr. Ritvo said, who, in the future, hopes to focus more on prevention and be able to offer physicians a chance to assess their behavior before they are reported for inappropriate behavior.

The Physicians Development Program isn't just for disruptive physicians, Dr. Harmon said. It can also be used by groups of physicians who want to provide confidential feedback about how they are impacting their staff and colleagues.

“It gives physicians a chance to see themselves as others see them, and maybe for the first time,” he said.

Prevention is key, Dr. Pomm said. Hospitals should conduct ongoing assessments of personnel and work environments and offer help to employees, he said.

State medical boards are also in a position to help physicians get help before a disciplinary action is necessary, said James N. Thompson, M.D., president and CEO of the Federation of State Medical Boards.

Developing a nonpunitive way to identify physicians who are heading toward trouble would serve the public, reduce disciplinary actions, and keep physicians in practice longer, Dr. Thompson said.

Behavior Checklist For Physicians

So how do you avoid becoming a disruptive physician? Dr. Ritvo and Dr. Harmon have put together some tips on how to ensure that your behavior is appropriate:

▸ Periodically ask staff, supervisors, and colleagues how you are doing with “teamwork.”

▸ Let your staff know when they are doing a good job.

▸ Praise in public; reprimand in private.

▸ Reprimand the mistake, not the person.

▸ Foster positive and open communication with staff.

▸ Beware of sarcasm, tone of voice, and body language.

▸ Set clear and realistic goals for yourself and your staff and make sure the goals are communicated effectively.

▸ Develop stress reducing techniques.

▸ Humor can be an effective way to cope, but remember what is funny to one person may be offensive to another.

▸ Avoid all sexual comments at the office.

▸ Avoid excessive work hours.

▸ Add balance to your life.

▸ Seek help when needed.

More than 4 years ago, Raymond M. Pomm, M.D., started to see a pattern of disruptive behavior occurring in physicians across Florida, where he is the medical director for the state's Impaired Professionals Program.

Hospitals were reporting a range of inappropriate and disruptive behaviors, from yelling to berating nurses in front of other staffers to physical violence. But the behavior didn't fit any patterns typically associated with psychiatric disorders such as bipolar disorder or substance abuse, he said, so he searched the country for a person or program that could help to change the behavior. “It became a real dilemma,” Dr. Pomm said.

Then in 2002, Eva Ritvo, M.D., a psychiatrist, and Larry Harmon, Ph.D., a psychologist, stepped forward with a unique approach. They started the Physicians Development Program, which provides a complete psychiatric, psychological, and workplace evaluation of potentially disruptive physicians, offers referrals to local treatment, and monitors behavior to chart improvement.

“We really try to tailor the program to the individual doctor,” said Dr. Ritvo of the department of psychiatry and behavioral sciences at the University of Miami and chair of the department of psychiatry at Mount Sinai Medical Center in Miami Beach.

They also use the Physicians' Universal Leadership Skills Survey Enhancement (PULSE) tool to evaluate and monitor physician behavior. The survey was developed by asking a variety of health care professionals what their colleagues do at work that motivates them to perform at their best, and what disrupts or discourages them.

When a physician agrees to go through the program, Dr. Harmon sends the survey to nurses, physician colleagues, and hospital leadership to find out how the individual physician behaves.

This feedback gives the physician some insight into how he or she is viewed by colleagues. This is a “magic moment” in the program, said Dr. Harmon, chair of the ethics advisory board of the Florida Psychological Association.

The physicians, along with hospital administrators, choose the people who will complete the survey. “This is not mental health treatment, this is physician development,” Dr. Harmon said.

Seeing this report usually turns around the behavior, Dr. Harmon said. Once the behavior is pointed out in a structured, objective way by a neutral third party, the findings are seen as credible and have an impact on the doctor.

The feedback report allows Dr. Harmon to constructively confront the doctor's lack of insight, he said. Physicians do not notice their disruptive impact on others until they see the collective voice of their team members reflected in the report.

It's also the best way to find out if a physician isn't being disruptive, but may be a political target at the hospital.

After the survey is shown to the physician, Dr. Harmon conducts a follow-up survey to chart the physician's progress.

So far, all of the physicians who have been through the program have improved their behavior, he said.

About 42 physicians have completed the program since its inception in 2002. They come from around the country and from various specialties, Dr. Ritvo said.

“Typically, our physicians are not what you'd expect,” she said.

These physicians usually don't see their behavior as inappropriate and will say that they are just trying to get the best care for their patients. And they are usually excellent doctors but they are operating under a lot of stress and generally have some type of personality disorder involving obsessive behavior and control issues. “We see a lot of perfectionism,” said Dr. Ritvo said, who, in the future, hopes to focus more on prevention and be able to offer physicians a chance to assess their behavior before they are reported for inappropriate behavior.

The Physicians Development Program isn't just for disruptive physicians, Dr. Harmon said. It can also be used by groups of physicians who want to provide confidential feedback about how they are impacting their staff and colleagues.

“It gives physicians a chance to see themselves as others see them, and maybe for the first time,” he said.

Prevention is key, Dr. Pomm said. Hospitals should conduct ongoing assessments of personnel and work environments and offer help to employees, he said.

State medical boards are also in a position to help physicians get help before a disciplinary action is necessary, said James N. Thompson, M.D., president and CEO of the Federation of State Medical Boards.

Developing a nonpunitive way to identify physicians who are heading toward trouble would serve the public, reduce disciplinary actions, and keep physicians in practice longer, Dr. Thompson said.

Behavior Checklist For Physicians

So how do you avoid becoming a disruptive physician? Dr. Ritvo and Dr. Harmon have put together some tips on how to ensure that your behavior is appropriate:

▸ Periodically ask staff, supervisors, and colleagues how you are doing with “teamwork.”

▸ Let your staff know when they are doing a good job.

▸ Praise in public; reprimand in private.

▸ Reprimand the mistake, not the person.

▸ Foster positive and open communication with staff.

▸ Beware of sarcasm, tone of voice, and body language.

▸ Set clear and realistic goals for yourself and your staff and make sure the goals are communicated effectively.

▸ Develop stress reducing techniques.

▸ Humor can be an effective way to cope, but remember what is funny to one person may be offensive to another.

▸ Avoid all sexual comments at the office.

▸ Avoid excessive work hours.

▸ Add balance to your life.

▸ Seek help when needed.

A limited commercial program that would import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as being extraordinarily difficult and costly to implement safely. It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

“Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections,” according to the secretaries. “These drugs must have the same level of safety and effectiveness as FDA-approved products.”

In the letter, Bush administration officials outlined the requirements of such a system. For example, it should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are mostly likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could pose increased safety risks in an importation program, such as controlled substances or drugs that require refrigeration during shipping. And the program must avoid “anticompetitive provisions” including “forced sale” clauses and other types of price controls.

The letter also warns Congress that if its members pass legislation that stifles competition or fails to address safety concerns, the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet this criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position. The group said that it supports importation of prescription drugs by wholesalers and pharmacies, provided that the drugs have been FDA approved and are part of a closed distribution chain. AMA does not support personal importation via the Internet until patient safety can be assured.

“Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled,” AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation.

“Millions of American obtain prescription medicines from Canada and other countries every year and do so safely,” Sen. Dorgan said in a statement. “The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market, just because they can.”

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act. The law includes a provision to allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report on prescription drug importation is available online at http://www.hhs.gov/importtaskforce

A limited commercial program that would import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as being extraordinarily difficult and costly to implement safely. It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

“Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections,” according to the secretaries. “These drugs must have the same level of safety and effectiveness as FDA-approved products.”

In the letter, Bush administration officials outlined the requirements of such a system. For example, it should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are mostly likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could pose increased safety risks in an importation program, such as controlled substances or drugs that require refrigeration during shipping. And the program must avoid “anticompetitive provisions” including “forced sale” clauses and other types of price controls.

The letter also warns Congress that if its members pass legislation that stifles competition or fails to address safety concerns, the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet this criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position. The group said that it supports importation of prescription drugs by wholesalers and pharmacies, provided that the drugs have been FDA approved and are part of a closed distribution chain. AMA does not support personal importation via the Internet until patient safety can be assured.

“Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled,” AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation.

“Millions of American obtain prescription medicines from Canada and other countries every year and do so safely,” Sen. Dorgan said in a statement. “The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market, just because they can.”

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act. The law includes a provision to allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report on prescription drug importation is available online at http://www.hhs.gov/importtaskforce

A limited commercial program that would import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as being extraordinarily difficult and costly to implement safely. It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

“Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections,” according to the secretaries. “These drugs must have the same level of safety and effectiveness as FDA-approved products.”

In the letter, Bush administration officials outlined the requirements of such a system. For example, it should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are mostly likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could pose increased safety risks in an importation program, such as controlled substances or drugs that require refrigeration during shipping. And the program must avoid “anticompetitive provisions” including “forced sale” clauses and other types of price controls.

The letter also warns Congress that if its members pass legislation that stifles competition or fails to address safety concerns, the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet this criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position. The group said that it supports importation of prescription drugs by wholesalers and pharmacies, provided that the drugs have been FDA approved and are part of a closed distribution chain. AMA does not support personal importation via the Internet until patient safety can be assured.

“Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled,” AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation.

“Millions of American obtain prescription medicines from Canada and other countries every year and do so safely,” Sen. Dorgan said in a statement. “The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market, just because they can.”

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act. The law includes a provision to allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report on prescription drug importation is available online at http://www.hhs.gov/importtaskforce