Jennifer Silverman

Many questions surround the authority of a new drug safety board that would oversee the management of drug safety and provide emerging information to physicians and patients about the benefits and risks of medicines on the market.

Such a board is one of several steps that Health and Human Services Secretary Mike Leavitt is taking to improve oversight and “openness” at the Food and Drug Administration.

“Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to U.S. consumers,” said acting FDA Commissioner Lester Crawford, D.V.M., Ph.D.

The drug safety board is being touted as an independent entity, yet lawmakers and consumer groups have questioned how much independence or authority the board will actually have.

Larry Sasich, a pharmacist and research analyst for Public Citizen, noted that recommendations and concerns of the FDA's current Office of Drug Safety, which is a subunit of the Office of New Drugs, are often ignored by the agency's new drug reviewers.

If the new board reports in a similar manner, “it may be a stretch to call it an independent board,” Mr. Sasich said.

Secretary Leavitt said that the new board would resolve disagreements over approaches to drug safety issues, oversee development and implementation of center-wide drug safety policies, and assess the need for MedGuides.

The safety board would be comprised of FDA officials and medical experts from other federal agencies. Outside medical experts and consumer representatives would serve as consultants.

“We hope to nominate and confirm board members within the next few months,” an FDA spokeswoman said.

As another component of the oversight initiative, FDA plans to create a new “Drug Watch” Web page, a site to include emerging information for approved drugs about possible serious side effects, or other safety risks.

The Web site would also house drug safety information sheets for health care professionals and patients. Such information also would be available through MedWatch.

Through these direct communication channels, the agency plans to discuss emerging or potential safety problems with the public—even before considering a regulatory action.

Some lawmakers thought the department's new initiatives didn't go far enough to ensure drug safety.

“Consumer confidence in the FDA has been shaken to the core, and it will take more than cosmetic reforms to fix structural problems within the agency,” Sen. Christopher Dodd (D-Conn.) said in a statement.

Sen. Dodd also expressed concern that the FDA wouldn't have the resources to adequately oversee drug safety. “The president's budget provides only a $6.5 million increase for this critically important need, and that's far short of what is needed.”

Additional actions should be taken to increase FDA's resources to monitor drugs and to give it the authority to require drug companies to initiate and complete appropriate safety studies, suggested Sen. Edward M. Kennedy (D-Mass.)

The agency will eventually seek input on the quality and usefulness of this information, an FDA spokeswoman said.“We are not soliciting for public comment, or treating this as a proposed rule.”

The agency does plan on issuing draft guidance on procedures and criteria for identifying drugs and information for the Web page.

A spokesman for the Pharmaceutical Research and Manufacturers of America said that that organization supports any effort to address the quality of information used by the agency.

“For health care professionals and patients, it is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk,” said Jeff Trewhitt, adding that PhRMA would study the initiatives and respond to the FDA's request for input.

But Public Citizen's Mr. Sasich said the effort to step up monitoring of drugs seems like an attempt to deflect recent criticisms that FDA hasn't been meeting its charge as a public safety agency.

In particular, FDA has been criticized for not acting quickly enough to inform physicians and patients about the possible health repercussions of cyclooxygenase-2 (COX-2) inhibitor Vioxx (rofecoxib), which was withdrawn from the market last September 2004.

In PhRMA's view, the FDA has already responded “quickly and constructively” to concerns about Vioxx, Mr. Trewhitt said.

Many questions surround the authority of a new drug safety board that would oversee the management of drug safety and provide emerging information to physicians and patients about the benefits and risks of medicines on the market.

Such a board is one of several steps that Health and Human Services Secretary Mike Leavitt is taking to improve oversight and “openness” at the Food and Drug Administration.

“Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to U.S. consumers,” said acting FDA Commissioner Lester Crawford, D.V.M., Ph.D.

The drug safety board is being touted as an independent entity, yet lawmakers and consumer groups have questioned how much independence or authority the board will actually have.

Larry Sasich, a pharmacist and research analyst for Public Citizen, noted that recommendations and concerns of the FDA's current Office of Drug Safety, which is a subunit of the Office of New Drugs, are often ignored by the agency's new drug reviewers.

If the new board reports in a similar manner, “it may be a stretch to call it an independent board,” Mr. Sasich said.

Secretary Leavitt said that the new board would resolve disagreements over approaches to drug safety issues, oversee development and implementation of center-wide drug safety policies, and assess the need for MedGuides.

The safety board would be comprised of FDA officials and medical experts from other federal agencies. Outside medical experts and consumer representatives would serve as consultants.

“We hope to nominate and confirm board members within the next few months,” an FDA spokeswoman said.

As another component of the oversight initiative, FDA plans to create a new “Drug Watch” Web page, a site to include emerging information for approved drugs about possible serious side effects, or other safety risks.

The Web site would also house drug safety information sheets for health care professionals and patients. Such information also would be available through MedWatch.

Through these direct communication channels, the agency plans to discuss emerging or potential safety problems with the public—even before considering a regulatory action.

Some lawmakers thought the department's new initiatives didn't go far enough to ensure drug safety.

“Consumer confidence in the FDA has been shaken to the core, and it will take more than cosmetic reforms to fix structural problems within the agency,” Sen. Christopher Dodd (D-Conn.) said in a statement.

Sen. Dodd also expressed concern that the FDA wouldn't have the resources to adequately oversee drug safety. “The president's budget provides only a $6.5 million increase for this critically important need, and that's far short of what is needed.”

Additional actions should be taken to increase FDA's resources to monitor drugs and to give it the authority to require drug companies to initiate and complete appropriate safety studies, suggested Sen. Edward M. Kennedy (D-Mass.)

The agency will eventually seek input on the quality and usefulness of this information, an FDA spokeswoman said.“We are not soliciting for public comment, or treating this as a proposed rule.”

The agency does plan on issuing draft guidance on procedures and criteria for identifying drugs and information for the Web page.

A spokesman for the Pharmaceutical Research and Manufacturers of America said that that organization supports any effort to address the quality of information used by the agency.

“For health care professionals and patients, it is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk,” said Jeff Trewhitt, adding that PhRMA would study the initiatives and respond to the FDA's request for input.

But Public Citizen's Mr. Sasich said the effort to step up monitoring of drugs seems like an attempt to deflect recent criticisms that FDA hasn't been meeting its charge as a public safety agency.

In particular, FDA has been criticized for not acting quickly enough to inform physicians and patients about the possible health repercussions of cyclooxygenase-2 (COX-2) inhibitor Vioxx (rofecoxib), which was withdrawn from the market last September 2004.

In PhRMA's view, the FDA has already responded “quickly and constructively” to concerns about Vioxx, Mr. Trewhitt said.

Many questions surround the authority of a new drug safety board that would oversee the management of drug safety and provide emerging information to physicians and patients about the benefits and risks of medicines on the market.

Such a board is one of several steps that Health and Human Services Secretary Mike Leavitt is taking to improve oversight and “openness” at the Food and Drug Administration.

“Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to U.S. consumers,” said acting FDA Commissioner Lester Crawford, D.V.M., Ph.D.

The drug safety board is being touted as an independent entity, yet lawmakers and consumer groups have questioned how much independence or authority the board will actually have.

Larry Sasich, a pharmacist and research analyst for Public Citizen, noted that recommendations and concerns of the FDA's current Office of Drug Safety, which is a subunit of the Office of New Drugs, are often ignored by the agency's new drug reviewers.

If the new board reports in a similar manner, “it may be a stretch to call it an independent board,” Mr. Sasich said.

Secretary Leavitt said that the new board would resolve disagreements over approaches to drug safety issues, oversee development and implementation of center-wide drug safety policies, and assess the need for MedGuides.

The safety board would be comprised of FDA officials and medical experts from other federal agencies. Outside medical experts and consumer representatives would serve as consultants.

“We hope to nominate and confirm board members within the next few months,” an FDA spokeswoman said.

As another component of the oversight initiative, FDA plans to create a new “Drug Watch” Web page, a site to include emerging information for approved drugs about possible serious side effects, or other safety risks.

The Web site would also house drug safety information sheets for health care professionals and patients. Such information also would be available through MedWatch.

Through these direct communication channels, the agency plans to discuss emerging or potential safety problems with the public—even before considering a regulatory action.

Some lawmakers thought the department's new initiatives didn't go far enough to ensure drug safety.

“Consumer confidence in the FDA has been shaken to the core, and it will take more than cosmetic reforms to fix structural problems within the agency,” Sen. Christopher Dodd (D-Conn.) said in a statement.

Sen. Dodd also expressed concern that the FDA wouldn't have the resources to adequately oversee drug safety. “The president's budget provides only a $6.5 million increase for this critically important need, and that's far short of what is needed.”

Additional actions should be taken to increase FDA's resources to monitor drugs and to give it the authority to require drug companies to initiate and complete appropriate safety studies, suggested Sen. Edward M. Kennedy (D-Mass.)

The agency will eventually seek input on the quality and usefulness of this information, an FDA spokeswoman said.“We are not soliciting for public comment, or treating this as a proposed rule.”

The agency does plan on issuing draft guidance on procedures and criteria for identifying drugs and information for the Web page.

A spokesman for the Pharmaceutical Research and Manufacturers of America said that that organization supports any effort to address the quality of information used by the agency.

“For health care professionals and patients, it is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk,” said Jeff Trewhitt, adding that PhRMA would study the initiatives and respond to the FDA's request for input.

But Public Citizen's Mr. Sasich said the effort to step up monitoring of drugs seems like an attempt to deflect recent criticisms that FDA hasn't been meeting its charge as a public safety agency.

In particular, FDA has been criticized for not acting quickly enough to inform physicians and patients about the possible health repercussions of cyclooxygenase-2 (COX-2) inhibitor Vioxx (rofecoxib), which was withdrawn from the market last September 2004.

In PhRMA's view, the FDA has already responded “quickly and constructively” to concerns about Vioxx, Mr. Trewhitt said.

Online health information has the potential to become an important resource for seniors “but it's not there yet,” the Kaiser Family Foundation reported in a survey of 1,450 adults aged 50 and older.

Of the 583 respondents aged 65 and older, less than a third had ever gone online. But more than two-thirds of the next generation of seniors (50-64 years) has done so, indicating that online resources may soon play a much larger role among older Americans. Seniors whose annual household income is under $20,000 a year are much less likely to have gone online (15%) as opposed to those with incomes of $50,000 or more (65%).

“We know that the Internet can be a great health tool for seniors, but the majority are lower-income, less well-educated, and not online,” said Drew Altman, the foundation's president and chief executive officer.

Online health information has the potential to become an important resource for seniors “but it's not there yet,” the Kaiser Family Foundation reported in a survey of 1,450 adults aged 50 and older.

Of the 583 respondents aged 65 and older, less than a third had ever gone online. But more than two-thirds of the next generation of seniors (50-64 years) has done so, indicating that online resources may soon play a much larger role among older Americans. Seniors whose annual household income is under $20,000 a year are much less likely to have gone online (15%) as opposed to those with incomes of $50,000 or more (65%).

“We know that the Internet can be a great health tool for seniors, but the majority are lower-income, less well-educated, and not online,” said Drew Altman, the foundation's president and chief executive officer.

Online health information has the potential to become an important resource for seniors “but it's not there yet,” the Kaiser Family Foundation reported in a survey of 1,450 adults aged 50 and older.

Of the 583 respondents aged 65 and older, less than a third had ever gone online. But more than two-thirds of the next generation of seniors (50-64 years) has done so, indicating that online resources may soon play a much larger role among older Americans. Seniors whose annual household income is under $20,000 a year are much less likely to have gone online (15%) as opposed to those with incomes of $50,000 or more (65%).

“We know that the Internet can be a great health tool for seniors, but the majority are lower-income, less well-educated, and not online,” said Drew Altman, the foundation's president and chief executive officer.

Many questions surround the authority of a new drug safety board that would oversee the management of drug safety and provide emerging information to physicians and patients about the benefits and risks of medicines on the market.

Such a board is one of several steps that Health and Human Services Secretary Mike Leavitt is taking to improve oversight and “openness” at the Food and Drug Administration.

“Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to U.S. consumers,” said acting FDA Commissioner Lester Crawford, D.V.M., Ph.D.

The drug safety board is being touted as an independent entity, yet lawmakers and consumer groups have questioned how much independence or authority the board will actually have.

Larry Sasich, a pharmacist and research analyst for Public Citizen, noted that recommendations and concerns of the FDA's current Office of Drug Safety, which is a subunit of the Office of New Drugs, are often ignored by the agency's new drug reviewers.

If the new board reports in a similar manner, “it may be a stretch to call it an independent board,” Mr. Sasich said.

Secretary Leavitt said that the new board would resolve disagreements over approaches to drug safety issues, oversee development and implementation of center-wide drug safety policies, and assess the need for MedGuides.

The safety board would be composed of FDA officials and medical experts from other federal agencies. Outside medical experts and consumer representatives would serve as consultants.

“We hope to nominate and confirm board members within the next few months,” an FDA spokeswoman said.

As another component of the new oversight initiative, FDA plans to create a new “Drug Watch” Web page, a site to include emerging information for approved drugs about possible serious side effects, or other safety risks.

The Web site would also house drug safety information sheets for health care professionals and patients, Such information also would be available through MedWatch.

Through these direct communication channels, the agency plans to discuss emerging or potential safety problems with the public—even before considering a regulatory action. Some lawmakers thought that the department's new initiatives did not go far enough to ensure drug safety.

“Consumer confidence in the FDA has been shaken to the core, and it will take more than cosmetic reforms to fix structural problems within the agency,” Sen. Christopher Dodd (D-Conn.) said in a statement.

Sen. Dodd also expressed concern that the FDA wouldn't have the resources to adequately oversee drug safety. “The president's budget provides only a $6.5 million increase for this critically important need, and that's far short of what is needed.”

Additional actions should be taken to increase FDA's resources to monitor drugs and to give it the authority to require drug companies to initiate and complete appropriate safety studies, suggested Sen. Edward M. Kennedy (D-Mass.).

The agency will eventually seek input on the quality and usefulness of this information, an FDA spokeswoman said. “We are not soliciting for public comment, or treating this as a proposed rule.” The agency does plan on issuing draft guidance on procedures and criteria for identifying drugs and information for the Web page.

A spokesman for the Pharmaceutical Research and Manufacturers of America said that that organization supports any effort to address the quality of information used by the agency.

“For health care professionals and patients, it is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk. Physicians and patients should have a solid and comprehensive basis for their discussions and decisions,” said Jeff Trewhitt, adding that PhRMA would study the initiatives and respond to the FDA's request for input.

But Public Citizen's Mr. Sasich said the effort to step up monitoring of drugs seems like an attempt to deflect recent criticisms that FDA hasn't been meeting its charge as a public safety agency.

In particular, FDA has been criticized for not acting quickly enough to inform physicians and patients about the possible health repercussions of cyclooxygenase-2 (COX-2) inhibitor Vioxx (rofecoxib), which was withdrawn from the market last September. At a hearing last December, Senate Finance Committee Chairman Charles Grassley (R-Iowa) asserted that the FDA needed a more efficient, streamlined process for postmarketing drug safety

In PhRMA's view, the FDA has already responded “quickly and constructively” to concerns about Vioxx, asking the Institute of Medicine to conduct a thorough exam of the drug safety system, Mr. Trewhitt said. The oversight initiative “is one more step in that process.

For more information about the new FDA oversight initiative, seehttp://www.fda.gov/cder/drugsafety.htm

Many questions surround the authority of a new drug safety board that would oversee the management of drug safety and provide emerging information to physicians and patients about the benefits and risks of medicines on the market.

Such a board is one of several steps that Health and Human Services Secretary Mike Leavitt is taking to improve oversight and “openness” at the Food and Drug Administration.

“Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to U.S. consumers,” said acting FDA Commissioner Lester Crawford, D.V.M., Ph.D.

The drug safety board is being touted as an independent entity, yet lawmakers and consumer groups have questioned how much independence or authority the board will actually have.

Larry Sasich, a pharmacist and research analyst for Public Citizen, noted that recommendations and concerns of the FDA's current Office of Drug Safety, which is a subunit of the Office of New Drugs, are often ignored by the agency's new drug reviewers.

If the new board reports in a similar manner, “it may be a stretch to call it an independent board,” Mr. Sasich said.

Secretary Leavitt said that the new board would resolve disagreements over approaches to drug safety issues, oversee development and implementation of center-wide drug safety policies, and assess the need for MedGuides.

The safety board would be composed of FDA officials and medical experts from other federal agencies. Outside medical experts and consumer representatives would serve as consultants.

“We hope to nominate and confirm board members within the next few months,” an FDA spokeswoman said.

As another component of the new oversight initiative, FDA plans to create a new “Drug Watch” Web page, a site to include emerging information for approved drugs about possible serious side effects, or other safety risks.

The Web site would also house drug safety information sheets for health care professionals and patients, Such information also would be available through MedWatch.

Through these direct communication channels, the agency plans to discuss emerging or potential safety problems with the public—even before considering a regulatory action. Some lawmakers thought that the department's new initiatives did not go far enough to ensure drug safety.

“Consumer confidence in the FDA has been shaken to the core, and it will take more than cosmetic reforms to fix structural problems within the agency,” Sen. Christopher Dodd (D-Conn.) said in a statement.

Sen. Dodd also expressed concern that the FDA wouldn't have the resources to adequately oversee drug safety. “The president's budget provides only a $6.5 million increase for this critically important need, and that's far short of what is needed.”

Additional actions should be taken to increase FDA's resources to monitor drugs and to give it the authority to require drug companies to initiate and complete appropriate safety studies, suggested Sen. Edward M. Kennedy (D-Mass.).

The agency will eventually seek input on the quality and usefulness of this information, an FDA spokeswoman said. “We are not soliciting for public comment, or treating this as a proposed rule.” The agency does plan on issuing draft guidance on procedures and criteria for identifying drugs and information for the Web page.

A spokesman for the Pharmaceutical Research and Manufacturers of America said that that organization supports any effort to address the quality of information used by the agency.

“For health care professionals and patients, it is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk. Physicians and patients should have a solid and comprehensive basis for their discussions and decisions,” said Jeff Trewhitt, adding that PhRMA would study the initiatives and respond to the FDA's request for input.

But Public Citizen's Mr. Sasich said the effort to step up monitoring of drugs seems like an attempt to deflect recent criticisms that FDA hasn't been meeting its charge as a public safety agency.

In particular, FDA has been criticized for not acting quickly enough to inform physicians and patients about the possible health repercussions of cyclooxygenase-2 (COX-2) inhibitor Vioxx (rofecoxib), which was withdrawn from the market last September. At a hearing last December, Senate Finance Committee Chairman Charles Grassley (R-Iowa) asserted that the FDA needed a more efficient, streamlined process for postmarketing drug safety

In PhRMA's view, the FDA has already responded “quickly and constructively” to concerns about Vioxx, asking the Institute of Medicine to conduct a thorough exam of the drug safety system, Mr. Trewhitt said. The oversight initiative “is one more step in that process.

For more information about the new FDA oversight initiative, seehttp://www.fda.gov/cder/drugsafety.htm

Many questions surround the authority of a new drug safety board that would oversee the management of drug safety and provide emerging information to physicians and patients about the benefits and risks of medicines on the market.

Such a board is one of several steps that Health and Human Services Secretary Mike Leavitt is taking to improve oversight and “openness” at the Food and Drug Administration.

“Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to U.S. consumers,” said acting FDA Commissioner Lester Crawford, D.V.M., Ph.D.

The drug safety board is being touted as an independent entity, yet lawmakers and consumer groups have questioned how much independence or authority the board will actually have.

Larry Sasich, a pharmacist and research analyst for Public Citizen, noted that recommendations and concerns of the FDA's current Office of Drug Safety, which is a subunit of the Office of New Drugs, are often ignored by the agency's new drug reviewers.

If the new board reports in a similar manner, “it may be a stretch to call it an independent board,” Mr. Sasich said.

Secretary Leavitt said that the new board would resolve disagreements over approaches to drug safety issues, oversee development and implementation of center-wide drug safety policies, and assess the need for MedGuides.

The safety board would be composed of FDA officials and medical experts from other federal agencies. Outside medical experts and consumer representatives would serve as consultants.

“We hope to nominate and confirm board members within the next few months,” an FDA spokeswoman said.

As another component of the new oversight initiative, FDA plans to create a new “Drug Watch” Web page, a site to include emerging information for approved drugs about possible serious side effects, or other safety risks.

The Web site would also house drug safety information sheets for health care professionals and patients, Such information also would be available through MedWatch.

Through these direct communication channels, the agency plans to discuss emerging or potential safety problems with the public—even before considering a regulatory action. Some lawmakers thought that the department's new initiatives did not go far enough to ensure drug safety.

“Consumer confidence in the FDA has been shaken to the core, and it will take more than cosmetic reforms to fix structural problems within the agency,” Sen. Christopher Dodd (D-Conn.) said in a statement.

Sen. Dodd also expressed concern that the FDA wouldn't have the resources to adequately oversee drug safety. “The president's budget provides only a $6.5 million increase for this critically important need, and that's far short of what is needed.”

Additional actions should be taken to increase FDA's resources to monitor drugs and to give it the authority to require drug companies to initiate and complete appropriate safety studies, suggested Sen. Edward M. Kennedy (D-Mass.).

The agency will eventually seek input on the quality and usefulness of this information, an FDA spokeswoman said. “We are not soliciting for public comment, or treating this as a proposed rule.” The agency does plan on issuing draft guidance on procedures and criteria for identifying drugs and information for the Web page.

A spokesman for the Pharmaceutical Research and Manufacturers of America said that that organization supports any effort to address the quality of information used by the agency.

“For health care professionals and patients, it is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk. Physicians and patients should have a solid and comprehensive basis for their discussions and decisions,” said Jeff Trewhitt, adding that PhRMA would study the initiatives and respond to the FDA's request for input.

But Public Citizen's Mr. Sasich said the effort to step up monitoring of drugs seems like an attempt to deflect recent criticisms that FDA hasn't been meeting its charge as a public safety agency.

In particular, FDA has been criticized for not acting quickly enough to inform physicians and patients about the possible health repercussions of cyclooxygenase-2 (COX-2) inhibitor Vioxx (rofecoxib), which was withdrawn from the market last September. At a hearing last December, Senate Finance Committee Chairman Charles Grassley (R-Iowa) asserted that the FDA needed a more efficient, streamlined process for postmarketing drug safety

In PhRMA's view, the FDA has already responded “quickly and constructively” to concerns about Vioxx, asking the Institute of Medicine to conduct a thorough exam of the drug safety system, Mr. Trewhitt said. The oversight initiative “is one more step in that process.

For more information about the new FDA oversight initiative, seehttp://www.fda.gov/cder/drugsafety.htm

WASHINGTON — Congress should fix Medicare's payment formula before taking on any new reforms to pay physicians on the basis of quality, medical organizations testified at a hearing of the House Ways and Means Health Subcommittee.

If impending cuts to the fee schedule go into effect, “physicians will be hard pressed to undertake quality initiatives such as information technology,” testified Nancy H. Nielsen, M.D., trustee to the American Medical Association.

President Bush's budget request for fiscal year 2006 includes a scheduled 5.2% payment cut for physician services under Medicare. Actuaries have estimated that physician payments could decline by more than 30% through 2012, unless modifications are made to the sustainable growth rate (SGR), a component in the physician pay formula that determines each year's update.

Although the AMA has engaged in its own evidence-based, quality improvement measures, “it is critical to replace the flawed physician payment formula to allow quality initiatives to flourish,” Dr. Nielsen said.

Other medical organizations offered similar pleas in testimony and in statements to the subcommittee. Going ahead with pay-for-performance initiatives but not changing the formula to stave off the 5.2% cut “is unacceptable,” Jerome B. Connolly, senior government relations representative with the American Academy of Family Physicians, told this newspaper.

At the hearing, pay-for-performance proposals were touted as viable payment alternatives by witnesses and panel members. “We fundamentally have to rethink how we pay our doctors,” said Subcommittee Chair Nancy L. Johnson (R-Conn.).

Some physicians perform better than others in the quality of care they deliver, Glenn M. Hackbarth, chairman of the Medicare Payment Advisory Commission (MedPAC), testified. The SGR system “fails to create appropriate incentives to improve performance,” he said.

MedPAC in its March report to Congress recommended a quality incentive payment system for physicians under Medicare, using various types of information technology to manage patients.

Such an approach would establish exclusive performance standards and award physicians accordingly, while establishing standards to improve quality, he said.

Rep. Pete Stark (D-Calif.), the panel's ranking member, countered that he was “reluctant to get into the quality issue.” As far as reforming payments, “I think it's up to the doctors to regulate themselves.”

Any type of payment system that rewards providers by improving patient care and outcomes must not be punitive or used as a control for physician volume, said William F. Gee, M.D., a urologist from Lexington, Ky., who testified on behalf of the Alliance for Specialty Medicine.

In addition, the reporting of quality or efficiency indicators and health outcomes data could be administratively prohibitive to many physicians, especially those in small practices that don't have electronic health records, Dr. Gee testified.

There is some evidence that pay for performance can work, at least in the private sector. Since the implementation of three major pay-for-performance contracts with Partners Healthcare System in Boston, “we have steadily improved in targeted areas,” such as diabetes care, Thomas H. Lee, M.D., network president for the health care system, testified. The rate of rise in pharmacy spending under these contracts averaged about 5% in 2004, lower than the national average of 9%.

In addition, Partners has developed decision support to help guide physicians to more appropriate ordering of costly imaging tests. Early information indicates that the rate of rise for imaging is less than the national trend of 15%-18%, he said. The contracts cover the care of more than 500,000 primary care patients, and a number of referral patients to specialists.

Despite Cuts, Medicare Not Abandoned

Physicians did not run away from Medicare in 2002, despite a 5.4% cut to their payments, the Government Accountability Office reported.

In analyzing all Medicare physician claims for services provided from April 2000 to April 2002, the GAO found that the percentage of beneficiaries getting treatment actually increased—and that access increased in almost every part of the country.

For example, the percentage of beneficiaries receiving physician services during the month of April rose from 42% in 2000 to 46% in 2002.

The findings also suggest that Medicare beneficiaries were less likely to be exposed to balanced billing over time, from 1.7% of claims in 2000 to 1.3% in 2002.

Since 2002, Congress has provided some temporary fixes to prevent further cuts to the fee schedule, although a 5.2% cut is expected in 2006, unless permanent measures are taken.

Several such permanent changes have been proposed—all of which are costly.

GAO has estimated that removing prescription drugs from the SGR this year—an option favored by some medical organizations—would fall short of providing the immediate fix that physicians want. Fees would continue to decline by about 5% per year from 2006 through 2010, before rendering a positive update in 2011.

The Bush administration does have current authority to remove the drugs from the formula, Bruce Steinwald, GAO's director for health care, economic and payment issues, recently testified at a hearing of the House Ways and Means Health Subcommittee.

Further, Mark McClellan, M.D., administrator of the Centers for Medicare and Medicaid Services, recently told reporters that his agency is working with the AMA to identify administrative actions to prevent the cuts.

At the very least, Dr. McClellan's response “indicates that the payment issue is sharply on his radar screen,” Paul Speidell, government affairs representative with the Medical Group Management Association, told this newspaper.

WASHINGTON — Congress should fix Medicare's payment formula before taking on any new reforms to pay physicians on the basis of quality, medical organizations testified at a hearing of the House Ways and Means Health Subcommittee.

If impending cuts to the fee schedule go into effect, “physicians will be hard pressed to undertake quality initiatives such as information technology,” testified Nancy H. Nielsen, M.D., trustee to the American Medical Association.

President Bush's budget request for fiscal year 2006 includes a scheduled 5.2% payment cut for physician services under Medicare. Actuaries have estimated that physician payments could decline by more than 30% through 2012, unless modifications are made to the sustainable growth rate (SGR), a component in the physician pay formula that determines each year's update.

Although the AMA has engaged in its own evidence-based, quality improvement measures, “it is critical to replace the flawed physician payment formula to allow quality initiatives to flourish,” Dr. Nielsen said.

Other medical organizations offered similar pleas in testimony and in statements to the subcommittee. Going ahead with pay-for-performance initiatives but not changing the formula to stave off the 5.2% cut “is unacceptable,” Jerome B. Connolly, senior government relations representative with the American Academy of Family Physicians, told this newspaper.

At the hearing, pay-for-performance proposals were touted as viable payment alternatives by witnesses and panel members. “We fundamentally have to rethink how we pay our doctors,” said Subcommittee Chair Nancy L. Johnson (R-Conn.).

Some physicians perform better than others in the quality of care they deliver, Glenn M. Hackbarth, chairman of the Medicare Payment Advisory Commission (MedPAC), testified. The SGR system “fails to create appropriate incentives to improve performance,” he said.

MedPAC in its March report to Congress recommended a quality incentive payment system for physicians under Medicare, using various types of information technology to manage patients.

Such an approach would establish exclusive performance standards and award physicians accordingly, while establishing standards to improve quality, he said.

Rep. Pete Stark (D-Calif.), the panel's ranking member, countered that he was “reluctant to get into the quality issue.” As far as reforming payments, “I think it's up to the doctors to regulate themselves.”

Any type of payment system that rewards providers by improving patient care and outcomes must not be punitive or used as a control for physician volume, said William F. Gee, M.D., a urologist from Lexington, Ky., who testified on behalf of the Alliance for Specialty Medicine.

In addition, the reporting of quality or efficiency indicators and health outcomes data could be administratively prohibitive to many physicians, especially those in small practices that don't have electronic health records, Dr. Gee testified.

There is some evidence that pay for performance can work, at least in the private sector. Since the implementation of three major pay-for-performance contracts with Partners Healthcare System in Boston, “we have steadily improved in targeted areas,” such as diabetes care, Thomas H. Lee, M.D., network president for the health care system, testified. The rate of rise in pharmacy spending under these contracts averaged about 5% in 2004, lower than the national average of 9%.

In addition, Partners has developed decision support to help guide physicians to more appropriate ordering of costly imaging tests. Early information indicates that the rate of rise for imaging is less than the national trend of 15%-18%, he said. The contracts cover the care of more than 500,000 primary care patients, and a number of referral patients to specialists.

Despite Cuts, Medicare Not Abandoned

Physicians did not run away from Medicare in 2002, despite a 5.4% cut to their payments, the Government Accountability Office reported.

In analyzing all Medicare physician claims for services provided from April 2000 to April 2002, the GAO found that the percentage of beneficiaries getting treatment actually increased—and that access increased in almost every part of the country.

For example, the percentage of beneficiaries receiving physician services during the month of April rose from 42% in 2000 to 46% in 2002.

The findings also suggest that Medicare beneficiaries were less likely to be exposed to balanced billing over time, from 1.7% of claims in 2000 to 1.3% in 2002.

Since 2002, Congress has provided some temporary fixes to prevent further cuts to the fee schedule, although a 5.2% cut is expected in 2006, unless permanent measures are taken.

Several such permanent changes have been proposed—all of which are costly.

GAO has estimated that removing prescription drugs from the SGR this year—an option favored by some medical organizations—would fall short of providing the immediate fix that physicians want. Fees would continue to decline by about 5% per year from 2006 through 2010, before rendering a positive update in 2011.

The Bush administration does have current authority to remove the drugs from the formula, Bruce Steinwald, GAO's director for health care, economic and payment issues, recently testified at a hearing of the House Ways and Means Health Subcommittee.

Further, Mark McClellan, M.D., administrator of the Centers for Medicare and Medicaid Services, recently told reporters that his agency is working with the AMA to identify administrative actions to prevent the cuts.

At the very least, Dr. McClellan's response “indicates that the payment issue is sharply on his radar screen,” Paul Speidell, government affairs representative with the Medical Group Management Association, told this newspaper.

WASHINGTON — Congress should fix Medicare's payment formula before taking on any new reforms to pay physicians on the basis of quality, medical organizations testified at a hearing of the House Ways and Means Health Subcommittee.

If impending cuts to the fee schedule go into effect, “physicians will be hard pressed to undertake quality initiatives such as information technology,” testified Nancy H. Nielsen, M.D., trustee to the American Medical Association.

President Bush's budget request for fiscal year 2006 includes a scheduled 5.2% payment cut for physician services under Medicare. Actuaries have estimated that physician payments could decline by more than 30% through 2012, unless modifications are made to the sustainable growth rate (SGR), a component in the physician pay formula that determines each year's update.

Although the AMA has engaged in its own evidence-based, quality improvement measures, “it is critical to replace the flawed physician payment formula to allow quality initiatives to flourish,” Dr. Nielsen said.

Other medical organizations offered similar pleas in testimony and in statements to the subcommittee. Going ahead with pay-for-performance initiatives but not changing the formula to stave off the 5.2% cut “is unacceptable,” Jerome B. Connolly, senior government relations representative with the American Academy of Family Physicians, told this newspaper.

At the hearing, pay-for-performance proposals were touted as viable payment alternatives by witnesses and panel members. “We fundamentally have to rethink how we pay our doctors,” said Subcommittee Chair Nancy L. Johnson (R-Conn.).

Some physicians perform better than others in the quality of care they deliver, Glenn M. Hackbarth, chairman of the Medicare Payment Advisory Commission (MedPAC), testified. The SGR system “fails to create appropriate incentives to improve performance,” he said.

MedPAC in its March report to Congress recommended a quality incentive payment system for physicians under Medicare, using various types of information technology to manage patients.

Such an approach would establish exclusive performance standards and award physicians accordingly, while establishing standards to improve quality, he said.

Rep. Pete Stark (D-Calif.), the panel's ranking member, countered that he was “reluctant to get into the quality issue.” As far as reforming payments, “I think it's up to the doctors to regulate themselves.”

Any type of payment system that rewards providers by improving patient care and outcomes must not be punitive or used as a control for physician volume, said William F. Gee, M.D., a urologist from Lexington, Ky., who testified on behalf of the Alliance for Specialty Medicine.

In addition, the reporting of quality or efficiency indicators and health outcomes data could be administratively prohibitive to many physicians, especially those in small practices that don't have electronic health records, Dr. Gee testified.

There is some evidence that pay for performance can work, at least in the private sector. Since the implementation of three major pay-for-performance contracts with Partners Healthcare System in Boston, “we have steadily improved in targeted areas,” such as diabetes care, Thomas H. Lee, M.D., network president for the health care system, testified. The rate of rise in pharmacy spending under these contracts averaged about 5% in 2004, lower than the national average of 9%.

In addition, Partners has developed decision support to help guide physicians to more appropriate ordering of costly imaging tests. Early information indicates that the rate of rise for imaging is less than the national trend of 15%-18%, he said. The contracts cover the care of more than 500,000 primary care patients, and a number of referral patients to specialists.

Despite Cuts, Medicare Not Abandoned

Physicians did not run away from Medicare in 2002, despite a 5.4% cut to their payments, the Government Accountability Office reported.

In analyzing all Medicare physician claims for services provided from April 2000 to April 2002, the GAO found that the percentage of beneficiaries getting treatment actually increased—and that access increased in almost every part of the country.

For example, the percentage of beneficiaries receiving physician services during the month of April rose from 42% in 2000 to 46% in 2002.

The findings also suggest that Medicare beneficiaries were less likely to be exposed to balanced billing over time, from 1.7% of claims in 2000 to 1.3% in 2002.

Since 2002, Congress has provided some temporary fixes to prevent further cuts to the fee schedule, although a 5.2% cut is expected in 2006, unless permanent measures are taken.

Several such permanent changes have been proposed—all of which are costly.

GAO has estimated that removing prescription drugs from the SGR this year—an option favored by some medical organizations—would fall short of providing the immediate fix that physicians want. Fees would continue to decline by about 5% per year from 2006 through 2010, before rendering a positive update in 2011.

The Bush administration does have current authority to remove the drugs from the formula, Bruce Steinwald, GAO's director for health care, economic and payment issues, recently testified at a hearing of the House Ways and Means Health Subcommittee.

Further, Mark McClellan, M.D., administrator of the Centers for Medicare and Medicaid Services, recently told reporters that his agency is working with the AMA to identify administrative actions to prevent the cuts.

At the very least, Dr. McClellan's response “indicates that the payment issue is sharply on his radar screen,” Paul Speidell, government affairs representative with the Medical Group Management Association, told this newspaper.

WASHINGTON — Congress should establish a quality incentive payment policy for Medicare physicians, the Medicare Payment Advisory Commission recommended.

In light of the challenges facing Medicare, “nothing is more important” than distinguishing between providers based on performance, MedPAC Chairman Glenn Hackbarth said at a commission meeting.

“Providers are not all created equal—there's abundant evidence that some providers do a better job than others. To continue to pay them as if they're all performing equally well is a tragic situation.”

And that was just one of several of the commission's recommendations aimed at establishing a pay-for-perform- ance system across health care channels, using information technology in Medicare initiatives to financially reward providers on the basis of quality. At press time, the recommendations were scheduled to appear in MedPAC's March report to Congress.

“Physicians are ready for a pay-for-performance program,” Karen Milgate, a MedPAC research director said at the meeting.

Those participating in such a program could use various facets of information technology to manage patients, such as registries to track patients and identify when they need certain preventive services, or systems for detecting drug interactions, Ms. Milgate said. These types of information have the potential to improve important aspects of care, and increase physician ability to assess and report on their care.

“Without information technology, it would be difficult for physicians to keep up with and apply the latest clinical science and appropriately track and follow up with patients,” she said.

“This is true for primary care and especially for patients with chronic conditions. But [it is] also true for surgeons and other specialists, to ensure follow-up after acute events and coordination with other settings of care.”

Considering that it's the only information collected on physicians, Ms. Milgate noted that claims-based measures could be used to determine whether beneficiaries received appropriate follow-up care.

The claims-based process puts no burden on physicians and research shows it's widely available for a broad group of beneficiaries and physicians, she said. “However, the depth of information on each kind of physician is unclear and we do know that claims based measures are not available for every single type of physician.”

Because these actions would redistribute resources already in the system, they would not affect spending relative to current law, although they may increase or lower payments for providers, depending on the quality of their care, she said.

Nicholas Wolter, M.D., a MedPAC commissioner from Billings, Mont., cautioned that physicians may be reluctant to embrace yet another change that would limit their revenue, after the sustainable growth rate. Pay for performance might be “another irritation, rather than an incentive.”

Are all physicians equally ready for such a system? “I'm not sure that's true,” he added.

Smaller practices in particular may not be ready to provide the clinical information necessary for a mature pay for performance initiative, Alan Nelson, M.D., a commissioner representing the American College of Physicians, said in an interview. “However, the insistence of payers for incentives to promote quality is something that can't be ignored.”

Although a differential payment system that rewards higher quality “is almost certainly in our future,” Medicare should proceed with caution on this initiative, taking care to not increase the administrative burden—and always being aware of unintended consequences, Dr. Nelson said.

Most of these information technology developments “seem to apply more to primary care physicians than other specialties,” observed commissioner William Scanlon, Ph.D., a health policy consultant from Oak Hill, Va. “The question is how we would differentiate the rewards for different specialties even on the structural measures.

He suggested that Congress create a project to test these rewards on an ongoing basis, to accumulate evidence that it was working effectively among the various specialties.

WASHINGTON — Congress should establish a quality incentive payment policy for Medicare physicians, the Medicare Payment Advisory Commission recommended.

In light of the challenges facing Medicare, “nothing is more important” than distinguishing between providers based on performance, MedPAC Chairman Glenn Hackbarth said at a commission meeting.

“Providers are not all created equal—there's abundant evidence that some providers do a better job than others. To continue to pay them as if they're all performing equally well is a tragic situation.”

And that was just one of several of the commission's recommendations aimed at establishing a pay-for-perform- ance system across health care channels, using information technology in Medicare initiatives to financially reward providers on the basis of quality. At press time, the recommendations were scheduled to appear in MedPAC's March report to Congress.

“Physicians are ready for a pay-for-performance program,” Karen Milgate, a MedPAC research director said at the meeting.

Those participating in such a program could use various facets of information technology to manage patients, such as registries to track patients and identify when they need certain preventive services, or systems for detecting drug interactions, Ms. Milgate said. These types of information have the potential to improve important aspects of care, and increase physician ability to assess and report on their care.

“Without information technology, it would be difficult for physicians to keep up with and apply the latest clinical science and appropriately track and follow up with patients,” she said.

“This is true for primary care and especially for patients with chronic conditions. But [it is] also true for surgeons and other specialists, to ensure follow-up after acute events and coordination with other settings of care.”

Considering that it's the only information collected on physicians, Ms. Milgate noted that claims-based measures could be used to determine whether beneficiaries received appropriate follow-up care.

The claims-based process puts no burden on physicians and research shows it's widely available for a broad group of beneficiaries and physicians, she said. “However, the depth of information on each kind of physician is unclear and we do know that claims based measures are not available for every single type of physician.”

Because these actions would redistribute resources already in the system, they would not affect spending relative to current law, although they may increase or lower payments for providers, depending on the quality of their care, she said.

Nicholas Wolter, M.D., a MedPAC commissioner from Billings, Mont., cautioned that physicians may be reluctant to embrace yet another change that would limit their revenue, after the sustainable growth rate. Pay for performance might be “another irritation, rather than an incentive.”

Are all physicians equally ready for such a system? “I'm not sure that's true,” he added.

Smaller practices in particular may not be ready to provide the clinical information necessary for a mature pay for performance initiative, Alan Nelson, M.D., a commissioner representing the American College of Physicians, said in an interview. “However, the insistence of payers for incentives to promote quality is something that can't be ignored.”

Although a differential payment system that rewards higher quality “is almost certainly in our future,” Medicare should proceed with caution on this initiative, taking care to not increase the administrative burden—and always being aware of unintended consequences, Dr. Nelson said.

Most of these information technology developments “seem to apply more to primary care physicians than other specialties,” observed commissioner William Scanlon, Ph.D., a health policy consultant from Oak Hill, Va. “The question is how we would differentiate the rewards for different specialties even on the structural measures.

He suggested that Congress create a project to test these rewards on an ongoing basis, to accumulate evidence that it was working effectively among the various specialties.

WASHINGTON — Congress should establish a quality incentive payment policy for Medicare physicians, the Medicare Payment Advisory Commission recommended.

In light of the challenges facing Medicare, “nothing is more important” than distinguishing between providers based on performance, MedPAC Chairman Glenn Hackbarth said at a commission meeting.

“Providers are not all created equal—there's abundant evidence that some providers do a better job than others. To continue to pay them as if they're all performing equally well is a tragic situation.”

And that was just one of several of the commission's recommendations aimed at establishing a pay-for-perform- ance system across health care channels, using information technology in Medicare initiatives to financially reward providers on the basis of quality. At press time, the recommendations were scheduled to appear in MedPAC's March report to Congress.

“Physicians are ready for a pay-for-performance program,” Karen Milgate, a MedPAC research director said at the meeting.

Those participating in such a program could use various facets of information technology to manage patients, such as registries to track patients and identify when they need certain preventive services, or systems for detecting drug interactions, Ms. Milgate said. These types of information have the potential to improve important aspects of care, and increase physician ability to assess and report on their care.

“Without information technology, it would be difficult for physicians to keep up with and apply the latest clinical science and appropriately track and follow up with patients,” she said.

“This is true for primary care and especially for patients with chronic conditions. But [it is] also true for surgeons and other specialists, to ensure follow-up after acute events and coordination with other settings of care.”

Considering that it's the only information collected on physicians, Ms. Milgate noted that claims-based measures could be used to determine whether beneficiaries received appropriate follow-up care.

The claims-based process puts no burden on physicians and research shows it's widely available for a broad group of beneficiaries and physicians, she said. “However, the depth of information on each kind of physician is unclear and we do know that claims based measures are not available for every single type of physician.”

Because these actions would redistribute resources already in the system, they would not affect spending relative to current law, although they may increase or lower payments for providers, depending on the quality of their care, she said.

Nicholas Wolter, M.D., a MedPAC commissioner from Billings, Mont., cautioned that physicians may be reluctant to embrace yet another change that would limit their revenue, after the sustainable growth rate. Pay for performance might be “another irritation, rather than an incentive.”

Are all physicians equally ready for such a system? “I'm not sure that's true,” he added.

Smaller practices in particular may not be ready to provide the clinical information necessary for a mature pay for performance initiative, Alan Nelson, M.D., a commissioner representing the American College of Physicians, said in an interview. “However, the insistence of payers for incentives to promote quality is something that can't be ignored.”

Although a differential payment system that rewards higher quality “is almost certainly in our future,” Medicare should proceed with caution on this initiative, taking care to not increase the administrative burden—and always being aware of unintended consequences, Dr. Nelson said.

Most of these information technology developments “seem to apply more to primary care physicians than other specialties,” observed commissioner William Scanlon, Ph.D., a health policy consultant from Oak Hill, Va. “The question is how we would differentiate the rewards for different specialties even on the structural measures.

He suggested that Congress create a project to test these rewards on an ongoing basis, to accumulate evidence that it was working effectively among the various specialties.

WASHINGTON — Older patients are choosing their physician over the phone or using electronic resources to help them understand the complexities of the new prescription drug law.

Many beneficiaries don't understand what the new law does, and many are not comfortable looking for information online, Drew Altman, president and CEO of the Kaiser Family Foundation, said during the annual conference of the National Academy of Social Insurance.

In a Kaiser Family Foundation poll of more than 1,200 adults, only 13% said they understood the new law very well. More than half (53%) said they didn't have enough information about the law to understand how it would impact them personally.

The poll was conducted in December 2004 and included responses from 237 adults aged 65 years and older and 953 adults aged 18-64.

In a question specifically addressed to seniors, respondents were asked what sources they would turn to for help. The majority (38%) said they'd ask for their physician's counsel when deciding whether or not to enroll in a Medicare drug plan, Mr. Altman said.

Seniors also cited Medicare offices, Web sites, or phone number (31%); pharmacists (30%); and health insurance companies (25%) as consultation sources for the new drug benefit.

Upon closer look, however, it doesn't seem as if the Internet or the phone are popular venues to get information. Forty-three percent of the seniors who responded to the poll said they'd never heard of the 1-800 Medicare number, and 42% were aware of it but have never used it.

Only 6% of the respondents said they had heard of Medicare.gov

Most of the information isn't access friendly to the average beneficiary, Roslyn Taylor, M.D., a family physician in Savannah, Ga., said in an interview. “Many of the seniors do not have or know how to use computers.” Those patients who did “told me that even if they went on the Web site they still were confused.”

Thirty-seven percent of the seniors who responded to the survey said they would prefer to get their Medicare information from mailings, and 25% said they would not mind obtaining the information in person from Medicare or Social Security offices. Only 18% cited toll-free telephone hotlines as a preferred method.

Physicians themselves may need a quick tutorial on the new benefits. “I think that a lot of physicians are not aware of the details regarding what new things Medicare is covering—and under what specific rules,” said Colette Willins, M.D., a professor at Case Western Reserve University in Westlake, Ohio.

Older beneficiaries seemed more aware of specific benefits. Respectively, 86% and 67% of beneficiaries aged 65 and older knew about the discount drug card and a $600 subsidy on the costs of drugs for low-income people. Only 27% of beneficiaries aged 18-64 were aware of the subsidy.

Senior respondents seemed divided on their reported plans to enroll in the drug benefit in 2006. Nineteen percent said they would, 37% said they would not, and another 37% said they hadn't heard enough about the new benefit to decide.

Seniors who responded to the Kaiser survey thought low-income people on Medicare would benefit the most from the new law, although fewer respondents thought it would help the typical Medicare beneficiary. Only 34% thought it would be very or somewhat helpful to them, personally. “It does seem like a pretty difficult program to explain,” Dr. Farley said.

WASHINGTON — Older patients are choosing their physician over the phone or using electronic resources to help them understand the complexities of the new prescription drug law.

Many beneficiaries don't understand what the new law does, and many are not comfortable looking for information online, Drew Altman, president and CEO of the Kaiser Family Foundation, said during the annual conference of the National Academy of Social Insurance.

In a Kaiser Family Foundation poll of more than 1,200 adults, only 13% said they understood the new law very well. More than half (53%) said they didn't have enough information about the law to understand how it would impact them personally.

The poll was conducted in December 2004 and included responses from 237 adults aged 65 years and older and 953 adults aged 18-64.

In a question specifically addressed to seniors, respondents were asked what sources they would turn to for help. The majority (38%) said they'd ask for their physician's counsel when deciding whether or not to enroll in a Medicare drug plan, Mr. Altman said.

Seniors also cited Medicare offices, Web sites, or phone number (31%); pharmacists (30%); and health insurance companies (25%) as consultation sources for the new drug benefit.

Upon closer look, however, it doesn't seem as if the Internet or the phone are popular venues to get information. Forty-three percent of the seniors who responded to the poll said they'd never heard of the 1-800 Medicare number, and 42% were aware of it but have never used it.

Only 6% of the respondents said they had heard of Medicare.gov

Most of the information isn't access friendly to the average beneficiary, Roslyn Taylor, M.D., a family physician in Savannah, Ga., said in an interview. “Many of the seniors do not have or know how to use computers.” Those patients who did “told me that even if they went on the Web site they still were confused.”

Thirty-seven percent of the seniors who responded to the survey said they would prefer to get their Medicare information from mailings, and 25% said they would not mind obtaining the information in person from Medicare or Social Security offices. Only 18% cited toll-free telephone hotlines as a preferred method.

Physicians themselves may need a quick tutorial on the new benefits. “I think that a lot of physicians are not aware of the details regarding what new things Medicare is covering—and under what specific rules,” said Colette Willins, M.D., a professor at Case Western Reserve University in Westlake, Ohio.

Older beneficiaries seemed more aware of specific benefits. Respectively, 86% and 67% of beneficiaries aged 65 and older knew about the discount drug card and a $600 subsidy on the costs of drugs for low-income people. Only 27% of beneficiaries aged 18-64 were aware of the subsidy.

Senior respondents seemed divided on their reported plans to enroll in the drug benefit in 2006. Nineteen percent said they would, 37% said they would not, and another 37% said they hadn't heard enough about the new benefit to decide.

Seniors who responded to the Kaiser survey thought low-income people on Medicare would benefit the most from the new law, although fewer respondents thought it would help the typical Medicare beneficiary. Only 34% thought it would be very or somewhat helpful to them, personally. “It does seem like a pretty difficult program to explain,” Dr. Farley said.

WASHINGTON — Older patients are choosing their physician over the phone or using electronic resources to help them understand the complexities of the new prescription drug law.

Many beneficiaries don't understand what the new law does, and many are not comfortable looking for information online, Drew Altman, president and CEO of the Kaiser Family Foundation, said during the annual conference of the National Academy of Social Insurance.

In a Kaiser Family Foundation poll of more than 1,200 adults, only 13% said they understood the new law very well. More than half (53%) said they didn't have enough information about the law to understand how it would impact them personally.

The poll was conducted in December 2004 and included responses from 237 adults aged 65 years and older and 953 adults aged 18-64.

In a question specifically addressed to seniors, respondents were asked what sources they would turn to for help. The majority (38%) said they'd ask for their physician's counsel when deciding whether or not to enroll in a Medicare drug plan, Mr. Altman said.

Seniors also cited Medicare offices, Web sites, or phone number (31%); pharmacists (30%); and health insurance companies (25%) as consultation sources for the new drug benefit.

Upon closer look, however, it doesn't seem as if the Internet or the phone are popular venues to get information. Forty-three percent of the seniors who responded to the poll said they'd never heard of the 1-800 Medicare number, and 42% were aware of it but have never used it.

Only 6% of the respondents said they had heard of Medicare.gov

Most of the information isn't access friendly to the average beneficiary, Roslyn Taylor, M.D., a family physician in Savannah, Ga., said in an interview. “Many of the seniors do not have or know how to use computers.” Those patients who did “told me that even if they went on the Web site they still were confused.”

Thirty-seven percent of the seniors who responded to the survey said they would prefer to get their Medicare information from mailings, and 25% said they would not mind obtaining the information in person from Medicare or Social Security offices. Only 18% cited toll-free telephone hotlines as a preferred method.

Physicians themselves may need a quick tutorial on the new benefits. “I think that a lot of physicians are not aware of the details regarding what new things Medicare is covering—and under what specific rules,” said Colette Willins, M.D., a professor at Case Western Reserve University in Westlake, Ohio.

Older beneficiaries seemed more aware of specific benefits. Respectively, 86% and 67% of beneficiaries aged 65 and older knew about the discount drug card and a $600 subsidy on the costs of drugs for low-income people. Only 27% of beneficiaries aged 18-64 were aware of the subsidy.

Senior respondents seemed divided on their reported plans to enroll in the drug benefit in 2006. Nineteen percent said they would, 37% said they would not, and another 37% said they hadn't heard enough about the new benefit to decide.

Seniors who responded to the Kaiser survey thought low-income people on Medicare would benefit the most from the new law, although fewer respondents thought it would help the typical Medicare beneficiary. Only 34% thought it would be very or somewhat helpful to them, personally. “It does seem like a pretty difficult program to explain,” Dr. Farley said.

WASHINGTON — A federal advisory panel wants to raise the bar on quality and use of imaging services.

In a series of recommendations, the Medicare Payment Advisory Commission called for national standards for physicians who bill Medicare for interpreting diagnostic imaging services, and for any provider who bills Medicare for performing such services. MedPAC advises Congress on Medicare payment issues.

There is evidence of variations in the quality of physician interpretations and reports, MedPAC analyst Ariel Winter said at a recent commission meeting. “Ensuring that only qualified physicians are paid for interpreting imaging studies should improve diagnostic accuracy and treatment,” he said.

Standards for physicians would be based on education, training, and experience required to properly interpret studies. Private organizations would be charged with administering the standards, Mr. Winter said.

Several MedPAC commissioners questioned whether Medicare should get involved in the business of credentialing or accrediting physicians for interpreting imaging studies. Whether in cardiology or another specialty, Medicare would be taking on responsibilities that previously fell to licensing boards, specialty society certification, or other private sector organizations, said MedPAC commissioner Sheila Burke, R.N., of the Smithsonian Institution. “It is a new area and it's not entirely clear to me that Medicare may be the right place for that to occur.”

Mr. Winter acknowledged that some providers might not be able to meet these standards, or incur costs to meet them. Measuring physicians' use of imaging services should be part of MedPAC's broader effort to profile fee-for-service physicians on their use of all services, Mr. Winter said. Radiologists can influence which tests physicians order, but physicians are important to the analysis on imaging because “they determine whether a test is appropriate,” he said.

Under the MedPAC recommendations, CMS could develop measures of imaging volume for a patient seen by a physician, and could compare these measures to peer benchmarks or clinical guidelines, Mr. Winter said. The agency could then provide this information to the physician in confidence. “The goal is to encourage physicians who order significantly more tests than their peers to reconsider their practice patterns,” Mr. Winter said.

On other recommendations related to imaging, the panel voted that the Department of Health and Human Services improve Medicare's coding edits that detect unbundled diagnostic imaging services, and reduce the technical component payment for multiple imaging services performed on contiguous body parts. Better coding will help Medicare pay more accurately for imaging services and help to control rapid spending growth, Mr. Winter said. Providers who bill for unbundled or multiple imaging procedures would have a decrease in Medicare payments, though it's not anticipated that this would affect their willingness and ability to provide quality care to beneficiaries, he said.

MedPAC also proposed to strengthen the rules in the Ethics in Patient Referral Act (Stark law), which restrict physicians' investment in the imaging centers to which they refer Medicare or Medicaid patients. The restrictions already apply to radiology and other imaging services, but it's unclear whether nuclear medicine is a radiology service, Mr. Winter said.

The panel ultimately voted to include nuclear medicine and positron emission tomography procedures as designated health services under the Stark law. Investment in facilities that provide nuclear medicine services is associated with higher use, creating financial incentives to order additional services and to refer patients to facilities in which the physician is an investor, Mr. Winter said.

WASHINGTON — A federal advisory panel wants to raise the bar on quality and use of imaging services.

In a series of recommendations, the Medicare Payment Advisory Commission called for national standards for physicians who bill Medicare for interpreting diagnostic imaging services, and for any provider who bills Medicare for performing such services. MedPAC advises Congress on Medicare payment issues.

There is evidence of variations in the quality of physician interpretations and reports, MedPAC analyst Ariel Winter said at a recent commission meeting. “Ensuring that only qualified physicians are paid for interpreting imaging studies should improve diagnostic accuracy and treatment,” he said.

Standards for physicians would be based on education, training, and experience required to properly interpret studies. Private organizations would be charged with administering the standards, Mr. Winter said.

Several MedPAC commissioners questioned whether Medicare should get involved in the business of credentialing or accrediting physicians for interpreting imaging studies. Whether in cardiology or another specialty, Medicare would be taking on responsibilities that previously fell to licensing boards, specialty society certification, or other private sector organizations, said MedPAC commissioner Sheila Burke, R.N., of the Smithsonian Institution. “It is a new area and it's not entirely clear to me that Medicare may be the right place for that to occur.”

Mr. Winter acknowledged that some providers might not be able to meet these standards, or incur costs to meet them. Measuring physicians' use of imaging services should be part of MedPAC's broader effort to profile fee-for-service physicians on their use of all services, Mr. Winter said. Radiologists can influence which tests physicians order, but physicians are important to the analysis on imaging because “they determine whether a test is appropriate,” he said.

Under the MedPAC recommendations, CMS could develop measures of imaging volume for a patient seen by a physician, and could compare these measures to peer benchmarks or clinical guidelines, Mr. Winter said. The agency could then provide this information to the physician in confidence. “The goal is to encourage physicians who order significantly more tests than their peers to reconsider their practice patterns,” Mr. Winter said.

On other recommendations related to imaging, the panel voted that the Department of Health and Human Services improve Medicare's coding edits that detect unbundled diagnostic imaging services, and reduce the technical component payment for multiple imaging services performed on contiguous body parts. Better coding will help Medicare pay more accurately for imaging services and help to control rapid spending growth, Mr. Winter said. Providers who bill for unbundled or multiple imaging procedures would have a decrease in Medicare payments, though it's not anticipated that this would affect their willingness and ability to provide quality care to beneficiaries, he said.

MedPAC also proposed to strengthen the rules in the Ethics in Patient Referral Act (Stark law), which restrict physicians' investment in the imaging centers to which they refer Medicare or Medicaid patients. The restrictions already apply to radiology and other imaging services, but it's unclear whether nuclear medicine is a radiology service, Mr. Winter said.

The panel ultimately voted to include nuclear medicine and positron emission tomography procedures as designated health services under the Stark law. Investment in facilities that provide nuclear medicine services is associated with higher use, creating financial incentives to order additional services and to refer patients to facilities in which the physician is an investor, Mr. Winter said.

WASHINGTON — A federal advisory panel wants to raise the bar on quality and use of imaging services.

In a series of recommendations, the Medicare Payment Advisory Commission called for national standards for physicians who bill Medicare for interpreting diagnostic imaging services, and for any provider who bills Medicare for performing such services. MedPAC advises Congress on Medicare payment issues.

There is evidence of variations in the quality of physician interpretations and reports, MedPAC analyst Ariel Winter said at a recent commission meeting. “Ensuring that only qualified physicians are paid for interpreting imaging studies should improve diagnostic accuracy and treatment,” he said.

Standards for physicians would be based on education, training, and experience required to properly interpret studies. Private organizations would be charged with administering the standards, Mr. Winter said.

Several MedPAC commissioners questioned whether Medicare should get involved in the business of credentialing or accrediting physicians for interpreting imaging studies. Whether in cardiology or another specialty, Medicare would be taking on responsibilities that previously fell to licensing boards, specialty society certification, or other private sector organizations, said MedPAC commissioner Sheila Burke, R.N., of the Smithsonian Institution. “It is a new area and it's not entirely clear to me that Medicare may be the right place for that to occur.”

Mr. Winter acknowledged that some providers might not be able to meet these standards, or incur costs to meet them. Measuring physicians' use of imaging services should be part of MedPAC's broader effort to profile fee-for-service physicians on their use of all services, Mr. Winter said. Radiologists can influence which tests physicians order, but physicians are important to the analysis on imaging because “they determine whether a test is appropriate,” he said.

Under the MedPAC recommendations, CMS could develop measures of imaging volume for a patient seen by a physician, and could compare these measures to peer benchmarks or clinical guidelines, Mr. Winter said. The agency could then provide this information to the physician in confidence. “The goal is to encourage physicians who order significantly more tests than their peers to reconsider their practice patterns,” Mr. Winter said.

On other recommendations related to imaging, the panel voted that the Department of Health and Human Services improve Medicare's coding edits that detect unbundled diagnostic imaging services, and reduce the technical component payment for multiple imaging services performed on contiguous body parts. Better coding will help Medicare pay more accurately for imaging services and help to control rapid spending growth, Mr. Winter said. Providers who bill for unbundled or multiple imaging procedures would have a decrease in Medicare payments, though it's not anticipated that this would affect their willingness and ability to provide quality care to beneficiaries, he said.

MedPAC also proposed to strengthen the rules in the Ethics in Patient Referral Act (Stark law), which restrict physicians' investment in the imaging centers to which they refer Medicare or Medicaid patients. The restrictions already apply to radiology and other imaging services, but it's unclear whether nuclear medicine is a radiology service, Mr. Winter said.

The panel ultimately voted to include nuclear medicine and positron emission tomography procedures as designated health services under the Stark law. Investment in facilities that provide nuclear medicine services is associated with higher use, creating financial incentives to order additional services and to refer patients to facilities in which the physician is an investor, Mr. Winter said.

WASHINGTON — Congress should extend the Medicare Modernization Act's moratorium on the construction of physician-owned specialty hospitals for another 18 months, a federal advisory panel has recommended.

The Medicare Payment Advisory Commission in draft recommendations had set the extension for 1 year, but later changed it to 18 months after commission members decided that more time was needed to study the full impact of these hospitals.

MedPAC data indicate that specialty hospitals tend to concentrate on certain diagnosis-related groups (DRGs), treating relatively lower-severity patients, and lower shares of Medicaid patients. So far, they've had little financial impact on community hospitals, MedPAC analysts claim.

Commissioners at a January meeting decided to forgo tougher language that would have eliminated the “whole hospital” exemption, a provision in the self-referral regulations that allows physicians to refer patients to a hospital in which they have an investment interest as long as the interest is in the entire hospital.

Eliminating the exemption “is not the right step to take at this time due to the limited amount of data … on specialty hospitals and their performance,” MedPAC chairman Glenn Hackbarth said.

Existing specialty hospitals and hospitals under development were still eligible for the whole hospital exemption under the 2003 Medicare reform law, but new hospitals were not, effectively placing a moratorium on their construction.

The original moratorium, set to expire in June, would be effective until Jan. 1, 2007, if MedPAC's recommendation were adopted.

In a statement, Rick Pollack, executive vice president of the American Hospital Association, commended MedPAC for extending the moratorium. “This decision sends an important message to Congress that physician ownership and self-referral can cause serious conflict of interest concerns,” he said.

In other recommendations slated for MedPAC's March report to Congress, commissioners voted on several measures to refine the DRGs used to determine hospital payments to better account for differences in severity of illness among patients:

▸The Department of Health and Human Services should base the DRG relative weights on the estimated cost of providing care rather than on charges, and on the national average of hospitals' relative values in each DRG.

▸Congress should give the Department of Health and Human Services authority to adjust the DRG relative weights to account for differences in the prevalence of high-cost outlier cases. In addition, case-mix measurement and outlier policies should be developed over a transitional period.

▸HHS should have authority to regulate gainsharing arrangements between physicians and hospitals to protect quality of care and minimize financial incentives that could affect referrals.

WASHINGTON — Congress should extend the Medicare Modernization Act's moratorium on the construction of physician-owned specialty hospitals for another 18 months, a federal advisory panel has recommended.

The Medicare Payment Advisory Commission in draft recommendations had set the extension for 1 year, but later changed it to 18 months after commission members decided that more time was needed to study the full impact of these hospitals.

MedPAC data indicate that specialty hospitals tend to concentrate on certain diagnosis-related groups (DRGs), treating relatively lower-severity patients, and lower shares of Medicaid patients. So far, they've had little financial impact on community hospitals, MedPAC analysts claim.

Commissioners at a January meeting decided to forgo tougher language that would have eliminated the “whole hospital” exemption, a provision in the self-referral regulations that allows physicians to refer patients to a hospital in which they have an investment interest as long as the interest is in the entire hospital.

Eliminating the exemption “is not the right step to take at this time due to the limited amount of data … on specialty hospitals and their performance,” MedPAC chairman Glenn Hackbarth said.

Existing specialty hospitals and hospitals under development were still eligible for the whole hospital exemption under the 2003 Medicare reform law, but new hospitals were not, effectively placing a moratorium on their construction.

The original moratorium, set to expire in June, would be effective until Jan. 1, 2007, if MedPAC's recommendation were adopted.

In a statement, Rick Pollack, executive vice president of the American Hospital Association, commended MedPAC for extending the moratorium. “This decision sends an important message to Congress that physician ownership and self-referral can cause serious conflict of interest concerns,” he said.

In other recommendations slated for MedPAC's March report to Congress, commissioners voted on several measures to refine the DRGs used to determine hospital payments to better account for differences in severity of illness among patients:

▸The Department of Health and Human Services should base the DRG relative weights on the estimated cost of providing care rather than on charges, and on the national average of hospitals' relative values in each DRG.

▸Congress should give the Department of Health and Human Services authority to adjust the DRG relative weights to account for differences in the prevalence of high-cost outlier cases. In addition, case-mix measurement and outlier policies should be developed over a transitional period.

▸HHS should have authority to regulate gainsharing arrangements between physicians and hospitals to protect quality of care and minimize financial incentives that could affect referrals.

WASHINGTON — Congress should extend the Medicare Modernization Act's moratorium on the construction of physician-owned specialty hospitals for another 18 months, a federal advisory panel has recommended.

The Medicare Payment Advisory Commission in draft recommendations had set the extension for 1 year, but later changed it to 18 months after commission members decided that more time was needed to study the full impact of these hospitals.

MedPAC data indicate that specialty hospitals tend to concentrate on certain diagnosis-related groups (DRGs), treating relatively lower-severity patients, and lower shares of Medicaid patients. So far, they've had little financial impact on community hospitals, MedPAC analysts claim.

Commissioners at a January meeting decided to forgo tougher language that would have eliminated the “whole hospital” exemption, a provision in the self-referral regulations that allows physicians to refer patients to a hospital in which they have an investment interest as long as the interest is in the entire hospital.

Eliminating the exemption “is not the right step to take at this time due to the limited amount of data … on specialty hospitals and their performance,” MedPAC chairman Glenn Hackbarth said.

Existing specialty hospitals and hospitals under development were still eligible for the whole hospital exemption under the 2003 Medicare reform law, but new hospitals were not, effectively placing a moratorium on their construction.

The original moratorium, set to expire in June, would be effective until Jan. 1, 2007, if MedPAC's recommendation were adopted.

In a statement, Rick Pollack, executive vice president of the American Hospital Association, commended MedPAC for extending the moratorium. “This decision sends an important message to Congress that physician ownership and self-referral can cause serious conflict of interest concerns,” he said.

In other recommendations slated for MedPAC's March report to Congress, commissioners voted on several measures to refine the DRGs used to determine hospital payments to better account for differences in severity of illness among patients:

▸The Department of Health and Human Services should base the DRG relative weights on the estimated cost of providing care rather than on charges, and on the national average of hospitals' relative values in each DRG.

▸Congress should give the Department of Health and Human Services authority to adjust the DRG relative weights to account for differences in the prevalence of high-cost outlier cases. In addition, case-mix measurement and outlier policies should be developed over a transitional period.

▸HHS should have authority to regulate gainsharing arrangements between physicians and hospitals to protect quality of care and minimize financial incentives that could affect referrals.

Infant Mortality Rate Rises

Infant deaths increased to 27,970 in 2002, compared with 27,568 the year before, mainly because of a rise in the number of babies born at very low birth weights, the Centers for Disease Control and Prevention reported. This resulted in 7.0 infant deaths per 1,000 live births in 2002, the first increase in the infant mortality rate since 1958. The increase in the number of extremely small babies (weighing less than 1 pound, 10.5 ounces at birth) occurred primarily among mothers in the peak childbearing ages of 20-34 years and occurred across most racial and ethnic groups. Several factors might have contributed to the rise in low birth weights. The report, for example, documented a slight increase between 2001 and 2002 in rates of maternal anemia, diabetes, and chronic high blood pressure. But those conditions remain relatively rare, the CDC reported.

Health Insurance for All Children

Sen. John Kerry (D-Mass.) has introduced a bill, S.114, aimed at insuring every child in the United States. Under his plan, the Kids Come First Act, the federal government would pay for all Medicaid outreach and coverage costs for children under age 21 years with family incomes at or below poverty level. In exchange, the states would agree to cover the people in the same age bracket in families with incomes between the poverty level and three times the poverty level through the State Children's Health Insurance Program or Medicaid. The bill would also provide a refundable tax credit for health insurance coverage of children, call on parents to insure all children under age 19 and require proof of coverage to avoid losing the tax credit. It was referred to the Senate Committee on Finance.

Proposed Cuts to Medicaid

Medical organizations and other health care groups decried the $60 billion in proposed spending reductions to Medicaid over the next 10 years that were included in President Bush's budget request. The dollar amount lost in the fifth year of the proposal alone is the equivalent of giving health coverage to almost 1.8 million children, according to Ron Pollack, executive director of Families USA. The proposal contains some provisions aimed at covering more eligible children, including $1 billion in grants over 2 years to states, schools, and community organizations to enroll and provide coverage in Medicaid and SCHIP. That extra funding would be encouraging, but the money for benefits will decrease overall if Medicaid is capped and the number of enrollees continues to rise, said John Lewy, M.D., chair of the committee on federal government affairs with the American Academy of Pediatrics. A joint statement released by a group including the AAP said the proposed cuts would hurt service reimbursements to pediatricians and children's hospitals.

States Meet Their Match

States have been known to recycle payments returned by health care providers, using them to draw down additional federal dollars for Medicaid—and the feds are tired of it. The administration's budget request seeks to curb such tactics, by only matching those funds kept by health care providers as payment for services. Current law also allows states to make Medicaid payments to health care providers that are far in excess of the actual cost of services. According to the president's budget request, states use this additional money to leverage federal reimbursements in excess of their Medicaid matching rate or for other purposes. To halt this practice, the government proposes to limit reimbursement levels to no more than the cost of providing services. Both proposals are expected to save $5.9 billion over 5 years. Bill Pierce, spokesman for the Department of Health and Human Services, said in an interview that none of those efforts should affect the way in which physicians get paid under Medicaid.

Autism Education Costs High

The cost of educating children with autism is almost triple that of educating children who receive no special education services, according to a report from the Government Accountability Office. The GAO reviewed data from the Special Education Expenditure Project funded by the Department of Education and found that the average cost of educating a child with autism was $18,000 in the 1999-2000 school year. That estimate “was among the highest per-pupil expenditures for school-age children receiving special education services in public schools,” the report noted. The report also said that the number of children with autism who were given special education services has increased by more than 500% in the last decade. Rep. Diane Watson (D-Calif.), who cocommissioned the report, said further studies should be undertaken to explore the correlation between mercury-containing vaccines and higher autism rates.

—

Infant Mortality Rate Rises

Infant deaths increased to 27,970 in 2002, compared with 27,568 the year before, mainly because of a rise in the number of babies born at very low birth weights, the Centers for Disease Control and Prevention reported. This resulted in 7.0 infant deaths per 1,000 live births in 2002, the first increase in the infant mortality rate since 1958. The increase in the number of extremely small babies (weighing less than 1 pound, 10.5 ounces at birth) occurred primarily among mothers in the peak childbearing ages of 20-34 years and occurred across most racial and ethnic groups. Several factors might have contributed to the rise in low birth weights. The report, for example, documented a slight increase between 2001 and 2002 in rates of maternal anemia, diabetes, and chronic high blood pressure. But those conditions remain relatively rare, the CDC reported.

Health Insurance for All Children

Sen. John Kerry (D-Mass.) has introduced a bill, S.114, aimed at insuring every child in the United States. Under his plan, the Kids Come First Act, the federal government would pay for all Medicaid outreach and coverage costs for children under age 21 years with family incomes at or below poverty level. In exchange, the states would agree to cover the people in the same age bracket in families with incomes between the poverty level and three times the poverty level through the State Children's Health Insurance Program or Medicaid. The bill would also provide a refundable tax credit for health insurance coverage of children, call on parents to insure all children under age 19 and require proof of coverage to avoid losing the tax credit. It was referred to the Senate Committee on Finance.

Proposed Cuts to Medicaid

Medical organizations and other health care groups decried the $60 billion in proposed spending reductions to Medicaid over the next 10 years that were included in President Bush's budget request. The dollar amount lost in the fifth year of the proposal alone is the equivalent of giving health coverage to almost 1.8 million children, according to Ron Pollack, executive director of Families USA. The proposal contains some provisions aimed at covering more eligible children, including $1 billion in grants over 2 years to states, schools, and community organizations to enroll and provide coverage in Medicaid and SCHIP. That extra funding would be encouraging, but the money for benefits will decrease overall if Medicaid is capped and the number of enrollees continues to rise, said John Lewy, M.D., chair of the committee on federal government affairs with the American Academy of Pediatrics. A joint statement released by a group including the AAP said the proposed cuts would hurt service reimbursements to pediatricians and children's hospitals.

States Meet Their Match

States have been known to recycle payments returned by health care providers, using them to draw down additional federal dollars for Medicaid—and the feds are tired of it. The administration's budget request seeks to curb such tactics, by only matching those funds kept by health care providers as payment for services. Current law also allows states to make Medicaid payments to health care providers that are far in excess of the actual cost of services. According to the president's budget request, states use this additional money to leverage federal reimbursements in excess of their Medicaid matching rate or for other purposes. To halt this practice, the government proposes to limit reimbursement levels to no more than the cost of providing services. Both proposals are expected to save $5.9 billion over 5 years. Bill Pierce, spokesman for the Department of Health and Human Services, said in an interview that none of those efforts should affect the way in which physicians get paid under Medicaid.

Autism Education Costs High

The cost of educating children with autism is almost triple that of educating children who receive no special education services, according to a report from the Government Accountability Office. The GAO reviewed data from the Special Education Expenditure Project funded by the Department of Education and found that the average cost of educating a child with autism was $18,000 in the 1999-2000 school year. That estimate “was among the highest per-pupil expenditures for school-age children receiving special education services in public schools,” the report noted. The report also said that the number of children with autism who were given special education services has increased by more than 500% in the last decade. Rep. Diane Watson (D-Calif.), who cocommissioned the report, said further studies should be undertaken to explore the correlation between mercury-containing vaccines and higher autism rates.

—

Infant Mortality Rate Rises

Infant deaths increased to 27,970 in 2002, compared with 27,568 the year before, mainly because of a rise in the number of babies born at very low birth weights, the Centers for Disease Control and Prevention reported. This resulted in 7.0 infant deaths per 1,000 live births in 2002, the first increase in the infant mortality rate since 1958. The increase in the number of extremely small babies (weighing less than 1 pound, 10.5 ounces at birth) occurred primarily among mothers in the peak childbearing ages of 20-34 years and occurred across most racial and ethnic groups. Several factors might have contributed to the rise in low birth weights. The report, for example, documented a slight increase between 2001 and 2002 in rates of maternal anemia, diabetes, and chronic high blood pressure. But those conditions remain relatively rare, the CDC reported.

Health Insurance for All Children

Sen. John Kerry (D-Mass.) has introduced a bill, S.114, aimed at insuring every child in the United States. Under his plan, the Kids Come First Act, the federal government would pay for all Medicaid outreach and coverage costs for children under age 21 years with family incomes at or below poverty level. In exchange, the states would agree to cover the people in the same age bracket in families with incomes between the poverty level and three times the poverty level through the State Children's Health Insurance Program or Medicaid. The bill would also provide a refundable tax credit for health insurance coverage of children, call on parents to insure all children under age 19 and require proof of coverage to avoid losing the tax credit. It was referred to the Senate Committee on Finance.

Proposed Cuts to Medicaid

Medical organizations and other health care groups decried the $60 billion in proposed spending reductions to Medicaid over the next 10 years that were included in President Bush's budget request. The dollar amount lost in the fifth year of the proposal alone is the equivalent of giving health coverage to almost 1.8 million children, according to Ron Pollack, executive director of Families USA. The proposal contains some provisions aimed at covering more eligible children, including $1 billion in grants over 2 years to states, schools, and community organizations to enroll and provide coverage in Medicaid and SCHIP. That extra funding would be encouraging, but the money for benefits will decrease overall if Medicaid is capped and the number of enrollees continues to rise, said John Lewy, M.D., chair of the committee on federal government affairs with the American Academy of Pediatrics. A joint statement released by a group including the AAP said the proposed cuts would hurt service reimbursements to pediatricians and children's hospitals.

States Meet Their Match

States have been known to recycle payments returned by health care providers, using them to draw down additional federal dollars for Medicaid—and the feds are tired of it. The administration's budget request seeks to curb such tactics, by only matching those funds kept by health care providers as payment for services. Current law also allows states to make Medicaid payments to health care providers that are far in excess of the actual cost of services. According to the president's budget request, states use this additional money to leverage federal reimbursements in excess of their Medicaid matching rate or for other purposes. To halt this practice, the government proposes to limit reimbursement levels to no more than the cost of providing services. Both proposals are expected to save $5.9 billion over 5 years. Bill Pierce, spokesman for the Department of Health and Human Services, said in an interview that none of those efforts should affect the way in which physicians get paid under Medicaid.

Autism Education Costs High

The cost of educating children with autism is almost triple that of educating children who receive no special education services, according to a report from the Government Accountability Office. The GAO reviewed data from the Special Education Expenditure Project funded by the Department of Education and found that the average cost of educating a child with autism was $18,000 in the 1999-2000 school year. That estimate “was among the highest per-pupil expenditures for school-age children receiving special education services in public schools,” the report noted. The report also said that the number of children with autism who were given special education services has increased by more than 500% in the last decade. Rep. Diane Watson (D-Calif.), who cocommissioned the report, said further studies should be undertaken to explore the correlation between mercury-containing vaccines and higher autism rates.

—

Many questions surround the authority of a new drug safety board that would oversee the management of drug safety and provide emerging information to physicians and patients about the benefits and risks of medicines on the market.

Such a board is one of several steps that Health and Human Services Secretary Mike Leavitt is taking to improve oversight and “openness” at the Food and Drug Administration. “Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to U.S. consumers,” said acting FDA Commissioner Lester Crawford, D.V.M., Ph.D.

The drug safety board is being touted as an independent entity, yet lawmakers and consumer groups have questioned how much independence or authority the board will actually have.

Larry Sasich, a pharmacist and research analyst for Public Citizen, noted that recommendations and concerns of the FDA's current Office of Drug Safety, which is a subunit of the Office of New Drugs, are often ignored by the agency's new drug reviewers. If the new board reports in a similar manner, “it may be a stretch to call it an independent board,” Mr. Sasich said.

Secretary Leavitt said that the new board would resolve disagreements over approaches to drug safety issues, oversee development and implementation of center-wide drug safety policies, and assess the need for MedGuides.

The safety board would be composed of FDA officials and medical experts from other federal agencies. Outside medical experts and consumer representatives would serve as consultants.

As another component of the new oversight initiative, FDA plans to create a new “Drug Watch” Web page, a site to include emerging information for approved drugs about possible serious side effects, or other safety risks. The Web site would also house drug safety information sheets for health care professionals and patients, Such information also would be available through MedWatch.

Through these direct communication channels, the agency plans to discuss emerging or potential safety problems with the public—even before considering a regulatory action.

Some lawmakers thought the department's new initiatives didn't go far enough to ensure drug safety. “Consumer confidence in the FDA has been shaken to the core, and it will take more than cosmetic reforms to fix structural problems within the agency,” Sen. Christopher Dodd (D-Conn.) said in a statement.

Sen. Dodd also expressed concern that the FDA wouldn't have the resources to adequately oversee drug safety. “The president's budget provides only a $6.5 million increase for this critically important need, and that's far short of what is needed.”

Additional actions should be taken to increase FDA's resources to monitor drugs and to give it the authority to require drug companies to initiate and complete appropriate safety studies, suggested Sen. Edward M. Kennedy (D-Mass.).

The agency will eventually seek input on the quality and usefulness of this information, an FDA spokeswoman said. “We are not soliciting for public comment, or treating this as a proposed rule.” The agency does plan on issuing draft guidance on procedures and criteria for identifying drugs and information for the Web page.

A spokesman for the Pharmaceutical Research and Manufacturers of America explained that that organization supports any effort to address the quality of information used by the agency.

“For health care professionals and patients, it is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk. Physicians and patients should have a solid and comprehensive basis for their discussions and decisions,” said Jeff Trewhitt, adding that PhRMA would study the initiatives and respond to the FDA's request for input.

But Public Citizen's Mr. Sasich said the effort to step up monitoring of drugs seems like an attempt to deflect recent criticisms that FDA hasn't been meeting its charge as a public safety agency. In particular, FDA has been criticized for not acting quickly enough to inform physicians and patients about the possible health repercussions of cyclooxygenase-2 (COX-2) inhibitor Vioxx (rofecoxib), which was withdrawn from the market last September.

In PhRMA's view, the FDA has already responded “quickly and constructively” to concerns about Vioxx, asking the Institute of Medicine to conduct a thorough exam of the drug safety system, Mr. Trewhitt said. The oversight initiative “is one more step in that process.”

For more information about the new FDA oversight initiative, see www.fda.gov/cder/drugsafety.htm

Many questions surround the authority of a new drug safety board that would oversee the management of drug safety and provide emerging information to physicians and patients about the benefits and risks of medicines on the market.

Such a board is one of several steps that Health and Human Services Secretary Mike Leavitt is taking to improve oversight and “openness” at the Food and Drug Administration. “Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to U.S. consumers,” said acting FDA Commissioner Lester Crawford, D.V.M., Ph.D.

The drug safety board is being touted as an independent entity, yet lawmakers and consumer groups have questioned how much independence or authority the board will actually have.

Larry Sasich, a pharmacist and research analyst for Public Citizen, noted that recommendations and concerns of the FDA's current Office of Drug Safety, which is a subunit of the Office of New Drugs, are often ignored by the agency's new drug reviewers. If the new board reports in a similar manner, “it may be a stretch to call it an independent board,” Mr. Sasich said.

Secretary Leavitt said that the new board would resolve disagreements over approaches to drug safety issues, oversee development and implementation of center-wide drug safety policies, and assess the need for MedGuides.

The safety board would be composed of FDA officials and medical experts from other federal agencies. Outside medical experts and consumer representatives would serve as consultants.

As another component of the new oversight initiative, FDA plans to create a new “Drug Watch” Web page, a site to include emerging information for approved drugs about possible serious side effects, or other safety risks. The Web site would also house drug safety information sheets for health care professionals and patients, Such information also would be available through MedWatch.

Through these direct communication channels, the agency plans to discuss emerging or potential safety problems with the public—even before considering a regulatory action.

Some lawmakers thought the department's new initiatives didn't go far enough to ensure drug safety. “Consumer confidence in the FDA has been shaken to the core, and it will take more than cosmetic reforms to fix structural problems within the agency,” Sen. Christopher Dodd (D-Conn.) said in a statement.

Sen. Dodd also expressed concern that the FDA wouldn't have the resources to adequately oversee drug safety. “The president's budget provides only a $6.5 million increase for this critically important need, and that's far short of what is needed.”

Additional actions should be taken to increase FDA's resources to monitor drugs and to give it the authority to require drug companies to initiate and complete appropriate safety studies, suggested Sen. Edward M. Kennedy (D-Mass.).

The agency will eventually seek input on the quality and usefulness of this information, an FDA spokeswoman said. “We are not soliciting for public comment, or treating this as a proposed rule.” The agency does plan on issuing draft guidance on procedures and criteria for identifying drugs and information for the Web page.

A spokesman for the Pharmaceutical Research and Manufacturers of America explained that that organization supports any effort to address the quality of information used by the agency.

“For health care professionals and patients, it is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk. Physicians and patients should have a solid and comprehensive basis for their discussions and decisions,” said Jeff Trewhitt, adding that PhRMA would study the initiatives and respond to the FDA's request for input.

But Public Citizen's Mr. Sasich said the effort to step up monitoring of drugs seems like an attempt to deflect recent criticisms that FDA hasn't been meeting its charge as a public safety agency. In particular, FDA has been criticized for not acting quickly enough to inform physicians and patients about the possible health repercussions of cyclooxygenase-2 (COX-2) inhibitor Vioxx (rofecoxib), which was withdrawn from the market last September.

In PhRMA's view, the FDA has already responded “quickly and constructively” to concerns about Vioxx, asking the Institute of Medicine to conduct a thorough exam of the drug safety system, Mr. Trewhitt said. The oversight initiative “is one more step in that process.”

For more information about the new FDA oversight initiative, see www.fda.gov/cder/drugsafety.htm

Many questions surround the authority of a new drug safety board that would oversee the management of drug safety and provide emerging information to physicians and patients about the benefits and risks of medicines on the market.

Such a board is one of several steps that Health and Human Services Secretary Mike Leavitt is taking to improve oversight and “openness” at the Food and Drug Administration. “Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to U.S. consumers,” said acting FDA Commissioner Lester Crawford, D.V.M., Ph.D.

The drug safety board is being touted as an independent entity, yet lawmakers and consumer groups have questioned how much independence or authority the board will actually have.

Larry Sasich, a pharmacist and research analyst for Public Citizen, noted that recommendations and concerns of the FDA's current Office of Drug Safety, which is a subunit of the Office of New Drugs, are often ignored by the agency's new drug reviewers. If the new board reports in a similar manner, “it may be a stretch to call it an independent board,” Mr. Sasich said.

Secretary Leavitt said that the new board would resolve disagreements over approaches to drug safety issues, oversee development and implementation of center-wide drug safety policies, and assess the need for MedGuides.

The safety board would be composed of FDA officials and medical experts from other federal agencies. Outside medical experts and consumer representatives would serve as consultants.

As another component of the new oversight initiative, FDA plans to create a new “Drug Watch” Web page, a site to include emerging information for approved drugs about possible serious side effects, or other safety risks. The Web site would also house drug safety information sheets for health care professionals and patients, Such information also would be available through MedWatch.

Through these direct communication channels, the agency plans to discuss emerging or potential safety problems with the public—even before considering a regulatory action.

Some lawmakers thought the department's new initiatives didn't go far enough to ensure drug safety. “Consumer confidence in the FDA has been shaken to the core, and it will take more than cosmetic reforms to fix structural problems within the agency,” Sen. Christopher Dodd (D-Conn.) said in a statement.

Sen. Dodd also expressed concern that the FDA wouldn't have the resources to adequately oversee drug safety. “The president's budget provides only a $6.5 million increase for this critically important need, and that's far short of what is needed.”

Additional actions should be taken to increase FDA's resources to monitor drugs and to give it the authority to require drug companies to initiate and complete appropriate safety studies, suggested Sen. Edward M. Kennedy (D-Mass.).

The agency will eventually seek input on the quality and usefulness of this information, an FDA spokeswoman said. “We are not soliciting for public comment, or treating this as a proposed rule.” The agency does plan on issuing draft guidance on procedures and criteria for identifying drugs and information for the Web page.

A spokesman for the Pharmaceutical Research and Manufacturers of America explained that that organization supports any effort to address the quality of information used by the agency.

“For health care professionals and patients, it is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk. Physicians and patients should have a solid and comprehensive basis for their discussions and decisions,” said Jeff Trewhitt, adding that PhRMA would study the initiatives and respond to the FDA's request for input.

But Public Citizen's Mr. Sasich said the effort to step up monitoring of drugs seems like an attempt to deflect recent criticisms that FDA hasn't been meeting its charge as a public safety agency. In particular, FDA has been criticized for not acting quickly enough to inform physicians and patients about the possible health repercussions of cyclooxygenase-2 (COX-2) inhibitor Vioxx (rofecoxib), which was withdrawn from the market last September.

In PhRMA's view, the FDA has already responded “quickly and constructively” to concerns about Vioxx, asking the Institute of Medicine to conduct a thorough exam of the drug safety system, Mr. Trewhitt said. The oversight initiative “is one more step in that process.”

For more information about the new FDA oversight initiative, see www.fda.gov/cder/drugsafety.htm