Mary Ellen Schneider

The Food and Drug Administration is vowing to get tougher and act faster when it comes to protecting public health.

Over the past several years, the FDA's enforcement activities have declined significantly, and those enforcement actions taken have been hamstrung by delays, mostly due to internal red tape, said Dr. Margaret A. Hamburg, the agency's new commissioner.

“The pathways to enforcement action can be too long and arduous when the public's health is in jeopardy,” Dr. Hamburg said at a Food and Drug Law Institute conference in August. “We're fixing these pathways to improve the effectiveness of our enforcement system,” she said.

Dr. Hamburg outlined six steps to streamline the way the FDA handles enforcement across all regulated areas—drugs, devices, and food.

For example, in cases where agency officials deem that public health is at risk, the FDA is prepared to take enforcement action before issuing a formal warning letter. Agency officials will also work with other regulators—state, local, and international—to figure out who can act fastest in a public health emergency.

The FDA also plans to change some of its internal processes. The agency will establish a 15-day deadline for industry to respond once a significant problem is identified during an inspection. The agency will also aim to get warning letters out the door more quickly by limiting review to significant legal issues.

Prompt follow-up on warning letters and other enforcement actions is also part of Dr. Hamburg's plan.

The Food and Drug Administration will move more quickly in assessing corrective actions that are taken by industry after a warning letter is issued or a major product recall occurs. And in an effort to motivate industry to act quickly, the FDA is developing a formal warning letter “close-out” process.

Once the FDA has confirmed that a firm has fully corrected its violations, the agency will issue a “close-out” notice and post theinformation on the FDA Web site.

“What we want to create is really a standard of practice that is a little bit different than what's been happening in recent years, where we commit to being as transparent as possible about our expectations and industry commits to working in as responsive a way as possible to address our concerns,” Dr. Hamburg said.

The Food and Drug Administration is vowing to get tougher and act faster when it comes to protecting public health.

Over the past several years, the FDA's enforcement activities have declined significantly, and those enforcement actions taken have been hamstrung by delays, mostly due to internal red tape, said Dr. Margaret A. Hamburg, the agency's new commissioner.

“The pathways to enforcement action can be too long and arduous when the public's health is in jeopardy,” Dr. Hamburg said at a Food and Drug Law Institute conference in August. “We're fixing these pathways to improve the effectiveness of our enforcement system,” she said.

Dr. Hamburg outlined six steps to streamline the way the FDA handles enforcement across all regulated areas—drugs, devices, and food.

For example, in cases where agency officials deem that public health is at risk, the FDA is prepared to take enforcement action before issuing a formal warning letter. Agency officials will also work with other regulators—state, local, and international—to figure out who can act fastest in a public health emergency.

The FDA also plans to change some of its internal processes. The agency will establish a 15-day deadline for industry to respond once a significant problem is identified during an inspection. The agency will also aim to get warning letters out the door more quickly by limiting review to significant legal issues.

Prompt follow-up on warning letters and other enforcement actions is also part of Dr. Hamburg's plan.

The Food and Drug Administration will move more quickly in assessing corrective actions that are taken by industry after a warning letter is issued or a major product recall occurs. And in an effort to motivate industry to act quickly, the FDA is developing a formal warning letter “close-out” process.

Once the FDA has confirmed that a firm has fully corrected its violations, the agency will issue a “close-out” notice and post theinformation on the FDA Web site.

“What we want to create is really a standard of practice that is a little bit different than what's been happening in recent years, where we commit to being as transparent as possible about our expectations and industry commits to working in as responsive a way as possible to address our concerns,” Dr. Hamburg said.

The Food and Drug Administration is vowing to get tougher and act faster when it comes to protecting public health.

Over the past several years, the FDA's enforcement activities have declined significantly, and those enforcement actions taken have been hamstrung by delays, mostly due to internal red tape, said Dr. Margaret A. Hamburg, the agency's new commissioner.

“The pathways to enforcement action can be too long and arduous when the public's health is in jeopardy,” Dr. Hamburg said at a Food and Drug Law Institute conference in August. “We're fixing these pathways to improve the effectiveness of our enforcement system,” she said.

Dr. Hamburg outlined six steps to streamline the way the FDA handles enforcement across all regulated areas—drugs, devices, and food.

For example, in cases where agency officials deem that public health is at risk, the FDA is prepared to take enforcement action before issuing a formal warning letter. Agency officials will also work with other regulators—state, local, and international—to figure out who can act fastest in a public health emergency.

The FDA also plans to change some of its internal processes. The agency will establish a 15-day deadline for industry to respond once a significant problem is identified during an inspection. The agency will also aim to get warning letters out the door more quickly by limiting review to significant legal issues.

Prompt follow-up on warning letters and other enforcement actions is also part of Dr. Hamburg's plan.

The Food and Drug Administration will move more quickly in assessing corrective actions that are taken by industry after a warning letter is issued or a major product recall occurs. And in an effort to motivate industry to act quickly, the FDA is developing a formal warning letter “close-out” process.

Once the FDA has confirmed that a firm has fully corrected its violations, the agency will issue a “close-out” notice and post theinformation on the FDA Web site.

“What we want to create is really a standard of practice that is a little bit different than what's been happening in recent years, where we commit to being as transparent as possible about our expectations and industry commits to working in as responsive a way as possible to address our concerns,” Dr. Hamburg said.

The American Board of Dermatology's proposal to establish subspecialty certification for procedural dermatology is on hold while board leaders seek to address concerns raised by dermatology societies and individual physicians that certification could divide the specialty and lead to economic credentialing.

The board of directors of the American Board of Dermatology (ABD) will meet in December to discuss the status of the proposal.

“This process will not be completed in haste,” said Dr. Randall K. Roenigk, president of the ABD.

ABD leaders have heard the concerns of the dermatology community and are in deliberations to modify the proposal accordingly, but much of the controversy is the result of “mischaracterizations” about the impact that subspecialty certification would have for dermatologists without it, said Dr. Roenigk, chairman of the department of dermatology at the Mayo Clinic in Rochester, Minn.

The controversy began last year, when the ABD submitted an application to the American Board of Medical Specialties (ABMS) to create certification for the subspecialty of procedural dermatology. The American Society for Mohs Surgery took an early stand against the proposal and others followed.

Last month, the ABD was scheduled to submit a revised application to the ABMS Committee on Certification and Recertification but postponed on the advice of ABMS officials. In the meantime, the ABD has formed its own task force to review areas of concern raised by critics and to report back to the group's board of directors in December with specific recommendations.

Around the time that the ABD announced it was postponing its application, the American Academy of Dermatology also came out against the proposal. During an Aug. 1 meeting, the AAD board of directors approved a resolution opposing the ABD's proposal.

The American Society for Mohs Surgery, which has been critical of the move toward certification, is taking a wait-and-see attitude. Dr. Stephen Spencer, president of the society, said it will monitor the situation and evaluate a new proposal if and when it comes forward.

Despite the criticism, the ABD continues to argue that subspecialty certification in procedural dermatology is important both for patient care and for the specialty of dermatology.

There is a body of knowledge related to surgical and procedural dermatology that is not taught in dermatology residency programs and subspecialty certification would offer assurance to patients that the physician is qualified and possesses the necessary knowledge, experience, and skills. The specialty would also gain under the proposal because certification would establish surgery as an integral part of dermatology, according to ABD.

The ABD's board rebuts charges that subspecialty certification will lead to economic credentialing. Since certification would be voluntary, the lack of a subspecialty certificate would not indicate that a physician is unqualified to practice in the specialty, the ABD said.

Some critics, however, aren't satisfied with the ABD's assurances. Dr. Daniel E. Gormley, a dermatologist in Glendora, Calif., said that, as currently written, the ABD's proposal would only grant certification to dermatologists who have completed fellowship training in procedural dermatology, outside of those who would be grandfathered in. Eventually, only a small group of dermatologists would be certified to perform a wide range of procedures, he said.

Dr. Gormley said the main issue with the ABD proposal is that it will restrict the number of dermatologists who can performs Mohs surgery and related procedures. Instead of creating a small cadre of specially trained dermatologists, he said that all dermatology trainees should have the opportunity to learn these procedures during their residency.

“We want to share this knowledge and spread it around,” Dr. Gormley said.

The American Board of Dermatology's proposal to establish subspecialty certification for procedural dermatology is on hold while board leaders seek to address concerns raised by dermatology societies and individual physicians that certification could divide the specialty and lead to economic credentialing.

The board of directors of the American Board of Dermatology (ABD) will meet in December to discuss the status of the proposal.

“This process will not be completed in haste,” said Dr. Randall K. Roenigk, president of the ABD.

ABD leaders have heard the concerns of the dermatology community and are in deliberations to modify the proposal accordingly, but much of the controversy is the result of “mischaracterizations” about the impact that subspecialty certification would have for dermatologists without it, said Dr. Roenigk, chairman of the department of dermatology at the Mayo Clinic in Rochester, Minn.

The controversy began last year, when the ABD submitted an application to the American Board of Medical Specialties (ABMS) to create certification for the subspecialty of procedural dermatology. The American Society for Mohs Surgery took an early stand against the proposal and others followed.

Last month, the ABD was scheduled to submit a revised application to the ABMS Committee on Certification and Recertification but postponed on the advice of ABMS officials. In the meantime, the ABD has formed its own task force to review areas of concern raised by critics and to report back to the group's board of directors in December with specific recommendations.

Around the time that the ABD announced it was postponing its application, the American Academy of Dermatology also came out against the proposal. During an Aug. 1 meeting, the AAD board of directors approved a resolution opposing the ABD's proposal.

The American Society for Mohs Surgery, which has been critical of the move toward certification, is taking a wait-and-see attitude. Dr. Stephen Spencer, president of the society, said it will monitor the situation and evaluate a new proposal if and when it comes forward.

Despite the criticism, the ABD continues to argue that subspecialty certification in procedural dermatology is important both for patient care and for the specialty of dermatology.

There is a body of knowledge related to surgical and procedural dermatology that is not taught in dermatology residency programs and subspecialty certification would offer assurance to patients that the physician is qualified and possesses the necessary knowledge, experience, and skills. The specialty would also gain under the proposal because certification would establish surgery as an integral part of dermatology, according to ABD.

The ABD's board rebuts charges that subspecialty certification will lead to economic credentialing. Since certification would be voluntary, the lack of a subspecialty certificate would not indicate that a physician is unqualified to practice in the specialty, the ABD said.

Some critics, however, aren't satisfied with the ABD's assurances. Dr. Daniel E. Gormley, a dermatologist in Glendora, Calif., said that, as currently written, the ABD's proposal would only grant certification to dermatologists who have completed fellowship training in procedural dermatology, outside of those who would be grandfathered in. Eventually, only a small group of dermatologists would be certified to perform a wide range of procedures, he said.

Dr. Gormley said the main issue with the ABD proposal is that it will restrict the number of dermatologists who can performs Mohs surgery and related procedures. Instead of creating a small cadre of specially trained dermatologists, he said that all dermatology trainees should have the opportunity to learn these procedures during their residency.

“We want to share this knowledge and spread it around,” Dr. Gormley said.

The American Board of Dermatology's proposal to establish subspecialty certification for procedural dermatology is on hold while board leaders seek to address concerns raised by dermatology societies and individual physicians that certification could divide the specialty and lead to economic credentialing.

The board of directors of the American Board of Dermatology (ABD) will meet in December to discuss the status of the proposal.

“This process will not be completed in haste,” said Dr. Randall K. Roenigk, president of the ABD.

ABD leaders have heard the concerns of the dermatology community and are in deliberations to modify the proposal accordingly, but much of the controversy is the result of “mischaracterizations” about the impact that subspecialty certification would have for dermatologists without it, said Dr. Roenigk, chairman of the department of dermatology at the Mayo Clinic in Rochester, Minn.

The controversy began last year, when the ABD submitted an application to the American Board of Medical Specialties (ABMS) to create certification for the subspecialty of procedural dermatology. The American Society for Mohs Surgery took an early stand against the proposal and others followed.

Last month, the ABD was scheduled to submit a revised application to the ABMS Committee on Certification and Recertification but postponed on the advice of ABMS officials. In the meantime, the ABD has formed its own task force to review areas of concern raised by critics and to report back to the group's board of directors in December with specific recommendations.

Around the time that the ABD announced it was postponing its application, the American Academy of Dermatology also came out against the proposal. During an Aug. 1 meeting, the AAD board of directors approved a resolution opposing the ABD's proposal.

The American Society for Mohs Surgery, which has been critical of the move toward certification, is taking a wait-and-see attitude. Dr. Stephen Spencer, president of the society, said it will monitor the situation and evaluate a new proposal if and when it comes forward.

Despite the criticism, the ABD continues to argue that subspecialty certification in procedural dermatology is important both for patient care and for the specialty of dermatology.

There is a body of knowledge related to surgical and procedural dermatology that is not taught in dermatology residency programs and subspecialty certification would offer assurance to patients that the physician is qualified and possesses the necessary knowledge, experience, and skills. The specialty would also gain under the proposal because certification would establish surgery as an integral part of dermatology, according to ABD.

The ABD's board rebuts charges that subspecialty certification will lead to economic credentialing. Since certification would be voluntary, the lack of a subspecialty certificate would not indicate that a physician is unqualified to practice in the specialty, the ABD said.

Some critics, however, aren't satisfied with the ABD's assurances. Dr. Daniel E. Gormley, a dermatologist in Glendora, Calif., said that, as currently written, the ABD's proposal would only grant certification to dermatologists who have completed fellowship training in procedural dermatology, outside of those who would be grandfathered in. Eventually, only a small group of dermatologists would be certified to perform a wide range of procedures, he said.

Dr. Gormley said the main issue with the ABD proposal is that it will restrict the number of dermatologists who can performs Mohs surgery and related procedures. Instead of creating a small cadre of specially trained dermatologists, he said that all dermatology trainees should have the opportunity to learn these procedures during their residency.

“We want to share this knowledge and spread it around,” Dr. Gormley said.

Racial and ethnic minorities have higher rates of disease and reduced access to health care compared with the general population, according to a new report from the Department of Health and Human Services.

African Americans, for example, suffer from chronic diseases such as diabetes at nearly twice the rate of whites. About 15% of African Americans, 14% of Hispanics, and 18% of American Indians have type 2 diabetes, compared with 8% of whites, according to the report.

Racial and ethnic minorities and low income individuals also have reduced access to health care. For example, the report found that Hispanics are only half as likely as whites to have a usual source of medical care. Racial and ethnic minorities were also less likely to lack health insurance. These disparities highlight the need for larger health reform that invests in prevention and wellness and ensures access to affordable health care, the report concluded. HHS Secretary Kathleen Sebelius repeated that message during a roundtable discussion at the White House in June.

“Certainly the kind of disparities we've seen too often in the health care system are disproportionately represented by low income Americans and minority Americans,” she said. “Health reform is key to helping to address these challenges.”

But new health reform legislation will be only one part of the administration's push to reduce health disparities, Ms. Sebelius said. She pledged to do whatever possible under the current authority given to HHS to close the gap on disparities, including working within the Medicare and Medicaid programs.

The event included representatives from various minority and public health groups who offered their suggestions for how health reform legislation could help to close the gap on disparities.

Racial and ethnic minorities have higher rates of disease and reduced access to health care compared with the general population, according to a new report from the Department of Health and Human Services.

African Americans, for example, suffer from chronic diseases such as diabetes at nearly twice the rate of whites. About 15% of African Americans, 14% of Hispanics, and 18% of American Indians have type 2 diabetes, compared with 8% of whites, according to the report.

Racial and ethnic minorities and low income individuals also have reduced access to health care. For example, the report found that Hispanics are only half as likely as whites to have a usual source of medical care. Racial and ethnic minorities were also less likely to lack health insurance. These disparities highlight the need for larger health reform that invests in prevention and wellness and ensures access to affordable health care, the report concluded. HHS Secretary Kathleen Sebelius repeated that message during a roundtable discussion at the White House in June.

“Certainly the kind of disparities we've seen too often in the health care system are disproportionately represented by low income Americans and minority Americans,” she said. “Health reform is key to helping to address these challenges.”

But new health reform legislation will be only one part of the administration's push to reduce health disparities, Ms. Sebelius said. She pledged to do whatever possible under the current authority given to HHS to close the gap on disparities, including working within the Medicare and Medicaid programs.

The event included representatives from various minority and public health groups who offered their suggestions for how health reform legislation could help to close the gap on disparities.

Racial and ethnic minorities have higher rates of disease and reduced access to health care compared with the general population, according to a new report from the Department of Health and Human Services.

African Americans, for example, suffer from chronic diseases such as diabetes at nearly twice the rate of whites. About 15% of African Americans, 14% of Hispanics, and 18% of American Indians have type 2 diabetes, compared with 8% of whites, according to the report.

Racial and ethnic minorities and low income individuals also have reduced access to health care. For example, the report found that Hispanics are only half as likely as whites to have a usual source of medical care. Racial and ethnic minorities were also less likely to lack health insurance. These disparities highlight the need for larger health reform that invests in prevention and wellness and ensures access to affordable health care, the report concluded. HHS Secretary Kathleen Sebelius repeated that message during a roundtable discussion at the White House in June.

“Certainly the kind of disparities we've seen too often in the health care system are disproportionately represented by low income Americans and minority Americans,” she said. “Health reform is key to helping to address these challenges.”

But new health reform legislation will be only one part of the administration's push to reduce health disparities, Ms. Sebelius said. She pledged to do whatever possible under the current authority given to HHS to close the gap on disparities, including working within the Medicare and Medicaid programs.

The event included representatives from various minority and public health groups who offered their suggestions for how health reform legislation could help to close the gap on disparities.

Malpractice Payments Are Down

Medical malpractice payments were at record low levels in 2008, according to an analysis by the consumer advocacy group Public Citizen. In 2008, for the third straight year, the number of malpractice payments reached a new low since the federal government's National Practitioner Data Bank began tracking such data in 1990, the group said. The data showed that 11,037 payments were made last year, which Public Citizen said was nearly one-third lower than the historical average. The monetary value of payments was either the lowest or second lowest since 1990, depending on how inflation was calculated, the group said. The total cost of all malpractice insurance premiums fell to much less than 1% of the total $2.1 trillion in annual health costs in 2006 (the most recent year for which full data were available). The cost of actual malpractice payments to patients fell to 0.2% of overall health costs, the group said. David Arkush, director of Public Citizen's Congress Watch division, said in a statement that the numbers indicate that many victims of medical malpractice receive no compensation for their injuries.

OIG Sheds Light on Ultrasound Claims

Auditors in the Health and Human Services Department have urged Medicare officials to begin flagging “questionable” ultrasound claims and investigating providers who submit large numbers of them. The HHS office of inspector general estimated that 3.2 million ultrasound claims, about 1 in 5 nationwide, have at least one characteristic that is questionable. The most common of these is the lack of a service claim by the ordering physician. The report said that a group of 672 providers each billed 500 or more claims with questionable characteristics in 2007. Collectively, they billed more than $81 million in Part B ultrasound charges. The full report is available at

www.oig.hhs.gov/oei/reports/oei-01-08-00100.pdf

HIV Exclusion Would End

Under a new proposal by the Centers for Disease Control and Prevention, the United States would no longer bar immigrants with HIV. Starting in 1987, the infection—like AIDS—was listed as a communicable disease of public health significance, making infected people ineligible to receive U.S. visas. Last year, Congress removed AIDS from the list but left HIV infection to the discretion of the CDC. The proposed rule would officially remove HIV from the communicable disease list. “While HIV is a serious health condition, it does not represent a communicable disease that is a significant threat for introduction, transmission, and spread to the U.S. population through casual contact,” the CDC wrote in the proposed rule.

Violence Against Women Is Focus

The Obama administration named the first-ever White House adviser on violence against women. Lynn Rosenthal, a national expert on domestic violence policy, will advise the president and vice president and will work with federal agencies on their domestic violence and sexual assault prevention programs. In the newly created role, she also will consult advocacy groups and members of Congress to develop new policies. Ms. Rosenthal served most recently as the executive director of the New Mexico Coalition Against Domestic Violence. The White House announcement said she was a major advocate for reauthorizations of the Violence Against Women Act of 2000 and 2005 and helped states and communities implement the legislation. The announcement, from the vice president, said that Ms. Rosenthal's areas of expertise include housing, state and community responses to domestic violence, and survivor advocacy.

Many Young Adults Uninsured

Approximately 5 million adults aged 19–23 years in the United States had no health insurance in 2006 for the entire year, and 30% of them said they didn't think it was worth the cost, according to the Agency for Healthcare Research and Quality.

The AHRQ found that 46% of uninsured young adults worked full time and 26% worked part time. Only 19% of those who were uninsured throughout 2006 were full-time students, the agency said.

Malpractice Payments Are Down

Medical malpractice payments were at record low levels in 2008, according to an analysis by the consumer advocacy group Public Citizen. In 2008, for the third straight year, the number of malpractice payments reached a new low since the federal government's National Practitioner Data Bank began tracking such data in 1990, the group said. The data showed that 11,037 payments were made last year, which Public Citizen said was nearly one-third lower than the historical average. The monetary value of payments was either the lowest or second lowest since 1990, depending on how inflation was calculated, the group said. The total cost of all malpractice insurance premiums fell to much less than 1% of the total $2.1 trillion in annual health costs in 2006 (the most recent year for which full data were available). The cost of actual malpractice payments to patients fell to 0.2% of overall health costs, the group said. David Arkush, director of Public Citizen's Congress Watch division, said in a statement that the numbers indicate that many victims of medical malpractice receive no compensation for their injuries.

OIG Sheds Light on Ultrasound Claims

Auditors in the Health and Human Services Department have urged Medicare officials to begin flagging “questionable” ultrasound claims and investigating providers who submit large numbers of them. The HHS office of inspector general estimated that 3.2 million ultrasound claims, about 1 in 5 nationwide, have at least one characteristic that is questionable. The most common of these is the lack of a service claim by the ordering physician. The report said that a group of 672 providers each billed 500 or more claims with questionable characteristics in 2007. Collectively, they billed more than $81 million in Part B ultrasound charges. The full report is available at

www.oig.hhs.gov/oei/reports/oei-01-08-00100.pdf

HIV Exclusion Would End

Under a new proposal by the Centers for Disease Control and Prevention, the United States would no longer bar immigrants with HIV. Starting in 1987, the infection—like AIDS—was listed as a communicable disease of public health significance, making infected people ineligible to receive U.S. visas. Last year, Congress removed AIDS from the list but left HIV infection to the discretion of the CDC. The proposed rule would officially remove HIV from the communicable disease list. “While HIV is a serious health condition, it does not represent a communicable disease that is a significant threat for introduction, transmission, and spread to the U.S. population through casual contact,” the CDC wrote in the proposed rule.

Violence Against Women Is Focus

The Obama administration named the first-ever White House adviser on violence against women. Lynn Rosenthal, a national expert on domestic violence policy, will advise the president and vice president and will work with federal agencies on their domestic violence and sexual assault prevention programs. In the newly created role, she also will consult advocacy groups and members of Congress to develop new policies. Ms. Rosenthal served most recently as the executive director of the New Mexico Coalition Against Domestic Violence. The White House announcement said she was a major advocate for reauthorizations of the Violence Against Women Act of 2000 and 2005 and helped states and communities implement the legislation. The announcement, from the vice president, said that Ms. Rosenthal's areas of expertise include housing, state and community responses to domestic violence, and survivor advocacy.

Many Young Adults Uninsured

Approximately 5 million adults aged 19–23 years in the United States had no health insurance in 2006 for the entire year, and 30% of them said they didn't think it was worth the cost, according to the Agency for Healthcare Research and Quality.

The AHRQ found that 46% of uninsured young adults worked full time and 26% worked part time. Only 19% of those who were uninsured throughout 2006 were full-time students, the agency said.

Malpractice Payments Are Down

Medical malpractice payments were at record low levels in 2008, according to an analysis by the consumer advocacy group Public Citizen. In 2008, for the third straight year, the number of malpractice payments reached a new low since the federal government's National Practitioner Data Bank began tracking such data in 1990, the group said. The data showed that 11,037 payments were made last year, which Public Citizen said was nearly one-third lower than the historical average. The monetary value of payments was either the lowest or second lowest since 1990, depending on how inflation was calculated, the group said. The total cost of all malpractice insurance premiums fell to much less than 1% of the total $2.1 trillion in annual health costs in 2006 (the most recent year for which full data were available). The cost of actual malpractice payments to patients fell to 0.2% of overall health costs, the group said. David Arkush, director of Public Citizen's Congress Watch division, said in a statement that the numbers indicate that many victims of medical malpractice receive no compensation for their injuries.

OIG Sheds Light on Ultrasound Claims

Auditors in the Health and Human Services Department have urged Medicare officials to begin flagging “questionable” ultrasound claims and investigating providers who submit large numbers of them. The HHS office of inspector general estimated that 3.2 million ultrasound claims, about 1 in 5 nationwide, have at least one characteristic that is questionable. The most common of these is the lack of a service claim by the ordering physician. The report said that a group of 672 providers each billed 500 or more claims with questionable characteristics in 2007. Collectively, they billed more than $81 million in Part B ultrasound charges. The full report is available at

www.oig.hhs.gov/oei/reports/oei-01-08-00100.pdf

HIV Exclusion Would End

Under a new proposal by the Centers for Disease Control and Prevention, the United States would no longer bar immigrants with HIV. Starting in 1987, the infection—like AIDS—was listed as a communicable disease of public health significance, making infected people ineligible to receive U.S. visas. Last year, Congress removed AIDS from the list but left HIV infection to the discretion of the CDC. The proposed rule would officially remove HIV from the communicable disease list. “While HIV is a serious health condition, it does not represent a communicable disease that is a significant threat for introduction, transmission, and spread to the U.S. population through casual contact,” the CDC wrote in the proposed rule.

Violence Against Women Is Focus

The Obama administration named the first-ever White House adviser on violence against women. Lynn Rosenthal, a national expert on domestic violence policy, will advise the president and vice president and will work with federal agencies on their domestic violence and sexual assault prevention programs. In the newly created role, she also will consult advocacy groups and members of Congress to develop new policies. Ms. Rosenthal served most recently as the executive director of the New Mexico Coalition Against Domestic Violence. The White House announcement said she was a major advocate for reauthorizations of the Violence Against Women Act of 2000 and 2005 and helped states and communities implement the legislation. The announcement, from the vice president, said that Ms. Rosenthal's areas of expertise include housing, state and community responses to domestic violence, and survivor advocacy.

Many Young Adults Uninsured

Approximately 5 million adults aged 19–23 years in the United States had no health insurance in 2006 for the entire year, and 30% of them said they didn't think it was worth the cost, according to the Agency for Healthcare Research and Quality.

The AHRQ found that 46% of uninsured young adults worked full time and 26% worked part time. Only 19% of those who were uninsured throughout 2006 were full-time students, the agency said.

Increased pay for primary care physicians, decreased pay for specialists, and a potential way to get rid of the sustainable growth rate formula are addressed in the Obama Administration's proposed rule on the 2010 Medicare Physician Fee Schedule.

Physicians' organizations have sought repeal of the sustainable growth rate (SGR)—the statutory formula used to set physician payment rates under Medicare—saying that it is flawed and does not reflect the true cost of providing medical care.

One criticism is that the formula counts the price of physician-administered drugs, over which physicians have little control, as a physician service. Since the SGR is designed to cut payments when health care expenditures rise above a certain target, the inclusion of drugs has caused physicians to exceed those targets more rapidly and has contributed to pay cuts over the years.

The removal of physician-administered drugs from the SGR should reduce the number of years that physicians see pay cuts, according to the Centers for Medicare and Medicaid Services. And the American Medical Association is betting that the change will make it less expensive for Congress to repeal the SGR, which would also benefit physicians.

The removal of drugs from the SGR is one of several changes included in the 2010 Medicare Physician Fee Schedule proposed rule, published in the Federal Register on July 13. A final rule is expected in November.

Even if enacted, the proposal will not stop the 21.5% pay cut slated to go into effect on Jan. 1, 2010. However, several physicians interviewed said they were hopeful that Congress would step in again this year to roll back this cut, whether through health reform legislation or in a separate bill.

While the 21.5% cut would affect physicians across the board, the rest of the fee schedule proposal affects physicians quite differently depending on their specialty. For example, the proposed rule includes plans to eliminate the use of consultation codes, increase payments for evaluation and management (E&M) services, and update the practice expense component of physician fees based on new survey data.

Under the proposal, the CMS would eliminate the use of all consultation codes except telehealth codes starting Jan. 1. At the same time, the agency would increase the work relative value units for new and established office visits, increase the work values for initial hospital and initial nursing facility visits, and incorporate the increased use of these visits into the practice expense and malpractice relative value unit calculations.

“We believe the rationale for a different payment for a consultation service is no longer supported because documentation requirements are now similar across all E&M services,” the CMS wrote in the proposed rule.

Also included in the proposed rule is an increased payment for the Welcome to Medicare physical, which focuses on primary care, health promotion, and disease prevention.

The CMS estimates that the combination of the various proposals would mean a 6%-8% payment increase for primary care physicians, excluding the impact of the 21.5% cut.

“This is very welcome news to primary care physicians and is long overdue,” said Dr. Ted Epperly, president of the American Academy of Family Physicians.

If the 21.5% pay cut is stopped, 2010 could be a good year for primary care, Dr. Epperly said. In addition to the 6%-8% increase in the fee schedule proposed rule, primary care physicians could gain 5%-10% in payments through health reform legislation pending in Congress.

These increases will be critical for primary care physicians in practice today who need money to invest in changing their practice in order to provide care under the medical home model. “It provides the fuel for transformation,” Dr. Epperly said.

Conversely, subspecialists would lose out under the schedule proposal, experiencing either cuts or only small increases.

At press time, officials at the American College of Obstetricians and Gynecologists were still reviewing the 1,100-plus page rule. They plan to submit formal comments to the CMS by the end of August.

If the 21.5% pay cut is stopped, 2010 could be a good year for primary care.

Source DR. EPPERLY

Increased pay for primary care physicians, decreased pay for specialists, and a potential way to get rid of the sustainable growth rate formula are addressed in the Obama Administration's proposed rule on the 2010 Medicare Physician Fee Schedule.

Physicians' organizations have sought repeal of the sustainable growth rate (SGR)—the statutory formula used to set physician payment rates under Medicare—saying that it is flawed and does not reflect the true cost of providing medical care.

One criticism is that the formula counts the price of physician-administered drugs, over which physicians have little control, as a physician service. Since the SGR is designed to cut payments when health care expenditures rise above a certain target, the inclusion of drugs has caused physicians to exceed those targets more rapidly and has contributed to pay cuts over the years.

The removal of physician-administered drugs from the SGR should reduce the number of years that physicians see pay cuts, according to the Centers for Medicare and Medicaid Services. And the American Medical Association is betting that the change will make it less expensive for Congress to repeal the SGR, which would also benefit physicians.

The removal of drugs from the SGR is one of several changes included in the 2010 Medicare Physician Fee Schedule proposed rule, published in the Federal Register on July 13. A final rule is expected in November.

Even if enacted, the proposal will not stop the 21.5% pay cut slated to go into effect on Jan. 1, 2010. However, several physicians interviewed said they were hopeful that Congress would step in again this year to roll back this cut, whether through health reform legislation or in a separate bill.

While the 21.5% cut would affect physicians across the board, the rest of the fee schedule proposal affects physicians quite differently depending on their specialty. For example, the proposed rule includes plans to eliminate the use of consultation codes, increase payments for evaluation and management (E&M) services, and update the practice expense component of physician fees based on new survey data.

Under the proposal, the CMS would eliminate the use of all consultation codes except telehealth codes starting Jan. 1. At the same time, the agency would increase the work relative value units for new and established office visits, increase the work values for initial hospital and initial nursing facility visits, and incorporate the increased use of these visits into the practice expense and malpractice relative value unit calculations.

“We believe the rationale for a different payment for a consultation service is no longer supported because documentation requirements are now similar across all E&M services,” the CMS wrote in the proposed rule.

Also included in the proposed rule is an increased payment for the Welcome to Medicare physical, which focuses on primary care, health promotion, and disease prevention.

The CMS estimates that the combination of the various proposals would mean a 6%-8% payment increase for primary care physicians, excluding the impact of the 21.5% cut.

“This is very welcome news to primary care physicians and is long overdue,” said Dr. Ted Epperly, president of the American Academy of Family Physicians.

If the 21.5% pay cut is stopped, 2010 could be a good year for primary care, Dr. Epperly said. In addition to the 6%-8% increase in the fee schedule proposed rule, primary care physicians could gain 5%-10% in payments through health reform legislation pending in Congress.

These increases will be critical for primary care physicians in practice today who need money to invest in changing their practice in order to provide care under the medical home model. “It provides the fuel for transformation,” Dr. Epperly said.

Conversely, subspecialists would lose out under the schedule proposal, experiencing either cuts or only small increases.

At press time, officials at the American College of Obstetricians and Gynecologists were still reviewing the 1,100-plus page rule. They plan to submit formal comments to the CMS by the end of August.

If the 21.5% pay cut is stopped, 2010 could be a good year for primary care.

Source DR. EPPERLY

Increased pay for primary care physicians, decreased pay for specialists, and a potential way to get rid of the sustainable growth rate formula are addressed in the Obama Administration's proposed rule on the 2010 Medicare Physician Fee Schedule.

Physicians' organizations have sought repeal of the sustainable growth rate (SGR)—the statutory formula used to set physician payment rates under Medicare—saying that it is flawed and does not reflect the true cost of providing medical care.

One criticism is that the formula counts the price of physician-administered drugs, over which physicians have little control, as a physician service. Since the SGR is designed to cut payments when health care expenditures rise above a certain target, the inclusion of drugs has caused physicians to exceed those targets more rapidly and has contributed to pay cuts over the years.

The removal of physician-administered drugs from the SGR should reduce the number of years that physicians see pay cuts, according to the Centers for Medicare and Medicaid Services. And the American Medical Association is betting that the change will make it less expensive for Congress to repeal the SGR, which would also benefit physicians.

The removal of drugs from the SGR is one of several changes included in the 2010 Medicare Physician Fee Schedule proposed rule, published in the Federal Register on July 13. A final rule is expected in November.

Even if enacted, the proposal will not stop the 21.5% pay cut slated to go into effect on Jan. 1, 2010. However, several physicians interviewed said they were hopeful that Congress would step in again this year to roll back this cut, whether through health reform legislation or in a separate bill.

While the 21.5% cut would affect physicians across the board, the rest of the fee schedule proposal affects physicians quite differently depending on their specialty. For example, the proposed rule includes plans to eliminate the use of consultation codes, increase payments for evaluation and management (E&M) services, and update the practice expense component of physician fees based on new survey data.

Under the proposal, the CMS would eliminate the use of all consultation codes except telehealth codes starting Jan. 1. At the same time, the agency would increase the work relative value units for new and established office visits, increase the work values for initial hospital and initial nursing facility visits, and incorporate the increased use of these visits into the practice expense and malpractice relative value unit calculations.

“We believe the rationale for a different payment for a consultation service is no longer supported because documentation requirements are now similar across all E&M services,” the CMS wrote in the proposed rule.

Also included in the proposed rule is an increased payment for the Welcome to Medicare physical, which focuses on primary care, health promotion, and disease prevention.

The CMS estimates that the combination of the various proposals would mean a 6%-8% payment increase for primary care physicians, excluding the impact of the 21.5% cut.

“This is very welcome news to primary care physicians and is long overdue,” said Dr. Ted Epperly, president of the American Academy of Family Physicians.

If the 21.5% pay cut is stopped, 2010 could be a good year for primary care, Dr. Epperly said. In addition to the 6%-8% increase in the fee schedule proposed rule, primary care physicians could gain 5%-10% in payments through health reform legislation pending in Congress.

These increases will be critical for primary care physicians in practice today who need money to invest in changing their practice in order to provide care under the medical home model. “It provides the fuel for transformation,” Dr. Epperly said.

Conversely, subspecialists would lose out under the schedule proposal, experiencing either cuts or only small increases.

At press time, officials at the American College of Obstetricians and Gynecologists were still reviewing the 1,100-plus page rule. They plan to submit formal comments to the CMS by the end of August.

If the 21.5% pay cut is stopped, 2010 could be a good year for primary care.

Source DR. EPPERLY

Generic Biologics Get a Boost

Creating a process at the Food and Drug Administration for approving generic biologic drugs, called follow-on biologics (FOBs), could lower biologics' cost, the Federal Trade Commission said. But the 12- to 14-year exclusivity period sought by biologics manufacturers is too long, according to the agency. FOBs wouldn't tread deep into innovative products' turf—those drugs would retain 70%-90% of their market shares and continue making substantial profits—according to the FTC. Rep. Henry A. Waxman (D-Calif.), who has introduced legislation to create a regulatory pathway for FOBs, praised the report. But the Biotechnology Industry Organization blasted it as “fundamentally flawed” and based on a “lack of true understanding of the necessary conditions to drive future biomedical breakthroughs.” The full FTC report is available at

www.ftc.gov/os/2009/06/P083901biologicsreport.pdf

NIH Targets Rare Diseases

The National Institutes of Health has created a pipeline for drugs to treat rare and neglected diseases. This spring, Congress provided $24 million for the program, which focuses on collaborations among NIH researchers in these areas. The initiative is supposed to go beyond the Orphan Drug Act by offering support for preclinical research and product development. NIH will seek private companies to carry out testing with patients. The program “will develop promising treatments for rare diseases to the point that they are sufficiently 'derisked' for pharmaceutical companies, disease-oriented foundations, or others to undertake the necessary clinical trials,” Dr. Alan E. Guttmacher, acting director of NIH's National Human Genome Research Institute, said in a statement. NIH estimates that there are more than 6,800 rare diseases but only about 200 of them have effective drug treatments.

Vermont Bans Most Pharma Gifts

Vermont Gov. Jim Douglas (R) has signed into law a bill that prohibits manufacturers of drugs, medical devices, and biologics from providing free gifts, including meals and travel, to physicians and other health care providers. The toughest of its kind in the nation, the legislation also requires disclosure of any allowed gifts or payments, regardless of their value. Under the stronger law, manufacturers can give physicians only gifts such as samples intended for patients, “reasonable quantities” of medical device evaluation or demonstration units, and copies of peer-reviewed articles. They still can provide scholarships or other support for medical students, residents, and fellows to attend educational events held by professional associations.

More Flu Preparation Needed

Federal and state governments need to do more to prepare for possible pandemic flu, the Government Accountability Office (GAO) said after reviewing the H1N1 flu outbreak. The office acknowledged pandemic planning throughout government but said that more efforts are needed to improve disease surveillance and detection, address issues of coordination between various governmental entities, and improve capacity for patient care in the event of a pandemic. The GAO warned that the H1N1 virus could return next fall or winter in a more virulent form.

Generic Biologics Get a Boost

Creating a process at the Food and Drug Administration for approving generic biologic drugs, called follow-on biologics (FOBs), could lower biologics' cost, the Federal Trade Commission said. But the 12- to 14-year exclusivity period sought by biologics manufacturers is too long, according to the agency. FOBs wouldn't tread deep into innovative products' turf—those drugs would retain 70%-90% of their market shares and continue making substantial profits—according to the FTC. Rep. Henry A. Waxman (D-Calif.), who has introduced legislation to create a regulatory pathway for FOBs, praised the report. But the Biotechnology Industry Organization blasted it as “fundamentally flawed” and based on a “lack of true understanding of the necessary conditions to drive future biomedical breakthroughs.” The full FTC report is available at

www.ftc.gov/os/2009/06/P083901biologicsreport.pdf

NIH Targets Rare Diseases

The National Institutes of Health has created a pipeline for drugs to treat rare and neglected diseases. This spring, Congress provided $24 million for the program, which focuses on collaborations among NIH researchers in these areas. The initiative is supposed to go beyond the Orphan Drug Act by offering support for preclinical research and product development. NIH will seek private companies to carry out testing with patients. The program “will develop promising treatments for rare diseases to the point that they are sufficiently 'derisked' for pharmaceutical companies, disease-oriented foundations, or others to undertake the necessary clinical trials,” Dr. Alan E. Guttmacher, acting director of NIH's National Human Genome Research Institute, said in a statement. NIH estimates that there are more than 6,800 rare diseases but only about 200 of them have effective drug treatments.

Vermont Bans Most Pharma Gifts

Vermont Gov. Jim Douglas (R) has signed into law a bill that prohibits manufacturers of drugs, medical devices, and biologics from providing free gifts, including meals and travel, to physicians and other health care providers. The toughest of its kind in the nation, the legislation also requires disclosure of any allowed gifts or payments, regardless of their value. Under the stronger law, manufacturers can give physicians only gifts such as samples intended for patients, “reasonable quantities” of medical device evaluation or demonstration units, and copies of peer-reviewed articles. They still can provide scholarships or other support for medical students, residents, and fellows to attend educational events held by professional associations.

More Flu Preparation Needed

Federal and state governments need to do more to prepare for possible pandemic flu, the Government Accountability Office (GAO) said after reviewing the H1N1 flu outbreak. The office acknowledged pandemic planning throughout government but said that more efforts are needed to improve disease surveillance and detection, address issues of coordination between various governmental entities, and improve capacity for patient care in the event of a pandemic. The GAO warned that the H1N1 virus could return next fall or winter in a more virulent form.

Generic Biologics Get a Boost

Creating a process at the Food and Drug Administration for approving generic biologic drugs, called follow-on biologics (FOBs), could lower biologics' cost, the Federal Trade Commission said. But the 12- to 14-year exclusivity period sought by biologics manufacturers is too long, according to the agency. FOBs wouldn't tread deep into innovative products' turf—those drugs would retain 70%-90% of their market shares and continue making substantial profits—according to the FTC. Rep. Henry A. Waxman (D-Calif.), who has introduced legislation to create a regulatory pathway for FOBs, praised the report. But the Biotechnology Industry Organization blasted it as “fundamentally flawed” and based on a “lack of true understanding of the necessary conditions to drive future biomedical breakthroughs.” The full FTC report is available at

www.ftc.gov/os/2009/06/P083901biologicsreport.pdf

NIH Targets Rare Diseases

The National Institutes of Health has created a pipeline for drugs to treat rare and neglected diseases. This spring, Congress provided $24 million for the program, which focuses on collaborations among NIH researchers in these areas. The initiative is supposed to go beyond the Orphan Drug Act by offering support for preclinical research and product development. NIH will seek private companies to carry out testing with patients. The program “will develop promising treatments for rare diseases to the point that they are sufficiently 'derisked' for pharmaceutical companies, disease-oriented foundations, or others to undertake the necessary clinical trials,” Dr. Alan E. Guttmacher, acting director of NIH's National Human Genome Research Institute, said in a statement. NIH estimates that there are more than 6,800 rare diseases but only about 200 of them have effective drug treatments.

Vermont Bans Most Pharma Gifts

Vermont Gov. Jim Douglas (R) has signed into law a bill that prohibits manufacturers of drugs, medical devices, and biologics from providing free gifts, including meals and travel, to physicians and other health care providers. The toughest of its kind in the nation, the legislation also requires disclosure of any allowed gifts or payments, regardless of their value. Under the stronger law, manufacturers can give physicians only gifts such as samples intended for patients, “reasonable quantities” of medical device evaluation or demonstration units, and copies of peer-reviewed articles. They still can provide scholarships or other support for medical students, residents, and fellows to attend educational events held by professional associations.

More Flu Preparation Needed

Federal and state governments need to do more to prepare for possible pandemic flu, the Government Accountability Office (GAO) said after reviewing the H1N1 flu outbreak. The office acknowledged pandemic planning throughout government but said that more efforts are needed to improve disease surveillance and detection, address issues of coordination between various governmental entities, and improve capacity for patient care in the event of a pandemic. The GAO warned that the H1N1 virus could return next fall or winter in a more virulent form.

Decreased pay for subspecialists, increased pay for primary care physicians, and a potential way to get rid of the sustainable growth rate formula are addressed in the Obama Administration's proposed rule on the 2010 Medicare Physician Fee Schedule.

Physicians' organizations have sought repeal of the sustainable growth rate (SGR)—the statutory formula used to set physician payment rates under Medicare—saying that it is flawed and does not reflect the true cost of providing medical care.

One criticism is that the formula counts the price of physician-administered drugs, over which physicians have little control, as a physician service.

Since the SGR is designed to cut payments when health care expenditures rise above a certain target, the inclusion of drugs has caused physicians to exceed those targets more rapidly and has contributed to pay cuts over the years.

The removal of physician-administered drugs from the SGR should reduce the number of years that physicians see pay cuts, according to the Centers for Medicare and Medicaid Services.

And the American Medical Association is betting that the change will make it less expensive for Congress to repeal the SGR, which would also benefit physicians.

The removal of drugs from the SGR is one of several changes included in the 2010 Medicare Physician Fee Schedule proposed rule, published in the Federal Register on July 13.

A final rule is expected in November.

Even if enacted, the proposal will not stop the 21.5% pay cut slated to go into effect on Jan. 1, 2010. However, several physicians interviewed said they were hopeful that Congress would step in again this year to roll back this cut, whether through health reform legislation or in a separate bill.

While the 21.5% cut would affect physicians across the board, the rest of the fee schedule proposal affects physicians quite differently depending on their specialty. For example, the proposed rule includes plans to eliminate the use of consultation codes, increase payments for evaluation and management (E&M) services, and update the practice expense component of physician fees based on new survey data. Under the proposal, the CMS would eliminate the use of all consultation codes except telehealth codes starting Jan. 1.

At the same time, the agency would increase the work relative value units for new and established office visits, increase the work values for initial hospital and initial nursing facility visits, and incorporate the increased use of these visits into the practice expense and malpractice relative value unit calculations.

“We believe the rationale for a different payment for a consultation service is no longer supported because documentation requirements are now similar across all E&M services,” the CMS wrote in the proposed rule.

Also included in the proposed rule is an increased payment for the Welcome to Medicare physical, which focuses on primary care, health promotion, and disease prevention.

The CMS estimates that the combination of the various proposals would mean a 6%-8% payment increase for primary care physicians, excluding the impact of the 21.5% cut. The combined proposals will result in a 1% cut for rheumatologists on average, according to CMS estimates that do not include the 21.5% cut. The cut represents a dangerous precedent because it pits one group of physicians against another by taking money away from specialists to provide additional compensation to primary care, said Dr. Sharad Lakhanpal, clinical professor of internal medicine at the University of Texas Southwestern Medical School in Dallas and chairman of the government affairs committee at the American College of Rheumatology.

For rheumatologists, the shift is especially frustrating, he said, because they provide mainly cognitive care but aren't getting the same payment increases that primary care physicians are getting. “Most of our work is patient care, E&M services,” Dr. Lakhanpal said.

Since rheumatologists don't perform many procedures, most of their payments come from consultations. Dr. Lakhanpal said that the work involved in a consult warrants additional pay. For example, a consult with a complicated patient can be time consuming and involves reviewing sometimes extensive medical records before examining the patient. Dr. Lakhanpal said he hopes that the consult provision will not go into effect as written.

Dr. Ted Epperly, president of the American Academy of Family Physicians, said that assuming that the 21.5% cut is stopped, 2010 could be a good year for primary care. In addition to the 6%-8% increase in the fee schedule proposed rule, primary care physicians could gain 5%-10% in payments through health reform legislation pending in Congress.

These increases will be critical for primary care physicians in practice today who need money to invest in changing their practice in order to provide care under the medical home model. “It provides the fuel for transformation,” Dr. Epperly said.

Equally important, he said, is that increasing the payments sends the message to medical students that primary care is a viable field and that they don't have to go into subspecialties to earn a living.

Conversely, subspecialists would lose out under the schedule proposal, experiencing either cuts or only small increases.

The fee schedule proposal also includes policy changes related to imaging. The proposed rule would cut payments for certain high-cost imaging services by assuming that imaging equipment priced at more than $1 million is used 90% of the time, compared with the current assumption of use at 50%.

The proposed change is based on studies from the Medicare Payment Advisory Commission (MedPAC) showing that the use of high-cost imaging equipment is higher than previously thought. MedPAC found that in certain markets, MRIs were being used an average of about 46 hours a week, or 92% of a 50-hour workweek. As written, the rule would not affect lower-cost imaging services such as bone density testing and ultrasound. The agency said it will continue to examine the data for equipment valued at less than $1 million but is not proposing a change at this time. The CMS noted that it does not expect the imaging proposal to create access issues in rural areas.

The cut takes money away from specialists to provide additional compensation to primary care physicians.

Source DR. LAKHANPAL

This Month's Talk Back Question

What's your view of the proposal to cut Medicare pay for subspecialty physicians?

Decreased pay for subspecialists, increased pay for primary care physicians, and a potential way to get rid of the sustainable growth rate formula are addressed in the Obama Administration's proposed rule on the 2010 Medicare Physician Fee Schedule.

Physicians' organizations have sought repeal of the sustainable growth rate (SGR)—the statutory formula used to set physician payment rates under Medicare—saying that it is flawed and does not reflect the true cost of providing medical care.

One criticism is that the formula counts the price of physician-administered drugs, over which physicians have little control, as a physician service.

Since the SGR is designed to cut payments when health care expenditures rise above a certain target, the inclusion of drugs has caused physicians to exceed those targets more rapidly and has contributed to pay cuts over the years.

The removal of physician-administered drugs from the SGR should reduce the number of years that physicians see pay cuts, according to the Centers for Medicare and Medicaid Services.

And the American Medical Association is betting that the change will make it less expensive for Congress to repeal the SGR, which would also benefit physicians.

The removal of drugs from the SGR is one of several changes included in the 2010 Medicare Physician Fee Schedule proposed rule, published in the Federal Register on July 13.

A final rule is expected in November.

Even if enacted, the proposal will not stop the 21.5% pay cut slated to go into effect on Jan. 1, 2010. However, several physicians interviewed said they were hopeful that Congress would step in again this year to roll back this cut, whether through health reform legislation or in a separate bill.

While the 21.5% cut would affect physicians across the board, the rest of the fee schedule proposal affects physicians quite differently depending on their specialty. For example, the proposed rule includes plans to eliminate the use of consultation codes, increase payments for evaluation and management (E&M) services, and update the practice expense component of physician fees based on new survey data. Under the proposal, the CMS would eliminate the use of all consultation codes except telehealth codes starting Jan. 1.

At the same time, the agency would increase the work relative value units for new and established office visits, increase the work values for initial hospital and initial nursing facility visits, and incorporate the increased use of these visits into the practice expense and malpractice relative value unit calculations.

“We believe the rationale for a different payment for a consultation service is no longer supported because documentation requirements are now similar across all E&M services,” the CMS wrote in the proposed rule.

Also included in the proposed rule is an increased payment for the Welcome to Medicare physical, which focuses on primary care, health promotion, and disease prevention.

The CMS estimates that the combination of the various proposals would mean a 6%-8% payment increase for primary care physicians, excluding the impact of the 21.5% cut. The combined proposals will result in a 1% cut for rheumatologists on average, according to CMS estimates that do not include the 21.5% cut. The cut represents a dangerous precedent because it pits one group of physicians against another by taking money away from specialists to provide additional compensation to primary care, said Dr. Sharad Lakhanpal, clinical professor of internal medicine at the University of Texas Southwestern Medical School in Dallas and chairman of the government affairs committee at the American College of Rheumatology.

For rheumatologists, the shift is especially frustrating, he said, because they provide mainly cognitive care but aren't getting the same payment increases that primary care physicians are getting. “Most of our work is patient care, E&M services,” Dr. Lakhanpal said.

Since rheumatologists don't perform many procedures, most of their payments come from consultations. Dr. Lakhanpal said that the work involved in a consult warrants additional pay. For example, a consult with a complicated patient can be time consuming and involves reviewing sometimes extensive medical records before examining the patient. Dr. Lakhanpal said he hopes that the consult provision will not go into effect as written.

Dr. Ted Epperly, president of the American Academy of Family Physicians, said that assuming that the 21.5% cut is stopped, 2010 could be a good year for primary care. In addition to the 6%-8% increase in the fee schedule proposed rule, primary care physicians could gain 5%-10% in payments through health reform legislation pending in Congress.

These increases will be critical for primary care physicians in practice today who need money to invest in changing their practice in order to provide care under the medical home model. “It provides the fuel for transformation,” Dr. Epperly said.

Equally important, he said, is that increasing the payments sends the message to medical students that primary care is a viable field and that they don't have to go into subspecialties to earn a living.

Conversely, subspecialists would lose out under the schedule proposal, experiencing either cuts or only small increases.

The fee schedule proposal also includes policy changes related to imaging. The proposed rule would cut payments for certain high-cost imaging services by assuming that imaging equipment priced at more than $1 million is used 90% of the time, compared with the current assumption of use at 50%.

The proposed change is based on studies from the Medicare Payment Advisory Commission (MedPAC) showing that the use of high-cost imaging equipment is higher than previously thought. MedPAC found that in certain markets, MRIs were being used an average of about 46 hours a week, or 92% of a 50-hour workweek. As written, the rule would not affect lower-cost imaging services such as bone density testing and ultrasound. The agency said it will continue to examine the data for equipment valued at less than $1 million but is not proposing a change at this time. The CMS noted that it does not expect the imaging proposal to create access issues in rural areas.

The cut takes money away from specialists to provide additional compensation to primary care physicians.

Source DR. LAKHANPAL

This Month's Talk Back Question

What's your view of the proposal to cut Medicare pay for subspecialty physicians?

Decreased pay for subspecialists, increased pay for primary care physicians, and a potential way to get rid of the sustainable growth rate formula are addressed in the Obama Administration's proposed rule on the 2010 Medicare Physician Fee Schedule.

Physicians' organizations have sought repeal of the sustainable growth rate (SGR)—the statutory formula used to set physician payment rates under Medicare—saying that it is flawed and does not reflect the true cost of providing medical care.

One criticism is that the formula counts the price of physician-administered drugs, over which physicians have little control, as a physician service.

Since the SGR is designed to cut payments when health care expenditures rise above a certain target, the inclusion of drugs has caused physicians to exceed those targets more rapidly and has contributed to pay cuts over the years.

The removal of physician-administered drugs from the SGR should reduce the number of years that physicians see pay cuts, according to the Centers for Medicare and Medicaid Services.

And the American Medical Association is betting that the change will make it less expensive for Congress to repeal the SGR, which would also benefit physicians.

The removal of drugs from the SGR is one of several changes included in the 2010 Medicare Physician Fee Schedule proposed rule, published in the Federal Register on July 13.

A final rule is expected in November.

Even if enacted, the proposal will not stop the 21.5% pay cut slated to go into effect on Jan. 1, 2010. However, several physicians interviewed said they were hopeful that Congress would step in again this year to roll back this cut, whether through health reform legislation or in a separate bill.

While the 21.5% cut would affect physicians across the board, the rest of the fee schedule proposal affects physicians quite differently depending on their specialty. For example, the proposed rule includes plans to eliminate the use of consultation codes, increase payments for evaluation and management (E&M) services, and update the practice expense component of physician fees based on new survey data. Under the proposal, the CMS would eliminate the use of all consultation codes except telehealth codes starting Jan. 1.

At the same time, the agency would increase the work relative value units for new and established office visits, increase the work values for initial hospital and initial nursing facility visits, and incorporate the increased use of these visits into the practice expense and malpractice relative value unit calculations.

“We believe the rationale for a different payment for a consultation service is no longer supported because documentation requirements are now similar across all E&M services,” the CMS wrote in the proposed rule.

Also included in the proposed rule is an increased payment for the Welcome to Medicare physical, which focuses on primary care, health promotion, and disease prevention.

The CMS estimates that the combination of the various proposals would mean a 6%-8% payment increase for primary care physicians, excluding the impact of the 21.5% cut. The combined proposals will result in a 1% cut for rheumatologists on average, according to CMS estimates that do not include the 21.5% cut. The cut represents a dangerous precedent because it pits one group of physicians against another by taking money away from specialists to provide additional compensation to primary care, said Dr. Sharad Lakhanpal, clinical professor of internal medicine at the University of Texas Southwestern Medical School in Dallas and chairman of the government affairs committee at the American College of Rheumatology.

For rheumatologists, the shift is especially frustrating, he said, because they provide mainly cognitive care but aren't getting the same payment increases that primary care physicians are getting. “Most of our work is patient care, E&M services,” Dr. Lakhanpal said.

Since rheumatologists don't perform many procedures, most of their payments come from consultations. Dr. Lakhanpal said that the work involved in a consult warrants additional pay. For example, a consult with a complicated patient can be time consuming and involves reviewing sometimes extensive medical records before examining the patient. Dr. Lakhanpal said he hopes that the consult provision will not go into effect as written.

Dr. Ted Epperly, president of the American Academy of Family Physicians, said that assuming that the 21.5% cut is stopped, 2010 could be a good year for primary care. In addition to the 6%-8% increase in the fee schedule proposed rule, primary care physicians could gain 5%-10% in payments through health reform legislation pending in Congress.

These increases will be critical for primary care physicians in practice today who need money to invest in changing their practice in order to provide care under the medical home model. “It provides the fuel for transformation,” Dr. Epperly said.

Equally important, he said, is that increasing the payments sends the message to medical students that primary care is a viable field and that they don't have to go into subspecialties to earn a living.

Conversely, subspecialists would lose out under the schedule proposal, experiencing either cuts or only small increases.

The fee schedule proposal also includes policy changes related to imaging. The proposed rule would cut payments for certain high-cost imaging services by assuming that imaging equipment priced at more than $1 million is used 90% of the time, compared with the current assumption of use at 50%.

The proposed change is based on studies from the Medicare Payment Advisory Commission (MedPAC) showing that the use of high-cost imaging equipment is higher than previously thought. MedPAC found that in certain markets, MRIs were being used an average of about 46 hours a week, or 92% of a 50-hour workweek. As written, the rule would not affect lower-cost imaging services such as bone density testing and ultrasound. The agency said it will continue to examine the data for equipment valued at less than $1 million but is not proposing a change at this time. The CMS noted that it does not expect the imaging proposal to create access issues in rural areas.

The cut takes money away from specialists to provide additional compensation to primary care physicians.

Source DR. LAKHANPAL

This Month's Talk Back Question

What's your view of the proposal to cut Medicare pay for subspecialty physicians?

Conventional measures of disease activity, such as swollen joints, do not appear to be associated with fatigue in rheumatoid arthritis, according to a study that examined fatigue assessments from more than 16,000 rheumatoid arthritis patients in the U.S.

Reports of fatigue were closely associated with patient-measures of pain. But fatigue was weakly associated with clinical measures of inflammation such as sedimentation rate, joint swelling, joint tenderness, and physician-reported global assessment, Dr. Martin J. Bergman said at the annual European Congress of Rheumatology.

The results are not meant to downplay the impact of fatigue in RA patients, he said. Fatigue is a common and devastating complaint for many patients with RA, said Dr. Bergman, a Philadelphia-area rheumatologist.

In addition to examining levels of fatigue among RA patients, the researchers collected data on reported fatigue from about 3,500 patients with fibromyalgia and 4,600 patients with osteoarthritis. As with the patients with RA, these other patients were asked to rate their problems with “unusual fatigue” over the past week on a scale of 0-10.

The findings show that fatigue was common not only in fibromyalgia and rheumatoid arthritis but also in patients with osteoarthritis.

Conventional measures of disease activity, such as swollen joints, do not appear to be associated with fatigue in rheumatoid arthritis, according to a study that examined fatigue assessments from more than 16,000 rheumatoid arthritis patients in the U.S.

Reports of fatigue were closely associated with patient-measures of pain. But fatigue was weakly associated with clinical measures of inflammation such as sedimentation rate, joint swelling, joint tenderness, and physician-reported global assessment, Dr. Martin J. Bergman said at the annual European Congress of Rheumatology.

The results are not meant to downplay the impact of fatigue in RA patients, he said. Fatigue is a common and devastating complaint for many patients with RA, said Dr. Bergman, a Philadelphia-area rheumatologist.

In addition to examining levels of fatigue among RA patients, the researchers collected data on reported fatigue from about 3,500 patients with fibromyalgia and 4,600 patients with osteoarthritis. As with the patients with RA, these other patients were asked to rate their problems with “unusual fatigue” over the past week on a scale of 0-10.

The findings show that fatigue was common not only in fibromyalgia and rheumatoid arthritis but also in patients with osteoarthritis.

Conventional measures of disease activity, such as swollen joints, do not appear to be associated with fatigue in rheumatoid arthritis, according to a study that examined fatigue assessments from more than 16,000 rheumatoid arthritis patients in the U.S.

Reports of fatigue were closely associated with patient-measures of pain. But fatigue was weakly associated with clinical measures of inflammation such as sedimentation rate, joint swelling, joint tenderness, and physician-reported global assessment, Dr. Martin J. Bergman said at the annual European Congress of Rheumatology.

The results are not meant to downplay the impact of fatigue in RA patients, he said. Fatigue is a common and devastating complaint for many patients with RA, said Dr. Bergman, a Philadelphia-area rheumatologist.

In addition to examining levels of fatigue among RA patients, the researchers collected data on reported fatigue from about 3,500 patients with fibromyalgia and 4,600 patients with osteoarthritis. As with the patients with RA, these other patients were asked to rate their problems with “unusual fatigue” over the past week on a scale of 0-10.

The findings show that fatigue was common not only in fibromyalgia and rheumatoid arthritis but also in patients with osteoarthritis.

The Obama administration's proposed rule on the 2010 Medicare Physician Fee Schedule addresses increased pay for primary care physicians, decreased pay for specialists, and a way to get rid of the sustainable growth rate formula.

Physicians' organizations have sought repeal of the sustainable growth rate (SGR)—the statutory formula used to set payment rates under Medicare—saying it does not reflect the true cost of care.

One criticism is that the formula counts the price of physician-administered drugs as a physician service. Since the SGR is designed to cut payments when health care expenditures rise above a certain target, the inclusion of drugs has caused physicians to exceed those targets more rapidly.

The removal of physician-administered drugs from the SGR should reduce the number of years that physicians see pay cuts, according to the Centers for Medicare and Medicaid Services. And the American Medical Association is betting that the change will make it less expensive for Congress to repeal the SGR, which would also benefit physicians.

The change is one of several included in the 2010 Medicare Physician Fee Schedule proposed rule, published in the Federal Register on July 13. A final rule is expected in November.

Even if enacted, the proposal will not stop the 21.5% pay cut, effective Jan. 1, 2010, which would affect physicians across the board. The rest of the fee schedule proposal affects physicians differently, depending on their specialty. For example, the proposed rule includes plans to eliminate the use of consultation codes, increase payments for evaluation and management (E&M) services, and update the practice expense component of physician fees based on new survey data.

Under the proposal, the CMS would eliminate the use of all consultation codes except telehealth codes starting Jan. 1. “We believe the rationale for a different payment for a consultation service is no longer supported because documentation requirements are now similar across all E&M services,” the CMS wrote in the proposed rule.

The CMS estimates that the combination of the various proposals would mean a 6%-8% payment increase for primary care physicians, excluding the impact of the 21.5% cut.

Conversely, subspecialists would lose out under the schedule proposal, experiencing either cuts or only small increases.

The combined proposals will result in an average 11% cut in Medicare payments for cardiologists, in part due to the elimination of consultation codes, but also because of practice expense changes based on new survey data. The American College of Cardiology criticized the CMS for proposing significant payment cuts based on a small amount of survey data.

The cuts “are based on the incorporation of a few esoteric pieces of data into a complex formula,” Dr. Alfred Bove, ACC president, said in a statement. “The focus on this formula completely ignores the very important issues of access that are certain to be created by these huge slashes in payment.”

The Obama administration's proposed rule on the 2010 Medicare Physician Fee Schedule addresses increased pay for primary care physicians, decreased pay for specialists, and a way to get rid of the sustainable growth rate formula.

Physicians' organizations have sought repeal of the sustainable growth rate (SGR)—the statutory formula used to set payment rates under Medicare—saying it does not reflect the true cost of care.

One criticism is that the formula counts the price of physician-administered drugs as a physician service. Since the SGR is designed to cut payments when health care expenditures rise above a certain target, the inclusion of drugs has caused physicians to exceed those targets more rapidly.

The removal of physician-administered drugs from the SGR should reduce the number of years that physicians see pay cuts, according to the Centers for Medicare and Medicaid Services. And the American Medical Association is betting that the change will make it less expensive for Congress to repeal the SGR, which would also benefit physicians.

The change is one of several included in the 2010 Medicare Physician Fee Schedule proposed rule, published in the Federal Register on July 13. A final rule is expected in November.

Even if enacted, the proposal will not stop the 21.5% pay cut, effective Jan. 1, 2010, which would affect physicians across the board. The rest of the fee schedule proposal affects physicians differently, depending on their specialty. For example, the proposed rule includes plans to eliminate the use of consultation codes, increase payments for evaluation and management (E&M) services, and update the practice expense component of physician fees based on new survey data.

Under the proposal, the CMS would eliminate the use of all consultation codes except telehealth codes starting Jan. 1. “We believe the rationale for a different payment for a consultation service is no longer supported because documentation requirements are now similar across all E&M services,” the CMS wrote in the proposed rule.

The CMS estimates that the combination of the various proposals would mean a 6%-8% payment increase for primary care physicians, excluding the impact of the 21.5% cut.

Conversely, subspecialists would lose out under the schedule proposal, experiencing either cuts or only small increases.

The combined proposals will result in an average 11% cut in Medicare payments for cardiologists, in part due to the elimination of consultation codes, but also because of practice expense changes based on new survey data. The American College of Cardiology criticized the CMS for proposing significant payment cuts based on a small amount of survey data.

The cuts “are based on the incorporation of a few esoteric pieces of data into a complex formula,” Dr. Alfred Bove, ACC president, said in a statement. “The focus on this formula completely ignores the very important issues of access that are certain to be created by these huge slashes in payment.”

The Obama administration's proposed rule on the 2010 Medicare Physician Fee Schedule addresses increased pay for primary care physicians, decreased pay for specialists, and a way to get rid of the sustainable growth rate formula.

Physicians' organizations have sought repeal of the sustainable growth rate (SGR)—the statutory formula used to set payment rates under Medicare—saying it does not reflect the true cost of care.

One criticism is that the formula counts the price of physician-administered drugs as a physician service. Since the SGR is designed to cut payments when health care expenditures rise above a certain target, the inclusion of drugs has caused physicians to exceed those targets more rapidly.

The removal of physician-administered drugs from the SGR should reduce the number of years that physicians see pay cuts, according to the Centers for Medicare and Medicaid Services. And the American Medical Association is betting that the change will make it less expensive for Congress to repeal the SGR, which would also benefit physicians.

The change is one of several included in the 2010 Medicare Physician Fee Schedule proposed rule, published in the Federal Register on July 13. A final rule is expected in November.

Even if enacted, the proposal will not stop the 21.5% pay cut, effective Jan. 1, 2010, which would affect physicians across the board. The rest of the fee schedule proposal affects physicians differently, depending on their specialty. For example, the proposed rule includes plans to eliminate the use of consultation codes, increase payments for evaluation and management (E&M) services, and update the practice expense component of physician fees based on new survey data.

Under the proposal, the CMS would eliminate the use of all consultation codes except telehealth codes starting Jan. 1. “We believe the rationale for a different payment for a consultation service is no longer supported because documentation requirements are now similar across all E&M services,” the CMS wrote in the proposed rule.

The CMS estimates that the combination of the various proposals would mean a 6%-8% payment increase for primary care physicians, excluding the impact of the 21.5% cut.

Conversely, subspecialists would lose out under the schedule proposal, experiencing either cuts or only small increases.

The combined proposals will result in an average 11% cut in Medicare payments for cardiologists, in part due to the elimination of consultation codes, but also because of practice expense changes based on new survey data. The American College of Cardiology criticized the CMS for proposing significant payment cuts based on a small amount of survey data.

The cuts “are based on the incorporation of a few esoteric pieces of data into a complex formula,” Dr. Alfred Bove, ACC president, said in a statement. “The focus on this formula completely ignores the very important issues of access that are certain to be created by these huge slashes in payment.”

Physicians have a little more than 2 years to complete their transition to new HIPAA X12 standards for submitting administrative transactions electronically, according to Medicare officials.

As of Jan. 1, 2012, physicians and all other entities covered under HIPAA (Health Insurance Portability and Accountability Act) will be required to use the HIPAA X12 version 5010 format when submitting claims, receiving remittances, and sending claim status or eligibility inquiries electronically. The new standard replaces the version 4010A1 currently in use. The change will affect dealings not only with Medicare, but also with all private payers.

The Medicare fee-for-service program will begin its own system testing next year and will begin accepting administrative transactions using the 5010 version as of Jan. 1, 2011. Throughout 2011, the Centers for Medicare and Medicaid Services will accept both the 5010 and 4010A1 versions. However, beginning on Jan. 1, 2012, only transactions submitted using the 5010 version will be accepted.

During a recent conference call to update providers, officials at the Centers for Medicare and Medicaid Services urged physicians not to wait until the last minute to make the transition to the new format.

“There's no room to delay. We cannot possibly convert all of the Medicare trading partners at the 11th hour,” said Christine Stahlecker, who is director of the division of medicare billing procedures in the CMS Office of Information Services.

The switch is necessary, according to the CMS, because the 4010A1 version is outdated. For example, the industry currently relies heavily on companion guides to implement the standards, which limits their value. The new version includes some new functions aimed at improving claims processing, such as resolving ambiguities in the situational rules and providing more consistency across transactions.

But Medicare officials urged physicians to analyze the new version carefully prior to implementation. Billing software will need to be updated, and business processes may need to be changed as well. “There are real changes in these formats,” Ms. Stahlecker said.

A comparison of the current and new formats can be viewed online at www.cms.hhs.gov/ElectronicBillingEDITrans/18_5010D0.asp

Physicians have a little more than 2 years to complete their transition to new HIPAA X12 standards for submitting administrative transactions electronically, according to Medicare officials.

As of Jan. 1, 2012, physicians and all other entities covered under HIPAA (Health Insurance Portability and Accountability Act) will be required to use the HIPAA X12 version 5010 format when submitting claims, receiving remittances, and sending claim status or eligibility inquiries electronically. The new standard replaces the version 4010A1 currently in use. The change will affect dealings not only with Medicare, but also with all private payers.

The Medicare fee-for-service program will begin its own system testing next year and will begin accepting administrative transactions using the 5010 version as of Jan. 1, 2011. Throughout 2011, the Centers for Medicare and Medicaid Services will accept both the 5010 and 4010A1 versions. However, beginning on Jan. 1, 2012, only transactions submitted using the 5010 version will be accepted.

During a recent conference call to update providers, officials at the Centers for Medicare and Medicaid Services urged physicians not to wait until the last minute to make the transition to the new format.

“There's no room to delay. We cannot possibly convert all of the Medicare trading partners at the 11th hour,” said Christine Stahlecker, who is director of the division of medicare billing procedures in the CMS Office of Information Services.

The switch is necessary, according to the CMS, because the 4010A1 version is outdated. For example, the industry currently relies heavily on companion guides to implement the standards, which limits their value. The new version includes some new functions aimed at improving claims processing, such as resolving ambiguities in the situational rules and providing more consistency across transactions.

But Medicare officials urged physicians to analyze the new version carefully prior to implementation. Billing software will need to be updated, and business processes may need to be changed as well. “There are real changes in these formats,” Ms. Stahlecker said.

A comparison of the current and new formats can be viewed online at www.cms.hhs.gov/ElectronicBillingEDITrans/18_5010D0.asp

Physicians have a little more than 2 years to complete their transition to new HIPAA X12 standards for submitting administrative transactions electronically, according to Medicare officials.

As of Jan. 1, 2012, physicians and all other entities covered under HIPAA (Health Insurance Portability and Accountability Act) will be required to use the HIPAA X12 version 5010 format when submitting claims, receiving remittances, and sending claim status or eligibility inquiries electronically. The new standard replaces the version 4010A1 currently in use. The change will affect dealings not only with Medicare, but also with all private payers.

The Medicare fee-for-service program will begin its own system testing next year and will begin accepting administrative transactions using the 5010 version as of Jan. 1, 2011. Throughout 2011, the Centers for Medicare and Medicaid Services will accept both the 5010 and 4010A1 versions. However, beginning on Jan. 1, 2012, only transactions submitted using the 5010 version will be accepted.

During a recent conference call to update providers, officials at the Centers for Medicare and Medicaid Services urged physicians not to wait until the last minute to make the transition to the new format.

“There's no room to delay. We cannot possibly convert all of the Medicare trading partners at the 11th hour,” said Christine Stahlecker, who is director of the division of medicare billing procedures in the CMS Office of Information Services.

The switch is necessary, according to the CMS, because the 4010A1 version is outdated. For example, the industry currently relies heavily on companion guides to implement the standards, which limits their value. The new version includes some new functions aimed at improving claims processing, such as resolving ambiguities in the situational rules and providing more consistency across transactions.

But Medicare officials urged physicians to analyze the new version carefully prior to implementation. Billing software will need to be updated, and business processes may need to be changed as well. “There are real changes in these formats,” Ms. Stahlecker said.

A comparison of the current and new formats can be viewed online at www.cms.hhs.gov/ElectronicBillingEDITrans/18_5010D0.asp