Mary Ellen Schneider

Bill Halts 4.4% Cut

Congress' long-awaited passage of the budget reconciliation package (also called the Deficit Reduction Act) put a freeze on a 4.4% cut Medicare physicians experienced in the month of January. While the congressional action stopped any further reductions to payments, it did not increase Medicare physician pay for 2006. The Centers for Medicare and Medicaid Services will reimburse physicians retroactively for the reductions experienced in January, and has instructed its contractors to automatically reprocess claims. But work on this issue is far from over, Dr. J. Edward Hill, president of the American Medical Association, said in a statement. “With 6 years of cuts still scheduled to come as practice costs continue to rise—we fear more physicians will make difficult practice decisions about treating Medicare patients. … We must build on the momentum and awareness raised in 2005 to make 2006 the year Congress permanently repeals the broken Medicare physician payment formula.” President Bush's fiscal year 2007 budget request to Congress briefly mentioned the impending cuts, although it expounded on CMS's efforts to expand pay-for-performance initiatives to “achieve better outcomes at a lower overall cost.”

Diagnostic Catheterization Coverage

The decision about whether to cover diagnostic catheterization outside of a hospital setting will be left to local Medicare carriers, according to a recent announcement from the Centers for Medicare and Medicaid Services. Previously, CMS policy called for coverage in freestanding clinics with review and approval by Peer Review Organizations—now known as Quality Improvement Organizations. However, those organizations stopped reviewing cardiac catheterization in clinics in 1995. Under the new policy, coverage will be in the hands of local Medicare contractors. While these contractors will have the authority to not cover this procedure in facilities that do not meet locally-set requirements, CMS officials do not expect contractors to establish noncoverage policies, the agency said in its decision memorandum. The change is supported by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions. The two groups submitted joint comments to CMS that despite the lack of oversight by Peer Review Organizations for the past several years, catheterization procedures at freestanding clinics have been performed safely. But in its comments, the American Hospital Association expressed concern that there is a greater risk in performing diagnostic catheterization in the outpatient setting because there are no emergency or cardiac surgery services on site.

AHA's 2006 Priorities

The American Heart Association has announced plans to take on disparities in care in women and minorities, address obesity in children, and lobby for an increase in federal funding for cardiovascular disease research. AHA officials said they plan to urge involvement from their volunteers and supporters in raising awareness of heart disease and stoke. This May, about 600 volunteers from the organization will gather on Capitol Hill for Congressional Heart and Stroke Lobby Day. Specifically, AHA is seeking increased federal funding for the National Institutes of Health and the newly founded Heart and Stroke Division of the Centers for Disease Control and Prevention.

CVD Awareness Rises

More women are aware of cardiovascular disease, and that knowledge is causing them to take positive preventive health steps for themselves and family members, according to a recent study published in the journal Circulation. A survey of more than 1,000 women aged 25 and older found that awareness has nearly doubled since 1997. Of the women who completed the full survey in July 2005, 55% said that heart disease/heart attack is the leading cause of death. This is up from 30% in 1997. In addition, about 54% of women who reported seeing a health care professional on a regular basis said they had discussed their risk of heart disease within the past 6 months. The top reason women cited for not speaking to a physician or other health care professional about heart disease in the last year was that the provider did not bring it up. More than 80% of women surveyed said they had seen, heard, or read information about heart disease in the last year. The researchers reported that those women were “significantly more likely to increase their physical activity, decrease their intake of unhealthy food, and lose weight.”

2007 Medicare Formulary Guidance

The U.S. Pharmacopeia (USP) last month released its final model guidelines for use in developing Medicare prescription drug formularies in 2007. The model guidelines are used by the Centers for Medicare and Medicaid Services to evaluate the formularies created by private drug plans that participate in the Medicare Part D program. There are fewer unique categories and classes in the 2007 document—133 compared with 146 in 2006. In addition, the number of formulary key drug types, which are used by CMS to test the comprehensiveness of the formulary, has been increased from 118 to 141. The final model guidelines eliminate the distinction between nonsteroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors and between selective serotonin reuptake inhibitors and serotonin/norepinephrine reuptake inhibitors. The USP model guidelines are available online at

www.usp.org

Bill Halts 4.4% Cut

Congress' long-awaited passage of the budget reconciliation package (also called the Deficit Reduction Act) put a freeze on a 4.4% cut Medicare physicians experienced in the month of January. While the congressional action stopped any further reductions to payments, it did not increase Medicare physician pay for 2006. The Centers for Medicare and Medicaid Services will reimburse physicians retroactively for the reductions experienced in January, and has instructed its contractors to automatically reprocess claims. But work on this issue is far from over, Dr. J. Edward Hill, president of the American Medical Association, said in a statement. “With 6 years of cuts still scheduled to come as practice costs continue to rise—we fear more physicians will make difficult practice decisions about treating Medicare patients. … We must build on the momentum and awareness raised in 2005 to make 2006 the year Congress permanently repeals the broken Medicare physician payment formula.” President Bush's fiscal year 2007 budget request to Congress briefly mentioned the impending cuts, although it expounded on CMS's efforts to expand pay-for-performance initiatives to “achieve better outcomes at a lower overall cost.”

Diagnostic Catheterization Coverage

The decision about whether to cover diagnostic catheterization outside of a hospital setting will be left to local Medicare carriers, according to a recent announcement from the Centers for Medicare and Medicaid Services. Previously, CMS policy called for coverage in freestanding clinics with review and approval by Peer Review Organizations—now known as Quality Improvement Organizations. However, those organizations stopped reviewing cardiac catheterization in clinics in 1995. Under the new policy, coverage will be in the hands of local Medicare contractors. While these contractors will have the authority to not cover this procedure in facilities that do not meet locally-set requirements, CMS officials do not expect contractors to establish noncoverage policies, the agency said in its decision memorandum. The change is supported by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions. The two groups submitted joint comments to CMS that despite the lack of oversight by Peer Review Organizations for the past several years, catheterization procedures at freestanding clinics have been performed safely. But in its comments, the American Hospital Association expressed concern that there is a greater risk in performing diagnostic catheterization in the outpatient setting because there are no emergency or cardiac surgery services on site.

AHA's 2006 Priorities

The American Heart Association has announced plans to take on disparities in care in women and minorities, address obesity in children, and lobby for an increase in federal funding for cardiovascular disease research. AHA officials said they plan to urge involvement from their volunteers and supporters in raising awareness of heart disease and stoke. This May, about 600 volunteers from the organization will gather on Capitol Hill for Congressional Heart and Stroke Lobby Day. Specifically, AHA is seeking increased federal funding for the National Institutes of Health and the newly founded Heart and Stroke Division of the Centers for Disease Control and Prevention.

CVD Awareness Rises

More women are aware of cardiovascular disease, and that knowledge is causing them to take positive preventive health steps for themselves and family members, according to a recent study published in the journal Circulation. A survey of more than 1,000 women aged 25 and older found that awareness has nearly doubled since 1997. Of the women who completed the full survey in July 2005, 55% said that heart disease/heart attack is the leading cause of death. This is up from 30% in 1997. In addition, about 54% of women who reported seeing a health care professional on a regular basis said they had discussed their risk of heart disease within the past 6 months. The top reason women cited for not speaking to a physician or other health care professional about heart disease in the last year was that the provider did not bring it up. More than 80% of women surveyed said they had seen, heard, or read information about heart disease in the last year. The researchers reported that those women were “significantly more likely to increase their physical activity, decrease their intake of unhealthy food, and lose weight.”

2007 Medicare Formulary Guidance

The U.S. Pharmacopeia (USP) last month released its final model guidelines for use in developing Medicare prescription drug formularies in 2007. The model guidelines are used by the Centers for Medicare and Medicaid Services to evaluate the formularies created by private drug plans that participate in the Medicare Part D program. There are fewer unique categories and classes in the 2007 document—133 compared with 146 in 2006. In addition, the number of formulary key drug types, which are used by CMS to test the comprehensiveness of the formulary, has been increased from 118 to 141. The final model guidelines eliminate the distinction between nonsteroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors and between selective serotonin reuptake inhibitors and serotonin/norepinephrine reuptake inhibitors. The USP model guidelines are available online at

www.usp.org

Bill Halts 4.4% Cut

Congress' long-awaited passage of the budget reconciliation package (also called the Deficit Reduction Act) put a freeze on a 4.4% cut Medicare physicians experienced in the month of January. While the congressional action stopped any further reductions to payments, it did not increase Medicare physician pay for 2006. The Centers for Medicare and Medicaid Services will reimburse physicians retroactively for the reductions experienced in January, and has instructed its contractors to automatically reprocess claims. But work on this issue is far from over, Dr. J. Edward Hill, president of the American Medical Association, said in a statement. “With 6 years of cuts still scheduled to come as practice costs continue to rise—we fear more physicians will make difficult practice decisions about treating Medicare patients. … We must build on the momentum and awareness raised in 2005 to make 2006 the year Congress permanently repeals the broken Medicare physician payment formula.” President Bush's fiscal year 2007 budget request to Congress briefly mentioned the impending cuts, although it expounded on CMS's efforts to expand pay-for-performance initiatives to “achieve better outcomes at a lower overall cost.”

Diagnostic Catheterization Coverage

The decision about whether to cover diagnostic catheterization outside of a hospital setting will be left to local Medicare carriers, according to a recent announcement from the Centers for Medicare and Medicaid Services. Previously, CMS policy called for coverage in freestanding clinics with review and approval by Peer Review Organizations—now known as Quality Improvement Organizations. However, those organizations stopped reviewing cardiac catheterization in clinics in 1995. Under the new policy, coverage will be in the hands of local Medicare contractors. While these contractors will have the authority to not cover this procedure in facilities that do not meet locally-set requirements, CMS officials do not expect contractors to establish noncoverage policies, the agency said in its decision memorandum. The change is supported by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions. The two groups submitted joint comments to CMS that despite the lack of oversight by Peer Review Organizations for the past several years, catheterization procedures at freestanding clinics have been performed safely. But in its comments, the American Hospital Association expressed concern that there is a greater risk in performing diagnostic catheterization in the outpatient setting because there are no emergency or cardiac surgery services on site.

AHA's 2006 Priorities

The American Heart Association has announced plans to take on disparities in care in women and minorities, address obesity in children, and lobby for an increase in federal funding for cardiovascular disease research. AHA officials said they plan to urge involvement from their volunteers and supporters in raising awareness of heart disease and stoke. This May, about 600 volunteers from the organization will gather on Capitol Hill for Congressional Heart and Stroke Lobby Day. Specifically, AHA is seeking increased federal funding for the National Institutes of Health and the newly founded Heart and Stroke Division of the Centers for Disease Control and Prevention.

CVD Awareness Rises

More women are aware of cardiovascular disease, and that knowledge is causing them to take positive preventive health steps for themselves and family members, according to a recent study published in the journal Circulation. A survey of more than 1,000 women aged 25 and older found that awareness has nearly doubled since 1997. Of the women who completed the full survey in July 2005, 55% said that heart disease/heart attack is the leading cause of death. This is up from 30% in 1997. In addition, about 54% of women who reported seeing a health care professional on a regular basis said they had discussed their risk of heart disease within the past 6 months. The top reason women cited for not speaking to a physician or other health care professional about heart disease in the last year was that the provider did not bring it up. More than 80% of women surveyed said they had seen, heard, or read information about heart disease in the last year. The researchers reported that those women were “significantly more likely to increase their physical activity, decrease their intake of unhealthy food, and lose weight.”

2007 Medicare Formulary Guidance

The U.S. Pharmacopeia (USP) last month released its final model guidelines for use in developing Medicare prescription drug formularies in 2007. The model guidelines are used by the Centers for Medicare and Medicaid Services to evaluate the formularies created by private drug plans that participate in the Medicare Part D program. There are fewer unique categories and classes in the 2007 document—133 compared with 146 in 2006. In addition, the number of formulary key drug types, which are used by CMS to test the comprehensiveness of the formulary, has been increased from 118 to 141. The final model guidelines eliminate the distinction between nonsteroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors and between selective serotonin reuptake inhibitors and serotonin/norepinephrine reuptake inhibitors. The USP model guidelines are available online at

www.usp.org

WASHINGTON — Government officials and health information technology leaders plan to spend this year laying the groundwork for a system that would allow for the electronic transfer of ambulatory, emergency department, and laboratory data to public health agencies in less than a day.

Over time, officials would like to implement a real-time nationwide public health monitoring system. “The system we have is simply not adequate,” said Mike Leavitt, secretary of the Health and Human Services department, at a meeting of the American Health Information Community. The United States faces not only the possibility of a bioterrorist attack but also the threat of pandemic, he said.

Mr. Leavitt said he would like to get a “spotty net” of surveillance off the ground quickly by collecting a few key indicators from as many electronic data sources as possible. Getting just two to four basic data points from all available sources would be a “quantum leap forward,” he said.

Information from small- and medium-sized primary care practices will be key to any electronic biosurveillance system, said Dr. David Kibbe, who represented the American Academy of Family Physicians at the meeting. The American Health Information Community is an advisory committee to the Health and Human Services department.

“There is widespread agreement that information technology can substantially improve surveillance both for ongoing public health and for health emergencies,” said Dr. Thomas R. Frieden, commissioner of the New York City Department of Health and Mental Hygiene, who presented information on current electronic surveillance programs at the meeting.

Currently, there is a wide range of biosurveillance activities underway at the federal, state, and local levels, and in the private sector, Dr. Frieden said.

For example, the Centers for Disease Control and Prevention operates the Public Health Information Network, which provides an architecture for public health information technology. Most recently, the agency established the BioSense program, aimed at supporting the connection of clinical care to public health and supporting “situational awareness” at the national level. A number of state and local health departments have begun electronic reporting either from clinical laboratories or clinical information systems.

In New York City, the health department uses electronic reporting data on a daily basis. The system, which has been operating for more than 5 years, collects information from ambulance dispatches, emergency department visits, pharmacy purchases, outpatient visits, and other sources. It also collects free text, allowing officials to evaluate information they might not otherwise have thought about.

Currently, 50 hospitals—representing about 90% of emergency department visits in the city—report daily. The electronic reporting system has proved helpful in the early detection of pockets of influenza. The electronic syndromic system consistently picks up influenza activity 2–3 weeks before any other system.

New York City is not alone. North Carolina has a statewide, hospital-based clinical data monitoring system. It allows for monitoring of real-time inpatient, outpatient, and emergency department data.

But there are major needs that must be addressed to achieve a nationwide system, Dr. John Loonsk of the federal Office of the National Coordinator for Health Information Technology said at the meeting.

For example, data need to be standardized so they can be compared across reporting organizations, privacy and confidentiality must be ensured, and improvements need to be made in the current patchwork of state and local health information technology capability, he said.

In the short term, one area that could be implemented rapidly is the electronic reporting of lab results, Dr. Loonsk said. This has value to public health and for the routine use of clinicians, he said.

Information from small- and medium-sized primary care practices will be key. DR. KIBBE

WASHINGTON — Government officials and health information technology leaders plan to spend this year laying the groundwork for a system that would allow for the electronic transfer of ambulatory, emergency department, and laboratory data to public health agencies in less than a day.

Over time, officials would like to implement a real-time nationwide public health monitoring system. “The system we have is simply not adequate,” said Mike Leavitt, secretary of the Health and Human Services department, at a meeting of the American Health Information Community. The United States faces not only the possibility of a bioterrorist attack but also the threat of pandemic, he said.

Mr. Leavitt said he would like to get a “spotty net” of surveillance off the ground quickly by collecting a few key indicators from as many electronic data sources as possible. Getting just two to four basic data points from all available sources would be a “quantum leap forward,” he said.

Information from small- and medium-sized primary care practices will be key to any electronic biosurveillance system, said Dr. David Kibbe, who represented the American Academy of Family Physicians at the meeting. The American Health Information Community is an advisory committee to the Health and Human Services department.

“There is widespread agreement that information technology can substantially improve surveillance both for ongoing public health and for health emergencies,” said Dr. Thomas R. Frieden, commissioner of the New York City Department of Health and Mental Hygiene, who presented information on current electronic surveillance programs at the meeting.

Currently, there is a wide range of biosurveillance activities underway at the federal, state, and local levels, and in the private sector, Dr. Frieden said.

For example, the Centers for Disease Control and Prevention operates the Public Health Information Network, which provides an architecture for public health information technology. Most recently, the agency established the BioSense program, aimed at supporting the connection of clinical care to public health and supporting “situational awareness” at the national level. A number of state and local health departments have begun electronic reporting either from clinical laboratories or clinical information systems.

In New York City, the health department uses electronic reporting data on a daily basis. The system, which has been operating for more than 5 years, collects information from ambulance dispatches, emergency department visits, pharmacy purchases, outpatient visits, and other sources. It also collects free text, allowing officials to evaluate information they might not otherwise have thought about.

Currently, 50 hospitals—representing about 90% of emergency department visits in the city—report daily. The electronic reporting system has proved helpful in the early detection of pockets of influenza. The electronic syndromic system consistently picks up influenza activity 2–3 weeks before any other system.

New York City is not alone. North Carolina has a statewide, hospital-based clinical data monitoring system. It allows for monitoring of real-time inpatient, outpatient, and emergency department data.

But there are major needs that must be addressed to achieve a nationwide system, Dr. John Loonsk of the federal Office of the National Coordinator for Health Information Technology said at the meeting.

For example, data need to be standardized so they can be compared across reporting organizations, privacy and confidentiality must be ensured, and improvements need to be made in the current patchwork of state and local health information technology capability, he said.

In the short term, one area that could be implemented rapidly is the electronic reporting of lab results, Dr. Loonsk said. This has value to public health and for the routine use of clinicians, he said.

Information from small- and medium-sized primary care practices will be key. DR. KIBBE

WASHINGTON — Government officials and health information technology leaders plan to spend this year laying the groundwork for a system that would allow for the electronic transfer of ambulatory, emergency department, and laboratory data to public health agencies in less than a day.

Over time, officials would like to implement a real-time nationwide public health monitoring system. “The system we have is simply not adequate,” said Mike Leavitt, secretary of the Health and Human Services department, at a meeting of the American Health Information Community. The United States faces not only the possibility of a bioterrorist attack but also the threat of pandemic, he said.

Mr. Leavitt said he would like to get a “spotty net” of surveillance off the ground quickly by collecting a few key indicators from as many electronic data sources as possible. Getting just two to four basic data points from all available sources would be a “quantum leap forward,” he said.

Information from small- and medium-sized primary care practices will be key to any electronic biosurveillance system, said Dr. David Kibbe, who represented the American Academy of Family Physicians at the meeting. The American Health Information Community is an advisory committee to the Health and Human Services department.

“There is widespread agreement that information technology can substantially improve surveillance both for ongoing public health and for health emergencies,” said Dr. Thomas R. Frieden, commissioner of the New York City Department of Health and Mental Hygiene, who presented information on current electronic surveillance programs at the meeting.

Currently, there is a wide range of biosurveillance activities underway at the federal, state, and local levels, and in the private sector, Dr. Frieden said.

For example, the Centers for Disease Control and Prevention operates the Public Health Information Network, which provides an architecture for public health information technology. Most recently, the agency established the BioSense program, aimed at supporting the connection of clinical care to public health and supporting “situational awareness” at the national level. A number of state and local health departments have begun electronic reporting either from clinical laboratories or clinical information systems.

In New York City, the health department uses electronic reporting data on a daily basis. The system, which has been operating for more than 5 years, collects information from ambulance dispatches, emergency department visits, pharmacy purchases, outpatient visits, and other sources. It also collects free text, allowing officials to evaluate information they might not otherwise have thought about.

Currently, 50 hospitals—representing about 90% of emergency department visits in the city—report daily. The electronic reporting system has proved helpful in the early detection of pockets of influenza. The electronic syndromic system consistently picks up influenza activity 2–3 weeks before any other system.

New York City is not alone. North Carolina has a statewide, hospital-based clinical data monitoring system. It allows for monitoring of real-time inpatient, outpatient, and emergency department data.

But there are major needs that must be addressed to achieve a nationwide system, Dr. John Loonsk of the federal Office of the National Coordinator for Health Information Technology said at the meeting.

For example, data need to be standardized so they can be compared across reporting organizations, privacy and confidentiality must be ensured, and improvements need to be made in the current patchwork of state and local health information technology capability, he said.

In the short term, one area that could be implemented rapidly is the electronic reporting of lab results, Dr. Loonsk said. This has value to public health and for the routine use of clinicians, he said.

Information from small- and medium-sized primary care practices will be key. DR. KIBBE

LAS VEGAS — On Jan. 1, Medicare officials implemented a new five-step process for appealing Medicare Part B claims.

The changes apply to Part B initial claim determinations issued and mailed on or after that date, Edward R. Gaines III, senior vice president for compliance and general counsel at Healthcare Business Resources Inc. of Durham, N.C., said at a meeting on reimbursement sponsored by the American College of Emergency Physicians.

The new process includes some significant procedural differences that could benefit physicians, including an opportunity for an independent review earlier in the process, Mr. Gaines said in an interview. The new process includes these steps:

▸ Step 1. The process begins with a “redetermination” of the initial claim decision made by the Part B carrier. The redetermination is also made by the Part B carrier but the appeals decision is made by an employee who was not involved in the initial determination. This is the only step in the process that involves the Part B carrier that made the original decision, Mr. Gaines said.

Physicians have 120 days from the receipt of the notice of initial determination to file an appeal. Mr. Gaines recommended filing all documentation with the letter requesting a redetermination, including case summaries explaining your code selection. Otherwise, the carrier automatically receives up to 14 additional days to its 60-day decision deadline.

▸ Step 2. Providers can appeal the redetermination decision in a step called reconsideration. Physicians have 180 days from the date of receipt of the redetermination to file this appeal with the Qualified Independent Contractor (QIC) indicated in the Part B carrier letter.

The redetermination step replaces the old “fair hearing” process. The old process was frequently criticized since the fair hearing officer usually had close ties to the Part B carrier that made the original decision, Mr. Gaines said.

He recommended submitting all relevant evidence in support of the claim when the notice of reconsideration is submitted because this is a new review and the QIC will not consider what the carrier ruled previously.

QICs are bound by Medicare national coverage decisions, CMS rulings, laws, and federal regulations. But they are not bound by other documents including local coverage decisions, program guidance, or manual instructions, he said. The reconsideration decision is rendered within 60 days under the appeals process.

▸ Step 3. A hearing with an administrative law judge is held in person, by video, or by telephone. Otherwise, the administrative law judge (ALJ) will base his or her decision on the written record. To have an ALJ review the appeal, submit a written request within 60 days of the reconsideration notice. At this level of the appeal, at least $110 must be in dispute.

In order to get an in-person hearing, physicians must make that request before the hearing date is set and explain why a telephone or video hearing is not acceptable, Mr. Gaines said. Consider obtaining legal counsel at this point in the process, Mr. Gaines advised.

▸ Step 4. If still not satisfied, a provider may appeal to the Medicare Appeals Council. This must be done within 60 days from the receipt of the ALJ decision. The Medicare Appeals Council is another addition to the process. Previously, physicians who wanted to appeal a decision beyond the ALJ would have to go to federal district court, and few physicians took that step, Mr. Gaines said.

There is no right to a hearing before the council but physicians can request an oral argument. In addition, parties to the appeal can file briefs.

▸ Step 5. The final appeal is to the federal district court. This must be filed within 60 days of the Medicare Appeals Council decision. The case may be filed in the U.S. District Court where the appealing physician resides. At this step in the process, at least $1,090 must still be in dispute.

LAS VEGAS — On Jan. 1, Medicare officials implemented a new five-step process for appealing Medicare Part B claims.

The changes apply to Part B initial claim determinations issued and mailed on or after that date, Edward R. Gaines III, senior vice president for compliance and general counsel at Healthcare Business Resources Inc. of Durham, N.C., said at a meeting on reimbursement sponsored by the American College of Emergency Physicians.

The new process includes some significant procedural differences that could benefit physicians, including an opportunity for an independent review earlier in the process, Mr. Gaines said in an interview. The new process includes these steps:

▸ Step 1. The process begins with a “redetermination” of the initial claim decision made by the Part B carrier. The redetermination is also made by the Part B carrier but the appeals decision is made by an employee who was not involved in the initial determination. This is the only step in the process that involves the Part B carrier that made the original decision, Mr. Gaines said.

Physicians have 120 days from the receipt of the notice of initial determination to file an appeal. Mr. Gaines recommended filing all documentation with the letter requesting a redetermination, including case summaries explaining your code selection. Otherwise, the carrier automatically receives up to 14 additional days to its 60-day decision deadline.

▸ Step 2. Providers can appeal the redetermination decision in a step called reconsideration. Physicians have 180 days from the date of receipt of the redetermination to file this appeal with the Qualified Independent Contractor (QIC) indicated in the Part B carrier letter.

The redetermination step replaces the old “fair hearing” process. The old process was frequently criticized since the fair hearing officer usually had close ties to the Part B carrier that made the original decision, Mr. Gaines said.

He recommended submitting all relevant evidence in support of the claim when the notice of reconsideration is submitted because this is a new review and the QIC will not consider what the carrier ruled previously.

QICs are bound by Medicare national coverage decisions, CMS rulings, laws, and federal regulations. But they are not bound by other documents including local coverage decisions, program guidance, or manual instructions, he said. The reconsideration decision is rendered within 60 days under the appeals process.

▸ Step 3. A hearing with an administrative law judge is held in person, by video, or by telephone. Otherwise, the administrative law judge (ALJ) will base his or her decision on the written record. To have an ALJ review the appeal, submit a written request within 60 days of the reconsideration notice. At this level of the appeal, at least $110 must be in dispute.

In order to get an in-person hearing, physicians must make that request before the hearing date is set and explain why a telephone or video hearing is not acceptable, Mr. Gaines said. Consider obtaining legal counsel at this point in the process, Mr. Gaines advised.

▸ Step 4. If still not satisfied, a provider may appeal to the Medicare Appeals Council. This must be done within 60 days from the receipt of the ALJ decision. The Medicare Appeals Council is another addition to the process. Previously, physicians who wanted to appeal a decision beyond the ALJ would have to go to federal district court, and few physicians took that step, Mr. Gaines said.

There is no right to a hearing before the council but physicians can request an oral argument. In addition, parties to the appeal can file briefs.

▸ Step 5. The final appeal is to the federal district court. This must be filed within 60 days of the Medicare Appeals Council decision. The case may be filed in the U.S. District Court where the appealing physician resides. At this step in the process, at least $1,090 must still be in dispute.

LAS VEGAS — On Jan. 1, Medicare officials implemented a new five-step process for appealing Medicare Part B claims.

The changes apply to Part B initial claim determinations issued and mailed on or after that date, Edward R. Gaines III, senior vice president for compliance and general counsel at Healthcare Business Resources Inc. of Durham, N.C., said at a meeting on reimbursement sponsored by the American College of Emergency Physicians.

The new process includes some significant procedural differences that could benefit physicians, including an opportunity for an independent review earlier in the process, Mr. Gaines said in an interview. The new process includes these steps:

▸ Step 1. The process begins with a “redetermination” of the initial claim decision made by the Part B carrier. The redetermination is also made by the Part B carrier but the appeals decision is made by an employee who was not involved in the initial determination. This is the only step in the process that involves the Part B carrier that made the original decision, Mr. Gaines said.

Physicians have 120 days from the receipt of the notice of initial determination to file an appeal. Mr. Gaines recommended filing all documentation with the letter requesting a redetermination, including case summaries explaining your code selection. Otherwise, the carrier automatically receives up to 14 additional days to its 60-day decision deadline.

▸ Step 2. Providers can appeal the redetermination decision in a step called reconsideration. Physicians have 180 days from the date of receipt of the redetermination to file this appeal with the Qualified Independent Contractor (QIC) indicated in the Part B carrier letter.

The redetermination step replaces the old “fair hearing” process. The old process was frequently criticized since the fair hearing officer usually had close ties to the Part B carrier that made the original decision, Mr. Gaines said.

He recommended submitting all relevant evidence in support of the claim when the notice of reconsideration is submitted because this is a new review and the QIC will not consider what the carrier ruled previously.

QICs are bound by Medicare national coverage decisions, CMS rulings, laws, and federal regulations. But they are not bound by other documents including local coverage decisions, program guidance, or manual instructions, he said. The reconsideration decision is rendered within 60 days under the appeals process.

▸ Step 3. A hearing with an administrative law judge is held in person, by video, or by telephone. Otherwise, the administrative law judge (ALJ) will base his or her decision on the written record. To have an ALJ review the appeal, submit a written request within 60 days of the reconsideration notice. At this level of the appeal, at least $110 must be in dispute.

In order to get an in-person hearing, physicians must make that request before the hearing date is set and explain why a telephone or video hearing is not acceptable, Mr. Gaines said. Consider obtaining legal counsel at this point in the process, Mr. Gaines advised.

▸ Step 4. If still not satisfied, a provider may appeal to the Medicare Appeals Council. This must be done within 60 days from the receipt of the ALJ decision. The Medicare Appeals Council is another addition to the process. Previously, physicians who wanted to appeal a decision beyond the ALJ would have to go to federal district court, and few physicians took that step, Mr. Gaines said.

There is no right to a hearing before the council but physicians can request an oral argument. In addition, parties to the appeal can file briefs.

▸ Step 5. The final appeal is to the federal district court. This must be filed within 60 days of the Medicare Appeals Council decision. The case may be filed in the U.S. District Court where the appealing physician resides. At this step in the process, at least $1,090 must still be in dispute.

LAS VEGAS – On Jan. 1, Medicare officials implemented a new five-step process for appealing Medicare Part B claims.

The changes apply to Part B initial claim determinations issued and mailed on or after that date, Edward R. Gaines III, senior vice president for compliance and general counsel at Healthcare Business Resources, Inc. of Durham, N.C., said at a meeting on reimbursement sponsored by the American College of Emergency Physicians.

The new process includes some significant procedural differences that could benefit physicians, including an opportunity for an independent review earlier in the process, Mr. Gaines said in an interview. The new process includes these steps:

▸ Step 1. The process begins with a “redetermination” of the initial claim decision made by the Part B carrier. The redetermination is also made by the Part B carrier but the appeals decision is made by an employee who was not involved in the initial determination. This is the only step that involves the Part B carrier that made the original decision, Mr. Gaines said.

Physicians have 120 days from the receipt of the notice of initial determination to file an appeal. Mr. Gaines recommended filing all documentation with the letter requesting a redetermination, including case summaries explaining your code selection. Otherwise, the carrier automatically receives up to 14 additional days to its 60-day decision deadline.

▸ Step 2. Providers can appeal the redetermination decision in a step called reconsideration. Physicians have 180 days from the date of receipt of the redetermination to file this appeal with the Qualified Independent Contractor (QIC) indicated in the Part B carrier letter. The redetermination step replaces the old “fair hearing” process. The old process was frequently criticized since the fair hearing officer usually had close ties to the Part B carrier that made the original decision, Mr. Gaines said.

He recommended submitting all relevant evidence in support of the claim when the notice of reconsideration is submitted because this is a new review and the QIC will not consider the previous ruling.

QICs are bound by Medicare national coverage decisions, CMS rulings, laws, and federal regulations. But they are not bound by other documents including local coverage decisions, program guidance, or manual instructions, he said. The reconsideration decision is rendered within 60 days under the appeals process.

▸ Step 3. A hearing with an administrative law judge is held in person, by video, or by telephone. Otherwise, the administrative law judge (ALJ) will base his or her decision on the written record. To have an ALJ review the appeal, submit a written request within 60 days of the reconsideration notice. At this level of the appeal, at least $110 must be in dispute.

In order to get an in-person hearing, physicians must make that request before the hearing date is set and explain why a telephone or video hearing is not acceptable, Mr. Gaines said. Consider obtaining legal counsel at this point in the process, Mr. Gaines advised.

▸ Step 4. If still not satisfied, a provider may appeal to the Medicare Appeals Council. This must be done within 60 days from the receipt of the ALJ decision. The Medicare Appeals Council is another addition to the process. Previously, physicians who wanted to appeal a decision beyond the ALJ would have to go to federal district court, and few physicians took that step, Mr. Gaines said.

There is no right to a hearing before the council but physicians can request an oral argument. In addition, parties to the appeal can file briefs.

▸ Step 5. The final appeal is to the federal district court. This must be filed within 60 days of the Medicare Appeals Council decision. The case may be filed in the U.S. District Court where the appealing physician resides. At this step in the process, at least $1,090 must still be in dispute.

Since the new process applies only to initial claims determinations issued and mailed on or after Jan. 1, it will take several months to evaluate how the new process works for physicians, Mr. Gaines said.

LAS VEGAS – On Jan. 1, Medicare officials implemented a new five-step process for appealing Medicare Part B claims.

The changes apply to Part B initial claim determinations issued and mailed on or after that date, Edward R. Gaines III, senior vice president for compliance and general counsel at Healthcare Business Resources, Inc. of Durham, N.C., said at a meeting on reimbursement sponsored by the American College of Emergency Physicians.

The new process includes some significant procedural differences that could benefit physicians, including an opportunity for an independent review earlier in the process, Mr. Gaines said in an interview. The new process includes these steps:

▸ Step 1. The process begins with a “redetermination” of the initial claim decision made by the Part B carrier. The redetermination is also made by the Part B carrier but the appeals decision is made by an employee who was not involved in the initial determination. This is the only step that involves the Part B carrier that made the original decision, Mr. Gaines said.

Physicians have 120 days from the receipt of the notice of initial determination to file an appeal. Mr. Gaines recommended filing all documentation with the letter requesting a redetermination, including case summaries explaining your code selection. Otherwise, the carrier automatically receives up to 14 additional days to its 60-day decision deadline.

▸ Step 2. Providers can appeal the redetermination decision in a step called reconsideration. Physicians have 180 days from the date of receipt of the redetermination to file this appeal with the Qualified Independent Contractor (QIC) indicated in the Part B carrier letter. The redetermination step replaces the old “fair hearing” process. The old process was frequently criticized since the fair hearing officer usually had close ties to the Part B carrier that made the original decision, Mr. Gaines said.

He recommended submitting all relevant evidence in support of the claim when the notice of reconsideration is submitted because this is a new review and the QIC will not consider the previous ruling.

QICs are bound by Medicare national coverage decisions, CMS rulings, laws, and federal regulations. But they are not bound by other documents including local coverage decisions, program guidance, or manual instructions, he said. The reconsideration decision is rendered within 60 days under the appeals process.

▸ Step 3. A hearing with an administrative law judge is held in person, by video, or by telephone. Otherwise, the administrative law judge (ALJ) will base his or her decision on the written record. To have an ALJ review the appeal, submit a written request within 60 days of the reconsideration notice. At this level of the appeal, at least $110 must be in dispute.

In order to get an in-person hearing, physicians must make that request before the hearing date is set and explain why a telephone or video hearing is not acceptable, Mr. Gaines said. Consider obtaining legal counsel at this point in the process, Mr. Gaines advised.

▸ Step 4. If still not satisfied, a provider may appeal to the Medicare Appeals Council. This must be done within 60 days from the receipt of the ALJ decision. The Medicare Appeals Council is another addition to the process. Previously, physicians who wanted to appeal a decision beyond the ALJ would have to go to federal district court, and few physicians took that step, Mr. Gaines said.

There is no right to a hearing before the council but physicians can request an oral argument. In addition, parties to the appeal can file briefs.

▸ Step 5. The final appeal is to the federal district court. This must be filed within 60 days of the Medicare Appeals Council decision. The case may be filed in the U.S. District Court where the appealing physician resides. At this step in the process, at least $1,090 must still be in dispute.

Since the new process applies only to initial claims determinations issued and mailed on or after Jan. 1, it will take several months to evaluate how the new process works for physicians, Mr. Gaines said.

LAS VEGAS – On Jan. 1, Medicare officials implemented a new five-step process for appealing Medicare Part B claims.

The changes apply to Part B initial claim determinations issued and mailed on or after that date, Edward R. Gaines III, senior vice president for compliance and general counsel at Healthcare Business Resources, Inc. of Durham, N.C., said at a meeting on reimbursement sponsored by the American College of Emergency Physicians.

The new process includes some significant procedural differences that could benefit physicians, including an opportunity for an independent review earlier in the process, Mr. Gaines said in an interview. The new process includes these steps:

▸ Step 1. The process begins with a “redetermination” of the initial claim decision made by the Part B carrier. The redetermination is also made by the Part B carrier but the appeals decision is made by an employee who was not involved in the initial determination. This is the only step that involves the Part B carrier that made the original decision, Mr. Gaines said.

Physicians have 120 days from the receipt of the notice of initial determination to file an appeal. Mr. Gaines recommended filing all documentation with the letter requesting a redetermination, including case summaries explaining your code selection. Otherwise, the carrier automatically receives up to 14 additional days to its 60-day decision deadline.

▸ Step 2. Providers can appeal the redetermination decision in a step called reconsideration. Physicians have 180 days from the date of receipt of the redetermination to file this appeal with the Qualified Independent Contractor (QIC) indicated in the Part B carrier letter. The redetermination step replaces the old “fair hearing” process. The old process was frequently criticized since the fair hearing officer usually had close ties to the Part B carrier that made the original decision, Mr. Gaines said.

He recommended submitting all relevant evidence in support of the claim when the notice of reconsideration is submitted because this is a new review and the QIC will not consider the previous ruling.

QICs are bound by Medicare national coverage decisions, CMS rulings, laws, and federal regulations. But they are not bound by other documents including local coverage decisions, program guidance, or manual instructions, he said. The reconsideration decision is rendered within 60 days under the appeals process.

▸ Step 3. A hearing with an administrative law judge is held in person, by video, or by telephone. Otherwise, the administrative law judge (ALJ) will base his or her decision on the written record. To have an ALJ review the appeal, submit a written request within 60 days of the reconsideration notice. At this level of the appeal, at least $110 must be in dispute.

In order to get an in-person hearing, physicians must make that request before the hearing date is set and explain why a telephone or video hearing is not acceptable, Mr. Gaines said. Consider obtaining legal counsel at this point in the process, Mr. Gaines advised.

▸ Step 4. If still not satisfied, a provider may appeal to the Medicare Appeals Council. This must be done within 60 days from the receipt of the ALJ decision. The Medicare Appeals Council is another addition to the process. Previously, physicians who wanted to appeal a decision beyond the ALJ would have to go to federal district court, and few physicians took that step, Mr. Gaines said.

There is no right to a hearing before the council but physicians can request an oral argument. In addition, parties to the appeal can file briefs.

▸ Step 5. The final appeal is to the federal district court. This must be filed within 60 days of the Medicare Appeals Council decision. The case may be filed in the U.S. District Court where the appealing physician resides. At this step in the process, at least $1,090 must still be in dispute.

Since the new process applies only to initial claims determinations issued and mailed on or after Jan. 1, it will take several months to evaluate how the new process works for physicians, Mr. Gaines said.

LAS VEGAS – Proper documentation is key to an effective corporate compliance program and can serve as evidence of a good-faith program to investigators, one compliance expert said at a meeting on reimbursement sponsored by the American College of Emergency Physicians.

Documentation should include the group's compliance policies and procedures, training, and any compliance issues and the resolution, said Edward R. Gaines III, senior vice president for compliance and general counsel for Healthcare Business Resources Inc. of Durham, N.C.

But documentation can be a double-edged sword if it's inaccurate when it's created or if it has been manipulated to pass an audit, Mr. Gaines said.

The Health and Human Services Department Office of Inspector General outlines seven elements of an effective corporate compliance program:

▸ Compliance standards and policies

▸ Oversight

▸ Education and training

▸ Effective lines of communication

▸ Monitoring and auditing

▸ Enforcement and discipline

▸ Response and prevention

Another important element of a compliance program is the ability to prevent and detect fraud and abuse, Mr. Gaines said.

Implementing a corporate compliance program will mitigate the risk of potential liability, Mr. Gaines said.

Penalties under the Federal False Claims Act are possible as well. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) expanded the federal False Claims Act to all payers including commercial claims. And the government does not need proof of intent to take action. Physicians are liable for knowingly allowing or encouraging false claim submission, being deliberately ignorant, or having a reckless disregard for the truth, according to the HIPAA law.

In addition, even if the physician is not responsible for performing the billing and coding, he or she is liable if the claim is submitted in the physician's name.

The stakes in compliance are high, Mr. Gaines said. For example, in a two-hospital system with 100,000 annual visits and a 30% Medicare/Medicaid mix, if 0.1% of the claims from those 30,000 Medicare/Medicaid visits have compliance issues, that translates into a minimum of $16.5 million in penalties. If there was a finding of intentional bad conduct, that penalty is closer to $33 million.

Don't forget to account for attorney's fees, bad press, a loss of contracts, poor employee morale, and private payer audits, he said. And commercial payers do pay attention to what happens on the government side, he said.

Mr. Gaines advised physicians to start at the top by getting a commitment to the compliance program from senior level executives in the organization.

“One of the [places] where compliance programs frequently fail is that they don't have clear leadership from the top,” he said.

Create an environment where physicians and staff members are free to question without fear of retribution or retaliation. And groups should be willing to bring issues to resolution even if it takes years, Mr. Gaines said.

Some of the risk areas to address when creating a comprehensive compliance program include the role of nonphysician providers; teaching physicians and residents; coding for critical care, x-rays, and EKGs; and computer programs that provide instantaneous feedback for coding or billing purposes.

On the back end, discounts or copay waivers and secondary payer issues also must be taken into account, Mr. Gaines said.

Medicare contractors and other auditors will use data analysis to detect aberrant billing practices.

The auditors tend to rely on comparative billing reports that examine providers of the same specialty in a given area. The auditor might also look at increases in critical care utilization versus historical trends for the group, for example.

But physician groups can be prepared, Mr. Gaines said, by considering why their E/M coding and billing data might be different from CMS national or Medicare carrier data.

For example, higher coding could result from features such as the presence of urgent care facilities or clinics in close proximity to the emergency department, admission criteria, emergency medical service preference, or the presence of a nursing home nearby or on the hospital campus, he said.

LAS VEGAS – Proper documentation is key to an effective corporate compliance program and can serve as evidence of a good-faith program to investigators, one compliance expert said at a meeting on reimbursement sponsored by the American College of Emergency Physicians.

Documentation should include the group's compliance policies and procedures, training, and any compliance issues and the resolution, said Edward R. Gaines III, senior vice president for compliance and general counsel for Healthcare Business Resources Inc. of Durham, N.C.

But documentation can be a double-edged sword if it's inaccurate when it's created or if it has been manipulated to pass an audit, Mr. Gaines said.

The Health and Human Services Department Office of Inspector General outlines seven elements of an effective corporate compliance program:

▸ Compliance standards and policies

▸ Oversight

▸ Education and training

▸ Effective lines of communication

▸ Monitoring and auditing

▸ Enforcement and discipline

▸ Response and prevention

Another important element of a compliance program is the ability to prevent and detect fraud and abuse, Mr. Gaines said.

Implementing a corporate compliance program will mitigate the risk of potential liability, Mr. Gaines said.

Penalties under the Federal False Claims Act are possible as well. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) expanded the federal False Claims Act to all payers including commercial claims. And the government does not need proof of intent to take action. Physicians are liable for knowingly allowing or encouraging false claim submission, being deliberately ignorant, or having a reckless disregard for the truth, according to the HIPAA law.

In addition, even if the physician is not responsible for performing the billing and coding, he or she is liable if the claim is submitted in the physician's name.

The stakes in compliance are high, Mr. Gaines said. For example, in a two-hospital system with 100,000 annual visits and a 30% Medicare/Medicaid mix, if 0.1% of the claims from those 30,000 Medicare/Medicaid visits have compliance issues, that translates into a minimum of $16.5 million in penalties. If there was a finding of intentional bad conduct, that penalty is closer to $33 million.

Don't forget to account for attorney's fees, bad press, a loss of contracts, poor employee morale, and private payer audits, he said. And commercial payers do pay attention to what happens on the government side, he said.

Mr. Gaines advised physicians to start at the top by getting a commitment to the compliance program from senior level executives in the organization.

“One of the [places] where compliance programs frequently fail is that they don't have clear leadership from the top,” he said.

Create an environment where physicians and staff members are free to question without fear of retribution or retaliation. And groups should be willing to bring issues to resolution even if it takes years, Mr. Gaines said.

Some of the risk areas to address when creating a comprehensive compliance program include the role of nonphysician providers; teaching physicians and residents; coding for critical care, x-rays, and EKGs; and computer programs that provide instantaneous feedback for coding or billing purposes.

On the back end, discounts or copay waivers and secondary payer issues also must be taken into account, Mr. Gaines said.

Medicare contractors and other auditors will use data analysis to detect aberrant billing practices.

The auditors tend to rely on comparative billing reports that examine providers of the same specialty in a given area. The auditor might also look at increases in critical care utilization versus historical trends for the group, for example.

But physician groups can be prepared, Mr. Gaines said, by considering why their E/M coding and billing data might be different from CMS national or Medicare carrier data.

For example, higher coding could result from features such as the presence of urgent care facilities or clinics in close proximity to the emergency department, admission criteria, emergency medical service preference, or the presence of a nursing home nearby or on the hospital campus, he said.

LAS VEGAS – Proper documentation is key to an effective corporate compliance program and can serve as evidence of a good-faith program to investigators, one compliance expert said at a meeting on reimbursement sponsored by the American College of Emergency Physicians.

Documentation should include the group's compliance policies and procedures, training, and any compliance issues and the resolution, said Edward R. Gaines III, senior vice president for compliance and general counsel for Healthcare Business Resources Inc. of Durham, N.C.

But documentation can be a double-edged sword if it's inaccurate when it's created or if it has been manipulated to pass an audit, Mr. Gaines said.

The Health and Human Services Department Office of Inspector General outlines seven elements of an effective corporate compliance program:

▸ Compliance standards and policies

▸ Oversight

▸ Education and training

▸ Effective lines of communication

▸ Monitoring and auditing

▸ Enforcement and discipline

▸ Response and prevention

Another important element of a compliance program is the ability to prevent and detect fraud and abuse, Mr. Gaines said.

Implementing a corporate compliance program will mitigate the risk of potential liability, Mr. Gaines said.

Penalties under the Federal False Claims Act are possible as well. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) expanded the federal False Claims Act to all payers including commercial claims. And the government does not need proof of intent to take action. Physicians are liable for knowingly allowing or encouraging false claim submission, being deliberately ignorant, or having a reckless disregard for the truth, according to the HIPAA law.

In addition, even if the physician is not responsible for performing the billing and coding, he or she is liable if the claim is submitted in the physician's name.

The stakes in compliance are high, Mr. Gaines said. For example, in a two-hospital system with 100,000 annual visits and a 30% Medicare/Medicaid mix, if 0.1% of the claims from those 30,000 Medicare/Medicaid visits have compliance issues, that translates into a minimum of $16.5 million in penalties. If there was a finding of intentional bad conduct, that penalty is closer to $33 million.

Don't forget to account for attorney's fees, bad press, a loss of contracts, poor employee morale, and private payer audits, he said. And commercial payers do pay attention to what happens on the government side, he said.

Mr. Gaines advised physicians to start at the top by getting a commitment to the compliance program from senior level executives in the organization.

“One of the [places] where compliance programs frequently fail is that they don't have clear leadership from the top,” he said.

Create an environment where physicians and staff members are free to question without fear of retribution or retaliation. And groups should be willing to bring issues to resolution even if it takes years, Mr. Gaines said.

Some of the risk areas to address when creating a comprehensive compliance program include the role of nonphysician providers; teaching physicians and residents; coding for critical care, x-rays, and EKGs; and computer programs that provide instantaneous feedback for coding or billing purposes.

On the back end, discounts or copay waivers and secondary payer issues also must be taken into account, Mr. Gaines said.

Medicare contractors and other auditors will use data analysis to detect aberrant billing practices.

The auditors tend to rely on comparative billing reports that examine providers of the same specialty in a given area. The auditor might also look at increases in critical care utilization versus historical trends for the group, for example.

But physician groups can be prepared, Mr. Gaines said, by considering why their E/M coding and billing data might be different from CMS national or Medicare carrier data.

For example, higher coding could result from features such as the presence of urgent care facilities or clinics in close proximity to the emergency department, admission criteria, emergency medical service preference, or the presence of a nursing home nearby or on the hospital campus, he said.

Researchers now have a pathway for conducting early clinical testing of drugs in a small number of human subjects under new guidance from the Food and Drug Administration.

Officials at the FDA finalized guidance on exploratory investigational new drug (IND) studies which allows researchers to move forward with small human studies before beginning traditional phase I safety testing in humans. The guidance, published in January, makes recommendations on safety testing, manufacturing, and clinical approaches in these early studies.

The FDA also published draft guidance and a direct final rule in January that outlines new standards for the manufacture of drugs solely for use in phase I studies. The rule is aimed at making it easier for scientists to produce small quantities of drugs for small-scale, early-phase human testing.

“This is about saving lives and about building medicine's future,” said Dr. Andrew von Eschenbach, acting FDA Commissioner of Food and Drugs.

Currently, less than 10% of IND applications for new molecular entities progress beyond the investigational stage, according to the FDA. These changes will remove some of the hurdles from very early drug development, Dr. von Eschenbach said during a media teleconference sponsored by the FDA.

But critics of the approach say it relaxes needed human subjects protections at a time when the safety of clinical trials is already being questioned.

In guidance on the exploratory IND, FDA officials outline their thinking that drug sponsors have not taken full advantage of the flexibility in the existing regulations and often provide more supporting information than is required.

Exploratory IND studies involve administering either a subpharmacologic dose of a product or doses that are expected to produce a pharmacologic but not a toxic effect, so the risk to human subjects is considered lower than in a traditional phase I study, FDA said in its guidance documents. Since exploratory IND studies pose fewer risks, they can be initiated in humans with less, or different, preclinical support than what is required for traditional IND studies.

Previously, one of the major obstacles in the development of new drugs was that the requirements for beginning early experimental studies were the same as those for large pharmaceutical companies who are making drugs for thousands of patients, Dr. Steven Rosenberg, chief of surgery at the National Cancer Institute, said during the teleconference.

“We've been at the mercy of large biotech and pharmaceutical companies who have the resources to fulfill the very stringent regulations that exist for taking these new products to very large numbers of patients,” he said.

The changes made by the FDA will make it possible for scientists to take new ideas to small numbers of patients with desperate diseases and test those agents in ways that weren't possible before, he said.

But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said he remains concerned that the usual protection for human subjects has been “watered down.” Under the new process, a safety problem that might have been detected through more extensive animal studies now may be missed, he said.

And he is doubtful of the benefits. Dr. Wolfe said the types of studies described in the exploratory IND are already being done but with the previous protections in place for human subjects.

Sen. Charles Grassley (R-Iowa), chairman of the Senate Committee on Finance, which has been conducting oversight of the FDA's consumer protections, also expressed safety concerns: “At a time when new questions are being raised about whether participants in clinical trials are protected and treated ethically, the FDA is loosening the reins on drug companies.”

Researchers now have a pathway for conducting early clinical testing of drugs in a small number of human subjects under new guidance from the Food and Drug Administration.

Officials at the FDA finalized guidance on exploratory investigational new drug (IND) studies which allows researchers to move forward with small human studies before beginning traditional phase I safety testing in humans. The guidance, published in January, makes recommendations on safety testing, manufacturing, and clinical approaches in these early studies.

The FDA also published draft guidance and a direct final rule in January that outlines new standards for the manufacture of drugs solely for use in phase I studies. The rule is aimed at making it easier for scientists to produce small quantities of drugs for small-scale, early-phase human testing.

“This is about saving lives and about building medicine's future,” said Dr. Andrew von Eschenbach, acting FDA Commissioner of Food and Drugs.

Currently, less than 10% of IND applications for new molecular entities progress beyond the investigational stage, according to the FDA. These changes will remove some of the hurdles from very early drug development, Dr. von Eschenbach said during a media teleconference sponsored by the FDA.

But critics of the approach say it relaxes needed human subjects protections at a time when the safety of clinical trials is already being questioned.

In guidance on the exploratory IND, FDA officials outline their thinking that drug sponsors have not taken full advantage of the flexibility in the existing regulations and often provide more supporting information than is required.

Exploratory IND studies involve administering either a subpharmacologic dose of a product or doses that are expected to produce a pharmacologic but not a toxic effect, so the risk to human subjects is considered lower than in a traditional phase I study, FDA said in its guidance documents. Since exploratory IND studies pose fewer risks, they can be initiated in humans with less, or different, preclinical support than what is required for traditional IND studies.

Previously, one of the major obstacles in the development of new drugs was that the requirements for beginning early experimental studies were the same as those for large pharmaceutical companies who are making drugs for thousands of patients, Dr. Steven Rosenberg, chief of surgery at the National Cancer Institute, said during the teleconference.

“We've been at the mercy of large biotech and pharmaceutical companies who have the resources to fulfill the very stringent regulations that exist for taking these new products to very large numbers of patients,” he said.

The changes made by the FDA will make it possible for scientists to take new ideas to small numbers of patients with desperate diseases and test those agents in ways that weren't possible before, he said.

But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said he remains concerned that the usual protection for human subjects has been “watered down.” Under the new process, a safety problem that might have been detected through more extensive animal studies now may be missed, he said.

And he is doubtful of the benefits. Dr. Wolfe said the types of studies described in the exploratory IND are already being done but with the previous protections in place for human subjects.

Sen. Charles Grassley (R-Iowa), chairman of the Senate Committee on Finance, which has been conducting oversight of the FDA's consumer protections, also expressed safety concerns: “At a time when new questions are being raised about whether participants in clinical trials are protected and treated ethically, the FDA is loosening the reins on drug companies.”

Researchers now have a pathway for conducting early clinical testing of drugs in a small number of human subjects under new guidance from the Food and Drug Administration.

Officials at the FDA finalized guidance on exploratory investigational new drug (IND) studies which allows researchers to move forward with small human studies before beginning traditional phase I safety testing in humans. The guidance, published in January, makes recommendations on safety testing, manufacturing, and clinical approaches in these early studies.

The FDA also published draft guidance and a direct final rule in January that outlines new standards for the manufacture of drugs solely for use in phase I studies. The rule is aimed at making it easier for scientists to produce small quantities of drugs for small-scale, early-phase human testing.

“This is about saving lives and about building medicine's future,” said Dr. Andrew von Eschenbach, acting FDA Commissioner of Food and Drugs.

Currently, less than 10% of IND applications for new molecular entities progress beyond the investigational stage, according to the FDA. These changes will remove some of the hurdles from very early drug development, Dr. von Eschenbach said during a media teleconference sponsored by the FDA.

But critics of the approach say it relaxes needed human subjects protections at a time when the safety of clinical trials is already being questioned.

In guidance on the exploratory IND, FDA officials outline their thinking that drug sponsors have not taken full advantage of the flexibility in the existing regulations and often provide more supporting information than is required.

Exploratory IND studies involve administering either a subpharmacologic dose of a product or doses that are expected to produce a pharmacologic but not a toxic effect, so the risk to human subjects is considered lower than in a traditional phase I study, FDA said in its guidance documents. Since exploratory IND studies pose fewer risks, they can be initiated in humans with less, or different, preclinical support than what is required for traditional IND studies.

Previously, one of the major obstacles in the development of new drugs was that the requirements for beginning early experimental studies were the same as those for large pharmaceutical companies who are making drugs for thousands of patients, Dr. Steven Rosenberg, chief of surgery at the National Cancer Institute, said during the teleconference.

“We've been at the mercy of large biotech and pharmaceutical companies who have the resources to fulfill the very stringent regulations that exist for taking these new products to very large numbers of patients,” he said.

The changes made by the FDA will make it possible for scientists to take new ideas to small numbers of patients with desperate diseases and test those agents in ways that weren't possible before, he said.

But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said he remains concerned that the usual protection for human subjects has been “watered down.” Under the new process, a safety problem that might have been detected through more extensive animal studies now may be missed, he said.

And he is doubtful of the benefits. Dr. Wolfe said the types of studies described in the exploratory IND are already being done but with the previous protections in place for human subjects.

Sen. Charles Grassley (R-Iowa), chairman of the Senate Committee on Finance, which has been conducting oversight of the FDA's consumer protections, also expressed safety concerns: “At a time when new questions are being raised about whether participants in clinical trials are protected and treated ethically, the FDA is loosening the reins on drug companies.”

Wisconsin physicians are continuing to push for the reinstatement of a medical liability damage cap, despite recent legal and legislative setbacks.

"I think our legislature clearly understands that something has to be done," said Dr. Susan Turney, executive vice president and CEO of the Wisconsin Medical Society.

Last summer, the Wisconsin Supreme Court struck down the state's $445,775 cap on noneconomic damages as unconstitutional because it was set "unreasonably low." The state legislature acted quickly to pass legislation that enacted a $450,000 cap for adults age 18 and older and a $550,000 cap for those under 18.

But Gov. Jim Doyle (D) vetoed the bill last December, saying that legislators had passed virtually the same cap and ignored the concerns of the court.

"Legal experts agree that a court which found a $445,775 cap unconstitutional would most certainly strike down a cap not even $5,000 higher," Gov. Doyle said in his veto message. "Approving a law that would be quickly overturned doesn't do anyone any good. Instead, I encourage all the interested parties on all sides of this issue to get together and figure out a responsible and lasting solution that has a real chance of being upheld by the Wisconsin Supreme Court."

An attempt to override the governor's veto failed in January. Dr. Turney said she and her colleagues at the Wisconsin Medical Society are "concerned that the absence of caps" will hurt the state's "historically stable medical liability environment" and drive physicians out of state.

The Wisconsin Hospital Association reported that since the state Supreme Court struck down the cap last July, hospitals have had "greater difficulty recruiting physicians" and that damage awards and lawsuits have begun to rise. In addition, officials at the state's Injured Patients and Families Compensation Fund have proposed a 25% increase in annual fees.

Dr. Turney said she is optimistic that the state legislature will pass new legislation addressing the cap issue this spring.

Wisconsin physicians are continuing to push for the reinstatement of a medical liability damage cap, despite recent legal and legislative setbacks.

"I think our legislature clearly understands that something has to be done," said Dr. Susan Turney, executive vice president and CEO of the Wisconsin Medical Society.

Last summer, the Wisconsin Supreme Court struck down the state's $445,775 cap on noneconomic damages as unconstitutional because it was set "unreasonably low." The state legislature acted quickly to pass legislation that enacted a $450,000 cap for adults age 18 and older and a $550,000 cap for those under 18.

But Gov. Jim Doyle (D) vetoed the bill last December, saying that legislators had passed virtually the same cap and ignored the concerns of the court.

"Legal experts agree that a court which found a $445,775 cap unconstitutional would most certainly strike down a cap not even $5,000 higher," Gov. Doyle said in his veto message. "Approving a law that would be quickly overturned doesn't do anyone any good. Instead, I encourage all the interested parties on all sides of this issue to get together and figure out a responsible and lasting solution that has a real chance of being upheld by the Wisconsin Supreme Court."

An attempt to override the governor's veto failed in January. Dr. Turney said she and her colleagues at the Wisconsin Medical Society are "concerned that the absence of caps" will hurt the state's "historically stable medical liability environment" and drive physicians out of state.

The Wisconsin Hospital Association reported that since the state Supreme Court struck down the cap last July, hospitals have had "greater difficulty recruiting physicians" and that damage awards and lawsuits have begun to rise. In addition, officials at the state's Injured Patients and Families Compensation Fund have proposed a 25% increase in annual fees.

Dr. Turney said she is optimistic that the state legislature will pass new legislation addressing the cap issue this spring.

Wisconsin physicians are continuing to push for the reinstatement of a medical liability damage cap, despite recent legal and legislative setbacks.

"I think our legislature clearly understands that something has to be done," said Dr. Susan Turney, executive vice president and CEO of the Wisconsin Medical Society.

Last summer, the Wisconsin Supreme Court struck down the state's $445,775 cap on noneconomic damages as unconstitutional because it was set "unreasonably low." The state legislature acted quickly to pass legislation that enacted a $450,000 cap for adults age 18 and older and a $550,000 cap for those under 18.

But Gov. Jim Doyle (D) vetoed the bill last December, saying that legislators had passed virtually the same cap and ignored the concerns of the court.

"Legal experts agree that a court which found a $445,775 cap unconstitutional would most certainly strike down a cap not even $5,000 higher," Gov. Doyle said in his veto message. "Approving a law that would be quickly overturned doesn't do anyone any good. Instead, I encourage all the interested parties on all sides of this issue to get together and figure out a responsible and lasting solution that has a real chance of being upheld by the Wisconsin Supreme Court."

An attempt to override the governor's veto failed in January. Dr. Turney said she and her colleagues at the Wisconsin Medical Society are "concerned that the absence of caps" will hurt the state's "historically stable medical liability environment" and drive physicians out of state.

The Wisconsin Hospital Association reported that since the state Supreme Court struck down the cap last July, hospitals have had "greater difficulty recruiting physicians" and that damage awards and lawsuits have begun to rise. In addition, officials at the state's Injured Patients and Families Compensation Fund have proposed a 25% increase in annual fees.

Dr. Turney said she is optimistic that the state legislature will pass new legislation addressing the cap issue this spring.

LAS VEGAS — On Jan. 1, Medicare officials implemented a new five-step process for appealing Medicare Part B claims.

The changes apply to Part B initial claim determinations issued and mailed on or after that date, Edward R. Gaines III, senior vice president for compliance and general counsel at Healthcare Business Resources Inc. of Durham, N.C., said at a meeting on reimbursement sponsored by the American College of Emergency Physicians.

The new process includes some significant procedural differences that could benefit physicians, including an opportunity for an independent review earlier in the process, Mr. Gaines said in an interview.

▸ Step 1. The new process begins with a "redetermination" of the initial claim decision made by the Part B carrier. The redetermination is also made by the Part B carrier but the appeals decision is made by an employee who was not involved in the initial determination. This is the only step in the process that involves the Part B carrier that made the original decision, Mr. Gaines said.

Physicians have 120 days from the receipt of the notice of initial determination to file an appeal. Mr. Gaines recommended filing all documentation with the letter requesting a redetermination, including case summaries explaining your code selection. Otherwise, the carrier automatically receives up to 14 additional days to its 60-day decision deadline.

▸ Step 2. Providers can appeal the redetermination decision in a step called reconsideration. Physicians have 180 days from the date of receipt of the redetermination to file this appeal with the Qualified Independent Contractor (QIC) indicated in the Part B carrier letter.

The redetermination step replaces the old "fair hearing" process. The old process was frequently criticized since the fair hearing officer usually had close ties to the Part B carrier that made the original decision, Mr. Gaines said.

He recommended submitting all relevant evidence in support of the claim when the notice of reconsideration is submitted because this is a new review and the QIC will not consider what the carrier ruled previously.

QICs are bound by Medicare national coverage decisions, CMS rulings, laws, and federal regulations. But they are not bound by other documents including local coverage decisions, program guidance, or manual instructions, he said. The reconsideration decision is rendered within 60 days under the appeals process.

▸ Step 3. A hearing with an administrative law judge is held in person, by video, or by telephone. Otherwise, the administrative law judge (ALJ) will base his or her decision on the written record. To have an ALJ review the appeal, submit a written request within 60 days of the reconsideration notice. At this level of the appeal, at least $110 must be in dispute.

To get an in-person hearing, physicians must make that request before the hearing date is set and explain why a telephone or video hearing is not acceptable, Mr. Gaines said. Consider obtaining legal counsel at this point in the process, Mr. Gaines advised.

▸ Step 4. If still not satisfied, a provider may now appeal to the Medicare Appeals Council. This must be done within 60 days from the receipt of the ALJ decision. The Medicare Appeals Council is another addition to the process. Previously, physicians who wanted to appeal a decision beyond the ALJ would have to go to federal district court, and few physicians took that step, Mr. Gaines said.

There is no right to a hearing before the council, but physicians can request an oral argument. In addition, parties to the appeal can file briefs.

▸ Step 5. The final appeal is to the federal district court. This must be filed within 60 days of the Medicare Appeals Council decision. The case may be filed in the U.S. District Court where the appealing physician resides. At this step in the process, at least $1,090 must still be in dispute.

LAS VEGAS — On Jan. 1, Medicare officials implemented a new five-step process for appealing Medicare Part B claims.

The changes apply to Part B initial claim determinations issued and mailed on or after that date, Edward R. Gaines III, senior vice president for compliance and general counsel at Healthcare Business Resources Inc. of Durham, N.C., said at a meeting on reimbursement sponsored by the American College of Emergency Physicians.

The new process includes some significant procedural differences that could benefit physicians, including an opportunity for an independent review earlier in the process, Mr. Gaines said in an interview.

▸ Step 1. The new process begins with a "redetermination" of the initial claim decision made by the Part B carrier. The redetermination is also made by the Part B carrier but the appeals decision is made by an employee who was not involved in the initial determination. This is the only step in the process that involves the Part B carrier that made the original decision, Mr. Gaines said.

Physicians have 120 days from the receipt of the notice of initial determination to file an appeal. Mr. Gaines recommended filing all documentation with the letter requesting a redetermination, including case summaries explaining your code selection. Otherwise, the carrier automatically receives up to 14 additional days to its 60-day decision deadline.

▸ Step 2. Providers can appeal the redetermination decision in a step called reconsideration. Physicians have 180 days from the date of receipt of the redetermination to file this appeal with the Qualified Independent Contractor (QIC) indicated in the Part B carrier letter.

The redetermination step replaces the old "fair hearing" process. The old process was frequently criticized since the fair hearing officer usually had close ties to the Part B carrier that made the original decision, Mr. Gaines said.

He recommended submitting all relevant evidence in support of the claim when the notice of reconsideration is submitted because this is a new review and the QIC will not consider what the carrier ruled previously.

QICs are bound by Medicare national coverage decisions, CMS rulings, laws, and federal regulations. But they are not bound by other documents including local coverage decisions, program guidance, or manual instructions, he said. The reconsideration decision is rendered within 60 days under the appeals process.

▸ Step 3. A hearing with an administrative law judge is held in person, by video, or by telephone. Otherwise, the administrative law judge (ALJ) will base his or her decision on the written record. To have an ALJ review the appeal, submit a written request within 60 days of the reconsideration notice. At this level of the appeal, at least $110 must be in dispute.

To get an in-person hearing, physicians must make that request before the hearing date is set and explain why a telephone or video hearing is not acceptable, Mr. Gaines said. Consider obtaining legal counsel at this point in the process, Mr. Gaines advised.

▸ Step 4. If still not satisfied, a provider may now appeal to the Medicare Appeals Council. This must be done within 60 days from the receipt of the ALJ decision. The Medicare Appeals Council is another addition to the process. Previously, physicians who wanted to appeal a decision beyond the ALJ would have to go to federal district court, and few physicians took that step, Mr. Gaines said.

There is no right to a hearing before the council, but physicians can request an oral argument. In addition, parties to the appeal can file briefs.

▸ Step 5. The final appeal is to the federal district court. This must be filed within 60 days of the Medicare Appeals Council decision. The case may be filed in the U.S. District Court where the appealing physician resides. At this step in the process, at least $1,090 must still be in dispute.

LAS VEGAS — On Jan. 1, Medicare officials implemented a new five-step process for appealing Medicare Part B claims.

The changes apply to Part B initial claim determinations issued and mailed on or after that date, Edward R. Gaines III, senior vice president for compliance and general counsel at Healthcare Business Resources Inc. of Durham, N.C., said at a meeting on reimbursement sponsored by the American College of Emergency Physicians.

The new process includes some significant procedural differences that could benefit physicians, including an opportunity for an independent review earlier in the process, Mr. Gaines said in an interview.

▸ Step 1. The new process begins with a "redetermination" of the initial claim decision made by the Part B carrier. The redetermination is also made by the Part B carrier but the appeals decision is made by an employee who was not involved in the initial determination. This is the only step in the process that involves the Part B carrier that made the original decision, Mr. Gaines said.

Physicians have 120 days from the receipt of the notice of initial determination to file an appeal. Mr. Gaines recommended filing all documentation with the letter requesting a redetermination, including case summaries explaining your code selection. Otherwise, the carrier automatically receives up to 14 additional days to its 60-day decision deadline.

▸ Step 2. Providers can appeal the redetermination decision in a step called reconsideration. Physicians have 180 days from the date of receipt of the redetermination to file this appeal with the Qualified Independent Contractor (QIC) indicated in the Part B carrier letter.

The redetermination step replaces the old "fair hearing" process. The old process was frequently criticized since the fair hearing officer usually had close ties to the Part B carrier that made the original decision, Mr. Gaines said.

He recommended submitting all relevant evidence in support of the claim when the notice of reconsideration is submitted because this is a new review and the QIC will not consider what the carrier ruled previously.

QICs are bound by Medicare national coverage decisions, CMS rulings, laws, and federal regulations. But they are not bound by other documents including local coverage decisions, program guidance, or manual instructions, he said. The reconsideration decision is rendered within 60 days under the appeals process.

▸ Step 3. A hearing with an administrative law judge is held in person, by video, or by telephone. Otherwise, the administrative law judge (ALJ) will base his or her decision on the written record. To have an ALJ review the appeal, submit a written request within 60 days of the reconsideration notice. At this level of the appeal, at least $110 must be in dispute.

To get an in-person hearing, physicians must make that request before the hearing date is set and explain why a telephone or video hearing is not acceptable, Mr. Gaines said. Consider obtaining legal counsel at this point in the process, Mr. Gaines advised.

▸ Step 4. If still not satisfied, a provider may now appeal to the Medicare Appeals Council. This must be done within 60 days from the receipt of the ALJ decision. The Medicare Appeals Council is another addition to the process. Previously, physicians who wanted to appeal a decision beyond the ALJ would have to go to federal district court, and few physicians took that step, Mr. Gaines said.

There is no right to a hearing before the council, but physicians can request an oral argument. In addition, parties to the appeal can file briefs.

▸ Step 5. The final appeal is to the federal district court. This must be filed within 60 days of the Medicare Appeals Council decision. The case may be filed in the U.S. District Court where the appealing physician resides. At this step in the process, at least $1,090 must still be in dispute.

Researchers now have a pathway for conducting early clinical testing of drugs in a small number of human subjects under new guidance from the Food and Drug Administration.

Officials at the FDA finalized guidance on exploratory investigational new drug (IND) studies, which allows researchers to move forward with small human studies before beginning traditional phase I safety testing in humans. The guidance, published in January, makes recommendations on safety testing, manufacturing, and clinical approaches in these early studies.

The FDA also published draft guidance and a direct final rule in January outlining new standards for the manufacture of drugs solely for use in phase I studies. The rule is aimed at making it easier for scientists to produce small quantities of drugs for small-scale, early-phase human testing.

"This is about saving lives and building medicine's future," said Dr. Andrew von Eschenbach, acting FDA Commissioner of Food and Drugs. Currently, fewer than 10% of IND applications for new molecular entities progress beyond the investigational stage, according to the FDA. These changes will remove some of the hurdles from early drug development, he said during a media teleconference sponsored by the FDA.

But critics of the approach say it relaxes needed human-subject protections at a time when the safety of clinical trials is already being questioned.

In guidance on the exploratory IND, FDA officials argue that drug sponsors have not taken full advantage of the flexibility in the existing regulations and often provide more supporting information than is required for an exploratory IND.

Exploratory IND studies involve administering either a subpharmacologic dose of a product or doses that are expected to produce a pharmacologic but not a toxic effect, so the risk to human subjects is considered lower than in a traditional phase I study, FDA said in its guidance documents. Since exploratory IND studies pose fewer risks, the agency said, they can be initiated in humans with less, or different, preclinical support than what is required for traditional IND studies.

Previously, one of the major obstacles in the development of new drugs was that the requirements for beginning early experimental studies were the same as those for large pharmaceutical companies who are making drugs for thousands of patients, said Dr. Steven Rosenberg, chief of surgery at the National Cancer Institute. "We've been at the mercy of large biotech and pharmaceutical companies who have the resources to fulfill the very stringent regulations that exist for taking these new products to very large numbers of patients," he said during the teleconference.

The FDA changes will make it possible for scientists to take new ideas to small numbers of patients with desperate diseases and test those agents in ways that weren't possible before, he said, adding that he expects to see a lot of ideas tested now that might not otherwise have been taken to patients under the old framework.

But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said he remains concerned that the usual protection for human subjects has been "watered down." Under the new process outlined by the FDA, a safety problem that might have been detected through more extensive animal studies now may be missed, he said.

Dr. Wolfe said the types of studies described in the exploratory IND are already being done but with the previous protections in place for human subjects.

Sen. Charles Grassley (R-Iowa), chairman of the Senate Committee on Finance, which has been conducting oversight of the FDA's consumer protections, also expressed safety concerns.

"There have to be sufficient checks and balances in the drug approval process," he said in a statement. "When new questions are being raised about whether participants in clinical trials are protected and treated ethically, the FDA is loosening the reins on drug companies."

Researchers now have a pathway for conducting early clinical testing of drugs in a small number of human subjects under new guidance from the Food and Drug Administration.

Officials at the FDA finalized guidance on exploratory investigational new drug (IND) studies, which allows researchers to move forward with small human studies before beginning traditional phase I safety testing in humans. The guidance, published in January, makes recommendations on safety testing, manufacturing, and clinical approaches in these early studies.

The FDA also published draft guidance and a direct final rule in January outlining new standards for the manufacture of drugs solely for use in phase I studies. The rule is aimed at making it easier for scientists to produce small quantities of drugs for small-scale, early-phase human testing.

"This is about saving lives and building medicine's future," said Dr. Andrew von Eschenbach, acting FDA Commissioner of Food and Drugs. Currently, fewer than 10% of IND applications for new molecular entities progress beyond the investigational stage, according to the FDA. These changes will remove some of the hurdles from early drug development, he said during a media teleconference sponsored by the FDA.

But critics of the approach say it relaxes needed human-subject protections at a time when the safety of clinical trials is already being questioned.

In guidance on the exploratory IND, FDA officials argue that drug sponsors have not taken full advantage of the flexibility in the existing regulations and often provide more supporting information than is required for an exploratory IND.

Exploratory IND studies involve administering either a subpharmacologic dose of a product or doses that are expected to produce a pharmacologic but not a toxic effect, so the risk to human subjects is considered lower than in a traditional phase I study, FDA said in its guidance documents. Since exploratory IND studies pose fewer risks, the agency said, they can be initiated in humans with less, or different, preclinical support than what is required for traditional IND studies.

Previously, one of the major obstacles in the development of new drugs was that the requirements for beginning early experimental studies were the same as those for large pharmaceutical companies who are making drugs for thousands of patients, said Dr. Steven Rosenberg, chief of surgery at the National Cancer Institute. "We've been at the mercy of large biotech and pharmaceutical companies who have the resources to fulfill the very stringent regulations that exist for taking these new products to very large numbers of patients," he said during the teleconference.

The FDA changes will make it possible for scientists to take new ideas to small numbers of patients with desperate diseases and test those agents in ways that weren't possible before, he said, adding that he expects to see a lot of ideas tested now that might not otherwise have been taken to patients under the old framework.

But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said he remains concerned that the usual protection for human subjects has been "watered down." Under the new process outlined by the FDA, a safety problem that might have been detected through more extensive animal studies now may be missed, he said.

Dr. Wolfe said the types of studies described in the exploratory IND are already being done but with the previous protections in place for human subjects.

Sen. Charles Grassley (R-Iowa), chairman of the Senate Committee on Finance, which has been conducting oversight of the FDA's consumer protections, also expressed safety concerns.

"There have to be sufficient checks and balances in the drug approval process," he said in a statement. "When new questions are being raised about whether participants in clinical trials are protected and treated ethically, the FDA is loosening the reins on drug companies."

Researchers now have a pathway for conducting early clinical testing of drugs in a small number of human subjects under new guidance from the Food and Drug Administration.

Officials at the FDA finalized guidance on exploratory investigational new drug (IND) studies, which allows researchers to move forward with small human studies before beginning traditional phase I safety testing in humans. The guidance, published in January, makes recommendations on safety testing, manufacturing, and clinical approaches in these early studies.

The FDA also published draft guidance and a direct final rule in January outlining new standards for the manufacture of drugs solely for use in phase I studies. The rule is aimed at making it easier for scientists to produce small quantities of drugs for small-scale, early-phase human testing.

"This is about saving lives and building medicine's future," said Dr. Andrew von Eschenbach, acting FDA Commissioner of Food and Drugs. Currently, fewer than 10% of IND applications for new molecular entities progress beyond the investigational stage, according to the FDA. These changes will remove some of the hurdles from early drug development, he said during a media teleconference sponsored by the FDA.

But critics of the approach say it relaxes needed human-subject protections at a time when the safety of clinical trials is already being questioned.

In guidance on the exploratory IND, FDA officials argue that drug sponsors have not taken full advantage of the flexibility in the existing regulations and often provide more supporting information than is required for an exploratory IND.

Exploratory IND studies involve administering either a subpharmacologic dose of a product or doses that are expected to produce a pharmacologic but not a toxic effect, so the risk to human subjects is considered lower than in a traditional phase I study, FDA said in its guidance documents. Since exploratory IND studies pose fewer risks, the agency said, they can be initiated in humans with less, or different, preclinical support than what is required for traditional IND studies.

Previously, one of the major obstacles in the development of new drugs was that the requirements for beginning early experimental studies were the same as those for large pharmaceutical companies who are making drugs for thousands of patients, said Dr. Steven Rosenberg, chief of surgery at the National Cancer Institute. "We've been at the mercy of large biotech and pharmaceutical companies who have the resources to fulfill the very stringent regulations that exist for taking these new products to very large numbers of patients," he said during the teleconference.

The FDA changes will make it possible for scientists to take new ideas to small numbers of patients with desperate diseases and test those agents in ways that weren't possible before, he said, adding that he expects to see a lot of ideas tested now that might not otherwise have been taken to patients under the old framework.

But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said he remains concerned that the usual protection for human subjects has been "watered down." Under the new process outlined by the FDA, a safety problem that might have been detected through more extensive animal studies now may be missed, he said.

Dr. Wolfe said the types of studies described in the exploratory IND are already being done but with the previous protections in place for human subjects.

Sen. Charles Grassley (R-Iowa), chairman of the Senate Committee on Finance, which has been conducting oversight of the FDA's consumer protections, also expressed safety concerns.

"There have to be sufficient checks and balances in the drug approval process," he said in a statement. "When new questions are being raised about whether participants in clinical trials are protected and treated ethically, the FDA is loosening the reins on drug companies."

Penalties for Faux-tox

The case involving distribution of counterfeit Botox for use in humans came to a close in a Florida courtroom in January when U.S. District Court Judge James I. Cohn handed down fines and jail sentences. Naturopaths Chad Livdahl and Zarah Karim both pled guilty in November 2005 to charges related to their role in the scheme, which involved purchasing and then selling to other health care providers thousands of vials of botulinum toxin type A and other ingredients designed to mimic Botox. Mr. Livdahl was sentenced to 9 years in jail and Ms. Karim was sentenced to nearly 6 years in prison. Dr. Bach McComb, who pled guilty to one count of misbranding a drug in interstate commerce, was sentenced to 3 years in prison and Dr. Robert Baker, who pled guilty to one count of mail fraud, was sentenced to 180 days of home detention. "Doctors and medical practitioners have a solemn duty to those for whom they care," R. Alexander Acosta, U.S. Attorney for the Southern District of Florida, said in a statement. "These defendants breached that duty and endangered the lives of their patients by selling deadly toxin packaged in harmless-looking vials." These convictions follow license suspensions or restrictions for at least 10 Florida physicians, including several dermatologists, for their role in purchasing the unapproved drug ("Botulism Disaster Helps Uncover Fake Botox Market: Four physicians indicted on federal charges," SKIN & ALLERGY NEWS, May 2005, p. 1).

Vitamin D Controversy

It's unsafe and unnecessary for people to expose themselves to harmful doses of ultraviolet radiation in an effort to maintain the proper levels of vitamin D, according to a literature review published in the February issue of the Journal of the American Academy of Dermatology. In the latest chapter in the fight over the importance of sunlight in meeting vitamin D requirements, Dr. Barbara A. Gilchrest and Dr. Deon Wolpowitz of Boston University advise the public to get their vitamin D through fortified foods and nutritional supplements, not unprotected sun exposure. In the article, they noted that incidental, protected sunlight along with foods rich in vitamin D can easily provide young, fair-skinned individuals—who are often targeted by the tanning industry—with the appropriate amount of vitamin D.

Ben Franklin's Psoriasis

Psoriasis Cure Now, a patient advocacy group, has named Benjamin Franklin as its "greatest American with psoriasis" in an effort to raise awareness of the disease and increase federally funded psoriasis research. The group arranged for a Franklin look-alike to distribute psoriasis information to congressional staffers recently on Mr. Franklin's 300th birthday. The group also is developing a pamphlet for children featuring Benjamin Franklin. "His story is striking because many people with psoriasis are suffering as much today as he did so long ago," Psoriasis Cure Now President Michael Paranzino said in a statement. In his writings, Mr. Franklin referred to his psoriasis as a "troublesome disorder" and noted that it had flared up at the time he helped draft the Declaration of Independence and during his years in France where he lobbied for French support of the Revolutionary War. More information is available online at

www.ben300.org

E-Prescribing Pilots

Officials at the Centers for Medicare and Medicaid Services are launching pilots to study new e-prescribing standards that will be implemented in 2008. Under the Medicare Modernization Act, the initial e-prescribing standards must be tested through pilot projects this year, except where there is already adequate industry experience. Three standards were already adopted in a final rule published last November. The pilots will test standards related to formulary and benefit information, the exchange of medication history, prior authorization messages, and clinical drug terminology, among others. CMS also has asked participants in the pilot to consider the impact on quality of care, the impact on physician return on investment, and the possible cost savings. CMS is scheduled to report findings from the pilots to Congress in April 2007. The final standards will be issued no later than April 2008.

'Fair Share' for Health Care

Large employers in the state of Maryland will have to pay a "fair share" for health care under a new state law. Last April, the Maryland General Assembly passed the Fair Share Health Care Fund Act, which requires that employers with more than 10,000 employees must spend at least 8% of wages paid on health insurance, or pay the state the difference between what they do spend and 8%. The law was vetoed by Republican Gov. Robert Ehrlich, but the legislature overrode his veto in January. Currently, WalMart is the only employer in Maryland that is affected by the law.

Penalties for Faux-tox

The case involving distribution of counterfeit Botox for use in humans came to a close in a Florida courtroom in January when U.S. District Court Judge James I. Cohn handed down fines and jail sentences. Naturopaths Chad Livdahl and Zarah Karim both pled guilty in November 2005 to charges related to their role in the scheme, which involved purchasing and then selling to other health care providers thousands of vials of botulinum toxin type A and other ingredients designed to mimic Botox. Mr. Livdahl was sentenced to 9 years in jail and Ms. Karim was sentenced to nearly 6 years in prison. Dr. Bach McComb, who pled guilty to one count of misbranding a drug in interstate commerce, was sentenced to 3 years in prison and Dr. Robert Baker, who pled guilty to one count of mail fraud, was sentenced to 180 days of home detention. "Doctors and medical practitioners have a solemn duty to those for whom they care," R. Alexander Acosta, U.S. Attorney for the Southern District of Florida, said in a statement. "These defendants breached that duty and endangered the lives of their patients by selling deadly toxin packaged in harmless-looking vials." These convictions follow license suspensions or restrictions for at least 10 Florida physicians, including several dermatologists, for their role in purchasing the unapproved drug ("Botulism Disaster Helps Uncover Fake Botox Market: Four physicians indicted on federal charges," SKIN & ALLERGY NEWS, May 2005, p. 1).

Vitamin D Controversy

It's unsafe and unnecessary for people to expose themselves to harmful doses of ultraviolet radiation in an effort to maintain the proper levels of vitamin D, according to a literature review published in the February issue of the Journal of the American Academy of Dermatology. In the latest chapter in the fight over the importance of sunlight in meeting vitamin D requirements, Dr. Barbara A. Gilchrest and Dr. Deon Wolpowitz of Boston University advise the public to get their vitamin D through fortified foods and nutritional supplements, not unprotected sun exposure. In the article, they noted that incidental, protected sunlight along with foods rich in vitamin D can easily provide young, fair-skinned individuals—who are often targeted by the tanning industry—with the appropriate amount of vitamin D.

Ben Franklin's Psoriasis

Psoriasis Cure Now, a patient advocacy group, has named Benjamin Franklin as its "greatest American with psoriasis" in an effort to raise awareness of the disease and increase federally funded psoriasis research. The group arranged for a Franklin look-alike to distribute psoriasis information to congressional staffers recently on Mr. Franklin's 300th birthday. The group also is developing a pamphlet for children featuring Benjamin Franklin. "His story is striking because many people with psoriasis are suffering as much today as he did so long ago," Psoriasis Cure Now President Michael Paranzino said in a statement. In his writings, Mr. Franklin referred to his psoriasis as a "troublesome disorder" and noted that it had flared up at the time he helped draft the Declaration of Independence and during his years in France where he lobbied for French support of the Revolutionary War. More information is available online at

www.ben300.org

E-Prescribing Pilots

Officials at the Centers for Medicare and Medicaid Services are launching pilots to study new e-prescribing standards that will be implemented in 2008. Under the Medicare Modernization Act, the initial e-prescribing standards must be tested through pilot projects this year, except where there is already adequate industry experience. Three standards were already adopted in a final rule published last November. The pilots will test standards related to formulary and benefit information, the exchange of medication history, prior authorization messages, and clinical drug terminology, among others. CMS also has asked participants in the pilot to consider the impact on quality of care, the impact on physician return on investment, and the possible cost savings. CMS is scheduled to report findings from the pilots to Congress in April 2007. The final standards will be issued no later than April 2008.

'Fair Share' for Health Care

Large employers in the state of Maryland will have to pay a "fair share" for health care under a new state law. Last April, the Maryland General Assembly passed the Fair Share Health Care Fund Act, which requires that employers with more than 10,000 employees must spend at least 8% of wages paid on health insurance, or pay the state the difference between what they do spend and 8%. The law was vetoed by Republican Gov. Robert Ehrlich, but the legislature overrode his veto in January. Currently, WalMart is the only employer in Maryland that is affected by the law.

Penalties for Faux-tox

The case involving distribution of counterfeit Botox for use in humans came to a close in a Florida courtroom in January when U.S. District Court Judge James I. Cohn handed down fines and jail sentences. Naturopaths Chad Livdahl and Zarah Karim both pled guilty in November 2005 to charges related to their role in the scheme, which involved purchasing and then selling to other health care providers thousands of vials of botulinum toxin type A and other ingredients designed to mimic Botox. Mr. Livdahl was sentenced to 9 years in jail and Ms. Karim was sentenced to nearly 6 years in prison. Dr. Bach McComb, who pled guilty to one count of misbranding a drug in interstate commerce, was sentenced to 3 years in prison and Dr. Robert Baker, who pled guilty to one count of mail fraud, was sentenced to 180 days of home detention. "Doctors and medical practitioners have a solemn duty to those for whom they care," R. Alexander Acosta, U.S. Attorney for the Southern District of Florida, said in a statement. "These defendants breached that duty and endangered the lives of their patients by selling deadly toxin packaged in harmless-looking vials." These convictions follow license suspensions or restrictions for at least 10 Florida physicians, including several dermatologists, for their role in purchasing the unapproved drug ("Botulism Disaster Helps Uncover Fake Botox Market: Four physicians indicted on federal charges," SKIN & ALLERGY NEWS, May 2005, p. 1).

Vitamin D Controversy

It's unsafe and unnecessary for people to expose themselves to harmful doses of ultraviolet radiation in an effort to maintain the proper levels of vitamin D, according to a literature review published in the February issue of the Journal of the American Academy of Dermatology. In the latest chapter in the fight over the importance of sunlight in meeting vitamin D requirements, Dr. Barbara A. Gilchrest and Dr. Deon Wolpowitz of Boston University advise the public to get their vitamin D through fortified foods and nutritional supplements, not unprotected sun exposure. In the article, they noted that incidental, protected sunlight along with foods rich in vitamin D can easily provide young, fair-skinned individuals—who are often targeted by the tanning industry—with the appropriate amount of vitamin D.

Ben Franklin's Psoriasis

Psoriasis Cure Now, a patient advocacy group, has named Benjamin Franklin as its "greatest American with psoriasis" in an effort to raise awareness of the disease and increase federally funded psoriasis research. The group arranged for a Franklin look-alike to distribute psoriasis information to congressional staffers recently on Mr. Franklin's 300th birthday. The group also is developing a pamphlet for children featuring Benjamin Franklin. "His story is striking because many people with psoriasis are suffering as much today as he did so long ago," Psoriasis Cure Now President Michael Paranzino said in a statement. In his writings, Mr. Franklin referred to his psoriasis as a "troublesome disorder" and noted that it had flared up at the time he helped draft the Declaration of Independence and during his years in France where he lobbied for French support of the Revolutionary War. More information is available online at

www.ben300.org

E-Prescribing Pilots

Officials at the Centers for Medicare and Medicaid Services are launching pilots to study new e-prescribing standards that will be implemented in 2008. Under the Medicare Modernization Act, the initial e-prescribing standards must be tested through pilot projects this year, except where there is already adequate industry experience. Three standards were already adopted in a final rule published last November. The pilots will test standards related to formulary and benefit information, the exchange of medication history, prior authorization messages, and clinical drug terminology, among others. CMS also has asked participants in the pilot to consider the impact on quality of care, the impact on physician return on investment, and the possible cost savings. CMS is scheduled to report findings from the pilots to Congress in April 2007. The final standards will be issued no later than April 2008.

'Fair Share' for Health Care

Large employers in the state of Maryland will have to pay a "fair share" for health care under a new state law. Last April, the Maryland General Assembly passed the Fair Share Health Care Fund Act, which requires that employers with more than 10,000 employees must spend at least 8% of wages paid on health insurance, or pay the state the difference between what they do spend and 8%. The law was vetoed by Republican Gov. Robert Ehrlich, but the legislature overrode his veto in January. Currently, WalMart is the only employer in Maryland that is affected by the law.