Mary Ellen Schneider

Over the next year or so, leaders in the health information technology community will work on ways to make medication history and some general demographic information available to consumers in a portable health record.

Experts at a Webcast meeting of the American Health Information Community agreed that this is the "low-hanging fruit" that could eventually pave the way for widespread access to portable, consumer-controlled personal health records. The American Health Information Community is an advisory committee to the Department of Health and Human Services.

The development of portable electronic demographic information, or registration information, would be a way to do away with the medical clipboard, HHS Secretary Mike Leavitt said.

"The timeliness of access to medical information is critical to patients," said Nancy Davenport-Ennis, CEO of the National Patient Advocate Foundation and a member of the American Health Information Community. Today, most patients feel they own their medical record but when they go to get lab results from their physician, it can often take days or weeks, she said.

But one of the major hurdles in creating secure and portable patient health records is authentications, said Dr. Reed Tuckson of UnitedHealth Group, who presented information to the group.

Other obstacles include the inability to locate patient information across multiple settings, segmentation of the consumer market, privacy concerns, low levels of consumer trust, few electronic health records to connect to, and the lack of an established business model.

But there have been some successes, said David Lansky, Ph.D., of the Markle Foundation, who presented information to the group. For example, the Department of Veterans Affairs set up a patient portal, and the Department of Defense has a similar program. And some health plans offer pre-populated personal health records. "We're not starting with a blank slate," Dr. Lansky said.

Providing medication history electronically to patients is something that could be done quickly, Dr. Lanksy said. The Markle Foundation was one of the groups that helped spearhead efforts to do just that with www.katrinahealth.org

Over the next year or so, leaders in the health information technology community will work on ways to make medication history and some general demographic information available to consumers in a portable health record.

Experts at a Webcast meeting of the American Health Information Community agreed that this is the "low-hanging fruit" that could eventually pave the way for widespread access to portable, consumer-controlled personal health records. The American Health Information Community is an advisory committee to the Department of Health and Human Services.

The development of portable electronic demographic information, or registration information, would be a way to do away with the medical clipboard, HHS Secretary Mike Leavitt said.

"The timeliness of access to medical information is critical to patients," said Nancy Davenport-Ennis, CEO of the National Patient Advocate Foundation and a member of the American Health Information Community. Today, most patients feel they own their medical record but when they go to get lab results from their physician, it can often take days or weeks, she said.

But one of the major hurdles in creating secure and portable patient health records is authentications, said Dr. Reed Tuckson of UnitedHealth Group, who presented information to the group.

Other obstacles include the inability to locate patient information across multiple settings, segmentation of the consumer market, privacy concerns, low levels of consumer trust, few electronic health records to connect to, and the lack of an established business model.

But there have been some successes, said David Lansky, Ph.D., of the Markle Foundation, who presented information to the group. For example, the Department of Veterans Affairs set up a patient portal, and the Department of Defense has a similar program. And some health plans offer pre-populated personal health records. "We're not starting with a blank slate," Dr. Lansky said.

Providing medication history electronically to patients is something that could be done quickly, Dr. Lanksy said. The Markle Foundation was one of the groups that helped spearhead efforts to do just that with www.katrinahealth.org

Over the next year or so, leaders in the health information technology community will work on ways to make medication history and some general demographic information available to consumers in a portable health record.

Experts at a Webcast meeting of the American Health Information Community agreed that this is the "low-hanging fruit" that could eventually pave the way for widespread access to portable, consumer-controlled personal health records. The American Health Information Community is an advisory committee to the Department of Health and Human Services.

The development of portable electronic demographic information, or registration information, would be a way to do away with the medical clipboard, HHS Secretary Mike Leavitt said.

"The timeliness of access to medical information is critical to patients," said Nancy Davenport-Ennis, CEO of the National Patient Advocate Foundation and a member of the American Health Information Community. Today, most patients feel they own their medical record but when they go to get lab results from their physician, it can often take days or weeks, she said.

But one of the major hurdles in creating secure and portable patient health records is authentications, said Dr. Reed Tuckson of UnitedHealth Group, who presented information to the group.

Other obstacles include the inability to locate patient information across multiple settings, segmentation of the consumer market, privacy concerns, low levels of consumer trust, few electronic health records to connect to, and the lack of an established business model.

But there have been some successes, said David Lansky, Ph.D., of the Markle Foundation, who presented information to the group. For example, the Department of Veterans Affairs set up a patient portal, and the Department of Defense has a similar program. And some health plans offer pre-populated personal health records. "We're not starting with a blank slate," Dr. Lansky said.

Providing medication history electronically to patients is something that could be done quickly, Dr. Lanksy said. The Markle Foundation was one of the groups that helped spearhead efforts to do just that with www.katrinahealth.org

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.

The Health and Human Services Department's 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.

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, they are liable if the claim is submitted in their name.

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, he added.

Medicare contractors and other auditors will use data analysis to detect aberrant billing practices. The auditors tend to rely on billing reports that compare providers of the same specialty in an area. The auditor might also look at increases in critical care utilization versus historical trends for the group, for example.

But physicians 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.

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.

The Health and Human Services Department's 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.

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, they are liable if the claim is submitted in their name.

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, he added.

Medicare contractors and other auditors will use data analysis to detect aberrant billing practices. The auditors tend to rely on billing reports that compare providers of the same specialty in an area. The auditor might also look at increases in critical care utilization versus historical trends for the group, for example.

But physicians 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.

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.

The Health and Human Services Department's 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.

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, they are liable if the claim is submitted in their name.

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, he added.

Medicare contractors and other auditors will use data analysis to detect aberrant billing practices. The auditors tend to rely on billing reports that compare providers of the same specialty in an area. The auditor might also look at increases in critical care utilization versus historical trends for the group, for example.

But physicians 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.

Race and Pregnancy Outcomes

Early access to prenatal care has not been enough to improve pregnancy outcomes among minorities, according to a study published in the March issue of Obstetrics and Gynecology. The study analyzed data from the First- and Second-Trimester Evaluation of Risk trial to look at perinatal loss among women who had early access prenatal care. Of the more than 35,000 pregnant women in the study, 1.3% of the pregnancies ended in miscarriage or newborn death. While blacks made up only 5% of the study population, they accounted for about 16% of the perinatal mortality. Even after the authors controlled for other demographic factors, race remained a significant predictor of perinatal mortality. “Prenatal care, although unequivocally helpful and necessary, remains insufficient in its present form for minority women,” the researchers wrote. “Therefore, increasing early access to current prenatal care systems in the effort to minimize racial and ethnic disparities in perinatal mortality is insufficient.”

Review of Partial Birth Ban

The Supreme Court has agreed to hear arguments about the constitutionality of the Partial-Birth Abortion Ban Act of 2003. The U.S. Attorney General petitioned the court last fall to hear the case of Gonzales v. Carhart. In that case, Nebraska physician LeRoy Carhart and three other physicians sought to overturn the 2003 abortion ban. Most recently, the U.S. Court of Appeals for the Eighth Circuit struck down the ban as unconstitutional because it did not include a health exception for the woman. The Supreme Court will likely be revisiting some of the issues involved in the case of Stenberg v. Carhart, in which the court struck down a Nebraska ban on the so-called partial birth abortion procedure in 2000. In that case, which also was brought by Dr. Carhart, the decision hinged on the lack of a health exception. But court watchers are wondering whether the outcome will be different this time around with the changed makeup of the court, including new Chief Justice John G. Roberts Jr. and new Justice Samuel A. Alito Jr.

Women's Heart Health

The Society for Women's Health Research, the American Heart Association, and several other groups are mobilizing their members in support of new legislation aimed at educating physicians and patients about cardiovascular diseases among women. The HEART for Women Act (S. 2278/H.R. 4747), introduced in February, would authorize outreach activities to raise awareness of cardiovascular disease prevention and treatment in women and would tighten requirements for reporting gender-based data on new drugs and devices. The legislation was introduced as the Society for Women's Health Research and WomenHeart: The National Coalition for Women With Heart Disease released their report on the top 10 unanswered questions related to the development, diagnosis, and treatment of heart disease in women. The report also outlines a blueprint for research in this area. The report is available online at

www.womensheart.org

Wal-Mart Stocks Plan B

Wal-Mart will begin carrying Plan B emergency contraception at all of its U.S. pharmacies beginning on March 20. The retailer was already required to sell emergency contraception at pharmacies in Illinois and most recently in Massachusetts. The company could not justify being the only major pharmacy chain that didn't carry Plan B, Ron Chomiuk, Wal-Mart's vice president of pharmacy, said in a statement issued earlier this month. Mr. Chomiuk said Wal-Mart officials expect that more states will introduce requirements to sell emergency contraceptives in a matter of months. While Wal-Mart will carry emergency contraception at all stores, the company plans to continue its “conscientious objection” policy, which allows any Wal-Mart or Sam's Club pharmacy associate to refuse to dispense any prescription that he or she does not feel comfortable dispensing and to refer customers to another pharmacist or pharmacy. The announcement that Wal-Mart would sell Plan B was praised by reproductive rights advocates as an important first step. But Planned Parenthood Federation of American President Cecile Richards said Wal-Mart should not allow pharmacists to refuse to fill valid prescriptions. “We urge Wal-Mart to change its policy to ensure that prescriptions for contraception will always be filled in their stores without discrimination or delay,” she said.

Lester Crawford, Lobbyist

Former Food and Drug Administration Commissioner Lester Crawford, D.V.M., has taken a position at Policy Directions Inc., a Washington-based lobbying and consulting firm. Mr. Crawford will be senior counsel to the organization, which counts pharmaceutical manufacturers and biotechnology and food companies among its clients. By law, he will be barred from directly lobbying Congress for at least a year. Policy Directions declined to make him available for an interview. Mr. Crawford resigned abruptly from his FDA post in September, just 2 months after his confirmation by the Senate. In the 5 years of the Bush Administration, the FDA has had a permanent commissioner for 18 months. (Mr. Crawford served in an acting capacity for 16 months without Senate confirmation.)

Race and Pregnancy Outcomes

Early access to prenatal care has not been enough to improve pregnancy outcomes among minorities, according to a study published in the March issue of Obstetrics and Gynecology. The study analyzed data from the First- and Second-Trimester Evaluation of Risk trial to look at perinatal loss among women who had early access prenatal care. Of the more than 35,000 pregnant women in the study, 1.3% of the pregnancies ended in miscarriage or newborn death. While blacks made up only 5% of the study population, they accounted for about 16% of the perinatal mortality. Even after the authors controlled for other demographic factors, race remained a significant predictor of perinatal mortality. “Prenatal care, although unequivocally helpful and necessary, remains insufficient in its present form for minority women,” the researchers wrote. “Therefore, increasing early access to current prenatal care systems in the effort to minimize racial and ethnic disparities in perinatal mortality is insufficient.”

Review of Partial Birth Ban

The Supreme Court has agreed to hear arguments about the constitutionality of the Partial-Birth Abortion Ban Act of 2003. The U.S. Attorney General petitioned the court last fall to hear the case of Gonzales v. Carhart. In that case, Nebraska physician LeRoy Carhart and three other physicians sought to overturn the 2003 abortion ban. Most recently, the U.S. Court of Appeals for the Eighth Circuit struck down the ban as unconstitutional because it did not include a health exception for the woman. The Supreme Court will likely be revisiting some of the issues involved in the case of Stenberg v. Carhart, in which the court struck down a Nebraska ban on the so-called partial birth abortion procedure in 2000. In that case, which also was brought by Dr. Carhart, the decision hinged on the lack of a health exception. But court watchers are wondering whether the outcome will be different this time around with the changed makeup of the court, including new Chief Justice John G. Roberts Jr. and new Justice Samuel A. Alito Jr.

Women's Heart Health

The Society for Women's Health Research, the American Heart Association, and several other groups are mobilizing their members in support of new legislation aimed at educating physicians and patients about cardiovascular diseases among women. The HEART for Women Act (S. 2278/H.R. 4747), introduced in February, would authorize outreach activities to raise awareness of cardiovascular disease prevention and treatment in women and would tighten requirements for reporting gender-based data on new drugs and devices. The legislation was introduced as the Society for Women's Health Research and WomenHeart: The National Coalition for Women With Heart Disease released their report on the top 10 unanswered questions related to the development, diagnosis, and treatment of heart disease in women. The report also outlines a blueprint for research in this area. The report is available online at

www.womensheart.org

Wal-Mart Stocks Plan B

Wal-Mart will begin carrying Plan B emergency contraception at all of its U.S. pharmacies beginning on March 20. The retailer was already required to sell emergency contraception at pharmacies in Illinois and most recently in Massachusetts. The company could not justify being the only major pharmacy chain that didn't carry Plan B, Ron Chomiuk, Wal-Mart's vice president of pharmacy, said in a statement issued earlier this month. Mr. Chomiuk said Wal-Mart officials expect that more states will introduce requirements to sell emergency contraceptives in a matter of months. While Wal-Mart will carry emergency contraception at all stores, the company plans to continue its “conscientious objection” policy, which allows any Wal-Mart or Sam's Club pharmacy associate to refuse to dispense any prescription that he or she does not feel comfortable dispensing and to refer customers to another pharmacist or pharmacy. The announcement that Wal-Mart would sell Plan B was praised by reproductive rights advocates as an important first step. But Planned Parenthood Federation of American President Cecile Richards said Wal-Mart should not allow pharmacists to refuse to fill valid prescriptions. “We urge Wal-Mart to change its policy to ensure that prescriptions for contraception will always be filled in their stores without discrimination or delay,” she said.

Lester Crawford, Lobbyist

Former Food and Drug Administration Commissioner Lester Crawford, D.V.M., has taken a position at Policy Directions Inc., a Washington-based lobbying and consulting firm. Mr. Crawford will be senior counsel to the organization, which counts pharmaceutical manufacturers and biotechnology and food companies among its clients. By law, he will be barred from directly lobbying Congress for at least a year. Policy Directions declined to make him available for an interview. Mr. Crawford resigned abruptly from his FDA post in September, just 2 months after his confirmation by the Senate. In the 5 years of the Bush Administration, the FDA has had a permanent commissioner for 18 months. (Mr. Crawford served in an acting capacity for 16 months without Senate confirmation.)

Race and Pregnancy Outcomes

Early access to prenatal care has not been enough to improve pregnancy outcomes among minorities, according to a study published in the March issue of Obstetrics and Gynecology. The study analyzed data from the First- and Second-Trimester Evaluation of Risk trial to look at perinatal loss among women who had early access prenatal care. Of the more than 35,000 pregnant women in the study, 1.3% of the pregnancies ended in miscarriage or newborn death. While blacks made up only 5% of the study population, they accounted for about 16% of the perinatal mortality. Even after the authors controlled for other demographic factors, race remained a significant predictor of perinatal mortality. “Prenatal care, although unequivocally helpful and necessary, remains insufficient in its present form for minority women,” the researchers wrote. “Therefore, increasing early access to current prenatal care systems in the effort to minimize racial and ethnic disparities in perinatal mortality is insufficient.”

Review of Partial Birth Ban

The Supreme Court has agreed to hear arguments about the constitutionality of the Partial-Birth Abortion Ban Act of 2003. The U.S. Attorney General petitioned the court last fall to hear the case of Gonzales v. Carhart. In that case, Nebraska physician LeRoy Carhart and three other physicians sought to overturn the 2003 abortion ban. Most recently, the U.S. Court of Appeals for the Eighth Circuit struck down the ban as unconstitutional because it did not include a health exception for the woman. The Supreme Court will likely be revisiting some of the issues involved in the case of Stenberg v. Carhart, in which the court struck down a Nebraska ban on the so-called partial birth abortion procedure in 2000. In that case, which also was brought by Dr. Carhart, the decision hinged on the lack of a health exception. But court watchers are wondering whether the outcome will be different this time around with the changed makeup of the court, including new Chief Justice John G. Roberts Jr. and new Justice Samuel A. Alito Jr.

Women's Heart Health

The Society for Women's Health Research, the American Heart Association, and several other groups are mobilizing their members in support of new legislation aimed at educating physicians and patients about cardiovascular diseases among women. The HEART for Women Act (S. 2278/H.R. 4747), introduced in February, would authorize outreach activities to raise awareness of cardiovascular disease prevention and treatment in women and would tighten requirements for reporting gender-based data on new drugs and devices. The legislation was introduced as the Society for Women's Health Research and WomenHeart: The National Coalition for Women With Heart Disease released their report on the top 10 unanswered questions related to the development, diagnosis, and treatment of heart disease in women. The report also outlines a blueprint for research in this area. The report is available online at

www.womensheart.org

Wal-Mart Stocks Plan B

Wal-Mart will begin carrying Plan B emergency contraception at all of its U.S. pharmacies beginning on March 20. The retailer was already required to sell emergency contraception at pharmacies in Illinois and most recently in Massachusetts. The company could not justify being the only major pharmacy chain that didn't carry Plan B, Ron Chomiuk, Wal-Mart's vice president of pharmacy, said in a statement issued earlier this month. Mr. Chomiuk said Wal-Mart officials expect that more states will introduce requirements to sell emergency contraceptives in a matter of months. While Wal-Mart will carry emergency contraception at all stores, the company plans to continue its “conscientious objection” policy, which allows any Wal-Mart or Sam's Club pharmacy associate to refuse to dispense any prescription that he or she does not feel comfortable dispensing and to refer customers to another pharmacist or pharmacy. The announcement that Wal-Mart would sell Plan B was praised by reproductive rights advocates as an important first step. But Planned Parenthood Federation of American President Cecile Richards said Wal-Mart should not allow pharmacists to refuse to fill valid prescriptions. “We urge Wal-Mart to change its policy to ensure that prescriptions for contraception will always be filled in their stores without discrimination or delay,” she said.

Lester Crawford, Lobbyist

Former Food and Drug Administration Commissioner Lester Crawford, D.V.M., has taken a position at Policy Directions Inc., a Washington-based lobbying and consulting firm. Mr. Crawford will be senior counsel to the organization, which counts pharmaceutical manufacturers and biotechnology and food companies among its clients. By law, he will be barred from directly lobbying Congress for at least a year. Policy Directions declined to make him available for an interview. Mr. Crawford resigned abruptly from his FDA post in September, just 2 months after his confirmation by the Senate. In the 5 years of the Bush Administration, the FDA has had a permanent commissioner for 18 months. (Mr. Crawford served in an acting capacity for 16 months without Senate confirmation.)

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's Office of Inspector General names 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.

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, they are liable if the claim is submitted in their name.

Mr. Gaines advised physicians to start 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,” Mr. Gaines said.

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

Medicare contractors and other auditors will use data analysis to detect aberrant billing practices. The auditors tend to rely on billing reports that compare providers of the same specialty in an area. The auditor might also look at increases in critical care utilization versus historical trends for the group, for example.

But physicians groups can be prepared, Mr. Gaines said, but 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 ED, admission criteria, EMS 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's Office of Inspector General names 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.

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, they are liable if the claim is submitted in their name.

Mr. Gaines advised physicians to start 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,” Mr. Gaines said.

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

Medicare contractors and other auditors will use data analysis to detect aberrant billing practices. The auditors tend to rely on billing reports that compare providers of the same specialty in an area. The auditor might also look at increases in critical care utilization versus historical trends for the group, for example.

But physicians groups can be prepared, Mr. Gaines said, but 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 ED, admission criteria, EMS 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's Office of Inspector General names 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.

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, they are liable if the claim is submitted in their name.

Mr. Gaines advised physicians to start 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,” Mr. Gaines said.

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

Medicare contractors and other auditors will use data analysis to detect aberrant billing practices. The auditors tend to rely on billing reports that compare providers of the same specialty in an area. The auditor might also look at increases in critical care utilization versus historical trends for the group, for example.

But physicians groups can be prepared, Mr. Gaines said, but 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 ED, admission criteria, EMS preference, or the presence of a nursing home nearby or on the hospital campus, he said.

Pharmaceutical companies should not end their patient assistance programs because of the implementation of the Medicare Part D prescription drug program, according to a statement from the Centers for Medicare and Medicaid Services.

Companies can continue to provide free and reduced-cost drugs to Medicare beneficiaries as long as it is done outside of the Part D benefit.

For example, a pharmaceutical company can provide coverage for certain drugs that are part of the Medicare Part D benefit, but no claims for payment can be filed with the Medicare Part D drug plan for that medication and the cost of the medication will not be counted toward the beneficiary's true out-of-pocket costs, according to CMS.

The Department of Health and Human Services' Office of Inspector General (OIG) issued a special advisory bulletin last November warning that pharmaceutical companies would be at risk under the federal antikickback statute if they paid all or a portion of a Medicare beneficiary's Part D cost sharing for their company's products. But the OIG bulletin outlined alternative program designs that would allow Medicare beneficiaries to continue to receive assistance.

“The bulletin also makes clear that pharmaceutical companies may choose to provide free or reduced-price drugs to financially needy Part D beneficiaries, [as] long as the assistance program is properly structured and the free or reduced-price drugs are provided entirely outside the Part D benefit,” the CMS statement said.

In addition, the recent OIG guidance does not apply to uninsured patients and Medicare beneficiaries who have not enrolled in the Part D benefit.

But pharmaceutical companies are looking for additional information from both CMS and OIG to explain how companies can continue their current patient assistance programs to help Medicare beneficiaries.

Pharmaceutical companies should not end their patient assistance programs because of the implementation of the Medicare Part D prescription drug program, according to a statement from the Centers for Medicare and Medicaid Services.

Companies can continue to provide free and reduced-cost drugs to Medicare beneficiaries as long as it is done outside of the Part D benefit.

For example, a pharmaceutical company can provide coverage for certain drugs that are part of the Medicare Part D benefit, but no claims for payment can be filed with the Medicare Part D drug plan for that medication and the cost of the medication will not be counted toward the beneficiary's true out-of-pocket costs, according to CMS.

The Department of Health and Human Services' Office of Inspector General (OIG) issued a special advisory bulletin last November warning that pharmaceutical companies would be at risk under the federal antikickback statute if they paid all or a portion of a Medicare beneficiary's Part D cost sharing for their company's products. But the OIG bulletin outlined alternative program designs that would allow Medicare beneficiaries to continue to receive assistance.

“The bulletin also makes clear that pharmaceutical companies may choose to provide free or reduced-price drugs to financially needy Part D beneficiaries, [as] long as the assistance program is properly structured and the free or reduced-price drugs are provided entirely outside the Part D benefit,” the CMS statement said.

In addition, the recent OIG guidance does not apply to uninsured patients and Medicare beneficiaries who have not enrolled in the Part D benefit.

But pharmaceutical companies are looking for additional information from both CMS and OIG to explain how companies can continue their current patient assistance programs to help Medicare beneficiaries.

Pharmaceutical companies should not end their patient assistance programs because of the implementation of the Medicare Part D prescription drug program, according to a statement from the Centers for Medicare and Medicaid Services.

Companies can continue to provide free and reduced-cost drugs to Medicare beneficiaries as long as it is done outside of the Part D benefit.

For example, a pharmaceutical company can provide coverage for certain drugs that are part of the Medicare Part D benefit, but no claims for payment can be filed with the Medicare Part D drug plan for that medication and the cost of the medication will not be counted toward the beneficiary's true out-of-pocket costs, according to CMS.

The Department of Health and Human Services' Office of Inspector General (OIG) issued a special advisory bulletin last November warning that pharmaceutical companies would be at risk under the federal antikickback statute if they paid all or a portion of a Medicare beneficiary's Part D cost sharing for their company's products. But the OIG bulletin outlined alternative program designs that would allow Medicare beneficiaries to continue to receive assistance.

“The bulletin also makes clear that pharmaceutical companies may choose to provide free or reduced-price drugs to financially needy Part D beneficiaries, [as] long as the assistance program is properly structured and the free or reduced-price drugs are provided entirely outside the Part D benefit,” the CMS statement said.

In addition, the recent OIG guidance does not apply to uninsured patients and Medicare beneficiaries who have not enrolled in the Part D benefit.

But pharmaceutical companies are looking for additional information from both CMS and OIG to explain how companies can continue their current patient assistance programs to help Medicare beneficiaries.

Bill Halts 4.4% Medicare Cut

Congress' long-awaited passage of the budget reconciliation package 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.”

President's Health Care Agenda

The federal government has a responsibility to provide health care for the poor and the elderly, as well as confront its rising costs, strengthen the doctor-patient relationship, and help people afford insurance coverage, President Bush said in his State of the Union Address. Medical associations praised the president for his pledge to make broader use of electronic health records and calling medical liability reform a priority. “America's medical liability insurance crisis is hurting the women of this country and limiting their access to the obstetrician-gynecologists who care for them,” Dr. Michael T. Mennuti, president of the American College of Obstetricians and Gynecologists, said in a statement. But Ron Pollack, executive director of the consumer group Families USA, noted that the president failed to mention the recent efforts by the White House and Congress to cut Medicaid funding. “These Medicaid cuts will drive many low-income seniors and children out of the system and leave millions of people without any health care coverage whatsoever.”

Courts Overturn Partial Birth Ban Again

Federal appeals courts in California and New York recently upheld lower court rulings that the “Partial Birth Abortion Ban Act of 2003” is unconstitutional. In the New York case, the court ruled that the ban must contain an exception for the health of the woman and asked for additional legal briefs. The California court struck down the ban. “We are pleased that both courts have recognized that this ban needs an exception to protect women's health,” Vicki Saporta, president and CEO of the National Abortion Federation, said in a statement. “Doctors and women should be able to make medical decisions free from interference by politicians.” Last year, a third appeal of the statute also was struck down. That case has been sent to the Supreme Court. At press time, there was no word on whether the court would agree to hear the case.

Kansas Court Backs Abortion Privacy

Reproductive rights groups are claiming victory in Kansas after the state's Supreme Court ruled that all patient-identifying information must be removed before medical records can be reviewed by a local district court as part of an investigation launched by the state's attorney general. Kansas Attorney General Phill Kline had been seeking the full patient files of 90 girls and women who obtained abortions at two women's health clinics in 2003 as part of an investigation aimed at uncovering alleged unjustified late-term abortions and possible unreported child abuse. The two clinics that are targets of Mr. Kline's investigation—Comprehensive Health of Planned Parenthood and Wichita's Women's Health Services—have been fighting the subpoena, saying that it violates the privacy of their patients.

CVD Awareness by Women 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. Among 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. 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.”

Bill Halts 4.4% Medicare Cut

Congress' long-awaited passage of the budget reconciliation package 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.”

President's Health Care Agenda

The federal government has a responsibility to provide health care for the poor and the elderly, as well as confront its rising costs, strengthen the doctor-patient relationship, and help people afford insurance coverage, President Bush said in his State of the Union Address. Medical associations praised the president for his pledge to make broader use of electronic health records and calling medical liability reform a priority. “America's medical liability insurance crisis is hurting the women of this country and limiting their access to the obstetrician-gynecologists who care for them,” Dr. Michael T. Mennuti, president of the American College of Obstetricians and Gynecologists, said in a statement. But Ron Pollack, executive director of the consumer group Families USA, noted that the president failed to mention the recent efforts by the White House and Congress to cut Medicaid funding. “These Medicaid cuts will drive many low-income seniors and children out of the system and leave millions of people without any health care coverage whatsoever.”

Courts Overturn Partial Birth Ban Again

Federal appeals courts in California and New York recently upheld lower court rulings that the “Partial Birth Abortion Ban Act of 2003” is unconstitutional. In the New York case, the court ruled that the ban must contain an exception for the health of the woman and asked for additional legal briefs. The California court struck down the ban. “We are pleased that both courts have recognized that this ban needs an exception to protect women's health,” Vicki Saporta, president and CEO of the National Abortion Federation, said in a statement. “Doctors and women should be able to make medical decisions free from interference by politicians.” Last year, a third appeal of the statute also was struck down. That case has been sent to the Supreme Court. At press time, there was no word on whether the court would agree to hear the case.

Kansas Court Backs Abortion Privacy

Reproductive rights groups are claiming victory in Kansas after the state's Supreme Court ruled that all patient-identifying information must be removed before medical records can be reviewed by a local district court as part of an investigation launched by the state's attorney general. Kansas Attorney General Phill Kline had been seeking the full patient files of 90 girls and women who obtained abortions at two women's health clinics in 2003 as part of an investigation aimed at uncovering alleged unjustified late-term abortions and possible unreported child abuse. The two clinics that are targets of Mr. Kline's investigation—Comprehensive Health of Planned Parenthood and Wichita's Women's Health Services—have been fighting the subpoena, saying that it violates the privacy of their patients.

CVD Awareness by Women 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. Among 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. 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.”

Bill Halts 4.4% Medicare Cut

Congress' long-awaited passage of the budget reconciliation package 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.”

President's Health Care Agenda

The federal government has a responsibility to provide health care for the poor and the elderly, as well as confront its rising costs, strengthen the doctor-patient relationship, and help people afford insurance coverage, President Bush said in his State of the Union Address. Medical associations praised the president for his pledge to make broader use of electronic health records and calling medical liability reform a priority. “America's medical liability insurance crisis is hurting the women of this country and limiting their access to the obstetrician-gynecologists who care for them,” Dr. Michael T. Mennuti, president of the American College of Obstetricians and Gynecologists, said in a statement. But Ron Pollack, executive director of the consumer group Families USA, noted that the president failed to mention the recent efforts by the White House and Congress to cut Medicaid funding. “These Medicaid cuts will drive many low-income seniors and children out of the system and leave millions of people without any health care coverage whatsoever.”

Courts Overturn Partial Birth Ban Again

Federal appeals courts in California and New York recently upheld lower court rulings that the “Partial Birth Abortion Ban Act of 2003” is unconstitutional. In the New York case, the court ruled that the ban must contain an exception for the health of the woman and asked for additional legal briefs. The California court struck down the ban. “We are pleased that both courts have recognized that this ban needs an exception to protect women's health,” Vicki Saporta, president and CEO of the National Abortion Federation, said in a statement. “Doctors and women should be able to make medical decisions free from interference by politicians.” Last year, a third appeal of the statute also was struck down. That case has been sent to the Supreme Court. At press time, there was no word on whether the court would agree to hear the case.

Kansas Court Backs Abortion Privacy

Reproductive rights groups are claiming victory in Kansas after the state's Supreme Court ruled that all patient-identifying information must be removed before medical records can be reviewed by a local district court as part of an investigation launched by the state's attorney general. Kansas Attorney General Phill Kline had been seeking the full patient files of 90 girls and women who obtained abortions at two women's health clinics in 2003 as part of an investigation aimed at uncovering alleged unjustified late-term abortions and possible unreported child abuse. The two clinics that are targets of Mr. Kline's investigation—Comprehensive Health of Planned Parenthood and Wichita's Women's Health Services—have been fighting the subpoena, saying that it violates the privacy of their patients.

CVD Awareness by Women 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. Among 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. 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.”

LAS VEGAS — Medicare officials implemented a new five-step process for appealing Medicare Part B claims the same day the drug program went into effect.

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 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.

For an in-person hearing, requests must be made before the hearing date is set and explain why a telephone or video hearing is not acceptable. 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. Previously, physicians who wanted to appeal a decision beyond the ALJ would have to go to federal district court, 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.

The new process applies only to initial claims determinations issued and mailed on or after Jan. 1, Mr. Gaines said.

LAS VEGAS — Medicare officials implemented a new five-step process for appealing Medicare Part B claims the same day the drug program went into effect.

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 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.

For an in-person hearing, requests must be made before the hearing date is set and explain why a telephone or video hearing is not acceptable. 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. Previously, physicians who wanted to appeal a decision beyond the ALJ would have to go to federal district court, 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.

The new process applies only to initial claims determinations issued and mailed on or after Jan. 1, Mr. Gaines said.

LAS VEGAS — Medicare officials implemented a new five-step process for appealing Medicare Part B claims the same day the drug program went into effect.

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 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.

For an in-person hearing, requests must be made before the hearing date is set and explain why a telephone or video hearing is not acceptable. 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. Previously, physicians who wanted to appeal a decision beyond the ALJ would have to go to federal district court, 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.

The new process applies only to initial claims determinations issued and mailed on or after Jan. 1, 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 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, he 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 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.

The new process applies only to initial claims determinations issued and mailed on or after Jan. 1, so it will take several months to evaluate how the 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 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, he 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 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.

The new process applies only to initial claims determinations issued and mailed on or after Jan. 1, so it will take several months to evaluate how the 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 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, he 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 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.

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

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. Although 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.”

And On to the 2007 Budget

The president's 2007 budget request for the Department of Health and Human Services—$698 billion—is a $58 billion increase from 2006, but it contains a number of cost-containment measures that would either whittle down or cut certain programs entirely. A series of Medicare initiatives to “encourage efficient and appropriate payment for services; foster competition; and promote beneficiary involvement in their health care decisions” would save nearly $36 billion from 2007 to 2011, according to a statement from HHS. But Part A hospital payments would incur $22 billion of these cuts, which is “the wrong policy at the wrong time,” given that hospitals have been losing money caring for Medicare beneficiaries since 2003, said Chip Kahn, president of the Federation of American Hospitals. In an attempt to meet President Bush's goal of cutting the federal deficit in half by 2009, the budget request proposes other targeted reductions or the elimination of certain programs whose performance ratings were low or whose purposes are being covered by other HHS programs. These cuts include $133 million to rural health programs run by the Health Resources and Services Administration, and the elimination of the $630 million Community Services Block Grant program. The budget request did ask for more money for some programs. For example, to achieve the president's goal for most Americans to have secure personal electronic medical health records by 2014, $169 million was requested for 2007 ($59 million more than in 2006) for health information technology. The Food and Drug Administration's 2007 budget request totaled $1.95 billion, a $70.8 million or 3.8% increase over 2006.

Arthritis Research Funding

On the flip side, the president's 2007 budget request freezes the overall budget for the National Institutes of Health at $28.5 billion and cuts funding for the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Under the proposal, NIAMS funding would fall from about $508 million in FY 2006 to about $505 million in FY 2007. The president's budget was met with concern by a coalition of medical research-advocacy groups, including the National Health Council and Research!America. The coalition is calling for a 5% increase in NIH funding above its current level to allow research to keep pace with inflation. “Saving a little money today makes no sense when the price we pay tomorrow will surely be much higher in terms of lives that could have been saved and the loss of our competitive edge in medical research,” Myrl Weinberg, president of the National Health Council, said in a statement.

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 SSRIs 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. Although 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.”

And On to the 2007 Budget

The president's 2007 budget request for the Department of Health and Human Services—$698 billion—is a $58 billion increase from 2006, but it contains a number of cost-containment measures that would either whittle down or cut certain programs entirely. A series of Medicare initiatives to “encourage efficient and appropriate payment for services; foster competition; and promote beneficiary involvement in their health care decisions” would save nearly $36 billion from 2007 to 2011, according to a statement from HHS. But Part A hospital payments would incur $22 billion of these cuts, which is “the wrong policy at the wrong time,” given that hospitals have been losing money caring for Medicare beneficiaries since 2003, said Chip Kahn, president of the Federation of American Hospitals. In an attempt to meet President Bush's goal of cutting the federal deficit in half by 2009, the budget request proposes other targeted reductions or the elimination of certain programs whose performance ratings were low or whose purposes are being covered by other HHS programs. These cuts include $133 million to rural health programs run by the Health Resources and Services Administration, and the elimination of the $630 million Community Services Block Grant program. The budget request did ask for more money for some programs. For example, to achieve the president's goal for most Americans to have secure personal electronic medical health records by 2014, $169 million was requested for 2007 ($59 million more than in 2006) for health information technology. The Food and Drug Administration's 2007 budget request totaled $1.95 billion, a $70.8 million or 3.8% increase over 2006.

Arthritis Research Funding

On the flip side, the president's 2007 budget request freezes the overall budget for the National Institutes of Health at $28.5 billion and cuts funding for the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Under the proposal, NIAMS funding would fall from about $508 million in FY 2006 to about $505 million in FY 2007. The president's budget was met with concern by a coalition of medical research-advocacy groups, including the National Health Council and Research!America. The coalition is calling for a 5% increase in NIH funding above its current level to allow research to keep pace with inflation. “Saving a little money today makes no sense when the price we pay tomorrow will surely be much higher in terms of lives that could have been saved and the loss of our competitive edge in medical research,” Myrl Weinberg, president of the National Health Council, said in a statement.

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 SSRIs 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. Although 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.”

And On to the 2007 Budget

The president's 2007 budget request for the Department of Health and Human Services—$698 billion—is a $58 billion increase from 2006, but it contains a number of cost-containment measures that would either whittle down or cut certain programs entirely. A series of Medicare initiatives to “encourage efficient and appropriate payment for services; foster competition; and promote beneficiary involvement in their health care decisions” would save nearly $36 billion from 2007 to 2011, according to a statement from HHS. But Part A hospital payments would incur $22 billion of these cuts, which is “the wrong policy at the wrong time,” given that hospitals have been losing money caring for Medicare beneficiaries since 2003, said Chip Kahn, president of the Federation of American Hospitals. In an attempt to meet President Bush's goal of cutting the federal deficit in half by 2009, the budget request proposes other targeted reductions or the elimination of certain programs whose performance ratings were low or whose purposes are being covered by other HHS programs. These cuts include $133 million to rural health programs run by the Health Resources and Services Administration, and the elimination of the $630 million Community Services Block Grant program. The budget request did ask for more money for some programs. For example, to achieve the president's goal for most Americans to have secure personal electronic medical health records by 2014, $169 million was requested for 2007 ($59 million more than in 2006) for health information technology. The Food and Drug Administration's 2007 budget request totaled $1.95 billion, a $70.8 million or 3.8% increase over 2006.

Arthritis Research Funding

On the flip side, the president's 2007 budget request freezes the overall budget for the National Institutes of Health at $28.5 billion and cuts funding for the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Under the proposal, NIAMS funding would fall from about $508 million in FY 2006 to about $505 million in FY 2007. The president's budget was met with concern by a coalition of medical research-advocacy groups, including the National Health Council and Research!America. The coalition is calling for a 5% increase in NIH funding above its current level to allow research to keep pace with inflation. “Saving a little money today makes no sense when the price we pay tomorrow will surely be much higher in terms of lives that could have been saved and the loss of our competitive edge in medical research,” Myrl Weinberg, president of the National Health Council, said in a statement.

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 SSRIs and serotonin/norepinephrine reuptake inhibitors. The USP model guidelines are available online at

www.usp.org

NEW YORK — Physicians may be getting more options for the treatment of idiopathic pulmonary fibrosis as more therapies come down the research pipeline, Dr. Paul F. Simonelli said at a conference on pulmonary and critical care medicine sponsored by Columbia University.

Among the therapies under evaluation in recently completed or ongoing clinical trials for idiopathic pulmonary fibrosis (IPF), are interferon-gamma-1b, N-acetylcysteine, bosentan, etanercept, and imatinib. In addition, there are some molecules, such as pirfenidone, being tested that currently have no other approved uses, said Dr. Simonelli of Columbia University (New York).

The development of new therapies is critical because there are no approved treatments for IPF and the standard approaches are not getting results, he said.

“IPF is a serious disease. It's a debilitating disease, and up to now we've had no effective therapy,” Dr. Simonelli said.

The prevalence of the disease is about 83,000 cases in the United States with about 31,000 new cases each year. And the disease has a mortality worse than that of almost any other major disease, except lung cancer. Patients with IPF face a 5-year survivorship of less than 50%, Dr. Simonelli said.

The majority of available data relates to the use of interferon-gamma-1b in IPF. An earlier phase III trial of about 330 patients showed no difference between the drug and placebo for the trial's primary endpoint of progression-free survival (N. Engl. J. Med. 2004;350:125–33). However, a subgroup analysis indicated possible survival benefits with the drug. A second phase III trial looking at survival as the primary end point is underway, and the drug maker InterMune is recruiting patients.

A European study showed promising results for N-acetylcysteine in treating IPF. The drug showed improvement in vital capacity and diffusing capacity compared to treatment with prednisone and azathioprine (N. Engl. J. Med. 2005;353:2229–42). But Dr. Simonelli said the results are hard to interpret since the standard of care in Europe is the use of prednisone and azathioprine instead of a true placebo.

Another much-discussed possible treatment is pirfenidone. Three trials have been conducted on the drug—an open-label phase II trial in North America, a Japanese trial stopped early because patients on placebo were experiencing severe exacerbations, and a third trial ongoing in Europe. Additional trials of the drug are expected to begin in the United States sometime this year.

NEW YORK — Physicians may be getting more options for the treatment of idiopathic pulmonary fibrosis as more therapies come down the research pipeline, Dr. Paul F. Simonelli said at a conference on pulmonary and critical care medicine sponsored by Columbia University.

Among the therapies under evaluation in recently completed or ongoing clinical trials for idiopathic pulmonary fibrosis (IPF), are interferon-gamma-1b, N-acetylcysteine, bosentan, etanercept, and imatinib. In addition, there are some molecules, such as pirfenidone, being tested that currently have no other approved uses, said Dr. Simonelli of Columbia University (New York).

The development of new therapies is critical because there are no approved treatments for IPF and the standard approaches are not getting results, he said.

“IPF is a serious disease. It's a debilitating disease, and up to now we've had no effective therapy,” Dr. Simonelli said.

The prevalence of the disease is about 83,000 cases in the United States with about 31,000 new cases each year. And the disease has a mortality worse than that of almost any other major disease, except lung cancer. Patients with IPF face a 5-year survivorship of less than 50%, Dr. Simonelli said.

The majority of available data relates to the use of interferon-gamma-1b in IPF. An earlier phase III trial of about 330 patients showed no difference between the drug and placebo for the trial's primary endpoint of progression-free survival (N. Engl. J. Med. 2004;350:125–33). However, a subgroup analysis indicated possible survival benefits with the drug. A second phase III trial looking at survival as the primary end point is underway, and the drug maker InterMune is recruiting patients.

A European study showed promising results for N-acetylcysteine in treating IPF. The drug showed improvement in vital capacity and diffusing capacity compared to treatment with prednisone and azathioprine (N. Engl. J. Med. 2005;353:2229–42). But Dr. Simonelli said the results are hard to interpret since the standard of care in Europe is the use of prednisone and azathioprine instead of a true placebo.

Another much-discussed possible treatment is pirfenidone. Three trials have been conducted on the drug—an open-label phase II trial in North America, a Japanese trial stopped early because patients on placebo were experiencing severe exacerbations, and a third trial ongoing in Europe. Additional trials of the drug are expected to begin in the United States sometime this year.

NEW YORK — Physicians may be getting more options for the treatment of idiopathic pulmonary fibrosis as more therapies come down the research pipeline, Dr. Paul F. Simonelli said at a conference on pulmonary and critical care medicine sponsored by Columbia University.

Among the therapies under evaluation in recently completed or ongoing clinical trials for idiopathic pulmonary fibrosis (IPF), are interferon-gamma-1b, N-acetylcysteine, bosentan, etanercept, and imatinib. In addition, there are some molecules, such as pirfenidone, being tested that currently have no other approved uses, said Dr. Simonelli of Columbia University (New York).

The development of new therapies is critical because there are no approved treatments for IPF and the standard approaches are not getting results, he said.

“IPF is a serious disease. It's a debilitating disease, and up to now we've had no effective therapy,” Dr. Simonelli said.

The prevalence of the disease is about 83,000 cases in the United States with about 31,000 new cases each year. And the disease has a mortality worse than that of almost any other major disease, except lung cancer. Patients with IPF face a 5-year survivorship of less than 50%, Dr. Simonelli said.

The majority of available data relates to the use of interferon-gamma-1b in IPF. An earlier phase III trial of about 330 patients showed no difference between the drug and placebo for the trial's primary endpoint of progression-free survival (N. Engl. J. Med. 2004;350:125–33). However, a subgroup analysis indicated possible survival benefits with the drug. A second phase III trial looking at survival as the primary end point is underway, and the drug maker InterMune is recruiting patients.

A European study showed promising results for N-acetylcysteine in treating IPF. The drug showed improvement in vital capacity and diffusing capacity compared to treatment with prednisone and azathioprine (N. Engl. J. Med. 2005;353:2229–42). But Dr. Simonelli said the results are hard to interpret since the standard of care in Europe is the use of prednisone and azathioprine instead of a true placebo.

Another much-discussed possible treatment is pirfenidone. Three trials have been conducted on the drug—an open-label phase II trial in North America, a Japanese trial stopped early because patients on placebo were experiencing severe exacerbations, and a third trial ongoing in Europe. Additional trials of the drug are expected to begin in the United States sometime this year.