Mary Ellen Schneider

Some Medicare beneficiaries may still qualify for extra help in purchasing drugs through patient assistance programs, despite the new Medicare Part D drug benefit that started Jan. 1.

But pharmaceutical manufacturers that offer assistance will have to tread carefully to avoid running afoul of the federal antikickback statute, according to a special advisory bulletin from the Department of Health and Human Services' Office of Inspector General.

In the bulletin, Inspector General Daniel R. Levinson said that it would raise serious concerns if the manufacturer of a drug covered under the Part D program were to subsidize cost-sharing amounts for its product.

In the meantime, drug manufacturers that operate patient assistance programs do not need to rush to disenroll all their Medicare Part D beneficiaries. During the first year of the Medicare drug benefit, OIG officials will take into consideration whether the assistance program is taking “prompt, reasonable, verifiable, and meaningful steps to transition patients who enroll in Part D to alternative assistance models, such as independent charities.”

OIG said the practice of pharmaceutical company-sponsored programs offering assistance to Part D beneficiaries could steer patients to particular drugs, increase costs to Medicare, provide a financial advantage over competing drugs, and reduce beneficiaries' incentives to use less expensive alternatives.

The OIG bulletin also raised questions about the practice of bulk replacement, in which drug makers donate their products to pharmacies, health centers, clinics, and other facilities.

Such programs would need to be evaluated on a case-by-case basis, according to OIG, but these arrangements could potentially violate the antikickback statute if the recipient of the free drugs is in a position to generate federal health care program business for the drug maker.

Alternative program designs could allow Medicare beneficiaries to continue to receive assistance. For example, a pharmaceutical manufacturer could donate its products to an independent, bona fide charity that provides cost-sharing subsidies for Part D drugs. This action would raise few, if any, concerns under the antikickback statute as long as the patient assistance program was not functioning as a conduit for payments by the drug maker and did not unduly influence beneficiaries' drug choices.

Patient assistance programs are also less likely to run into legal trouble if the patients are not receiving Medicare Part D benefits at the same time, OIG said. To prevent the potential for fraud and abuse in this case, the patient assistance program would need to notify the Part D plan that the drug is being provided so that no payment is made and the cost of the subsidized drug is not counted toward the beneficiary's true out-of-pocket costs.

Some Medicare beneficiaries may still qualify for extra help in purchasing drugs through patient assistance programs, despite the new Medicare Part D drug benefit that started Jan. 1.

But pharmaceutical manufacturers that offer assistance will have to tread carefully to avoid running afoul of the federal antikickback statute, according to a special advisory bulletin from the Department of Health and Human Services' Office of Inspector General.

In the bulletin, Inspector General Daniel R. Levinson said that it would raise serious concerns if the manufacturer of a drug covered under the Part D program were to subsidize cost-sharing amounts for its product.

In the meantime, drug manufacturers that operate patient assistance programs do not need to rush to disenroll all their Medicare Part D beneficiaries. During the first year of the Medicare drug benefit, OIG officials will take into consideration whether the assistance program is taking “prompt, reasonable, verifiable, and meaningful steps to transition patients who enroll in Part D to alternative assistance models, such as independent charities.”

OIG said the practice of pharmaceutical company-sponsored programs offering assistance to Part D beneficiaries could steer patients to particular drugs, increase costs to Medicare, provide a financial advantage over competing drugs, and reduce beneficiaries' incentives to use less expensive alternatives.

The OIG bulletin also raised questions about the practice of bulk replacement, in which drug makers donate their products to pharmacies, health centers, clinics, and other facilities.

Such programs would need to be evaluated on a case-by-case basis, according to OIG, but these arrangements could potentially violate the antikickback statute if the recipient of the free drugs is in a position to generate federal health care program business for the drug maker.

Alternative program designs could allow Medicare beneficiaries to continue to receive assistance. For example, a pharmaceutical manufacturer could donate its products to an independent, bona fide charity that provides cost-sharing subsidies for Part D drugs. This action would raise few, if any, concerns under the antikickback statute as long as the patient assistance program was not functioning as a conduit for payments by the drug maker and did not unduly influence beneficiaries' drug choices.

Patient assistance programs are also less likely to run into legal trouble if the patients are not receiving Medicare Part D benefits at the same time, OIG said. To prevent the potential for fraud and abuse in this case, the patient assistance program would need to notify the Part D plan that the drug is being provided so that no payment is made and the cost of the subsidized drug is not counted toward the beneficiary's true out-of-pocket costs.

Some Medicare beneficiaries may still qualify for extra help in purchasing drugs through patient assistance programs, despite the new Medicare Part D drug benefit that started Jan. 1.

But pharmaceutical manufacturers that offer assistance will have to tread carefully to avoid running afoul of the federal antikickback statute, according to a special advisory bulletin from the Department of Health and Human Services' Office of Inspector General.

In the bulletin, Inspector General Daniel R. Levinson said that it would raise serious concerns if the manufacturer of a drug covered under the Part D program were to subsidize cost-sharing amounts for its product.

In the meantime, drug manufacturers that operate patient assistance programs do not need to rush to disenroll all their Medicare Part D beneficiaries. During the first year of the Medicare drug benefit, OIG officials will take into consideration whether the assistance program is taking “prompt, reasonable, verifiable, and meaningful steps to transition patients who enroll in Part D to alternative assistance models, such as independent charities.”

OIG said the practice of pharmaceutical company-sponsored programs offering assistance to Part D beneficiaries could steer patients to particular drugs, increase costs to Medicare, provide a financial advantage over competing drugs, and reduce beneficiaries' incentives to use less expensive alternatives.

The OIG bulletin also raised questions about the practice of bulk replacement, in which drug makers donate their products to pharmacies, health centers, clinics, and other facilities.

Such programs would need to be evaluated on a case-by-case basis, according to OIG, but these arrangements could potentially violate the antikickback statute if the recipient of the free drugs is in a position to generate federal health care program business for the drug maker.

Alternative program designs could allow Medicare beneficiaries to continue to receive assistance. For example, a pharmaceutical manufacturer could donate its products to an independent, bona fide charity that provides cost-sharing subsidies for Part D drugs. This action would raise few, if any, concerns under the antikickback statute as long as the patient assistance program was not functioning as a conduit for payments by the drug maker and did not unduly influence beneficiaries' drug choices.

Patient assistance programs are also less likely to run into legal trouble if the patients are not receiving Medicare Part D benefits at the same time, OIG said. To prevent the potential for fraud and abuse in this case, the patient assistance program would need to notify the Part D plan that the drug is being provided so that no payment is made and the cost of the subsidized drug is not counted toward the beneficiary's true out-of-pocket costs.

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

Over time, government officials would like to implement a real-time nationwide public health monitoring system.

“The system we have is simply not adequate,” Mike Leavitt, secretary of the Health and Human Services department, said at a meeting of the American Health Information Community. The United States faces not only the possibility of a bioterrorist attack but also the threat of pandemic, he said.

Mr. Leavitt said he would like to get a “spotty net” of surveillance off the ground quickly by collecting a few key indicators from as many electronic data sources as possible. Getting just 2–4 basic data points from all available sources would be a “quantum leap forward,” he said.

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

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

A wide range of biosurveillance activities is underway at the federal, state, and local levels, and in the private sector, Dr. Frieden said. For example, the Centers for Disease Control and Prevention operates the Public Health Information Network, which provides an architecture for public health information technology. The agency recently established the BioSense program, aimed at supporting the connection of clinical care to public health and supporting “situational awareness” at the national level. A number of state and local health departments have begun electronic reporting from clinical laboratories or clinical information systems.

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

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

New York City is not alone. North Carolina has a statewide, hospital-based clinical data monitoring system. It allows for monitoring of real-time inpatient, outpatient, and emergency department data. But there are major needs that must be addressed to reach the goal of a nationwide system, Dr. John Loonsk of the federal Office of the National Coordinator for Health Information Technology said at the meeting.

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

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

A 'spotty net' that collects just 2–4 key indicators from all available sources would be a 'quantum leap forward.' MR. LEAVITT

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

Over time, government officials would like to implement a real-time nationwide public health monitoring system.

“The system we have is simply not adequate,” Mike Leavitt, secretary of the Health and Human Services department, said at a meeting of the American Health Information Community. The United States faces not only the possibility of a bioterrorist attack but also the threat of pandemic, he said.

Mr. Leavitt said he would like to get a “spotty net” of surveillance off the ground quickly by collecting a few key indicators from as many electronic data sources as possible. Getting just 2–4 basic data points from all available sources would be a “quantum leap forward,” he said.

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

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

A wide range of biosurveillance activities is underway at the federal, state, and local levels, and in the private sector, Dr. Frieden said. For example, the Centers for Disease Control and Prevention operates the Public Health Information Network, which provides an architecture for public health information technology. The agency recently established the BioSense program, aimed at supporting the connection of clinical care to public health and supporting “situational awareness” at the national level. A number of state and local health departments have begun electronic reporting from clinical laboratories or clinical information systems.

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

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

New York City is not alone. North Carolina has a statewide, hospital-based clinical data monitoring system. It allows for monitoring of real-time inpatient, outpatient, and emergency department data. But there are major needs that must be addressed to reach the goal of a nationwide system, Dr. John Loonsk of the federal Office of the National Coordinator for Health Information Technology said at the meeting.

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

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

A 'spotty net' that collects just 2–4 key indicators from all available sources would be a 'quantum leap forward.' MR. LEAVITT

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

Over time, government officials would like to implement a real-time nationwide public health monitoring system.

“The system we have is simply not adequate,” Mike Leavitt, secretary of the Health and Human Services department, said at a meeting of the American Health Information Community. The United States faces not only the possibility of a bioterrorist attack but also the threat of pandemic, he said.

Mr. Leavitt said he would like to get a “spotty net” of surveillance off the ground quickly by collecting a few key indicators from as many electronic data sources as possible. Getting just 2–4 basic data points from all available sources would be a “quantum leap forward,” he said.

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

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

A wide range of biosurveillance activities is underway at the federal, state, and local levels, and in the private sector, Dr. Frieden said. For example, the Centers for Disease Control and Prevention operates the Public Health Information Network, which provides an architecture for public health information technology. The agency recently established the BioSense program, aimed at supporting the connection of clinical care to public health and supporting “situational awareness” at the national level. A number of state and local health departments have begun electronic reporting from clinical laboratories or clinical information systems.

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

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

New York City is not alone. North Carolina has a statewide, hospital-based clinical data monitoring system. It allows for monitoring of real-time inpatient, outpatient, and emergency department data. But there are major needs that must be addressed to reach the goal of a nationwide system, Dr. John Loonsk of the federal Office of the National Coordinator for Health Information Technology said at the meeting.

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

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

A 'spotty net' that collects just 2–4 key indicators from all available sources would be a 'quantum leap forward.' MR. LEAVITT

Over the next year, leaders in the health information technology community will be working toward creating a basic, consumer-controlled personal health record.

At a Webcast meeting of the American Health Information Community, experts agreed that a personal health record containing an individual's medication history and general demographic information 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.

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

One of the major hurdles in creating secure and portable patient health records is authentication, 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.

In the federal sector, some successful steps have been taken toward creating personal health records, 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 [on this project] with a blank slate,” Dr. Lansky said. Providing patients with electronic medication histories is something that could be done quickly.

The Markle Foundation was one of the groups that helped spearhead efforts to do just that with www.katrinahealth.org

It's helpful that the public already recognizes the value of using this type of information in an emergency situation, Dr. Lansky said.

Providing electronic access to general demographic data or registration information holds the potential for increasing convenience for patients and improving accuracy when sharing information. But privacy issues would need to be addressed and there is the potential for replicating errors, he said.

Over the next year, leaders in the health information technology community will be working toward creating a basic, consumer-controlled personal health record.

At a Webcast meeting of the American Health Information Community, experts agreed that a personal health record containing an individual's medication history and general demographic information 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.

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

One of the major hurdles in creating secure and portable patient health records is authentication, 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.

In the federal sector, some successful steps have been taken toward creating personal health records, 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 [on this project] with a blank slate,” Dr. Lansky said. Providing patients with electronic medication histories is something that could be done quickly.

The Markle Foundation was one of the groups that helped spearhead efforts to do just that with www.katrinahealth.org

It's helpful that the public already recognizes the value of using this type of information in an emergency situation, Dr. Lansky said.

Providing electronic access to general demographic data or registration information holds the potential for increasing convenience for patients and improving accuracy when sharing information. But privacy issues would need to be addressed and there is the potential for replicating errors, he said.

Over the next year, leaders in the health information technology community will be working toward creating a basic, consumer-controlled personal health record.

At a Webcast meeting of the American Health Information Community, experts agreed that a personal health record containing an individual's medication history and general demographic information 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.

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

One of the major hurdles in creating secure and portable patient health records is authentication, 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.

In the federal sector, some successful steps have been taken toward creating personal health records, 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 [on this project] with a blank slate,” Dr. Lansky said. Providing patients with electronic medication histories is something that could be done quickly.

The Markle Foundation was one of the groups that helped spearhead efforts to do just that with www.katrinahealth.org

It's helpful that the public already recognizes the value of using this type of information in an emergency situation, Dr. Lansky said.

Providing electronic access to general demographic data or registration information holds the potential for increasing convenience for patients and improving accuracy when sharing information. But privacy issues would need to be addressed and there is the potential for replicating errors, he said.

2006 Outlook

This year, officials at the American College of Obstetricians and Gynecologists say that they plan to continue work on a number of the society's top priorities from last year. These ongoing issues include medical liability reform, in particular caps on noneconomic damage; Medicare physician payment and pay for performance; imaging; and preserving access to reproductive health services. ACOG officials said that the organization will formally decide on its 2006 legislative and regulatory agenda in February.

Medical Liability Reform

Passage of medical liability reform legislation, particularly caps on noneconomic damages, once again failed to gain traction in the Senate in 2005 despite passage of a bill (H.R. 5) in the House. Shifting priorities in the wake of Hurricane Katrina may have contributed to the lack of attention paid to the issue, said an ACOG government affairs spokesperson. But ACOG officials expect to see a Senate vote this year. The college also will continue to support alternative remedies that don't deal directly with caps such as the Fair and Reliable Medical Justice Act (S. 1337), which was introduced this summer. That bill proposes to fund state demonstration programs to evaluate alternatives to the current medical tort system.

Physician Pay and P4P

At press time, physicians were anticipating a 4.3% cut in Medicare payments in 2006. ACOG officials said the college remains opposed to the pay cut and supports a permanent change to the Sustainable Growth Rate (SGR) formula used to pay physicians under Medicare. If no changes are made to the current formula, physicians can expect to see their Medicare payments cut by about 25% by 2011 while seeing their office expenses increase by 19% over the same time period, according to ACOG. This means that physicians won't have any capital to make investments in information technology and other changes that could improve care. ACOG also opposes pay-for-performance proposals that are tied to the SGR formula, which they consider inadequate. ACOG supports a reasonable pay-for-performance plan but it must be based on a payment formula that reflects the actual cost of medical care, an ACOG government affairs spokesperson said.

Imaging

Another hot topic carrying on into 2006 is who can perform and be paid for imaging. ACOG plans to push for ob.gyns. to continue to provide imaging to patients and to be paid for that service. Some radiology organizations want to restrict who can provide imaging services.

Reproductive Health Access

Access to reproductive health services—in particular, providing information on and access to emergency contraception—also continues to be a top priority at ACOG. Most notably, ACOG continues to support over-the-counter status for the emergency contraceptive Plan B and has condemned the Food and Drug Administration for delaying its decision on the product. The college also is continuing to support access to emergency contraception for rape victims. The Compassionate Assistance for Rape Emergencies Act (H.R. 2928/S. 1264), which was introduced last summer, directs hospitals to provide information on emergency contraception to all sexual assault victims and to offer emergency contraception regardless of the patient's ability to pay.

FDA's Unusual Plan B Review

The FDA's decision in 2004 not to approve the emergency contraception product Plan B for over-the-counter sale was not typical of the 67 other prescription-to-OTC switch decisions made by the agency between 1994 and 2004, according to a report from the Government Accountability Office (GAO). The FDA denied an application to approve Plan B for OTC sale in May 2004 saying that officials had safety concerns about the use of the product in women aged under 16 years. Among the differences is that FDA officials took the rare step of not approving the Rx-to-OTC switch against the advice of its agency's own advisory committee, which had voted to recommend approval of the application. GAO's review also found that the FDA has placed no age-related marketing restrictions for safety reasons on any prescription or OTC contraceptive. But the FDA questioned the integrity of the GAO's investigative process. “The report mischaracterizes facts and does not appear to take into consideration the input provided by the FDA,” an FDA spokesperson said in a statement. “We stand by the original decision to issue a Not Approvable letter to Barr Labs for OTC Plan B.” The FDA is still considering an application by the Plan B manufacturer, Barr Pharmaceuticals Inc., to market Plan B OTC only for women aged 16 and older.

2006 Outlook

This year, officials at the American College of Obstetricians and Gynecologists say that they plan to continue work on a number of the society's top priorities from last year. These ongoing issues include medical liability reform, in particular caps on noneconomic damage; Medicare physician payment and pay for performance; imaging; and preserving access to reproductive health services. ACOG officials said that the organization will formally decide on its 2006 legislative and regulatory agenda in February.

Medical Liability Reform

Passage of medical liability reform legislation, particularly caps on noneconomic damages, once again failed to gain traction in the Senate in 2005 despite passage of a bill (H.R. 5) in the House. Shifting priorities in the wake of Hurricane Katrina may have contributed to the lack of attention paid to the issue, said an ACOG government affairs spokesperson. But ACOG officials expect to see a Senate vote this year. The college also will continue to support alternative remedies that don't deal directly with caps such as the Fair and Reliable Medical Justice Act (S. 1337), which was introduced this summer. That bill proposes to fund state demonstration programs to evaluate alternatives to the current medical tort system.

Physician Pay and P4P

At press time, physicians were anticipating a 4.3% cut in Medicare payments in 2006. ACOG officials said the college remains opposed to the pay cut and supports a permanent change to the Sustainable Growth Rate (SGR) formula used to pay physicians under Medicare. If no changes are made to the current formula, physicians can expect to see their Medicare payments cut by about 25% by 2011 while seeing their office expenses increase by 19% over the same time period, according to ACOG. This means that physicians won't have any capital to make investments in information technology and other changes that could improve care. ACOG also opposes pay-for-performance proposals that are tied to the SGR formula, which they consider inadequate. ACOG supports a reasonable pay-for-performance plan but it must be based on a payment formula that reflects the actual cost of medical care, an ACOG government affairs spokesperson said.

Imaging

Another hot topic carrying on into 2006 is who can perform and be paid for imaging. ACOG plans to push for ob.gyns. to continue to provide imaging to patients and to be paid for that service. Some radiology organizations want to restrict who can provide imaging services.

Reproductive Health Access

Access to reproductive health services—in particular, providing information on and access to emergency contraception—also continues to be a top priority at ACOG. Most notably, ACOG continues to support over-the-counter status for the emergency contraceptive Plan B and has condemned the Food and Drug Administration for delaying its decision on the product. The college also is continuing to support access to emergency contraception for rape victims. The Compassionate Assistance for Rape Emergencies Act (H.R. 2928/S. 1264), which was introduced last summer, directs hospitals to provide information on emergency contraception to all sexual assault victims and to offer emergency contraception regardless of the patient's ability to pay.

FDA's Unusual Plan B Review

The FDA's decision in 2004 not to approve the emergency contraception product Plan B for over-the-counter sale was not typical of the 67 other prescription-to-OTC switch decisions made by the agency between 1994 and 2004, according to a report from the Government Accountability Office (GAO). The FDA denied an application to approve Plan B for OTC sale in May 2004 saying that officials had safety concerns about the use of the product in women aged under 16 years. Among the differences is that FDA officials took the rare step of not approving the Rx-to-OTC switch against the advice of its agency's own advisory committee, which had voted to recommend approval of the application. GAO's review also found that the FDA has placed no age-related marketing restrictions for safety reasons on any prescription or OTC contraceptive. But the FDA questioned the integrity of the GAO's investigative process. “The report mischaracterizes facts and does not appear to take into consideration the input provided by the FDA,” an FDA spokesperson said in a statement. “We stand by the original decision to issue a Not Approvable letter to Barr Labs for OTC Plan B.” The FDA is still considering an application by the Plan B manufacturer, Barr Pharmaceuticals Inc., to market Plan B OTC only for women aged 16 and older.

2006 Outlook

This year, officials at the American College of Obstetricians and Gynecologists say that they plan to continue work on a number of the society's top priorities from last year. These ongoing issues include medical liability reform, in particular caps on noneconomic damage; Medicare physician payment and pay for performance; imaging; and preserving access to reproductive health services. ACOG officials said that the organization will formally decide on its 2006 legislative and regulatory agenda in February.

Medical Liability Reform

Passage of medical liability reform legislation, particularly caps on noneconomic damages, once again failed to gain traction in the Senate in 2005 despite passage of a bill (H.R. 5) in the House. Shifting priorities in the wake of Hurricane Katrina may have contributed to the lack of attention paid to the issue, said an ACOG government affairs spokesperson. But ACOG officials expect to see a Senate vote this year. The college also will continue to support alternative remedies that don't deal directly with caps such as the Fair and Reliable Medical Justice Act (S. 1337), which was introduced this summer. That bill proposes to fund state demonstration programs to evaluate alternatives to the current medical tort system.

Physician Pay and P4P

At press time, physicians were anticipating a 4.3% cut in Medicare payments in 2006. ACOG officials said the college remains opposed to the pay cut and supports a permanent change to the Sustainable Growth Rate (SGR) formula used to pay physicians under Medicare. If no changes are made to the current formula, physicians can expect to see their Medicare payments cut by about 25% by 2011 while seeing their office expenses increase by 19% over the same time period, according to ACOG. This means that physicians won't have any capital to make investments in information technology and other changes that could improve care. ACOG also opposes pay-for-performance proposals that are tied to the SGR formula, which they consider inadequate. ACOG supports a reasonable pay-for-performance plan but it must be based on a payment formula that reflects the actual cost of medical care, an ACOG government affairs spokesperson said.

Imaging

Another hot topic carrying on into 2006 is who can perform and be paid for imaging. ACOG plans to push for ob.gyns. to continue to provide imaging to patients and to be paid for that service. Some radiology organizations want to restrict who can provide imaging services.

Reproductive Health Access

Access to reproductive health services—in particular, providing information on and access to emergency contraception—also continues to be a top priority at ACOG. Most notably, ACOG continues to support over-the-counter status for the emergency contraceptive Plan B and has condemned the Food and Drug Administration for delaying its decision on the product. The college also is continuing to support access to emergency contraception for rape victims. The Compassionate Assistance for Rape Emergencies Act (H.R. 2928/S. 1264), which was introduced last summer, directs hospitals to provide information on emergency contraception to all sexual assault victims and to offer emergency contraception regardless of the patient's ability to pay.

FDA's Unusual Plan B Review

The FDA's decision in 2004 not to approve the emergency contraception product Plan B for over-the-counter sale was not typical of the 67 other prescription-to-OTC switch decisions made by the agency between 1994 and 2004, according to a report from the Government Accountability Office (GAO). The FDA denied an application to approve Plan B for OTC sale in May 2004 saying that officials had safety concerns about the use of the product in women aged under 16 years. Among the differences is that FDA officials took the rare step of not approving the Rx-to-OTC switch against the advice of its agency's own advisory committee, which had voted to recommend approval of the application. GAO's review also found that the FDA has placed no age-related marketing restrictions for safety reasons on any prescription or OTC contraceptive. But the FDA questioned the integrity of the GAO's investigative process. “The report mischaracterizes facts and does not appear to take into consideration the input provided by the FDA,” an FDA spokesperson said in a statement. “We stand by the original decision to issue a Not Approvable letter to Barr Labs for OTC Plan B.” The FDA is still considering an application by the Plan B manufacturer, Barr Pharmaceuticals Inc., to market Plan B OTC only for women aged 16 and older.

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

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

Mr. Leavitt said he would like to get a “spotty net” of surveillance off the ground quickly by collecting a few key indicators from as many electronic data sources as possible. Getting just 2–4 basic data points from all available sources would be a “quantum leap forward,” he said.

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

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

Currently, there is a wide range of biosurveillance activities underway at the federal, state, and local levels, and in the private sector, Dr. Frieden said. For example, the Centers for Disease Control and Prevention operates the Public Health Information Network, which provides an architecture for public health information technology. Mostly recently, the agency established the BioSense program which is aimed at supporting the connection of clinical care to public health and supporting “situational awareness” at the national level.

A number of state and local health departments have begun electronic reporting either from clinical laboratories or clinical information systems. In New York City, the health department uses electronic reporting data on a daily basis. The system, which has been operating for more than 5 years, collects information from ambulance dispatches, emergency department visits, pharmacy purchases, outpatient visits, and other sources. The system also collects free text, which allows officials to evaluate information they might not have thought about otherwise.

Currently, 50 hospitals—representing about 90% of emergency department visits in the city—report daily.

The electronic reporting system has proved helpful in the early detection of pockets of influenza. The electronic syndromic system consistently picks up influenza activity 2–3 weeks before any other system.

North Carolina has a statewide, hospital-based real-time clinical data monitoring system of inpatient, outpatient, and emergency department data.

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

Data need to be standardized so they can be compared across reporting organizations, privacy and confidentially must be ensured, and improvements need to be made in the current patchwork of state and local health information technology capability. Electronic reporting of lab results could be implemented rapidly, Dr. Loonsk said. This has value both to public health and for the routine use of clinicians, he said.

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

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

Mr. Leavitt said he would like to get a “spotty net” of surveillance off the ground quickly by collecting a few key indicators from as many electronic data sources as possible. Getting just 2–4 basic data points from all available sources would be a “quantum leap forward,” he said.

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

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

Currently, there is a wide range of biosurveillance activities underway at the federal, state, and local levels, and in the private sector, Dr. Frieden said. For example, the Centers for Disease Control and Prevention operates the Public Health Information Network, which provides an architecture for public health information technology. Mostly recently, the agency established the BioSense program which is aimed at supporting the connection of clinical care to public health and supporting “situational awareness” at the national level.

A number of state and local health departments have begun electronic reporting either from clinical laboratories or clinical information systems. In New York City, the health department uses electronic reporting data on a daily basis. The system, which has been operating for more than 5 years, collects information from ambulance dispatches, emergency department visits, pharmacy purchases, outpatient visits, and other sources. The system also collects free text, which allows officials to evaluate information they might not have thought about otherwise.

Currently, 50 hospitals—representing about 90% of emergency department visits in the city—report daily.

The electronic reporting system has proved helpful in the early detection of pockets of influenza. The electronic syndromic system consistently picks up influenza activity 2–3 weeks before any other system.

North Carolina has a statewide, hospital-based real-time clinical data monitoring system of inpatient, outpatient, and emergency department data.

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

Data need to be standardized so they can be compared across reporting organizations, privacy and confidentially must be ensured, and improvements need to be made in the current patchwork of state and local health information technology capability. Electronic reporting of lab results could be implemented rapidly, Dr. Loonsk said. This has value both to public health and for the routine use of clinicians, he said.

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

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

Mr. Leavitt said he would like to get a “spotty net” of surveillance off the ground quickly by collecting a few key indicators from as many electronic data sources as possible. Getting just 2–4 basic data points from all available sources would be a “quantum leap forward,” he said.

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

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

Currently, there is a wide range of biosurveillance activities underway at the federal, state, and local levels, and in the private sector, Dr. Frieden said. For example, the Centers for Disease Control and Prevention operates the Public Health Information Network, which provides an architecture for public health information technology. Mostly recently, the agency established the BioSense program which is aimed at supporting the connection of clinical care to public health and supporting “situational awareness” at the national level.

A number of state and local health departments have begun electronic reporting either from clinical laboratories or clinical information systems. In New York City, the health department uses electronic reporting data on a daily basis. The system, which has been operating for more than 5 years, collects information from ambulance dispatches, emergency department visits, pharmacy purchases, outpatient visits, and other sources. The system also collects free text, which allows officials to evaluate information they might not have thought about otherwise.

Currently, 50 hospitals—representing about 90% of emergency department visits in the city—report daily.

The electronic reporting system has proved helpful in the early detection of pockets of influenza. The electronic syndromic system consistently picks up influenza activity 2–3 weeks before any other system.

North Carolina has a statewide, hospital-based real-time clinical data monitoring system of inpatient, outpatient, and emergency department data.

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

Data need to be standardized so they can be compared across reporting organizations, privacy and confidentially must be ensured, and improvements need to be made in the current patchwork of state and local health information technology capability. Electronic reporting of lab results could be implemented rapidly, Dr. Loonsk said. This has value both to public health and for the routine use of clinicians, he said.

The net effect of new guidelines from the American Academy of Neurology that outline the qualifications and proper conduct for neurologists offering medical expert testimony may be to make neurologists less likely to serve that function at trial, according to one lawyer.

John Vail, senior litigation counsel for the Center for Constitutional Litigation P.C., agrees that AAN's existing guidelines, in place since 1989, have made it harder to find willing experts. The revisions won't change that.

The efforts by medical societies in this arena are “punitive and very dangerous,” according to Mr. Vail.

The AAN guidelines, more than those issued by other medical groups, seem to be trying to narrow the definition of what makes a medical expert, he said. Mr. Vail said that if AAN officials want to change the way courts define experts, they should address it with the courts, not by trying to constrain their own members.

Dr. Michael A. Williams, a member of AAN's grievance committee, which developed the guidelines, said in an interview that neurologists who violate the provisions of the guidelines while they are members of the academy could face disciplinary action by the AAN ranging from a warning letter to expulsion.

And the guidelines specify that testimony by a medical expert generates a public record that is subject to peer review and could be the basis for disciplinary action not just from professional organizations, but also from courts and licensing agencies.

Members of AAN's grievance committee, who review a range of complaints from members and patients, noticed an increase in the number of complaints specifically related to expert medical testimony given by members. AAN also wanted to address some gaps in the previous policy statement addressing expert witness testimony, which hadn't been updated since 1989, Dr. Williams said.

“We want neurologists to participate in expert witness testimony,” said Dr. Williams of the neurology department at Johns Hopkins University, Baltimore. When done properly, an expert witness can assist the court in finding the facts of the case, he said. The purpose of the AAN guidelines is simply to let neurologists know how to perform that role properly, he said.

The AAN guidelines outline a number of qualifications for a medical expert, including:

▸ An expert should have a valid and unrestricted license to practice medicine.

▸ The expert witness should be a diplomate of a specialty board recognized by the American Board of Medical Specialties or the American Osteopathic Association or a board with equivalent standards, and should be qualified in the subject matter of the case.

▸ Experts who are not active in clinical practice should be prepared to demonstrate competence; recent relevant publications or active teaching experience can apply.

▸ Medical experts who spend more than 20% of their professional time on medicolegal activities should be prepared to demonstrate competence.

The AAN guidelines also call on neurologists offering testimony to state whether an opinion is based on their personal clinical experience, published information, practice guidelines, or a prevailing expert opinion. Physicians should also disclose when their opinion represents a minority view on the standard of care, according to the guidelines.

And while physicians can be reasonably compensated for their time and effort, they shouldn't have a financial stake in the outcome of the case. Contingency fees, which tie the level of payment to the outcome of the case, are unethical, according to the guidelines.

AAN officials reviewed guidelines from a number of different medical societies, discussed their own experiences, and identified gaps in the 1989 guidelines, Dr. Williams said.

Neurologists are not the only medical specialists taking this issue seriously. One of the oldest and most comprehensive policies on expert witnesses comes from the American Association of Neurological Surgeons (AANS).

AANS's expert witness guidelines were developed in 1983. Members who are found to have violated the guidelines by giving false testimony can be censured or expelled by the group, according to AANS general counsel Russell M. Pelton.

The net effect of new guidelines from the American Academy of Neurology that outline the qualifications and proper conduct for neurologists offering medical expert testimony may be to make neurologists less likely to serve that function at trial, according to one lawyer.

John Vail, senior litigation counsel for the Center for Constitutional Litigation P.C., agrees that AAN's existing guidelines, in place since 1989, have made it harder to find willing experts. The revisions won't change that.

The efforts by medical societies in this arena are “punitive and very dangerous,” according to Mr. Vail.

The AAN guidelines, more than those issued by other medical groups, seem to be trying to narrow the definition of what makes a medical expert, he said. Mr. Vail said that if AAN officials want to change the way courts define experts, they should address it with the courts, not by trying to constrain their own members.

Dr. Michael A. Williams, a member of AAN's grievance committee, which developed the guidelines, said in an interview that neurologists who violate the provisions of the guidelines while they are members of the academy could face disciplinary action by the AAN ranging from a warning letter to expulsion.

And the guidelines specify that testimony by a medical expert generates a public record that is subject to peer review and could be the basis for disciplinary action not just from professional organizations, but also from courts and licensing agencies.

Members of AAN's grievance committee, who review a range of complaints from members and patients, noticed an increase in the number of complaints specifically related to expert medical testimony given by members. AAN also wanted to address some gaps in the previous policy statement addressing expert witness testimony, which hadn't been updated since 1989, Dr. Williams said.

“We want neurologists to participate in expert witness testimony,” said Dr. Williams of the neurology department at Johns Hopkins University, Baltimore. When done properly, an expert witness can assist the court in finding the facts of the case, he said. The purpose of the AAN guidelines is simply to let neurologists know how to perform that role properly, he said.

The AAN guidelines outline a number of qualifications for a medical expert, including:

▸ An expert should have a valid and unrestricted license to practice medicine.

▸ The expert witness should be a diplomate of a specialty board recognized by the American Board of Medical Specialties or the American Osteopathic Association or a board with equivalent standards, and should be qualified in the subject matter of the case.

▸ Experts who are not active in clinical practice should be prepared to demonstrate competence; recent relevant publications or active teaching experience can apply.

▸ Medical experts who spend more than 20% of their professional time on medicolegal activities should be prepared to demonstrate competence.

The AAN guidelines also call on neurologists offering testimony to state whether an opinion is based on their personal clinical experience, published information, practice guidelines, or a prevailing expert opinion. Physicians should also disclose when their opinion represents a minority view on the standard of care, according to the guidelines.

And while physicians can be reasonably compensated for their time and effort, they shouldn't have a financial stake in the outcome of the case. Contingency fees, which tie the level of payment to the outcome of the case, are unethical, according to the guidelines.

AAN officials reviewed guidelines from a number of different medical societies, discussed their own experiences, and identified gaps in the 1989 guidelines, Dr. Williams said.

Neurologists are not the only medical specialists taking this issue seriously. One of the oldest and most comprehensive policies on expert witnesses comes from the American Association of Neurological Surgeons (AANS).

AANS's expert witness guidelines were developed in 1983. Members who are found to have violated the guidelines by giving false testimony can be censured or expelled by the group, according to AANS general counsel Russell M. Pelton.

The net effect of new guidelines from the American Academy of Neurology that outline the qualifications and proper conduct for neurologists offering medical expert testimony may be to make neurologists less likely to serve that function at trial, according to one lawyer.

John Vail, senior litigation counsel for the Center for Constitutional Litigation P.C., agrees that AAN's existing guidelines, in place since 1989, have made it harder to find willing experts. The revisions won't change that.

The efforts by medical societies in this arena are “punitive and very dangerous,” according to Mr. Vail.

The AAN guidelines, more than those issued by other medical groups, seem to be trying to narrow the definition of what makes a medical expert, he said. Mr. Vail said that if AAN officials want to change the way courts define experts, they should address it with the courts, not by trying to constrain their own members.

Dr. Michael A. Williams, a member of AAN's grievance committee, which developed the guidelines, said in an interview that neurologists who violate the provisions of the guidelines while they are members of the academy could face disciplinary action by the AAN ranging from a warning letter to expulsion.

And the guidelines specify that testimony by a medical expert generates a public record that is subject to peer review and could be the basis for disciplinary action not just from professional organizations, but also from courts and licensing agencies.

Members of AAN's grievance committee, who review a range of complaints from members and patients, noticed an increase in the number of complaints specifically related to expert medical testimony given by members. AAN also wanted to address some gaps in the previous policy statement addressing expert witness testimony, which hadn't been updated since 1989, Dr. Williams said.

“We want neurologists to participate in expert witness testimony,” said Dr. Williams of the neurology department at Johns Hopkins University, Baltimore. When done properly, an expert witness can assist the court in finding the facts of the case, he said. The purpose of the AAN guidelines is simply to let neurologists know how to perform that role properly, he said.

The AAN guidelines outline a number of qualifications for a medical expert, including:

▸ An expert should have a valid and unrestricted license to practice medicine.

▸ The expert witness should be a diplomate of a specialty board recognized by the American Board of Medical Specialties or the American Osteopathic Association or a board with equivalent standards, and should be qualified in the subject matter of the case.

▸ Experts who are not active in clinical practice should be prepared to demonstrate competence; recent relevant publications or active teaching experience can apply.

▸ Medical experts who spend more than 20% of their professional time on medicolegal activities should be prepared to demonstrate competence.

The AAN guidelines also call on neurologists offering testimony to state whether an opinion is based on their personal clinical experience, published information, practice guidelines, or a prevailing expert opinion. Physicians should also disclose when their opinion represents a minority view on the standard of care, according to the guidelines.

And while physicians can be reasonably compensated for their time and effort, they shouldn't have a financial stake in the outcome of the case. Contingency fees, which tie the level of payment to the outcome of the case, are unethical, according to the guidelines.

AAN officials reviewed guidelines from a number of different medical societies, discussed their own experiences, and identified gaps in the 1989 guidelines, Dr. Williams said.

Neurologists are not the only medical specialists taking this issue seriously. One of the oldest and most comprehensive policies on expert witnesses comes from the American Association of Neurological Surgeons (AANS).

AANS's expert witness guidelines were developed in 1983. Members who are found to have violated the guidelines by giving false testimony can be censured or expelled by the group, according to AANS general counsel Russell M. Pelton.

Some Medicare beneficiaries may still qualify for extra help in purchasing drugs through patient assistance programs, despite the new Medicare Part D drug benefit that started Jan. 1.

But pharmaceutical manufacturers that offer assistance will have to tread carefully to avoid running afoul of the federal antikickback statute, according to a special advisory bulletin from the Department of Health and Human Services' Office of Inspector General.

In the bulletin, Inspector General Daniel R. Levinson said that it would raise serious concerns if the manufacturer of a drug covered under the Part D program were to subsidize cost-sharing amounts for its product.

In the meantime, drug manufacturers that operate patient assistance programs do not need to rush to disenroll all their Medicare Part D beneficiaries. During the first year of the Medicare drug benefit, OIG officials will take into consideration whether the assistance program is taking “prompt, reasonable, verifiable, and meaningful steps to transition patients who enroll in Part D to alternative assistance models, such as independent charities.”

OIG said the practice of pharmaceutical company-sponsored programs offering assistance to Part D beneficiaries could steer patients to particular drugs, increase costs to Medicare, provide a financial advantage over competing drugs, and reduce beneficiaries' incentives to use less expensive alternatives.

The OIG bulletin also raised questions about the practice of bulk replacement in which drug makers donate their products to pharmacies, health centers, clinics, and other facilities.

Such programs would need to be evaluated on a case-by-case basis, according to OIG, but these arrangements could potentially violate the antikickback statute if the recipient of the free drugs is in a position to generate federal health care program business for the drug maker.

Alternative program designs could allow Medicare beneficiaries to continue to receive assistance. For example, a pharmaceutical manufacturer could donate its products to an independent, bona fide charity that provides cost-sharing subsidies for Part D drugs.

This action would raise few, if any, concerns under the antikickback statute as long as the patient assistance program was not functioning as a conduit for payments by the drug maker and did not unduly influence beneficiaries' drug choices.

Patient assistance programs are also less likely to run into legal trouble if the patients are not receiving Medicare Part D benefits at the same time, OIG said.

To eliminate the potential for fraud and abuse in such a case, the patient assistance program would need to notify the Part D plan that the drug is being provided so that no payment would be made and the cost of the subsidized drug would not be counted toward the beneficiary's true out-of-pocket costs.

Some Medicare beneficiaries may still qualify for extra help in purchasing drugs through patient assistance programs, despite the new Medicare Part D drug benefit that started Jan. 1.

But pharmaceutical manufacturers that offer assistance will have to tread carefully to avoid running afoul of the federal antikickback statute, according to a special advisory bulletin from the Department of Health and Human Services' Office of Inspector General.

In the bulletin, Inspector General Daniel R. Levinson said that it would raise serious concerns if the manufacturer of a drug covered under the Part D program were to subsidize cost-sharing amounts for its product.

In the meantime, drug manufacturers that operate patient assistance programs do not need to rush to disenroll all their Medicare Part D beneficiaries. During the first year of the Medicare drug benefit, OIG officials will take into consideration whether the assistance program is taking “prompt, reasonable, verifiable, and meaningful steps to transition patients who enroll in Part D to alternative assistance models, such as independent charities.”

OIG said the practice of pharmaceutical company-sponsored programs offering assistance to Part D beneficiaries could steer patients to particular drugs, increase costs to Medicare, provide a financial advantage over competing drugs, and reduce beneficiaries' incentives to use less expensive alternatives.

The OIG bulletin also raised questions about the practice of bulk replacement in which drug makers donate their products to pharmacies, health centers, clinics, and other facilities.

Such programs would need to be evaluated on a case-by-case basis, according to OIG, but these arrangements could potentially violate the antikickback statute if the recipient of the free drugs is in a position to generate federal health care program business for the drug maker.

Alternative program designs could allow Medicare beneficiaries to continue to receive assistance. For example, a pharmaceutical manufacturer could donate its products to an independent, bona fide charity that provides cost-sharing subsidies for Part D drugs.

This action would raise few, if any, concerns under the antikickback statute as long as the patient assistance program was not functioning as a conduit for payments by the drug maker and did not unduly influence beneficiaries' drug choices.

Patient assistance programs are also less likely to run into legal trouble if the patients are not receiving Medicare Part D benefits at the same time, OIG said.

To eliminate the potential for fraud and abuse in such a case, the patient assistance program would need to notify the Part D plan that the drug is being provided so that no payment would be made and the cost of the subsidized drug would not be counted toward the beneficiary's true out-of-pocket costs.

Some Medicare beneficiaries may still qualify for extra help in purchasing drugs through patient assistance programs, despite the new Medicare Part D drug benefit that started Jan. 1.

But pharmaceutical manufacturers that offer assistance will have to tread carefully to avoid running afoul of the federal antikickback statute, according to a special advisory bulletin from the Department of Health and Human Services' Office of Inspector General.

In the bulletin, Inspector General Daniel R. Levinson said that it would raise serious concerns if the manufacturer of a drug covered under the Part D program were to subsidize cost-sharing amounts for its product.

In the meantime, drug manufacturers that operate patient assistance programs do not need to rush to disenroll all their Medicare Part D beneficiaries. During the first year of the Medicare drug benefit, OIG officials will take into consideration whether the assistance program is taking “prompt, reasonable, verifiable, and meaningful steps to transition patients who enroll in Part D to alternative assistance models, such as independent charities.”

OIG said the practice of pharmaceutical company-sponsored programs offering assistance to Part D beneficiaries could steer patients to particular drugs, increase costs to Medicare, provide a financial advantage over competing drugs, and reduce beneficiaries' incentives to use less expensive alternatives.

The OIG bulletin also raised questions about the practice of bulk replacement in which drug makers donate their products to pharmacies, health centers, clinics, and other facilities.

Such programs would need to be evaluated on a case-by-case basis, according to OIG, but these arrangements could potentially violate the antikickback statute if the recipient of the free drugs is in a position to generate federal health care program business for the drug maker.

Alternative program designs could allow Medicare beneficiaries to continue to receive assistance. For example, a pharmaceutical manufacturer could donate its products to an independent, bona fide charity that provides cost-sharing subsidies for Part D drugs.

This action would raise few, if any, concerns under the antikickback statute as long as the patient assistance program was not functioning as a conduit for payments by the drug maker and did not unduly influence beneficiaries' drug choices.

Patient assistance programs are also less likely to run into legal trouble if the patients are not receiving Medicare Part D benefits at the same time, OIG said.

To eliminate the potential for fraud and abuse in such a case, the patient assistance program would need to notify the Part D plan that the drug is being provided so that no payment would be made and the cost of the subsidized drug would not be counted toward the beneficiary's true out-of-pocket costs.

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 authentication, 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. Lansky said.

The Markle Foundation was one of the groups that helped spearhead efforts to do just that with www.katrinahealth.org

It's helpful that the public already recognizes the value of using this type of information in an emergency situation, Dr. Lansky said.

Providing electronic access to general demographic data or registration information holds the potential for increasing convenience for patients and improving accuracy when sharing information. But privacy issues would need to be addressed and there is the potential for replicating errors, he said.

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 authentication, 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. Lansky said.

The Markle Foundation was one of the groups that helped spearhead efforts to do just that with www.katrinahealth.org

It's helpful that the public already recognizes the value of using this type of information in an emergency situation, Dr. Lansky said.

Providing electronic access to general demographic data or registration information holds the potential for increasing convenience for patients and improving accuracy when sharing information. But privacy issues would need to be addressed and there is the potential for replicating errors, he said.

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 authentication, 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. Lansky said.

The Markle Foundation was one of the groups that helped spearhead efforts to do just that with www.katrinahealth.org

It's helpful that the public already recognizes the value of using this type of information in an emergency situation, Dr. Lansky said.

Providing electronic access to general demographic data or registration information holds the potential for increasing convenience for patients and improving accuracy when sharing information. But privacy issues would need to be addressed and there is the potential for replicating errors, he said.

Physician payments under Medicare, passing arthritis-related legislation, and increasing governmental sponsorship of research will top the legislative agenda for the American College of Rheumatology this year.

Medicare Physician Pay

Along with many other medical specialty societies, the American College of Rheumatology's top legislative priority this year is to find a fix for the sustainable growth rate (SGR) formula used to calculate physician payments under Medicare, according to Dr. Joseph Flood, chair of ACR's government affairs committee and a member of the clinical faculty at Ohio State University in Columbus. The SGR has led to a 4.4% cut in physician pay under Medicare this year even as physicians face increased costs. But this is especially tough on rheumatologists, who bill mostly for evaluation and management codes and have high overhead costs, Dr. Flood said. “Our margin is so tight,” he said. But Dr. Flood said he is cautiously optimistic about the prospects of reforming the payment system this year because members of Congress are generally more responsive in an election year and because some of the major issues of 2005, like Hurricane Katrina response, will be more settled.

Arthritis Legislation

ACR officials said they also plan to focus on winning passage for the Arthritis Prevention, Control and Cure Act of 2005 (H.R. 583/S. 424). The legislation would create greater access to education and more outreach, and aims to address the shortage of pediatric rheumatologists through loan forgiveness. The bill has a lot of cosponsors, Dr. Flood said, but has yet to make it to the floor for a vote.

Research Funding

Increasing government sponsorship of research is another key ACR priority for 2006, Dr. Flood said. Government sponsorship of research projects, through the National Institutes of Health, is essential to encourage continued research in rheumatology, he said. In the meantime, Dr. Flood said that ACR is developing its own research agenda and funding researchers through its Research and Education Foundation.

Quality Indicators

On the regulatory side, officials at ACR are working with the Centers for Medicare and Medicaid Services to compile appropriate indicators of quality for rheumatic disease care. An ACR committee focused on quality of care has been working on this issue and is already compiling a list of quality indicators for major diseases in rheumatology. Dr. Flood said they would like to work with CMS to develop a possible pilot project to test some of these indicators.

Infusion Therapy

Another important area for rheumatologists in 2006 will be compensation for infusion therapy. Dr. Flood said that officials at ACR are continuing to work with CMS in an effort to gain better compensation for performing infusions. For a year, CMS has been paying physicians the average sales price plus 6% for Part B drugs administered to Medicare patients. Dr. Flood said that ACR is pushing for a continued refinement of the payment methodology to ensure that physicians in smaller practices aren't penalized. For instance, physicians in small practices may not get the best prices because they don't order drugs in bulk. Also, smaller practices have higher overhead because they can't achieve the same economies of scale as larger practices. Continuing to refine the payment system in this area is especially important as new infusion drugs enter the market, Dr. Flood said.

Part D Enrollment Begins

Starting in November, Medicare beneficiaries began enrolling in prescription drug plans as part of the new Medicare Part D benefit that began this month. Beneficiaries who enroll in drug plans by the end of 2005 can begin receiving benefits on Jan. 1, but individuals who haven't made up their minds can continue to enroll until May 15, 2006. As the enrollment period kicked off, the health insurance industry was optimistic. Karen Ignagni, president and CEO of America's Health Insurance Plans, said its members' health plans were seeing higher than expected numbers of calls from Medicare beneficiaries with questions about the plans. And the questions are specific, with beneficiaries asking about drug availability, which pharmacies are participating in plans, and how much their out-of-pocket expenses will be with a plan, Ms. Ignagni said at a press conference. She recommended that Medicare beneficiaries who are evaluating different prescription drug plans consider five issues: Do they have drug coverage now? What drugs do they take? Do they purchase drugs from a particular pharmacy? How much will they pay in out-of-pocket costs for a particular plan? And do they want to stay in traditional Medicare and choose a separate drug plan or switch to a Medicare managed care plan that includes prescription drugs, physician services, and hospital care?

New Head for FDA Women's Health

Dr. Kathleen Uhl has been named director of the Office of Women's Health at the Food and Drug Administration. Dr. Uhl, a family physician and a captain in the U.S. Public Health Service, most recently served as a supervisory medical officer in the FDA's Center for Drug Evaluation and Research. “Kathleen brings a breadth of professional experience, as well as a strong science background and passion for women's health, to her new position,” said FDA Acting Commissioner Dr. Andrew von Eschenbach. Dr. Uhl's experience includes clinical practice, basic science and clinical research, drug application review, drug safety oversight, and women's health issues. She also has dual faculty appointments at the Uniformed Services University of the Health Sciences in family medicine and internal medicine.

Physician payments under Medicare, passing arthritis-related legislation, and increasing governmental sponsorship of research will top the legislative agenda for the American College of Rheumatology this year.

Medicare Physician Pay

Along with many other medical specialty societies, the American College of Rheumatology's top legislative priority this year is to find a fix for the sustainable growth rate (SGR) formula used to calculate physician payments under Medicare, according to Dr. Joseph Flood, chair of ACR's government affairs committee and a member of the clinical faculty at Ohio State University in Columbus. The SGR has led to a 4.4% cut in physician pay under Medicare this year even as physicians face increased costs. But this is especially tough on rheumatologists, who bill mostly for evaluation and management codes and have high overhead costs, Dr. Flood said. “Our margin is so tight,” he said. But Dr. Flood said he is cautiously optimistic about the prospects of reforming the payment system this year because members of Congress are generally more responsive in an election year and because some of the major issues of 2005, like Hurricane Katrina response, will be more settled.

Arthritis Legislation

ACR officials said they also plan to focus on winning passage for the Arthritis Prevention, Control and Cure Act of 2005 (H.R. 583/S. 424). The legislation would create greater access to education and more outreach, and aims to address the shortage of pediatric rheumatologists through loan forgiveness. The bill has a lot of cosponsors, Dr. Flood said, but has yet to make it to the floor for a vote.

Research Funding

Increasing government sponsorship of research is another key ACR priority for 2006, Dr. Flood said. Government sponsorship of research projects, through the National Institutes of Health, is essential to encourage continued research in rheumatology, he said. In the meantime, Dr. Flood said that ACR is developing its own research agenda and funding researchers through its Research and Education Foundation.

Quality Indicators

On the regulatory side, officials at ACR are working with the Centers for Medicare and Medicaid Services to compile appropriate indicators of quality for rheumatic disease care. An ACR committee focused on quality of care has been working on this issue and is already compiling a list of quality indicators for major diseases in rheumatology. Dr. Flood said they would like to work with CMS to develop a possible pilot project to test some of these indicators.

Infusion Therapy

Another important area for rheumatologists in 2006 will be compensation for infusion therapy. Dr. Flood said that officials at ACR are continuing to work with CMS in an effort to gain better compensation for performing infusions. For a year, CMS has been paying physicians the average sales price plus 6% for Part B drugs administered to Medicare patients. Dr. Flood said that ACR is pushing for a continued refinement of the payment methodology to ensure that physicians in smaller practices aren't penalized. For instance, physicians in small practices may not get the best prices because they don't order drugs in bulk. Also, smaller practices have higher overhead because they can't achieve the same economies of scale as larger practices. Continuing to refine the payment system in this area is especially important as new infusion drugs enter the market, Dr. Flood said.

Part D Enrollment Begins

Starting in November, Medicare beneficiaries began enrolling in prescription drug plans as part of the new Medicare Part D benefit that began this month. Beneficiaries who enroll in drug plans by the end of 2005 can begin receiving benefits on Jan. 1, but individuals who haven't made up their minds can continue to enroll until May 15, 2006. As the enrollment period kicked off, the health insurance industry was optimistic. Karen Ignagni, president and CEO of America's Health Insurance Plans, said its members' health plans were seeing higher than expected numbers of calls from Medicare beneficiaries with questions about the plans. And the questions are specific, with beneficiaries asking about drug availability, which pharmacies are participating in plans, and how much their out-of-pocket expenses will be with a plan, Ms. Ignagni said at a press conference. She recommended that Medicare beneficiaries who are evaluating different prescription drug plans consider five issues: Do they have drug coverage now? What drugs do they take? Do they purchase drugs from a particular pharmacy? How much will they pay in out-of-pocket costs for a particular plan? And do they want to stay in traditional Medicare and choose a separate drug plan or switch to a Medicare managed care plan that includes prescription drugs, physician services, and hospital care?

New Head for FDA Women's Health

Dr. Kathleen Uhl has been named director of the Office of Women's Health at the Food and Drug Administration. Dr. Uhl, a family physician and a captain in the U.S. Public Health Service, most recently served as a supervisory medical officer in the FDA's Center for Drug Evaluation and Research. “Kathleen brings a breadth of professional experience, as well as a strong science background and passion for women's health, to her new position,” said FDA Acting Commissioner Dr. Andrew von Eschenbach. Dr. Uhl's experience includes clinical practice, basic science and clinical research, drug application review, drug safety oversight, and women's health issues. She also has dual faculty appointments at the Uniformed Services University of the Health Sciences in family medicine and internal medicine.

Physician payments under Medicare, passing arthritis-related legislation, and increasing governmental sponsorship of research will top the legislative agenda for the American College of Rheumatology this year.

Medicare Physician Pay

Along with many other medical specialty societies, the American College of Rheumatology's top legislative priority this year is to find a fix for the sustainable growth rate (SGR) formula used to calculate physician payments under Medicare, according to Dr. Joseph Flood, chair of ACR's government affairs committee and a member of the clinical faculty at Ohio State University in Columbus. The SGR has led to a 4.4% cut in physician pay under Medicare this year even as physicians face increased costs. But this is especially tough on rheumatologists, who bill mostly for evaluation and management codes and have high overhead costs, Dr. Flood said. “Our margin is so tight,” he said. But Dr. Flood said he is cautiously optimistic about the prospects of reforming the payment system this year because members of Congress are generally more responsive in an election year and because some of the major issues of 2005, like Hurricane Katrina response, will be more settled.

Arthritis Legislation

ACR officials said they also plan to focus on winning passage for the Arthritis Prevention, Control and Cure Act of 2005 (H.R. 583/S. 424). The legislation would create greater access to education and more outreach, and aims to address the shortage of pediatric rheumatologists through loan forgiveness. The bill has a lot of cosponsors, Dr. Flood said, but has yet to make it to the floor for a vote.

Research Funding

Increasing government sponsorship of research is another key ACR priority for 2006, Dr. Flood said. Government sponsorship of research projects, through the National Institutes of Health, is essential to encourage continued research in rheumatology, he said. In the meantime, Dr. Flood said that ACR is developing its own research agenda and funding researchers through its Research and Education Foundation.

Quality Indicators

On the regulatory side, officials at ACR are working with the Centers for Medicare and Medicaid Services to compile appropriate indicators of quality for rheumatic disease care. An ACR committee focused on quality of care has been working on this issue and is already compiling a list of quality indicators for major diseases in rheumatology. Dr. Flood said they would like to work with CMS to develop a possible pilot project to test some of these indicators.

Infusion Therapy

Another important area for rheumatologists in 2006 will be compensation for infusion therapy. Dr. Flood said that officials at ACR are continuing to work with CMS in an effort to gain better compensation for performing infusions. For a year, CMS has been paying physicians the average sales price plus 6% for Part B drugs administered to Medicare patients. Dr. Flood said that ACR is pushing for a continued refinement of the payment methodology to ensure that physicians in smaller practices aren't penalized. For instance, physicians in small practices may not get the best prices because they don't order drugs in bulk. Also, smaller practices have higher overhead because they can't achieve the same economies of scale as larger practices. Continuing to refine the payment system in this area is especially important as new infusion drugs enter the market, Dr. Flood said.

Part D Enrollment Begins

Starting in November, Medicare beneficiaries began enrolling in prescription drug plans as part of the new Medicare Part D benefit that began this month. Beneficiaries who enroll in drug plans by the end of 2005 can begin receiving benefits on Jan. 1, but individuals who haven't made up their minds can continue to enroll until May 15, 2006. As the enrollment period kicked off, the health insurance industry was optimistic. Karen Ignagni, president and CEO of America's Health Insurance Plans, said its members' health plans were seeing higher than expected numbers of calls from Medicare beneficiaries with questions about the plans. And the questions are specific, with beneficiaries asking about drug availability, which pharmacies are participating in plans, and how much their out-of-pocket expenses will be with a plan, Ms. Ignagni said at a press conference. She recommended that Medicare beneficiaries who are evaluating different prescription drug plans consider five issues: Do they have drug coverage now? What drugs do they take? Do they purchase drugs from a particular pharmacy? How much will they pay in out-of-pocket costs for a particular plan? And do they want to stay in traditional Medicare and choose a separate drug plan or switch to a Medicare managed care plan that includes prescription drugs, physician services, and hospital care?

New Head for FDA Women's Health

Dr. Kathleen Uhl has been named director of the Office of Women's Health at the Food and Drug Administration. Dr. Uhl, a family physician and a captain in the U.S. Public Health Service, most recently served as a supervisory medical officer in the FDA's Center for Drug Evaluation and Research. “Kathleen brings a breadth of professional experience, as well as a strong science background and passion for women's health, to her new position,” said FDA Acting Commissioner Dr. Andrew von Eschenbach. Dr. Uhl's experience includes clinical practice, basic science and clinical research, drug application review, drug safety oversight, and women's health issues. She also has dual faculty appointments at the Uniformed Services University of the Health Sciences in family medicine and internal medicine.

Outlook 2006

Wide access to imaging, increasing Medicare physician payment, and reforming the medical liability system still top this year's agenda for the American College of Cardiology. “They are all battles that have not yet been won,” said Dr. Pamela S. Douglas, ACC president.

Imaging

Officials at the ACC have partnered with the Coalition for Patient-Centered Imaging, which also includes the American Society of Nuclear Cardiology and the Heart Rhythm Society, to ensure that imaging services are not restricted. Dr. Douglas said officials at the ACC want to ensure that all properly trained physicians continue to be able to perform and be paid for imaging services. The college has urged Congress to oppose efforts to impose physician certification policies benefiting one specialty over another. ACC officials also have opposed efforts to expand accreditation requirements for independent diagnostic testing facilities to physician offices. But the growth in imaging should be done with quality in mind, Dr. Douglas said.

Physician Payment

Without a fix to the Medicare physician payment system, this year's planned 4.4% cut will be the first of many years of cuts to physician fees for seeing Medicare patients. As a result, Dr. Douglas said ACC supports the elimination of the current Sustainable Growth Rate formula used in calculating physician reimbursement levels. The SGR is tied to changes in the gross domestic products, which does not accurately reflect the cost of providing care to Medicare patients, according to the ACC. Instead, the SGR should be replaced with a medical growth formula, Dr. Douglas said. As cardiovascular care is increasingly successful, patients are living longer but require more care to stay well. But the current payment system fails to recognize the complexity of care delivered by cardiologists, she said.

Medical Liability Reform

ACCofficials have partnered with Doctors for Medical Liability Reform in a multiyear effort to win federal legislation to help curb rising professional liability insurance premiums. Last year, the House moved forward on medical liability reform by passing the Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act (H.R. 5), which would have imposed a $250,000 cap on noneconomic damages. But the issue failed in the Senate.

Pay for Performance

On the regulatory side, Dr. Douglas said ACC favors efforts to develop pay-for-performance programs as long as they are properly designed. But it's key that the programs include incentives for physicians and are not used solely as a way for payers to contain costs. There is a cost to physicians for tracking and reporting quality, Dr. Douglas said, and those costs need to be covered.

Redding Doctors Settle

Four physicians accused of performing unnecessary heart surgeries at Redding (Calif.) Medical Center have agreed to pay a total of approximately $27 million to settle lawsuits. The money will go to compensate patients and the Medicare and Medi-Cal programs. In addition, the Tenet Healthcare Corporation, which used to own Redding Medical Center, will pay $5.5 million. Tenet has already paid $54 million to settle claims that it defrauded the government by billing Medicare for unnecessary cardiac catheterizations and bypass surgeries. Two of the physicians from Redding Medical Center have also agreed to never again perform cardiology procedures or surgeries on Medicare, Medi-Cal, or TRICARE patients. Under the terms of the settlement, the physicians have received a commitment that the U.S. Attorney's Office will not initiate criminal charges against them.

New Head for FDA Women's Health

Dr. Kathleen Uhl has been named director of the Office of Women's Health at the Food and Drug Administration. Dr. Uhl, a family physician and a captain in the U.S. Public Health Service, was most recently a supervisory medical officer in the FDA's Center for Drug Evaluation and Research. “Kathleen brings a breadth of professional experience, as well as a strong science background and passion for women's health, to her new position,” said Dr. Andrew von Eschenbach, FDA acting commissioner. Dr. Uhl's experience includes clinical practice, basic science and clinical research, drug application review, drug safety oversight, and women's health issues. She also has dual faculty appointments at the Uniformed Services University of the Health Sciences in family medicine and internal medicine.

Groups Sue Over Part D

Countless numbers of poor men and women “will fall through the cracks” during transition to the new Part D drug benefit, medical groups stated in a lawsuit against the federal government. More than 6 million “dual-eligible” patients—those who are enrolled in both Medicare and Medicaid—will lose their Medicaid drug coverage on Jan. 1. The groups said they're seeking protections for patients who are not seamlessly and immediately transitioned to the new drug program. “The poorest, sickest, and oldest Americans face grave risk of losing their life-saving medications once the clock strikes twelve on New Year's,” said Robert M. Hayes, president of the Medicare Rights Center, a national consumer service group and one of the plaintiffs. In particular, those beneficiaries who are cognitively impaired or only have a high school diploma will have problems mastering the complexity of the new drug benefit, the lawsuit indicated. A spokesman with the Centers for Medicare and Medicaid Services said the agency was not commenting on the pending lawsuit.

Outlook 2006

Wide access to imaging, increasing Medicare physician payment, and reforming the medical liability system still top this year's agenda for the American College of Cardiology. “They are all battles that have not yet been won,” said Dr. Pamela S. Douglas, ACC president.

Imaging

Officials at the ACC have partnered with the Coalition for Patient-Centered Imaging, which also includes the American Society of Nuclear Cardiology and the Heart Rhythm Society, to ensure that imaging services are not restricted. Dr. Douglas said officials at the ACC want to ensure that all properly trained physicians continue to be able to perform and be paid for imaging services. The college has urged Congress to oppose efforts to impose physician certification policies benefiting one specialty over another. ACC officials also have opposed efforts to expand accreditation requirements for independent diagnostic testing facilities to physician offices. But the growth in imaging should be done with quality in mind, Dr. Douglas said.

Physician Payment

Without a fix to the Medicare physician payment system, this year's planned 4.4% cut will be the first of many years of cuts to physician fees for seeing Medicare patients. As a result, Dr. Douglas said ACC supports the elimination of the current Sustainable Growth Rate formula used in calculating physician reimbursement levels. The SGR is tied to changes in the gross domestic products, which does not accurately reflect the cost of providing care to Medicare patients, according to the ACC. Instead, the SGR should be replaced with a medical growth formula, Dr. Douglas said. As cardiovascular care is increasingly successful, patients are living longer but require more care to stay well. But the current payment system fails to recognize the complexity of care delivered by cardiologists, she said.

Medical Liability Reform

ACCofficials have partnered with Doctors for Medical Liability Reform in a multiyear effort to win federal legislation to help curb rising professional liability insurance premiums. Last year, the House moved forward on medical liability reform by passing the Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act (H.R. 5), which would have imposed a $250,000 cap on noneconomic damages. But the issue failed in the Senate.

Pay for Performance

On the regulatory side, Dr. Douglas said ACC favors efforts to develop pay-for-performance programs as long as they are properly designed. But it's key that the programs include incentives for physicians and are not used solely as a way for payers to contain costs. There is a cost to physicians for tracking and reporting quality, Dr. Douglas said, and those costs need to be covered.

Redding Doctors Settle

Four physicians accused of performing unnecessary heart surgeries at Redding (Calif.) Medical Center have agreed to pay a total of approximately $27 million to settle lawsuits. The money will go to compensate patients and the Medicare and Medi-Cal programs. In addition, the Tenet Healthcare Corporation, which used to own Redding Medical Center, will pay $5.5 million. Tenet has already paid $54 million to settle claims that it defrauded the government by billing Medicare for unnecessary cardiac catheterizations and bypass surgeries. Two of the physicians from Redding Medical Center have also agreed to never again perform cardiology procedures or surgeries on Medicare, Medi-Cal, or TRICARE patients. Under the terms of the settlement, the physicians have received a commitment that the U.S. Attorney's Office will not initiate criminal charges against them.

New Head for FDA Women's Health

Dr. Kathleen Uhl has been named director of the Office of Women's Health at the Food and Drug Administration. Dr. Uhl, a family physician and a captain in the U.S. Public Health Service, was most recently a supervisory medical officer in the FDA's Center for Drug Evaluation and Research. “Kathleen brings a breadth of professional experience, as well as a strong science background and passion for women's health, to her new position,” said Dr. Andrew von Eschenbach, FDA acting commissioner. Dr. Uhl's experience includes clinical practice, basic science and clinical research, drug application review, drug safety oversight, and women's health issues. She also has dual faculty appointments at the Uniformed Services University of the Health Sciences in family medicine and internal medicine.

Groups Sue Over Part D

Countless numbers of poor men and women “will fall through the cracks” during transition to the new Part D drug benefit, medical groups stated in a lawsuit against the federal government. More than 6 million “dual-eligible” patients—those who are enrolled in both Medicare and Medicaid—will lose their Medicaid drug coverage on Jan. 1. The groups said they're seeking protections for patients who are not seamlessly and immediately transitioned to the new drug program. “The poorest, sickest, and oldest Americans face grave risk of losing their life-saving medications once the clock strikes twelve on New Year's,” said Robert M. Hayes, president of the Medicare Rights Center, a national consumer service group and one of the plaintiffs. In particular, those beneficiaries who are cognitively impaired or only have a high school diploma will have problems mastering the complexity of the new drug benefit, the lawsuit indicated. A spokesman with the Centers for Medicare and Medicaid Services said the agency was not commenting on the pending lawsuit.

Outlook 2006

Wide access to imaging, increasing Medicare physician payment, and reforming the medical liability system still top this year's agenda for the American College of Cardiology. “They are all battles that have not yet been won,” said Dr. Pamela S. Douglas, ACC president.

Imaging

Officials at the ACC have partnered with the Coalition for Patient-Centered Imaging, which also includes the American Society of Nuclear Cardiology and the Heart Rhythm Society, to ensure that imaging services are not restricted. Dr. Douglas said officials at the ACC want to ensure that all properly trained physicians continue to be able to perform and be paid for imaging services. The college has urged Congress to oppose efforts to impose physician certification policies benefiting one specialty over another. ACC officials also have opposed efforts to expand accreditation requirements for independent diagnostic testing facilities to physician offices. But the growth in imaging should be done with quality in mind, Dr. Douglas said.

Physician Payment

Without a fix to the Medicare physician payment system, this year's planned 4.4% cut will be the first of many years of cuts to physician fees for seeing Medicare patients. As a result, Dr. Douglas said ACC supports the elimination of the current Sustainable Growth Rate formula used in calculating physician reimbursement levels. The SGR is tied to changes in the gross domestic products, which does not accurately reflect the cost of providing care to Medicare patients, according to the ACC. Instead, the SGR should be replaced with a medical growth formula, Dr. Douglas said. As cardiovascular care is increasingly successful, patients are living longer but require more care to stay well. But the current payment system fails to recognize the complexity of care delivered by cardiologists, she said.

Medical Liability Reform

ACCofficials have partnered with Doctors for Medical Liability Reform in a multiyear effort to win federal legislation to help curb rising professional liability insurance premiums. Last year, the House moved forward on medical liability reform by passing the Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act (H.R. 5), which would have imposed a $250,000 cap on noneconomic damages. But the issue failed in the Senate.

Pay for Performance

On the regulatory side, Dr. Douglas said ACC favors efforts to develop pay-for-performance programs as long as they are properly designed. But it's key that the programs include incentives for physicians and are not used solely as a way for payers to contain costs. There is a cost to physicians for tracking and reporting quality, Dr. Douglas said, and those costs need to be covered.

Redding Doctors Settle

Four physicians accused of performing unnecessary heart surgeries at Redding (Calif.) Medical Center have agreed to pay a total of approximately $27 million to settle lawsuits. The money will go to compensate patients and the Medicare and Medi-Cal programs. In addition, the Tenet Healthcare Corporation, which used to own Redding Medical Center, will pay $5.5 million. Tenet has already paid $54 million to settle claims that it defrauded the government by billing Medicare for unnecessary cardiac catheterizations and bypass surgeries. Two of the physicians from Redding Medical Center have also agreed to never again perform cardiology procedures or surgeries on Medicare, Medi-Cal, or TRICARE patients. Under the terms of the settlement, the physicians have received a commitment that the U.S. Attorney's Office will not initiate criminal charges against them.

New Head for FDA Women's Health

Dr. Kathleen Uhl has been named director of the Office of Women's Health at the Food and Drug Administration. Dr. Uhl, a family physician and a captain in the U.S. Public Health Service, was most recently a supervisory medical officer in the FDA's Center for Drug Evaluation and Research. “Kathleen brings a breadth of professional experience, as well as a strong science background and passion for women's health, to her new position,” said Dr. Andrew von Eschenbach, FDA acting commissioner. Dr. Uhl's experience includes clinical practice, basic science and clinical research, drug application review, drug safety oversight, and women's health issues. She also has dual faculty appointments at the Uniformed Services University of the Health Sciences in family medicine and internal medicine.

Groups Sue Over Part D

Countless numbers of poor men and women “will fall through the cracks” during transition to the new Part D drug benefit, medical groups stated in a lawsuit against the federal government. More than 6 million “dual-eligible” patients—those who are enrolled in both Medicare and Medicaid—will lose their Medicaid drug coverage on Jan. 1. The groups said they're seeking protections for patients who are not seamlessly and immediately transitioned to the new drug program. “The poorest, sickest, and oldest Americans face grave risk of losing their life-saving medications once the clock strikes twelve on New Year's,” said Robert M. Hayes, president of the Medicare Rights Center, a national consumer service group and one of the plaintiffs. In particular, those beneficiaries who are cognitively impaired or only have a high school diploma will have problems mastering the complexity of the new drug benefit, the lawsuit indicated. A spokesman with the Centers for Medicare and Medicaid Services said the agency was not commenting on the pending lawsuit.