Mary Ellen Schneider

The Certification Commission for Healthcare Information Technology has unveiled an initial list of 22 ambulatory electronic health record products that meet its standards for functionality, interoperability, and security.

CCHIT was formed in 2004 by three leading health IT management and technology industry associations. Since last fall, CCHIT has been under contract to the federal government to develop certification criteria for EHRs and evaluate products. The CCHIT process has also been endorsed by the American Academy of Family Physicians, the American College of Physicians, and the American Academy of Pediatrics. In this first round, CCHIT officials gave their seal of approval to 22 products that met all certification standards. Going forward, CCHIT officials will evaluate ambulatory EHR products on a quarterly basis, and are expected to make the next announcement about newly certified EHR systems in late October. In the meantime, the group will begin work on certification for inpatient EHRs and for the network systems that support information exchange between physicians and health care institutions.

The certified products are designed to serve the spectrum of physician practices, Dr. Mark Leavitt, CCHIT chair, said during a press conference. Vendors whose products were certified in this first round received a CCHIT seal of approval that the product met 2006 standards, Dr. Leavitt said. That certification is good for up to 3 years or vendors can come back to CCHIT each year to be certified under the updated standards, he said.

This year's standards included some baseline interoperability functionality related to receiving lab results, but the bulk of the interoperability criteria will be applied starting next year, once standards in this area have been harmonized, he said.

“This certification process provides folks with a short list, if you will,” Dr. Michael S. Barr, vice president of practice advocacy and improvement at the American College of Physicians, said in an interview.

Having a list of certified products reduces some of the risk for physicians buying EHR systems, Dr. Barr said. But it does not mean that physicians shouldn't do their homework when it comes to buying a system, since every practice will be looking for different types of functionality, he said.

Leaders in health IT are quickly approaching the time when they will no longer have to sell people on the benefits of EHRs, he said, but there is a need to continue to talk about the importance of the interoperability of these systems.

The full list of certified products is available at www.cchit.org/certified/2006/CCHIT+Certified+Products+by+Product.htm

The Certification Commission for Healthcare Information Technology has unveiled an initial list of 22 ambulatory electronic health record products that meet its standards for functionality, interoperability, and security.

CCHIT was formed in 2004 by three leading health IT management and technology industry associations. Since last fall, CCHIT has been under contract to the federal government to develop certification criteria for EHRs and evaluate products. The CCHIT process has also been endorsed by the American Academy of Family Physicians, the American College of Physicians, and the American Academy of Pediatrics. In this first round, CCHIT officials gave their seal of approval to 22 products that met all certification standards. Going forward, CCHIT officials will evaluate ambulatory EHR products on a quarterly basis, and are expected to make the next announcement about newly certified EHR systems in late October. In the meantime, the group will begin work on certification for inpatient EHRs and for the network systems that support information exchange between physicians and health care institutions.

The certified products are designed to serve the spectrum of physician practices, Dr. Mark Leavitt, CCHIT chair, said during a press conference. Vendors whose products were certified in this first round received a CCHIT seal of approval that the product met 2006 standards, Dr. Leavitt said. That certification is good for up to 3 years or vendors can come back to CCHIT each year to be certified under the updated standards, he said.

This year's standards included some baseline interoperability functionality related to receiving lab results, but the bulk of the interoperability criteria will be applied starting next year, once standards in this area have been harmonized, he said.

“This certification process provides folks with a short list, if you will,” Dr. Michael S. Barr, vice president of practice advocacy and improvement at the American College of Physicians, said in an interview.

Having a list of certified products reduces some of the risk for physicians buying EHR systems, Dr. Barr said. But it does not mean that physicians shouldn't do their homework when it comes to buying a system, since every practice will be looking for different types of functionality, he said.

Leaders in health IT are quickly approaching the time when they will no longer have to sell people on the benefits of EHRs, he said, but there is a need to continue to talk about the importance of the interoperability of these systems.

The full list of certified products is available at www.cchit.org/certified/2006/CCHIT+Certified+Products+by+Product.htm

The Certification Commission for Healthcare Information Technology has unveiled an initial list of 22 ambulatory electronic health record products that meet its standards for functionality, interoperability, and security.

CCHIT was formed in 2004 by three leading health IT management and technology industry associations. Since last fall, CCHIT has been under contract to the federal government to develop certification criteria for EHRs and evaluate products. The CCHIT process has also been endorsed by the American Academy of Family Physicians, the American College of Physicians, and the American Academy of Pediatrics. In this first round, CCHIT officials gave their seal of approval to 22 products that met all certification standards. Going forward, CCHIT officials will evaluate ambulatory EHR products on a quarterly basis, and are expected to make the next announcement about newly certified EHR systems in late October. In the meantime, the group will begin work on certification for inpatient EHRs and for the network systems that support information exchange between physicians and health care institutions.

The certified products are designed to serve the spectrum of physician practices, Dr. Mark Leavitt, CCHIT chair, said during a press conference. Vendors whose products were certified in this first round received a CCHIT seal of approval that the product met 2006 standards, Dr. Leavitt said. That certification is good for up to 3 years or vendors can come back to CCHIT each year to be certified under the updated standards, he said.

This year's standards included some baseline interoperability functionality related to receiving lab results, but the bulk of the interoperability criteria will be applied starting next year, once standards in this area have been harmonized, he said.

“This certification process provides folks with a short list, if you will,” Dr. Michael S. Barr, vice president of practice advocacy and improvement at the American College of Physicians, said in an interview.

Having a list of certified products reduces some of the risk for physicians buying EHR systems, Dr. Barr said. But it does not mean that physicians shouldn't do their homework when it comes to buying a system, since every practice will be looking for different types of functionality, he said.

Leaders in health IT are quickly approaching the time when they will no longer have to sell people on the benefits of EHRs, he said, but there is a need to continue to talk about the importance of the interoperability of these systems.

The full list of certified products is available at www.cchit.org/certified/2006/CCHIT+Certified+Products+by+Product.htm

Public and private payers may soon be testing reimbursement strategies for secure electronic messaging between clinicians and patients, if the American Health Information Community has anything to say about it.

The group, which advises Health and Human Services Secretary Mike Leavitt on health information technology (IT) interoperability issues, voted to urge payers to pilot-test secure messaging to evaluate possible forms of reimbursement, physician workflow issues, and the impact on patients' involvement in their care.

AHIC also voted to recommend that the Healthcare Information Technology Standards Panel, an independent group that facilitates harmonization of standards, work on defining standards for secure messaging that will be interoperable with electronic health records.

And in an effort to ensure that access to secure messaging is available to all patients and clinicians, AHIC is asking officials at the Health and Human Services Department to look at different methods to address the gaps in access to computers and the Internet for poor and underserved populations and their safety net providers.

AHIC also recommended that the federal government work with state agencies and professional societies to develop new licensing alternatives that address the ability to provide electronic care delivery across state lines through secure messaging systems. This will be especially important in times of national emergency, said Dr. Mark McClellan, administrator of the Centers for Medicare and Medicaid Services and cochair of AHIC's chronic care workgroup.

Public and private payers may soon be testing reimbursement strategies for secure electronic messaging between clinicians and patients, if the American Health Information Community has anything to say about it.

The group, which advises Health and Human Services Secretary Mike Leavitt on health information technology (IT) interoperability issues, voted to urge payers to pilot-test secure messaging to evaluate possible forms of reimbursement, physician workflow issues, and the impact on patients' involvement in their care.

AHIC also voted to recommend that the Healthcare Information Technology Standards Panel, an independent group that facilitates harmonization of standards, work on defining standards for secure messaging that will be interoperable with electronic health records.

And in an effort to ensure that access to secure messaging is available to all patients and clinicians, AHIC is asking officials at the Health and Human Services Department to look at different methods to address the gaps in access to computers and the Internet for poor and underserved populations and their safety net providers.

AHIC also recommended that the federal government work with state agencies and professional societies to develop new licensing alternatives that address the ability to provide electronic care delivery across state lines through secure messaging systems. This will be especially important in times of national emergency, said Dr. Mark McClellan, administrator of the Centers for Medicare and Medicaid Services and cochair of AHIC's chronic care workgroup.

Public and private payers may soon be testing reimbursement strategies for secure electronic messaging between clinicians and patients, if the American Health Information Community has anything to say about it.

The group, which advises Health and Human Services Secretary Mike Leavitt on health information technology (IT) interoperability issues, voted to urge payers to pilot-test secure messaging to evaluate possible forms of reimbursement, physician workflow issues, and the impact on patients' involvement in their care.

AHIC also voted to recommend that the Healthcare Information Technology Standards Panel, an independent group that facilitates harmonization of standards, work on defining standards for secure messaging that will be interoperable with electronic health records.

And in an effort to ensure that access to secure messaging is available to all patients and clinicians, AHIC is asking officials at the Health and Human Services Department to look at different methods to address the gaps in access to computers and the Internet for poor and underserved populations and their safety net providers.

AHIC also recommended that the federal government work with state agencies and professional societies to develop new licensing alternatives that address the ability to provide electronic care delivery across state lines through secure messaging systems. This will be especially important in times of national emergency, said Dr. Mark McClellan, administrator of the Centers for Medicare and Medicaid Services and cochair of AHIC's chronic care workgroup.

In the Dark on the Plan B Plan

Despite the controversy surrounding the proposal to provide Plan B emergency contraception without a prescription, only about one-quarter of Americans in a recent survey said they had heard a lot about the debate. And nearly an equal number said they had heard nothing about the politically charged issue. The survey was commissioned by the Pew Research Center for the People & the Press and the Pew Forum on Religion & Public Life. The survey also found that about 48% of those surveyed favored selling emergency contraception without a prescription, whereas about 41% opposed the idea. The national telephone survey was conducted in July among more than 2,000 U.S. adults.

Fix the SGR, Delay Imaging Cuts

Rep. Michael Burgess (R-Tex.), an ob.gyn., has introduced legislation (H.R. 5866) that would put an end to physician fee cuts under Medicare by halting application of the sustainable growth rate by Jan. 1, 2007. Each year, the SGR has contributed to a decrease in payments; in 2007, that cut will be at least 4.6%. Rep. Burgess is proposing to tie physician fees to one factor only: the Medicare Economic Index minus 1%. According to Rep. Burgess, this places “more value on actual cost inputs.” The bill also would establish a system of quality measures to give patients more information about Medicare providers, delay by 1 year proposed cuts in imaging services reimbursement, and require the Institute of Medicine to perform a study on the question of whether imaging saves money. The American College of Obstetricians and Gynecologists has backed the bill. “Elimination of the SGR is necessary to move forward on reporting on performance indicators and we thank you for recognizing this important link in your legislation,” said Dr. Douglas W. Laube, ACOG president, in a statement.

HIV Treatment Adherence

Educational programs can be effective at improving adherence to HIV drug regimens when the programs are one-on-one and provide practical medication management strategies, according to a review of 19 randomized controlled trials. The literature review, which was published in the Cochrane Library in July, also noted that interventions tended to be successful if they were conducted for longer periods of time, usually 12 weeks or more. Interventions that were performed on a one-on-one basis were successful in improving adherence to medication in 10 out of 15 such studies (67%). Comparatively, in the four studies conducted in group settings, none were successful in improving adherence. The 19 studies reviewed included 2,159 patients. The reviewers did not find evidence to support the use of more “complex psychological constructs” such as self-efficacy, stress management, and motivation. These interventions may be ineffective or take longer to produce an effect, the reviewers wrote.

Screening Knowledge Gap

Most women are unaware of when to receive screening tests such as mammograms and Pap tests, according to the results of a 2005 government survey. But despite the lack of knowledge about when screening is required, women are receiving recommended screening care anyway, the survey found. The Health Information National Trends Survey, developed by the National Cancer Institute, is a nationally representative telephone survey of the general U.S. population conducted in 2002–2003 and 2005. An analysis of the 2005 data showed that 57% of U.S. women were unaware that they should have a mammogram to screen for breast cancer starting at age 40 years. However, 74% said they had received a mammogram within the recommended time period. When it came to Pap smears, most women didn't know they only needed to be screened at least once every 3 years. Instead, 87% of women who had ever received a Pap test said they received it annually as part of their regular exam. “We must significantly increase our efforts to inform all Americans of what cancer screening tests are available so that we can catch cancer in its earliest stages when it is most treatable,” Dr. John E. Niederhuber, acting director of the National Cancer Institute, said in a statement.

Regulating Nanotechnology

The Food and Drug Administration has launched an internal nanotechnology task force aimed at figuring out new regulatory approaches for pharmaceutical products and devices that use nanotechnology materials. Nanotechnology materials measure about 1–100 nm and often have different chemical and physical properties—such as altered magnetic properties and increased chemical and biological activity—than do larger materials, according to the FDA. The agency will kick off its efforts with a public meeting scheduled for Oct. 10.

In the Dark on the Plan B Plan

Despite the controversy surrounding the proposal to provide Plan B emergency contraception without a prescription, only about one-quarter of Americans in a recent survey said they had heard a lot about the debate. And nearly an equal number said they had heard nothing about the politically charged issue. The survey was commissioned by the Pew Research Center for the People & the Press and the Pew Forum on Religion & Public Life. The survey also found that about 48% of those surveyed favored selling emergency contraception without a prescription, whereas about 41% opposed the idea. The national telephone survey was conducted in July among more than 2,000 U.S. adults.

Fix the SGR, Delay Imaging Cuts

Rep. Michael Burgess (R-Tex.), an ob.gyn., has introduced legislation (H.R. 5866) that would put an end to physician fee cuts under Medicare by halting application of the sustainable growth rate by Jan. 1, 2007. Each year, the SGR has contributed to a decrease in payments; in 2007, that cut will be at least 4.6%. Rep. Burgess is proposing to tie physician fees to one factor only: the Medicare Economic Index minus 1%. According to Rep. Burgess, this places “more value on actual cost inputs.” The bill also would establish a system of quality measures to give patients more information about Medicare providers, delay by 1 year proposed cuts in imaging services reimbursement, and require the Institute of Medicine to perform a study on the question of whether imaging saves money. The American College of Obstetricians and Gynecologists has backed the bill. “Elimination of the SGR is necessary to move forward on reporting on performance indicators and we thank you for recognizing this important link in your legislation,” said Dr. Douglas W. Laube, ACOG president, in a statement.

HIV Treatment Adherence

Educational programs can be effective at improving adherence to HIV drug regimens when the programs are one-on-one and provide practical medication management strategies, according to a review of 19 randomized controlled trials. The literature review, which was published in the Cochrane Library in July, also noted that interventions tended to be successful if they were conducted for longer periods of time, usually 12 weeks or more. Interventions that were performed on a one-on-one basis were successful in improving adherence to medication in 10 out of 15 such studies (67%). Comparatively, in the four studies conducted in group settings, none were successful in improving adherence. The 19 studies reviewed included 2,159 patients. The reviewers did not find evidence to support the use of more “complex psychological constructs” such as self-efficacy, stress management, and motivation. These interventions may be ineffective or take longer to produce an effect, the reviewers wrote.

Screening Knowledge Gap

Most women are unaware of when to receive screening tests such as mammograms and Pap tests, according to the results of a 2005 government survey. But despite the lack of knowledge about when screening is required, women are receiving recommended screening care anyway, the survey found. The Health Information National Trends Survey, developed by the National Cancer Institute, is a nationally representative telephone survey of the general U.S. population conducted in 2002–2003 and 2005. An analysis of the 2005 data showed that 57% of U.S. women were unaware that they should have a mammogram to screen for breast cancer starting at age 40 years. However, 74% said they had received a mammogram within the recommended time period. When it came to Pap smears, most women didn't know they only needed to be screened at least once every 3 years. Instead, 87% of women who had ever received a Pap test said they received it annually as part of their regular exam. “We must significantly increase our efforts to inform all Americans of what cancer screening tests are available so that we can catch cancer in its earliest stages when it is most treatable,” Dr. John E. Niederhuber, acting director of the National Cancer Institute, said in a statement.

Regulating Nanotechnology

The Food and Drug Administration has launched an internal nanotechnology task force aimed at figuring out new regulatory approaches for pharmaceutical products and devices that use nanotechnology materials. Nanotechnology materials measure about 1–100 nm and often have different chemical and physical properties—such as altered magnetic properties and increased chemical and biological activity—than do larger materials, according to the FDA. The agency will kick off its efforts with a public meeting scheduled for Oct. 10.

In the Dark on the Plan B Plan

Despite the controversy surrounding the proposal to provide Plan B emergency contraception without a prescription, only about one-quarter of Americans in a recent survey said they had heard a lot about the debate. And nearly an equal number said they had heard nothing about the politically charged issue. The survey was commissioned by the Pew Research Center for the People & the Press and the Pew Forum on Religion & Public Life. The survey also found that about 48% of those surveyed favored selling emergency contraception without a prescription, whereas about 41% opposed the idea. The national telephone survey was conducted in July among more than 2,000 U.S. adults.

Fix the SGR, Delay Imaging Cuts

Rep. Michael Burgess (R-Tex.), an ob.gyn., has introduced legislation (H.R. 5866) that would put an end to physician fee cuts under Medicare by halting application of the sustainable growth rate by Jan. 1, 2007. Each year, the SGR has contributed to a decrease in payments; in 2007, that cut will be at least 4.6%. Rep. Burgess is proposing to tie physician fees to one factor only: the Medicare Economic Index minus 1%. According to Rep. Burgess, this places “more value on actual cost inputs.” The bill also would establish a system of quality measures to give patients more information about Medicare providers, delay by 1 year proposed cuts in imaging services reimbursement, and require the Institute of Medicine to perform a study on the question of whether imaging saves money. The American College of Obstetricians and Gynecologists has backed the bill. “Elimination of the SGR is necessary to move forward on reporting on performance indicators and we thank you for recognizing this important link in your legislation,” said Dr. Douglas W. Laube, ACOG president, in a statement.

HIV Treatment Adherence

Educational programs can be effective at improving adherence to HIV drug regimens when the programs are one-on-one and provide practical medication management strategies, according to a review of 19 randomized controlled trials. The literature review, which was published in the Cochrane Library in July, also noted that interventions tended to be successful if they were conducted for longer periods of time, usually 12 weeks or more. Interventions that were performed on a one-on-one basis were successful in improving adherence to medication in 10 out of 15 such studies (67%). Comparatively, in the four studies conducted in group settings, none were successful in improving adherence. The 19 studies reviewed included 2,159 patients. The reviewers did not find evidence to support the use of more “complex psychological constructs” such as self-efficacy, stress management, and motivation. These interventions may be ineffective or take longer to produce an effect, the reviewers wrote.

Screening Knowledge Gap

Most women are unaware of when to receive screening tests such as mammograms and Pap tests, according to the results of a 2005 government survey. But despite the lack of knowledge about when screening is required, women are receiving recommended screening care anyway, the survey found. The Health Information National Trends Survey, developed by the National Cancer Institute, is a nationally representative telephone survey of the general U.S. population conducted in 2002–2003 and 2005. An analysis of the 2005 data showed that 57% of U.S. women were unaware that they should have a mammogram to screen for breast cancer starting at age 40 years. However, 74% said they had received a mammogram within the recommended time period. When it came to Pap smears, most women didn't know they only needed to be screened at least once every 3 years. Instead, 87% of women who had ever received a Pap test said they received it annually as part of their regular exam. “We must significantly increase our efforts to inform all Americans of what cancer screening tests are available so that we can catch cancer in its earliest stages when it is most treatable,” Dr. John E. Niederhuber, acting director of the National Cancer Institute, said in a statement.

Regulating Nanotechnology

The Food and Drug Administration has launched an internal nanotechnology task force aimed at figuring out new regulatory approaches for pharmaceutical products and devices that use nanotechnology materials. Nanotechnology materials measure about 1–100 nm and often have different chemical and physical properties—such as altered magnetic properties and increased chemical and biological activity—than do larger materials, according to the FDA. The agency will kick off its efforts with a public meeting scheduled for Oct. 10.

Hospitals, health plans, and other health care organizations will soon be able to assist physicians in obtaining health information technology without running afoul of federal fraud laws under regulations issued last month by the Department of Health and Human Services.

In two final regulations published in the Federal Register on Aug. 8, the Centers for Medicare and Medicaid Services and the HHS Office of Inspector General carved out new exceptions to the Stark physician self-referral law and the federal antikickback statute. Under these new exceptions, certain health care entities will be able to donate interoperable electronic health record (EHR) software and training. And hospitals and other health care organizations will also be able to provide hardware, software, and training services that are “necessary and used solely” for electronic prescribing.

The regulations did not cap the donations to physicians for electronic prescribing technology, but the government is requiring physicians to share some of the costs of donated electronic health record technology. Under the rules, physicians will be required to pay 15% of the donor's cost of the EHR technology and services.

The regulations go into effect in early October (60 days after publication in the Federal Register). The provisions related to EHR arrangements are slated to sunset on Dec. 31, 2013.

The regulations were widely praised by physician organizations and health IT industry groups for breaking down barriers to physician adoption. But Patrick Hope, legislative counsel for the American College of Physicians, said the changes aren't likely to do a whole lot to speed physician adoption of the technologies since few hospitals will be able to afford to donate the expensive technology to physicians.

“They are operating at the margins just as physician offices are,” Mr. Hope said.

ACP officials are urging members of Congress to establish an add-on payment to the Medicare reimbursement for an office visit in an effort to help offset the ongoing costs of an electronic health record system, Mr. Hope said. While the regulations are helpful in removing some barriers, he said, an add-on payment would create a better business case for physician adoption of health IT.

The jury is still out as to what impact these regulations will have on physician adoption, said Chantal Worzala, senior associate director for policy at the American Hospital Association. Not all hospitals will have the financial resources to donate health IT services, she said, since only about a third of U.S. hospitals are making a profit.

But the regulations will give hospital administrators more options. “Hospitals really should have flexibility in working with community physicians,” she said.

While some health plans may be interested in offering electronic prescribing products, Ms. Worzala said, hospitals are likely to want to help physicians acquire more comprehensive EHR systems.

The relaxation of the Stark physician self-referral law and the antikickback statute is a good thing, said Dr. Steven E. Waldren, assistant director of the American Academy of Family Physicians' Center for Health Information Technology, since the changes will allow more health IT resources to flow to physicians. However, he cautioned physicians not to count on getting this support.

This type of support won't be available to all physicians and in some cases may not be appropriate, he said. For example, Dr. Waldren said that some hospital electronic health record systems are not designed for the ambulatory environment and may end up costing physicians more money in the long run. The bottom line is that physicians need to continue to do their “due diligence” in researching systems, he said.

The Medicare Modernization Act of 2003 mandated that the HHS Secretary create exemptions that would allow for certain health care organizations to help furnish physician practices with electronic prescribing technology. The changes were originally outlined in a proposed rule issued last October.

Under the provisions related to electronic prescribing technology, hospitals can donate hardware, software, and services to members of their medical staffs; group practices can donate to physician members; and Medicare prescription drug plan sponsors and Medicare Advantage plans can donate to pharmacies and prescribing physicians. The Stark law exemption and antikickback safe harbors have slightly different definitions of who can donate the comprehensive electronic health record system software and training.

The electronic prescribing safe harbors and exemptions allow organizations to donate hardware, software, Internet connectivity, and training and support services. The provisions for electronic health records are slightly different and do not include hardware.

Hospitals, health plans, and other health care organizations will soon be able to assist physicians in obtaining health information technology without running afoul of federal fraud laws under regulations issued last month by the Department of Health and Human Services.

In two final regulations published in the Federal Register on Aug. 8, the Centers for Medicare and Medicaid Services and the HHS Office of Inspector General carved out new exceptions to the Stark physician self-referral law and the federal antikickback statute. Under these new exceptions, certain health care entities will be able to donate interoperable electronic health record (EHR) software and training. And hospitals and other health care organizations will also be able to provide hardware, software, and training services that are “necessary and used solely” for electronic prescribing.

The regulations did not cap the donations to physicians for electronic prescribing technology, but the government is requiring physicians to share some of the costs of donated electronic health record technology. Under the rules, physicians will be required to pay 15% of the donor's cost of the EHR technology and services.

The regulations go into effect in early October (60 days after publication in the Federal Register). The provisions related to EHR arrangements are slated to sunset on Dec. 31, 2013.

The regulations were widely praised by physician organizations and health IT industry groups for breaking down barriers to physician adoption. But Patrick Hope, legislative counsel for the American College of Physicians, said the changes aren't likely to do a whole lot to speed physician adoption of the technologies since few hospitals will be able to afford to donate the expensive technology to physicians.

“They are operating at the margins just as physician offices are,” Mr. Hope said.

ACP officials are urging members of Congress to establish an add-on payment to the Medicare reimbursement for an office visit in an effort to help offset the ongoing costs of an electronic health record system, Mr. Hope said. While the regulations are helpful in removing some barriers, he said, an add-on payment would create a better business case for physician adoption of health IT.

The jury is still out as to what impact these regulations will have on physician adoption, said Chantal Worzala, senior associate director for policy at the American Hospital Association. Not all hospitals will have the financial resources to donate health IT services, she said, since only about a third of U.S. hospitals are making a profit.

But the regulations will give hospital administrators more options. “Hospitals really should have flexibility in working with community physicians,” she said.

While some health plans may be interested in offering electronic prescribing products, Ms. Worzala said, hospitals are likely to want to help physicians acquire more comprehensive EHR systems.

The relaxation of the Stark physician self-referral law and the antikickback statute is a good thing, said Dr. Steven E. Waldren, assistant director of the American Academy of Family Physicians' Center for Health Information Technology, since the changes will allow more health IT resources to flow to physicians. However, he cautioned physicians not to count on getting this support.

This type of support won't be available to all physicians and in some cases may not be appropriate, he said. For example, Dr. Waldren said that some hospital electronic health record systems are not designed for the ambulatory environment and may end up costing physicians more money in the long run. The bottom line is that physicians need to continue to do their “due diligence” in researching systems, he said.

The Medicare Modernization Act of 2003 mandated that the HHS Secretary create exemptions that would allow for certain health care organizations to help furnish physician practices with electronic prescribing technology. The changes were originally outlined in a proposed rule issued last October.

Under the provisions related to electronic prescribing technology, hospitals can donate hardware, software, and services to members of their medical staffs; group practices can donate to physician members; and Medicare prescription drug plan sponsors and Medicare Advantage plans can donate to pharmacies and prescribing physicians. The Stark law exemption and antikickback safe harbors have slightly different definitions of who can donate the comprehensive electronic health record system software and training.

The electronic prescribing safe harbors and exemptions allow organizations to donate hardware, software, Internet connectivity, and training and support services. The provisions for electronic health records are slightly different and do not include hardware.

Hospitals, health plans, and other health care organizations will soon be able to assist physicians in obtaining health information technology without running afoul of federal fraud laws under regulations issued last month by the Department of Health and Human Services.

In two final regulations published in the Federal Register on Aug. 8, the Centers for Medicare and Medicaid Services and the HHS Office of Inspector General carved out new exceptions to the Stark physician self-referral law and the federal antikickback statute. Under these new exceptions, certain health care entities will be able to donate interoperable electronic health record (EHR) software and training. And hospitals and other health care organizations will also be able to provide hardware, software, and training services that are “necessary and used solely” for electronic prescribing.

The regulations did not cap the donations to physicians for electronic prescribing technology, but the government is requiring physicians to share some of the costs of donated electronic health record technology. Under the rules, physicians will be required to pay 15% of the donor's cost of the EHR technology and services.

The regulations go into effect in early October (60 days after publication in the Federal Register). The provisions related to EHR arrangements are slated to sunset on Dec. 31, 2013.

The regulations were widely praised by physician organizations and health IT industry groups for breaking down barriers to physician adoption. But Patrick Hope, legislative counsel for the American College of Physicians, said the changes aren't likely to do a whole lot to speed physician adoption of the technologies since few hospitals will be able to afford to donate the expensive technology to physicians.

“They are operating at the margins just as physician offices are,” Mr. Hope said.

ACP officials are urging members of Congress to establish an add-on payment to the Medicare reimbursement for an office visit in an effort to help offset the ongoing costs of an electronic health record system, Mr. Hope said. While the regulations are helpful in removing some barriers, he said, an add-on payment would create a better business case for physician adoption of health IT.

The jury is still out as to what impact these regulations will have on physician adoption, said Chantal Worzala, senior associate director for policy at the American Hospital Association. Not all hospitals will have the financial resources to donate health IT services, she said, since only about a third of U.S. hospitals are making a profit.

But the regulations will give hospital administrators more options. “Hospitals really should have flexibility in working with community physicians,” she said.

While some health plans may be interested in offering electronic prescribing products, Ms. Worzala said, hospitals are likely to want to help physicians acquire more comprehensive EHR systems.

The relaxation of the Stark physician self-referral law and the antikickback statute is a good thing, said Dr. Steven E. Waldren, assistant director of the American Academy of Family Physicians' Center for Health Information Technology, since the changes will allow more health IT resources to flow to physicians. However, he cautioned physicians not to count on getting this support.

This type of support won't be available to all physicians and in some cases may not be appropriate, he said. For example, Dr. Waldren said that some hospital electronic health record systems are not designed for the ambulatory environment and may end up costing physicians more money in the long run. The bottom line is that physicians need to continue to do their “due diligence” in researching systems, he said.

The Medicare Modernization Act of 2003 mandated that the HHS Secretary create exemptions that would allow for certain health care organizations to help furnish physician practices with electronic prescribing technology. The changes were originally outlined in a proposed rule issued last October.

Under the provisions related to electronic prescribing technology, hospitals can donate hardware, software, and services to members of their medical staffs; group practices can donate to physician members; and Medicare prescription drug plan sponsors and Medicare Advantage plans can donate to pharmacies and prescribing physicians. The Stark law exemption and antikickback safe harbors have slightly different definitions of who can donate the comprehensive electronic health record system software and training.

The electronic prescribing safe harbors and exemptions allow organizations to donate hardware, software, Internet connectivity, and training and support services. The provisions for electronic health records are slightly different and do not include hardware.

NIH Stroke Funding

The American Academy of Neurology is urging Congress to increase funding for the National Institutes of Health for stroke prevention and treatment. The cost of ischemic stroke in the United States will exceed $2.2 trillion by 2050, according to a study published in the academy's journal, Neurology. “It is essential the NIH have the resources to halt this impending epidemic,” Catherine M. Rydell, CEO and executive director of AAN, said in a statement. “The NIH has the ability to perform the research that can save countless lives and billions of dollars in health care costs if Congress would adequately fund its mission.” AAN is urging Congress to increase the FY 2007 NIH budget by 5%, bringing the total agency budget to around $30 billion. Under the current bill being considered by the Senate (S. 3708), NIH would be funded at approximately $28.5 billion in FY 2007. The House is considering legislation (H.R. 5647) that would fund the agency at about $28.3 billion.

Diagnosing Alzheimer's Disease

Members of the Congressional Task Force on Alzheimer's Disease have introduced a resolution to encourage Americans to seek evaluation of the disease. A resolution (H. Res. 964), introduced in the House by Rep. Christopher Smith (R-N.J.) and Rep. Edward J. Markey (D-Mass.), encourages anyone who may be experiencing memory impairment to contact their physician to seek an evaluation and diagnosis. The Alzheimer's Foundation of America had been pushing for the resolution as part of a national strategy to raise awareness of the importance of early detection. Fear of stigma, denial, lack of knowledge, and concern about health care costs can all delay diagnosis, according to the Alzheimer's Foundation of America. “We hope that this resolution will give Americans that extra push to take action if they notice signs of dementia,” Eric J. Hall, the group's CEO, said in a statement.

Medicare Risk Reduction Demo

Officials at the Centers for Medicare and Medicaid Services are seeking proposals for a new demonstration project that will test the effectiveness of health promotion programs in the Medicare population. The Medicare Senior Risk Reduction Demonstration will target multiple risk factors for chronic diseases including physical inactivity, obesity, smoking, depression, high blood pressure, high cholesterol, and high blood sugar. Officials will also look at underuse of Medicare preventive benefits. CMS officials plan to select up to five organizations to participate in a 3-year demonstration project; participants will be announced next spring. Officials plan to invite about 85,000 Medicare fee-for-service beneficiaries to take part. Beneficiaries will complete a risk assessment, receive information on their specific health risk factors, and receive referrals to community resources that can help them to make lifestyle changes. They will have the option of sharing the information with their physicians. “This demonstration can support doctors and other health professionals by providing support in their efforts to help seniors make important changes, such as starting an exercise program and using recommended preventive care,” Dr. Mark McClellan, CMS administrator, said in a statement.

Fueling the Rise in Medicare Costs

The rapid growth in spending for Medicare beneficiaries is largely because of the increasing portion of those beneficiaries receiving treatment for five or more conditions in a year, according to a study published in an online edition of Health Affairs. Between 1987 and 2002, the number of beneficiaries who sought care for five or more conditions rose from about 9 million to 19.8 million. In 2002, beneficiaries with five or more conditions accounted for more than 75% of health spending, according to the study. And Medicare beneficiaries with three or more conditions accounted for 92.9% of health care spending in 2002. The researchers analyzed the total health care spending for Medicare beneficiaries across all sources of payment including Medicare, private insurance, and out-of-pocket spending. “One of the biggest challenges we face is that the Medicare system makes it very difficult for physicians to effectively treat people with multiple chronic illnesses,” Kenneth E. Thorpe, the study's lead author and chair of the department of health policy management at Emory University, Atlanta, said in a statement. “Medicare's fee-for-service structure does not reimburse for services critical to medically managing chronic illness—preventative measures, monitoring medication intake and blood sugar,” he said. The researchers of the study received support from the Pharmaceutical Research and Manufacturers of America.

NIH Stroke Funding

The American Academy of Neurology is urging Congress to increase funding for the National Institutes of Health for stroke prevention and treatment. The cost of ischemic stroke in the United States will exceed $2.2 trillion by 2050, according to a study published in the academy's journal, Neurology. “It is essential the NIH have the resources to halt this impending epidemic,” Catherine M. Rydell, CEO and executive director of AAN, said in a statement. “The NIH has the ability to perform the research that can save countless lives and billions of dollars in health care costs if Congress would adequately fund its mission.” AAN is urging Congress to increase the FY 2007 NIH budget by 5%, bringing the total agency budget to around $30 billion. Under the current bill being considered by the Senate (S. 3708), NIH would be funded at approximately $28.5 billion in FY 2007. The House is considering legislation (H.R. 5647) that would fund the agency at about $28.3 billion.

Diagnosing Alzheimer's Disease

Members of the Congressional Task Force on Alzheimer's Disease have introduced a resolution to encourage Americans to seek evaluation of the disease. A resolution (H. Res. 964), introduced in the House by Rep. Christopher Smith (R-N.J.) and Rep. Edward J. Markey (D-Mass.), encourages anyone who may be experiencing memory impairment to contact their physician to seek an evaluation and diagnosis. The Alzheimer's Foundation of America had been pushing for the resolution as part of a national strategy to raise awareness of the importance of early detection. Fear of stigma, denial, lack of knowledge, and concern about health care costs can all delay diagnosis, according to the Alzheimer's Foundation of America. “We hope that this resolution will give Americans that extra push to take action if they notice signs of dementia,” Eric J. Hall, the group's CEO, said in a statement.

Medicare Risk Reduction Demo

Officials at the Centers for Medicare and Medicaid Services are seeking proposals for a new demonstration project that will test the effectiveness of health promotion programs in the Medicare population. The Medicare Senior Risk Reduction Demonstration will target multiple risk factors for chronic diseases including physical inactivity, obesity, smoking, depression, high blood pressure, high cholesterol, and high blood sugar. Officials will also look at underuse of Medicare preventive benefits. CMS officials plan to select up to five organizations to participate in a 3-year demonstration project; participants will be announced next spring. Officials plan to invite about 85,000 Medicare fee-for-service beneficiaries to take part. Beneficiaries will complete a risk assessment, receive information on their specific health risk factors, and receive referrals to community resources that can help them to make lifestyle changes. They will have the option of sharing the information with their physicians. “This demonstration can support doctors and other health professionals by providing support in their efforts to help seniors make important changes, such as starting an exercise program and using recommended preventive care,” Dr. Mark McClellan, CMS administrator, said in a statement.

Fueling the Rise in Medicare Costs

The rapid growth in spending for Medicare beneficiaries is largely because of the increasing portion of those beneficiaries receiving treatment for five or more conditions in a year, according to a study published in an online edition of Health Affairs. Between 1987 and 2002, the number of beneficiaries who sought care for five or more conditions rose from about 9 million to 19.8 million. In 2002, beneficiaries with five or more conditions accounted for more than 75% of health spending, according to the study. And Medicare beneficiaries with three or more conditions accounted for 92.9% of health care spending in 2002. The researchers analyzed the total health care spending for Medicare beneficiaries across all sources of payment including Medicare, private insurance, and out-of-pocket spending. “One of the biggest challenges we face is that the Medicare system makes it very difficult for physicians to effectively treat people with multiple chronic illnesses,” Kenneth E. Thorpe, the study's lead author and chair of the department of health policy management at Emory University, Atlanta, said in a statement. “Medicare's fee-for-service structure does not reimburse for services critical to medically managing chronic illness—preventative measures, monitoring medication intake and blood sugar,” he said. The researchers of the study received support from the Pharmaceutical Research and Manufacturers of America.

NIH Stroke Funding

The American Academy of Neurology is urging Congress to increase funding for the National Institutes of Health for stroke prevention and treatment. The cost of ischemic stroke in the United States will exceed $2.2 trillion by 2050, according to a study published in the academy's journal, Neurology. “It is essential the NIH have the resources to halt this impending epidemic,” Catherine M. Rydell, CEO and executive director of AAN, said in a statement. “The NIH has the ability to perform the research that can save countless lives and billions of dollars in health care costs if Congress would adequately fund its mission.” AAN is urging Congress to increase the FY 2007 NIH budget by 5%, bringing the total agency budget to around $30 billion. Under the current bill being considered by the Senate (S. 3708), NIH would be funded at approximately $28.5 billion in FY 2007. The House is considering legislation (H.R. 5647) that would fund the agency at about $28.3 billion.

Diagnosing Alzheimer's Disease

Members of the Congressional Task Force on Alzheimer's Disease have introduced a resolution to encourage Americans to seek evaluation of the disease. A resolution (H. Res. 964), introduced in the House by Rep. Christopher Smith (R-N.J.) and Rep. Edward J. Markey (D-Mass.), encourages anyone who may be experiencing memory impairment to contact their physician to seek an evaluation and diagnosis. The Alzheimer's Foundation of America had been pushing for the resolution as part of a national strategy to raise awareness of the importance of early detection. Fear of stigma, denial, lack of knowledge, and concern about health care costs can all delay diagnosis, according to the Alzheimer's Foundation of America. “We hope that this resolution will give Americans that extra push to take action if they notice signs of dementia,” Eric J. Hall, the group's CEO, said in a statement.

Medicare Risk Reduction Demo

Officials at the Centers for Medicare and Medicaid Services are seeking proposals for a new demonstration project that will test the effectiveness of health promotion programs in the Medicare population. The Medicare Senior Risk Reduction Demonstration will target multiple risk factors for chronic diseases including physical inactivity, obesity, smoking, depression, high blood pressure, high cholesterol, and high blood sugar. Officials will also look at underuse of Medicare preventive benefits. CMS officials plan to select up to five organizations to participate in a 3-year demonstration project; participants will be announced next spring. Officials plan to invite about 85,000 Medicare fee-for-service beneficiaries to take part. Beneficiaries will complete a risk assessment, receive information on their specific health risk factors, and receive referrals to community resources that can help them to make lifestyle changes. They will have the option of sharing the information with their physicians. “This demonstration can support doctors and other health professionals by providing support in their efforts to help seniors make important changes, such as starting an exercise program and using recommended preventive care,” Dr. Mark McClellan, CMS administrator, said in a statement.

Fueling the Rise in Medicare Costs

The rapid growth in spending for Medicare beneficiaries is largely because of the increasing portion of those beneficiaries receiving treatment for five or more conditions in a year, according to a study published in an online edition of Health Affairs. Between 1987 and 2002, the number of beneficiaries who sought care for five or more conditions rose from about 9 million to 19.8 million. In 2002, beneficiaries with five or more conditions accounted for more than 75% of health spending, according to the study. And Medicare beneficiaries with three or more conditions accounted for 92.9% of health care spending in 2002. The researchers analyzed the total health care spending for Medicare beneficiaries across all sources of payment including Medicare, private insurance, and out-of-pocket spending. “One of the biggest challenges we face is that the Medicare system makes it very difficult for physicians to effectively treat people with multiple chronic illnesses,” Kenneth E. Thorpe, the study's lead author and chair of the department of health policy management at Emory University, Atlanta, said in a statement. “Medicare's fee-for-service structure does not reimburse for services critical to medically managing chronic illness—preventative measures, monitoring medication intake and blood sugar,” he said. The researchers of the study received support from the Pharmaceutical Research and Manufacturers of America.

A new proposal from the Centers for Medicare and Medicaid Services could result in a better bottom line next year for physicians who spend a lot of time on evaluation and management services.

CMS officials are seeking to increase the work component for relative value units (RVUs) for a number of evaluation and management service codes. For example, Medicare is proposing to increase the work RVUs for the commonly used established office visit codes 99213 and 99214. The proposed changes, which are the result of a mandatory 5-year review by the CMS, would take effect in January 2007.

The proposed rule, issued on June 29, also calls for changes in the practice expense methodology that would involve the use of practice expense survey data from eight specialties—including cardiology, dermatology, and gastroenterology—to better calculate the costs incurred by physicians. These changes would begin in January but would be phased in over 4 years.

To pay for the proposed increases in reimbursement, the CMS is required to impose across-the-board cuts in work RVUs. This could mean payment cuts for physicians who provide fewer evaluation and management services.

Moreover, the expected increase for primary care physicians could be offset by the end of the year if physicians are unable to get a temporary fix to the sustainable growth rate formula, which is expected to cut physician payments under Medicare by nearly 5%.

“The CMS proposal reinforces the urgent need for Congress to act to stop the Medicare physician payment cuts and ensure that payments keep up to practice costs,” Dr. Cecil Wilson, AMA board chair, said in a statement.

Dr. J. Leonard Lichtenfeld said the proposed changes to evaluation and management services would help address the underfunding of primary care. Dr. Lichtenfeld, a medical oncologist, is the American College of Physicians' representative on the Relative Value Update Committee (RUC) of the American Medical Association. The RUC is a 29-member multispecialty committee that makes recommendations to the CMS annually on payment issues.

But although these changes go a long way in helping struggling physicians, it's not a complete solution, Dr. Lichtenfeld said, because it doesn't solve the underlying problem of inadequate funds in Medicare. “Someone's got to be there to be the captain of the ship,” he said.

Primary care physicians aren't the only ones who will benefit from the increases for evaluation and management codes, he noted. Surgeons will see some benefit because of increases for surgical postoperative care, as well as physicians in cognitive specialties such as neurology, he said.

For Dr. Douglas Leahy, an alternate delegate to the RUC for the ACP and a general internist, the proposed increases would mean the chance to spend more time with patients. Dr. Leahy, who works in a large multispecialty practice in Knoxville, Tenn., said that with better reimbursement for evaluation and management services, he could devote more time to important areas such as diabetes prevention or counseling family members of an Alzheimer's patient.

Gauging the Impact

At press time, ACP officials were still calculating the financial impact of the changes for internists. But a rough estimate based on the CMS proposal shows that internists could see a $4,000–$6,000 increase in revenue in 2007 depending on the services they provide, said Brett Baker, ACP's director of regulatory affairs.

CMS estimates in its proposed rule that internists will see an increase of about 5% in allowed charges in 2007 based on the combined impact of both work and practice expense RVU changes.

The changes also were praised by other primary care specialties. If finalized as proposed, the evaluation and management increases would be good news for family physicians, according to Dr. Thomas Felger, the American Academy of Family Physicians' representative on the RUC. The two main evaluation and management codes used by family physicians—99213 and 99214—are set to increase an average of about 10% in 2007, Dr. Felger said.

Ultimately the impact for physicians could be greater than estimated by the CMS, since private payers generally adopt the RVUs established by CMS, Dr. Felger said.

Dr. Felger, associate director of family medicine residency at St. Joseph's Regional Medical Center in South Bend, Ind., said the AAFP and a number of the other cognitive specialties had been pushing for these changes over the last few years. The work involved in an evaluation and management visit is much different from 10 years ago, when the CMS last made changes to how it values those services, he said.

For example, more preventive care is provided to Medicare patients and it's almost routine for a Medicare patient to have three chronic illnesses. The AAFP and others wanted the work RVUs to reflect the new requirements being placed on physicians, he said.

The proposal “recognizes that an office visit is more intense and more complex than it was 10 years ago,” Dr. Felger said.

Specialty Societies Speak Out

Although primary care groups have expressed support for the CMS proposal, some specialties are complaining about the way the practice expense changes were calculated. The agency put out a notice asking various specialties to submit their own data for consideration by CMS. One member of the Practicing Physicians Advisory Council, which advises the CMS on issues affecting physicians, took the agency to task at the council's May meeting for allowing only some specialties to submit new data.

“I am more than a little frustrated that there [already] was a data set which admittedly was old, but it was collected from all specialties at the same time,” said Dr. Tye Ouzounian, an orthopedic surgeon from Tarzana, Calif. “Now some specialties have selectively submitted new data, which is 10 years newer, which is probably going to be more extensive. Those societies are being allowed to use new data, whereas other societies were not allowed to use new data, and that's not fair.”

The only way to make things fair, he continued, “is to allow all societies to participate equally on the same footing with the same survey at the same time. To cherry-pick data that are 10 years newer from 4 or 7 specialties is not fair to the groups that didn't do it.”

Don Thompson, senior technical advisor to the CMS, said that although he had heard similar comments from specialty societies that didn't participate in the survey, “we also received comments from those specialty societies that did do surveys. The thrust of their argument is that other medical specialty societies had an opportunity to do surveys and chose not to, and their assumption was those societies felt the value they had was correct.”

Mr. Thompson added that the agency had invited all the specialty societies to do surveys, “and we had criteria ahead of time about what we would [need] to accept surveys. The surveys that were done that met the requirements—random surveys, internally consistent—we had proposed to use them on that basis.” Ideally, he said, “we would like to see more recent survey data for all specialties.”

Dr. Ouzounian noted that the American Medical Association was discussing coordinating a survey of practice expenses for a large number of specialties. Mr. Thompson seemed receptive to that idea. “We would be supportive of the AMA going out and doing a survey, and if the data that resulted are better than what we have now, we'd want to incorporate that into our methodology,” Mr. Thompson said.

Although the increased payments for evaluation and management services and surgical postoperative care are needed, they are accompanied by an average 5% across-the-board cut in payments, according to the AMA. That cut is the result of the budget neutrality adjustment that the CMS is required by law to make whenever changes in RVUs cause an increase or decrease in overall physician fee schedule outlays of more than $20 million. The proposed work RVU changes are estimated to increase expenditures by about $4 billion, according to the CMS.

The proposal was published in the June 29 issue of the Federal Register. The CMS is accepting comments until Aug. 21.

The proposed rule is available online at

www.cms.hhs.gov/PhysicianFeeSched

This Month's Talk Back Question

How optimistic are you about plans to boost Medicare payments for evaluation and management services?

A new proposal from the Centers for Medicare and Medicaid Services could result in a better bottom line next year for physicians who spend a lot of time on evaluation and management services.

CMS officials are seeking to increase the work component for relative value units (RVUs) for a number of evaluation and management service codes. For example, Medicare is proposing to increase the work RVUs for the commonly used established office visit codes 99213 and 99214. The proposed changes, which are the result of a mandatory 5-year review by the CMS, would take effect in January 2007.

The proposed rule, issued on June 29, also calls for changes in the practice expense methodology that would involve the use of practice expense survey data from eight specialties—including cardiology, dermatology, and gastroenterology—to better calculate the costs incurred by physicians. These changes would begin in January but would be phased in over 4 years.

To pay for the proposed increases in reimbursement, the CMS is required to impose across-the-board cuts in work RVUs. This could mean payment cuts for physicians who provide fewer evaluation and management services.

Moreover, the expected increase for primary care physicians could be offset by the end of the year if physicians are unable to get a temporary fix to the sustainable growth rate formula, which is expected to cut physician payments under Medicare by nearly 5%.

“The CMS proposal reinforces the urgent need for Congress to act to stop the Medicare physician payment cuts and ensure that payments keep up to practice costs,” Dr. Cecil Wilson, AMA board chair, said in a statement.

Dr. J. Leonard Lichtenfeld said the proposed changes to evaluation and management services would help address the underfunding of primary care. Dr. Lichtenfeld, a medical oncologist, is the American College of Physicians' representative on the Relative Value Update Committee (RUC) of the American Medical Association. The RUC is a 29-member multispecialty committee that makes recommendations to the CMS annually on payment issues.

But although these changes go a long way in helping struggling physicians, it's not a complete solution, Dr. Lichtenfeld said, because it doesn't solve the underlying problem of inadequate funds in Medicare. “Someone's got to be there to be the captain of the ship,” he said.

Primary care physicians aren't the only ones who will benefit from the increases for evaluation and management codes, he noted. Surgeons will see some benefit because of increases for surgical postoperative care, as well as physicians in cognitive specialties such as neurology, he said.

For Dr. Douglas Leahy, an alternate delegate to the RUC for the ACP and a general internist, the proposed increases would mean the chance to spend more time with patients. Dr. Leahy, who works in a large multispecialty practice in Knoxville, Tenn., said that with better reimbursement for evaluation and management services, he could devote more time to important areas such as diabetes prevention or counseling family members of an Alzheimer's patient.

Gauging the Impact

At press time, ACP officials were still calculating the financial impact of the changes for internists. But a rough estimate based on the CMS proposal shows that internists could see a $4,000–$6,000 increase in revenue in 2007 depending on the services they provide, said Brett Baker, ACP's director of regulatory affairs.

CMS estimates in its proposed rule that internists will see an increase of about 5% in allowed charges in 2007 based on the combined impact of both work and practice expense RVU changes.

The changes also were praised by other primary care specialties. If finalized as proposed, the evaluation and management increases would be good news for family physicians, according to Dr. Thomas Felger, the American Academy of Family Physicians' representative on the RUC. The two main evaluation and management codes used by family physicians—99213 and 99214—are set to increase an average of about 10% in 2007, Dr. Felger said.

Ultimately the impact for physicians could be greater than estimated by the CMS, since private payers generally adopt the RVUs established by CMS, Dr. Felger said.

Dr. Felger, associate director of family medicine residency at St. Joseph's Regional Medical Center in South Bend, Ind., said the AAFP and a number of the other cognitive specialties had been pushing for these changes over the last few years. The work involved in an evaluation and management visit is much different from 10 years ago, when the CMS last made changes to how it values those services, he said.

For example, more preventive care is provided to Medicare patients and it's almost routine for a Medicare patient to have three chronic illnesses. The AAFP and others wanted the work RVUs to reflect the new requirements being placed on physicians, he said.

The proposal “recognizes that an office visit is more intense and more complex than it was 10 years ago,” Dr. Felger said.

Specialty Societies Speak Out

Although primary care groups have expressed support for the CMS proposal, some specialties are complaining about the way the practice expense changes were calculated. The agency put out a notice asking various specialties to submit their own data for consideration by CMS. One member of the Practicing Physicians Advisory Council, which advises the CMS on issues affecting physicians, took the agency to task at the council's May meeting for allowing only some specialties to submit new data.

“I am more than a little frustrated that there [already] was a data set which admittedly was old, but it was collected from all specialties at the same time,” said Dr. Tye Ouzounian, an orthopedic surgeon from Tarzana, Calif. “Now some specialties have selectively submitted new data, which is 10 years newer, which is probably going to be more extensive. Those societies are being allowed to use new data, whereas other societies were not allowed to use new data, and that's not fair.”

The only way to make things fair, he continued, “is to allow all societies to participate equally on the same footing with the same survey at the same time. To cherry-pick data that are 10 years newer from 4 or 7 specialties is not fair to the groups that didn't do it.”

Don Thompson, senior technical advisor to the CMS, said that although he had heard similar comments from specialty societies that didn't participate in the survey, “we also received comments from those specialty societies that did do surveys. The thrust of their argument is that other medical specialty societies had an opportunity to do surveys and chose not to, and their assumption was those societies felt the value they had was correct.”

Mr. Thompson added that the agency had invited all the specialty societies to do surveys, “and we had criteria ahead of time about what we would [need] to accept surveys. The surveys that were done that met the requirements—random surveys, internally consistent—we had proposed to use them on that basis.” Ideally, he said, “we would like to see more recent survey data for all specialties.”

Dr. Ouzounian noted that the American Medical Association was discussing coordinating a survey of practice expenses for a large number of specialties. Mr. Thompson seemed receptive to that idea. “We would be supportive of the AMA going out and doing a survey, and if the data that resulted are better than what we have now, we'd want to incorporate that into our methodology,” Mr. Thompson said.

Although the increased payments for evaluation and management services and surgical postoperative care are needed, they are accompanied by an average 5% across-the-board cut in payments, according to the AMA. That cut is the result of the budget neutrality adjustment that the CMS is required by law to make whenever changes in RVUs cause an increase or decrease in overall physician fee schedule outlays of more than $20 million. The proposed work RVU changes are estimated to increase expenditures by about $4 billion, according to the CMS.

The proposal was published in the June 29 issue of the Federal Register. The CMS is accepting comments until Aug. 21.

The proposed rule is available online at

www.cms.hhs.gov/PhysicianFeeSched

This Month's Talk Back Question

How optimistic are you about plans to boost Medicare payments for evaluation and management services?

A new proposal from the Centers for Medicare and Medicaid Services could result in a better bottom line next year for physicians who spend a lot of time on evaluation and management services.

CMS officials are seeking to increase the work component for relative value units (RVUs) for a number of evaluation and management service codes. For example, Medicare is proposing to increase the work RVUs for the commonly used established office visit codes 99213 and 99214. The proposed changes, which are the result of a mandatory 5-year review by the CMS, would take effect in January 2007.

The proposed rule, issued on June 29, also calls for changes in the practice expense methodology that would involve the use of practice expense survey data from eight specialties—including cardiology, dermatology, and gastroenterology—to better calculate the costs incurred by physicians. These changes would begin in January but would be phased in over 4 years.

To pay for the proposed increases in reimbursement, the CMS is required to impose across-the-board cuts in work RVUs. This could mean payment cuts for physicians who provide fewer evaluation and management services.

Moreover, the expected increase for primary care physicians could be offset by the end of the year if physicians are unable to get a temporary fix to the sustainable growth rate formula, which is expected to cut physician payments under Medicare by nearly 5%.

“The CMS proposal reinforces the urgent need for Congress to act to stop the Medicare physician payment cuts and ensure that payments keep up to practice costs,” Dr. Cecil Wilson, AMA board chair, said in a statement.

Dr. J. Leonard Lichtenfeld said the proposed changes to evaluation and management services would help address the underfunding of primary care. Dr. Lichtenfeld, a medical oncologist, is the American College of Physicians' representative on the Relative Value Update Committee (RUC) of the American Medical Association. The RUC is a 29-member multispecialty committee that makes recommendations to the CMS annually on payment issues.

But although these changes go a long way in helping struggling physicians, it's not a complete solution, Dr. Lichtenfeld said, because it doesn't solve the underlying problem of inadequate funds in Medicare. “Someone's got to be there to be the captain of the ship,” he said.

Primary care physicians aren't the only ones who will benefit from the increases for evaluation and management codes, he noted. Surgeons will see some benefit because of increases for surgical postoperative care, as well as physicians in cognitive specialties such as neurology, he said.

For Dr. Douglas Leahy, an alternate delegate to the RUC for the ACP and a general internist, the proposed increases would mean the chance to spend more time with patients. Dr. Leahy, who works in a large multispecialty practice in Knoxville, Tenn., said that with better reimbursement for evaluation and management services, he could devote more time to important areas such as diabetes prevention or counseling family members of an Alzheimer's patient.

Gauging the Impact

At press time, ACP officials were still calculating the financial impact of the changes for internists. But a rough estimate based on the CMS proposal shows that internists could see a $4,000–$6,000 increase in revenue in 2007 depending on the services they provide, said Brett Baker, ACP's director of regulatory affairs.

CMS estimates in its proposed rule that internists will see an increase of about 5% in allowed charges in 2007 based on the combined impact of both work and practice expense RVU changes.

The changes also were praised by other primary care specialties. If finalized as proposed, the evaluation and management increases would be good news for family physicians, according to Dr. Thomas Felger, the American Academy of Family Physicians' representative on the RUC. The two main evaluation and management codes used by family physicians—99213 and 99214—are set to increase an average of about 10% in 2007, Dr. Felger said.

Ultimately the impact for physicians could be greater than estimated by the CMS, since private payers generally adopt the RVUs established by CMS, Dr. Felger said.

Dr. Felger, associate director of family medicine residency at St. Joseph's Regional Medical Center in South Bend, Ind., said the AAFP and a number of the other cognitive specialties had been pushing for these changes over the last few years. The work involved in an evaluation and management visit is much different from 10 years ago, when the CMS last made changes to how it values those services, he said.

For example, more preventive care is provided to Medicare patients and it's almost routine for a Medicare patient to have three chronic illnesses. The AAFP and others wanted the work RVUs to reflect the new requirements being placed on physicians, he said.

The proposal “recognizes that an office visit is more intense and more complex than it was 10 years ago,” Dr. Felger said.

Specialty Societies Speak Out

Although primary care groups have expressed support for the CMS proposal, some specialties are complaining about the way the practice expense changes were calculated. The agency put out a notice asking various specialties to submit their own data for consideration by CMS. One member of the Practicing Physicians Advisory Council, which advises the CMS on issues affecting physicians, took the agency to task at the council's May meeting for allowing only some specialties to submit new data.

“I am more than a little frustrated that there [already] was a data set which admittedly was old, but it was collected from all specialties at the same time,” said Dr. Tye Ouzounian, an orthopedic surgeon from Tarzana, Calif. “Now some specialties have selectively submitted new data, which is 10 years newer, which is probably going to be more extensive. Those societies are being allowed to use new data, whereas other societies were not allowed to use new data, and that's not fair.”

The only way to make things fair, he continued, “is to allow all societies to participate equally on the same footing with the same survey at the same time. To cherry-pick data that are 10 years newer from 4 or 7 specialties is not fair to the groups that didn't do it.”

Don Thompson, senior technical advisor to the CMS, said that although he had heard similar comments from specialty societies that didn't participate in the survey, “we also received comments from those specialty societies that did do surveys. The thrust of their argument is that other medical specialty societies had an opportunity to do surveys and chose not to, and their assumption was those societies felt the value they had was correct.”

Mr. Thompson added that the agency had invited all the specialty societies to do surveys, “and we had criteria ahead of time about what we would [need] to accept surveys. The surveys that were done that met the requirements—random surveys, internally consistent—we had proposed to use them on that basis.” Ideally, he said, “we would like to see more recent survey data for all specialties.”

Dr. Ouzounian noted that the American Medical Association was discussing coordinating a survey of practice expenses for a large number of specialties. Mr. Thompson seemed receptive to that idea. “We would be supportive of the AMA going out and doing a survey, and if the data that resulted are better than what we have now, we'd want to incorporate that into our methodology,” Mr. Thompson said.

Although the increased payments for evaluation and management services and surgical postoperative care are needed, they are accompanied by an average 5% across-the-board cut in payments, according to the AMA. That cut is the result of the budget neutrality adjustment that the CMS is required by law to make whenever changes in RVUs cause an increase or decrease in overall physician fee schedule outlays of more than $20 million. The proposed work RVU changes are estimated to increase expenditures by about $4 billion, according to the CMS.

The proposal was published in the June 29 issue of the Federal Register. The CMS is accepting comments until Aug. 21.

The proposed rule is available online at

www.cms.hhs.gov/PhysicianFeeSched

This Month's Talk Back Question

How optimistic are you about plans to boost Medicare payments for evaluation and management services?

NIH Osteoarthritis Initiative

The Osteoarthritis Initiative, sponsored by the National Institutes of Health, last month released its first set of baseline data to researchers. The initiative is a multicenter, 4-year observational study of nearly 5,000 men and women with either early-stage and advanced knee osteoarthritis, as well as those at risk for developing the disease. The first data set includes baseline questionnaire and exam data for about 2,600 participants. In addition, baseline x-ray and MRI images for a 200-patient sample are available to researchers upon request. Study investigators are scheduled to release the second set of data later this year and a third set in early 2007. Other data set will be released about every six months, according to NIH. The data are available online at

www.oai.ucsf.edu

Mixed Reviews for Merck

The most recent Vioxx court cases have produced mixed results for the drugmaker Merck & Co. In August, a Los Angeles jury ruled in the company's favor, finding that Vioxx (rofecoxib) was not responsible for the heart attack of Stewart Grossberg, who had been taking the drug intermittently. Merck argued successfully that Vioxx was not responsible for Mr. Grossberg's heart attack because he has high cholesterol levels, atherosclerosis, and a family history of cardiac problems. But about 2 weeks later, a federal jury in New Orleans found Merck liable for $51 million in damages in the 2002 heart attack of Gerald Barnett, a 62-year-old retired special agent of the FBI. The company is currently exploring grounds for appeal including insufficient evidence and the application of incorrect legal standards, according to Merck. The company was also dealt another blow in August, when a New Jersey judge decided to set aside a 2005 jury verdict that had been in Merck's favor. The judge ordered a new trial to take place early next year. The judge cited a December 2005 New England Journal of Medicine editorial expressing concerns about Vioxx-related study data as the basis for throwing out the jury verdict (N. Engl. J. Med. 2005;353:2813–4).

Focusing on Quality

A Michigan insurer aims to improve quality in low back care by providing special designation to health care facilities that have demonstrated better outcomes and fewer complications. The Blue Care Network of Michigan last month announced 61 Centers of Excellence facilities across the state for low back pain. These Centers of Excellence had to score at or above the 80th percentile overall for criteria that included having a multidisciplinary approach to treating low back pain, evidence-based treatments that have improved outcomes in low back pain, a medical director for the facility and physical therapists on-site, and access to a mental health professional. The designation will last for 2 years, after which the facility must reapply. Blue Care Network plans to promote the Centers for Excellence to its members, as well as to physicians involved in the treatment of low back pain. And Blue Care Network members who are seeking low back pain treatment are “strongly encouraged” to seek care at one of the 61 designated centers, according to the insurer. A list of the centers is available at

www.MiBCN.com/coe

Senate Bill to Boost Drug Safety

After months of public discourse, Sen. Edward Kennedy (D-Mass.) and Sen. Mike Enzi (R-Wyo.) have introduced a bill that aims to increase assurances that drugs are safe before they reach the marketplace or at least have a plan in place to more closely monitor when they need to be withdrawn. The Enhancing Drug Safety and Innovation Act would require pharmaceutical manufacturers to be more proactive about safety problems. Companies would have to establish risk evaluation and management strategies that would be agreed upon by the manufacturer and the Food and Drug Administration before the product is approved. The companies would have to submit adverse event reports every 15 days, quarterly, and annually. If a company knowingly does not comply with the agreed-upon strategy, the FDA can impose monetary penalties. The senators also proposed that manufacturers make clinical trial results public. The bill also would overhaul the FDA's process for vetting outside advisory panel members, with a goal of minimizing conflicts of interest and then ensuring that they are fully disclosed.

Regulating Nanotechnology

The Food and Drug Administration has launched an internal nanotechnology task force aimed at figuring out new regulatory approaches for pharmaceutical products and devices that use nanotechnology materials. Nanotechnology materials are about 1–100 nm and often have different chemical and physical properties than larger materials do, such as altered magnetic properties and increased chemical and biologic activity, according to the FDA.

NIH Osteoarthritis Initiative

The Osteoarthritis Initiative, sponsored by the National Institutes of Health, last month released its first set of baseline data to researchers. The initiative is a multicenter, 4-year observational study of nearly 5,000 men and women with either early-stage and advanced knee osteoarthritis, as well as those at risk for developing the disease. The first data set includes baseline questionnaire and exam data for about 2,600 participants. In addition, baseline x-ray and MRI images for a 200-patient sample are available to researchers upon request. Study investigators are scheduled to release the second set of data later this year and a third set in early 2007. Other data set will be released about every six months, according to NIH. The data are available online at

www.oai.ucsf.edu

Mixed Reviews for Merck

The most recent Vioxx court cases have produced mixed results for the drugmaker Merck & Co. In August, a Los Angeles jury ruled in the company's favor, finding that Vioxx (rofecoxib) was not responsible for the heart attack of Stewart Grossberg, who had been taking the drug intermittently. Merck argued successfully that Vioxx was not responsible for Mr. Grossberg's heart attack because he has high cholesterol levels, atherosclerosis, and a family history of cardiac problems. But about 2 weeks later, a federal jury in New Orleans found Merck liable for $51 million in damages in the 2002 heart attack of Gerald Barnett, a 62-year-old retired special agent of the FBI. The company is currently exploring grounds for appeal including insufficient evidence and the application of incorrect legal standards, according to Merck. The company was also dealt another blow in August, when a New Jersey judge decided to set aside a 2005 jury verdict that had been in Merck's favor. The judge ordered a new trial to take place early next year. The judge cited a December 2005 New England Journal of Medicine editorial expressing concerns about Vioxx-related study data as the basis for throwing out the jury verdict (N. Engl. J. Med. 2005;353:2813–4).

Focusing on Quality

A Michigan insurer aims to improve quality in low back care by providing special designation to health care facilities that have demonstrated better outcomes and fewer complications. The Blue Care Network of Michigan last month announced 61 Centers of Excellence facilities across the state for low back pain. These Centers of Excellence had to score at or above the 80th percentile overall for criteria that included having a multidisciplinary approach to treating low back pain, evidence-based treatments that have improved outcomes in low back pain, a medical director for the facility and physical therapists on-site, and access to a mental health professional. The designation will last for 2 years, after which the facility must reapply. Blue Care Network plans to promote the Centers for Excellence to its members, as well as to physicians involved in the treatment of low back pain. And Blue Care Network members who are seeking low back pain treatment are “strongly encouraged” to seek care at one of the 61 designated centers, according to the insurer. A list of the centers is available at

www.MiBCN.com/coe

Senate Bill to Boost Drug Safety

After months of public discourse, Sen. Edward Kennedy (D-Mass.) and Sen. Mike Enzi (R-Wyo.) have introduced a bill that aims to increase assurances that drugs are safe before they reach the marketplace or at least have a plan in place to more closely monitor when they need to be withdrawn. The Enhancing Drug Safety and Innovation Act would require pharmaceutical manufacturers to be more proactive about safety problems. Companies would have to establish risk evaluation and management strategies that would be agreed upon by the manufacturer and the Food and Drug Administration before the product is approved. The companies would have to submit adverse event reports every 15 days, quarterly, and annually. If a company knowingly does not comply with the agreed-upon strategy, the FDA can impose monetary penalties. The senators also proposed that manufacturers make clinical trial results public. The bill also would overhaul the FDA's process for vetting outside advisory panel members, with a goal of minimizing conflicts of interest and then ensuring that they are fully disclosed.

Regulating Nanotechnology

The Food and Drug Administration has launched an internal nanotechnology task force aimed at figuring out new regulatory approaches for pharmaceutical products and devices that use nanotechnology materials. Nanotechnology materials are about 1–100 nm and often have different chemical and physical properties than larger materials do, such as altered magnetic properties and increased chemical and biologic activity, according to the FDA.

NIH Osteoarthritis Initiative

The Osteoarthritis Initiative, sponsored by the National Institutes of Health, last month released its first set of baseline data to researchers. The initiative is a multicenter, 4-year observational study of nearly 5,000 men and women with either early-stage and advanced knee osteoarthritis, as well as those at risk for developing the disease. The first data set includes baseline questionnaire and exam data for about 2,600 participants. In addition, baseline x-ray and MRI images for a 200-patient sample are available to researchers upon request. Study investigators are scheduled to release the second set of data later this year and a third set in early 2007. Other data set will be released about every six months, according to NIH. The data are available online at

www.oai.ucsf.edu

Mixed Reviews for Merck

The most recent Vioxx court cases have produced mixed results for the drugmaker Merck & Co. In August, a Los Angeles jury ruled in the company's favor, finding that Vioxx (rofecoxib) was not responsible for the heart attack of Stewart Grossberg, who had been taking the drug intermittently. Merck argued successfully that Vioxx was not responsible for Mr. Grossberg's heart attack because he has high cholesterol levels, atherosclerosis, and a family history of cardiac problems. But about 2 weeks later, a federal jury in New Orleans found Merck liable for $51 million in damages in the 2002 heart attack of Gerald Barnett, a 62-year-old retired special agent of the FBI. The company is currently exploring grounds for appeal including insufficient evidence and the application of incorrect legal standards, according to Merck. The company was also dealt another blow in August, when a New Jersey judge decided to set aside a 2005 jury verdict that had been in Merck's favor. The judge ordered a new trial to take place early next year. The judge cited a December 2005 New England Journal of Medicine editorial expressing concerns about Vioxx-related study data as the basis for throwing out the jury verdict (N. Engl. J. Med. 2005;353:2813–4).

Focusing on Quality

A Michigan insurer aims to improve quality in low back care by providing special designation to health care facilities that have demonstrated better outcomes and fewer complications. The Blue Care Network of Michigan last month announced 61 Centers of Excellence facilities across the state for low back pain. These Centers of Excellence had to score at or above the 80th percentile overall for criteria that included having a multidisciplinary approach to treating low back pain, evidence-based treatments that have improved outcomes in low back pain, a medical director for the facility and physical therapists on-site, and access to a mental health professional. The designation will last for 2 years, after which the facility must reapply. Blue Care Network plans to promote the Centers for Excellence to its members, as well as to physicians involved in the treatment of low back pain. And Blue Care Network members who are seeking low back pain treatment are “strongly encouraged” to seek care at one of the 61 designated centers, according to the insurer. A list of the centers is available at

www.MiBCN.com/coe

Senate Bill to Boost Drug Safety

After months of public discourse, Sen. Edward Kennedy (D-Mass.) and Sen. Mike Enzi (R-Wyo.) have introduced a bill that aims to increase assurances that drugs are safe before they reach the marketplace or at least have a plan in place to more closely monitor when they need to be withdrawn. The Enhancing Drug Safety and Innovation Act would require pharmaceutical manufacturers to be more proactive about safety problems. Companies would have to establish risk evaluation and management strategies that would be agreed upon by the manufacturer and the Food and Drug Administration before the product is approved. The companies would have to submit adverse event reports every 15 days, quarterly, and annually. If a company knowingly does not comply with the agreed-upon strategy, the FDA can impose monetary penalties. The senators also proposed that manufacturers make clinical trial results public. The bill also would overhaul the FDA's process for vetting outside advisory panel members, with a goal of minimizing conflicts of interest and then ensuring that they are fully disclosed.

Regulating Nanotechnology

The Food and Drug Administration has launched an internal nanotechnology task force aimed at figuring out new regulatory approaches for pharmaceutical products and devices that use nanotechnology materials. Nanotechnology materials are about 1–100 nm and often have different chemical and physical properties than larger materials do, such as altered magnetic properties and increased chemical and biologic activity, according to the FDA.

The Certification Commission for Healthcare Information Technology has unveiled an initial list of 22 ambulatory electronic health record products that meet its standards for functionality, interoperability, and security.

CCHIT was formed in 2004 by three leading health IT management and technology industry associations. Since last fall, CCHIT has been under contract to the federal government to develop certification criteria for EHRs and evaluate products. The CCHIT process has also been endorsed by the American Academy of Family Physicians, the American College of Physicians, and the American Academy of Pediatrics.

In this first round, CCHIT officials gave their seal of approval to 22 products that met all certification standards. Going forward, CCHIT officials will evaluate ambulatory EHR products on a quarterly basis, and are expected to make the next announcement about newly certified EHR systems in late October. In the meantime, the group will begin work on certification for inpatient EHRs and for the network systems that support information exchange between physicians and health care institutions.

The certified products are designed to serve the spectrum of physician practices, Dr. Mark Leavitt, CCHIT chair, said during a press conference. Vendors whose products were certified in this first round received a CCHIT seal of approval that the product met 2006 standards, Dr. Leavitt said. That certification is good for up to 3 years or vendors can come back to CCHIT each year to be certified under the updated standards, he said.

“This is just a first step along a long, long path,” Health and Human Services Secretary Mike Leavitt said during the press conference.

Leaders in health IT are quickly approaching the time when they will no longer have to sell people on the benefits of EHRs, he said, but there is a need to continue to talk about the importance of the interoperability of these systems. In the long term, interoperable systems will become a condition of doing business with the federal government, said Mr. Leavitt, who is not related to Dr. Leavitt.

The full list of certified products is available at www.cchit.org

The certified products are designed to serve the spectrum of physician practices. DR. LEAVITT

The Certification Commission for Healthcare Information Technology has unveiled an initial list of 22 ambulatory electronic health record products that meet its standards for functionality, interoperability, and security.

CCHIT was formed in 2004 by three leading health IT management and technology industry associations. Since last fall, CCHIT has been under contract to the federal government to develop certification criteria for EHRs and evaluate products. The CCHIT process has also been endorsed by the American Academy of Family Physicians, the American College of Physicians, and the American Academy of Pediatrics.

In this first round, CCHIT officials gave their seal of approval to 22 products that met all certification standards. Going forward, CCHIT officials will evaluate ambulatory EHR products on a quarterly basis, and are expected to make the next announcement about newly certified EHR systems in late October. In the meantime, the group will begin work on certification for inpatient EHRs and for the network systems that support information exchange between physicians and health care institutions.

The certified products are designed to serve the spectrum of physician practices, Dr. Mark Leavitt, CCHIT chair, said during a press conference. Vendors whose products were certified in this first round received a CCHIT seal of approval that the product met 2006 standards, Dr. Leavitt said. That certification is good for up to 3 years or vendors can come back to CCHIT each year to be certified under the updated standards, he said.

“This is just a first step along a long, long path,” Health and Human Services Secretary Mike Leavitt said during the press conference.

Leaders in health IT are quickly approaching the time when they will no longer have to sell people on the benefits of EHRs, he said, but there is a need to continue to talk about the importance of the interoperability of these systems. In the long term, interoperable systems will become a condition of doing business with the federal government, said Mr. Leavitt, who is not related to Dr. Leavitt.

The full list of certified products is available at www.cchit.org

The certified products are designed to serve the spectrum of physician practices. DR. LEAVITT

The Certification Commission for Healthcare Information Technology has unveiled an initial list of 22 ambulatory electronic health record products that meet its standards for functionality, interoperability, and security.

CCHIT was formed in 2004 by three leading health IT management and technology industry associations. Since last fall, CCHIT has been under contract to the federal government to develop certification criteria for EHRs and evaluate products. The CCHIT process has also been endorsed by the American Academy of Family Physicians, the American College of Physicians, and the American Academy of Pediatrics.

In this first round, CCHIT officials gave their seal of approval to 22 products that met all certification standards. Going forward, CCHIT officials will evaluate ambulatory EHR products on a quarterly basis, and are expected to make the next announcement about newly certified EHR systems in late October. In the meantime, the group will begin work on certification for inpatient EHRs and for the network systems that support information exchange between physicians and health care institutions.

The certified products are designed to serve the spectrum of physician practices, Dr. Mark Leavitt, CCHIT chair, said during a press conference. Vendors whose products were certified in this first round received a CCHIT seal of approval that the product met 2006 standards, Dr. Leavitt said. That certification is good for up to 3 years or vendors can come back to CCHIT each year to be certified under the updated standards, he said.

“This is just a first step along a long, long path,” Health and Human Services Secretary Mike Leavitt said during the press conference.

Leaders in health IT are quickly approaching the time when they will no longer have to sell people on the benefits of EHRs, he said, but there is a need to continue to talk about the importance of the interoperability of these systems. In the long term, interoperable systems will become a condition of doing business with the federal government, said Mr. Leavitt, who is not related to Dr. Leavitt.

The full list of certified products is available at www.cchit.org

The certified products are designed to serve the spectrum of physician practices. DR. LEAVITT

Hospitals, health plans, and other health care organizations will soon be able to assist physicians in obtaining health information technology without running afoul of federal fraud laws under regulations issued last month by the Department of Health and Human Services.

In two final regulations published in the Federal Register on August 8, the Centers for Medicare and Medicaid Services and the HHS Office of Inspector General carved out new exceptions to the Stark physician self-referral law and the federal antikickback statute. Under these new exceptions, certain health care entities will be able to donate interoperable electronic health record (EHR) software and training. And hospitals and other health care organizations will also be able to provide hardware, software, and training services that are “necessary and used solely” for electronic prescribing.

The regulations, which go into effect in early October, did not cap the donations to physicians for electronic prescribing technology, but the government is requiring physicians to share some of the costs of donated electronic health record technology. Under the rules, physicians will be required to pay 15% of the donor's cost of the EHR technology and services.

The regulations were widely praised by physician organizations and health IT industry groups for breaking down barriers to physician adoption. But Patrick Hope, legislative counsel for the American College of Physicians, said the changes aren't likely to do a whole lot to speed physician adoption of the technologies since few hospitals will be able to afford to donate the expensive technology to physicians. “They are operating at the margins just as physician offices are,” Mr. Hope said.

ACP officials are urging members of Congress to establish an add-on payment to the Medicare reimbursement for an office visit in an effort to help offset the ongoing costs of an electronic health record system, Mr. Hope said. While the regulations are helpful in removing some barriers, he said, an add-on payment would create a better business case for physician adoption of health IT.

The jury is still out as to what impact these regulations will have on physician adoption, said Chantal Worzala, senior associate director for policy at the American Hospital Association. Not all hospitals will have the financial resources to donate health IT services, she said, since only about a third of U.S. hospitals are making a profit.

But the regulations will give hospital administrators more options. “Hospitals really should have flexibility in working with community physicians,” she said.

The relaxation of the Stark physician self-referral law and the antikickback statute is a good thing, said Dr. Steven E. Waldren, assistant director of the American Academy of Family Physicians' Center for Health Information Technology, since the changes will allow more health IT resources to flow to physicians. However, he cautioned physicians not to count on getting this support.

This type of support won't be available to all physicians and in some cases may not be appropriate, he said. For example, Dr. Waldren said that some hospital electronic health record systems are not designed for the ambulatory environment and may end up costing physicians more money in the long run. The bottom line is that physicians need to continue to do their “due diligence” in researching systems, he said.

The Medicare Modernization Act of 2003 mandated that the HHS Secretary create exemptions that would allow for certain health care organizations to help furnish physician practices with electronic prescribing technology. The changes were originally outlined in a proposed rule issued last October.

Under the provisions related to electronic prescribing technology, hospitals can donate hardware, software, and services to members of their medical staffs; group practices can donate to physician members; and Medicare prescription drug plan sponsors and Medicare Advantage plans can donate to pharmacies and prescribing physicians. The Stark law exemption and antikickback safe harbors have slightly different definitions of who can donate the comprehensive electronic health record system software and training.

The electronic prescribing safe harbors and exemptions allow organizations to donate hardware, software, Internet connectivity, and training and support services. The provisions for electronic health records are slightly different and do not include hardware. For EHRs, organizations can donate software, which must include an electronic prescribing component.

Hospitals, health plans, and other health care organizations will soon be able to assist physicians in obtaining health information technology without running afoul of federal fraud laws under regulations issued last month by the Department of Health and Human Services.

In two final regulations published in the Federal Register on August 8, the Centers for Medicare and Medicaid Services and the HHS Office of Inspector General carved out new exceptions to the Stark physician self-referral law and the federal antikickback statute. Under these new exceptions, certain health care entities will be able to donate interoperable electronic health record (EHR) software and training. And hospitals and other health care organizations will also be able to provide hardware, software, and training services that are “necessary and used solely” for electronic prescribing.

The regulations, which go into effect in early October, did not cap the donations to physicians for electronic prescribing technology, but the government is requiring physicians to share some of the costs of donated electronic health record technology. Under the rules, physicians will be required to pay 15% of the donor's cost of the EHR technology and services.

The regulations were widely praised by physician organizations and health IT industry groups for breaking down barriers to physician adoption. But Patrick Hope, legislative counsel for the American College of Physicians, said the changes aren't likely to do a whole lot to speed physician adoption of the technologies since few hospitals will be able to afford to donate the expensive technology to physicians. “They are operating at the margins just as physician offices are,” Mr. Hope said.

ACP officials are urging members of Congress to establish an add-on payment to the Medicare reimbursement for an office visit in an effort to help offset the ongoing costs of an electronic health record system, Mr. Hope said. While the regulations are helpful in removing some barriers, he said, an add-on payment would create a better business case for physician adoption of health IT.

The jury is still out as to what impact these regulations will have on physician adoption, said Chantal Worzala, senior associate director for policy at the American Hospital Association. Not all hospitals will have the financial resources to donate health IT services, she said, since only about a third of U.S. hospitals are making a profit.

But the regulations will give hospital administrators more options. “Hospitals really should have flexibility in working with community physicians,” she said.

The relaxation of the Stark physician self-referral law and the antikickback statute is a good thing, said Dr. Steven E. Waldren, assistant director of the American Academy of Family Physicians' Center for Health Information Technology, since the changes will allow more health IT resources to flow to physicians. However, he cautioned physicians not to count on getting this support.

This type of support won't be available to all physicians and in some cases may not be appropriate, he said. For example, Dr. Waldren said that some hospital electronic health record systems are not designed for the ambulatory environment and may end up costing physicians more money in the long run. The bottom line is that physicians need to continue to do their “due diligence” in researching systems, he said.

The Medicare Modernization Act of 2003 mandated that the HHS Secretary create exemptions that would allow for certain health care organizations to help furnish physician practices with electronic prescribing technology. The changes were originally outlined in a proposed rule issued last October.

Under the provisions related to electronic prescribing technology, hospitals can donate hardware, software, and services to members of their medical staffs; group practices can donate to physician members; and Medicare prescription drug plan sponsors and Medicare Advantage plans can donate to pharmacies and prescribing physicians. The Stark law exemption and antikickback safe harbors have slightly different definitions of who can donate the comprehensive electronic health record system software and training.

The electronic prescribing safe harbors and exemptions allow organizations to donate hardware, software, Internet connectivity, and training and support services. The provisions for electronic health records are slightly different and do not include hardware. For EHRs, organizations can donate software, which must include an electronic prescribing component.

Hospitals, health plans, and other health care organizations will soon be able to assist physicians in obtaining health information technology without running afoul of federal fraud laws under regulations issued last month by the Department of Health and Human Services.

In two final regulations published in the Federal Register on August 8, the Centers for Medicare and Medicaid Services and the HHS Office of Inspector General carved out new exceptions to the Stark physician self-referral law and the federal antikickback statute. Under these new exceptions, certain health care entities will be able to donate interoperable electronic health record (EHR) software and training. And hospitals and other health care organizations will also be able to provide hardware, software, and training services that are “necessary and used solely” for electronic prescribing.

The regulations, which go into effect in early October, did not cap the donations to physicians for electronic prescribing technology, but the government is requiring physicians to share some of the costs of donated electronic health record technology. Under the rules, physicians will be required to pay 15% of the donor's cost of the EHR technology and services.

The regulations were widely praised by physician organizations and health IT industry groups for breaking down barriers to physician adoption. But Patrick Hope, legislative counsel for the American College of Physicians, said the changes aren't likely to do a whole lot to speed physician adoption of the technologies since few hospitals will be able to afford to donate the expensive technology to physicians. “They are operating at the margins just as physician offices are,” Mr. Hope said.

ACP officials are urging members of Congress to establish an add-on payment to the Medicare reimbursement for an office visit in an effort to help offset the ongoing costs of an electronic health record system, Mr. Hope said. While the regulations are helpful in removing some barriers, he said, an add-on payment would create a better business case for physician adoption of health IT.

The jury is still out as to what impact these regulations will have on physician adoption, said Chantal Worzala, senior associate director for policy at the American Hospital Association. Not all hospitals will have the financial resources to donate health IT services, she said, since only about a third of U.S. hospitals are making a profit.

But the regulations will give hospital administrators more options. “Hospitals really should have flexibility in working with community physicians,” she said.

The relaxation of the Stark physician self-referral law and the antikickback statute is a good thing, said Dr. Steven E. Waldren, assistant director of the American Academy of Family Physicians' Center for Health Information Technology, since the changes will allow more health IT resources to flow to physicians. However, he cautioned physicians not to count on getting this support.

This type of support won't be available to all physicians and in some cases may not be appropriate, he said. For example, Dr. Waldren said that some hospital electronic health record systems are not designed for the ambulatory environment and may end up costing physicians more money in the long run. The bottom line is that physicians need to continue to do their “due diligence” in researching systems, he said.

The Medicare Modernization Act of 2003 mandated that the HHS Secretary create exemptions that would allow for certain health care organizations to help furnish physician practices with electronic prescribing technology. The changes were originally outlined in a proposed rule issued last October.

Under the provisions related to electronic prescribing technology, hospitals can donate hardware, software, and services to members of their medical staffs; group practices can donate to physician members; and Medicare prescription drug plan sponsors and Medicare Advantage plans can donate to pharmacies and prescribing physicians. The Stark law exemption and antikickback safe harbors have slightly different definitions of who can donate the comprehensive electronic health record system software and training.

The electronic prescribing safe harbors and exemptions allow organizations to donate hardware, software, Internet connectivity, and training and support services. The provisions for electronic health records are slightly different and do not include hardware. For EHRs, organizations can donate software, which must include an electronic prescribing component.

PHILADELPHIA — A costly electronic health record system is not necessary to engage in quality improvement and participate in the growing number of pay-for-performance programs, Dr. Rodney Hornbake said at the annual meeting of the American College of Physicians.

Patient registry software is a lower-cost alternative that allows physicians to track their care of patients with chronic diseases.

“It's really an excellent starting place for quality improvement in the ambulatory setting,” said Dr. Hornbake, an internist in private practice in Essex, Conn.

Patient registries are one of the best tools for physicians participating in pay-for-performance programs, Dr. Hornbake said. Many electronic health records (EHRs) may not have population-based functionality, and therefore cannot generate simple reports on the physician's performance on certain measures. Most EHR vendors can build interfaces with patient registry software, but that's generally an added cost, he said.

There are a number of patient registry programs available; a comprehensive program can be purchased for less than $1,000 per provider, Dr. Hornbake said. Some are available for free.

For example, Dr. Hornbake tested the Comorbid Disease Management Database (COMMAND) software in his practice. This registry system is available for free from the Mississippi Quality Improvement Organization. And technology-savvy physicians can use programs like Microsoft Access to design their own registries, he said.

Dr. Hornbake tried out COMMAND in his practice to help keep up with the pay-for-performance programs in his local market. One insurer—Anthem Health Plans Inc. of Connecticut—has a program that offers incentives for process and outcomes measures, as well as for the use of health-related information technology, including electronic prescribing, EHRs, and patient registries. The insurer also offers incentives to physicians for generic prescribing, he said.

Dr. Hornbake said that he exported demographic information from his billing system into COMMAND and manually entered the clinical information from patient charts himself. After using the billing system to identify all of the patients who had conditions included in his registry, he had his staff put red stickers on those patient charts.

This flagged the patients for special attention from the staff, he said. For example, patients whose charts had stickers received follow-up calls if they missed an appointment. To keep the registry up to date, every 2 months the staff pulls the charts of all registry patients and Dr. Hornbake updates the system manually. He spends about 1.5 hours entering data on 125 patients.

He said he prefers to enter the information in periodic batches, because it helps him to identify any chronic disease patients who have slipped through the cracks.

Even factoring in his time, Dr. Hornbake said that he saw an immediate return on investment with the patient registry system. Unlike implementation of an EHR system, he added, patient registry software tends to fit in easily with the normal workflow of the office.

Physicians also can manage their patient care using a paper-based patient registry, he said, but once they begin to track 20 or more measures, a paper system quickly becomes unworkable.

So far, Dr. Hornbake said that he has resisted purchasing an EHR system because he still can't make a financial case for the investment. He advised physicians to buy or upgrade an EHR system based on its ability to support pay for performance and manage a population of specific patients. Many of the other selling points for an EHR system—that it will eliminate transcription, cut down on needed staff positions, and improve coding—don't hold true for all physicians.

PHILADELPHIA — A costly electronic health record system is not necessary to engage in quality improvement and participate in the growing number of pay-for-performance programs, Dr. Rodney Hornbake said at the annual meeting of the American College of Physicians.

Patient registry software is a lower-cost alternative that allows physicians to track their care of patients with chronic diseases.

“It's really an excellent starting place for quality improvement in the ambulatory setting,” said Dr. Hornbake, an internist in private practice in Essex, Conn.

Patient registries are one of the best tools for physicians participating in pay-for-performance programs, Dr. Hornbake said. Many electronic health records (EHRs) may not have population-based functionality, and therefore cannot generate simple reports on the physician's performance on certain measures. Most EHR vendors can build interfaces with patient registry software, but that's generally an added cost, he said.

There are a number of patient registry programs available; a comprehensive program can be purchased for less than $1,000 per provider, Dr. Hornbake said. Some are available for free.

For example, Dr. Hornbake tested the Comorbid Disease Management Database (COMMAND) software in his practice. This registry system is available for free from the Mississippi Quality Improvement Organization. And technology-savvy physicians can use programs like Microsoft Access to design their own registries, he said.

Dr. Hornbake tried out COMMAND in his practice to help keep up with the pay-for-performance programs in his local market. One insurer—Anthem Health Plans Inc. of Connecticut—has a program that offers incentives for process and outcomes measures, as well as for the use of health-related information technology, including electronic prescribing, EHRs, and patient registries. The insurer also offers incentives to physicians for generic prescribing, he said.

Dr. Hornbake said that he exported demographic information from his billing system into COMMAND and manually entered the clinical information from patient charts himself. After using the billing system to identify all of the patients who had conditions included in his registry, he had his staff put red stickers on those patient charts.

This flagged the patients for special attention from the staff, he said. For example, patients whose charts had stickers received follow-up calls if they missed an appointment. To keep the registry up to date, every 2 months the staff pulls the charts of all registry patients and Dr. Hornbake updates the system manually. He spends about 1.5 hours entering data on 125 patients.

He said he prefers to enter the information in periodic batches, because it helps him to identify any chronic disease patients who have slipped through the cracks.

Even factoring in his time, Dr. Hornbake said that he saw an immediate return on investment with the patient registry system. Unlike implementation of an EHR system, he added, patient registry software tends to fit in easily with the normal workflow of the office.

Physicians also can manage their patient care using a paper-based patient registry, he said, but once they begin to track 20 or more measures, a paper system quickly becomes unworkable.

So far, Dr. Hornbake said that he has resisted purchasing an EHR system because he still can't make a financial case for the investment. He advised physicians to buy or upgrade an EHR system based on its ability to support pay for performance and manage a population of specific patients. Many of the other selling points for an EHR system—that it will eliminate transcription, cut down on needed staff positions, and improve coding—don't hold true for all physicians.

PHILADELPHIA — A costly electronic health record system is not necessary to engage in quality improvement and participate in the growing number of pay-for-performance programs, Dr. Rodney Hornbake said at the annual meeting of the American College of Physicians.

Patient registry software is a lower-cost alternative that allows physicians to track their care of patients with chronic diseases.

“It's really an excellent starting place for quality improvement in the ambulatory setting,” said Dr. Hornbake, an internist in private practice in Essex, Conn.

Patient registries are one of the best tools for physicians participating in pay-for-performance programs, Dr. Hornbake said. Many electronic health records (EHRs) may not have population-based functionality, and therefore cannot generate simple reports on the physician's performance on certain measures. Most EHR vendors can build interfaces with patient registry software, but that's generally an added cost, he said.

There are a number of patient registry programs available; a comprehensive program can be purchased for less than $1,000 per provider, Dr. Hornbake said. Some are available for free.

For example, Dr. Hornbake tested the Comorbid Disease Management Database (COMMAND) software in his practice. This registry system is available for free from the Mississippi Quality Improvement Organization. And technology-savvy physicians can use programs like Microsoft Access to design their own registries, he said.

Dr. Hornbake tried out COMMAND in his practice to help keep up with the pay-for-performance programs in his local market. One insurer—Anthem Health Plans Inc. of Connecticut—has a program that offers incentives for process and outcomes measures, as well as for the use of health-related information technology, including electronic prescribing, EHRs, and patient registries. The insurer also offers incentives to physicians for generic prescribing, he said.

Dr. Hornbake said that he exported demographic information from his billing system into COMMAND and manually entered the clinical information from patient charts himself. After using the billing system to identify all of the patients who had conditions included in his registry, he had his staff put red stickers on those patient charts.

This flagged the patients for special attention from the staff, he said. For example, patients whose charts had stickers received follow-up calls if they missed an appointment. To keep the registry up to date, every 2 months the staff pulls the charts of all registry patients and Dr. Hornbake updates the system manually. He spends about 1.5 hours entering data on 125 patients.

He said he prefers to enter the information in periodic batches, because it helps him to identify any chronic disease patients who have slipped through the cracks.

Even factoring in his time, Dr. Hornbake said that he saw an immediate return on investment with the patient registry system. Unlike implementation of an EHR system, he added, patient registry software tends to fit in easily with the normal workflow of the office.

Physicians also can manage their patient care using a paper-based patient registry, he said, but once they begin to track 20 or more measures, a paper system quickly becomes unworkable.

So far, Dr. Hornbake said that he has resisted purchasing an EHR system because he still can't make a financial case for the investment. He advised physicians to buy or upgrade an EHR system based on its ability to support pay for performance and manage a population of specific patients. Many of the other selling points for an EHR system—that it will eliminate transcription, cut down on needed staff positions, and improve coding—don't hold true for all physicians.