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 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 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.

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

Eventually, interoperable systems will become a condition of doing business with the federal government, said Mr. Leavitt, who is not related to Dr. Leavitt.

In an effort to aid physician adoption of EHRs, the HHS has published a final regulation (see article on p. 66) creating safe harbors in the federal antikickback statute and physician self-referral law (Stark law) that allow hospital systems and other large provider groups to donate health IT products to physicians in certain cases.

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 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 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.

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

Eventually, interoperable systems will become a condition of doing business with the federal government, said Mr. Leavitt, who is not related to Dr. Leavitt.

In an effort to aid physician adoption of EHRs, the HHS has published a final regulation (see article on p. 66) creating safe harbors in the federal antikickback statute and physician self-referral law (Stark law) that allow hospital systems and other large provider groups to donate health IT products to physicians in certain cases.

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 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 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.

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

Eventually, interoperable systems will become a condition of doing business with the federal government, said Mr. Leavitt, who is not related to Dr. Leavitt.

In an effort to aid physician adoption of EHRs, the HHS has published a final regulation (see article on p. 66) creating safe harbors in the federal antikickback statute and physician self-referral law (Stark law) that allow hospital systems and other large provider groups to donate health IT products to physicians in certain cases.

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

PHILADELPHIA — There are just as many systems failures at the root of malpractice cases as individual errors or negligence, Dr. Luke Sato said at the annual meeting of the American College of Physicians.

For example, the Risk Management Foundation of the Harvard Medical Institutes Inc., the insurance carrier for 18 hospitals and about 10,000 physicians in the Massachusetts area, has spent nearly the same amount of money over the years on malpractice cases involving clinical support processes as on cases resulting from a problem with the patient-clinician interaction. "What we see is that this is a process reengineering problem," said Dr. Sato, assistant professor of medicine at Harvard University and chief medical officer and vice president of the Risk Management Foundation.

An analysis of 2,270 malpractice cases within the insurance carrier from September 1995 to August 2005 shows that there are four high-risk categories in the system—obstetrics, surgery, medication-related problems, and diagnosis-related problems. Dr. Sato advised physicians to take a look at their office processes and set up ways within the practice to gather and document information that is critical to both the continuity of care and to avoiding malpractice claims.

Examples of best practices from the system are given online at www.rmf.harvard.edu

PHILADELPHIA — There are just as many systems failures at the root of malpractice cases as individual errors or negligence, Dr. Luke Sato said at the annual meeting of the American College of Physicians.

For example, the Risk Management Foundation of the Harvard Medical Institutes Inc., the insurance carrier for 18 hospitals and about 10,000 physicians in the Massachusetts area, has spent nearly the same amount of money over the years on malpractice cases involving clinical support processes as on cases resulting from a problem with the patient-clinician interaction. "What we see is that this is a process reengineering problem," said Dr. Sato, assistant professor of medicine at Harvard University and chief medical officer and vice president of the Risk Management Foundation.

An analysis of 2,270 malpractice cases within the insurance carrier from September 1995 to August 2005 shows that there are four high-risk categories in the system—obstetrics, surgery, medication-related problems, and diagnosis-related problems. Dr. Sato advised physicians to take a look at their office processes and set up ways within the practice to gather and document information that is critical to both the continuity of care and to avoiding malpractice claims.

Examples of best practices from the system are given online at www.rmf.harvard.edu

PHILADELPHIA — There are just as many systems failures at the root of malpractice cases as individual errors or negligence, Dr. Luke Sato said at the annual meeting of the American College of Physicians.

For example, the Risk Management Foundation of the Harvard Medical Institutes Inc., the insurance carrier for 18 hospitals and about 10,000 physicians in the Massachusetts area, has spent nearly the same amount of money over the years on malpractice cases involving clinical support processes as on cases resulting from a problem with the patient-clinician interaction. "What we see is that this is a process reengineering problem," said Dr. Sato, assistant professor of medicine at Harvard University and chief medical officer and vice president of the Risk Management Foundation.

An analysis of 2,270 malpractice cases within the insurance carrier from September 1995 to August 2005 shows that there are four high-risk categories in the system—obstetrics, surgery, medication-related problems, and diagnosis-related problems. Dr. Sato advised physicians to take a look at their office processes and set up ways within the practice to gather and document information that is critical to both the continuity of care and to avoiding malpractice claims.

Examples of best practices from the system are given online at www.rmf.harvard.edu

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 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 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 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. For EHRs, organizations can donate software, which must include an electronic prescribing component. Also, organizations can donate information technology and training services, which can include Internet connectivity.

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 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 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 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. For EHRs, organizations can donate software, which must include an electronic prescribing component. Also, organizations can donate information technology and training services, which can include Internet connectivity.

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 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 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 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. For EHRs, organizations can donate software, which must include an electronic prescribing component. Also, organizations can donate information technology and training services, which can include Internet connectivity.

Federally Funded Disinformation?

Many federally funded crisis pregnancy centers or pregnancy resource centers provide pregnant women with misleading information about the risks of abortion, according to a report from the Democratic staff of the House Committee on Government Reform. Investigators working for the committee called 25 federally funded crisis pregnancy centers and posed as pregnant 17-year-olds trying to decide whether to have an abortion. Of the 23 centers that were reached by investigators, 20 (87%) provided medically inaccurate information about the health effects of abortion, including about the link between abortion and breast cancer, the effect of abortion on fertility, and the mental health effects of abortion. Since 2001, the federal government has spent more than $30 million to fund these centers, according to the report.

Relief Sought on Imaging Pay Cuts

With Medicare due to slash payments for imaging services by 35%–55% in January 2007, provider organizations are rallying to delay or repeal the cuts, which call for payments for the technical component—equipment, supplies, and overhead for imaging services—to be reimbursed at the hospital outpatient payment rate if it is lower than the physician fee schedule. At a hearing of the House Energy and Commerce Health Subcommittee, Democrats and Republicans said they were concerned the reductions were enacted without public input and without any assessment of the impact on beneficiaries. The cuts were inserted into the Deficit Reduction Act during a House-Senate conference; the act was signed in February 2006. H.R. 5704, sponsored by Rep. Joseph Pitts (R-Penn.), would institute a 2-year moratorium, and Rep. Carolyn McCarthy (D-N.Y.) has introduced a bill that would repeal the cuts (H.R. 5238). At the hearing, the American College of Obstetricians and Gynecologists also urged Congress to exempt ultrasound performed in the physician's office from proposals that would place restrictions on the use of imaging, such as requiring accreditation standards. Dr. Douglas W. Laube, ACOG president, told that congressional committee that ob.gyns. are well trained to perform ultrasound and that the diagnostic test increases the quality of clinical care and ultimately results in cost savings.

Genetic Testing Specialty Urged

Officials at the Centers for Medicare and Medicaid Services should establish a genetic testing specialty under the Clinical Laboratory Improvement Amendments (CLIA) of 1998, according to a coalition of 14 women's health groups. In a letter to CMS Administrator Mark McClellan, the groups urged him to move forward with a Notice of Intent of proposed rulemaking issued in 2000 on the development of a genetic testing specialty. The science is outpacing the current regulations, the groups wrote. Currently there are about 1,000 tests for genetic diseases available clinically and several hundred more under development. Signatories to the letter include the Association for Reproductive Health Professionals, the Reproductive Health Technologies Project, and the Society for Women's Health Research.

HIV Vaccine Research Gets $287M

The Bill and Melinda Gates Foundation has awarded $287 million to researchers in an effort to accelerate development of an HIV vaccine. The sum will fund 16 grants to more than 165 investigators from around the world. “Some of the vaccine concepts that will be pursued have been talked about for years, but have never been adequately studied,” Dr. Nicholas Hellmann, acting director of the Gates Foundation's HIV, TB, and Reproductive Health program, said in a statement. “If successful, they could lead to entirely new paradigms for HIV vaccine development.”

'Wal-Mart Bill' Overturned in Court

A federal judge last month<July> overturned a Maryland law that would have required for-profit companies with 10,000 or more employees to spend at least 8% of total employee wages on health insurance costs or pay the same amount to the state. The law was directed at Wal-Mart. The judge threw out the law, which would have gone into effect in January, on the grounds that it violated the federal Employment Retirement Income Security Act of 1974. The court's decision was praised by the Retail Industry Leaders Association, which brought the suit, saying the court's decision spared national companies from facing a “costly patchwork” of state and local regulation of health plans. The group has also filed suit in an effort to overturn a similar law passed in Suffolk County in New York State. In a statement, Paul Blank, campaign director for WakeUp

WalMart.com

Federally Funded Disinformation?

Many federally funded crisis pregnancy centers or pregnancy resource centers provide pregnant women with misleading information about the risks of abortion, according to a report from the Democratic staff of the House Committee on Government Reform. Investigators working for the committee called 25 federally funded crisis pregnancy centers and posed as pregnant 17-year-olds trying to decide whether to have an abortion. Of the 23 centers that were reached by investigators, 20 (87%) provided medically inaccurate information about the health effects of abortion, including about the link between abortion and breast cancer, the effect of abortion on fertility, and the mental health effects of abortion. Since 2001, the federal government has spent more than &dollar;30 million to fund these centers, according to the report.

Relief Sought on Imaging Pay Cuts

With Medicare due to slash payments for imaging services by 35%–55% in January 2007, provider organizations are rallying to delay or repeal the cuts, which call for payments for the technical component—equipment, supplies, and overhead for imaging services—to be reimbursed at the hospital outpatient payment rate if it is lower than the physician fee schedule. At a hearing of the House Energy and Commerce Health Subcommittee, Democrats and Republicans said they were concerned the reductions were enacted without public input and without any assessment of the impact on beneficiaries. The cuts were inserted into the Deficit Reduction Act during a House-Senate conference; the act was signed in February 2006. H.R. 5704, sponsored by Rep. Joseph Pitts (R-Penn.), would institute a 2-year moratorium, and Rep. Carolyn McCarthy (D-N.Y.) has introduced a bill that would repeal the cuts (H.R. 5238). At the hearing, the American College of Obstetricians and Gynecologists also urged Congress to exempt ultrasound performed in the physician's office from proposals that would place restrictions on the use of imaging, such as requiring accreditation standards. Dr. Douglas W. Laube, ACOG president, told that congressional committee that ob.gyns. are well trained to perform ultrasound and that the diagnostic test increases the quality of clinical care and ultimately results in cost savings.

Genetic Testing Specialty Urged

Officials at the Centers for Medicare and Medicaid Services should establish a genetic testing specialty under the Clinical Laboratory Improvement Amendments (CLIA) of 1998, according to a coalition of 14 women's health groups. In a letter to CMS Administrator Mark McClellan, the groups urged him to move forward with a Notice of Intent of proposed rulemaking issued in 2000 on the development of a genetic testing specialty. The science is outpacing the current regulations, the groups wrote. Currently there are about 1,000 tests for genetic diseases available clinically and several hundred more under development. Signatories to the letter include the Association for Reproductive Health Professionals, the Reproductive Health Technologies Project, and the Society for Women's Health Research.

HIV Vaccine Research Gets &dollar;287M

The Bill and Melinda Gates Foundation has awarded &dollar;287 million to researchers in an effort to accelerate development of an HIV vaccine. The sum will fund 16 grants to more than 165 investigators from around the world. “Some of the vaccine concepts that will be pursued have been talked about for years, but have never been adequately studied,” Dr. Nicholas Hellmann, acting director of the Gates Foundation's HIV, TB, and Reproductive Health program, said in a statement. “If successful, they could lead to entirely new paradigms for HIV vaccine development.”

'Wal-Mart Bill' Overturned in Court

A federal judge last month<July> overturned a Maryland law that would have required for-profit companies with 10,000 or more employees to spend at least 8% of total employee wages on health insurance costs or pay the same amount to the state. The law was directed at Wal-Mart. The judge threw out the law, which would have gone into effect in January, on the grounds that it violated the federal Employment Retirement Income Security Act of 1974. The court's decision was praised by the Retail Industry Leaders Association, which brought the suit, saying the court's decision spared national companies from facing a “costly patchwork” of state and local regulation of health plans. The group has also filed suit in an effort to overturn a similar law passed in Suffolk County in New York State. In a statement, Paul Blank, campaign director for WakeUp

WalMart.com

Federally Funded Disinformation?

Many federally funded crisis pregnancy centers or pregnancy resource centers provide pregnant women with misleading information about the risks of abortion, according to a report from the Democratic staff of the House Committee on Government Reform. Investigators working for the committee called 25 federally funded crisis pregnancy centers and posed as pregnant 17-year-olds trying to decide whether to have an abortion. Of the 23 centers that were reached by investigators, 20 (87%) provided medically inaccurate information about the health effects of abortion, including about the link between abortion and breast cancer, the effect of abortion on fertility, and the mental health effects of abortion. Since 2001, the federal government has spent more than &dollar;30 million to fund these centers, according to the report.

Relief Sought on Imaging Pay Cuts

With Medicare due to slash payments for imaging services by 35%–55% in January 2007, provider organizations are rallying to delay or repeal the cuts, which call for payments for the technical component—equipment, supplies, and overhead for imaging services—to be reimbursed at the hospital outpatient payment rate if it is lower than the physician fee schedule. At a hearing of the House Energy and Commerce Health Subcommittee, Democrats and Republicans said they were concerned the reductions were enacted without public input and without any assessment of the impact on beneficiaries. The cuts were inserted into the Deficit Reduction Act during a House-Senate conference; the act was signed in February 2006. H.R. 5704, sponsored by Rep. Joseph Pitts (R-Penn.), would institute a 2-year moratorium, and Rep. Carolyn McCarthy (D-N.Y.) has introduced a bill that would repeal the cuts (H.R. 5238). At the hearing, the American College of Obstetricians and Gynecologists also urged Congress to exempt ultrasound performed in the physician's office from proposals that would place restrictions on the use of imaging, such as requiring accreditation standards. Dr. Douglas W. Laube, ACOG president, told that congressional committee that ob.gyns. are well trained to perform ultrasound and that the diagnostic test increases the quality of clinical care and ultimately results in cost savings.

Genetic Testing Specialty Urged

Officials at the Centers for Medicare and Medicaid Services should establish a genetic testing specialty under the Clinical Laboratory Improvement Amendments (CLIA) of 1998, according to a coalition of 14 women's health groups. In a letter to CMS Administrator Mark McClellan, the groups urged him to move forward with a Notice of Intent of proposed rulemaking issued in 2000 on the development of a genetic testing specialty. The science is outpacing the current regulations, the groups wrote. Currently there are about 1,000 tests for genetic diseases available clinically and several hundred more under development. Signatories to the letter include the Association for Reproductive Health Professionals, the Reproductive Health Technologies Project, and the Society for Women's Health Research.

HIV Vaccine Research Gets &dollar;287M

The Bill and Melinda Gates Foundation has awarded &dollar;287 million to researchers in an effort to accelerate development of an HIV vaccine. The sum will fund 16 grants to more than 165 investigators from around the world. “Some of the vaccine concepts that will be pursued have been talked about for years, but have never been adequately studied,” Dr. Nicholas Hellmann, acting director of the Gates Foundation's HIV, TB, and Reproductive Health program, said in a statement. “If successful, they could lead to entirely new paradigms for HIV vaccine development.”

'Wal-Mart Bill' Overturned in Court

A federal judge last month<July> overturned a Maryland law that would have required for-profit companies with 10,000 or more employees to spend at least 8% of total employee wages on health insurance costs or pay the same amount to the state. The law was directed at Wal-Mart. The judge threw out the law, which would have gone into effect in January, on the grounds that it violated the federal Employment Retirement Income Security Act of 1974. The court's decision was praised by the Retail Industry Leaders Association, which brought the suit, saying the court's decision spared national companies from facing a “costly patchwork” of state and local regulation of health plans. The group has also filed suit in an effort to overturn a similar law passed in Suffolk County in New York State. In a statement, Paul Blank, campaign director for WakeUp

WalMart.com

BOSTON — Women diagnosed with polycystic ovarian morphology and normal menstrual cycles do not appear to be at significant risk for developing polycystic ovary syndrome, according to a study presented at the annual meeting of the Endocrine Society.

Researchers at Harvard University and Massachusetts General Hospital in Boston followed 40 women with regular menstrual cycles and either polycystic or normal ovarian morphology to see which women would develop polycystic ovary syndrome (PCOS).

The women were followed for 1.7–17.5 years after the initial ultrasound and given a follow-up ultrasound by the same ultrasonographic technician.

The researchers defined polycystic ovarian morphology (PCOM) as either an ovary with 12 or more follicles, ranging in size from 2 mm to 10 mm, in a single plane or an ovarian volume of more than 10 mL without a dominant follicle.

At baseline, 17 women had normal morphology and 23 were diagnosed with PCOM.

The average age at baseline was 30, and the average age at follow-up was 38, according to Meagan K. Murphy, a medical student at Harvard University who presented the results of the study.

At follow-up, 1 of the 17 women with normal ovarian morphology at the beginning of the study had developed PCOM.

Of the 23 women who had PCOM at baseline, about half had PCOM at follow-up and the rest had converted to normal ovarian morphology, Ms. Murphy said.

In those women who developed normal ovarian morphology, their follicle and ovarian volume decreased significantly.

One woman who was classified as having PCOM at baseline was diagnosed with PCOS by her physician. However, her menses became regular with weight loss and the previous diagnosis of PCOS was not confirmed within the study.

The development of PCOS is uncommon in women with PCOM and regular cycles, the researchers concluded. And a normal drop in follicle number with aging may result in women with PCOM developing normal cycles over time, Ms. Murphy said.

BOSTON — Women diagnosed with polycystic ovarian morphology and normal menstrual cycles do not appear to be at significant risk for developing polycystic ovary syndrome, according to a study presented at the annual meeting of the Endocrine Society.

Researchers at Harvard University and Massachusetts General Hospital in Boston followed 40 women with regular menstrual cycles and either polycystic or normal ovarian morphology to see which women would develop polycystic ovary syndrome (PCOS).

The women were followed for 1.7–17.5 years after the initial ultrasound and given a follow-up ultrasound by the same ultrasonographic technician.

The researchers defined polycystic ovarian morphology (PCOM) as either an ovary with 12 or more follicles, ranging in size from 2 mm to 10 mm, in a single plane or an ovarian volume of more than 10 mL without a dominant follicle.

At baseline, 17 women had normal morphology and 23 were diagnosed with PCOM.

The average age at baseline was 30, and the average age at follow-up was 38, according to Meagan K. Murphy, a medical student at Harvard University who presented the results of the study.

At follow-up, 1 of the 17 women with normal ovarian morphology at the beginning of the study had developed PCOM.

Of the 23 women who had PCOM at baseline, about half had PCOM at follow-up and the rest had converted to normal ovarian morphology, Ms. Murphy said.

In those women who developed normal ovarian morphology, their follicle and ovarian volume decreased significantly.

One woman who was classified as having PCOM at baseline was diagnosed with PCOS by her physician. However, her menses became regular with weight loss and the previous diagnosis of PCOS was not confirmed within the study.

The development of PCOS is uncommon in women with PCOM and regular cycles, the researchers concluded. And a normal drop in follicle number with aging may result in women with PCOM developing normal cycles over time, Ms. Murphy said.

BOSTON — Women diagnosed with polycystic ovarian morphology and normal menstrual cycles do not appear to be at significant risk for developing polycystic ovary syndrome, according to a study presented at the annual meeting of the Endocrine Society.

Researchers at Harvard University and Massachusetts General Hospital in Boston followed 40 women with regular menstrual cycles and either polycystic or normal ovarian morphology to see which women would develop polycystic ovary syndrome (PCOS).

The women were followed for 1.7–17.5 years after the initial ultrasound and given a follow-up ultrasound by the same ultrasonographic technician.

The researchers defined polycystic ovarian morphology (PCOM) as either an ovary with 12 or more follicles, ranging in size from 2 mm to 10 mm, in a single plane or an ovarian volume of more than 10 mL without a dominant follicle.

At baseline, 17 women had normal morphology and 23 were diagnosed with PCOM.

The average age at baseline was 30, and the average age at follow-up was 38, according to Meagan K. Murphy, a medical student at Harvard University who presented the results of the study.

At follow-up, 1 of the 17 women with normal ovarian morphology at the beginning of the study had developed PCOM.

Of the 23 women who had PCOM at baseline, about half had PCOM at follow-up and the rest had converted to normal ovarian morphology, Ms. Murphy said.

In those women who developed normal ovarian morphology, their follicle and ovarian volume decreased significantly.

One woman who was classified as having PCOM at baseline was diagnosed with PCOS by her physician. However, her menses became regular with weight loss and the previous diagnosis of PCOS was not confirmed within the study.

The development of PCOS is uncommon in women with PCOM and regular cycles, the researchers concluded. And a normal drop in follicle number with aging may result in women with PCOM developing normal cycles over time, Ms. Murphy said.

For couples with unexplained subfertility and more than a 30% chance of pregnancy without treatment, the use of intrauterine insemination with controlled ovarian hyperstimulation offers little benefit, reported Dr. Pieternel Steures, of the Academic Medical Center in Amsterdam, and colleagues.

Correctly identifying couples who are unlikely to benefit from the use of these techniques can help prevent the misuse of facilities and resources, the researchers concluded (Lancet 2006;368:216–21).

The study compared the effectiveness of intrauterine insemination for 6 months with controlled ovarian hyperstimulation versus 6 months of expectant management in couples with unexplained subfertility who had a 30%–40% chance of a spontaneously ongoing pregnancy within a year. (The prognosis was calculated using a prediction model that incorporates factors such as the woman's age, duration of subfertility, and postcoital test results.)

The study protocol recommended the use of follicle-stimulating hormone for controlled ovarian hyperstimulation, but in 11% of cycles an antiestrogenic drug was used.

Couples were recruited from 26 fertility centers in the Netherlands and underwent a basic fertility assessment to determine their chances of conceiving naturally within the next 12 months.

The researchers randomized 253 couples to receive either intrauterine insemination with controlled ovarian hyperstimulation or expectant management for 6 months. The primary end point of the study was ongoing pregnancy within 6 months.

The researchers assumed that the expectant management group would have a pregnancy rate of about 22% in 6 months based on the 30%–40% chance of ongoing pregnancy within 12 months. The intrauterine insemination plus ovarian hyperstimulation intervention would be considered beneficial only if the ongoing pregnancy rate after 6 months was at least 35%, the researchers wrote.

After 6 months, 42 (33%) pregnancies occurred in the intervention group and 29 (23%) were ongoing, compared with 40 (32%) pregnancies in the expectant management group, of which 34 (27%) were ongoing.

Of the 42 women who conceived in the intervention group, 6 had spontaneous pregnancies before treatment started and 7 had spontaneous pregnancies between treatment cycles. In the intervention group, 444 cycles of intrauterine insemination were started and 63 were canceled. There was a 6.5% total pregnancy rate per started cycle and a 4.1% ongoing pregnancy rate per started cycle, the researchers wrote.

Within the expectant management group, 25 (20%) couples started treatment with intrauterine insemination with controlled ovarian hyperstimulation before 6 months of expectant management, which resulted in 4 of the 34 total ongoing pregnancies in that group.

The study had some possible limitations, the researchers wrote. For example, while the study protocol called for the use of follicle-stimulating hormone to be used for controlled ovarian hyperstimulation, an antiestrogenic drug was used in 11% of cycles. There were also variations in the intrauterine insemination protocols at each of the centers involved in the study. Finally, the researchers noted that their study had a lower ongoing pregnancy rate per started cycle than the figures cited in previous studies.

Physicians need to appreciate that couples with an intermediate prognosis as described in the study can get pregnant without treatment, and patients should be told about those chances, Dr. William D. Schlaff, professor and chief of reproductive endocrinology at the University of Colorado Health Sciences Center in Denver, said in an interview. However, there are still some unanswered questions from the study, he said.

For couples with unexplained subfertility and more than a 30% chance of pregnancy without treatment, the use of intrauterine insemination with controlled ovarian hyperstimulation offers little benefit, reported Dr. Pieternel Steures, of the Academic Medical Center in Amsterdam, and colleagues.

Correctly identifying couples who are unlikely to benefit from the use of these techniques can help prevent the misuse of facilities and resources, the researchers concluded (Lancet 2006;368:216–21).

The study compared the effectiveness of intrauterine insemination for 6 months with controlled ovarian hyperstimulation versus 6 months of expectant management in couples with unexplained subfertility who had a 30%–40% chance of a spontaneously ongoing pregnancy within a year. (The prognosis was calculated using a prediction model that incorporates factors such as the woman's age, duration of subfertility, and postcoital test results.)

The study protocol recommended the use of follicle-stimulating hormone for controlled ovarian hyperstimulation, but in 11% of cycles an antiestrogenic drug was used.

Couples were recruited from 26 fertility centers in the Netherlands and underwent a basic fertility assessment to determine their chances of conceiving naturally within the next 12 months.

The researchers randomized 253 couples to receive either intrauterine insemination with controlled ovarian hyperstimulation or expectant management for 6 months. The primary end point of the study was ongoing pregnancy within 6 months.

The researchers assumed that the expectant management group would have a pregnancy rate of about 22% in 6 months based on the 30%–40% chance of ongoing pregnancy within 12 months. The intrauterine insemination plus ovarian hyperstimulation intervention would be considered beneficial only if the ongoing pregnancy rate after 6 months was at least 35%, the researchers wrote.

After 6 months, 42 (33%) pregnancies occurred in the intervention group and 29 (23%) were ongoing, compared with 40 (32%) pregnancies in the expectant management group, of which 34 (27%) were ongoing.

Of the 42 women who conceived in the intervention group, 6 had spontaneous pregnancies before treatment started and 7 had spontaneous pregnancies between treatment cycles. In the intervention group, 444 cycles of intrauterine insemination were started and 63 were canceled. There was a 6.5% total pregnancy rate per started cycle and a 4.1% ongoing pregnancy rate per started cycle, the researchers wrote.

Within the expectant management group, 25 (20%) couples started treatment with intrauterine insemination with controlled ovarian hyperstimulation before 6 months of expectant management, which resulted in 4 of the 34 total ongoing pregnancies in that group.

The study had some possible limitations, the researchers wrote. For example, while the study protocol called for the use of follicle-stimulating hormone to be used for controlled ovarian hyperstimulation, an antiestrogenic drug was used in 11% of cycles. There were also variations in the intrauterine insemination protocols at each of the centers involved in the study. Finally, the researchers noted that their study had a lower ongoing pregnancy rate per started cycle than the figures cited in previous studies.

Physicians need to appreciate that couples with an intermediate prognosis as described in the study can get pregnant without treatment, and patients should be told about those chances, Dr. William D. Schlaff, professor and chief of reproductive endocrinology at the University of Colorado Health Sciences Center in Denver, said in an interview. However, there are still some unanswered questions from the study, he said.

For couples with unexplained subfertility and more than a 30% chance of pregnancy without treatment, the use of intrauterine insemination with controlled ovarian hyperstimulation offers little benefit, reported Dr. Pieternel Steures, of the Academic Medical Center in Amsterdam, and colleagues.

Correctly identifying couples who are unlikely to benefit from the use of these techniques can help prevent the misuse of facilities and resources, the researchers concluded (Lancet 2006;368:216–21).

The study compared the effectiveness of intrauterine insemination for 6 months with controlled ovarian hyperstimulation versus 6 months of expectant management in couples with unexplained subfertility who had a 30%–40% chance of a spontaneously ongoing pregnancy within a year. (The prognosis was calculated using a prediction model that incorporates factors such as the woman's age, duration of subfertility, and postcoital test results.)

The study protocol recommended the use of follicle-stimulating hormone for controlled ovarian hyperstimulation, but in 11% of cycles an antiestrogenic drug was used.

Couples were recruited from 26 fertility centers in the Netherlands and underwent a basic fertility assessment to determine their chances of conceiving naturally within the next 12 months.

The researchers randomized 253 couples to receive either intrauterine insemination with controlled ovarian hyperstimulation or expectant management for 6 months. The primary end point of the study was ongoing pregnancy within 6 months.

The researchers assumed that the expectant management group would have a pregnancy rate of about 22% in 6 months based on the 30%–40% chance of ongoing pregnancy within 12 months. The intrauterine insemination plus ovarian hyperstimulation intervention would be considered beneficial only if the ongoing pregnancy rate after 6 months was at least 35%, the researchers wrote.

After 6 months, 42 (33%) pregnancies occurred in the intervention group and 29 (23%) were ongoing, compared with 40 (32%) pregnancies in the expectant management group, of which 34 (27%) were ongoing.

Of the 42 women who conceived in the intervention group, 6 had spontaneous pregnancies before treatment started and 7 had spontaneous pregnancies between treatment cycles. In the intervention group, 444 cycles of intrauterine insemination were started and 63 were canceled. There was a 6.5% total pregnancy rate per started cycle and a 4.1% ongoing pregnancy rate per started cycle, the researchers wrote.

Within the expectant management group, 25 (20%) couples started treatment with intrauterine insemination with controlled ovarian hyperstimulation before 6 months of expectant management, which resulted in 4 of the 34 total ongoing pregnancies in that group.

The study had some possible limitations, the researchers wrote. For example, while the study protocol called for the use of follicle-stimulating hormone to be used for controlled ovarian hyperstimulation, an antiestrogenic drug was used in 11% of cycles. There were also variations in the intrauterine insemination protocols at each of the centers involved in the study. Finally, the researchers noted that their study had a lower ongoing pregnancy rate per started cycle than the figures cited in previous studies.

Physicians need to appreciate that couples with an intermediate prognosis as described in the study can get pregnant without treatment, and patients should be told about those chances, Dr. William D. Schlaff, professor and chief of reproductive endocrinology at the University of Colorado Health Sciences Center in Denver, said in an interview. However, there are still some unanswered questions from the study, he said.

More than 500,000 infants or about 12.5% of infants born in 2004 in the United States were preterm and the rate of preterm births has risen by about 30% since 1981, according to a new report from the National Academy of Sciences' Institute of Medicine.

Preterm birth, defined as any birth that occurs at less than 37 completed weeks of gestation, disproportionately affects women in certain racial, ethnic, and socioeconomic groups. For example, in 2003, nearly 18% of African American women had preterm births, compared with 11.9% of Hispanic women and 11.5% of non-Hispanic white women, the Institute of Medicine (IOM) report said.

“This is a growing problem that can result in significant consequences for families and for society as a whole,” Dr. Richard E. Behrman, chair of the IOM committee that produced the report, said during a press conference. “Yet preterm birth is not receiving the attention and funding necessary to fully understand the causes and consequences and to identify ways to reduce the number of preterm deliveries.”

Infants delivered preterm are at greater risk for a variety of health and developmental problems than full-term infants but there are also significant economic costs associated with preterm births. The cost of medical care in infancy, maternal care, early intervention services, special education, and lost productivity from preterm birth added up to more than &dollar;26 billion in 2005, according to the IOM report. And this is likely to be a conservative estimate, said Dr. Behrman, who is executive chair of the Pediatric Education Steering Committee for the Federation of Pediatric Organizations Inc., in Menlo Park, Calif.

In addition to defining the scope of the problem, the IOM report outlines a multidisciplinary research agenda aimed at improving information on the causes and treatment of preterm birth. The report calls on the federal government and private institutions to do a better job on collecting preterm birth data and to increase research that will lead to better identification of women at risk for preterm labor.

Although there have been significant improvements in treating preterm infants, there has been comparatively little success in understanding and preventing preterm birth, Dr. Behrman said. In effort to address some of those gaps, the IOM committee made a series of recommendations for public and private researchers. Some of the recommendations include:

▸ Multidisciplinary research centers. The National Institutes of Health and private foundations should establish integrated multidisciplinary research centers to focus on better understanding the causes of preterm birth and health outcomes for women and infants, the IOM committee recommended.

▸ Ultrasound use. Professional societies should encourage the use of ultrasound before 20 weeks' gestation and establish standards of practice for training personnel to improve the reliability of ultrasound data, the IOM committee recommended. These efforts are important to gain accurate measures of gestational age, according to the report.

▸ Infertility treatments. NIH, CDC, and other agencies should support research into how fertility treatments can increase the risk for preterm birth. The report also calls on professional societies to establish guidelines aimed at reducing the number of multiple gestations, such as single embryo transfer and restricted use of superovulation drugs. The Society for Assisted Reproductive Technology and the American Society for Reproductive Medicine, which have already issued guidelines on the number of embryos that should be transferred per cycle, announced that upcoming revisions to their guidelines should help to further reduce the incidence of multiples and preterm births associated with assisted reproductive technology.

▸ Identification and treatment. Researchers should focus on ways to identify and treat women who have an increased risk of preterm labor, such as studying known markers of preterm labor and potential new genetic markers that could lead to the creation of an “individualized composite assessment of risk.” Better methods are needed to diagnose preterm labor, assess fetal health, and arrest labor, the report said.

▸ Perinatal data. National Center for Health Statistics, part of the Centers for Disease Control and Prevention, should collect and report national perinatal data, the IOM committee recommended.

▸ Etiologic and epidemiologic studies. Public and private funding agencies should support research into the etiologies of preterm birth, the report said. The IOM committee also urged agencies to promote research that would simultaneously examine multiple risk factors for preterm birth instead of looking at risk factors individually.

▸ Health disparities. NIH and other agencies should examine the causes of racial, ethnic, and socioeconomic disparities related to preterm birth and devote resources to developing prevention strategies, the IOM committee recommended.

The report is a “call to arms” for the federal government to devote significantly more resources to preterm birth, Dr. Charles Lockwood, professor and chair of the department of obstetrics and gynecology and reproductive sciences at Yale University, said in an interview. Dr. Lockwood, who was one of the reviewers of the IOM report, said a 10-fold increase in current government spending on preterm birth would be a good start.

The IOM report “elevates the seriousness of the problem,” Jennifer Howse, Ph.D., president of the March of Dimes said in an interview. The report, which was cosponsored by the March of Dimes, is a realistic assessment of prematurity in the United States, she said.

Although the March of Dimes endorsed the recommendations in the report, the group also called on Congress to pass pending federal legislation that would authorize more federal research into preterm birth. The Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act or PREEMIE bill (S. 707/H.R. 2861) was introduced last year and was passed by the Senate in August.

Copies of the IOM report are available online at www.nap.edu

More than 500,000 infants or about 12.5% of infants born in 2004 in the United States were preterm and the rate of preterm births has risen by about 30% since 1981, according to a new report from the National Academy of Sciences' Institute of Medicine.

Preterm birth, defined as any birth that occurs at less than 37 completed weeks of gestation, disproportionately affects women in certain racial, ethnic, and socioeconomic groups. For example, in 2003, nearly 18% of African American women had preterm births, compared with 11.9% of Hispanic women and 11.5% of non-Hispanic white women, the Institute of Medicine (IOM) report said.

“This is a growing problem that can result in significant consequences for families and for society as a whole,” Dr. Richard E. Behrman, chair of the IOM committee that produced the report, said during a press conference. “Yet preterm birth is not receiving the attention and funding necessary to fully understand the causes and consequences and to identify ways to reduce the number of preterm deliveries.”

Infants delivered preterm are at greater risk for a variety of health and developmental problems than full-term infants but there are also significant economic costs associated with preterm births. The cost of medical care in infancy, maternal care, early intervention services, special education, and lost productivity from preterm birth added up to more than &dollar;26 billion in 2005, according to the IOM report. And this is likely to be a conservative estimate, said Dr. Behrman, who is executive chair of the Pediatric Education Steering Committee for the Federation of Pediatric Organizations Inc., in Menlo Park, Calif.

In addition to defining the scope of the problem, the IOM report outlines a multidisciplinary research agenda aimed at improving information on the causes and treatment of preterm birth. The report calls on the federal government and private institutions to do a better job on collecting preterm birth data and to increase research that will lead to better identification of women at risk for preterm labor.

Although there have been significant improvements in treating preterm infants, there has been comparatively little success in understanding and preventing preterm birth, Dr. Behrman said. In effort to address some of those gaps, the IOM committee made a series of recommendations for public and private researchers. Some of the recommendations include:

▸ Multidisciplinary research centers. The National Institutes of Health and private foundations should establish integrated multidisciplinary research centers to focus on better understanding the causes of preterm birth and health outcomes for women and infants, the IOM committee recommended.

▸ Ultrasound use. Professional societies should encourage the use of ultrasound before 20 weeks' gestation and establish standards of practice for training personnel to improve the reliability of ultrasound data, the IOM committee recommended. These efforts are important to gain accurate measures of gestational age, according to the report.

▸ Infertility treatments. NIH, CDC, and other agencies should support research into how fertility treatments can increase the risk for preterm birth. The report also calls on professional societies to establish guidelines aimed at reducing the number of multiple gestations, such as single embryo transfer and restricted use of superovulation drugs. The Society for Assisted Reproductive Technology and the American Society for Reproductive Medicine, which have already issued guidelines on the number of embryos that should be transferred per cycle, announced that upcoming revisions to their guidelines should help to further reduce the incidence of multiples and preterm births associated with assisted reproductive technology.

▸ Identification and treatment. Researchers should focus on ways to identify and treat women who have an increased risk of preterm labor, such as studying known markers of preterm labor and potential new genetic markers that could lead to the creation of an “individualized composite assessment of risk.” Better methods are needed to diagnose preterm labor, assess fetal health, and arrest labor, the report said.

▸ Perinatal data. National Center for Health Statistics, part of the Centers for Disease Control and Prevention, should collect and report national perinatal data, the IOM committee recommended.

▸ Etiologic and epidemiologic studies. Public and private funding agencies should support research into the etiologies of preterm birth, the report said. The IOM committee also urged agencies to promote research that would simultaneously examine multiple risk factors for preterm birth instead of looking at risk factors individually.

▸ Health disparities. NIH and other agencies should examine the causes of racial, ethnic, and socioeconomic disparities related to preterm birth and devote resources to developing prevention strategies, the IOM committee recommended.

The report is a “call to arms” for the federal government to devote significantly more resources to preterm birth, Dr. Charles Lockwood, professor and chair of the department of obstetrics and gynecology and reproductive sciences at Yale University, said in an interview. Dr. Lockwood, who was one of the reviewers of the IOM report, said a 10-fold increase in current government spending on preterm birth would be a good start.

The IOM report “elevates the seriousness of the problem,” Jennifer Howse, Ph.D., president of the March of Dimes said in an interview. The report, which was cosponsored by the March of Dimes, is a realistic assessment of prematurity in the United States, she said.

Although the March of Dimes endorsed the recommendations in the report, the group also called on Congress to pass pending federal legislation that would authorize more federal research into preterm birth. The Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act or PREEMIE bill (S. 707/H.R. 2861) was introduced last year and was passed by the Senate in August.

Copies of the IOM report are available online at www.nap.edu

More than 500,000 infants or about 12.5% of infants born in 2004 in the United States were preterm and the rate of preterm births has risen by about 30% since 1981, according to a new report from the National Academy of Sciences' Institute of Medicine.

Preterm birth, defined as any birth that occurs at less than 37 completed weeks of gestation, disproportionately affects women in certain racial, ethnic, and socioeconomic groups. For example, in 2003, nearly 18% of African American women had preterm births, compared with 11.9% of Hispanic women and 11.5% of non-Hispanic white women, the Institute of Medicine (IOM) report said.

“This is a growing problem that can result in significant consequences for families and for society as a whole,” Dr. Richard E. Behrman, chair of the IOM committee that produced the report, said during a press conference. “Yet preterm birth is not receiving the attention and funding necessary to fully understand the causes and consequences and to identify ways to reduce the number of preterm deliveries.”

Infants delivered preterm are at greater risk for a variety of health and developmental problems than full-term infants but there are also significant economic costs associated with preterm births. The cost of medical care in infancy, maternal care, early intervention services, special education, and lost productivity from preterm birth added up to more than &dollar;26 billion in 2005, according to the IOM report. And this is likely to be a conservative estimate, said Dr. Behrman, who is executive chair of the Pediatric Education Steering Committee for the Federation of Pediatric Organizations Inc., in Menlo Park, Calif.

In addition to defining the scope of the problem, the IOM report outlines a multidisciplinary research agenda aimed at improving information on the causes and treatment of preterm birth. The report calls on the federal government and private institutions to do a better job on collecting preterm birth data and to increase research that will lead to better identification of women at risk for preterm labor.

Although there have been significant improvements in treating preterm infants, there has been comparatively little success in understanding and preventing preterm birth, Dr. Behrman said. In effort to address some of those gaps, the IOM committee made a series of recommendations for public and private researchers. Some of the recommendations include:

▸ Multidisciplinary research centers. The National Institutes of Health and private foundations should establish integrated multidisciplinary research centers to focus on better understanding the causes of preterm birth and health outcomes for women and infants, the IOM committee recommended.

▸ Ultrasound use. Professional societies should encourage the use of ultrasound before 20 weeks' gestation and establish standards of practice for training personnel to improve the reliability of ultrasound data, the IOM committee recommended. These efforts are important to gain accurate measures of gestational age, according to the report.

▸ Infertility treatments. NIH, CDC, and other agencies should support research into how fertility treatments can increase the risk for preterm birth. The report also calls on professional societies to establish guidelines aimed at reducing the number of multiple gestations, such as single embryo transfer and restricted use of superovulation drugs. The Society for Assisted Reproductive Technology and the American Society for Reproductive Medicine, which have already issued guidelines on the number of embryos that should be transferred per cycle, announced that upcoming revisions to their guidelines should help to further reduce the incidence of multiples and preterm births associated with assisted reproductive technology.

▸ Identification and treatment. Researchers should focus on ways to identify and treat women who have an increased risk of preterm labor, such as studying known markers of preterm labor and potential new genetic markers that could lead to the creation of an “individualized composite assessment of risk.” Better methods are needed to diagnose preterm labor, assess fetal health, and arrest labor, the report said.

▸ Perinatal data. National Center for Health Statistics, part of the Centers for Disease Control and Prevention, should collect and report national perinatal data, the IOM committee recommended.

▸ Etiologic and epidemiologic studies. Public and private funding agencies should support research into the etiologies of preterm birth, the report said. The IOM committee also urged agencies to promote research that would simultaneously examine multiple risk factors for preterm birth instead of looking at risk factors individually.

▸ Health disparities. NIH and other agencies should examine the causes of racial, ethnic, and socioeconomic disparities related to preterm birth and devote resources to developing prevention strategies, the IOM committee recommended.

The report is a “call to arms” for the federal government to devote significantly more resources to preterm birth, Dr. Charles Lockwood, professor and chair of the department of obstetrics and gynecology and reproductive sciences at Yale University, said in an interview. Dr. Lockwood, who was one of the reviewers of the IOM report, said a 10-fold increase in current government spending on preterm birth would be a good start.

The IOM report “elevates the seriousness of the problem,” Jennifer Howse, Ph.D., president of the March of Dimes said in an interview. The report, which was cosponsored by the March of Dimes, is a realistic assessment of prematurity in the United States, she said.

Although the March of Dimes endorsed the recommendations in the report, the group also called on Congress to pass pending federal legislation that would authorize more federal research into preterm birth. The Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act or PREEMIE bill (S. 707/H.R. 2861) was introduced last year and was passed by the Senate in August.

Copies of the IOM report are available online at www.nap.edu

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 in late June, 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 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 a member of the AMA's Relative Value Update Committee (RUC). The RUC is a 29-member multispecialty committee that makes recommendations to the CMS annually on payment issues.

In addition to primary care physicians, endocrinologists were among the big winners under the CMS proposal. For endocrinologists, CMS estimates that there will be a 6% increase in allowed Medicare charges in 2007 based on the combined impact of the work and practice expense RVU changes. Surgeons also will see some benefit because of increases for surgical postoperative care.

Although the increased payments for evaluation and management services 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 &dollar;20 million. CMS estimates that the proposed work RVU changes will increase expenditures by about &dollar;4 billion.

CMS is accepting comments to the proposed rule until Aug. 21.

The proposed rule is available online at www.cms.hhs.gov/PhysicianFeeSched

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 in late June, 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 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 a member of the AMA's Relative Value Update Committee (RUC). The RUC is a 29-member multispecialty committee that makes recommendations to the CMS annually on payment issues.

In addition to primary care physicians, endocrinologists were among the big winners under the CMS proposal. For endocrinologists, CMS estimates that there will be a 6% increase in allowed Medicare charges in 2007 based on the combined impact of the work and practice expense RVU changes. Surgeons also will see some benefit because of increases for surgical postoperative care.

Although the increased payments for evaluation and management services 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 &dollar;20 million. CMS estimates that the proposed work RVU changes will increase expenditures by about &dollar;4 billion.

CMS is accepting comments to the proposed rule until Aug. 21.

The proposed rule is available online at www.cms.hhs.gov/PhysicianFeeSched

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 in late June, 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 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 a member of the AMA's Relative Value Update Committee (RUC). The RUC is a 29-member multispecialty committee that makes recommendations to the CMS annually on payment issues.

In addition to primary care physicians, endocrinologists were among the big winners under the CMS proposal. For endocrinologists, CMS estimates that there will be a 6% increase in allowed Medicare charges in 2007 based on the combined impact of the work and practice expense RVU changes. Surgeons also will see some benefit because of increases for surgical postoperative care.

Although the increased payments for evaluation and management services 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 &dollar;20 million. CMS estimates that the proposed work RVU changes will increase expenditures by about &dollar;4 billion.

CMS is accepting comments to the proposed rule until Aug. 21.

The proposed rule is available online at www.cms.hhs.gov/PhysicianFeeSched

The Certification Commission for Healthcare Information Technology has unveiled its first list of 20 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. It is under contract to the federal government to develop certification criteria for EHRs and evaluate products. In this first round, CCHIT officials gave their seal of approval to 18 products that met all certification standards. Two additional products were given conditional premarket certification pending verification by users.

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 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 requirements will be applied starting next year, once standards have been harmonized, he said.

At the press conference, Health and Human Services Secretary Mike Leavitt announced HHS soon will publish a final rule creating safe harbors in federal antikickback statute and physician self-referral laws that would allow hospital systems and other large provider groups to donate health IT products to physicians in certain cases. The proposed rule was issued in October.

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

The Certification Commission for Healthcare Information Technology has unveiled its first list of 20 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. It is under contract to the federal government to develop certification criteria for EHRs and evaluate products. In this first round, CCHIT officials gave their seal of approval to 18 products that met all certification standards. Two additional products were given conditional premarket certification pending verification by users.

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 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 requirements will be applied starting next year, once standards have been harmonized, he said.

At the press conference, Health and Human Services Secretary Mike Leavitt announced HHS soon will publish a final rule creating safe harbors in federal antikickback statute and physician self-referral laws that would allow hospital systems and other large provider groups to donate health IT products to physicians in certain cases. The proposed rule was issued in October.

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

The Certification Commission for Healthcare Information Technology has unveiled its first list of 20 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. It is under contract to the federal government to develop certification criteria for EHRs and evaluate products. In this first round, CCHIT officials gave their seal of approval to 18 products that met all certification standards. Two additional products were given conditional premarket certification pending verification by users.

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 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 requirements will be applied starting next year, once standards have been harmonized, he said.

At the press conference, Health and Human Services Secretary Mike Leavitt announced HHS soon will publish a final rule creating safe harbors in federal antikickback statute and physician self-referral laws that would allow hospital systems and other large provider groups to donate health IT products to physicians in certain cases. The proposed rule was issued in October.

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

Plan B Investigation

Two Democratic senators are calling on the Government Accountability Office (GAO) to investigate the Food and Drug Administration's decision to hire a private contractor to collect and review comments submitted on the Plan B emergency contraception application for over-the-counter marketing status for women aged 16 years and older. Sen. Hillary Rodham Clinton (D-N.Y.) and Sen. Patty Murray (D-Wash.) recently sent a letter to the GAO asking officials there to look into the contract FDA has entered into with Booz Allen Hamilton and report back as soon as possible. Last fall, the FDA announced that it would accept public comments on the Plan B application. Sen. Clinton and Sen. Murray said they want to know why the FDA outsourced the work, the cost of the contracts, and whether there are any other contracts related to Plan B. “Outsourcing public comments on Plan B is yet another warning sign that the FDA is not taking seriously its responsibility to make a decision on Plan B, yes or no,” the senators said in a joint statement.

HIV Postexposure Prophylaxis

There is low adherence to postexposure HIV prophylaxis by adolescents who have been victims of sexual assault, according to a study published in the July issue of the Archives of Pediatrics and Adolescent Medicine. The researchers found that only about 15% of patients who were referred for follow-up to an academic medical center and provided with a 28-day course of antiretroviral medications actually completed the full course of treatment. Researchers at two Boston academic medical centers performed a chart review of all adolescent sexual assault victims who visited their two pediatric emergency departments between July 1, 2001, and June 30, 2003. They included charts from adolescents aged 12–22 years who were examined within 72 hours of a penetrating sexual assault. Of 145, 129 (89%) were offered a course of antiretroviral medications for postexposure prophylaxis and 110 (76%) agreed to take them. There were follow-up data available for 86 of the 110 patients who agreed to take the medication. Of those 86 patients, 13 (15%) completed the full course of prophylaxis.

Support for Contraception

More than 80% of Americans polled in a recent survey said they tend to agree that providing access to birth control is a good way to prevent abortions. While the results of the Wall Street Journal Online/Harris Interactive Health Care Poll show that a majority of respondents (89%) tend to agree that there should be more access to information about birth control options, respondents were split when it came to teenagers accessing birth control. About two-thirds of respondents said they tend to agree that abstinence is the best option for protecting teens from unwanted pregnancies. On the issue of whether teenagers should be allowed to access birth control without their parents' knowledge, 46% tended to agree, 41% tended to disagree, and 13% were unsure. The online survey included 2,689 adults in the United States.

Postmarketing Study Failure

The Food and Drug Administration is doing a poor job of ensuring that pharmaceutical companies live up to postmarketing study commitments, according to a new report by the Department of Health and Human Services' Office of Inspector General. The OIG reviewed new drug applications from 1990 to 2004; 48% of those applications had at least one postmarketing study commitment. Drugmakers are required to submit annual status reports. The OIG found that 35% of the reports that should have been submitted in fiscal 2004 were missing or had no information on the study commitments. The OIG noted that the FDA has limited enforcement power in this area, but suggested that the agency require more, and more relevant, information from drugmakers. In response, the FDA said it could not do that without additional regulations, but agreed that it needed to do more to improve its monitoring and to ensure that commitments are honored and that annual reports are thorough.

In-Office AIDS Test, Please

Americans would much prefer to be tested for AIDS in a physician's office or clinic, instead of performing a home test, according to a survey of 2,500 adults by the Kaiser Family Foundation. Overall, 62% of respondents preferred a doctor's office or clinic, compared with 26% who preferred home testing; only 10% said the location did not matter. However, respondents did think home tests should be an option; 65% said home tests help people who otherwise would not learn their HIV status. On the other hand, 27% agreed with the statement that home tests are “a bad idea” because people need counseling that is available only in a physician's office or clinic.

Plan B Investigation

Two Democratic senators are calling on the Government Accountability Office (GAO) to investigate the Food and Drug Administration's decision to hire a private contractor to collect and review comments submitted on the Plan B emergency contraception application for over-the-counter marketing status for women aged 16 years and older. Sen. Hillary Rodham Clinton (D-N.Y.) and Sen. Patty Murray (D-Wash.) recently sent a letter to the GAO asking officials there to look into the contract FDA has entered into with Booz Allen Hamilton and report back as soon as possible. Last fall, the FDA announced that it would accept public comments on the Plan B application. Sen. Clinton and Sen. Murray said they want to know why the FDA outsourced the work, the cost of the contracts, and whether there are any other contracts related to Plan B. “Outsourcing public comments on Plan B is yet another warning sign that the FDA is not taking seriously its responsibility to make a decision on Plan B, yes or no,” the senators said in a joint statement.

HIV Postexposure Prophylaxis

There is low adherence to postexposure HIV prophylaxis by adolescents who have been victims of sexual assault, according to a study published in the July issue of the Archives of Pediatrics and Adolescent Medicine. The researchers found that only about 15% of patients who were referred for follow-up to an academic medical center and provided with a 28-day course of antiretroviral medications actually completed the full course of treatment. Researchers at two Boston academic medical centers performed a chart review of all adolescent sexual assault victims who visited their two pediatric emergency departments between July 1, 2001, and June 30, 2003. They included charts from adolescents aged 12–22 years who were examined within 72 hours of a penetrating sexual assault. Of 145, 129 (89%) were offered a course of antiretroviral medications for postexposure prophylaxis and 110 (76%) agreed to take them. There were follow-up data available for 86 of the 110 patients who agreed to take the medication. Of those 86 patients, 13 (15%) completed the full course of prophylaxis.

Support for Contraception

More than 80% of Americans polled in a recent survey said they tend to agree that providing access to birth control is a good way to prevent abortions. While the results of the Wall Street Journal Online/Harris Interactive Health Care Poll show that a majority of respondents (89%) tend to agree that there should be more access to information about birth control options, respondents were split when it came to teenagers accessing birth control. About two-thirds of respondents said they tend to agree that abstinence is the best option for protecting teens from unwanted pregnancies. On the issue of whether teenagers should be allowed to access birth control without their parents' knowledge, 46% tended to agree, 41% tended to disagree, and 13% were unsure. The online survey included 2,689 adults in the United States.

Postmarketing Study Failure

The Food and Drug Administration is doing a poor job of ensuring that pharmaceutical companies live up to postmarketing study commitments, according to a new report by the Department of Health and Human Services' Office of Inspector General. The OIG reviewed new drug applications from 1990 to 2004; 48% of those applications had at least one postmarketing study commitment. Drugmakers are required to submit annual status reports. The OIG found that 35% of the reports that should have been submitted in fiscal 2004 were missing or had no information on the study commitments. The OIG noted that the FDA has limited enforcement power in this area, but suggested that the agency require more, and more relevant, information from drugmakers. In response, the FDA said it could not do that without additional regulations, but agreed that it needed to do more to improve its monitoring and to ensure that commitments are honored and that annual reports are thorough.

In-Office AIDS Test, Please

Americans would much prefer to be tested for AIDS in a physician's office or clinic, instead of performing a home test, according to a survey of 2,500 adults by the Kaiser Family Foundation. Overall, 62% of respondents preferred a doctor's office or clinic, compared with 26% who preferred home testing; only 10% said the location did not matter. However, respondents did think home tests should be an option; 65% said home tests help people who otherwise would not learn their HIV status. On the other hand, 27% agreed with the statement that home tests are “a bad idea” because people need counseling that is available only in a physician's office or clinic.

Plan B Investigation

Two Democratic senators are calling on the Government Accountability Office (GAO) to investigate the Food and Drug Administration's decision to hire a private contractor to collect and review comments submitted on the Plan B emergency contraception application for over-the-counter marketing status for women aged 16 years and older. Sen. Hillary Rodham Clinton (D-N.Y.) and Sen. Patty Murray (D-Wash.) recently sent a letter to the GAO asking officials there to look into the contract FDA has entered into with Booz Allen Hamilton and report back as soon as possible. Last fall, the FDA announced that it would accept public comments on the Plan B application. Sen. Clinton and Sen. Murray said they want to know why the FDA outsourced the work, the cost of the contracts, and whether there are any other contracts related to Plan B. “Outsourcing public comments on Plan B is yet another warning sign that the FDA is not taking seriously its responsibility to make a decision on Plan B, yes or no,” the senators said in a joint statement.

HIV Postexposure Prophylaxis

There is low adherence to postexposure HIV prophylaxis by adolescents who have been victims of sexual assault, according to a study published in the July issue of the Archives of Pediatrics and Adolescent Medicine. The researchers found that only about 15% of patients who were referred for follow-up to an academic medical center and provided with a 28-day course of antiretroviral medications actually completed the full course of treatment. Researchers at two Boston academic medical centers performed a chart review of all adolescent sexual assault victims who visited their two pediatric emergency departments between July 1, 2001, and June 30, 2003. They included charts from adolescents aged 12–22 years who were examined within 72 hours of a penetrating sexual assault. Of 145, 129 (89%) were offered a course of antiretroviral medications for postexposure prophylaxis and 110 (76%) agreed to take them. There were follow-up data available for 86 of the 110 patients who agreed to take the medication. Of those 86 patients, 13 (15%) completed the full course of prophylaxis.

Support for Contraception

More than 80% of Americans polled in a recent survey said they tend to agree that providing access to birth control is a good way to prevent abortions. While the results of the Wall Street Journal Online/Harris Interactive Health Care Poll show that a majority of respondents (89%) tend to agree that there should be more access to information about birth control options, respondents were split when it came to teenagers accessing birth control. About two-thirds of respondents said they tend to agree that abstinence is the best option for protecting teens from unwanted pregnancies. On the issue of whether teenagers should be allowed to access birth control without their parents' knowledge, 46% tended to agree, 41% tended to disagree, and 13% were unsure. The online survey included 2,689 adults in the United States.

Postmarketing Study Failure

The Food and Drug Administration is doing a poor job of ensuring that pharmaceutical companies live up to postmarketing study commitments, according to a new report by the Department of Health and Human Services' Office of Inspector General. The OIG reviewed new drug applications from 1990 to 2004; 48% of those applications had at least one postmarketing study commitment. Drugmakers are required to submit annual status reports. The OIG found that 35% of the reports that should have been submitted in fiscal 2004 were missing or had no information on the study commitments. The OIG noted that the FDA has limited enforcement power in this area, but suggested that the agency require more, and more relevant, information from drugmakers. In response, the FDA said it could not do that without additional regulations, but agreed that it needed to do more to improve its monitoring and to ensure that commitments are honored and that annual reports are thorough.

In-Office AIDS Test, Please

Americans would much prefer to be tested for AIDS in a physician's office or clinic, instead of performing a home test, according to a survey of 2,500 adults by the Kaiser Family Foundation. Overall, 62% of respondents preferred a doctor's office or clinic, compared with 26% who preferred home testing; only 10% said the location did not matter. However, respondents did think home tests should be an option; 65% said home tests help people who otherwise would not learn their HIV status. On the other hand, 27% agreed with the statement that home tests are “a bad idea” because people need counseling that is available only in a physician's office or clinic.