Joyce Frieden

In one of her first public acts at the Food and Drug Administration, new commissioner Dr. Margaret Hamburg announced that the agency aims to be more transparent about its daily work and decision-making process.

“Over the years, complaints have been made about FDA's lack of transparency,” Dr. Hamburg said in announcing the launch of a transparency task force. “The agency has been referred to as a 'black box' that makes important decisions without disclosing them. The agency can and should communicate in a way that provides more transparency, not less.” The commissioner said it was her goal that the public looks first to FDA for trustworthy and useful information about drugs and devices.

“On President Obama's first day in office, he pledged to strengthen democracy … by creating an unprecedented level of openness” in government, noted Dr. Hamburg, who took over at FDA in May. “This will be an agencywide effort charged with figuring out how to make the FDA and its processes more transparent to the public.”

The transparency task force will include the directors of all FDA centers as well as the agency's associate commissioner for regulatory affairs, its chief counsel, and its chief scientist. Its first meeting took place in June; another will take place in the fall. All meetings will be open to the public. The task force “expects to submit a written report to the commissioner about 6 months from now,” according to FDA principal deputy commissioner and task force chair Dr. Joshua Sharfstein.

Being clearer about why the agency decides things a certain way is one area of interest for Dr. Sharfstein. “People don't understand why the FDA may have done something or not done something,” he said. “In many cases, the agency has an explanation, but you don't necessarily hear that explanation very clearly.”

Dr. Hamburg said she expects that a wide range of recommendations could emerge from the task force's work. Some recommendations “will be in areas that we can implement swiftly, but there may be other types of information that will take more time, and there may be some areas where we have limitations within the current law and need to examine whether appropriate changes can and should be made,” she said.

Both Dr. Hamburg and Dr. Sharfstein emphasized, however, that a balance will need to be struck between providing more information and the appropriate use of confidentiality.

“We recognize that there are other policy goals besides transparency, and one of the other questions is what information should remain confidential,” Dr. Sharfstein said. “The secret formula for how to make X pill may be legitimately confidential information.”

Another balancing act will come in terms of clinical trials, Dr. Sharfstein continued. “What is the argument for different amounts of data [being disclosed] at different points in the drug development process, and on the other side, what are the confidentiality concerns and the reasons for them?”

The call for transparency comes at a time when FDA already has a backlog of requests under the Freedom of Information Act. Asked how she planned to handle personnel needs at a time when the agency is behind in its work, Dr. Hamburg said, “When the recommendations come in, I will work with the task force and others on implementation. Some activity may result in more work, and some may result in decreased work. If we make more information available, there may be fewer Freedom of Information Act requests and citizen petitions.”

In one of her first public acts at the Food and Drug Administration, new commissioner Dr. Margaret Hamburg announced that the agency aims to be more transparent about its daily work and decision-making process.

“Over the years, complaints have been made about FDA's lack of transparency,” Dr. Hamburg said in announcing the launch of a transparency task force. “The agency has been referred to as a 'black box' that makes important decisions without disclosing them. The agency can and should communicate in a way that provides more transparency, not less.” The commissioner said it was her goal that the public looks first to FDA for trustworthy and useful information about drugs and devices.

“On President Obama's first day in office, he pledged to strengthen democracy … by creating an unprecedented level of openness” in government, noted Dr. Hamburg, who took over at FDA in May. “This will be an agencywide effort charged with figuring out how to make the FDA and its processes more transparent to the public.”

The transparency task force will include the directors of all FDA centers as well as the agency's associate commissioner for regulatory affairs, its chief counsel, and its chief scientist. Its first meeting took place in June; another will take place in the fall. All meetings will be open to the public. The task force “expects to submit a written report to the commissioner about 6 months from now,” according to FDA principal deputy commissioner and task force chair Dr. Joshua Sharfstein.

Being clearer about why the agency decides things a certain way is one area of interest for Dr. Sharfstein. “People don't understand why the FDA may have done something or not done something,” he said. “In many cases, the agency has an explanation, but you don't necessarily hear that explanation very clearly.”

Dr. Hamburg said she expects that a wide range of recommendations could emerge from the task force's work. Some recommendations “will be in areas that we can implement swiftly, but there may be other types of information that will take more time, and there may be some areas where we have limitations within the current law and need to examine whether appropriate changes can and should be made,” she said.

Both Dr. Hamburg and Dr. Sharfstein emphasized, however, that a balance will need to be struck between providing more information and the appropriate use of confidentiality.

“We recognize that there are other policy goals besides transparency, and one of the other questions is what information should remain confidential,” Dr. Sharfstein said. “The secret formula for how to make X pill may be legitimately confidential information.”

Another balancing act will come in terms of clinical trials, Dr. Sharfstein continued. “What is the argument for different amounts of data [being disclosed] at different points in the drug development process, and on the other side, what are the confidentiality concerns and the reasons for them?”

The call for transparency comes at a time when FDA already has a backlog of requests under the Freedom of Information Act. Asked how she planned to handle personnel needs at a time when the agency is behind in its work, Dr. Hamburg said, “When the recommendations come in, I will work with the task force and others on implementation. Some activity may result in more work, and some may result in decreased work. If we make more information available, there may be fewer Freedom of Information Act requests and citizen petitions.”

In one of her first public acts at the Food and Drug Administration, new commissioner Dr. Margaret Hamburg announced that the agency aims to be more transparent about its daily work and decision-making process.

“Over the years, complaints have been made about FDA's lack of transparency,” Dr. Hamburg said in announcing the launch of a transparency task force. “The agency has been referred to as a 'black box' that makes important decisions without disclosing them. The agency can and should communicate in a way that provides more transparency, not less.” The commissioner said it was her goal that the public looks first to FDA for trustworthy and useful information about drugs and devices.

“On President Obama's first day in office, he pledged to strengthen democracy … by creating an unprecedented level of openness” in government, noted Dr. Hamburg, who took over at FDA in May. “This will be an agencywide effort charged with figuring out how to make the FDA and its processes more transparent to the public.”

The transparency task force will include the directors of all FDA centers as well as the agency's associate commissioner for regulatory affairs, its chief counsel, and its chief scientist. Its first meeting took place in June; another will take place in the fall. All meetings will be open to the public. The task force “expects to submit a written report to the commissioner about 6 months from now,” according to FDA principal deputy commissioner and task force chair Dr. Joshua Sharfstein.

Being clearer about why the agency decides things a certain way is one area of interest for Dr. Sharfstein. “People don't understand why the FDA may have done something or not done something,” he said. “In many cases, the agency has an explanation, but you don't necessarily hear that explanation very clearly.”

Dr. Hamburg said she expects that a wide range of recommendations could emerge from the task force's work. Some recommendations “will be in areas that we can implement swiftly, but there may be other types of information that will take more time, and there may be some areas where we have limitations within the current law and need to examine whether appropriate changes can and should be made,” she said.

Both Dr. Hamburg and Dr. Sharfstein emphasized, however, that a balance will need to be struck between providing more information and the appropriate use of confidentiality.

“We recognize that there are other policy goals besides transparency, and one of the other questions is what information should remain confidential,” Dr. Sharfstein said. “The secret formula for how to make X pill may be legitimately confidential information.”

Another balancing act will come in terms of clinical trials, Dr. Sharfstein continued. “What is the argument for different amounts of data [being disclosed] at different points in the drug development process, and on the other side, what are the confidentiality concerns and the reasons for them?”

The call for transparency comes at a time when FDA already has a backlog of requests under the Freedom of Information Act. Asked how she planned to handle personnel needs at a time when the agency is behind in its work, Dr. Hamburg said, “When the recommendations come in, I will work with the task force and others on implementation. Some activity may result in more work, and some may result in decreased work. If we make more information available, there may be fewer Freedom of Information Act requests and citizen petitions.”

Federally funded human embryonic stem cell research may only use stem cells from embryos created by in vitro fertilization for reproductive purposes and that are no longer needed, according to final guidelines issued by the Obama administration.

The human embryonic stem cells (hESCs) must be donated by individuals “who gave voluntary written consent for the human embryos to be used for research purposes,” according to the guidelines. Researchers must obtain written documentation that hESCs meet requirements, including:

▸ All options for disposition of embryos no longer needed for treatment were explained to the donors;

▸ No payments of any kind were offered for the embryos;

▸ Policies were in place ensuring that neither consenting nor refusing to donate embryos would affect the treatment given to any patient;

▸ Decisions about whether to donate embryos were made free of influence from stem cell researchers.

▸ Donors were informed that they retained the right to withdraw their donation up until the embryo was actually used.

“The guidelines will ensure that [National Institutes of Health]-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law,” according to a statement from the NIH, which will oversee all federally funded hESC research.

“Internal NIH policies and procedures, consistent with [President Obama's March 9 executive order] and these guidelines, will govern the conduct of intramural NIH stem cell research.”

Under the Bush administration, federal funding for human embryonic stem cell research was limited to studies using only the few stem cell lines that were in existence when the policy was created in August 2001. President Obama's executive order lifted those restrictions and allowed funded research to include embryonic stem cell lines created after that date. It also called for the NIH to develop new stem cell research guidelines. However, the order did not lift a current ban on using federal funds to create stem cell lines if the creation involved destruction of human embryos. Federal policy does not affect privately funded stem cell research.

One question raised by the executive order was how the guidelines would treat stem cell lines already in existence when the guidelines were issued.

In a document accompanying the guidelines, NIH officials note that “many lines were derived consistent with ethical standard and/or guidelines developed by various states, countries, and other entities such as … the National Academy of Sciences. These various policies have many common features, rely on a consistent ethical base, and require an informed consent process, but they differ in details of implementation.”

The guidelines authorize use of such stem cell lines if they are either compliant with the new guidelines or if they undergo a review by an NIH working group. “Working group review will enable pre-existing hESCs derived in a responsible manner to be eligible for use in NIH-funded research,” the document states.

The draft hESC guidelines, which were released in April, generated 49,000 comments.

When the draft guidelines were announced, Dr. David Stevens, CEO of the Christian Medical Association, in Bristol, Tenn., cited both moral and scientific problems with embryonic stem cell research. “We understand that embryos are human beings. Every one of us was an embryo,” he said. “When you destroy an embryo, you destroy a distinct human being.” On the scientific side, the prospects for embryonic stem cell research have been overblown, he said.

Several groups reacted positively to the release of the final guidelines. The Association of American Medical Colleges, for example, said it was “pleased that the NIH has issued clear guidelines on stem cell research, and established a pathway for existing lines to be considered for federal funding.”

Federally funded human embryonic stem cell research may only use stem cells from embryos created by in vitro fertilization for reproductive purposes and that are no longer needed, according to final guidelines issued by the Obama administration.

The human embryonic stem cells (hESCs) must be donated by individuals “who gave voluntary written consent for the human embryos to be used for research purposes,” according to the guidelines. Researchers must obtain written documentation that hESCs meet requirements, including:

▸ All options for disposition of embryos no longer needed for treatment were explained to the donors;

▸ No payments of any kind were offered for the embryos;

▸ Policies were in place ensuring that neither consenting nor refusing to donate embryos would affect the treatment given to any patient;

▸ Decisions about whether to donate embryos were made free of influence from stem cell researchers.

▸ Donors were informed that they retained the right to withdraw their donation up until the embryo was actually used.

“The guidelines will ensure that [National Institutes of Health]-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law,” according to a statement from the NIH, which will oversee all federally funded hESC research.

“Internal NIH policies and procedures, consistent with [President Obama's March 9 executive order] and these guidelines, will govern the conduct of intramural NIH stem cell research.”

Under the Bush administration, federal funding for human embryonic stem cell research was limited to studies using only the few stem cell lines that were in existence when the policy was created in August 2001. President Obama's executive order lifted those restrictions and allowed funded research to include embryonic stem cell lines created after that date. It also called for the NIH to develop new stem cell research guidelines. However, the order did not lift a current ban on using federal funds to create stem cell lines if the creation involved destruction of human embryos. Federal policy does not affect privately funded stem cell research.

One question raised by the executive order was how the guidelines would treat stem cell lines already in existence when the guidelines were issued.

In a document accompanying the guidelines, NIH officials note that “many lines were derived consistent with ethical standard and/or guidelines developed by various states, countries, and other entities such as … the National Academy of Sciences. These various policies have many common features, rely on a consistent ethical base, and require an informed consent process, but they differ in details of implementation.”

The guidelines authorize use of such stem cell lines if they are either compliant with the new guidelines or if they undergo a review by an NIH working group. “Working group review will enable pre-existing hESCs derived in a responsible manner to be eligible for use in NIH-funded research,” the document states.

The draft hESC guidelines, which were released in April, generated 49,000 comments.

When the draft guidelines were announced, Dr. David Stevens, CEO of the Christian Medical Association, in Bristol, Tenn., cited both moral and scientific problems with embryonic stem cell research. “We understand that embryos are human beings. Every one of us was an embryo,” he said. “When you destroy an embryo, you destroy a distinct human being.” On the scientific side, the prospects for embryonic stem cell research have been overblown, he said.

Several groups reacted positively to the release of the final guidelines. The Association of American Medical Colleges, for example, said it was “pleased that the NIH has issued clear guidelines on stem cell research, and established a pathway for existing lines to be considered for federal funding.”

Federally funded human embryonic stem cell research may only use stem cells from embryos created by in vitro fertilization for reproductive purposes and that are no longer needed, according to final guidelines issued by the Obama administration.

The human embryonic stem cells (hESCs) must be donated by individuals “who gave voluntary written consent for the human embryos to be used for research purposes,” according to the guidelines. Researchers must obtain written documentation that hESCs meet requirements, including:

▸ All options for disposition of embryos no longer needed for treatment were explained to the donors;

▸ No payments of any kind were offered for the embryos;

▸ Policies were in place ensuring that neither consenting nor refusing to donate embryos would affect the treatment given to any patient;

▸ Decisions about whether to donate embryos were made free of influence from stem cell researchers.

▸ Donors were informed that they retained the right to withdraw their donation up until the embryo was actually used.

“The guidelines will ensure that [National Institutes of Health]-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law,” according to a statement from the NIH, which will oversee all federally funded hESC research.

“Internal NIH policies and procedures, consistent with [President Obama's March 9 executive order] and these guidelines, will govern the conduct of intramural NIH stem cell research.”

Under the Bush administration, federal funding for human embryonic stem cell research was limited to studies using only the few stem cell lines that were in existence when the policy was created in August 2001. President Obama's executive order lifted those restrictions and allowed funded research to include embryonic stem cell lines created after that date. It also called for the NIH to develop new stem cell research guidelines. However, the order did not lift a current ban on using federal funds to create stem cell lines if the creation involved destruction of human embryos. Federal policy does not affect privately funded stem cell research.

One question raised by the executive order was how the guidelines would treat stem cell lines already in existence when the guidelines were issued.

In a document accompanying the guidelines, NIH officials note that “many lines were derived consistent with ethical standard and/or guidelines developed by various states, countries, and other entities such as … the National Academy of Sciences. These various policies have many common features, rely on a consistent ethical base, and require an informed consent process, but they differ in details of implementation.”

The guidelines authorize use of such stem cell lines if they are either compliant with the new guidelines or if they undergo a review by an NIH working group. “Working group review will enable pre-existing hESCs derived in a responsible manner to be eligible for use in NIH-funded research,” the document states.

The draft hESC guidelines, which were released in April, generated 49,000 comments.

When the draft guidelines were announced, Dr. David Stevens, CEO of the Christian Medical Association, in Bristol, Tenn., cited both moral and scientific problems with embryonic stem cell research. “We understand that embryos are human beings. Every one of us was an embryo,” he said. “When you destroy an embryo, you destroy a distinct human being.” On the scientific side, the prospects for embryonic stem cell research have been overblown, he said.

Several groups reacted positively to the release of the final guidelines. The Association of American Medical Colleges, for example, said it was “pleased that the NIH has issued clear guidelines on stem cell research, and established a pathway for existing lines to be considered for federal funding.”

WASHINGTON — Women with polycystic ovary syndrome who have a high body mass index or poor body self-esteem are more likely to be depressed, according to results from a study of 67 untreated PCOS patients.

Depression is very common in PCOS patients, with previous studies showing depression rates of 35%-50% in PCOS patients compared with 12%-14% in the general female population, said Lisa Pastore, Ph.D., of the department of obstetrics and gynecology at the University of Virginia, Charlottesville, at the annual meeting of the Androgen Excess and PCOS Society. Prior research also has shown neither the degree of hirsutism nor that of acne are related to body self-esteem in PCOS patients, she added.

Eligibility criteria for the current study included a diagnosis of PCOS using the National Institute of Child Health and Human Development criteria, age 18–43 years, weight less than 250 pounds, and at least one menses in the past 6 months but no more than eight periods in the most recent 12 months without hormonal intervention. Exclusion criteria included use of metformin or hormones in the prior 60 days, current pregnancy or breastfeeding in the prior 30 days, acupuncture treatment for ovulatory disorders in the prior 30 days, and any bleeding disorder.

The mean age of study participants was 27 years; 54% were single. Overall, 39% of participants were normal weight, 12% were overweight, and 49% were obese; 27% were of minority ethnicity.

Study participants were asked to rate each of 35 items, including body parts and functions, on a 5-point Likert scale with possible responses ranging from 1 (very negative feelings) to 5 (very positive feelings).

Respondents also completed the Quick Inventory of Depressive Symptomatology-Self Report, which includes 16 items used to assess depressive episodes or major depressive disorders. Areas covered include sad mood, self-criticism, suicidal ideation, decreases or increases in appetite and weight. Participants self-reported frequency and severity of symptoms over the previous 7 days, rating severity on a scale of 0–3.

Patients underwent chemiluminescent immunoassay of total testosterone and testing for dehydroepiandrosterone sulfate and sex hormone binding globulin (SHBG). Mathematically derived free testosterone also was calculated.

Respondents' total testosterone ranged from 19 ng/dL to 161 ng/dL with a mean of 62 ng/dL. SHBG ranged from 2 nmol/L to 86 nmol/L with a mean of 31 nmol/L. Free testosterone ranged from 3 pg/mL to 45 pg/mL with a mean of 13 pg/mL. Nearly half of the patients in the study were depressed; 70% of those had mild depression, according to Dr. Pastore, the study's lead author.

The study was consistent with an association between depression severity and body esteem among PCOS patients after the researchers controlled for age, education, and BMI. Higher BMI also was correlated with depression, although body self-esteem was an independent predictor of depression in both lean and obese women.

In addition, although none of the androgens was predictive of depression severity, “there was some curvilinear relationship,” with depression severity lowest among patients with very high or very low free testosterone levels, Dr. Pastore said.

The study was funded by the National Center for Complementary and Alternative Medicine and the National Center for Research Resources. Dr. Pastore disclosed no conflicts of interest.

WASHINGTON — Women with polycystic ovary syndrome who have a high body mass index or poor body self-esteem are more likely to be depressed, according to results from a study of 67 untreated PCOS patients.

Depression is very common in PCOS patients, with previous studies showing depression rates of 35%-50% in PCOS patients compared with 12%-14% in the general female population, said Lisa Pastore, Ph.D., of the department of obstetrics and gynecology at the University of Virginia, Charlottesville, at the annual meeting of the Androgen Excess and PCOS Society. Prior research also has shown neither the degree of hirsutism nor that of acne are related to body self-esteem in PCOS patients, she added.

Eligibility criteria for the current study included a diagnosis of PCOS using the National Institute of Child Health and Human Development criteria, age 18–43 years, weight less than 250 pounds, and at least one menses in the past 6 months but no more than eight periods in the most recent 12 months without hormonal intervention. Exclusion criteria included use of metformin or hormones in the prior 60 days, current pregnancy or breastfeeding in the prior 30 days, acupuncture treatment for ovulatory disorders in the prior 30 days, and any bleeding disorder.

The mean age of study participants was 27 years; 54% were single. Overall, 39% of participants were normal weight, 12% were overweight, and 49% were obese; 27% were of minority ethnicity.

Study participants were asked to rate each of 35 items, including body parts and functions, on a 5-point Likert scale with possible responses ranging from 1 (very negative feelings) to 5 (very positive feelings).

Respondents also completed the Quick Inventory of Depressive Symptomatology-Self Report, which includes 16 items used to assess depressive episodes or major depressive disorders. Areas covered include sad mood, self-criticism, suicidal ideation, decreases or increases in appetite and weight. Participants self-reported frequency and severity of symptoms over the previous 7 days, rating severity on a scale of 0–3.

Patients underwent chemiluminescent immunoassay of total testosterone and testing for dehydroepiandrosterone sulfate and sex hormone binding globulin (SHBG). Mathematically derived free testosterone also was calculated.

Respondents' total testosterone ranged from 19 ng/dL to 161 ng/dL with a mean of 62 ng/dL. SHBG ranged from 2 nmol/L to 86 nmol/L with a mean of 31 nmol/L. Free testosterone ranged from 3 pg/mL to 45 pg/mL with a mean of 13 pg/mL. Nearly half of the patients in the study were depressed; 70% of those had mild depression, according to Dr. Pastore, the study's lead author.

The study was consistent with an association between depression severity and body esteem among PCOS patients after the researchers controlled for age, education, and BMI. Higher BMI also was correlated with depression, although body self-esteem was an independent predictor of depression in both lean and obese women.

In addition, although none of the androgens was predictive of depression severity, “there was some curvilinear relationship,” with depression severity lowest among patients with very high or very low free testosterone levels, Dr. Pastore said.

The study was funded by the National Center for Complementary and Alternative Medicine and the National Center for Research Resources. Dr. Pastore disclosed no conflicts of interest.

WASHINGTON — Women with polycystic ovary syndrome who have a high body mass index or poor body self-esteem are more likely to be depressed, according to results from a study of 67 untreated PCOS patients.

Depression is very common in PCOS patients, with previous studies showing depression rates of 35%-50% in PCOS patients compared with 12%-14% in the general female population, said Lisa Pastore, Ph.D., of the department of obstetrics and gynecology at the University of Virginia, Charlottesville, at the annual meeting of the Androgen Excess and PCOS Society. Prior research also has shown neither the degree of hirsutism nor that of acne are related to body self-esteem in PCOS patients, she added.

Eligibility criteria for the current study included a diagnosis of PCOS using the National Institute of Child Health and Human Development criteria, age 18–43 years, weight less than 250 pounds, and at least one menses in the past 6 months but no more than eight periods in the most recent 12 months without hormonal intervention. Exclusion criteria included use of metformin or hormones in the prior 60 days, current pregnancy or breastfeeding in the prior 30 days, acupuncture treatment for ovulatory disorders in the prior 30 days, and any bleeding disorder.

The mean age of study participants was 27 years; 54% were single. Overall, 39% of participants were normal weight, 12% were overweight, and 49% were obese; 27% were of minority ethnicity.

Study participants were asked to rate each of 35 items, including body parts and functions, on a 5-point Likert scale with possible responses ranging from 1 (very negative feelings) to 5 (very positive feelings).

Respondents also completed the Quick Inventory of Depressive Symptomatology-Self Report, which includes 16 items used to assess depressive episodes or major depressive disorders. Areas covered include sad mood, self-criticism, suicidal ideation, decreases or increases in appetite and weight. Participants self-reported frequency and severity of symptoms over the previous 7 days, rating severity on a scale of 0–3.

Patients underwent chemiluminescent immunoassay of total testosterone and testing for dehydroepiandrosterone sulfate and sex hormone binding globulin (SHBG). Mathematically derived free testosterone also was calculated.

Respondents' total testosterone ranged from 19 ng/dL to 161 ng/dL with a mean of 62 ng/dL. SHBG ranged from 2 nmol/L to 86 nmol/L with a mean of 31 nmol/L. Free testosterone ranged from 3 pg/mL to 45 pg/mL with a mean of 13 pg/mL. Nearly half of the patients in the study were depressed; 70% of those had mild depression, according to Dr. Pastore, the study's lead author.

The study was consistent with an association between depression severity and body esteem among PCOS patients after the researchers controlled for age, education, and BMI. Higher BMI also was correlated with depression, although body self-esteem was an independent predictor of depression in both lean and obese women.

In addition, although none of the androgens was predictive of depression severity, “there was some curvilinear relationship,” with depression severity lowest among patients with very high or very low free testosterone levels, Dr. Pastore said.

The study was funded by the National Center for Complementary and Alternative Medicine and the National Center for Research Resources. Dr. Pastore disclosed no conflicts of interest.

A proposed payment rule from the Centers for Medicare and Medicaid Services would increase the number and duration of payments to hospitals for cardiac and pulmonary rehabilitation services.

The expanded cardiac benefit is “very exciting,” said Dr. Alfred Bove, president of the American College of Cardiology. “A lot of us have been advocating rehabilitation for a long time, and lots of patients say, 'I can't afford it.' This would be a tremendous program for a lot of people after a major heart event.”

Currently, Medicare patients who experience a heart attack or heart failure usually are covered for 8 weeks of cardiac rehabilitation with a maximum of three 1-hour sessions per week, Dr. Bove said. Under the proposed benefit, patients could receive up to 72 sessions—up to 6 sessions per day—of intensive cardiac rehabilitation over an 18-week period.

Being able to spread the sessions out would be quite valuable, Dr. Bove said. “So much of recovering is giving people confidence in what they can handle … Improvement of depression and other symptoms [also] is better if you can get them into a rehab program.”

Medicare's approval of the expanded sessions also would put pressure on private insurers to create the same kind of benefit, he noted.

Other outpatient payment changes proposed in the rule include:

▸ Physician supervision requirements. Nonphysician providers may directly supervise all hospital outpatient therapeutic services that they are personally able to perform within their state scope of practice and hospital-granted privileges. Current Medicare policy allows only for physicians to provide direct supervision of these services.

▸ Kidney disease education. Establish payment to rural providers under the Medicare Physician Fee Schedule for kidney disease education services furnished on or after Jan. 1, 2010, for beneficiaries diagnosed with stage IV chronic kidney disease.

▸ Validation of quality reporting. To ensure that hospitals are accurately reporting measures using chart-abstracted data, the CMS would take samples of actual patient records and compare the hospital reports with the requirements of the Hospital Outpatient Department Quality Reporting Program. Although the CMS will begin validating hospital-submitted data for purposes of the 2011 payment update, the validation results will not affect a hospital's outpatient payments until 2012, according to the proposal.

The CMS also plans to implement the third of four phases of its revised payment system for ambulatory surgery centers (ASCs). The revised payment rate for any given service is a percentage of the rate for the same service under the Outpatient Prospective Payment System. However, for new ASC services usually performed in physicians' offices, the ASC payment is capped at the amount the physician is paid under the Medicare fee schedule for practice expenses in the office.

The CMS will accept comments on the proposed rule until Aug. 31; the final rule will be issued by Nov. 1.

Information on the outpatient payment proposals is available online at www.cms.hhs.gov/HospitalOutpatientPPS

A proposed payment rule from the Centers for Medicare and Medicaid Services would increase the number and duration of payments to hospitals for cardiac and pulmonary rehabilitation services.

The expanded cardiac benefit is “very exciting,” said Dr. Alfred Bove, president of the American College of Cardiology. “A lot of us have been advocating rehabilitation for a long time, and lots of patients say, 'I can't afford it.' This would be a tremendous program for a lot of people after a major heart event.”

Currently, Medicare patients who experience a heart attack or heart failure usually are covered for 8 weeks of cardiac rehabilitation with a maximum of three 1-hour sessions per week, Dr. Bove said. Under the proposed benefit, patients could receive up to 72 sessions—up to 6 sessions per day—of intensive cardiac rehabilitation over an 18-week period.

Being able to spread the sessions out would be quite valuable, Dr. Bove said. “So much of recovering is giving people confidence in what they can handle … Improvement of depression and other symptoms [also] is better if you can get them into a rehab program.”

Medicare's approval of the expanded sessions also would put pressure on private insurers to create the same kind of benefit, he noted.

Other outpatient payment changes proposed in the rule include:

▸ Physician supervision requirements. Nonphysician providers may directly supervise all hospital outpatient therapeutic services that they are personally able to perform within their state scope of practice and hospital-granted privileges. Current Medicare policy allows only for physicians to provide direct supervision of these services.

▸ Kidney disease education. Establish payment to rural providers under the Medicare Physician Fee Schedule for kidney disease education services furnished on or after Jan. 1, 2010, for beneficiaries diagnosed with stage IV chronic kidney disease.

▸ Validation of quality reporting. To ensure that hospitals are accurately reporting measures using chart-abstracted data, the CMS would take samples of actual patient records and compare the hospital reports with the requirements of the Hospital Outpatient Department Quality Reporting Program. Although the CMS will begin validating hospital-submitted data for purposes of the 2011 payment update, the validation results will not affect a hospital's outpatient payments until 2012, according to the proposal.

The CMS also plans to implement the third of four phases of its revised payment system for ambulatory surgery centers (ASCs). The revised payment rate for any given service is a percentage of the rate for the same service under the Outpatient Prospective Payment System. However, for new ASC services usually performed in physicians' offices, the ASC payment is capped at the amount the physician is paid under the Medicare fee schedule for practice expenses in the office.

The CMS will accept comments on the proposed rule until Aug. 31; the final rule will be issued by Nov. 1.

Information on the outpatient payment proposals is available online at www.cms.hhs.gov/HospitalOutpatientPPS

A proposed payment rule from the Centers for Medicare and Medicaid Services would increase the number and duration of payments to hospitals for cardiac and pulmonary rehabilitation services.

The expanded cardiac benefit is “very exciting,” said Dr. Alfred Bove, president of the American College of Cardiology. “A lot of us have been advocating rehabilitation for a long time, and lots of patients say, 'I can't afford it.' This would be a tremendous program for a lot of people after a major heart event.”

Currently, Medicare patients who experience a heart attack or heart failure usually are covered for 8 weeks of cardiac rehabilitation with a maximum of three 1-hour sessions per week, Dr. Bove said. Under the proposed benefit, patients could receive up to 72 sessions—up to 6 sessions per day—of intensive cardiac rehabilitation over an 18-week period.

Being able to spread the sessions out would be quite valuable, Dr. Bove said. “So much of recovering is giving people confidence in what they can handle … Improvement of depression and other symptoms [also] is better if you can get them into a rehab program.”

Medicare's approval of the expanded sessions also would put pressure on private insurers to create the same kind of benefit, he noted.

Other outpatient payment changes proposed in the rule include:

▸ Physician supervision requirements. Nonphysician providers may directly supervise all hospital outpatient therapeutic services that they are personally able to perform within their state scope of practice and hospital-granted privileges. Current Medicare policy allows only for physicians to provide direct supervision of these services.

▸ Kidney disease education. Establish payment to rural providers under the Medicare Physician Fee Schedule for kidney disease education services furnished on or after Jan. 1, 2010, for beneficiaries diagnosed with stage IV chronic kidney disease.

▸ Validation of quality reporting. To ensure that hospitals are accurately reporting measures using chart-abstracted data, the CMS would take samples of actual patient records and compare the hospital reports with the requirements of the Hospital Outpatient Department Quality Reporting Program. Although the CMS will begin validating hospital-submitted data for purposes of the 2011 payment update, the validation results will not affect a hospital's outpatient payments until 2012, according to the proposal.

The CMS also plans to implement the third of four phases of its revised payment system for ambulatory surgery centers (ASCs). The revised payment rate for any given service is a percentage of the rate for the same service under the Outpatient Prospective Payment System. However, for new ASC services usually performed in physicians' offices, the ASC payment is capped at the amount the physician is paid under the Medicare fee schedule for practice expenses in the office.

The CMS will accept comments on the proposed rule until Aug. 31; the final rule will be issued by Nov. 1.

Information on the outpatient payment proposals is available online at www.cms.hhs.gov/HospitalOutpatientPPS

WASHINGTON — The upcoming ICD-10 diagnosis and procedure coding system is more complicated than was its predecessor, ICD-9, but it will allow for a greater level of clinical detail and will be better able to keep up with advances in technology, according to several speakers at a meeting sponsored by the American Health Information Management Association.

“ICD-9 badly needs to be replaced,” said Nelly Leon-Chisen, director of coding and classification at the American Hospital Association. “It's 30 years old, and the terminology and classification of some conditions are obsolete.”

There are two parts to ICD-10, formally known as the International Classification of Diseases, 10th revision, which goes into effect in the United States on Oct. 1, 2013: ICD-10-CM, which is the clinical modification of the World Health Organization's ICD-10 diagnostic coding system; and ICD-10-PCS, an inpatient procedural coding system developed under contract to the Centers for Medicare and Medicaid Services.

ICD-10 “will have better data for evaluating and improving quality of care. It will provide codes for a more complete picture,” she added, noting that the new code set will allow health officials to be “better able to track and respond to global health threats.”

Because ICD-10 can more precisely document diagnoses and procedures, it will bring better justification of medical necessity for billing purposes, “but not from day 1,” said Ms. Leon-Chisen. “It will take a little while” for people to adjust to the new codes. The new system also may reduce opportunities for fraud.

Ms. Leon-Chisen outlined a few basic differences between ICD-9 and ICD-10 diagnosis codes:

▸ ICD-9 codes contain 3-5 characters, whereas ICD-10 contains 3-7 characters.

▸ In ICD-9 codes, the first character can be alphabetic or numeric, but in ICD-10, the first character is always alphabetic.

▸ ICD-10 codes can include the use of a placeholder “x,” whereas ICD-9 codes cannot.

She also gave an example, showing the differences between the two revisions. Under the ICD-9 coding system, a patient with a pressure ulcer on the right buttock might receive a diagnosis code of 707.05, “pressure ulcer, buttock.” Under ICD-10, the same patient would get L89.111, “decubitus ulcer of right buttock limited to breakdown of the skin.” A pressure ulcer on the left buttock or a more severe one including necrosis of the bone would get a different ICD-10 code.

Alphabetic characters are not case sensitive.

WASHINGTON — The upcoming ICD-10 diagnosis and procedure coding system is more complicated than was its predecessor, ICD-9, but it will allow for a greater level of clinical detail and will be better able to keep up with advances in technology, according to several speakers at a meeting sponsored by the American Health Information Management Association.

“ICD-9 badly needs to be replaced,” said Nelly Leon-Chisen, director of coding and classification at the American Hospital Association. “It's 30 years old, and the terminology and classification of some conditions are obsolete.”

There are two parts to ICD-10, formally known as the International Classification of Diseases, 10th revision, which goes into effect in the United States on Oct. 1, 2013: ICD-10-CM, which is the clinical modification of the World Health Organization's ICD-10 diagnostic coding system; and ICD-10-PCS, an inpatient procedural coding system developed under contract to the Centers for Medicare and Medicaid Services.

ICD-10 “will have better data for evaluating and improving quality of care. It will provide codes for a more complete picture,” she added, noting that the new code set will allow health officials to be “better able to track and respond to global health threats.”

Because ICD-10 can more precisely document diagnoses and procedures, it will bring better justification of medical necessity for billing purposes, “but not from day 1,” said Ms. Leon-Chisen. “It will take a little while” for people to adjust to the new codes. The new system also may reduce opportunities for fraud.

Ms. Leon-Chisen outlined a few basic differences between ICD-9 and ICD-10 diagnosis codes:

▸ ICD-9 codes contain 3-5 characters, whereas ICD-10 contains 3-7 characters.

▸ In ICD-9 codes, the first character can be alphabetic or numeric, but in ICD-10, the first character is always alphabetic.

▸ ICD-10 codes can include the use of a placeholder “x,” whereas ICD-9 codes cannot.

She also gave an example, showing the differences between the two revisions. Under the ICD-9 coding system, a patient with a pressure ulcer on the right buttock might receive a diagnosis code of 707.05, “pressure ulcer, buttock.” Under ICD-10, the same patient would get L89.111, “decubitus ulcer of right buttock limited to breakdown of the skin.” A pressure ulcer on the left buttock or a more severe one including necrosis of the bone would get a different ICD-10 code.

Alphabetic characters are not case sensitive.

WASHINGTON — The upcoming ICD-10 diagnosis and procedure coding system is more complicated than was its predecessor, ICD-9, but it will allow for a greater level of clinical detail and will be better able to keep up with advances in technology, according to several speakers at a meeting sponsored by the American Health Information Management Association.

“ICD-9 badly needs to be replaced,” said Nelly Leon-Chisen, director of coding and classification at the American Hospital Association. “It's 30 years old, and the terminology and classification of some conditions are obsolete.”

There are two parts to ICD-10, formally known as the International Classification of Diseases, 10th revision, which goes into effect in the United States on Oct. 1, 2013: ICD-10-CM, which is the clinical modification of the World Health Organization's ICD-10 diagnostic coding system; and ICD-10-PCS, an inpatient procedural coding system developed under contract to the Centers for Medicare and Medicaid Services.

ICD-10 “will have better data for evaluating and improving quality of care. It will provide codes for a more complete picture,” she added, noting that the new code set will allow health officials to be “better able to track and respond to global health threats.”

Because ICD-10 can more precisely document diagnoses and procedures, it will bring better justification of medical necessity for billing purposes, “but not from day 1,” said Ms. Leon-Chisen. “It will take a little while” for people to adjust to the new codes. The new system also may reduce opportunities for fraud.

Ms. Leon-Chisen outlined a few basic differences between ICD-9 and ICD-10 diagnosis codes:

▸ ICD-9 codes contain 3-5 characters, whereas ICD-10 contains 3-7 characters.

▸ In ICD-9 codes, the first character can be alphabetic or numeric, but in ICD-10, the first character is always alphabetic.

▸ ICD-10 codes can include the use of a placeholder “x,” whereas ICD-9 codes cannot.

She also gave an example, showing the differences between the two revisions. Under the ICD-9 coding system, a patient with a pressure ulcer on the right buttock might receive a diagnosis code of 707.05, “pressure ulcer, buttock.” Under ICD-10, the same patient would get L89.111, “decubitus ulcer of right buttock limited to breakdown of the skin.” A pressure ulcer on the left buttock or a more severe one including necrosis of the bone would get a different ICD-10 code.

Alphabetic characters are not case sensitive.

Major pharmaceutical firms have agreed to offer drug discounts to Medicare beneficiaries who are trapped in the Part D “doughnut hole,” President Obama announced.

The president endorsed an agreement reached between the Pharmaceutical Research and Manufacturers of America (PhRMA) and Sen. Max Baucus (D-Mont.), chairman of the Senate Finance Committee. Mr. Obama explained that “as part of the health care reform I expect Congress to enact this year, Medicare beneficiaries whose spending falls within this gap will now receive a discount on prescription drugs of at least 50% from the negotiated price their plan pays. It's a reform that will make prescription drugs more affordable for millions of seniors, and restore a measure of fairness to Medicare Part D.”

The estimated cost of the discount program, which applies only to brand-name drugs, is $80 billion over the next decade.

Medicare Part D enrollees who are in the doughnut hole will receive their discounts at the pharmacy and will not have to fill out any additional paperwork. They also will receive credit for the full cost of a drug against their spending obligation in the doughnut hole, even though they are actually paying half that amount.

President Obama noted that under the Medicare Part D prescription drug benefit, “Medicare covers up to $2,700 in yearly prescription costs and then stops, and the coverage starts back up when the costs exceed $6,100. [That] means between $2,700 and $6,100, folks are out of luck. And this gap in coverage has placed a crushing burden on many older Americans who live on fixed incomes and can't afford thousands of dollars in out-of-pocket expenses.”

At the White House event, Barry Rand, CEO of AARP, which endorsed the agreement, called the deal “an early win for reform and a major step forward.”

Mr. Rand said, “Too many Americans who fall into the coverage gap stop taking their medications because they simply cannot afford them. They will now have a new opportunity to lead a healthier life.”

Billy Tauzin, president and CEO of PhRMA, noted in a statement that “even though we have had policy disagreements in the past [with AARP], this is an historic coming-together moment. AARP, the largest advocacy organization on behalf of American seniors, clearly recognizes the importance of innovative, cutting-edge medicines to the lives of patients everywhere.

Sen. Baucus noted in a statement that when it was created, the Part D benefit “helped address the problem of skyrocketing prescription drug prices for millions of seniors. [With this agreement] we helped fill the gap in coverage and finished the job. … This benefit is part of our continued commitment to seniors and our ongoing effort to reform health care by lowering health care costs and ensuring all Americans have access to the quality, affordable health care coverage they deserve.”

The Medicare Rights Center, a consumer group that advocates improved Medicare benefits, expressed cautious optimism about the agreement. “As always, the devil is in the details,” center president Joe Baker said in a statement.

“We look forward to working with President Obama and the Congress to making the promised discount most useful.” He added that the discount complements the health-reform proposal from the chairmen of three House committees to phase out the Part D doughnut hole. “Full coverage of both brand-name and generic drugs is the best way to ensure people with Medicare can afford the medicines they need,” said Mr. Baker.

Major pharmaceutical firms have agreed to offer drug discounts to Medicare beneficiaries who are trapped in the Part D “doughnut hole,” President Obama announced.

The president endorsed an agreement reached between the Pharmaceutical Research and Manufacturers of America (PhRMA) and Sen. Max Baucus (D-Mont.), chairman of the Senate Finance Committee. Mr. Obama explained that “as part of the health care reform I expect Congress to enact this year, Medicare beneficiaries whose spending falls within this gap will now receive a discount on prescription drugs of at least 50% from the negotiated price their plan pays. It's a reform that will make prescription drugs more affordable for millions of seniors, and restore a measure of fairness to Medicare Part D.”

The estimated cost of the discount program, which applies only to brand-name drugs, is $80 billion over the next decade.

Medicare Part D enrollees who are in the doughnut hole will receive their discounts at the pharmacy and will not have to fill out any additional paperwork. They also will receive credit for the full cost of a drug against their spending obligation in the doughnut hole, even though they are actually paying half that amount.

President Obama noted that under the Medicare Part D prescription drug benefit, “Medicare covers up to $2,700 in yearly prescription costs and then stops, and the coverage starts back up when the costs exceed $6,100. [That] means between $2,700 and $6,100, folks are out of luck. And this gap in coverage has placed a crushing burden on many older Americans who live on fixed incomes and can't afford thousands of dollars in out-of-pocket expenses.”

At the White House event, Barry Rand, CEO of AARP, which endorsed the agreement, called the deal “an early win for reform and a major step forward.”

Mr. Rand said, “Too many Americans who fall into the coverage gap stop taking their medications because they simply cannot afford them. They will now have a new opportunity to lead a healthier life.”

Billy Tauzin, president and CEO of PhRMA, noted in a statement that “even though we have had policy disagreements in the past [with AARP], this is an historic coming-together moment. AARP, the largest advocacy organization on behalf of American seniors, clearly recognizes the importance of innovative, cutting-edge medicines to the lives of patients everywhere.

Sen. Baucus noted in a statement that when it was created, the Part D benefit “helped address the problem of skyrocketing prescription drug prices for millions of seniors. [With this agreement] we helped fill the gap in coverage and finished the job. … This benefit is part of our continued commitment to seniors and our ongoing effort to reform health care by lowering health care costs and ensuring all Americans have access to the quality, affordable health care coverage they deserve.”

The Medicare Rights Center, a consumer group that advocates improved Medicare benefits, expressed cautious optimism about the agreement. “As always, the devil is in the details,” center president Joe Baker said in a statement.

“We look forward to working with President Obama and the Congress to making the promised discount most useful.” He added that the discount complements the health-reform proposal from the chairmen of three House committees to phase out the Part D doughnut hole. “Full coverage of both brand-name and generic drugs is the best way to ensure people with Medicare can afford the medicines they need,” said Mr. Baker.

Major pharmaceutical firms have agreed to offer drug discounts to Medicare beneficiaries who are trapped in the Part D “doughnut hole,” President Obama announced.

The president endorsed an agreement reached between the Pharmaceutical Research and Manufacturers of America (PhRMA) and Sen. Max Baucus (D-Mont.), chairman of the Senate Finance Committee. Mr. Obama explained that “as part of the health care reform I expect Congress to enact this year, Medicare beneficiaries whose spending falls within this gap will now receive a discount on prescription drugs of at least 50% from the negotiated price their plan pays. It's a reform that will make prescription drugs more affordable for millions of seniors, and restore a measure of fairness to Medicare Part D.”

The estimated cost of the discount program, which applies only to brand-name drugs, is $80 billion over the next decade.

Medicare Part D enrollees who are in the doughnut hole will receive their discounts at the pharmacy and will not have to fill out any additional paperwork. They also will receive credit for the full cost of a drug against their spending obligation in the doughnut hole, even though they are actually paying half that amount.

President Obama noted that under the Medicare Part D prescription drug benefit, “Medicare covers up to $2,700 in yearly prescription costs and then stops, and the coverage starts back up when the costs exceed $6,100. [That] means between $2,700 and $6,100, folks are out of luck. And this gap in coverage has placed a crushing burden on many older Americans who live on fixed incomes and can't afford thousands of dollars in out-of-pocket expenses.”

At the White House event, Barry Rand, CEO of AARP, which endorsed the agreement, called the deal “an early win for reform and a major step forward.”

Mr. Rand said, “Too many Americans who fall into the coverage gap stop taking their medications because they simply cannot afford them. They will now have a new opportunity to lead a healthier life.”

Billy Tauzin, president and CEO of PhRMA, noted in a statement that “even though we have had policy disagreements in the past [with AARP], this is an historic coming-together moment. AARP, the largest advocacy organization on behalf of American seniors, clearly recognizes the importance of innovative, cutting-edge medicines to the lives of patients everywhere.

Sen. Baucus noted in a statement that when it was created, the Part D benefit “helped address the problem of skyrocketing prescription drug prices for millions of seniors. [With this agreement] we helped fill the gap in coverage and finished the job. … This benefit is part of our continued commitment to seniors and our ongoing effort to reform health care by lowering health care costs and ensuring all Americans have access to the quality, affordable health care coverage they deserve.”

The Medicare Rights Center, a consumer group that advocates improved Medicare benefits, expressed cautious optimism about the agreement. “As always, the devil is in the details,” center president Joe Baker said in a statement.

“We look forward to working with President Obama and the Congress to making the promised discount most useful.” He added that the discount complements the health-reform proposal from the chairmen of three House committees to phase out the Part D doughnut hole. “Full coverage of both brand-name and generic drugs is the best way to ensure people with Medicare can afford the medicines they need,” said Mr. Baker.

The big box store Sam's Club, which is owned by Wal-Mart, is setting its sights on the information technology frontier: The stores are starting to market electronic health record systems aimed at medical practices with one to three physicians.

Not everyone, though, is buying the ability of such off-the-shelf systems to be used in a meaningful way in clinical practice. And with EHR systems being held up as essential to health care reform and the ability to get a grip on unnecessary spending, a lot is riding on these products.

With the package offered by Sam's Club, practices will receive three laptops and a tablet notebook from Dell, a laser printer, and EHR and practice management software from eClinicalWorks. The package also includes 12 weeks of on-site setup, customization, and support. The package costs less than $25,000 for the first physician and up to $10,000 for each additional physician in the practice. The package, which is available for purchase online, is currently being sold only to physicians in Georgia, Illinois, and Virginia, with a nationwide rollout planned for later this year.

"We have 200,000 medical-type [business members] at our 600 clubs nationwide," explained Susan Koehler, senior manager in corporate communications at the Sam's Club home office in Bentonville, Ark. Wal-Mart had amassed some experience using Dell and eClinical Works EHR systems at its walk-in medical RediClinics and it worked well, so the idea was born to start marketing it to Sam's Club members.

The company chose Sam's Club rather than Wal-Mart to distribute the EHR because, unlike Wal-Mart, Sam's Club has a one-on-one relationship with the local businesses that buy their supplies at the club, "so we have relationships at the local level with those doctors," Ms. Koehler said.

Georgia, Illinois, and Virginia were selected for the rollout because "they were a good representation of broad-band access with a mix of rural and small-town community doctors," she said. At the same time, those states include big cities such as Atlanta and Chicago. Ms. Koehler would not say how many systems have been sold since the product was launched in early April, but "we're very pleased with the interest" it has gotten, she said.

Discounted hardware from Dell and some money saved on "interfaces coming out of the box" allowed Sam's Club to price its EHR system aggressively, explained Girish Navani, cofounder and CEO of eClinicalWorks in Westborough, Mass.

Yet the package does not offer any less customization than if a physician practice was to buy a system individually, Mr. Navani said.

Dr. Steven Waldren, director of the Center for Health Information Technology at the American Academy of Family Physicians (AAFP), said that packages like Sam's Club's have advantages and disadvantages. Although the product is off the shelf, "it's really a product and service package, not [just] a box of software that you order and then get installed," he noted, yet the disadvantage is that it is prepackaged, "so decisions are made for you when they put it together."

Two factors are key in EHR selection: content and workflow, Dr. Waldren said. An EHR system may have plenty of content, but "does it have the templates you need and want?" If you have midlevel personnel, "how does the signoff process work?" Does the nursing staff put in a review of the present illness "and then you verify that? If [the workflow] doesn't work for you, what type of customization is possible?"

By prepackaging elements together, off-the-shelf systems will be less expensive, "but there are probably going to be disadvantages around customization and the flexibility practices are going to have," he said.

Although the package is aggressively priced, it is designed to be customized.

Source MR. NAVANI

'There are probably going to be disadvantages around customization' and flexibility.

Source DR. WALDREN

The big box store Sam's Club, which is owned by Wal-Mart, is setting its sights on the information technology frontier: The stores are starting to market electronic health record systems aimed at medical practices with one to three physicians.

Not everyone, though, is buying the ability of such off-the-shelf systems to be used in a meaningful way in clinical practice. And with EHR systems being held up as essential to health care reform and the ability to get a grip on unnecessary spending, a lot is riding on these products.

With the package offered by Sam's Club, practices will receive three laptops and a tablet notebook from Dell, a laser printer, and EHR and practice management software from eClinicalWorks. The package also includes 12 weeks of on-site setup, customization, and support. The package costs less than $25,000 for the first physician and up to $10,000 for each additional physician in the practice. The package, which is available for purchase online, is currently being sold only to physicians in Georgia, Illinois, and Virginia, with a nationwide rollout planned for later this year.

"We have 200,000 medical-type [business members] at our 600 clubs nationwide," explained Susan Koehler, senior manager in corporate communications at the Sam's Club home office in Bentonville, Ark. Wal-Mart had amassed some experience using Dell and eClinical Works EHR systems at its walk-in medical RediClinics and it worked well, so the idea was born to start marketing it to Sam's Club members.

The company chose Sam's Club rather than Wal-Mart to distribute the EHR because, unlike Wal-Mart, Sam's Club has a one-on-one relationship with the local businesses that buy their supplies at the club, "so we have relationships at the local level with those doctors," Ms. Koehler said.

Georgia, Illinois, and Virginia were selected for the rollout because "they were a good representation of broad-band access with a mix of rural and small-town community doctors," she said. At the same time, those states include big cities such as Atlanta and Chicago. Ms. Koehler would not say how many systems have been sold since the product was launched in early April, but "we're very pleased with the interest" it has gotten, she said.

Discounted hardware from Dell and some money saved on "interfaces coming out of the box" allowed Sam's Club to price its EHR system aggressively, explained Girish Navani, cofounder and CEO of eClinicalWorks in Westborough, Mass.

Yet the package does not offer any less customization than if a physician practice was to buy a system individually, Mr. Navani said.

Dr. Steven Waldren, director of the Center for Health Information Technology at the American Academy of Family Physicians (AAFP), said that packages like Sam's Club's have advantages and disadvantages. Although the product is off the shelf, "it's really a product and service package, not [just] a box of software that you order and then get installed," he noted, yet the disadvantage is that it is prepackaged, "so decisions are made for you when they put it together."

Two factors are key in EHR selection: content and workflow, Dr. Waldren said. An EHR system may have plenty of content, but "does it have the templates you need and want?" If you have midlevel personnel, "how does the signoff process work?" Does the nursing staff put in a review of the present illness "and then you verify that? If [the workflow] doesn't work for you, what type of customization is possible?"

By prepackaging elements together, off-the-shelf systems will be less expensive, "but there are probably going to be disadvantages around customization and the flexibility practices are going to have," he said.

Although the package is aggressively priced, it is designed to be customized.

Source MR. NAVANI

'There are probably going to be disadvantages around customization' and flexibility.

Source DR. WALDREN

The big box store Sam's Club, which is owned by Wal-Mart, is setting its sights on the information technology frontier: The stores are starting to market electronic health record systems aimed at medical practices with one to three physicians.

Not everyone, though, is buying the ability of such off-the-shelf systems to be used in a meaningful way in clinical practice. And with EHR systems being held up as essential to health care reform and the ability to get a grip on unnecessary spending, a lot is riding on these products.

With the package offered by Sam's Club, practices will receive three laptops and a tablet notebook from Dell, a laser printer, and EHR and practice management software from eClinicalWorks. The package also includes 12 weeks of on-site setup, customization, and support. The package costs less than $25,000 for the first physician and up to $10,000 for each additional physician in the practice. The package, which is available for purchase online, is currently being sold only to physicians in Georgia, Illinois, and Virginia, with a nationwide rollout planned for later this year.

"We have 200,000 medical-type [business members] at our 600 clubs nationwide," explained Susan Koehler, senior manager in corporate communications at the Sam's Club home office in Bentonville, Ark. Wal-Mart had amassed some experience using Dell and eClinical Works EHR systems at its walk-in medical RediClinics and it worked well, so the idea was born to start marketing it to Sam's Club members.

The company chose Sam's Club rather than Wal-Mart to distribute the EHR because, unlike Wal-Mart, Sam's Club has a one-on-one relationship with the local businesses that buy their supplies at the club, "so we have relationships at the local level with those doctors," Ms. Koehler said.

Georgia, Illinois, and Virginia were selected for the rollout because "they were a good representation of broad-band access with a mix of rural and small-town community doctors," she said. At the same time, those states include big cities such as Atlanta and Chicago. Ms. Koehler would not say how many systems have been sold since the product was launched in early April, but "we're very pleased with the interest" it has gotten, she said.

Discounted hardware from Dell and some money saved on "interfaces coming out of the box" allowed Sam's Club to price its EHR system aggressively, explained Girish Navani, cofounder and CEO of eClinicalWorks in Westborough, Mass.

Yet the package does not offer any less customization than if a physician practice was to buy a system individually, Mr. Navani said.

Dr. Steven Waldren, director of the Center for Health Information Technology at the American Academy of Family Physicians (AAFP), said that packages like Sam's Club's have advantages and disadvantages. Although the product is off the shelf, "it's really a product and service package, not [just] a box of software that you order and then get installed," he noted, yet the disadvantage is that it is prepackaged, "so decisions are made for you when they put it together."

Two factors are key in EHR selection: content and workflow, Dr. Waldren said. An EHR system may have plenty of content, but "does it have the templates you need and want?" If you have midlevel personnel, "how does the signoff process work?" Does the nursing staff put in a review of the present illness "and then you verify that? If [the workflow] doesn't work for you, what type of customization is possible?"

By prepackaging elements together, off-the-shelf systems will be less expensive, "but there are probably going to be disadvantages around customization and the flexibility practices are going to have," he said.

Although the package is aggressively priced, it is designed to be customized.

Source MR. NAVANI

'There are probably going to be disadvantages around customization' and flexibility.

Source DR. WALDREN

WASHINGTON — Requirements for making "meaningful use" of an electronic health records system can't be too onerous, or physicians will be discouraged from buying and using an EHR, Dr. Neil Calman said at a health information technology meeting convened by the Department of Health and Human Services.

Under the Recovery Act, formally known as the American Recovery and Reinvestment Act, $19 billion in stimulus money has been set aside to encourage adoption of health information technology, including electronic health records (EHRs). The money includes $44,000 in financial incentives for each physician who purchases a certified EHR system and makes "meaningful use" of it by 2011; physicians who adopt EHRs later will also get an incentive, but the amount will diminish gradually over several years and disappear completely after 2014. Providers who have not adopted EHRs by 2015 will see reductions in their Medicare reimbursement.

To put the law into effect, the government has to define "meaningful use." A health information technology (HIT) Policy Committee will make recommendations for the definition; the actual regulations will be written by staff members at the Centers for Medicare and Medicaid Services (CMS).

At a recent meeting, HIT Policy Committee member Anthony Trenkle, director of the CMS Office of E-Health Standards and Services, said that the agency plans to issue draft regulations at the end of the year, with 60 days for a comment period. The final regulations are slated to be issued early next year.

The committee heard a preliminary report from the meaningful use subgroup, which outlined its suggestions for meaningful use requirements in 2011, 2013, and 2015 (see box). Committee members expressed varying opinions on whether the requirements were too few or too many.

"This is a very aggressive model," said Gayle Harrell, a former Florida state legislator. She described her recent visit to a Florida health system where administrators estimated it would take 3 years to install a computerized order entry system in its 35 clinics. "My great concern is that this is going to be difficult to achieve."

But Dr. Calman, who also serves on the committee, disagreed. "I don't think we should base our policy on what one organization is doing," he said. Dr. Calman is president and CEO of the Institute for Family Health, Bronx, New York. "We have lots of models [that have worked more efficiently] and we should focus on that."

David Lansky, Ph.D., of the Pacific Business Group on Health, said he would favor accelerating implementation of a small number of items, such as clinical decision support, from 2013 to 2011. "For 2013, we would [show that we have] a full slate of stringent requirements, so people know what's coming," he said. For example, physicians who don't purchase a system until 2014 would have to make sure their system met the meaningful use requirements for both 2011 and 2013.

The committee needs to be aware of how such changes would affect providers who adopt EHRs in later years, according to Dr. Calman.

"We're creating another incentive for people to adopt early," he said. Not only do the incentives get smaller and smaller, but the bar gets higher and higher over time. "If that's what we want to do, that's OK, but we ought to be conscious of that."

In reality there are two timelines: The first is based on what we'd like our delivery system to be able to do and the second is based on what somebody may be able to achieve in the first year or the second year, he said.

Proposed Definition Requirements by Year

In 2011:

▸ Capturing and sharing data. This encompasses maintaining a current problem list, maintaining an active medication list, recording vital signs, and incorporating test results into the EHR.

▸ Using computerized physician order entry (CPOE) for all types of orders. This includes electronic prescribing and similar functions, such as drug allergy and formulary checks.

▸ Managing patient populations. This begins with generating lists of patients sorted by condition and sending patient reminders as needed.

In 2013:

▸ Improving quality, safety, and efficiency. This involves using evidence-based order sets, implementing clinical decision support at the point of care, and reporting information to an external disease registry.

▸ Engaging patients and families. This includes offering patient-provider electronic messaging, documenting family medical history, and uploading data from home monitoring devices.

▸ Ensuring privacy and protecting security. This involves using de-identified data when reporting population-wide health information.

In 2015:

▸ Improving population and public health. This includes using data derived from EHRs, automating real-time patient surveillance, and generating ad hoc quality reports.

▸ Coordinating care. Accessing comprehensive patient data from available sources.

▸ Continue to engage patients and families. This is expanded to include providing access to a personal health record with data from the EHR, providing patients with self-management tools, and receiving electronic data on patients' experience of care.

Source: June 2009 HIT Policy Committee

WASHINGTON — Requirements for making "meaningful use" of an electronic health records system can't be too onerous, or physicians will be discouraged from buying and using an EHR, Dr. Neil Calman said at a health information technology meeting convened by the Department of Health and Human Services.

Under the Recovery Act, formally known as the American Recovery and Reinvestment Act, $19 billion in stimulus money has been set aside to encourage adoption of health information technology, including electronic health records (EHRs). The money includes $44,000 in financial incentives for each physician who purchases a certified EHR system and makes "meaningful use" of it by 2011; physicians who adopt EHRs later will also get an incentive, but the amount will diminish gradually over several years and disappear completely after 2014. Providers who have not adopted EHRs by 2015 will see reductions in their Medicare reimbursement.

To put the law into effect, the government has to define "meaningful use." A health information technology (HIT) Policy Committee will make recommendations for the definition; the actual regulations will be written by staff members at the Centers for Medicare and Medicaid Services (CMS).

At a recent meeting, HIT Policy Committee member Anthony Trenkle, director of the CMS Office of E-Health Standards and Services, said that the agency plans to issue draft regulations at the end of the year, with 60 days for a comment period. The final regulations are slated to be issued early next year.

The committee heard a preliminary report from the meaningful use subgroup, which outlined its suggestions for meaningful use requirements in 2011, 2013, and 2015 (see box). Committee members expressed varying opinions on whether the requirements were too few or too many.

"This is a very aggressive model," said Gayle Harrell, a former Florida state legislator. She described her recent visit to a Florida health system where administrators estimated it would take 3 years to install a computerized order entry system in its 35 clinics. "My great concern is that this is going to be difficult to achieve."

But Dr. Calman, who also serves on the committee, disagreed. "I don't think we should base our policy on what one organization is doing," he said. Dr. Calman is president and CEO of the Institute for Family Health, Bronx, New York. "We have lots of models [that have worked more efficiently] and we should focus on that."

David Lansky, Ph.D., of the Pacific Business Group on Health, said he would favor accelerating implementation of a small number of items, such as clinical decision support, from 2013 to 2011. "For 2013, we would [show that we have] a full slate of stringent requirements, so people know what's coming," he said. For example, physicians who don't purchase a system until 2014 would have to make sure their system met the meaningful use requirements for both 2011 and 2013.

The committee needs to be aware of how such changes would affect providers who adopt EHRs in later years, according to Dr. Calman.

"We're creating another incentive for people to adopt early," he said. Not only do the incentives get smaller and smaller, but the bar gets higher and higher over time. "If that's what we want to do, that's OK, but we ought to be conscious of that."

In reality there are two timelines: The first is based on what we'd like our delivery system to be able to do and the second is based on what somebody may be able to achieve in the first year or the second year, he said.

Proposed Definition Requirements by Year

In 2011:

▸ Capturing and sharing data. This encompasses maintaining a current problem list, maintaining an active medication list, recording vital signs, and incorporating test results into the EHR.

▸ Using computerized physician order entry (CPOE) for all types of orders. This includes electronic prescribing and similar functions, such as drug allergy and formulary checks.

▸ Managing patient populations. This begins with generating lists of patients sorted by condition and sending patient reminders as needed.

In 2013:

▸ Improving quality, safety, and efficiency. This involves using evidence-based order sets, implementing clinical decision support at the point of care, and reporting information to an external disease registry.

▸ Engaging patients and families. This includes offering patient-provider electronic messaging, documenting family medical history, and uploading data from home monitoring devices.

▸ Ensuring privacy and protecting security. This involves using de-identified data when reporting population-wide health information.

In 2015:

▸ Improving population and public health. This includes using data derived from EHRs, automating real-time patient surveillance, and generating ad hoc quality reports.

▸ Coordinating care. Accessing comprehensive patient data from available sources.

▸ Continue to engage patients and families. This is expanded to include providing access to a personal health record with data from the EHR, providing patients with self-management tools, and receiving electronic data on patients' experience of care.

Source: June 2009 HIT Policy Committee

WASHINGTON — Requirements for making "meaningful use" of an electronic health records system can't be too onerous, or physicians will be discouraged from buying and using an EHR, Dr. Neil Calman said at a health information technology meeting convened by the Department of Health and Human Services.

Under the Recovery Act, formally known as the American Recovery and Reinvestment Act, $19 billion in stimulus money has been set aside to encourage adoption of health information technology, including electronic health records (EHRs). The money includes $44,000 in financial incentives for each physician who purchases a certified EHR system and makes "meaningful use" of it by 2011; physicians who adopt EHRs later will also get an incentive, but the amount will diminish gradually over several years and disappear completely after 2014. Providers who have not adopted EHRs by 2015 will see reductions in their Medicare reimbursement.

To put the law into effect, the government has to define "meaningful use." A health information technology (HIT) Policy Committee will make recommendations for the definition; the actual regulations will be written by staff members at the Centers for Medicare and Medicaid Services (CMS).

At a recent meeting, HIT Policy Committee member Anthony Trenkle, director of the CMS Office of E-Health Standards and Services, said that the agency plans to issue draft regulations at the end of the year, with 60 days for a comment period. The final regulations are slated to be issued early next year.

The committee heard a preliminary report from the meaningful use subgroup, which outlined its suggestions for meaningful use requirements in 2011, 2013, and 2015 (see box). Committee members expressed varying opinions on whether the requirements were too few or too many.

"This is a very aggressive model," said Gayle Harrell, a former Florida state legislator. She described her recent visit to a Florida health system where administrators estimated it would take 3 years to install a computerized order entry system in its 35 clinics. "My great concern is that this is going to be difficult to achieve."

But Dr. Calman, who also serves on the committee, disagreed. "I don't think we should base our policy on what one organization is doing," he said. Dr. Calman is president and CEO of the Institute for Family Health, Bronx, New York. "We have lots of models [that have worked more efficiently] and we should focus on that."

David Lansky, Ph.D., of the Pacific Business Group on Health, said he would favor accelerating implementation of a small number of items, such as clinical decision support, from 2013 to 2011. "For 2013, we would [show that we have] a full slate of stringent requirements, so people know what's coming," he said. For example, physicians who don't purchase a system until 2014 would have to make sure their system met the meaningful use requirements for both 2011 and 2013.

The committee needs to be aware of how such changes would affect providers who adopt EHRs in later years, according to Dr. Calman.

"We're creating another incentive for people to adopt early," he said. Not only do the incentives get smaller and smaller, but the bar gets higher and higher over time. "If that's what we want to do, that's OK, but we ought to be conscious of that."

In reality there are two timelines: The first is based on what we'd like our delivery system to be able to do and the second is based on what somebody may be able to achieve in the first year or the second year, he said.

Proposed Definition Requirements by Year

In 2011:

▸ Capturing and sharing data. This encompasses maintaining a current problem list, maintaining an active medication list, recording vital signs, and incorporating test results into the EHR.

▸ Using computerized physician order entry (CPOE) for all types of orders. This includes electronic prescribing and similar functions, such as drug allergy and formulary checks.

▸ Managing patient populations. This begins with generating lists of patients sorted by condition and sending patient reminders as needed.

In 2013:

▸ Improving quality, safety, and efficiency. This involves using evidence-based order sets, implementing clinical decision support at the point of care, and reporting information to an external disease registry.

▸ Engaging patients and families. This includes offering patient-provider electronic messaging, documenting family medical history, and uploading data from home monitoring devices.

▸ Ensuring privacy and protecting security. This involves using de-identified data when reporting population-wide health information.

In 2015:

▸ Improving population and public health. This includes using data derived from EHRs, automating real-time patient surveillance, and generating ad hoc quality reports.

▸ Coordinating care. Accessing comprehensive patient data from available sources.

▸ Continue to engage patients and families. This is expanded to include providing access to a personal health record with data from the EHR, providing patients with self-management tools, and receiving electronic data on patients' experience of care.

Source: June 2009 HIT Policy Committee

Federally funded human embryonic stem cell research may only use stem cells from embryos created by in vitro fertilization for reproductive purposes and that are no longer needed, according to final guidelines issued by the Obama administration.

The human embryonic stem cells (hESCs) must be donated by individuals “who gave voluntary written consent for the human embryos to be used for research purposes,” according to the guidelines. Researchers must obtain written documentation that hESCs meet requirements, including:

▸ All options for disposition of embryos no longer needed for treatment were explained to the donors.

▸ No payments of any kind were offered for the embryos.

▸ Policies were in place ensuring that neither consenting nor refusing to donate embryos would affect the treatment given to any patient.

▸ Decisions about whether to donate embryos were made free of influence from stem cell researchers.

▸ Donors were informed that they retained the right to withdraw their donation up until the embryo was used.

“The guidelines will ensure that [National Institutes of Health]-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law,” according to a statement from the NIH, which will oversee all federally funded hESC research. “Internal NIH policies and procedures, consistent with [President Obama's March 9 executive order] and these guidelines, will govern the conduct of intramural NIH stem cell research.”

Under the Bush administration, federal funding for human embryonic stem cell research was limited to studies using only the few stem cell lines that were in existence when the policy was created in August 2001.

President Obama's executive order lifted those restrictions and allowed funded research to include embryonic stem cell lines created after that date. It also called for the NIH to develop new stem cell research guidelines.

However, the order did not lift a current ban on using federal funds to create stem cell lines if the creation involved destruction of human embryos. Federal policy does not affect privately funded stem cell research.

One question raised by the executive order was how the guidelines would treat stem cell lines already in existence when the guidelines were issued.

In a document accompanying the guidelines, NIH officials note that “many lines were derived consistent with ethical standard and/or guidelines developed by various states, countries, and other entities such as … the National Academy of Sciences. These various policies have many common features, rely on a consistent ethical base, and require an informed consent process, but they differ in details of implementation.”

The guidelines authorize use of such stem cell lines if they are either compliant with the new guidelines or if they undergo a review by an NIH working group. “Working group review will enable pre-existing hESCs derived in a responsible manner to be eligible for use in NIH-funded research,” the document states.

The draft hESC guidelines generated 49,000 comments.

Federally funded human embryonic stem cell research may only use stem cells from embryos created by in vitro fertilization for reproductive purposes and that are no longer needed, according to final guidelines issued by the Obama administration.

The human embryonic stem cells (hESCs) must be donated by individuals “who gave voluntary written consent for the human embryos to be used for research purposes,” according to the guidelines. Researchers must obtain written documentation that hESCs meet requirements, including:

▸ All options for disposition of embryos no longer needed for treatment were explained to the donors.

▸ No payments of any kind were offered for the embryos.

▸ Policies were in place ensuring that neither consenting nor refusing to donate embryos would affect the treatment given to any patient.

▸ Decisions about whether to donate embryos were made free of influence from stem cell researchers.

▸ Donors were informed that they retained the right to withdraw their donation up until the embryo was used.

“The guidelines will ensure that [National Institutes of Health]-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law,” according to a statement from the NIH, which will oversee all federally funded hESC research. “Internal NIH policies and procedures, consistent with [President Obama's March 9 executive order] and these guidelines, will govern the conduct of intramural NIH stem cell research.”

Under the Bush administration, federal funding for human embryonic stem cell research was limited to studies using only the few stem cell lines that were in existence when the policy was created in August 2001.

President Obama's executive order lifted those restrictions and allowed funded research to include embryonic stem cell lines created after that date. It also called for the NIH to develop new stem cell research guidelines.

However, the order did not lift a current ban on using federal funds to create stem cell lines if the creation involved destruction of human embryos. Federal policy does not affect privately funded stem cell research.

One question raised by the executive order was how the guidelines would treat stem cell lines already in existence when the guidelines were issued.

In a document accompanying the guidelines, NIH officials note that “many lines were derived consistent with ethical standard and/or guidelines developed by various states, countries, and other entities such as … the National Academy of Sciences. These various policies have many common features, rely on a consistent ethical base, and require an informed consent process, but they differ in details of implementation.”

The guidelines authorize use of such stem cell lines if they are either compliant with the new guidelines or if they undergo a review by an NIH working group. “Working group review will enable pre-existing hESCs derived in a responsible manner to be eligible for use in NIH-funded research,” the document states.

The draft hESC guidelines generated 49,000 comments.

Federally funded human embryonic stem cell research may only use stem cells from embryos created by in vitro fertilization for reproductive purposes and that are no longer needed, according to final guidelines issued by the Obama administration.

The human embryonic stem cells (hESCs) must be donated by individuals “who gave voluntary written consent for the human embryos to be used for research purposes,” according to the guidelines. Researchers must obtain written documentation that hESCs meet requirements, including:

▸ All options for disposition of embryos no longer needed for treatment were explained to the donors.

▸ No payments of any kind were offered for the embryos.

▸ Policies were in place ensuring that neither consenting nor refusing to donate embryos would affect the treatment given to any patient.

▸ Decisions about whether to donate embryos were made free of influence from stem cell researchers.

▸ Donors were informed that they retained the right to withdraw their donation up until the embryo was used.

“The guidelines will ensure that [National Institutes of Health]-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law,” according to a statement from the NIH, which will oversee all federally funded hESC research. “Internal NIH policies and procedures, consistent with [President Obama's March 9 executive order] and these guidelines, will govern the conduct of intramural NIH stem cell research.”

Under the Bush administration, federal funding for human embryonic stem cell research was limited to studies using only the few stem cell lines that were in existence when the policy was created in August 2001.

President Obama's executive order lifted those restrictions and allowed funded research to include embryonic stem cell lines created after that date. It also called for the NIH to develop new stem cell research guidelines.

However, the order did not lift a current ban on using federal funds to create stem cell lines if the creation involved destruction of human embryos. Federal policy does not affect privately funded stem cell research.

One question raised by the executive order was how the guidelines would treat stem cell lines already in existence when the guidelines were issued.

In a document accompanying the guidelines, NIH officials note that “many lines were derived consistent with ethical standard and/or guidelines developed by various states, countries, and other entities such as … the National Academy of Sciences. These various policies have many common features, rely on a consistent ethical base, and require an informed consent process, but they differ in details of implementation.”

The guidelines authorize use of such stem cell lines if they are either compliant with the new guidelines or if they undergo a review by an NIH working group. “Working group review will enable pre-existing hESCs derived in a responsible manner to be eligible for use in NIH-funded research,” the document states.

The draft hESC guidelines generated 49,000 comments.

In one of her first public acts at the Food and Drug Administration, new commissioner Margaret Hamburg announced that the agency aims to be more transparent about its daily work and decision making process.

“Over the years, complaints have been made about FDA's lack of transparency,” Dr. Hamburg said June 2 in announcing the launch of a transparency task force. “The agency has been referred to as a 'black box' that makes important decisions without disclosing them. The agency can and should communicate in a way that provides more transparency, not less.”

“On President Obama's first day in office, he pledged to strengthen democracy … by creating an unprecedented level of openness” in government, noted Dr. Hamburg, who took over at FDA on May 22. “This will be an agency-wide effort charged with figuring out how to make the FDA and its processes more transparent to the public.”

The transparency task force will include the directors of all FDA centers as well as the agency's associate commissioner for regulatory affairs, its chief counsel, and its chief scientist. Its first public meeting was held June 24; another will take place in the fall. The task force “expects to submit a written report to the commissioner about 6 months from now,” according to Dr. Joshua Sharfstein, FDA principal deputy commissioner and task force chair.

Clarity is one area of interest for Dr. Sharfstein. “People don't understand why the FDA may have done something or not done something,” he said. “In many cases, the agency has an explanation, but you don't necessarily hear that explanation very clearly.”

Dr. Hamburg said she expects that a wide range of recommendations could emerge from the task force's work. Some recommendations “will be in areas that we can implement swiftly, but there may be other types of information that will take more time, and there may be some areas where we have limitations within the current law and need to examine whether appropriate changes can and should be made,” she said.

Dr. Hamburg and Dr. Sharfstein emphasized that a balance will need to be struck between providing more information and the appropriate use of confidentiality.

“There are other policy goals besides transparency, and one of the other questions is what information should remain confidential,” Dr. Sharfstein said. “The secret formula for how to make X pill may be legitimately confidential information.”

Another balancing act will come in terms of clinical trials, Dr. Sharfstein said. “What is the argument for different amounts of data [being disclosed] at different points in the drug development process, and on the other side, what are the confidentiality concerns and the reasons for them?”

The call for transparency comes at a time when the FDA has a backlog of requests under the Freedom of Information Act. Asked how she planned to handle personnel needs while the agency is behind in its work, Dr. Hamburg said, “When the recommendations come in, I will work with the task force and others on implementation. Some activity may result in more work, and some may result in decreased work. If we make more information available, there may be fewer Freedom of Information Act requests and citizen petitions.”

The Federal Register notice announcing the task force's formation is available online at www.federalregister.gov/OFRUpload/OFRData/2009-12902_PI.pdf

In one of her first public acts at the Food and Drug Administration, new commissioner Margaret Hamburg announced that the agency aims to be more transparent about its daily work and decision making process.

“Over the years, complaints have been made about FDA's lack of transparency,” Dr. Hamburg said June 2 in announcing the launch of a transparency task force. “The agency has been referred to as a 'black box' that makes important decisions without disclosing them. The agency can and should communicate in a way that provides more transparency, not less.”

“On President Obama's first day in office, he pledged to strengthen democracy … by creating an unprecedented level of openness” in government, noted Dr. Hamburg, who took over at FDA on May 22. “This will be an agency-wide effort charged with figuring out how to make the FDA and its processes more transparent to the public.”

The transparency task force will include the directors of all FDA centers as well as the agency's associate commissioner for regulatory affairs, its chief counsel, and its chief scientist. Its first public meeting was held June 24; another will take place in the fall. The task force “expects to submit a written report to the commissioner about 6 months from now,” according to Dr. Joshua Sharfstein, FDA principal deputy commissioner and task force chair.

Clarity is one area of interest for Dr. Sharfstein. “People don't understand why the FDA may have done something or not done something,” he said. “In many cases, the agency has an explanation, but you don't necessarily hear that explanation very clearly.”

Dr. Hamburg said she expects that a wide range of recommendations could emerge from the task force's work. Some recommendations “will be in areas that we can implement swiftly, but there may be other types of information that will take more time, and there may be some areas where we have limitations within the current law and need to examine whether appropriate changes can and should be made,” she said.

Dr. Hamburg and Dr. Sharfstein emphasized that a balance will need to be struck between providing more information and the appropriate use of confidentiality.

“There are other policy goals besides transparency, and one of the other questions is what information should remain confidential,” Dr. Sharfstein said. “The secret formula for how to make X pill may be legitimately confidential information.”

Another balancing act will come in terms of clinical trials, Dr. Sharfstein said. “What is the argument for different amounts of data [being disclosed] at different points in the drug development process, and on the other side, what are the confidentiality concerns and the reasons for them?”

The call for transparency comes at a time when the FDA has a backlog of requests under the Freedom of Information Act. Asked how she planned to handle personnel needs while the agency is behind in its work, Dr. Hamburg said, “When the recommendations come in, I will work with the task force and others on implementation. Some activity may result in more work, and some may result in decreased work. If we make more information available, there may be fewer Freedom of Information Act requests and citizen petitions.”

The Federal Register notice announcing the task force's formation is available online at www.federalregister.gov/OFRUpload/OFRData/2009-12902_PI.pdf

In one of her first public acts at the Food and Drug Administration, new commissioner Margaret Hamburg announced that the agency aims to be more transparent about its daily work and decision making process.

“Over the years, complaints have been made about FDA's lack of transparency,” Dr. Hamburg said June 2 in announcing the launch of a transparency task force. “The agency has been referred to as a 'black box' that makes important decisions without disclosing them. The agency can and should communicate in a way that provides more transparency, not less.”

“On President Obama's first day in office, he pledged to strengthen democracy … by creating an unprecedented level of openness” in government, noted Dr. Hamburg, who took over at FDA on May 22. “This will be an agency-wide effort charged with figuring out how to make the FDA and its processes more transparent to the public.”

The transparency task force will include the directors of all FDA centers as well as the agency's associate commissioner for regulatory affairs, its chief counsel, and its chief scientist. Its first public meeting was held June 24; another will take place in the fall. The task force “expects to submit a written report to the commissioner about 6 months from now,” according to Dr. Joshua Sharfstein, FDA principal deputy commissioner and task force chair.

Clarity is one area of interest for Dr. Sharfstein. “People don't understand why the FDA may have done something or not done something,” he said. “In many cases, the agency has an explanation, but you don't necessarily hear that explanation very clearly.”

Dr. Hamburg said she expects that a wide range of recommendations could emerge from the task force's work. Some recommendations “will be in areas that we can implement swiftly, but there may be other types of information that will take more time, and there may be some areas where we have limitations within the current law and need to examine whether appropriate changes can and should be made,” she said.

Dr. Hamburg and Dr. Sharfstein emphasized that a balance will need to be struck between providing more information and the appropriate use of confidentiality.

“There are other policy goals besides transparency, and one of the other questions is what information should remain confidential,” Dr. Sharfstein said. “The secret formula for how to make X pill may be legitimately confidential information.”

Another balancing act will come in terms of clinical trials, Dr. Sharfstein said. “What is the argument for different amounts of data [being disclosed] at different points in the drug development process, and on the other side, what are the confidentiality concerns and the reasons for them?”

The call for transparency comes at a time when the FDA has a backlog of requests under the Freedom of Information Act. Asked how she planned to handle personnel needs while the agency is behind in its work, Dr. Hamburg said, “When the recommendations come in, I will work with the task force and others on implementation. Some activity may result in more work, and some may result in decreased work. If we make more information available, there may be fewer Freedom of Information Act requests and citizen petitions.”

The Federal Register notice announcing the task force's formation is available online at www.federalregister.gov/OFRUpload/OFRData/2009-12902_PI.pdf