Mary Ellen Schneider

Officials at the Food and Drug Administration are planning to reorganize its Center for Drug Evaluation and Research in an effort to improve the agency's approach to drug safety and to help improve drug development.

The FDA plans to appoint a new associate director at the Center for Drug Evaluation and Research (CDER) to focus on broad drug safety, policy, and communication issues. Agency officials also plan to consolidate some drug safety-related activities and have that staff report to the new associate director. This would include MedWatch reporting staff and Drug Safety Oversight Board staff.

The reorganization plans also call for elevating the status of the current Office of Drug Safety, which is primarily responsible for epidemiology and surveillance activities, and its staff will report to the CDER director. The name of the office will also be changed.

“Over the past year, the Center has been the focus of intense internal and external scrutiny regarding drug safety,” said Dr. Steven K. Galson, CDER director, in a memo to the center staff. “The current organizational structure perpetuates the misperception that ensuring drug safety is solely the responsibility of the current Office of Drug Safety.”

While the Office of Drug Safety is a small unit, about half of CDER's resources are dedicated to drug safety activities, said Deborah Henderson, R.N., director of the Office of Executive Programs at CDER.

But the proposal includes no plans to make the Office of Drug Safety independent from CDER, as some in Congress have proposed. When reviewing drugs, FDA staff members need to balance the effectiveness of the drug against the risks, Ms. Henderson said, so pulling the safety activities out of the center wouldn't be in the best interests of public health.

FDA officials plan to implement the changes over the next 6 months.

The changes will also help to improve regulatory and drug development science through the agency's Critical Path Initiative—a top FDA priority that calls for partnering with industry and academia to improve the drug development process.

Through the Critical Path Initiative, FDA hopes to help industry find better biomarkers and improve clinical trial designs, Ms. Henderson said, which would ultimately lead to better, more targeted drugs.

While a number of CDER staff have been working on the Critical Path Initiative, there has not been a central office within CDER. Under the proposed reorganization, the FDA will create a new office that will report to the CDER director and provide a hub for Critical Path activities.

The FDA also plans to make other changes, including establishing an Office of Counterterrorism and Emergency Operations, which will report to the Office of the Center Director; and realigning the Division of Scientific Investigations from the Office of Medical Policy into the Office of Compliance.

“A reorganization is not designed to achieve instant solutions to the challenges CDER faces, although I believe it will address many of the criticisms and suggestions which have been offered on how to approach our work, including drug safety,” Dr. Galson said in his memo to CDER staff.

But real improvements in drug safety need to happen outside the FDA, said Curt D. Furberg, Ph.D., professor in the department of public health sciences at Wake Forest University in Winston-Salem, N.C.

Congress needs to act to give the FDA greater authority to change labels, withdraw drugs, and levy penalties against drug makers who don't live up to their postmarket promises, he said. “FDA can't do that on its own,” Dr. Furberg said. “Congress is failing.”

The streamlining being proposed by the FDA is a good idea, he said, but it won't address the larger problem. “The issue of safety is much bigger,” he said.

Officials at the Food and Drug Administration are planning to reorganize its Center for Drug Evaluation and Research in an effort to improve the agency's approach to drug safety and to help improve drug development.

The FDA plans to appoint a new associate director at the Center for Drug Evaluation and Research (CDER) to focus on broad drug safety, policy, and communication issues. Agency officials also plan to consolidate some drug safety-related activities and have that staff report to the new associate director. This would include MedWatch reporting staff and Drug Safety Oversight Board staff.

The reorganization plans also call for elevating the status of the current Office of Drug Safety, which is primarily responsible for epidemiology and surveillance activities, and its staff will report to the CDER director. The name of the office will also be changed.

“Over the past year, the Center has been the focus of intense internal and external scrutiny regarding drug safety,” said Dr. Steven K. Galson, CDER director, in a memo to the center staff. “The current organizational structure perpetuates the misperception that ensuring drug safety is solely the responsibility of the current Office of Drug Safety.”

While the Office of Drug Safety is a small unit, about half of CDER's resources are dedicated to drug safety activities, said Deborah Henderson, R.N., director of the Office of Executive Programs at CDER.

But the proposal includes no plans to make the Office of Drug Safety independent from CDER, as some in Congress have proposed. When reviewing drugs, FDA staff members need to balance the effectiveness of the drug against the risks, Ms. Henderson said, so pulling the safety activities out of the center wouldn't be in the best interests of public health.

FDA officials plan to implement the changes over the next 6 months.

The changes will also help to improve regulatory and drug development science through the agency's Critical Path Initiative—a top FDA priority that calls for partnering with industry and academia to improve the drug development process.

Through the Critical Path Initiative, FDA hopes to help industry find better biomarkers and improve clinical trial designs, Ms. Henderson said, which would ultimately lead to better, more targeted drugs.

While a number of CDER staff have been working on the Critical Path Initiative, there has not been a central office within CDER. Under the proposed reorganization, the FDA will create a new office that will report to the CDER director and provide a hub for Critical Path activities.

The FDA also plans to make other changes, including establishing an Office of Counterterrorism and Emergency Operations, which will report to the Office of the Center Director; and realigning the Division of Scientific Investigations from the Office of Medical Policy into the Office of Compliance.

“A reorganization is not designed to achieve instant solutions to the challenges CDER faces, although I believe it will address many of the criticisms and suggestions which have been offered on how to approach our work, including drug safety,” Dr. Galson said in his memo to CDER staff.

But real improvements in drug safety need to happen outside the FDA, said Curt D. Furberg, Ph.D., professor in the department of public health sciences at Wake Forest University in Winston-Salem, N.C.

Congress needs to act to give the FDA greater authority to change labels, withdraw drugs, and levy penalties against drug makers who don't live up to their postmarket promises, he said. “FDA can't do that on its own,” Dr. Furberg said. “Congress is failing.”

The streamlining being proposed by the FDA is a good idea, he said, but it won't address the larger problem. “The issue of safety is much bigger,” he said.

Officials at the Food and Drug Administration are planning to reorganize its Center for Drug Evaluation and Research in an effort to improve the agency's approach to drug safety and to help improve drug development.

The FDA plans to appoint a new associate director at the Center for Drug Evaluation and Research (CDER) to focus on broad drug safety, policy, and communication issues. Agency officials also plan to consolidate some drug safety-related activities and have that staff report to the new associate director. This would include MedWatch reporting staff and Drug Safety Oversight Board staff.

The reorganization plans also call for elevating the status of the current Office of Drug Safety, which is primarily responsible for epidemiology and surveillance activities, and its staff will report to the CDER director. The name of the office will also be changed.

“Over the past year, the Center has been the focus of intense internal and external scrutiny regarding drug safety,” said Dr. Steven K. Galson, CDER director, in a memo to the center staff. “The current organizational structure perpetuates the misperception that ensuring drug safety is solely the responsibility of the current Office of Drug Safety.”

While the Office of Drug Safety is a small unit, about half of CDER's resources are dedicated to drug safety activities, said Deborah Henderson, R.N., director of the Office of Executive Programs at CDER.

But the proposal includes no plans to make the Office of Drug Safety independent from CDER, as some in Congress have proposed. When reviewing drugs, FDA staff members need to balance the effectiveness of the drug against the risks, Ms. Henderson said, so pulling the safety activities out of the center wouldn't be in the best interests of public health.

FDA officials plan to implement the changes over the next 6 months.

The changes will also help to improve regulatory and drug development science through the agency's Critical Path Initiative—a top FDA priority that calls for partnering with industry and academia to improve the drug development process.

Through the Critical Path Initiative, FDA hopes to help industry find better biomarkers and improve clinical trial designs, Ms. Henderson said, which would ultimately lead to better, more targeted drugs.

While a number of CDER staff have been working on the Critical Path Initiative, there has not been a central office within CDER. Under the proposed reorganization, the FDA will create a new office that will report to the CDER director and provide a hub for Critical Path activities.

The FDA also plans to make other changes, including establishing an Office of Counterterrorism and Emergency Operations, which will report to the Office of the Center Director; and realigning the Division of Scientific Investigations from the Office of Medical Policy into the Office of Compliance.

“A reorganization is not designed to achieve instant solutions to the challenges CDER faces, although I believe it will address many of the criticisms and suggestions which have been offered on how to approach our work, including drug safety,” Dr. Galson said in his memo to CDER staff.

But real improvements in drug safety need to happen outside the FDA, said Curt D. Furberg, Ph.D., professor in the department of public health sciences at Wake Forest University in Winston-Salem, N.C.

Congress needs to act to give the FDA greater authority to change labels, withdraw drugs, and levy penalties against drug makers who don't live up to their postmarket promises, he said. “FDA can't do that on its own,” Dr. Furberg said. “Congress is failing.”

The streamlining being proposed by the FDA is a good idea, he said, but it won't address the larger problem. “The issue of safety is much bigger,” he said.

New guidance from the Food and Drug Administration proposes that latex condom labels inform users that condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of contracting or spreading HIV or other sexually transmitted diseases.

The draft guidance from FDA, which is nonbinding, also recommends that the package insert for latex condoms say that condoms cannot protect against STDs such as human papilloma virus (HPV) and genital herpes when they are spread through contact with infected skin outside the area covered by the condom.

The draft guidance also includes statements that nonoxynol-9 could irritate the vagina and rectum and therefore may increase the risk of acquiring HIV/AIDS from an infected partner.

The proposed guidance is the result of a 5-year-old law that directs the FDA to ensure that condom labels are medically accurate, specifically with regard to their overall effectiveness in preventing STDs.

But the original congressional supporters of the provision—Sen. Tom Coburn (R-Okla.) and Rep. Mark Souder (R-Ind.)—are not completely satisfied with FDA's conclusions. “This is a step in the right direction,” Rep. Souder said in a statement. “Inasmuch as the new label recommendations finally acknowledge that condoms will not protect against some STDs.”

But he added that he is discouraged that FDA says that condom use may lower the risk of developing HPV-related diseases, such as genital warts and cancer.

The draft is available at www.fda.gov/cdrh/comp/guidance/1548.html

New guidance from the Food and Drug Administration proposes that latex condom labels inform users that condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of contracting or spreading HIV or other sexually transmitted diseases.

The draft guidance from FDA, which is nonbinding, also recommends that the package insert for latex condoms say that condoms cannot protect against STDs such as human papilloma virus (HPV) and genital herpes when they are spread through contact with infected skin outside the area covered by the condom.

The draft guidance also includes statements that nonoxynol-9 could irritate the vagina and rectum and therefore may increase the risk of acquiring HIV/AIDS from an infected partner.

The proposed guidance is the result of a 5-year-old law that directs the FDA to ensure that condom labels are medically accurate, specifically with regard to their overall effectiveness in preventing STDs.

But the original congressional supporters of the provision—Sen. Tom Coburn (R-Okla.) and Rep. Mark Souder (R-Ind.)—are not completely satisfied with FDA's conclusions. “This is a step in the right direction,” Rep. Souder said in a statement. “Inasmuch as the new label recommendations finally acknowledge that condoms will not protect against some STDs.”

But he added that he is discouraged that FDA says that condom use may lower the risk of developing HPV-related diseases, such as genital warts and cancer.

The draft is available at www.fda.gov/cdrh/comp/guidance/1548.html

New guidance from the Food and Drug Administration proposes that latex condom labels inform users that condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of contracting or spreading HIV or other sexually transmitted diseases.

The draft guidance from FDA, which is nonbinding, also recommends that the package insert for latex condoms say that condoms cannot protect against STDs such as human papilloma virus (HPV) and genital herpes when they are spread through contact with infected skin outside the area covered by the condom.

The draft guidance also includes statements that nonoxynol-9 could irritate the vagina and rectum and therefore may increase the risk of acquiring HIV/AIDS from an infected partner.

The proposed guidance is the result of a 5-year-old law that directs the FDA to ensure that condom labels are medically accurate, specifically with regard to their overall effectiveness in preventing STDs.

But the original congressional supporters of the provision—Sen. Tom Coburn (R-Okla.) and Rep. Mark Souder (R-Ind.)—are not completely satisfied with FDA's conclusions. “This is a step in the right direction,” Rep. Souder said in a statement. “Inasmuch as the new label recommendations finally acknowledge that condoms will not protect against some STDs.”

But he added that he is discouraged that FDA says that condom use may lower the risk of developing HPV-related diseases, such as genital warts and cancer.

The draft is available at www.fda.gov/cdrh/comp/guidance/1548.html

The pharmaceutical industry may be breathing a collective sigh of relief over the latest court verdict involving Merck & Co.'s Vioxx, but it may not be time to pop the cork on the champagne.

Experts say the two very different jury decisions handed down so far could still have some negative implications for the pharmaceutical industry—as well as for physicians.

In August, a Texas jury awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib), but in November a New Jersey jury found no fault with the company's actions in the case of a man who claimed that taking Vioxx contributed to his having a heart attack.

This latest verdict is "definitely a huge victory for Merck," with its implication that at least some of the 6,000 pending cases against the company will be dropped, said Daphne Monie, Ph.D., an analyst in the immune and inflammatory disorders group at Decision Resources Inc., a market research firm that conducts analysis of trends in the drug industry.

However, it could spell trouble for the pharmaceutical industry.

The first case shows that a jury is willing to hold the company responsible for the adverse effects of the drug, even as a different jury concluded that the company provided adequate warning to physicians and the public about risks. When taken together, the verdicts send the message that drug companies could be held liable for adverse effects even when the risks are properly disclosed, she said.

And it's possible that physicians could also become the target of lawsuits. If the precedent is set that Merck can be held liable for adverse events even when providing adequate warning about the risks, physicians may be held responsible for prescribing the drugs. At press time, Dr. Monie knew of no such cases against physicians involving Vioxx.

But Dr. Eric Matteson, a rheumatologist and professor of medicine at the Mayo Clinic in Rochester, Minn., said that cases against physicians are unlikely because Vioxx was an FDA-approved drug and there were limited warnings about its use. "I think physicians prescribed in good faith," he said.

The two very different verdicts in these cases reflect the complexity of trying to attribute cardiovascular events to exposure to a particular drug especially when other drugs and comorbidities are involved, he added.

The risk information about cyclooxygenase-2 (COX-2) inhibitors in general has made everyone a lot more cautious. It definitely seems to be slowing down the release of new COX-2s onto the market, he said, and it may have an effect on the willingness of physicians to prescribe COX-2s when the agents do become available.

Physicians should be aware that these drugs have a limited utility and that global prescribing for pain and inflammation in unselected patients is not a good practice, Dr. Matteson added.

Regardless of the recent verdicts, the courtroom is not the best place to be debating the safety of Vioxx, said Dr. W. Hayes Wilson, who is a national medical advisor for the Arthritis Foundation and chief of rheumatology at Piedmont Hospital in Atlanta.

"There is no correlation between jury verdicts and scientific literature," Dr. Wilson explained. "Scientific literature is not best evaluated in a court of law." In that context, the jurors can only decide based on the information that is presented to them.

The likely outcome of all the events surrounding the withdrawal of Vioxx is that there will be fewer choices for patients, he said.

The pharmaceutical industry may be breathing a collective sigh of relief over the latest court verdict involving Merck & Co.'s Vioxx, but it may not be time to pop the cork on the champagne.

Experts say the two very different jury decisions handed down so far could still have some negative implications for the pharmaceutical industry—as well as for physicians.

In August, a Texas jury awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib), but in November a New Jersey jury found no fault with the company's actions in the case of a man who claimed that taking Vioxx contributed to his having a heart attack.

This latest verdict is "definitely a huge victory for Merck," with its implication that at least some of the 6,000 pending cases against the company will be dropped, said Daphne Monie, Ph.D., an analyst in the immune and inflammatory disorders group at Decision Resources Inc., a market research firm that conducts analysis of trends in the drug industry.

However, it could spell trouble for the pharmaceutical industry.

The first case shows that a jury is willing to hold the company responsible for the adverse effects of the drug, even as a different jury concluded that the company provided adequate warning to physicians and the public about risks. When taken together, the verdicts send the message that drug companies could be held liable for adverse effects even when the risks are properly disclosed, she said.

And it's possible that physicians could also become the target of lawsuits. If the precedent is set that Merck can be held liable for adverse events even when providing adequate warning about the risks, physicians may be held responsible for prescribing the drugs. At press time, Dr. Monie knew of no such cases against physicians involving Vioxx.

But Dr. Eric Matteson, a rheumatologist and professor of medicine at the Mayo Clinic in Rochester, Minn., said that cases against physicians are unlikely because Vioxx was an FDA-approved drug and there were limited warnings about its use. "I think physicians prescribed in good faith," he said.

The two very different verdicts in these cases reflect the complexity of trying to attribute cardiovascular events to exposure to a particular drug especially when other drugs and comorbidities are involved, he added.

The risk information about cyclooxygenase-2 (COX-2) inhibitors in general has made everyone a lot more cautious. It definitely seems to be slowing down the release of new COX-2s onto the market, he said, and it may have an effect on the willingness of physicians to prescribe COX-2s when the agents do become available.

Physicians should be aware that these drugs have a limited utility and that global prescribing for pain and inflammation in unselected patients is not a good practice, Dr. Matteson added.

Regardless of the recent verdicts, the courtroom is not the best place to be debating the safety of Vioxx, said Dr. W. Hayes Wilson, who is a national medical advisor for the Arthritis Foundation and chief of rheumatology at Piedmont Hospital in Atlanta.

"There is no correlation between jury verdicts and scientific literature," Dr. Wilson explained. "Scientific literature is not best evaluated in a court of law." In that context, the jurors can only decide based on the information that is presented to them.

The likely outcome of all the events surrounding the withdrawal of Vioxx is that there will be fewer choices for patients, he said.

The pharmaceutical industry may be breathing a collective sigh of relief over the latest court verdict involving Merck & Co.'s Vioxx, but it may not be time to pop the cork on the champagne.

Experts say the two very different jury decisions handed down so far could still have some negative implications for the pharmaceutical industry—as well as for physicians.

In August, a Texas jury awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib), but in November a New Jersey jury found no fault with the company's actions in the case of a man who claimed that taking Vioxx contributed to his having a heart attack.

This latest verdict is "definitely a huge victory for Merck," with its implication that at least some of the 6,000 pending cases against the company will be dropped, said Daphne Monie, Ph.D., an analyst in the immune and inflammatory disorders group at Decision Resources Inc., a market research firm that conducts analysis of trends in the drug industry.

However, it could spell trouble for the pharmaceutical industry.

The first case shows that a jury is willing to hold the company responsible for the adverse effects of the drug, even as a different jury concluded that the company provided adequate warning to physicians and the public about risks. When taken together, the verdicts send the message that drug companies could be held liable for adverse effects even when the risks are properly disclosed, she said.

And it's possible that physicians could also become the target of lawsuits. If the precedent is set that Merck can be held liable for adverse events even when providing adequate warning about the risks, physicians may be held responsible for prescribing the drugs. At press time, Dr. Monie knew of no such cases against physicians involving Vioxx.

But Dr. Eric Matteson, a rheumatologist and professor of medicine at the Mayo Clinic in Rochester, Minn., said that cases against physicians are unlikely because Vioxx was an FDA-approved drug and there were limited warnings about its use. "I think physicians prescribed in good faith," he said.

The two very different verdicts in these cases reflect the complexity of trying to attribute cardiovascular events to exposure to a particular drug especially when other drugs and comorbidities are involved, he added.

The risk information about cyclooxygenase-2 (COX-2) inhibitors in general has made everyone a lot more cautious. It definitely seems to be slowing down the release of new COX-2s onto the market, he said, and it may have an effect on the willingness of physicians to prescribe COX-2s when the agents do become available.

Physicians should be aware that these drugs have a limited utility and that global prescribing for pain and inflammation in unselected patients is not a good practice, Dr. Matteson added.

Regardless of the recent verdicts, the courtroom is not the best place to be debating the safety of Vioxx, said Dr. W. Hayes Wilson, who is a national medical advisor for the Arthritis Foundation and chief of rheumatology at Piedmont Hospital in Atlanta.

"There is no correlation between jury verdicts and scientific literature," Dr. Wilson explained. "Scientific literature is not best evaluated in a court of law." In that context, the jurors can only decide based on the information that is presented to them.

The likely outcome of all the events surrounding the withdrawal of Vioxx is that there will be fewer choices for patients, he said.

NASHVILLE, TENN. — State policy-makers are seeking innovative approaches to expand access to health insurance.

"There seems to be renewed interest in trying to build on [employer-sponsored insurance]," Sharon Silow-Carroll, senior vice president of the Economic and Social Research Institute in Teaneck, N.J., said at the annual conference of the National Academy for State Health Policy.

Trends that have combined to spur action in this area include the decline in employer-sponsored insurance, the financial strains on state Medicaid programs, and the rising cost of health care.

States have responded with a number of different approaches:

▸ Limited benefit plans. Some states are allowing the sale of lower-cost, limited- benefit plans and other options such as health savings accounts coupled with high-deductible plans.

▸ Premium assistance. Other states are offering premium assistance through Medicaid, State Children's Health Insurance Program (SCHIP), and other public programs. For example, Rhode Island offers subsidies and wraparound benefits to those eligible for Medicaid and other state health programs. For those individuals who earn 150% of the federal poverty level or less, the state pays the employee's share of the employer-sponsored premium.

▸ Reinsurance. There has also been a lot of interest in reinsurance through indirect subsidies to employers and workers, Ms. Silow-Carroll said. New York pays 90% of claims between $5,000 and $75,000 for eligible individuals.

▸ State-negotiated health plans. States are also using their purchasing power with or without additional subsidies to provide more affordable health insurance options.

▸ Employer mandates. State policymakers can also try to increase employer-sponsored coverage with mandates that require employers to cover workers or pay a fee to the state to arrange coverage. Such a proposal was recently defeated in California.

Such "pay-or-play" proposals "reemerge every few years in the states," she said. "If a state is very serious about boosting [employer sponsored insurance] in a big way, a pay-or-play type approach really should be on the table as one of the options considered." All of these strategies can stand alone but should comprise a comprehensive approach that deals with cost containment, cost issues, and quality issues, and aspects of different uninsured populations.

Strategies that build on employer-sponsored insurance have advantages for states, Ms. Silow-Carroll said, because they offer a way to expand access to coverage without the state bearing the full cost.

But a key limitation, she said, is that under voluntary strategies there has historically been fairly low employer participation—especially among employers who have never offered coverage in the past.

NASHVILLE, TENN. — State policy-makers are seeking innovative approaches to expand access to health insurance.

"There seems to be renewed interest in trying to build on [employer-sponsored insurance]," Sharon Silow-Carroll, senior vice president of the Economic and Social Research Institute in Teaneck, N.J., said at the annual conference of the National Academy for State Health Policy.

Trends that have combined to spur action in this area include the decline in employer-sponsored insurance, the financial strains on state Medicaid programs, and the rising cost of health care.

States have responded with a number of different approaches:

▸ Limited benefit plans. Some states are allowing the sale of lower-cost, limited- benefit plans and other options such as health savings accounts coupled with high-deductible plans.

▸ Premium assistance. Other states are offering premium assistance through Medicaid, State Children's Health Insurance Program (SCHIP), and other public programs. For example, Rhode Island offers subsidies and wraparound benefits to those eligible for Medicaid and other state health programs. For those individuals who earn 150% of the federal poverty level or less, the state pays the employee's share of the employer-sponsored premium.

▸ Reinsurance. There has also been a lot of interest in reinsurance through indirect subsidies to employers and workers, Ms. Silow-Carroll said. New York pays 90% of claims between $5,000 and $75,000 for eligible individuals.

▸ State-negotiated health plans. States are also using their purchasing power with or without additional subsidies to provide more affordable health insurance options.

▸ Employer mandates. State policymakers can also try to increase employer-sponsored coverage with mandates that require employers to cover workers or pay a fee to the state to arrange coverage. Such a proposal was recently defeated in California.

Such "pay-or-play" proposals "reemerge every few years in the states," she said. "If a state is very serious about boosting [employer sponsored insurance] in a big way, a pay-or-play type approach really should be on the table as one of the options considered." All of these strategies can stand alone but should comprise a comprehensive approach that deals with cost containment, cost issues, and quality issues, and aspects of different uninsured populations.

Strategies that build on employer-sponsored insurance have advantages for states, Ms. Silow-Carroll said, because they offer a way to expand access to coverage without the state bearing the full cost.

But a key limitation, she said, is that under voluntary strategies there has historically been fairly low employer participation—especially among employers who have never offered coverage in the past.

NASHVILLE, TENN. — State policy-makers are seeking innovative approaches to expand access to health insurance.

"There seems to be renewed interest in trying to build on [employer-sponsored insurance]," Sharon Silow-Carroll, senior vice president of the Economic and Social Research Institute in Teaneck, N.J., said at the annual conference of the National Academy for State Health Policy.

Trends that have combined to spur action in this area include the decline in employer-sponsored insurance, the financial strains on state Medicaid programs, and the rising cost of health care.

States have responded with a number of different approaches:

▸ Limited benefit plans. Some states are allowing the sale of lower-cost, limited- benefit plans and other options such as health savings accounts coupled with high-deductible plans.

▸ Premium assistance. Other states are offering premium assistance through Medicaid, State Children's Health Insurance Program (SCHIP), and other public programs. For example, Rhode Island offers subsidies and wraparound benefits to those eligible for Medicaid and other state health programs. For those individuals who earn 150% of the federal poverty level or less, the state pays the employee's share of the employer-sponsored premium.

▸ Reinsurance. There has also been a lot of interest in reinsurance through indirect subsidies to employers and workers, Ms. Silow-Carroll said. New York pays 90% of claims between $5,000 and $75,000 for eligible individuals.

▸ State-negotiated health plans. States are also using their purchasing power with or without additional subsidies to provide more affordable health insurance options.

▸ Employer mandates. State policymakers can also try to increase employer-sponsored coverage with mandates that require employers to cover workers or pay a fee to the state to arrange coverage. Such a proposal was recently defeated in California.

Such "pay-or-play" proposals "reemerge every few years in the states," she said. "If a state is very serious about boosting [employer sponsored insurance] in a big way, a pay-or-play type approach really should be on the table as one of the options considered." All of these strategies can stand alone but should comprise a comprehensive approach that deals with cost containment, cost issues, and quality issues, and aspects of different uninsured populations.

Strategies that build on employer-sponsored insurance have advantages for states, Ms. Silow-Carroll said, because they offer a way to expand access to coverage without the state bearing the full cost.

But a key limitation, she said, is that under voluntary strategies there has historically been fairly low employer participation—especially among employers who have never offered coverage in the past.

Physicians at the Department of Veterans Affairs have been using an electronic medical record for about 20 years, so officials there are getting ready to take the next step—online patient access to their medical records.

Next May, the VA plans to provide patients with online access to their medical information through an existing patient portal called My HealtheVet—www.myhealth.va.gov

Currently, the project is in a pilot phase at nine VA medical centers around the country. As part of the pilot, patients are able to log in and see features of their medical record including hospital admissions, allergies, prescriptions, a problem list, progress notes, discharge summaries, vital signs, lab reports, radiology reports, and ECG reports.

"It really represents a fundamental advancement," said Dr. Robert Kolodner chief health informatics officer at the Veterans Health Administration.

VA officials are now working on the details to allow nationwide patient access to medical records. Though a small number of institutions and physicians offer some type of patient portal access, it's still not the norm, Dr. Kolodner said.

But this may be about to change, according to Dr. Steven E. Waldren assistant director of the Center for Health Information Technology at the American Academy of Family Physicians.

More widespread adoption of patient portals and personal health records may be driven by the emergence of health savings accounts, which put more decision making in the hands of patients. In addition, the development of the Continuity of Care Record—a standard that allows personal health summary information in an electronic file to be transferred in multiple formats—is likely to aid the development of these products, Dr. Waldren said.

When the VA project is expanded nationally, there will be some small changes from the pilot. For example, patients won't have access to their progress notes, at least not at first, Dr. Kolodner said. The release of progress notes will happen in a later phase of the rollout, he said. But once they are added, physicians will be able to use the notes as a tool for patient education by adding instructions that patients can later read at home.

Officials are also working out the appropriate time lag between when lab results are available to the physician and when they are released to the patient's online record. The idea is to give the clinician time to notify the patient of a lab result so patients aren't seeing that information for the first time online, he said.

The VA has yet to perform a formal evaluation of the pilot, said My HealtheVet program director Ginger Price. But questionnaires completed by patients participating in the pilot indicate that there is widespread support for expanding the program nationally. And anecdotal reports show that the online record has made it easier for patients to share information with their caregivers, she said.

But online access won't be entirely new for VA patients. For the past 2 years, patients across the VA system have been able to access the online patient portal MyHealtheVet to self-enter both personal and medical information.

The Web site allows veterans to enter personal data such as their contact information, emergency telephone numbers, health care providers, treatment locations, and health insurance.

VA patients can also enter their prescription information and view their prescription and refill history. And they can order refills online through the site.

In addition to prescriptions, they can enter medical information such as over-the-counter drugs and herbal supplements that they take. They can also record their allergies, tests, medical events, and immunizations.

For example, the medical event section allows patients to enter the type of events, the start date and stop date, and the response from their physician.

The site also includes a Health eLog feature where patients can enter their blood pressure, blood sugar level, cholesterol level, body temperature, weight, heart rate, and pain level.

For pain information, patients enter data that includes the time and their pain level on a scale from 0 to 10. And patients can enter additional comments on their pain.

VA patients can also record their military health history on the site.

The idea is that patients will use the site to help them better manage their health, get patient education information, or print out their self-entered information and bring it in to their physician, Dr. Kolodner said. But the self-entered information is entirely controlled by the patient. VA physicians do not have access to the site, and it's up to patients whether they want to share the information with health care providers or caregivers.

On Veterans Day, the portal will be expanded to include food and activity journals. In addition, patients can begin adding pulse oximetry results to the Health eLog.

When the pilot is completed this spring, patients will be able to access their medical record in the same place as their self-entered data. But the patients will retain control of the self-entered information, Dr. Kolodner said. At that point, patients can choose whether to allow their physician electronic access to the self-entered information.

In the future, patients will also have the opportunity to integrate their self-entered information into their VA medical record. "The decision to share the information is the patient's," Dr. Kolodner said.

VA officials are also considering secure online messaging as a possible future improvement to the patient portal. The feedback from physicians has been that they would like to have messaging so that they can communicate online with patients, Ms. Price said.

Physicians at the Department of Veterans Affairs have been using an electronic medical record for about 20 years, so officials there are getting ready to take the next step—online patient access to their medical records.

Next May, the VA plans to provide patients with online access to their medical information through an existing patient portal called My HealtheVet—www.myhealth.va.gov

Currently, the project is in a pilot phase at nine VA medical centers around the country. As part of the pilot, patients are able to log in and see features of their medical record including hospital admissions, allergies, prescriptions, a problem list, progress notes, discharge summaries, vital signs, lab reports, radiology reports, and ECG reports.

"It really represents a fundamental advancement," said Dr. Robert Kolodner chief health informatics officer at the Veterans Health Administration.

VA officials are now working on the details to allow nationwide patient access to medical records. Though a small number of institutions and physicians offer some type of patient portal access, it's still not the norm, Dr. Kolodner said.

But this may be about to change, according to Dr. Steven E. Waldren assistant director of the Center for Health Information Technology at the American Academy of Family Physicians.

More widespread adoption of patient portals and personal health records may be driven by the emergence of health savings accounts, which put more decision making in the hands of patients. In addition, the development of the Continuity of Care Record—a standard that allows personal health summary information in an electronic file to be transferred in multiple formats—is likely to aid the development of these products, Dr. Waldren said.

When the VA project is expanded nationally, there will be some small changes from the pilot. For example, patients won't have access to their progress notes, at least not at first, Dr. Kolodner said. The release of progress notes will happen in a later phase of the rollout, he said. But once they are added, physicians will be able to use the notes as a tool for patient education by adding instructions that patients can later read at home.

Officials are also working out the appropriate time lag between when lab results are available to the physician and when they are released to the patient's online record. The idea is to give the clinician time to notify the patient of a lab result so patients aren't seeing that information for the first time online, he said.

The VA has yet to perform a formal evaluation of the pilot, said My HealtheVet program director Ginger Price. But questionnaires completed by patients participating in the pilot indicate that there is widespread support for expanding the program nationally. And anecdotal reports show that the online record has made it easier for patients to share information with their caregivers, she said.

But online access won't be entirely new for VA patients. For the past 2 years, patients across the VA system have been able to access the online patient portal MyHealtheVet to self-enter both personal and medical information.

The Web site allows veterans to enter personal data such as their contact information, emergency telephone numbers, health care providers, treatment locations, and health insurance.

VA patients can also enter their prescription information and view their prescription and refill history. And they can order refills online through the site.

In addition to prescriptions, they can enter medical information such as over-the-counter drugs and herbal supplements that they take. They can also record their allergies, tests, medical events, and immunizations.

For example, the medical event section allows patients to enter the type of events, the start date and stop date, and the response from their physician.

The site also includes a Health eLog feature where patients can enter their blood pressure, blood sugar level, cholesterol level, body temperature, weight, heart rate, and pain level.

For pain information, patients enter data that includes the time and their pain level on a scale from 0 to 10. And patients can enter additional comments on their pain.

VA patients can also record their military health history on the site.

The idea is that patients will use the site to help them better manage their health, get patient education information, or print out their self-entered information and bring it in to their physician, Dr. Kolodner said. But the self-entered information is entirely controlled by the patient. VA physicians do not have access to the site, and it's up to patients whether they want to share the information with health care providers or caregivers.

On Veterans Day, the portal will be expanded to include food and activity journals. In addition, patients can begin adding pulse oximetry results to the Health eLog.

When the pilot is completed this spring, patients will be able to access their medical record in the same place as their self-entered data. But the patients will retain control of the self-entered information, Dr. Kolodner said. At that point, patients can choose whether to allow their physician electronic access to the self-entered information.

In the future, patients will also have the opportunity to integrate their self-entered information into their VA medical record. "The decision to share the information is the patient's," Dr. Kolodner said.

VA officials are also considering secure online messaging as a possible future improvement to the patient portal. The feedback from physicians has been that they would like to have messaging so that they can communicate online with patients, Ms. Price said.

Physicians at the Department of Veterans Affairs have been using an electronic medical record for about 20 years, so officials there are getting ready to take the next step—online patient access to their medical records.

Next May, the VA plans to provide patients with online access to their medical information through an existing patient portal called My HealtheVet—www.myhealth.va.gov

Currently, the project is in a pilot phase at nine VA medical centers around the country. As part of the pilot, patients are able to log in and see features of their medical record including hospital admissions, allergies, prescriptions, a problem list, progress notes, discharge summaries, vital signs, lab reports, radiology reports, and ECG reports.

"It really represents a fundamental advancement," said Dr. Robert Kolodner chief health informatics officer at the Veterans Health Administration.

VA officials are now working on the details to allow nationwide patient access to medical records. Though a small number of institutions and physicians offer some type of patient portal access, it's still not the norm, Dr. Kolodner said.

But this may be about to change, according to Dr. Steven E. Waldren assistant director of the Center for Health Information Technology at the American Academy of Family Physicians.

More widespread adoption of patient portals and personal health records may be driven by the emergence of health savings accounts, which put more decision making in the hands of patients. In addition, the development of the Continuity of Care Record—a standard that allows personal health summary information in an electronic file to be transferred in multiple formats—is likely to aid the development of these products, Dr. Waldren said.

When the VA project is expanded nationally, there will be some small changes from the pilot. For example, patients won't have access to their progress notes, at least not at first, Dr. Kolodner said. The release of progress notes will happen in a later phase of the rollout, he said. But once they are added, physicians will be able to use the notes as a tool for patient education by adding instructions that patients can later read at home.

Officials are also working out the appropriate time lag between when lab results are available to the physician and when they are released to the patient's online record. The idea is to give the clinician time to notify the patient of a lab result so patients aren't seeing that information for the first time online, he said.

The VA has yet to perform a formal evaluation of the pilot, said My HealtheVet program director Ginger Price. But questionnaires completed by patients participating in the pilot indicate that there is widespread support for expanding the program nationally. And anecdotal reports show that the online record has made it easier for patients to share information with their caregivers, she said.

But online access won't be entirely new for VA patients. For the past 2 years, patients across the VA system have been able to access the online patient portal MyHealtheVet to self-enter both personal and medical information.

The Web site allows veterans to enter personal data such as their contact information, emergency telephone numbers, health care providers, treatment locations, and health insurance.

VA patients can also enter their prescription information and view their prescription and refill history. And they can order refills online through the site.

In addition to prescriptions, they can enter medical information such as over-the-counter drugs and herbal supplements that they take. They can also record their allergies, tests, medical events, and immunizations.

For example, the medical event section allows patients to enter the type of events, the start date and stop date, and the response from their physician.

The site also includes a Health eLog feature where patients can enter their blood pressure, blood sugar level, cholesterol level, body temperature, weight, heart rate, and pain level.

For pain information, patients enter data that includes the time and their pain level on a scale from 0 to 10. And patients can enter additional comments on their pain.

VA patients can also record their military health history on the site.

The idea is that patients will use the site to help them better manage their health, get patient education information, or print out their self-entered information and bring it in to their physician, Dr. Kolodner said. But the self-entered information is entirely controlled by the patient. VA physicians do not have access to the site, and it's up to patients whether they want to share the information with health care providers or caregivers.

On Veterans Day, the portal will be expanded to include food and activity journals. In addition, patients can begin adding pulse oximetry results to the Health eLog.

When the pilot is completed this spring, patients will be able to access their medical record in the same place as their self-entered data. But the patients will retain control of the self-entered information, Dr. Kolodner said. At that point, patients can choose whether to allow their physician electronic access to the self-entered information.

In the future, patients will also have the opportunity to integrate their self-entered information into their VA medical record. "The decision to share the information is the patient's," Dr. Kolodner said.

VA officials are also considering secure online messaging as a possible future improvement to the patient portal. The feedback from physicians has been that they would like to have messaging so that they can communicate online with patients, Ms. Price said.

Officials at the Food and Drug Administration are planning to reorganize its Center for Drug Evaluation and Research in an effort to improve the agency's approach to drug safety and to help improve drug development.

The FDA plans to appoint a new associate director at the Center for Drug Evaluation and Research (CDER) to focus on broad drug safety, policy, and communication issues.

Agency officials also plan to consolidate some drug safety-related activities and have that staff report to the new associate director. This would include MedWatch reporting staff and Drug Safety Oversight Board staff.

The reorganization plans also call for elevating the status of the current Office of Drug Safety, which is primarily responsible for epidemiology and surveillance activities, and its staff will report to the CDER director. The name of the office will also be changed.

"Over the past year, the Center has been the focus of intense internal and external scrutiny regarding drug safety," Dr. Steven K. Galson, CDER director, said in a memo to the center staff. "The current organizational structure perpetuates the misperception that ensuring drug safety is solely the responsibility of the current Office of Drug Safety."

While the Office of Drug Safety is a small unit, about half of CDER's resources are dedicated to drug safety activities, said Deborah Henderson, R.N., director of the Office of Executive Programs at CDER.

But the proposal includes no plans to make the Office of Drug Safety independent from CDER, as some in Congress have proposed. When reviewing drugs, FDA staff members need to balance the effectiveness of the drug against the risks, Ms. Henderson said, so pulling the safety activities out of the center wouldn't be in the best interests of public health.

FDA officials plan to implement the changes over the next 6 months.

The changes will also help to improve regulatory and drug development science through the agency's Critical Path Initiative—a top FDA priority that calls for partnering with industry and academia to improve the drug development process.

Through the Critical Path Initiative, FDA hopes to help industry find better biomarkers and improve clinical trial designs, Ms. Henderson said, which would ultimately lead to better, more targeted drugs.

While a number of CDER staff have been working on the Critical Path Initiative, there has not been a central office within CDER. Under the proposed reorganization, the FDA will create a new office that will report to the CDER director and provide a hub for Critical Path activities.

The FDA also plans to make other changes, including establishing an Office of Counterterrorism and Emergency Operations, which will report to the Office of the Center Director; and realigning the Division of Scientific Investigations from the Office of Medical Policy into the Office of Compliance.

"A reorganization is not designed to achieve instant solutions to the challenges CDER faces, although I believe it will address many of the criticisms and suggestions which have been offered on how to approach our work, including drug safety," Dr. Galson said in his memo to CDER staff.

But real improvements in drug safety need to happen outside the FDA, said Curt D. Furberg, Ph.D., professor in the department of public health sciences at Wake Forest University in Winston-Salem, N.C.

Congress needs to act to give the FDA greater authority to change labels, withdraw drugs, and levy penalties against drug makers who don't live up to their postmarket promises, he said. "FDA can't do that on its own," Dr. Furberg said. "Congress is failing."

The streamlining being proposed by the FDA is a good idea, he said, but it won't address the larger problem. "The issue of safety is much bigger," he said.

Officials at the Food and Drug Administration are planning to reorganize its Center for Drug Evaluation and Research in an effort to improve the agency's approach to drug safety and to help improve drug development.

The FDA plans to appoint a new associate director at the Center for Drug Evaluation and Research (CDER) to focus on broad drug safety, policy, and communication issues.

Agency officials also plan to consolidate some drug safety-related activities and have that staff report to the new associate director. This would include MedWatch reporting staff and Drug Safety Oversight Board staff.

The reorganization plans also call for elevating the status of the current Office of Drug Safety, which is primarily responsible for epidemiology and surveillance activities, and its staff will report to the CDER director. The name of the office will also be changed.

"Over the past year, the Center has been the focus of intense internal and external scrutiny regarding drug safety," Dr. Steven K. Galson, CDER director, said in a memo to the center staff. "The current organizational structure perpetuates the misperception that ensuring drug safety is solely the responsibility of the current Office of Drug Safety."

While the Office of Drug Safety is a small unit, about half of CDER's resources are dedicated to drug safety activities, said Deborah Henderson, R.N., director of the Office of Executive Programs at CDER.

But the proposal includes no plans to make the Office of Drug Safety independent from CDER, as some in Congress have proposed. When reviewing drugs, FDA staff members need to balance the effectiveness of the drug against the risks, Ms. Henderson said, so pulling the safety activities out of the center wouldn't be in the best interests of public health.

FDA officials plan to implement the changes over the next 6 months.

The changes will also help to improve regulatory and drug development science through the agency's Critical Path Initiative—a top FDA priority that calls for partnering with industry and academia to improve the drug development process.

Through the Critical Path Initiative, FDA hopes to help industry find better biomarkers and improve clinical trial designs, Ms. Henderson said, which would ultimately lead to better, more targeted drugs.

While a number of CDER staff have been working on the Critical Path Initiative, there has not been a central office within CDER. Under the proposed reorganization, the FDA will create a new office that will report to the CDER director and provide a hub for Critical Path activities.

The FDA also plans to make other changes, including establishing an Office of Counterterrorism and Emergency Operations, which will report to the Office of the Center Director; and realigning the Division of Scientific Investigations from the Office of Medical Policy into the Office of Compliance.

"A reorganization is not designed to achieve instant solutions to the challenges CDER faces, although I believe it will address many of the criticisms and suggestions which have been offered on how to approach our work, including drug safety," Dr. Galson said in his memo to CDER staff.

But real improvements in drug safety need to happen outside the FDA, said Curt D. Furberg, Ph.D., professor in the department of public health sciences at Wake Forest University in Winston-Salem, N.C.

Congress needs to act to give the FDA greater authority to change labels, withdraw drugs, and levy penalties against drug makers who don't live up to their postmarket promises, he said. "FDA can't do that on its own," Dr. Furberg said. "Congress is failing."

The streamlining being proposed by the FDA is a good idea, he said, but it won't address the larger problem. "The issue of safety is much bigger," he said.

Officials at the Food and Drug Administration are planning to reorganize its Center for Drug Evaluation and Research in an effort to improve the agency's approach to drug safety and to help improve drug development.

The FDA plans to appoint a new associate director at the Center for Drug Evaluation and Research (CDER) to focus on broad drug safety, policy, and communication issues.

Agency officials also plan to consolidate some drug safety-related activities and have that staff report to the new associate director. This would include MedWatch reporting staff and Drug Safety Oversight Board staff.

The reorganization plans also call for elevating the status of the current Office of Drug Safety, which is primarily responsible for epidemiology and surveillance activities, and its staff will report to the CDER director. The name of the office will also be changed.

"Over the past year, the Center has been the focus of intense internal and external scrutiny regarding drug safety," Dr. Steven K. Galson, CDER director, said in a memo to the center staff. "The current organizational structure perpetuates the misperception that ensuring drug safety is solely the responsibility of the current Office of Drug Safety."

While the Office of Drug Safety is a small unit, about half of CDER's resources are dedicated to drug safety activities, said Deborah Henderson, R.N., director of the Office of Executive Programs at CDER.

But the proposal includes no plans to make the Office of Drug Safety independent from CDER, as some in Congress have proposed. When reviewing drugs, FDA staff members need to balance the effectiveness of the drug against the risks, Ms. Henderson said, so pulling the safety activities out of the center wouldn't be in the best interests of public health.

FDA officials plan to implement the changes over the next 6 months.

The changes will also help to improve regulatory and drug development science through the agency's Critical Path Initiative—a top FDA priority that calls for partnering with industry and academia to improve the drug development process.

Through the Critical Path Initiative, FDA hopes to help industry find better biomarkers and improve clinical trial designs, Ms. Henderson said, which would ultimately lead to better, more targeted drugs.

While a number of CDER staff have been working on the Critical Path Initiative, there has not been a central office within CDER. Under the proposed reorganization, the FDA will create a new office that will report to the CDER director and provide a hub for Critical Path activities.

The FDA also plans to make other changes, including establishing an Office of Counterterrorism and Emergency Operations, which will report to the Office of the Center Director; and realigning the Division of Scientific Investigations from the Office of Medical Policy into the Office of Compliance.

"A reorganization is not designed to achieve instant solutions to the challenges CDER faces, although I believe it will address many of the criticisms and suggestions which have been offered on how to approach our work, including drug safety," Dr. Galson said in his memo to CDER staff.

But real improvements in drug safety need to happen outside the FDA, said Curt D. Furberg, Ph.D., professor in the department of public health sciences at Wake Forest University in Winston-Salem, N.C.

Congress needs to act to give the FDA greater authority to change labels, withdraw drugs, and levy penalties against drug makers who don't live up to their postmarket promises, he said. "FDA can't do that on its own," Dr. Furberg said. "Congress is failing."

The streamlining being proposed by the FDA is a good idea, he said, but it won't address the larger problem. "The issue of safety is much bigger," he said.

2006 Outlook

Physician payment under Medicare, medical liability reform, access to isotretinoin, and funding for skin disease research will once again top the agenda for the American Academy of Dermatology Association (AADA), the lobbying arm of the American Academy of Dermatology.

iPLEDGE

Starting this March, dermatologists and other prescribers will need to be registered and activated under the iPLEDGE program in order to prescribe isotretinoin. The new mandatory registry program has come under fire from a number of dermatologists who say it is burdensome and will unnecessarily restrict access to the drug. Officials at AADA are continuing to work with the FDA and the iPLEDGE program to make improvements. For example, AADA wants to see written material made available online, more patient kits available to physicians, and less of a lag time between when physicians register and when they can be activated under the program. They are also pushing to make isotretinoin available to the indigent under the iPLEDGE program.

Medical Liability Reform

AADA will also continue to press members of Congress for meaningful medical liability reform, specifically reform that is modeled after California's Medical Injury Compensation Reform Act of 1975 (MICRA). But officials at AADA said that are flexible on the amount of the cap. The House has repeatedly passed legislation capping noneconomic damages at $250,000. But the issue has continued to remain stalled in the Senate.

Reimbursement

Reimbursement for physicians under Medicare is another top priority, according to the AADA. At press time, physicians were facing a 4.4% payment cut under Medicare, although last-minute congressional negotiations were underway for a possible 1% increase. Temporary fixes aside, physicians need a permanent change to the way their payments are calculated, said Dr. Margaret Parsons, AADA's chair of the council on government affairs and health policy and practice. Congress needs to change the way it calculates the Sustainable Growth Rate formula to better reflect the actual cost of providing medical care, she said, adding that a cut in Medicare payments has a much broader impact since the fee schedule used Medicare influences private insurance reimbursement rates. "A lot of us are very concerned about how hard it will hit us across the board," Dr. Parsons said. Dr. Parsons said a cut could limit access by patients as dermatologists choose to limit or drop Medicare patients from their practice. Even if the cuts don't result in a mass exodus from Medicare, fewer students may choose medicine as a career, said Dr. Brett Coldiron, of the University of Cincinnati. And existing dermatologists may convert their practices to concierge practices as a way to escape declining payments from Medicare and private insurers, he said.

Research Funding

Last April, the AADA and the Society for Investigative Dermatology released a report that estimated the burden of skin disease to be about $37 billion. This year, the AADA will continue to seek increased funding for the National Institutes of Health in an effort to boost skin disease research efforts.

Botox Guilty Pleas

Several of the major players in a scheme to distribute counterfeit Botox for use in humans pleaded guilty in federal court last November. The defendants—who include two physicians, two naturopaths, and four companies—are alleged to have purchased more than 3,000 vials of botulinum toxin type A and other ingredients in a formulation design to imitate Allergan's Botox product and sold them to health care providers. Dr. Bach McComb pleaded guilty in November to one count of felony misbranding in violation of the federal Food, Drug, and Cosmetic Act. Later that month, naturopaths Dr. Chad Livdahl and Dr. Zarah Karim pleaded guilt to one count of conspiracy to commit wire fraud, mail fraud, and misbranding, and one count of mail fraud. Dr. Robert Baker also pleaded guilty to one count of mail fraud. In addition, Toxin Research International Inc., Powderz Inc., Z-Spa Inc., and The Cosmetic Pharmacy Inc. all entered guilty pleas to one count of conspiracy. Sentencing for all parties is schedule to take place on Jan. 26, according to the U.S. attorney's office in the Southern District of Florida.

More on Drug-Only Treatment

The number of patients entering treatment for both alcohol and drug abuse problems has declined, but the number of patients getting substance abuse treatment alone has increased, according to data from the Substance Abuse and Mental Health Services Administration. The National Survey of Substance Abuse Treatment Services: 2004 found that of the 1.07 million people enrolled in substance abuse treatment on March 31, 2004, 46% were receiving both drug and alcohol abuse treatment, down from 49% in 1998. Another 34% were in treatment for drug abuse alone, up from 27% in 1998, while 20% were in treatment only for alcohol abuse, down from 24% in 1998. "These data will assist SAMHSA and state and local governments assess the nature and extent of service provided in state-supported and other treatment facilities, and forecast treatment resource requirements," said SAMHSA Administrator Charles Curie.

2006 Outlook

Physician payment under Medicare, medical liability reform, access to isotretinoin, and funding for skin disease research will once again top the agenda for the American Academy of Dermatology Association (AADA), the lobbying arm of the American Academy of Dermatology.

iPLEDGE

Starting this March, dermatologists and other prescribers will need to be registered and activated under the iPLEDGE program in order to prescribe isotretinoin. The new mandatory registry program has come under fire from a number of dermatologists who say it is burdensome and will unnecessarily restrict access to the drug. Officials at AADA are continuing to work with the FDA and the iPLEDGE program to make improvements. For example, AADA wants to see written material made available online, more patient kits available to physicians, and less of a lag time between when physicians register and when they can be activated under the program. They are also pushing to make isotretinoin available to the indigent under the iPLEDGE program.

Medical Liability Reform

AADA will also continue to press members of Congress for meaningful medical liability reform, specifically reform that is modeled after California's Medical Injury Compensation Reform Act of 1975 (MICRA). But officials at AADA said that are flexible on the amount of the cap. The House has repeatedly passed legislation capping noneconomic damages at $250,000. But the issue has continued to remain stalled in the Senate.

Reimbursement

Reimbursement for physicians under Medicare is another top priority, according to the AADA. At press time, physicians were facing a 4.4% payment cut under Medicare, although last-minute congressional negotiations were underway for a possible 1% increase. Temporary fixes aside, physicians need a permanent change to the way their payments are calculated, said Dr. Margaret Parsons, AADA's chair of the council on government affairs and health policy and practice. Congress needs to change the way it calculates the Sustainable Growth Rate formula to better reflect the actual cost of providing medical care, she said, adding that a cut in Medicare payments has a much broader impact since the fee schedule used Medicare influences private insurance reimbursement rates. "A lot of us are very concerned about how hard it will hit us across the board," Dr. Parsons said. Dr. Parsons said a cut could limit access by patients as dermatologists choose to limit or drop Medicare patients from their practice. Even if the cuts don't result in a mass exodus from Medicare, fewer students may choose medicine as a career, said Dr. Brett Coldiron, of the University of Cincinnati. And existing dermatologists may convert their practices to concierge practices as a way to escape declining payments from Medicare and private insurers, he said.

Research Funding

Last April, the AADA and the Society for Investigative Dermatology released a report that estimated the burden of skin disease to be about $37 billion. This year, the AADA will continue to seek increased funding for the National Institutes of Health in an effort to boost skin disease research efforts.

Botox Guilty Pleas

Several of the major players in a scheme to distribute counterfeit Botox for use in humans pleaded guilty in federal court last November. The defendants—who include two physicians, two naturopaths, and four companies—are alleged to have purchased more than 3,000 vials of botulinum toxin type A and other ingredients in a formulation design to imitate Allergan's Botox product and sold them to health care providers. Dr. Bach McComb pleaded guilty in November to one count of felony misbranding in violation of the federal Food, Drug, and Cosmetic Act. Later that month, naturopaths Dr. Chad Livdahl and Dr. Zarah Karim pleaded guilt to one count of conspiracy to commit wire fraud, mail fraud, and misbranding, and one count of mail fraud. Dr. Robert Baker also pleaded guilty to one count of mail fraud. In addition, Toxin Research International Inc., Powderz Inc., Z-Spa Inc., and The Cosmetic Pharmacy Inc. all entered guilty pleas to one count of conspiracy. Sentencing for all parties is schedule to take place on Jan. 26, according to the U.S. attorney's office in the Southern District of Florida.

More on Drug-Only Treatment

The number of patients entering treatment for both alcohol and drug abuse problems has declined, but the number of patients getting substance abuse treatment alone has increased, according to data from the Substance Abuse and Mental Health Services Administration. The National Survey of Substance Abuse Treatment Services: 2004 found that of the 1.07 million people enrolled in substance abuse treatment on March 31, 2004, 46% were receiving both drug and alcohol abuse treatment, down from 49% in 1998. Another 34% were in treatment for drug abuse alone, up from 27% in 1998, while 20% were in treatment only for alcohol abuse, down from 24% in 1998. "These data will assist SAMHSA and state and local governments assess the nature and extent of service provided in state-supported and other treatment facilities, and forecast treatment resource requirements," said SAMHSA Administrator Charles Curie.

2006 Outlook

Physician payment under Medicare, medical liability reform, access to isotretinoin, and funding for skin disease research will once again top the agenda for the American Academy of Dermatology Association (AADA), the lobbying arm of the American Academy of Dermatology.

iPLEDGE

Starting this March, dermatologists and other prescribers will need to be registered and activated under the iPLEDGE program in order to prescribe isotretinoin. The new mandatory registry program has come under fire from a number of dermatologists who say it is burdensome and will unnecessarily restrict access to the drug. Officials at AADA are continuing to work with the FDA and the iPLEDGE program to make improvements. For example, AADA wants to see written material made available online, more patient kits available to physicians, and less of a lag time between when physicians register and when they can be activated under the program. They are also pushing to make isotretinoin available to the indigent under the iPLEDGE program.

Medical Liability Reform

AADA will also continue to press members of Congress for meaningful medical liability reform, specifically reform that is modeled after California's Medical Injury Compensation Reform Act of 1975 (MICRA). But officials at AADA said that are flexible on the amount of the cap. The House has repeatedly passed legislation capping noneconomic damages at $250,000. But the issue has continued to remain stalled in the Senate.

Reimbursement

Reimbursement for physicians under Medicare is another top priority, according to the AADA. At press time, physicians were facing a 4.4% payment cut under Medicare, although last-minute congressional negotiations were underway for a possible 1% increase. Temporary fixes aside, physicians need a permanent change to the way their payments are calculated, said Dr. Margaret Parsons, AADA's chair of the council on government affairs and health policy and practice. Congress needs to change the way it calculates the Sustainable Growth Rate formula to better reflect the actual cost of providing medical care, she said, adding that a cut in Medicare payments has a much broader impact since the fee schedule used Medicare influences private insurance reimbursement rates. "A lot of us are very concerned about how hard it will hit us across the board," Dr. Parsons said. Dr. Parsons said a cut could limit access by patients as dermatologists choose to limit or drop Medicare patients from their practice. Even if the cuts don't result in a mass exodus from Medicare, fewer students may choose medicine as a career, said Dr. Brett Coldiron, of the University of Cincinnati. And existing dermatologists may convert their practices to concierge practices as a way to escape declining payments from Medicare and private insurers, he said.

Research Funding

Last April, the AADA and the Society for Investigative Dermatology released a report that estimated the burden of skin disease to be about $37 billion. This year, the AADA will continue to seek increased funding for the National Institutes of Health in an effort to boost skin disease research efforts.

Botox Guilty Pleas

Several of the major players in a scheme to distribute counterfeit Botox for use in humans pleaded guilty in federal court last November. The defendants—who include two physicians, two naturopaths, and four companies—are alleged to have purchased more than 3,000 vials of botulinum toxin type A and other ingredients in a formulation design to imitate Allergan's Botox product and sold them to health care providers. Dr. Bach McComb pleaded guilty in November to one count of felony misbranding in violation of the federal Food, Drug, and Cosmetic Act. Later that month, naturopaths Dr. Chad Livdahl and Dr. Zarah Karim pleaded guilt to one count of conspiracy to commit wire fraud, mail fraud, and misbranding, and one count of mail fraud. Dr. Robert Baker also pleaded guilty to one count of mail fraud. In addition, Toxin Research International Inc., Powderz Inc., Z-Spa Inc., and The Cosmetic Pharmacy Inc. all entered guilty pleas to one count of conspiracy. Sentencing for all parties is schedule to take place on Jan. 26, according to the U.S. attorney's office in the Southern District of Florida.

More on Drug-Only Treatment

The number of patients entering treatment for both alcohol and drug abuse problems has declined, but the number of patients getting substance abuse treatment alone has increased, according to data from the Substance Abuse and Mental Health Services Administration. The National Survey of Substance Abuse Treatment Services: 2004 found that of the 1.07 million people enrolled in substance abuse treatment on March 31, 2004, 46% were receiving both drug and alcohol abuse treatment, down from 49% in 1998. Another 34% were in treatment for drug abuse alone, up from 27% in 1998, while 20% were in treatment only for alcohol abuse, down from 24% in 1998. "These data will assist SAMHSA and state and local governments assess the nature and extent of service provided in state-supported and other treatment facilities, and forecast treatment resource requirements," said SAMHSA Administrator Charles Curie.

New FDA Women's Health Director

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

Alternative Hormone Therapies

The FDA recently sent warning letters to 16 dietary supplement and hormone cream manufacturers for making unproven claims about their products. The companies were marketing their products as “alternative hormone therapy” for treating or preventing serious diseases including cancer, heart disease, and osteoporosis. In conjunction with the FDA's effort, the Federal Trade Commission is issuing letters to 34 Web sites that are making similar claims about “alternative hormone therapy” products. “FDA takes seriously its responsibility to protect consumers from products promoted with unproven claims,” Margaret O'K. Glavin, associate commissioner for regulatory affairs, said in a statement. “It's particularly troublesome when these claims provide false hope to patients with serious or life-threatening conditions.”

Trends in Prenatal Care

Nearly 84% of mothers began prenatal care in the first trimester of pregnancy in 2004, according to figures from the National Center for Health Statistics. That figure did not rise between 2003 and 2004 after more than a decade of increases in first-trimester prenatal care. Also in 2004, the percentage of women who did not begin prenatal care until the last trimester, or who had no care, increased from 3.56% in 2003 to 3.59% in 2004. The data are based on a 41-state reporting area. Preliminary U.S. birth data from the National Center for Health Statistics also shows that the percentage of infants delivered at less than 37 weeks' gestation rose to 12.5% in 2004 from 11.6% in 2000 and 10.6% in 1990.

Misusing Research Findings

In the debate over reproductive health issues, policymakers need to beware of faulty science and advocates who misuse research findings, according to an article in the November issue of the Guttmacher Report on Public Policy. Policymakers should put stock in the scientific process—peer-review and published research methodology—not just in individuals or organizations with a similar ideology. For example, scientific reviews in 2003 and 2004 show there is no evidence linking abortion and breast cancer but many abortion opponents continue to rely on discredited studies to support legislation that requires that women be told of a link, according to the article. “Far too often in the uproar over sexual and reproductive health issues, the protections built into the scientific process are simply ignored,” wrote Adam Sonfield, the article author and an associate at the Guttmacher Institute.

Switch to Electronic Records

Physicians too nervous to convert their offices to electronic health records can start with “baby steps” to make it less intimidating, Daniel Sands, M.D., said at a health care congress sponsored by the Wall Street Journal and CNBC. Physicians are often reluctant to leap into an EHR system because of its complexity and the expense involved, said Dr. Sands of Harvard University, Boston. One idea is to use electronic communications with patients and staff instead of using handwritten phone messages. “A simple step like that is a good way to get people engaged with technology.”

New FDA Women's Health Director

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

Alternative Hormone Therapies

The FDA recently sent warning letters to 16 dietary supplement and hormone cream manufacturers for making unproven claims about their products. The companies were marketing their products as “alternative hormone therapy” for treating or preventing serious diseases including cancer, heart disease, and osteoporosis. In conjunction with the FDA's effort, the Federal Trade Commission is issuing letters to 34 Web sites that are making similar claims about “alternative hormone therapy” products. “FDA takes seriously its responsibility to protect consumers from products promoted with unproven claims,” Margaret O'K. Glavin, associate commissioner for regulatory affairs, said in a statement. “It's particularly troublesome when these claims provide false hope to patients with serious or life-threatening conditions.”

Trends in Prenatal Care

Nearly 84% of mothers began prenatal care in the first trimester of pregnancy in 2004, according to figures from the National Center for Health Statistics. That figure did not rise between 2003 and 2004 after more than a decade of increases in first-trimester prenatal care. Also in 2004, the percentage of women who did not begin prenatal care until the last trimester, or who had no care, increased from 3.56% in 2003 to 3.59% in 2004. The data are based on a 41-state reporting area. Preliminary U.S. birth data from the National Center for Health Statistics also shows that the percentage of infants delivered at less than 37 weeks' gestation rose to 12.5% in 2004 from 11.6% in 2000 and 10.6% in 1990.

Misusing Research Findings

In the debate over reproductive health issues, policymakers need to beware of faulty science and advocates who misuse research findings, according to an article in the November issue of the Guttmacher Report on Public Policy. Policymakers should put stock in the scientific process—peer-review and published research methodology—not just in individuals or organizations with a similar ideology. For example, scientific reviews in 2003 and 2004 show there is no evidence linking abortion and breast cancer but many abortion opponents continue to rely on discredited studies to support legislation that requires that women be told of a link, according to the article. “Far too often in the uproar over sexual and reproductive health issues, the protections built into the scientific process are simply ignored,” wrote Adam Sonfield, the article author and an associate at the Guttmacher Institute.

Switch to Electronic Records

Physicians too nervous to convert their offices to electronic health records can start with “baby steps” to make it less intimidating, Daniel Sands, M.D., said at a health care congress sponsored by the Wall Street Journal and CNBC. Physicians are often reluctant to leap into an EHR system because of its complexity and the expense involved, said Dr. Sands of Harvard University, Boston. One idea is to use electronic communications with patients and staff instead of using handwritten phone messages. “A simple step like that is a good way to get people engaged with technology.”

New FDA Women's Health Director

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

Alternative Hormone Therapies

The FDA recently sent warning letters to 16 dietary supplement and hormone cream manufacturers for making unproven claims about their products. The companies were marketing their products as “alternative hormone therapy” for treating or preventing serious diseases including cancer, heart disease, and osteoporosis. In conjunction with the FDA's effort, the Federal Trade Commission is issuing letters to 34 Web sites that are making similar claims about “alternative hormone therapy” products. “FDA takes seriously its responsibility to protect consumers from products promoted with unproven claims,” Margaret O'K. Glavin, associate commissioner for regulatory affairs, said in a statement. “It's particularly troublesome when these claims provide false hope to patients with serious or life-threatening conditions.”

Trends in Prenatal Care

Nearly 84% of mothers began prenatal care in the first trimester of pregnancy in 2004, according to figures from the National Center for Health Statistics. That figure did not rise between 2003 and 2004 after more than a decade of increases in first-trimester prenatal care. Also in 2004, the percentage of women who did not begin prenatal care until the last trimester, or who had no care, increased from 3.56% in 2003 to 3.59% in 2004. The data are based on a 41-state reporting area. Preliminary U.S. birth data from the National Center for Health Statistics also shows that the percentage of infants delivered at less than 37 weeks' gestation rose to 12.5% in 2004 from 11.6% in 2000 and 10.6% in 1990.

Misusing Research Findings

In the debate over reproductive health issues, policymakers need to beware of faulty science and advocates who misuse research findings, according to an article in the November issue of the Guttmacher Report on Public Policy. Policymakers should put stock in the scientific process—peer-review and published research methodology—not just in individuals or organizations with a similar ideology. For example, scientific reviews in 2003 and 2004 show there is no evidence linking abortion and breast cancer but many abortion opponents continue to rely on discredited studies to support legislation that requires that women be told of a link, according to the article. “Far too often in the uproar over sexual and reproductive health issues, the protections built into the scientific process are simply ignored,” wrote Adam Sonfield, the article author and an associate at the Guttmacher Institute.

Switch to Electronic Records

Physicians too nervous to convert their offices to electronic health records can start with “baby steps” to make it less intimidating, Daniel Sands, M.D., said at a health care congress sponsored by the Wall Street Journal and CNBC. Physicians are often reluctant to leap into an EHR system because of its complexity and the expense involved, said Dr. Sands of Harvard University, Boston. One idea is to use electronic communications with patients and staff instead of using handwritten phone messages. “A simple step like that is a good way to get people engaged with technology.”

The Food and Drug Administration has formed a Task Force on Pandemic Influenza charged with helping to speed the development and production of vaccines, antivirals, and diagnostics.

This work will provide the basis for developing a comprehensive FDA action plan to combat pandemic influenza including the management of an avian flu outbreak among birds and ensuring the safety of the human food and animal feed supply.

“This is a commissioner's initiative that will bring together a cross-functional, intra-agency team,” acting FDA Commissioner Andrew C. von Eschenbach, M.D., said in a memo to FDA staff members.

“The new task force will be charged with spearheading FDA's participation in the President's National Strategy for Pandemic Influenza and the Department of Health and Human Services' Pandemic Influenza Plan,” he said.

The task force will incorporate the FDA Pandemic Influenza Rapid Response Team, a group formed in October to ensure an adequate supply of antivirals in case of a flu pandemic.

The task force, which held its first meeting last month, will be cochaired by Boris D.Lushniak, M.D., FDA's assistant commissioner for counterterrorism policy, and Jeffrey Shuren, M.D., FDA's assistant commissioner for policy. Other members are being drawn from the five FDA centers, the National Center for Toxicological Research, and various other FDA offices.

The Food and Drug Administration has formed a Task Force on Pandemic Influenza charged with helping to speed the development and production of vaccines, antivirals, and diagnostics.

This work will provide the basis for developing a comprehensive FDA action plan to combat pandemic influenza including the management of an avian flu outbreak among birds and ensuring the safety of the human food and animal feed supply.

“This is a commissioner's initiative that will bring together a cross-functional, intra-agency team,” acting FDA Commissioner Andrew C. von Eschenbach, M.D., said in a memo to FDA staff members.

“The new task force will be charged with spearheading FDA's participation in the President's National Strategy for Pandemic Influenza and the Department of Health and Human Services' Pandemic Influenza Plan,” he said.

The task force will incorporate the FDA Pandemic Influenza Rapid Response Team, a group formed in October to ensure an adequate supply of antivirals in case of a flu pandemic.

The task force, which held its first meeting last month, will be cochaired by Boris D.Lushniak, M.D., FDA's assistant commissioner for counterterrorism policy, and Jeffrey Shuren, M.D., FDA's assistant commissioner for policy. Other members are being drawn from the five FDA centers, the National Center for Toxicological Research, and various other FDA offices.

The Food and Drug Administration has formed a Task Force on Pandemic Influenza charged with helping to speed the development and production of vaccines, antivirals, and diagnostics.

This work will provide the basis for developing a comprehensive FDA action plan to combat pandemic influenza including the management of an avian flu outbreak among birds and ensuring the safety of the human food and animal feed supply.

“This is a commissioner's initiative that will bring together a cross-functional, intra-agency team,” acting FDA Commissioner Andrew C. von Eschenbach, M.D., said in a memo to FDA staff members.

“The new task force will be charged with spearheading FDA's participation in the President's National Strategy for Pandemic Influenza and the Department of Health and Human Services' Pandemic Influenza Plan,” he said.

The task force will incorporate the FDA Pandemic Influenza Rapid Response Team, a group formed in October to ensure an adequate supply of antivirals in case of a flu pandemic.

The task force, which held its first meeting last month, will be cochaired by Boris D.Lushniak, M.D., FDA's assistant commissioner for counterterrorism policy, and Jeffrey Shuren, M.D., FDA's assistant commissioner for policy. Other members are being drawn from the five FDA centers, the National Center for Toxicological Research, and various other FDA offices.

Nearly 25% of trauma surgeons report that they have been denied payment by an insurer in the last 6 months because a patient was under the influence of alcohol or drugs when his or her traumatic injury occurred, according to Larry M. Gentilello, M.D., of the University of Texas Southwestern Medical Center at Dallas, and his colleagues.

The failure to pay on the part of insurance companies may be affecting alcohol screening and treatment practices in hospitals, the researchers said.

The researchers analyzed responses from 98 general trauma surgeons around the country and found that less than half reported routinely measuring blood alcohol concentration among their patients even though 91% of respondents said it was important to do so. The findings are slated to be published in the Journal of Trauma Injury, Infection, and Critical Care.

The barrier for many physicians is the Uniform Accident and Sickness Policy Provision Law (UPPL), a national model law that allows insurance carriers to deny coverage for injuries sustained while under the influence of alcohol or drugs. The model law was developed in 1947 by the National Association of Insurance Commissioners, and as of April 2004, it had been adopted by 38 states and the District of Columbia.

But in 2001, the commissioners amended the model law to prohibit insurers from applying the substance abuse exclusion to medical expenses. As of April 2004, six states adopted the new model law.

In general, trauma surgeons were not familiar with the UPPL. For example, only 13% reported that they practiced in a state with a UPPL in effect, but 70% of the respondents were from states with such a statute in place. However, the survey results also indicate that the general fear of insurance denials may be causing some physicians to circumvent the laws by not documenting the use of alcohol or drugs.

Dr. Gentilello and his colleagues found that only 37% of surgeons report that half or more of their patients with alcohol problems receive counseling. And 82% of the respondents said that if there were no insurance barriers, they would be willing to help their trauma center establish a brief alcohol intervention program if provided with other clinical tools.

Either physicians are not screening and documenting intoxication or insurers are not applying the law in every case, the researchers wrote, because with 35%–50% of trauma patients estimated to be under the influence of alcohol or drugs, trauma centers could not absorb the resulting cost of uncompensated care.

The researchers conducted a separate anonymous e-mail survey of state legislative leaders. Researchers analyzed responses from 56 legislators. Most were not sure whether the UPPL existed in their state but generally favored prohibiting alcohol-related exclusions in medical expense policies.

Studies specifically looking at alcohol screening and intervention among injured patients show that brief interventions can reduce future alcohol use and hospital readmissions, Dr. Gentilello, professor of surgery and chairman of the division of burns, trauma, and critical care at the University of Texas Southwestern Medical School, said in an interview.

After being treated for a serious injury resulting from substance abuse, most patients are in an ideal state of mind for this counseling. “They've had a real teachable moment,” Dr. Gentilello said. “Trauma presents a crisis we can capitalize on.”

But the existence of the UPPL means that physicians who practice good medicine by screening and treating alcohol and drug abuse are denied payment, said Eric Goplerud, Ph.D., professor at the George Washington University in Washington and director of Ensuring Solutions to Alcohol Problems, a group that provides research information on effective alcohol treatment as a part of the university's medical center.

Nearly 25% of trauma surgeons report that they have been denied payment by an insurer in the last 6 months because a patient was under the influence of alcohol or drugs when his or her traumatic injury occurred, according to Larry M. Gentilello, M.D., of the University of Texas Southwestern Medical Center at Dallas, and his colleagues.

The failure to pay on the part of insurance companies may be affecting alcohol screening and treatment practices in hospitals, the researchers said.

The researchers analyzed responses from 98 general trauma surgeons around the country and found that less than half reported routinely measuring blood alcohol concentration among their patients even though 91% of respondents said it was important to do so. The findings are slated to be published in the Journal of Trauma Injury, Infection, and Critical Care.

The barrier for many physicians is the Uniform Accident and Sickness Policy Provision Law (UPPL), a national model law that allows insurance carriers to deny coverage for injuries sustained while under the influence of alcohol or drugs. The model law was developed in 1947 by the National Association of Insurance Commissioners, and as of April 2004, it had been adopted by 38 states and the District of Columbia.

But in 2001, the commissioners amended the model law to prohibit insurers from applying the substance abuse exclusion to medical expenses. As of April 2004, six states adopted the new model law.

In general, trauma surgeons were not familiar with the UPPL. For example, only 13% reported that they practiced in a state with a UPPL in effect, but 70% of the respondents were from states with such a statute in place. However, the survey results also indicate that the general fear of insurance denials may be causing some physicians to circumvent the laws by not documenting the use of alcohol or drugs.

Dr. Gentilello and his colleagues found that only 37% of surgeons report that half or more of their patients with alcohol problems receive counseling. And 82% of the respondents said that if there were no insurance barriers, they would be willing to help their trauma center establish a brief alcohol intervention program if provided with other clinical tools.

Either physicians are not screening and documenting intoxication or insurers are not applying the law in every case, the researchers wrote, because with 35%–50% of trauma patients estimated to be under the influence of alcohol or drugs, trauma centers could not absorb the resulting cost of uncompensated care.

The researchers conducted a separate anonymous e-mail survey of state legislative leaders. Researchers analyzed responses from 56 legislators. Most were not sure whether the UPPL existed in their state but generally favored prohibiting alcohol-related exclusions in medical expense policies.

Studies specifically looking at alcohol screening and intervention among injured patients show that brief interventions can reduce future alcohol use and hospital readmissions, Dr. Gentilello, professor of surgery and chairman of the division of burns, trauma, and critical care at the University of Texas Southwestern Medical School, said in an interview.

After being treated for a serious injury resulting from substance abuse, most patients are in an ideal state of mind for this counseling. “They've had a real teachable moment,” Dr. Gentilello said. “Trauma presents a crisis we can capitalize on.”

But the existence of the UPPL means that physicians who practice good medicine by screening and treating alcohol and drug abuse are denied payment, said Eric Goplerud, Ph.D., professor at the George Washington University in Washington and director of Ensuring Solutions to Alcohol Problems, a group that provides research information on effective alcohol treatment as a part of the university's medical center.

Nearly 25% of trauma surgeons report that they have been denied payment by an insurer in the last 6 months because a patient was under the influence of alcohol or drugs when his or her traumatic injury occurred, according to Larry M. Gentilello, M.D., of the University of Texas Southwestern Medical Center at Dallas, and his colleagues.

The failure to pay on the part of insurance companies may be affecting alcohol screening and treatment practices in hospitals, the researchers said.

The researchers analyzed responses from 98 general trauma surgeons around the country and found that less than half reported routinely measuring blood alcohol concentration among their patients even though 91% of respondents said it was important to do so. The findings are slated to be published in the Journal of Trauma Injury, Infection, and Critical Care.

The barrier for many physicians is the Uniform Accident and Sickness Policy Provision Law (UPPL), a national model law that allows insurance carriers to deny coverage for injuries sustained while under the influence of alcohol or drugs. The model law was developed in 1947 by the National Association of Insurance Commissioners, and as of April 2004, it had been adopted by 38 states and the District of Columbia.

But in 2001, the commissioners amended the model law to prohibit insurers from applying the substance abuse exclusion to medical expenses. As of April 2004, six states adopted the new model law.

In general, trauma surgeons were not familiar with the UPPL. For example, only 13% reported that they practiced in a state with a UPPL in effect, but 70% of the respondents were from states with such a statute in place. However, the survey results also indicate that the general fear of insurance denials may be causing some physicians to circumvent the laws by not documenting the use of alcohol or drugs.

Dr. Gentilello and his colleagues found that only 37% of surgeons report that half or more of their patients with alcohol problems receive counseling. And 82% of the respondents said that if there were no insurance barriers, they would be willing to help their trauma center establish a brief alcohol intervention program if provided with other clinical tools.

Either physicians are not screening and documenting intoxication or insurers are not applying the law in every case, the researchers wrote, because with 35%–50% of trauma patients estimated to be under the influence of alcohol or drugs, trauma centers could not absorb the resulting cost of uncompensated care.

The researchers conducted a separate anonymous e-mail survey of state legislative leaders. Researchers analyzed responses from 56 legislators. Most were not sure whether the UPPL existed in their state but generally favored prohibiting alcohol-related exclusions in medical expense policies.

Studies specifically looking at alcohol screening and intervention among injured patients show that brief interventions can reduce future alcohol use and hospital readmissions, Dr. Gentilello, professor of surgery and chairman of the division of burns, trauma, and critical care at the University of Texas Southwestern Medical School, said in an interview.

After being treated for a serious injury resulting from substance abuse, most patients are in an ideal state of mind for this counseling. “They've had a real teachable moment,” Dr. Gentilello said. “Trauma presents a crisis we can capitalize on.”

But the existence of the UPPL means that physicians who practice good medicine by screening and treating alcohol and drug abuse are denied payment, said Eric Goplerud, Ph.D., professor at the George Washington University in Washington and director of Ensuring Solutions to Alcohol Problems, a group that provides research information on effective alcohol treatment as a part of the university's medical center.