Alicia Ault

Soon after President Bush delivered on his promise to veto the bipartisan reauthorization of the State Children's Health Insurance Program (SCHIP) on Oct. 3, professional medical societies and children's advocates said they would join with Democrats in the U.S. House who have vowed to round up the votes needed to override the veto.

“We're going to do a full-court press to get that vote,” Dr. James King, president of the American Academy of Family Physicians, said in an interview.

If the status quo were preserved, as proposed by the White House, at least 1 million children nationwide would lose coverage, said Dr. King, who is in private practice in Selmer, Tenn.

“There should be pressure on everybody who doesn't do the right thing for children,” said Dr. Jay Berkelhamer, president of the American Academy of Pediatrics, in an interview.

Dr. Berkelhamer said he did not understand how the president could veto a bill that had such strong bipartisan agreement. The package was not an expansion, but it did ensure that at a minimum, children currently in the program would continue to receive benefits, he said.

Families USA Executive Director Ron Pollack said that even if the House is not successful in overriding the veto, the SCHIP legislation will eventually be approved, and with most of the package intact. “I think there will be increasing pressure on the White House to offer concessions to get this adopted,” said Mr. Pollack in an interview, noting that every round of votes against SCHIP will prove increasingly embarrassing to Republican lawmakers.

Advocates have some time to make their case—SCHIP, which expired Sept. 30, is able to tap funds appropriated as part of a continuing resolution that was approved by Congress to keep the government running until Nov. 16.

The SCHIP program currently covers an estimated 6 million children; the package that was passed by the House and Senate (H.R. 976) and vetoed by the president would have added $35 billion in funding to the program, increasing the enrollment by as many as 4 million children. The new funding was to come from an increase in the excise tax on tobacco.

The package introduced several new elements, including dental benefits and mental health parity. States would have been given the ability to seek a waiver to extend coverage to low-income pregnant women. And the Department of Health and Human Services was directed to develop of a core set of measures to track quality in the Medicaid and SCHIP programs.

The president signaled his intention to veto for at least a month, saying that the initial package passed by the House would be a step toward government-run health care and that it also would give coverage to higher-income children. Those children might drop private coverage to join SCHIP, said Mr. Bush.

The final package acknowledged that the program might be overreaching and directed the Government Accountability Office to study and share best practices in states that have successfully prevented children from higher-income families from dropping private coverage. That may have been the only point of convergence for the White House and Congress.

President Bush's veto was met with resounding criticism, even from Republican members of Congress.

The Democrats were more vehement. Sen. Edward Kennedy (D-Mass.) said, “Today we learned that the same president who is willing to throw away half a trillion dollars in Iraq is unwilling to spend a small fraction of that amount to bring health care to American children.”

In a statement, Dr. Edward L. Langston, board chair of the American Medical Association, called the veto disappointing. “The number of uninsured kids has increased by nearly 1 million over the past year, and action must be taken to reverse this trend.”

In the meantime, a handful of states are challenging a controversial change in SCHIP issued in August that limits their ability to extend coverage to children in families with incomes more than 250% of the federal poverty level. The stated goal of the administrative change, issued by the Centers for Medicare and Medicaid Services, is to ensure that these families are not opting for SCHIP instead of private insurance.

On Oct. 2, New York sued, alleging that the changes were issued without an opportunity for public comment, as is required by law. The suit seeks to block CMS for using the rules when evaluating states' plans to raise income eligibility limits.

CMS did just that in September when it rejected New York's proposal to cover children in families of four with incomes of up to $82,600.

The New York suit was joined by Arizona, California, Illinois, Maryland, New Hampshire, and Washington. New Jersey has filed a separate suit.

Soon after President Bush delivered on his promise to veto the bipartisan reauthorization of the State Children's Health Insurance Program (SCHIP) on Oct. 3, professional medical societies and children's advocates said they would join with Democrats in the U.S. House who have vowed to round up the votes needed to override the veto.

“We're going to do a full-court press to get that vote,” Dr. James King, president of the American Academy of Family Physicians, said in an interview.

If the status quo were preserved, as proposed by the White House, at least 1 million children nationwide would lose coverage, said Dr. King, who is in private practice in Selmer, Tenn.

“There should be pressure on everybody who doesn't do the right thing for children,” said Dr. Jay Berkelhamer, president of the American Academy of Pediatrics, in an interview.

Dr. Berkelhamer said he did not understand how the president could veto a bill that had such strong bipartisan agreement. The package was not an expansion, but it did ensure that at a minimum, children currently in the program would continue to receive benefits, he said.

Families USA Executive Director Ron Pollack said that even if the House is not successful in overriding the veto, the SCHIP legislation will eventually be approved, and with most of the package intact. “I think there will be increasing pressure on the White House to offer concessions to get this adopted,” said Mr. Pollack in an interview, noting that every round of votes against SCHIP will prove increasingly embarrassing to Republican lawmakers.

Advocates have some time to make their case—SCHIP, which expired Sept. 30, is able to tap funds appropriated as part of a continuing resolution that was approved by Congress to keep the government running until Nov. 16.

The SCHIP program currently covers an estimated 6 million children; the package that was passed by the House and Senate (H.R. 976) and vetoed by the president would have added $35 billion in funding to the program, increasing the enrollment by as many as 4 million children. The new funding was to come from an increase in the excise tax on tobacco.

The package introduced several new elements, including dental benefits and mental health parity. States would have been given the ability to seek a waiver to extend coverage to low-income pregnant women. And the Department of Health and Human Services was directed to develop of a core set of measures to track quality in the Medicaid and SCHIP programs.

The president signaled his intention to veto for at least a month, saying that the initial package passed by the House would be a step toward government-run health care and that it also would give coverage to higher-income children. Those children might drop private coverage to join SCHIP, said Mr. Bush.

The final package acknowledged that the program might be overreaching and directed the Government Accountability Office to study and share best practices in states that have successfully prevented children from higher-income families from dropping private coverage. That may have been the only point of convergence for the White House and Congress.

President Bush's veto was met with resounding criticism, even from Republican members of Congress.

The Democrats were more vehement. Sen. Edward Kennedy (D-Mass.) said, “Today we learned that the same president who is willing to throw away half a trillion dollars in Iraq is unwilling to spend a small fraction of that amount to bring health care to American children.”

In a statement, Dr. Edward L. Langston, board chair of the American Medical Association, called the veto disappointing. “The number of uninsured kids has increased by nearly 1 million over the past year, and action must be taken to reverse this trend.”

In the meantime, a handful of states are challenging a controversial change in SCHIP issued in August that limits their ability to extend coverage to children in families with incomes more than 250% of the federal poverty level. The stated goal of the administrative change, issued by the Centers for Medicare and Medicaid Services, is to ensure that these families are not opting for SCHIP instead of private insurance.

On Oct. 2, New York sued, alleging that the changes were issued without an opportunity for public comment, as is required by law. The suit seeks to block CMS for using the rules when evaluating states' plans to raise income eligibility limits.

CMS did just that in September when it rejected New York's proposal to cover children in families of four with incomes of up to $82,600.

The New York suit was joined by Arizona, California, Illinois, Maryland, New Hampshire, and Washington. New Jersey has filed a separate suit.

Soon after President Bush delivered on his promise to veto the bipartisan reauthorization of the State Children's Health Insurance Program (SCHIP) on Oct. 3, professional medical societies and children's advocates said they would join with Democrats in the U.S. House who have vowed to round up the votes needed to override the veto.

“We're going to do a full-court press to get that vote,” Dr. James King, president of the American Academy of Family Physicians, said in an interview.

If the status quo were preserved, as proposed by the White House, at least 1 million children nationwide would lose coverage, said Dr. King, who is in private practice in Selmer, Tenn.

“There should be pressure on everybody who doesn't do the right thing for children,” said Dr. Jay Berkelhamer, president of the American Academy of Pediatrics, in an interview.

Dr. Berkelhamer said he did not understand how the president could veto a bill that had such strong bipartisan agreement. The package was not an expansion, but it did ensure that at a minimum, children currently in the program would continue to receive benefits, he said.

Families USA Executive Director Ron Pollack said that even if the House is not successful in overriding the veto, the SCHIP legislation will eventually be approved, and with most of the package intact. “I think there will be increasing pressure on the White House to offer concessions to get this adopted,” said Mr. Pollack in an interview, noting that every round of votes against SCHIP will prove increasingly embarrassing to Republican lawmakers.

Advocates have some time to make their case—SCHIP, which expired Sept. 30, is able to tap funds appropriated as part of a continuing resolution that was approved by Congress to keep the government running until Nov. 16.

The SCHIP program currently covers an estimated 6 million children; the package that was passed by the House and Senate (H.R. 976) and vetoed by the president would have added $35 billion in funding to the program, increasing the enrollment by as many as 4 million children. The new funding was to come from an increase in the excise tax on tobacco.

The package introduced several new elements, including dental benefits and mental health parity. States would have been given the ability to seek a waiver to extend coverage to low-income pregnant women. And the Department of Health and Human Services was directed to develop of a core set of measures to track quality in the Medicaid and SCHIP programs.

The president signaled his intention to veto for at least a month, saying that the initial package passed by the House would be a step toward government-run health care and that it also would give coverage to higher-income children. Those children might drop private coverage to join SCHIP, said Mr. Bush.

The final package acknowledged that the program might be overreaching and directed the Government Accountability Office to study and share best practices in states that have successfully prevented children from higher-income families from dropping private coverage. That may have been the only point of convergence for the White House and Congress.

President Bush's veto was met with resounding criticism, even from Republican members of Congress.

The Democrats were more vehement. Sen. Edward Kennedy (D-Mass.) said, “Today we learned that the same president who is willing to throw away half a trillion dollars in Iraq is unwilling to spend a small fraction of that amount to bring health care to American children.”

In a statement, Dr. Edward L. Langston, board chair of the American Medical Association, called the veto disappointing. “The number of uninsured kids has increased by nearly 1 million over the past year, and action must be taken to reverse this trend.”

In the meantime, a handful of states are challenging a controversial change in SCHIP issued in August that limits their ability to extend coverage to children in families with incomes more than 250% of the federal poverty level. The stated goal of the administrative change, issued by the Centers for Medicare and Medicaid Services, is to ensure that these families are not opting for SCHIP instead of private insurance.

On Oct. 2, New York sued, alleging that the changes were issued without an opportunity for public comment, as is required by law. The suit seeks to block CMS for using the rules when evaluating states' plans to raise income eligibility limits.

CMS did just that in September when it rejected New York's proposal to cover children in families of four with incomes of up to $82,600.

The New York suit was joined by Arizona, California, Illinois, Maryland, New Hampshire, and Washington. New Jersey has filed a separate suit.

The Food and Drug Administration approved the nasal influenza vaccine FluMist for children aged 2–5 years, which could help push up childhood vaccination rates.

FluMist manufacturer MedImmune Inc. said that it anticipated shipping the vaccine to physicians and health care providers almost immediately.

The Centers for Disease Control and Prevention (CDC) currently recommends that all children aged 6 months to 5 years be vaccinated against influenza. The trivalent FluMist vaccine has previously been approved only for healthy children over age 5 years and for adults aged 18–49 years.

Dr. Sarah Long, chief of infectious diseases at St. Christopher's Hospital for Children in Philadelphia, said that the new FluMist approval is likely to spur higher vaccination rates. But, she added, physicians probably will not widely use the vaccine in young children until the CDC's Advisory Committee on Immunization Practices recommends it for the approved populations. Without an ACIP endorsement, insurers are reluctant to reimburse for a vaccine, Dr. Long, a member of the American Academy of Pediatrics committee on infectious diseases, said in an interview.

That recommendation is likely to come at ACIP's next meeting in late October, as FluMist's likely approval for use in young children had been discussed at its last meeting, Dr. Long said.

The AAP and the CDC agree that children of all ages are vastly undervaccinated. The CDC just issued vaccination statistics on children age 6–23 months. Overall, only 21% of children under the age of 2 years received full vaccination coverage—that is, two doses—in the 2005–2006 flu season, said Dr. Jeanne M. Santoli, deputy director of the Immunization Services Division in the CDC's National Immunization Program, at a press briefing on the upcoming flu season convened by the National Foundation for Infectious Diseases that occurred as the FluMist approval was granted.

FluMist joins two other vaccines currently approved for use in young children. Sanofi Pasteur's Fluzone is indicated for anyone over 6 months of age, and Novartis' Fluvirin for anyone aged 4 years or older. “This approval also offers parents and health professionals a needle-free option for squeamish toddlers, who may be reluctant to get a traditional influenza shot,” said Dr. Jesse L. Goodman, director of the Food and Drug Administration's Center for Biologics Evaluation and Research in a statement.

The approval was based on a pivotal study of 4,000 children aged 2–5 years who received the live attenuated vaccine during the 2004–2005 flu season. According to MedImmune, there was a 54% reduction in influenza in children given FluMist, compared with those who received a traditional injection.

The FluMist vaccine is contraindicated in those with asthma, children under age 2 years, and children under age 5 years who have recurrent wheezing because there is an increased risk of exacerbation of that symptom. It also should not be given to children receiving concomitant aspirin, or therapy containing aspirin, according to MedImmune, which will charge $17.95 per dose this flu season.

The Food and Drug Administration approved the nasal influenza vaccine FluMist for children aged 2–5 years, which could help push up childhood vaccination rates.

FluMist manufacturer MedImmune Inc. said that it anticipated shipping the vaccine to physicians and health care providers almost immediately.

The Centers for Disease Control and Prevention (CDC) currently recommends that all children aged 6 months to 5 years be vaccinated against influenza. The trivalent FluMist vaccine has previously been approved only for healthy children over age 5 years and for adults aged 18–49 years.

Dr. Sarah Long, chief of infectious diseases at St. Christopher's Hospital for Children in Philadelphia, said that the new FluMist approval is likely to spur higher vaccination rates. But, she added, physicians probably will not widely use the vaccine in young children until the CDC's Advisory Committee on Immunization Practices recommends it for the approved populations. Without an ACIP endorsement, insurers are reluctant to reimburse for a vaccine, Dr. Long, a member of the American Academy of Pediatrics committee on infectious diseases, said in an interview.

That recommendation is likely to come at ACIP's next meeting in late October, as FluMist's likely approval for use in young children had been discussed at its last meeting, Dr. Long said.

The AAP and the CDC agree that children of all ages are vastly undervaccinated. The CDC just issued vaccination statistics on children age 6–23 months. Overall, only 21% of children under the age of 2 years received full vaccination coverage—that is, two doses—in the 2005–2006 flu season, said Dr. Jeanne M. Santoli, deputy director of the Immunization Services Division in the CDC's National Immunization Program, at a press briefing on the upcoming flu season convened by the National Foundation for Infectious Diseases that occurred as the FluMist approval was granted.

FluMist joins two other vaccines currently approved for use in young children. Sanofi Pasteur's Fluzone is indicated for anyone over 6 months of age, and Novartis' Fluvirin for anyone aged 4 years or older. “This approval also offers parents and health professionals a needle-free option for squeamish toddlers, who may be reluctant to get a traditional influenza shot,” said Dr. Jesse L. Goodman, director of the Food and Drug Administration's Center for Biologics Evaluation and Research in a statement.

The approval was based on a pivotal study of 4,000 children aged 2–5 years who received the live attenuated vaccine during the 2004–2005 flu season. According to MedImmune, there was a 54% reduction in influenza in children given FluMist, compared with those who received a traditional injection.

The FluMist vaccine is contraindicated in those with asthma, children under age 2 years, and children under age 5 years who have recurrent wheezing because there is an increased risk of exacerbation of that symptom. It also should not be given to children receiving concomitant aspirin, or therapy containing aspirin, according to MedImmune, which will charge $17.95 per dose this flu season.

The Food and Drug Administration approved the nasal influenza vaccine FluMist for children aged 2–5 years, which could help push up childhood vaccination rates.

FluMist manufacturer MedImmune Inc. said that it anticipated shipping the vaccine to physicians and health care providers almost immediately.

The Centers for Disease Control and Prevention (CDC) currently recommends that all children aged 6 months to 5 years be vaccinated against influenza. The trivalent FluMist vaccine has previously been approved only for healthy children over age 5 years and for adults aged 18–49 years.

Dr. Sarah Long, chief of infectious diseases at St. Christopher's Hospital for Children in Philadelphia, said that the new FluMist approval is likely to spur higher vaccination rates. But, she added, physicians probably will not widely use the vaccine in young children until the CDC's Advisory Committee on Immunization Practices recommends it for the approved populations. Without an ACIP endorsement, insurers are reluctant to reimburse for a vaccine, Dr. Long, a member of the American Academy of Pediatrics committee on infectious diseases, said in an interview.

That recommendation is likely to come at ACIP's next meeting in late October, as FluMist's likely approval for use in young children had been discussed at its last meeting, Dr. Long said.

The AAP and the CDC agree that children of all ages are vastly undervaccinated. The CDC just issued vaccination statistics on children age 6–23 months. Overall, only 21% of children under the age of 2 years received full vaccination coverage—that is, two doses—in the 2005–2006 flu season, said Dr. Jeanne M. Santoli, deputy director of the Immunization Services Division in the CDC's National Immunization Program, at a press briefing on the upcoming flu season convened by the National Foundation for Infectious Diseases that occurred as the FluMist approval was granted.

FluMist joins two other vaccines currently approved for use in young children. Sanofi Pasteur's Fluzone is indicated for anyone over 6 months of age, and Novartis' Fluvirin for anyone aged 4 years or older. “This approval also offers parents and health professionals a needle-free option for squeamish toddlers, who may be reluctant to get a traditional influenza shot,” said Dr. Jesse L. Goodman, director of the Food and Drug Administration's Center for Biologics Evaluation and Research in a statement.

The approval was based on a pivotal study of 4,000 children aged 2–5 years who received the live attenuated vaccine during the 2004–2005 flu season. According to MedImmune, there was a 54% reduction in influenza in children given FluMist, compared with those who received a traditional injection.

The FluMist vaccine is contraindicated in those with asthma, children under age 2 years, and children under age 5 years who have recurrent wheezing because there is an increased risk of exacerbation of that symptom. It also should not be given to children receiving concomitant aspirin, or therapy containing aspirin, according to MedImmune, which will charge $17.95 per dose this flu season.

More Angioplasties Than CABG

The number of angioplasties almost doubled from 1993 to 2005, while the number of coronary artery bypass graft operations was on the decline over the same period, according to the latest data from the Agency for Healthcare Quality and Research's Healthcare Cost and Utilization Project. By 2005, there were about 800,000 percutaneous procedures each year, while only about 278,000 CABG procedures were performed. Even though the length of stay for an angioplasty had decreased to about 2.7 days in 2005, hospital charges rose 50% from 1993 to 2005, to about $48,000, adjusted for inflation, according to the AHQR. Coronary artery disease accounted for just over 1 million hospitalizations in 2005, making it the third-leading reason for a hospital stay.

Boston Settles Guidant Claims

Boston Scientific has agreed to pay $16.75 million to settle with attorneys general in 35 states and the District of Columbia, all of whom were investigating the circumstances surrounding recalls of three Guidant Corp. defibrillators: the Ventak Prizm 2DR Model 1861, Contak Renewal Model H135, and Contak Renewal 2 Model H155. The company admits no liability, but it has agreed to extend the supplemental warranty on the devices for 6 additional months. Boston Scientific, which acquired Guidant last year, also said in a statement that it would continue to work on making changes recommended by Guidant's independent panel, including establishing a patient safety advisory board and improving communications about product performance.

… And Is Warned on Stent Study

The Food and Drug Administration has issued a warning letter to Boston Scientific, citing the company's failure to report two of at least five deaths that occurred during a phase I U.S. study of the TriVascular stent for abdominal aortic aneurysms. The company also did not report to the agency in a timely manner on stent fractures, which occurred in at least 25 patients, according to the FDA letter. The study was initiated in 2003 by TriVascular Inc., which Boston Scientific bought in 2005. Boston Scientific cancelled the trial in 2006, and abandoned development of the stent. But the company is still required to submit required paperwork to the FDA, including progress reports on patient deaths, and a corrective action plan to address the deficiencies cited by the agency.

Bill Seeks MD Gift Disclosure

Legislation in the Senate would require quarterly disclosure of gifts, honoraria, travel, and other payments to physicians by pharmaceutical, medical device, and biotechnology manufacturers. The bill, S. 2029, was introduced by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wisc.) and would apply to manufacturers with more than $100 million in gross revenues. The U.S. Health and Human Services Department would be required to make the disclosure data available on the Internet. Penalties would range from $10,000 to $100,000 per violation. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said in a statement that his group had not yet reviewed the bill but that contact with physicians is essential for education purposes. The group's guidelines suggest gifts to physicians should not exceed $100. The American Medical Association had also not yet read the proposal, but in testimony earlier this year, noted that it has extensive guidelines on accepting anything from industry.

Rise in Adverse Drug Event Reports

The number of serious and fatal adverse drug events reported to the FDA more than doubled between 1998 and 2005, according to a report in Sept. 10 issue of the Archives of Internal Medicine. The agency defines a serious adverse event as an one resulting in death, a birth defect, disability, or hospitalization, or one that requires intervention. During the 8-year period, the number of reported serious adverse drug events increased from 34,966 in 1998 to 89,842 in 2005, a 2.6-fold increase; the number of reported deaths during that time increased 2.7-fold, from 5,519 to 15,107. The increase was largely a result of expedited reports from manufacturers of serious events not included on the label. Contrary to expectation, drugs related to safety withdrawals accounted for a “modest share” of reported events and declined over time. Of the 15 drugs most frequently cited in fatal events, there was a “disproportionate contribution of pain medications [7] and drugs that modify the immune system [4].” Drugs named in serious adverse drug events spanned a variety of classes, but within that group, events tied to 13 new biotechnology products increased almost 16-fold, from 580 in 1998 to 9,181 in 2005.

More Angioplasties Than CABG

The number of angioplasties almost doubled from 1993 to 2005, while the number of coronary artery bypass graft operations was on the decline over the same period, according to the latest data from the Agency for Healthcare Quality and Research's Healthcare Cost and Utilization Project. By 2005, there were about 800,000 percutaneous procedures each year, while only about 278,000 CABG procedures were performed. Even though the length of stay for an angioplasty had decreased to about 2.7 days in 2005, hospital charges rose 50% from 1993 to 2005, to about $48,000, adjusted for inflation, according to the AHQR. Coronary artery disease accounted for just over 1 million hospitalizations in 2005, making it the third-leading reason for a hospital stay.

Boston Settles Guidant Claims

Boston Scientific has agreed to pay $16.75 million to settle with attorneys general in 35 states and the District of Columbia, all of whom were investigating the circumstances surrounding recalls of three Guidant Corp. defibrillators: the Ventak Prizm 2DR Model 1861, Contak Renewal Model H135, and Contak Renewal 2 Model H155. The company admits no liability, but it has agreed to extend the supplemental warranty on the devices for 6 additional months. Boston Scientific, which acquired Guidant last year, also said in a statement that it would continue to work on making changes recommended by Guidant's independent panel, including establishing a patient safety advisory board and improving communications about product performance.

… And Is Warned on Stent Study

The Food and Drug Administration has issued a warning letter to Boston Scientific, citing the company's failure to report two of at least five deaths that occurred during a phase I U.S. study of the TriVascular stent for abdominal aortic aneurysms. The company also did not report to the agency in a timely manner on stent fractures, which occurred in at least 25 patients, according to the FDA letter. The study was initiated in 2003 by TriVascular Inc., which Boston Scientific bought in 2005. Boston Scientific cancelled the trial in 2006, and abandoned development of the stent. But the company is still required to submit required paperwork to the FDA, including progress reports on patient deaths, and a corrective action plan to address the deficiencies cited by the agency.

Bill Seeks MD Gift Disclosure

Legislation in the Senate would require quarterly disclosure of gifts, honoraria, travel, and other payments to physicians by pharmaceutical, medical device, and biotechnology manufacturers. The bill, S. 2029, was introduced by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wisc.) and would apply to manufacturers with more than $100 million in gross revenues. The U.S. Health and Human Services Department would be required to make the disclosure data available on the Internet. Penalties would range from $10,000 to $100,000 per violation. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said in a statement that his group had not yet reviewed the bill but that contact with physicians is essential for education purposes. The group's guidelines suggest gifts to physicians should not exceed $100. The American Medical Association had also not yet read the proposal, but in testimony earlier this year, noted that it has extensive guidelines on accepting anything from industry.

Rise in Adverse Drug Event Reports

The number of serious and fatal adverse drug events reported to the FDA more than doubled between 1998 and 2005, according to a report in Sept. 10 issue of the Archives of Internal Medicine. The agency defines a serious adverse event as an one resulting in death, a birth defect, disability, or hospitalization, or one that requires intervention. During the 8-year period, the number of reported serious adverse drug events increased from 34,966 in 1998 to 89,842 in 2005, a 2.6-fold increase; the number of reported deaths during that time increased 2.7-fold, from 5,519 to 15,107. The increase was largely a result of expedited reports from manufacturers of serious events not included on the label. Contrary to expectation, drugs related to safety withdrawals accounted for a “modest share” of reported events and declined over time. Of the 15 drugs most frequently cited in fatal events, there was a “disproportionate contribution of pain medications [7] and drugs that modify the immune system [4].” Drugs named in serious adverse drug events spanned a variety of classes, but within that group, events tied to 13 new biotechnology products increased almost 16-fold, from 580 in 1998 to 9,181 in 2005.

More Angioplasties Than CABG

The number of angioplasties almost doubled from 1993 to 2005, while the number of coronary artery bypass graft operations was on the decline over the same period, according to the latest data from the Agency for Healthcare Quality and Research's Healthcare Cost and Utilization Project. By 2005, there were about 800,000 percutaneous procedures each year, while only about 278,000 CABG procedures were performed. Even though the length of stay for an angioplasty had decreased to about 2.7 days in 2005, hospital charges rose 50% from 1993 to 2005, to about $48,000, adjusted for inflation, according to the AHQR. Coronary artery disease accounted for just over 1 million hospitalizations in 2005, making it the third-leading reason for a hospital stay.

Boston Settles Guidant Claims

Boston Scientific has agreed to pay $16.75 million to settle with attorneys general in 35 states and the District of Columbia, all of whom were investigating the circumstances surrounding recalls of three Guidant Corp. defibrillators: the Ventak Prizm 2DR Model 1861, Contak Renewal Model H135, and Contak Renewal 2 Model H155. The company admits no liability, but it has agreed to extend the supplemental warranty on the devices for 6 additional months. Boston Scientific, which acquired Guidant last year, also said in a statement that it would continue to work on making changes recommended by Guidant's independent panel, including establishing a patient safety advisory board and improving communications about product performance.

… And Is Warned on Stent Study

The Food and Drug Administration has issued a warning letter to Boston Scientific, citing the company's failure to report two of at least five deaths that occurred during a phase I U.S. study of the TriVascular stent for abdominal aortic aneurysms. The company also did not report to the agency in a timely manner on stent fractures, which occurred in at least 25 patients, according to the FDA letter. The study was initiated in 2003 by TriVascular Inc., which Boston Scientific bought in 2005. Boston Scientific cancelled the trial in 2006, and abandoned development of the stent. But the company is still required to submit required paperwork to the FDA, including progress reports on patient deaths, and a corrective action plan to address the deficiencies cited by the agency.

Bill Seeks MD Gift Disclosure

Legislation in the Senate would require quarterly disclosure of gifts, honoraria, travel, and other payments to physicians by pharmaceutical, medical device, and biotechnology manufacturers. The bill, S. 2029, was introduced by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wisc.) and would apply to manufacturers with more than $100 million in gross revenues. The U.S. Health and Human Services Department would be required to make the disclosure data available on the Internet. Penalties would range from $10,000 to $100,000 per violation. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said in a statement that his group had not yet reviewed the bill but that contact with physicians is essential for education purposes. The group's guidelines suggest gifts to physicians should not exceed $100. The American Medical Association had also not yet read the proposal, but in testimony earlier this year, noted that it has extensive guidelines on accepting anything from industry.

Rise in Adverse Drug Event Reports

The number of serious and fatal adverse drug events reported to the FDA more than doubled between 1998 and 2005, according to a report in Sept. 10 issue of the Archives of Internal Medicine. The agency defines a serious adverse event as an one resulting in death, a birth defect, disability, or hospitalization, or one that requires intervention. During the 8-year period, the number of reported serious adverse drug events increased from 34,966 in 1998 to 89,842 in 2005, a 2.6-fold increase; the number of reported deaths during that time increased 2.7-fold, from 5,519 to 15,107. The increase was largely a result of expedited reports from manufacturers of serious events not included on the label. Contrary to expectation, drugs related to safety withdrawals accounted for a “modest share” of reported events and declined over time. Of the 15 drugs most frequently cited in fatal events, there was a “disproportionate contribution of pain medications [7] and drugs that modify the immune system [4].” Drugs named in serious adverse drug events spanned a variety of classes, but within that group, events tied to 13 new biotechnology products increased almost 16-fold, from 580 in 1998 to 9,181 in 2005.

In issuing the third phase of the final regulations implementing the physician self-referral rule, also known as the Stark law, the Center for Medicare and Medicaid Services has returned to a stance it held in the first phase.

The Stark law governs whether, how, and when it is acceptable for physicians to refer patients to hospitals, laboratories, imaging facilities, or other entities in which they may have an ownership interest.

Under the new rule, known as Stark III, published in the Federal Register on Sept. 5, physicians will be considered to be “standing in the shoes” of the group practice when their investment arrangements are evaluated for compliance, according to several attorneys.

This reversion back to the initial Stark policy is among the most important changes in the 516-page document, said Daniel H. Melvin, J.D., a partner in the health law department of McDermott, Will & Emery's Chicago office. As a result, “the application of exceptions will be different going forward,” Mr. Melvin said in an interview.

That means that most physicians who have referral arrangements will have “a lot of contracts that will have to be looked at and possibly revised,” said Amy E. Nordeng, J.D., a counsel in the government affairs office of the Medical Group Management Association. Ms. Nordeng agreed that the return to the “stand in the shoes” view was the most significant component of Stark III.

Under Stark II—an interim policy that began in 2004—physicians were considered to be individuals, outside of their practices. Exceptions to the law were evaluated using an indirect compensation analysis, which ended up being onerous and was the subject of many complaints to CMS. In comments on Stark II, physician groups, hospitals, and other facilities (called designated health services, or DHS entities) urged CMS to revert to the old policy.

CMS itself came to see the indirect compensation analysis as a loophole that allowed potentially questionable investment arrangements to slip through, said Mr. Melvin.

In the Stark III rule, CMS wrote that the change in policy means that, “many compensation arrangements that were analyzed under Phase II as indirect compensation arrangements are now analyzed as direct compensation arrangements that must comply with an applicable exception for direct compensation arrangements.”

There were several other notable changes in Stark III.

The regulations clarify that physicians who administer pharmaceuticals under Medicare Part B are entitled to get direct productivity credit for those orders. The clarification applies to those two ancillary services only, not to radiology or laboratories, or other services typically offered in-house, said Mr. Melvin.

CMS also lifted the prohibition on noncompete agreements. Under Stark II, practices could not impose noncompete agreements on physician recruits. Now, practices can bar competition for up to 2 years, but it's not clear how far, geographically, that noncompete can extend, Mr. Melvin added.

With the new rule, practices have to “go back and look at everything,” including how their physicians are being compensated and the arrangements the practice may have for equipment and leasing or services with hospitals or other DHS entities, he said.

The final Stark rule goes into effect on December 5, 2007.

In issuing the third phase of the final regulations implementing the physician self-referral rule, also known as the Stark law, the Center for Medicare and Medicaid Services has returned to a stance it held in the first phase.

The Stark law governs whether, how, and when it is acceptable for physicians to refer patients to hospitals, laboratories, imaging facilities, or other entities in which they may have an ownership interest.

Under the new rule, known as Stark III, published in the Federal Register on Sept. 5, physicians will be considered to be “standing in the shoes” of the group practice when their investment arrangements are evaluated for compliance, according to several attorneys.

This reversion back to the initial Stark policy is among the most important changes in the 516-page document, said Daniel H. Melvin, J.D., a partner in the health law department of McDermott, Will & Emery's Chicago office. As a result, “the application of exceptions will be different going forward,” Mr. Melvin said in an interview.

That means that most physicians who have referral arrangements will have “a lot of contracts that will have to be looked at and possibly revised,” said Amy E. Nordeng, J.D., a counsel in the government affairs office of the Medical Group Management Association. Ms. Nordeng agreed that the return to the “stand in the shoes” view was the most significant component of Stark III.

Under Stark II—an interim policy that began in 2004—physicians were considered to be individuals, outside of their practices. Exceptions to the law were evaluated using an indirect compensation analysis, which ended up being onerous and was the subject of many complaints to CMS. In comments on Stark II, physician groups, hospitals, and other facilities (called designated health services, or DHS entities) urged CMS to revert to the old policy.

CMS itself came to see the indirect compensation analysis as a loophole that allowed potentially questionable investment arrangements to slip through, said Mr. Melvin.

In the Stark III rule, CMS wrote that the change in policy means that, “many compensation arrangements that were analyzed under Phase II as indirect compensation arrangements are now analyzed as direct compensation arrangements that must comply with an applicable exception for direct compensation arrangements.”

There were several other notable changes in Stark III.

The regulations clarify that physicians who administer pharmaceuticals under Medicare Part B are entitled to get direct productivity credit for those orders. The clarification applies to those two ancillary services only, not to radiology or laboratories, or other services typically offered in-house, said Mr. Melvin.

CMS also lifted the prohibition on noncompete agreements. Under Stark II, practices could not impose noncompete agreements on physician recruits. Now, practices can bar competition for up to 2 years, but it's not clear how far, geographically, that noncompete can extend, Mr. Melvin added.

With the new rule, practices have to “go back and look at everything,” including how their physicians are being compensated and the arrangements the practice may have for equipment and leasing or services with hospitals or other DHS entities, he said.

The final Stark rule goes into effect on December 5, 2007.

In issuing the third phase of the final regulations implementing the physician self-referral rule, also known as the Stark law, the Center for Medicare and Medicaid Services has returned to a stance it held in the first phase.

The Stark law governs whether, how, and when it is acceptable for physicians to refer patients to hospitals, laboratories, imaging facilities, or other entities in which they may have an ownership interest.

Under the new rule, known as Stark III, published in the Federal Register on Sept. 5, physicians will be considered to be “standing in the shoes” of the group practice when their investment arrangements are evaluated for compliance, according to several attorneys.

This reversion back to the initial Stark policy is among the most important changes in the 516-page document, said Daniel H. Melvin, J.D., a partner in the health law department of McDermott, Will & Emery's Chicago office. As a result, “the application of exceptions will be different going forward,” Mr. Melvin said in an interview.

That means that most physicians who have referral arrangements will have “a lot of contracts that will have to be looked at and possibly revised,” said Amy E. Nordeng, J.D., a counsel in the government affairs office of the Medical Group Management Association. Ms. Nordeng agreed that the return to the “stand in the shoes” view was the most significant component of Stark III.

Under Stark II—an interim policy that began in 2004—physicians were considered to be individuals, outside of their practices. Exceptions to the law were evaluated using an indirect compensation analysis, which ended up being onerous and was the subject of many complaints to CMS. In comments on Stark II, physician groups, hospitals, and other facilities (called designated health services, or DHS entities) urged CMS to revert to the old policy.

CMS itself came to see the indirect compensation analysis as a loophole that allowed potentially questionable investment arrangements to slip through, said Mr. Melvin.

In the Stark III rule, CMS wrote that the change in policy means that, “many compensation arrangements that were analyzed under Phase II as indirect compensation arrangements are now analyzed as direct compensation arrangements that must comply with an applicable exception for direct compensation arrangements.”

There were several other notable changes in Stark III.

The regulations clarify that physicians who administer pharmaceuticals under Medicare Part B are entitled to get direct productivity credit for those orders. The clarification applies to those two ancillary services only, not to radiology or laboratories, or other services typically offered in-house, said Mr. Melvin.

CMS also lifted the prohibition on noncompete agreements. Under Stark II, practices could not impose noncompete agreements on physician recruits. Now, practices can bar competition for up to 2 years, but it's not clear how far, geographically, that noncompete can extend, Mr. Melvin added.

With the new rule, practices have to “go back and look at everything,” including how their physicians are being compensated and the arrangements the practice may have for equipment and leasing or services with hospitals or other DHS entities, he said.

The final Stark rule goes into effect on December 5, 2007.

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

Ms. Norwalk estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies have submitted bids to CMS proposing charges for the items.

CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

The new bidding process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./ Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale- Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan- Caguas-Guaynabo, Puerto Rico.

The 10 categories include: oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays).

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

Ms. Norwalk estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies have submitted bids to CMS proposing charges for the items.

CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

The new bidding process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./ Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale- Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan- Caguas-Guaynabo, Puerto Rico.

The 10 categories include: oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays).

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

Ms. Norwalk estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies have submitted bids to CMS proposing charges for the items.

CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

The new bidding process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./ Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale- Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan- Caguas-Guaynabo, Puerto Rico.

The 10 categories include: oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays).

In issuing the third phase of the final regulations implementing the physician self-referral rule, also known as the Stark law, the Center for Medicare and Medicaid Services has returned to a stance it held in the first phase.

The Stark law governs whether, how, and when it is acceptable for physicians to refer patients to hospitals, laboratories, imaging facilities, or other entities in which they may have an ownership interest.

Under the new rule, known as Stark III, published in the Federal Register on September 5, physicians will be considered to be “standing in the shoes” of the group practice when their investment arrangements are evaluated for compliance, according to several attorneys.

This reversion to the initial Stark policy is among the most important changes in the 516-page document, said Daniel H. Melvin, J.D., a partner in the health law department of McDermott, Will & Emery's Chicago office. As a result, “the application of exceptions will be different going forward,” he said in an interview.

That means that most physicians who have referral arrangements will have “a lot of contracts that will have to be looked at and possibly revised,” said Amy E. Nordeng, J.D., a counsel in the government affairs office of the Medical Group Management Association.

Under Stark II—an interim policy that began in 2004—physicians were considered to be individuals, outside of their practices. Exceptions to the law were evaluated using an indirect compensation analysis, which ended up being onerous and was the subject of many complaints to CMS. In comments on Stark II, physician groups, hospitals, and other facilities (called designated health services, or DHS entities under the Stark law) urged CMS to revert to the old policy.

CMS came to see the indirect compensation analysis as a loophole that allowed potentially questionable investment arrangements to slip through, said Mr. Melvin.

In the Stark III rule, CMS wrote that the change in policy means that, “many compensation arrangements that were analyzed under Phase II as indirect compensation arrangements are now analyzed as direct compensation arrangements that must comply with an applicable exception for direct compensation arrangements.”

There were several other notable changes in Stark III.

The regulations clarify that physicians who administer pharmaceuticals under Medicare Part B or who prescribe physical therapy, occupational therapy, and speech-language pathology, are entitled to get direct productivity credit for those orders, said Mr. Melvin. The clarification applies to those two ancillary services only, not to radiology or laboratories, or other services typically offered in-house.

CMS also lifted the prohibition on noncompete agreements. Under Stark II, practices could not impose noncompete agreements on physician recruits. Now, practices can bar competition for up to 2 years, but it's not clear how far, geographically, that noncompete can extend, said Mr. Melvin.

With the new rule, practices will have to review all their arrangements, from physician compensation to leasing or services agreements, to see if any of the exceptions they relied on will change with Stark III, added Ms. Nordeng. The final Stark rule goes into effect on December 5, 2007.

In issuing the third phase of the final regulations implementing the physician self-referral rule, also known as the Stark law, the Center for Medicare and Medicaid Services has returned to a stance it held in the first phase.

The Stark law governs whether, how, and when it is acceptable for physicians to refer patients to hospitals, laboratories, imaging facilities, or other entities in which they may have an ownership interest.

Under the new rule, known as Stark III, published in the Federal Register on September 5, physicians will be considered to be “standing in the shoes” of the group practice when their investment arrangements are evaluated for compliance, according to several attorneys.

This reversion to the initial Stark policy is among the most important changes in the 516-page document, said Daniel H. Melvin, J.D., a partner in the health law department of McDermott, Will & Emery's Chicago office. As a result, “the application of exceptions will be different going forward,” he said in an interview.

That means that most physicians who have referral arrangements will have “a lot of contracts that will have to be looked at and possibly revised,” said Amy E. Nordeng, J.D., a counsel in the government affairs office of the Medical Group Management Association.

Under Stark II—an interim policy that began in 2004—physicians were considered to be individuals, outside of their practices. Exceptions to the law were evaluated using an indirect compensation analysis, which ended up being onerous and was the subject of many complaints to CMS. In comments on Stark II, physician groups, hospitals, and other facilities (called designated health services, or DHS entities under the Stark law) urged CMS to revert to the old policy.

CMS came to see the indirect compensation analysis as a loophole that allowed potentially questionable investment arrangements to slip through, said Mr. Melvin.

In the Stark III rule, CMS wrote that the change in policy means that, “many compensation arrangements that were analyzed under Phase II as indirect compensation arrangements are now analyzed as direct compensation arrangements that must comply with an applicable exception for direct compensation arrangements.”

There were several other notable changes in Stark III.

The regulations clarify that physicians who administer pharmaceuticals under Medicare Part B or who prescribe physical therapy, occupational therapy, and speech-language pathology, are entitled to get direct productivity credit for those orders, said Mr. Melvin. The clarification applies to those two ancillary services only, not to radiology or laboratories, or other services typically offered in-house.

CMS also lifted the prohibition on noncompete agreements. Under Stark II, practices could not impose noncompete agreements on physician recruits. Now, practices can bar competition for up to 2 years, but it's not clear how far, geographically, that noncompete can extend, said Mr. Melvin.

With the new rule, practices will have to review all their arrangements, from physician compensation to leasing or services agreements, to see if any of the exceptions they relied on will change with Stark III, added Ms. Nordeng. The final Stark rule goes into effect on December 5, 2007.

In issuing the third phase of the final regulations implementing the physician self-referral rule, also known as the Stark law, the Center for Medicare and Medicaid Services has returned to a stance it held in the first phase.

The Stark law governs whether, how, and when it is acceptable for physicians to refer patients to hospitals, laboratories, imaging facilities, or other entities in which they may have an ownership interest.

Under the new rule, known as Stark III, published in the Federal Register on September 5, physicians will be considered to be “standing in the shoes” of the group practice when their investment arrangements are evaluated for compliance, according to several attorneys.

This reversion to the initial Stark policy is among the most important changes in the 516-page document, said Daniel H. Melvin, J.D., a partner in the health law department of McDermott, Will & Emery's Chicago office. As a result, “the application of exceptions will be different going forward,” he said in an interview.

That means that most physicians who have referral arrangements will have “a lot of contracts that will have to be looked at and possibly revised,” said Amy E. Nordeng, J.D., a counsel in the government affairs office of the Medical Group Management Association.

Under Stark II—an interim policy that began in 2004—physicians were considered to be individuals, outside of their practices. Exceptions to the law were evaluated using an indirect compensation analysis, which ended up being onerous and was the subject of many complaints to CMS. In comments on Stark II, physician groups, hospitals, and other facilities (called designated health services, or DHS entities under the Stark law) urged CMS to revert to the old policy.

CMS came to see the indirect compensation analysis as a loophole that allowed potentially questionable investment arrangements to slip through, said Mr. Melvin.

In the Stark III rule, CMS wrote that the change in policy means that, “many compensation arrangements that were analyzed under Phase II as indirect compensation arrangements are now analyzed as direct compensation arrangements that must comply with an applicable exception for direct compensation arrangements.”

There were several other notable changes in Stark III.

The regulations clarify that physicians who administer pharmaceuticals under Medicare Part B or who prescribe physical therapy, occupational therapy, and speech-language pathology, are entitled to get direct productivity credit for those orders, said Mr. Melvin. The clarification applies to those two ancillary services only, not to radiology or laboratories, or other services typically offered in-house.

CMS also lifted the prohibition on noncompete agreements. Under Stark II, practices could not impose noncompete agreements on physician recruits. Now, practices can bar competition for up to 2 years, but it's not clear how far, geographically, that noncompete can extend, said Mr. Melvin.

With the new rule, practices will have to review all their arrangements, from physician compensation to leasing or services agreements, to see if any of the exceptions they relied on will change with Stark III, added Ms. Nordeng. The final Stark rule goes into effect on December 5, 2007.

In issuing the third phase of the final regulations implementing the physician self-referral rule, also known as the Stark law, the Center for Medicare and Medicaid Services has returned to a stance it held in the first phase.

The Stark law governs whether, how, and when it is acceptable for physicians to refer patients to hospitals, laboratories, imaging facilities, or other entities in which they may have an ownership interest.

Under the new rule, known as Stark III, published in the Federal Register on Sept. 5, physicians will be considered to be “standing in the shoes” of the group practice when their investment arrangements are evaluated for compliance, according to several attorneys.

This reversion back to the initial Stark policy is among the most important changes in the 516-page document, said Daniel H. Melvin, J.D., a partner in the health law department of McDermott, Will & Emery's Chicago office.

As a result, “the application of exceptions will be different going forward,” Mr. Melvin said in an interview.

That means most physicians who have referral arrangements will have “a lot of contracts that will have to be looked at and possibly revised,” said Amy E. Nordeng, J.D., a counsel in the government affairs office of the Medical Group Management Association. Ms. Nordeng agreed that the return to the “stand in the shoes” view was the most significant component of Stark III.

Under Stark II–an interim policy that began in 2004–physicians were considered to be individuals, outside of their practices.

Exceptions to the law were evaluated using an indirect compensation analysis, which ended up being onerous and was the subject of many complaints to CMS. In comments on Stark II, physician groups, hospitals, and other facilities (called designated health services, or DHS entities under the Stark law) urged CMS to revert to the old policy.

CMS itself came to see the indirect compensation analysis as a loophole that allowed potentially questionable investment arrangements to slip through, said Mr. Melvin.

In the Stark III rule, CMS wrote that the change in policy means that, “many compensation arrangements that were analyzed under Phase II as indirect compensation arrangements are now analyzed as direct compensation arrangements that must comply with an applicable exception for direct compensation arrangements.”

There were several other notable changes in Stark III.

The regulations clarify that physicians who administer pharmaceuticals under Medicare Part B (such as chemotherapy or infusions) or who prescribe physical therapy, occupational therapy, and speech-language pathology, are entitled to get direct productivity credit for those orders, said Mr. Melvin.

The clarification applies to those two ancillary services only, not to radiology or laboratories, or other services typically offered in-house, he said.

CMS also lifted the prohibition on noncompete agreements. Under Stark II, practices could not impose noncompete agreements on physician recruits. Now, practices can bar competition for up to 2 years, but it's not clear how far, geographically, that noncompete can extend, he said.

With the new rule, practices have to “go back and look at everything,” including how their physicians are being compensated and the arrangements the practice may have for equipment and leasing or services with hospitals or other DHS entities, Mr. Melvin said.

“At the very least, they're going to want to do a review of the arrangements in place,” to see if any of the exceptions being relied on will change with Stark III, added Ms. Nordeng.

The final Stark rule goes into effect on Dec. 5, 2007.

In issuing the third phase of the final regulations implementing the physician self-referral rule, also known as the Stark law, the Center for Medicare and Medicaid Services has returned to a stance it held in the first phase.

The Stark law governs whether, how, and when it is acceptable for physicians to refer patients to hospitals, laboratories, imaging facilities, or other entities in which they may have an ownership interest.

Under the new rule, known as Stark III, published in the Federal Register on Sept. 5, physicians will be considered to be “standing in the shoes” of the group practice when their investment arrangements are evaluated for compliance, according to several attorneys.

This reversion back to the initial Stark policy is among the most important changes in the 516-page document, said Daniel H. Melvin, J.D., a partner in the health law department of McDermott, Will & Emery's Chicago office.

As a result, “the application of exceptions will be different going forward,” Mr. Melvin said in an interview.

That means most physicians who have referral arrangements will have “a lot of contracts that will have to be looked at and possibly revised,” said Amy E. Nordeng, J.D., a counsel in the government affairs office of the Medical Group Management Association. Ms. Nordeng agreed that the return to the “stand in the shoes” view was the most significant component of Stark III.

Under Stark II–an interim policy that began in 2004–physicians were considered to be individuals, outside of their practices.

Exceptions to the law were evaluated using an indirect compensation analysis, which ended up being onerous and was the subject of many complaints to CMS. In comments on Stark II, physician groups, hospitals, and other facilities (called designated health services, or DHS entities under the Stark law) urged CMS to revert to the old policy.

CMS itself came to see the indirect compensation analysis as a loophole that allowed potentially questionable investment arrangements to slip through, said Mr. Melvin.

In the Stark III rule, CMS wrote that the change in policy means that, “many compensation arrangements that were analyzed under Phase II as indirect compensation arrangements are now analyzed as direct compensation arrangements that must comply with an applicable exception for direct compensation arrangements.”

There were several other notable changes in Stark III.

The regulations clarify that physicians who administer pharmaceuticals under Medicare Part B (such as chemotherapy or infusions) or who prescribe physical therapy, occupational therapy, and speech-language pathology, are entitled to get direct productivity credit for those orders, said Mr. Melvin.

The clarification applies to those two ancillary services only, not to radiology or laboratories, or other services typically offered in-house, he said.

CMS also lifted the prohibition on noncompete agreements. Under Stark II, practices could not impose noncompete agreements on physician recruits. Now, practices can bar competition for up to 2 years, but it's not clear how far, geographically, that noncompete can extend, he said.

With the new rule, practices have to “go back and look at everything,” including how their physicians are being compensated and the arrangements the practice may have for equipment and leasing or services with hospitals or other DHS entities, Mr. Melvin said.

“At the very least, they're going to want to do a review of the arrangements in place,” to see if any of the exceptions being relied on will change with Stark III, added Ms. Nordeng.

The final Stark rule goes into effect on Dec. 5, 2007.

In issuing the third phase of the final regulations implementing the physician self-referral rule, also known as the Stark law, the Center for Medicare and Medicaid Services has returned to a stance it held in the first phase.

The Stark law governs whether, how, and when it is acceptable for physicians to refer patients to hospitals, laboratories, imaging facilities, or other entities in which they may have an ownership interest.

Under the new rule, known as Stark III, published in the Federal Register on Sept. 5, physicians will be considered to be “standing in the shoes” of the group practice when their investment arrangements are evaluated for compliance, according to several attorneys.

This reversion back to the initial Stark policy is among the most important changes in the 516-page document, said Daniel H. Melvin, J.D., a partner in the health law department of McDermott, Will & Emery's Chicago office.

As a result, “the application of exceptions will be different going forward,” Mr. Melvin said in an interview.

That means most physicians who have referral arrangements will have “a lot of contracts that will have to be looked at and possibly revised,” said Amy E. Nordeng, J.D., a counsel in the government affairs office of the Medical Group Management Association. Ms. Nordeng agreed that the return to the “stand in the shoes” view was the most significant component of Stark III.

Under Stark II–an interim policy that began in 2004–physicians were considered to be individuals, outside of their practices.

Exceptions to the law were evaluated using an indirect compensation analysis, which ended up being onerous and was the subject of many complaints to CMS. In comments on Stark II, physician groups, hospitals, and other facilities (called designated health services, or DHS entities under the Stark law) urged CMS to revert to the old policy.

CMS itself came to see the indirect compensation analysis as a loophole that allowed potentially questionable investment arrangements to slip through, said Mr. Melvin.

In the Stark III rule, CMS wrote that the change in policy means that, “many compensation arrangements that were analyzed under Phase II as indirect compensation arrangements are now analyzed as direct compensation arrangements that must comply with an applicable exception for direct compensation arrangements.”

There were several other notable changes in Stark III.

The regulations clarify that physicians who administer pharmaceuticals under Medicare Part B (such as chemotherapy or infusions) or who prescribe physical therapy, occupational therapy, and speech-language pathology, are entitled to get direct productivity credit for those orders, said Mr. Melvin.

The clarification applies to those two ancillary services only, not to radiology or laboratories, or other services typically offered in-house, he said.

CMS also lifted the prohibition on noncompete agreements. Under Stark II, practices could not impose noncompete agreements on physician recruits. Now, practices can bar competition for up to 2 years, but it's not clear how far, geographically, that noncompete can extend, he said.

With the new rule, practices have to “go back and look at everything,” including how their physicians are being compensated and the arrangements the practice may have for equipment and leasing or services with hospitals or other DHS entities, Mr. Melvin said.

“At the very least, they're going to want to do a review of the arrangements in place,” to see if any of the exceptions being relied on will change with Stark III, added Ms. Nordeng.

The final Stark rule goes into effect on Dec. 5, 2007.

NQF Substance Abuse Standards

The National Quality Forum has issued a set of national, evidence-based consensus standards on identifying and treating substance abuse. The 11 practices were endorsed by 365 NQF member organizations, including health care providers, professional societies, purchasers, and federal agencies. Voluntary adoption of the standards would lead to improved patient outcomes, according to the NQF. The recommendations cover identification of substance use conditions, initiation and engagement in treatment, therapeutic interventions, and continuing care management. The guidelines can be purchased at the NQF Web site,

www.qualityforum.org

Settlement on Zyprexa Leaks

A former consultant to Eli Lilly & Co. has agreed to pay the drug maker $100,000 to settle complaints that he leaked confidential information about Zyprexa (olanzapine) to a plaintiffs' attorney. Dr. David Egilman was an expert witness for the plaintiffs in Zyprexa product liability suits. Under the agreement, Dr. Egilman acknowledged that he had intentionally and illegally given attorney James Gottstein documents that had been made available by Lilly during discovery, and that “he knew that these materials painted an incomplete picture of the issues related to Zyprexa,” according to a statement by Lilly. Mr. Gottstein shared the documents with the New York Times, which wrote a series of articles in December 2006 contending that Lilly had withheld information about side effects. Lilly said it would donate Dr. Egilman's settlement to the International Center for Clubhouse Development.

Court Date Set for Ayres

Psychiatrist Dr. William Ayres is set to go before a jury in San Mateo County, Calif., in March 2008 to face charges that he molested seven young male patients. In his Sept. 6 arraignment, Dr. Ayres pleaded not guilty. He has maintained his innocence since he was first arrested in April 2007 and charged with molesting at least five former patients. The arrest came after a 4-year investigation conducted by the San Mateo County Police Department. Dr. Ayres, who is 75, is a former president of the American Academy of Child and Adolescent Psychiatry.

Lawmakers OK Delay in Rx Rule

Coming down to the wire on a new federal mandate requiring the use of tamper-resistant prescription pads for all Medicaid prescriptions beginning Oct. 1, lawmakers in the House and the Senate passed legislation in late September that would delay the mandate's start until March 31, 2008. At press time, President Bush was expected to sign the legislation, although it was not clear whether he would sign it by Oct. 1, National Community Pharmacists Association spokesman John Norton told this newspaper. The tamper-proof prescription pad mandate delay was bundled with extensions on several programs due to expire Sept. 30, including an abstinence education initiative that the Bush administration supports, Mr. Norton said. The original mandate, passed as part of war funding legislation earlier this year, requires all Medicaid prescription be written on “tamper resistant” paper to be eligible for federal reimbursement. Even though many states have similar requirements, pharmacists' organizations have maintained that most physicians do not currently use these types of pads, nor are supplies readily available.

Rise in Adverse Drug Event Reports

The number of serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration more than doubled between 1998 and 2005, according to a report in the Sept. 10 issue of Archives of Internal Medicine. The agency defines a serious adverse event as an event resulting in death, a birth defect, disability, hospitalization, or that requires intervention. During the 8-year period, 467,809 serious events met the inclusion criteria. The number of reported serious ADEs increased from 34,966 in 1998 to 89,842 in 2005, a 2.6-fold increase; the number of reported deaths during that time increased 2.7-fold, from 5,519 to 15,107. The increase was largely a result of expedited reports from manufacturers of serious events not included on the label.

Task Force Looks at Physician Gifts

In New Jersey, which is sometimes called the nation's medicine cabinet, the state's attorney general is taking a closer look at the gift-giving practices of pharmaceutical and medical device companies. The Attorney General's Advisory Task Force on Physician Compensation, which met for the first time in September, is examining the potential impact of payments and gifts to physicians from the drug and device industry. The task force will also consider possible public disclosure of gifts, direct disclosure to patients, and limits on payments to physicians. Vermont, Maine, Minnesota, West Virginia, and the District of Columbia have passed laws requiring some form of reporting of payments made to physicians by pharmaceutical and medical device companies. In response to the formation of the task force, the Pharmaceutical Research and Manufacturers of America issued a statement citing PhRMA's 2002 Code on Interactions with Healthcare Professionals as an important safeguard. The code declares all forms of entertainment to be inappropriate and says that any gifts that are given to physicians should support medical practice and be valued at less than $100. The New Jersey task force includes the state's Health and Senior Services Commissioner, members of the State Board of Medical Examiners, physicians, industry representatives, and consumer advocates.

NQF Substance Abuse Standards

The National Quality Forum has issued a set of national, evidence-based consensus standards on identifying and treating substance abuse. The 11 practices were endorsed by 365 NQF member organizations, including health care providers, professional societies, purchasers, and federal agencies. Voluntary adoption of the standards would lead to improved patient outcomes, according to the NQF. The recommendations cover identification of substance use conditions, initiation and engagement in treatment, therapeutic interventions, and continuing care management. The guidelines can be purchased at the NQF Web site,

www.qualityforum.org

Settlement on Zyprexa Leaks

A former consultant to Eli Lilly & Co. has agreed to pay the drug maker $100,000 to settle complaints that he leaked confidential information about Zyprexa (olanzapine) to a plaintiffs' attorney. Dr. David Egilman was an expert witness for the plaintiffs in Zyprexa product liability suits. Under the agreement, Dr. Egilman acknowledged that he had intentionally and illegally given attorney James Gottstein documents that had been made available by Lilly during discovery, and that “he knew that these materials painted an incomplete picture of the issues related to Zyprexa,” according to a statement by Lilly. Mr. Gottstein shared the documents with the New York Times, which wrote a series of articles in December 2006 contending that Lilly had withheld information about side effects. Lilly said it would donate Dr. Egilman's settlement to the International Center for Clubhouse Development.

Court Date Set for Ayres

Psychiatrist Dr. William Ayres is set to go before a jury in San Mateo County, Calif., in March 2008 to face charges that he molested seven young male patients. In his Sept. 6 arraignment, Dr. Ayres pleaded not guilty. He has maintained his innocence since he was first arrested in April 2007 and charged with molesting at least five former patients. The arrest came after a 4-year investigation conducted by the San Mateo County Police Department. Dr. Ayres, who is 75, is a former president of the American Academy of Child and Adolescent Psychiatry.

Lawmakers OK Delay in Rx Rule

Coming down to the wire on a new federal mandate requiring the use of tamper-resistant prescription pads for all Medicaid prescriptions beginning Oct. 1, lawmakers in the House and the Senate passed legislation in late September that would delay the mandate's start until March 31, 2008. At press time, President Bush was expected to sign the legislation, although it was not clear whether he would sign it by Oct. 1, National Community Pharmacists Association spokesman John Norton told this newspaper. The tamper-proof prescription pad mandate delay was bundled with extensions on several programs due to expire Sept. 30, including an abstinence education initiative that the Bush administration supports, Mr. Norton said. The original mandate, passed as part of war funding legislation earlier this year, requires all Medicaid prescription be written on “tamper resistant” paper to be eligible for federal reimbursement. Even though many states have similar requirements, pharmacists' organizations have maintained that most physicians do not currently use these types of pads, nor are supplies readily available.

Rise in Adverse Drug Event Reports

The number of serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration more than doubled between 1998 and 2005, according to a report in the Sept. 10 issue of Archives of Internal Medicine. The agency defines a serious adverse event as an event resulting in death, a birth defect, disability, hospitalization, or that requires intervention. During the 8-year period, 467,809 serious events met the inclusion criteria. The number of reported serious ADEs increased from 34,966 in 1998 to 89,842 in 2005, a 2.6-fold increase; the number of reported deaths during that time increased 2.7-fold, from 5,519 to 15,107. The increase was largely a result of expedited reports from manufacturers of serious events not included on the label.

Task Force Looks at Physician Gifts

In New Jersey, which is sometimes called the nation's medicine cabinet, the state's attorney general is taking a closer look at the gift-giving practices of pharmaceutical and medical device companies. The Attorney General's Advisory Task Force on Physician Compensation, which met for the first time in September, is examining the potential impact of payments and gifts to physicians from the drug and device industry. The task force will also consider possible public disclosure of gifts, direct disclosure to patients, and limits on payments to physicians. Vermont, Maine, Minnesota, West Virginia, and the District of Columbia have passed laws requiring some form of reporting of payments made to physicians by pharmaceutical and medical device companies. In response to the formation of the task force, the Pharmaceutical Research and Manufacturers of America issued a statement citing PhRMA's 2002 Code on Interactions with Healthcare Professionals as an important safeguard. The code declares all forms of entertainment to be inappropriate and says that any gifts that are given to physicians should support medical practice and be valued at less than $100. The New Jersey task force includes the state's Health and Senior Services Commissioner, members of the State Board of Medical Examiners, physicians, industry representatives, and consumer advocates.

NQF Substance Abuse Standards

The National Quality Forum has issued a set of national, evidence-based consensus standards on identifying and treating substance abuse. The 11 practices were endorsed by 365 NQF member organizations, including health care providers, professional societies, purchasers, and federal agencies. Voluntary adoption of the standards would lead to improved patient outcomes, according to the NQF. The recommendations cover identification of substance use conditions, initiation and engagement in treatment, therapeutic interventions, and continuing care management. The guidelines can be purchased at the NQF Web site,

www.qualityforum.org

Settlement on Zyprexa Leaks

A former consultant to Eli Lilly & Co. has agreed to pay the drug maker $100,000 to settle complaints that he leaked confidential information about Zyprexa (olanzapine) to a plaintiffs' attorney. Dr. David Egilman was an expert witness for the plaintiffs in Zyprexa product liability suits. Under the agreement, Dr. Egilman acknowledged that he had intentionally and illegally given attorney James Gottstein documents that had been made available by Lilly during discovery, and that “he knew that these materials painted an incomplete picture of the issues related to Zyprexa,” according to a statement by Lilly. Mr. Gottstein shared the documents with the New York Times, which wrote a series of articles in December 2006 contending that Lilly had withheld information about side effects. Lilly said it would donate Dr. Egilman's settlement to the International Center for Clubhouse Development.

Court Date Set for Ayres

Psychiatrist Dr. William Ayres is set to go before a jury in San Mateo County, Calif., in March 2008 to face charges that he molested seven young male patients. In his Sept. 6 arraignment, Dr. Ayres pleaded not guilty. He has maintained his innocence since he was first arrested in April 2007 and charged with molesting at least five former patients. The arrest came after a 4-year investigation conducted by the San Mateo County Police Department. Dr. Ayres, who is 75, is a former president of the American Academy of Child and Adolescent Psychiatry.

Lawmakers OK Delay in Rx Rule

Coming down to the wire on a new federal mandate requiring the use of tamper-resistant prescription pads for all Medicaid prescriptions beginning Oct. 1, lawmakers in the House and the Senate passed legislation in late September that would delay the mandate's start until March 31, 2008. At press time, President Bush was expected to sign the legislation, although it was not clear whether he would sign it by Oct. 1, National Community Pharmacists Association spokesman John Norton told this newspaper. The tamper-proof prescription pad mandate delay was bundled with extensions on several programs due to expire Sept. 30, including an abstinence education initiative that the Bush administration supports, Mr. Norton said. The original mandate, passed as part of war funding legislation earlier this year, requires all Medicaid prescription be written on “tamper resistant” paper to be eligible for federal reimbursement. Even though many states have similar requirements, pharmacists' organizations have maintained that most physicians do not currently use these types of pads, nor are supplies readily available.

Rise in Adverse Drug Event Reports

The number of serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration more than doubled between 1998 and 2005, according to a report in the Sept. 10 issue of Archives of Internal Medicine. The agency defines a serious adverse event as an event resulting in death, a birth defect, disability, hospitalization, or that requires intervention. During the 8-year period, 467,809 serious events met the inclusion criteria. The number of reported serious ADEs increased from 34,966 in 1998 to 89,842 in 2005, a 2.6-fold increase; the number of reported deaths during that time increased 2.7-fold, from 5,519 to 15,107. The increase was largely a result of expedited reports from manufacturers of serious events not included on the label.

Task Force Looks at Physician Gifts

In New Jersey, which is sometimes called the nation's medicine cabinet, the state's attorney general is taking a closer look at the gift-giving practices of pharmaceutical and medical device companies. The Attorney General's Advisory Task Force on Physician Compensation, which met for the first time in September, is examining the potential impact of payments and gifts to physicians from the drug and device industry. The task force will also consider possible public disclosure of gifts, direct disclosure to patients, and limits on payments to physicians. Vermont, Maine, Minnesota, West Virginia, and the District of Columbia have passed laws requiring some form of reporting of payments made to physicians by pharmaceutical and medical device companies. In response to the formation of the task force, the Pharmaceutical Research and Manufacturers of America issued a statement citing PhRMA's 2002 Code on Interactions with Healthcare Professionals as an important safeguard. The code declares all forms of entertainment to be inappropriate and says that any gifts that are given to physicians should support medical practice and be valued at less than $100. The New Jersey task force includes the state's Health and Senior Services Commissioner, members of the State Board of Medical Examiners, physicians, industry representatives, and consumer advocates.

CHICAGO – Headache is the fifth most common emergency department complaint, but only a small percentage of migraineurs use emergency care for treatment, according to an analysis of the American Migraine Prevalence and Prevention study presented at the annual meeting of the American Headache Society.

Dr. Benjamin Friedman of the Albert Einstein College of Medicine, New York, said he and his colleagues sought to determine how often Americans with headache use the ED or an urgent care facility, and what the risk factors were for frequent use.

The goal of the study was to discern ways to prevent urgent headache visits. Currently there are about 5 million visits a year for headache, he said.

The American Migraine Prevalence and Prevention study (AMPP) is an ongoing multisite survey that began in 2004 when a self-administered headache questionnaire was mailed to a random sample of 120,000 households. The study was supported by a grant to the National Headache Foundation from Ortho-McNeil Inc. Of the 162,576 individuals who responded, 30,721 self-reported severe headaches. Dr. Friedman and his colleagues mailed a follow-up survey in 2005 to a random subsample of 24,000 of the headache sufferers, asking for data on emergency or urgent care use within the previous 12 months.

Data were collected on 13,451 respondents. Among those categorized with migraine or probable migraine, 94% did not visit the emergency department at all, leaving 859 patients who did report a visit. Among those, 48% (412) reported only one visit within the past year. About a third (274) reported 2–3 visits, only 14% (120) reported up to nine visits, and 53 patients reported more than nine visits.

The frequent users, which he classified as 20% of the 859 ED visitors, accounted for 51% of all visits.

The most-cited reasons for going to the ED or urgent care facility included unbearable pain, the inability to reach a primary physician, the ability to get better or different medications, and concern about the significance of the pain (for instance, whether it might be the result of meningitis). A small number of patients said the ED was the primary source of care, and an equal number cited insurance or other financial barriers to care as the reason why they went to an urgent facility instead of a primary physician.

Using a multivariate analysis, Dr. Friedman and his colleagues determined that the main risk factors for urgent care use were the use of those facilities for nonheadache care and a severe migraine disability assessment scale (MIDAS) score. Having insurance was protective against ED visits, he said. The risk factors were similar in frequent ED users, with stronger associations.

The investigators concluded that urgent care facilities are used infrequently for the management of severe headache on a population level, but–because the disorder is so prevalent–headache is a common complaint in the ED. Frequent users are uncommon, but they account for the majority of visits to ED and urgent care. In terms of modifiable risk factors, ED use is associated with more severe headache, so treating the underlying headache may help prevent urgent care visits, Dr. Friedman said.

Dr. Friedman noted that the study is limited by its reliance on self-reporting of ED visits and because it is cross-sectional. Dr. Friedman reported no disclosures other than the study funding.

CHICAGO – Headache is the fifth most common emergency department complaint, but only a small percentage of migraineurs use emergency care for treatment, according to an analysis of the American Migraine Prevalence and Prevention study presented at the annual meeting of the American Headache Society.

Dr. Benjamin Friedman of the Albert Einstein College of Medicine, New York, said he and his colleagues sought to determine how often Americans with headache use the ED or an urgent care facility, and what the risk factors were for frequent use.

The goal of the study was to discern ways to prevent urgent headache visits. Currently there are about 5 million visits a year for headache, he said.

The American Migraine Prevalence and Prevention study (AMPP) is an ongoing multisite survey that began in 2004 when a self-administered headache questionnaire was mailed to a random sample of 120,000 households. The study was supported by a grant to the National Headache Foundation from Ortho-McNeil Inc. Of the 162,576 individuals who responded, 30,721 self-reported severe headaches. Dr. Friedman and his colleagues mailed a follow-up survey in 2005 to a random subsample of 24,000 of the headache sufferers, asking for data on emergency or urgent care use within the previous 12 months.

Data were collected on 13,451 respondents. Among those categorized with migraine or probable migraine, 94% did not visit the emergency department at all, leaving 859 patients who did report a visit. Among those, 48% (412) reported only one visit within the past year. About a third (274) reported 2–3 visits, only 14% (120) reported up to nine visits, and 53 patients reported more than nine visits.

The frequent users, which he classified as 20% of the 859 ED visitors, accounted for 51% of all visits.

The most-cited reasons for going to the ED or urgent care facility included unbearable pain, the inability to reach a primary physician, the ability to get better or different medications, and concern about the significance of the pain (for instance, whether it might be the result of meningitis). A small number of patients said the ED was the primary source of care, and an equal number cited insurance or other financial barriers to care as the reason why they went to an urgent facility instead of a primary physician.

Using a multivariate analysis, Dr. Friedman and his colleagues determined that the main risk factors for urgent care use were the use of those facilities for nonheadache care and a severe migraine disability assessment scale (MIDAS) score. Having insurance was protective against ED visits, he said. The risk factors were similar in frequent ED users, with stronger associations.

The investigators concluded that urgent care facilities are used infrequently for the management of severe headache on a population level, but–because the disorder is so prevalent–headache is a common complaint in the ED. Frequent users are uncommon, but they account for the majority of visits to ED and urgent care. In terms of modifiable risk factors, ED use is associated with more severe headache, so treating the underlying headache may help prevent urgent care visits, Dr. Friedman said.

Dr. Friedman noted that the study is limited by its reliance on self-reporting of ED visits and because it is cross-sectional. Dr. Friedman reported no disclosures other than the study funding.

CHICAGO – Headache is the fifth most common emergency department complaint, but only a small percentage of migraineurs use emergency care for treatment, according to an analysis of the American Migraine Prevalence and Prevention study presented at the annual meeting of the American Headache Society.

Dr. Benjamin Friedman of the Albert Einstein College of Medicine, New York, said he and his colleagues sought to determine how often Americans with headache use the ED or an urgent care facility, and what the risk factors were for frequent use.

The goal of the study was to discern ways to prevent urgent headache visits. Currently there are about 5 million visits a year for headache, he said.

The American Migraine Prevalence and Prevention study (AMPP) is an ongoing multisite survey that began in 2004 when a self-administered headache questionnaire was mailed to a random sample of 120,000 households. The study was supported by a grant to the National Headache Foundation from Ortho-McNeil Inc. Of the 162,576 individuals who responded, 30,721 self-reported severe headaches. Dr. Friedman and his colleagues mailed a follow-up survey in 2005 to a random subsample of 24,000 of the headache sufferers, asking for data on emergency or urgent care use within the previous 12 months.

Data were collected on 13,451 respondents. Among those categorized with migraine or probable migraine, 94% did not visit the emergency department at all, leaving 859 patients who did report a visit. Among those, 48% (412) reported only one visit within the past year. About a third (274) reported 2–3 visits, only 14% (120) reported up to nine visits, and 53 patients reported more than nine visits.

The frequent users, which he classified as 20% of the 859 ED visitors, accounted for 51% of all visits.

The most-cited reasons for going to the ED or urgent care facility included unbearable pain, the inability to reach a primary physician, the ability to get better or different medications, and concern about the significance of the pain (for instance, whether it might be the result of meningitis). A small number of patients said the ED was the primary source of care, and an equal number cited insurance or other financial barriers to care as the reason why they went to an urgent facility instead of a primary physician.

Using a multivariate analysis, Dr. Friedman and his colleagues determined that the main risk factors for urgent care use were the use of those facilities for nonheadache care and a severe migraine disability assessment scale (MIDAS) score. Having insurance was protective against ED visits, he said. The risk factors were similar in frequent ED users, with stronger associations.

The investigators concluded that urgent care facilities are used infrequently for the management of severe headache on a population level, but–because the disorder is so prevalent–headache is a common complaint in the ED. Frequent users are uncommon, but they account for the majority of visits to ED and urgent care. In terms of modifiable risk factors, ED use is associated with more severe headache, so treating the underlying headache may help prevent urgent care visits, Dr. Friedman said.

Dr. Friedman noted that the study is limited by its reliance on self-reporting of ED visits and because it is cross-sectional. Dr. Friedman reported no disclosures other than the study funding.

NEW ORLEANS – Rates of suicide are highest, proportionately, among the elderly, and seem to be very high among seniors who receive home care in the Rochester, N.Y., area, according to a poster presented at the annual meeting of the American Association for Geriatric Psychiatry.

Thomas Richardson, P.A., and his coinvestigator, Dr. Yeates Conwell, both of the University of Rochester, were looking for precursors of suicide in an attempt to determine how to prevent it.

They randomly selected and interviewed clients receiving home care through the Aging Services Network of Rochester. Overall, 211 patients were selected. Most were white (88%) and female (69%), and 101 patients (48%) lived alone. The mean age was 77 years, with a range of 60–102. This also was a fairly low-income group, with almost 45% of the patients having an income of less than $1,250 a month.

They were evaluated using the Paykel Suicide Scale, the physical activities of daily living and instrumental activities of daily living scales, a modified version of the Louisville Older Persons Events Scale, Lubben Social Network Scale, and the Multidimensional Scale of Perceived Social Support.

Of the 211 patients, 65 admitted to feeling that life was not worth living in the past year, 44 said they had wished they were dead, 21 thought of taking their own life, and 8 seriously considered taking their own life, they wrote.

Some of the patients had these thoughts before. Seven percent, or 14 patients, admitted to at least one lifetime suicide attempt and 2 had tried in the past year.

Patients with lower functional status, more stressful life events, and less social support were at higher risk for suicidal ideation.

Mr. Richardson said the rates were surprising to him, despite the high numbers of suicides nationally each year. He and Dr. Conwell are hoping to build a network of providers who can reach out to these home-based patients and provide suicide prevention and treatment. They have received a 5-year grant from the National Institute of Mental Health to develop a system in which social workers would treat home care patients for depression and interface with physicians.

NEW ORLEANS – Rates of suicide are highest, proportionately, among the elderly, and seem to be very high among seniors who receive home care in the Rochester, N.Y., area, according to a poster presented at the annual meeting of the American Association for Geriatric Psychiatry.

Thomas Richardson, P.A., and his coinvestigator, Dr. Yeates Conwell, both of the University of Rochester, were looking for precursors of suicide in an attempt to determine how to prevent it.

They randomly selected and interviewed clients receiving home care through the Aging Services Network of Rochester. Overall, 211 patients were selected. Most were white (88%) and female (69%), and 101 patients (48%) lived alone. The mean age was 77 years, with a range of 60–102. This also was a fairly low-income group, with almost 45% of the patients having an income of less than $1,250 a month.

They were evaluated using the Paykel Suicide Scale, the physical activities of daily living and instrumental activities of daily living scales, a modified version of the Louisville Older Persons Events Scale, Lubben Social Network Scale, and the Multidimensional Scale of Perceived Social Support.

Of the 211 patients, 65 admitted to feeling that life was not worth living in the past year, 44 said they had wished they were dead, 21 thought of taking their own life, and 8 seriously considered taking their own life, they wrote.

Some of the patients had these thoughts before. Seven percent, or 14 patients, admitted to at least one lifetime suicide attempt and 2 had tried in the past year.

Patients with lower functional status, more stressful life events, and less social support were at higher risk for suicidal ideation.

Mr. Richardson said the rates were surprising to him, despite the high numbers of suicides nationally each year. He and Dr. Conwell are hoping to build a network of providers who can reach out to these home-based patients and provide suicide prevention and treatment. They have received a 5-year grant from the National Institute of Mental Health to develop a system in which social workers would treat home care patients for depression and interface with physicians.

NEW ORLEANS – Rates of suicide are highest, proportionately, among the elderly, and seem to be very high among seniors who receive home care in the Rochester, N.Y., area, according to a poster presented at the annual meeting of the American Association for Geriatric Psychiatry.

Thomas Richardson, P.A., and his coinvestigator, Dr. Yeates Conwell, both of the University of Rochester, were looking for precursors of suicide in an attempt to determine how to prevent it.

They randomly selected and interviewed clients receiving home care through the Aging Services Network of Rochester. Overall, 211 patients were selected. Most were white (88%) and female (69%), and 101 patients (48%) lived alone. The mean age was 77 years, with a range of 60–102. This also was a fairly low-income group, with almost 45% of the patients having an income of less than $1,250 a month.

They were evaluated using the Paykel Suicide Scale, the physical activities of daily living and instrumental activities of daily living scales, a modified version of the Louisville Older Persons Events Scale, Lubben Social Network Scale, and the Multidimensional Scale of Perceived Social Support.

Of the 211 patients, 65 admitted to feeling that life was not worth living in the past year, 44 said they had wished they were dead, 21 thought of taking their own life, and 8 seriously considered taking their own life, they wrote.

Some of the patients had these thoughts before. Seven percent, or 14 patients, admitted to at least one lifetime suicide attempt and 2 had tried in the past year.

Patients with lower functional status, more stressful life events, and less social support were at higher risk for suicidal ideation.

Mr. Richardson said the rates were surprising to him, despite the high numbers of suicides nationally each year. He and Dr. Conwell are hoping to build a network of providers who can reach out to these home-based patients and provide suicide prevention and treatment. They have received a 5-year grant from the National Institute of Mental Health to develop a system in which social workers would treat home care patients for depression and interface with physicians.