Mary Ellen Schneider

Courts Strike Abortion Restrictions

Judges in two Plains states have blocked abortion restrictions from taking effect in their jurisdictions. Oklahoma District Court Judge Vicki Robertson ruled that a state law requiring an ultrasound before an abortion could be performed was too broad. The state is expected to appeal the case to the Oklahoma Supreme Court. In South Dakota, a U.S. District Court struck down parts of a state law outlining informed consent requirements for abortion. The court ruled as unconstitutional provisions requiring physicians to tell women that suicide and suicide ideation are known medical risks associated with abortion. The court also struck down the provision that required physicians to say that having an abortion would terminate an “existing relationship” between the woman and the fetus. However, the court let stand a requirement that physicians tell women that by choosing an abortion they will “terminate the life of a whole, separate, unique, living human being.”

Home Visits Could Get Boost

Initiatives to teach parenting skills to at-risk mothers in their homes could be gaining political traction, according to the Guttmacher Institute. The programs bring in nurses or social workers to guide mothers and prevent child abuse. While such programs have received federal and state funds, there has been no ongoing, dedicated source of support. This could change, according to the institute's analysis, because the programs have the potential to be favored by both abortion rights advocates and abortion foes. “Interventions with a strong family planning component help vulnerable women delay subsequent pregnancies and increase birth spacing, and also help improve women's parenting skills,” said Heather D. Boonstra, a senior public policy associate at the Guttmacher Institute, in a statement. “That's why expanding home visiting programs is an effort that partisans on both sides of the abortion debate should be able to get behind.” President Obama has proposed more than $8 billion in support over the next decade, but the programs are costly and may suffer under tight government budgets, according to the analysis.

Survey Shows Career Satisfaction

More than 80% of ob.gyns. report being somewhat or very satisfied with their medical careers, according to a survey from the Center for Studying Health System Change. That figure held among other medical specialties, with about 82% of physicians overall reporting job satisfaction. The nationally representative survey included responses from more than 4,700 U.S. physicians providing direct patient care in 2008. About 15% of ob.gyns. said they were somewhat or very dissatisfied, with the remainder saying they were neither satisfied nor dissatisfied.

Flying Deemed Safe in Pregnancy

Air travel is just as safe for healthy pregnant women as for the general public, according to the American College of Obstetricians and Gynecologists. “Questions from our patients about air travel during pregnancy are some of the most common during obstetric visits,” Dr. William H. Barth Jr., chair of ACOG's Committee on Obstetric Practice, said in a statement. “When a patient with an uncomplicated pregnancy asks about occasional flying, we should feel comfortable saying, 'It's safe.' ” Dr. Barth's committee noted that pregnant women can minimize their risk for lower-extremity edema and venous thrombotic events by using support stockings, periodically moving around, avoiding restrictive clothing, and staying hydrated. But while seated, pregnant women should use a seatbelt “low on the hipbones, between the protuberant abdomen and pelvis.” And “gas-producing foods or drinks should be avoided before scheduled flights because entrapped gases expand at altitude.” ACOG said it also aims to dispel concerns about radiation during flights. Occasional travelers are unlikely to exceed more than 15% of the radiation limit for a 40-week pregnancy even during the longest intercontinental flight, ACOG said. However, airline crewmembers and frequent flyers could exceed the limit during pregnancy. But flying isn't recommended for women who may need emergency care or who have medical or obstetric conditions that would be aggravated by flying, said ACOG. Its opinion was to be published in this month's issue of Obstetrics and Gynecology.

HHS Awards Adoption Incentives

The Department of Health and Human Services announced the distribution of $35 million to 38 states and Puerto Rico to increase adoptions among children in foster care. Congress created the Adoptions Incentive program in 1997 as part of the Adoption and Safe Families Act, particularly to move older children and those with special needs into permanent homes. As part of the program, states can earn $4,000 for each additional adopted foster child above a baseline rate established in 2007. They receive additional payments for the adoption of foster children older than age 8 and those with special needs. States use the incentive payments to improve their programs for abused and neglected children

Courts Strike Abortion Restrictions

Judges in two Plains states have blocked abortion restrictions from taking effect in their jurisdictions. Oklahoma District Court Judge Vicki Robertson ruled that a state law requiring an ultrasound before an abortion could be performed was too broad. The state is expected to appeal the case to the Oklahoma Supreme Court. In South Dakota, a U.S. District Court struck down parts of a state law outlining informed consent requirements for abortion. The court ruled as unconstitutional provisions requiring physicians to tell women that suicide and suicide ideation are known medical risks associated with abortion. The court also struck down the provision that required physicians to say that having an abortion would terminate an “existing relationship” between the woman and the fetus. However, the court let stand a requirement that physicians tell women that by choosing an abortion they will “terminate the life of a whole, separate, unique, living human being.”

Home Visits Could Get Boost

Initiatives to teach parenting skills to at-risk mothers in their homes could be gaining political traction, according to the Guttmacher Institute. The programs bring in nurses or social workers to guide mothers and prevent child abuse. While such programs have received federal and state funds, there has been no ongoing, dedicated source of support. This could change, according to the institute's analysis, because the programs have the potential to be favored by both abortion rights advocates and abortion foes. “Interventions with a strong family planning component help vulnerable women delay subsequent pregnancies and increase birth spacing, and also help improve women's parenting skills,” said Heather D. Boonstra, a senior public policy associate at the Guttmacher Institute, in a statement. “That's why expanding home visiting programs is an effort that partisans on both sides of the abortion debate should be able to get behind.” President Obama has proposed more than $8 billion in support over the next decade, but the programs are costly and may suffer under tight government budgets, according to the analysis.

Survey Shows Career Satisfaction

More than 80% of ob.gyns. report being somewhat or very satisfied with their medical careers, according to a survey from the Center for Studying Health System Change. That figure held among other medical specialties, with about 82% of physicians overall reporting job satisfaction. The nationally representative survey included responses from more than 4,700 U.S. physicians providing direct patient care in 2008. About 15% of ob.gyns. said they were somewhat or very dissatisfied, with the remainder saying they were neither satisfied nor dissatisfied.

Flying Deemed Safe in Pregnancy

Air travel is just as safe for healthy pregnant women as for the general public, according to the American College of Obstetricians and Gynecologists. “Questions from our patients about air travel during pregnancy are some of the most common during obstetric visits,” Dr. William H. Barth Jr., chair of ACOG's Committee on Obstetric Practice, said in a statement. “When a patient with an uncomplicated pregnancy asks about occasional flying, we should feel comfortable saying, 'It's safe.' ” Dr. Barth's committee noted that pregnant women can minimize their risk for lower-extremity edema and venous thrombotic events by using support stockings, periodically moving around, avoiding restrictive clothing, and staying hydrated. But while seated, pregnant women should use a seatbelt “low on the hipbones, between the protuberant abdomen and pelvis.” And “gas-producing foods or drinks should be avoided before scheduled flights because entrapped gases expand at altitude.” ACOG said it also aims to dispel concerns about radiation during flights. Occasional travelers are unlikely to exceed more than 15% of the radiation limit for a 40-week pregnancy even during the longest intercontinental flight, ACOG said. However, airline crewmembers and frequent flyers could exceed the limit during pregnancy. But flying isn't recommended for women who may need emergency care or who have medical or obstetric conditions that would be aggravated by flying, said ACOG. Its opinion was to be published in this month's issue of Obstetrics and Gynecology.

HHS Awards Adoption Incentives

The Department of Health and Human Services announced the distribution of $35 million to 38 states and Puerto Rico to increase adoptions among children in foster care. Congress created the Adoptions Incentive program in 1997 as part of the Adoption and Safe Families Act, particularly to move older children and those with special needs into permanent homes. As part of the program, states can earn $4,000 for each additional adopted foster child above a baseline rate established in 2007. They receive additional payments for the adoption of foster children older than age 8 and those with special needs. States use the incentive payments to improve their programs for abused and neglected children

Courts Strike Abortion Restrictions

Judges in two Plains states have blocked abortion restrictions from taking effect in their jurisdictions. Oklahoma District Court Judge Vicki Robertson ruled that a state law requiring an ultrasound before an abortion could be performed was too broad. The state is expected to appeal the case to the Oklahoma Supreme Court. In South Dakota, a U.S. District Court struck down parts of a state law outlining informed consent requirements for abortion. The court ruled as unconstitutional provisions requiring physicians to tell women that suicide and suicide ideation are known medical risks associated with abortion. The court also struck down the provision that required physicians to say that having an abortion would terminate an “existing relationship” between the woman and the fetus. However, the court let stand a requirement that physicians tell women that by choosing an abortion they will “terminate the life of a whole, separate, unique, living human being.”

Home Visits Could Get Boost

Initiatives to teach parenting skills to at-risk mothers in their homes could be gaining political traction, according to the Guttmacher Institute. The programs bring in nurses or social workers to guide mothers and prevent child abuse. While such programs have received federal and state funds, there has been no ongoing, dedicated source of support. This could change, according to the institute's analysis, because the programs have the potential to be favored by both abortion rights advocates and abortion foes. “Interventions with a strong family planning component help vulnerable women delay subsequent pregnancies and increase birth spacing, and also help improve women's parenting skills,” said Heather D. Boonstra, a senior public policy associate at the Guttmacher Institute, in a statement. “That's why expanding home visiting programs is an effort that partisans on both sides of the abortion debate should be able to get behind.” President Obama has proposed more than $8 billion in support over the next decade, but the programs are costly and may suffer under tight government budgets, according to the analysis.

Survey Shows Career Satisfaction

More than 80% of ob.gyns. report being somewhat or very satisfied with their medical careers, according to a survey from the Center for Studying Health System Change. That figure held among other medical specialties, with about 82% of physicians overall reporting job satisfaction. The nationally representative survey included responses from more than 4,700 U.S. physicians providing direct patient care in 2008. About 15% of ob.gyns. said they were somewhat or very dissatisfied, with the remainder saying they were neither satisfied nor dissatisfied.

Flying Deemed Safe in Pregnancy

Air travel is just as safe for healthy pregnant women as for the general public, according to the American College of Obstetricians and Gynecologists. “Questions from our patients about air travel during pregnancy are some of the most common during obstetric visits,” Dr. William H. Barth Jr., chair of ACOG's Committee on Obstetric Practice, said in a statement. “When a patient with an uncomplicated pregnancy asks about occasional flying, we should feel comfortable saying, 'It's safe.' ” Dr. Barth's committee noted that pregnant women can minimize their risk for lower-extremity edema and venous thrombotic events by using support stockings, periodically moving around, avoiding restrictive clothing, and staying hydrated. But while seated, pregnant women should use a seatbelt “low on the hipbones, between the protuberant abdomen and pelvis.” And “gas-producing foods or drinks should be avoided before scheduled flights because entrapped gases expand at altitude.” ACOG said it also aims to dispel concerns about radiation during flights. Occasional travelers are unlikely to exceed more than 15% of the radiation limit for a 40-week pregnancy even during the longest intercontinental flight, ACOG said. However, airline crewmembers and frequent flyers could exceed the limit during pregnancy. But flying isn't recommended for women who may need emergency care or who have medical or obstetric conditions that would be aggravated by flying, said ACOG. Its opinion was to be published in this month's issue of Obstetrics and Gynecology.

HHS Awards Adoption Incentives

The Department of Health and Human Services announced the distribution of $35 million to 38 states and Puerto Rico to increase adoptions among children in foster care. Congress created the Adoptions Incentive program in 1997 as part of the Adoption and Safe Families Act, particularly to move older children and those with special needs into permanent homes. As part of the program, states can earn $4,000 for each additional adopted foster child above a baseline rate established in 2007. They receive additional payments for the adoption of foster children older than age 8 and those with special needs. States use the incentive payments to improve their programs for abused and neglected children

$1.3 B Penalty for Bextra Fraud

Pharmacia & Upjohn Co., a subsidiary of Pfizer Inc., has agreed to pay $1.3 billion in criminal penalties to resolve charges that it illegally promoted the arthritis drug Bextra (valdecoxib) for off-label uses such as general acute pain and surgical pain. The company had originally sought approval from the Food and Drug Administration to market the NSAID at a higher dose for general pain relief, but the agency rejected the application because of safety concerns. The U.S. Attorney's Office charged that from February 2002 until Bextra was removed from the market in April 2005, Pharmacia & Upjohn continued to promote the drug for the unapproved uses without mentioning the FDA's safety concerns. Under a plea agreement, Pharmacia & Upjohn agreed to pay a fine of nearly $1.2 billion and forfeit an additional $105 million. In early September, Pfizer agreed to pay $1 billion plus interest to settle civil claims that it had fraudulently promoted Bextra and three other drugs.

VA Links Bone Loss, POW Status

The federal government has officially recognized a link between being a prisoner of war (POW) and developing osteoporosis. As of August, the Department of Veterans Affairs established a presumption of service connection for osteoporosis among former POWs who were interned for at least 30 days and whose osteoporosis is at least 10% disabling. The VA also established the connection for POWs, regardless of length of imprisonment, who have a diagnosis of posttraumatic stress disorder and osteoporosis that is at least 10% disabling. Creating a presumption of service connection means that these veterans won't have to prove that their condition was caused by their military service in order to receive VA benefits. The VA said that several studies have shown that POWs have suffered serious bone loss because of dietary deficiencies during their imprisonments.

Boomers Ring Up Big Hospital Bills

U.S. hospitals spent nearly $56 billion caring for baby boomers in 2007, almost as much as they spent on older patients, according to a report from the Agency for Healthcare Research and Quality. The agency reported that baby boomers (adults aged 55–64 years) were similar to adults aged 65–74 years in their lengths of hospital stays, costs, and percentages of elective hospitalizations. Overall, baby boomers had 4.7 million hospitalizations in 2007 and accounted for 16% of the total hospital costs in the United States. Osteoporosis ranked second on the list, with 6.9 stays per 1,000 patients.

Insurance Premiums Exceed $13K

The average premium for employer-sponsored health insurance rose again this year, reaching $13,375 for family coverage and $4,824 for an individual, according to a survey of employers. Over the past decade, family premiums have risen 131%, outpacing both wages (up 38%) and inflation (up 28%) during the period. The annual survey, released by the Kaiser Family Foundation and the Health Research & Educational Trust, included responses from more than 3,100 firms. About 60% reported offering health benefits to their employees in 2009. But some said they had to cut back because of the poor economy. About 21% of businesses that offer insurance said they reduced benefits this year or increased employee cost sharing. The trend could continue into 2010. About 21% of the firms said they are “very likely” to raise their employees' premium contributions next year, and 16% said they are “very likely” to raise deductibles.

Supplement Maker Fined $70 M

In a case brought by the Federal Trade Commission, a marketing group that used infomercials to tout calcium and herbal supplements as effective treatments for autoimmune conditions cancer, Parkinson's disease, and heart disease has been ordered to pay about $70 million in consumer refunds. The U.S. District Court for the District of Massachusetts ruled in 2008 that the companies and individuals had falsely represented the supplements' safety and efficacy. Judge George O'toole considered financial penalties separately, and has now ordered the restitution in order to strip from the defendants all profits derived from the supplement sales.

MDs Lips Say 'No', Eyes Say 'Yes'

Despite concerns about physicians' willingness to accept new patients from public programs, most U.S. doctors say they're doing so, according to a Center for Studying Health System Change survey. About three-quarters of physicians reported accepting new Medicare patients and more than half took new Medicaid patients. The public programs provided nearly half of physicians' practice revenue in 2008, according to the survey. Other findings: Nearly one-third of physicians work in solo or two-physician practices. And the composition of the physician workforce by sex appears to be changing: Although nearly three-quarters of U.S. physicians were men in 2008, about 41% of those younger than 40 were women, a trend that the center says will continue.

$1.3 B Penalty for Bextra Fraud

Pharmacia & Upjohn Co., a subsidiary of Pfizer Inc., has agreed to pay $1.3 billion in criminal penalties to resolve charges that it illegally promoted the arthritis drug Bextra (valdecoxib) for off-label uses such as general acute pain and surgical pain. The company had originally sought approval from the Food and Drug Administration to market the NSAID at a higher dose for general pain relief, but the agency rejected the application because of safety concerns. The U.S. Attorney's Office charged that from February 2002 until Bextra was removed from the market in April 2005, Pharmacia & Upjohn continued to promote the drug for the unapproved uses without mentioning the FDA's safety concerns. Under a plea agreement, Pharmacia & Upjohn agreed to pay a fine of nearly $1.2 billion and forfeit an additional $105 million. In early September, Pfizer agreed to pay $1 billion plus interest to settle civil claims that it had fraudulently promoted Bextra and three other drugs.

VA Links Bone Loss, POW Status

The federal government has officially recognized a link between being a prisoner of war (POW) and developing osteoporosis. As of August, the Department of Veterans Affairs established a presumption of service connection for osteoporosis among former POWs who were interned for at least 30 days and whose osteoporosis is at least 10% disabling. The VA also established the connection for POWs, regardless of length of imprisonment, who have a diagnosis of posttraumatic stress disorder and osteoporosis that is at least 10% disabling. Creating a presumption of service connection means that these veterans won't have to prove that their condition was caused by their military service in order to receive VA benefits. The VA said that several studies have shown that POWs have suffered serious bone loss because of dietary deficiencies during their imprisonments.

Boomers Ring Up Big Hospital Bills

U.S. hospitals spent nearly $56 billion caring for baby boomers in 2007, almost as much as they spent on older patients, according to a report from the Agency for Healthcare Research and Quality. The agency reported that baby boomers (adults aged 55–64 years) were similar to adults aged 65–74 years in their lengths of hospital stays, costs, and percentages of elective hospitalizations. Overall, baby boomers had 4.7 million hospitalizations in 2007 and accounted for 16% of the total hospital costs in the United States. Osteoporosis ranked second on the list, with 6.9 stays per 1,000 patients.

Insurance Premiums Exceed $13K

The average premium for employer-sponsored health insurance rose again this year, reaching $13,375 for family coverage and $4,824 for an individual, according to a survey of employers. Over the past decade, family premiums have risen 131%, outpacing both wages (up 38%) and inflation (up 28%) during the period. The annual survey, released by the Kaiser Family Foundation and the Health Research & Educational Trust, included responses from more than 3,100 firms. About 60% reported offering health benefits to their employees in 2009. But some said they had to cut back because of the poor economy. About 21% of businesses that offer insurance said they reduced benefits this year or increased employee cost sharing. The trend could continue into 2010. About 21% of the firms said they are “very likely” to raise their employees' premium contributions next year, and 16% said they are “very likely” to raise deductibles.

Supplement Maker Fined $70 M

In a case brought by the Federal Trade Commission, a marketing group that used infomercials to tout calcium and herbal supplements as effective treatments for autoimmune conditions cancer, Parkinson's disease, and heart disease has been ordered to pay about $70 million in consumer refunds. The U.S. District Court for the District of Massachusetts ruled in 2008 that the companies and individuals had falsely represented the supplements' safety and efficacy. Judge George O'toole considered financial penalties separately, and has now ordered the restitution in order to strip from the defendants all profits derived from the supplement sales.

MDs Lips Say 'No', Eyes Say 'Yes'

Despite concerns about physicians' willingness to accept new patients from public programs, most U.S. doctors say they're doing so, according to a Center for Studying Health System Change survey. About three-quarters of physicians reported accepting new Medicare patients and more than half took new Medicaid patients. The public programs provided nearly half of physicians' practice revenue in 2008, according to the survey. Other findings: Nearly one-third of physicians work in solo or two-physician practices. And the composition of the physician workforce by sex appears to be changing: Although nearly three-quarters of U.S. physicians were men in 2008, about 41% of those younger than 40 were women, a trend that the center says will continue.

$1.3 B Penalty for Bextra Fraud

Pharmacia & Upjohn Co., a subsidiary of Pfizer Inc., has agreed to pay $1.3 billion in criminal penalties to resolve charges that it illegally promoted the arthritis drug Bextra (valdecoxib) for off-label uses such as general acute pain and surgical pain. The company had originally sought approval from the Food and Drug Administration to market the NSAID at a higher dose for general pain relief, but the agency rejected the application because of safety concerns. The U.S. Attorney's Office charged that from February 2002 until Bextra was removed from the market in April 2005, Pharmacia & Upjohn continued to promote the drug for the unapproved uses without mentioning the FDA's safety concerns. Under a plea agreement, Pharmacia & Upjohn agreed to pay a fine of nearly $1.2 billion and forfeit an additional $105 million. In early September, Pfizer agreed to pay $1 billion plus interest to settle civil claims that it had fraudulently promoted Bextra and three other drugs.

VA Links Bone Loss, POW Status

The federal government has officially recognized a link between being a prisoner of war (POW) and developing osteoporosis. As of August, the Department of Veterans Affairs established a presumption of service connection for osteoporosis among former POWs who were interned for at least 30 days and whose osteoporosis is at least 10% disabling. The VA also established the connection for POWs, regardless of length of imprisonment, who have a diagnosis of posttraumatic stress disorder and osteoporosis that is at least 10% disabling. Creating a presumption of service connection means that these veterans won't have to prove that their condition was caused by their military service in order to receive VA benefits. The VA said that several studies have shown that POWs have suffered serious bone loss because of dietary deficiencies during their imprisonments.

Boomers Ring Up Big Hospital Bills

U.S. hospitals spent nearly $56 billion caring for baby boomers in 2007, almost as much as they spent on older patients, according to a report from the Agency for Healthcare Research and Quality. The agency reported that baby boomers (adults aged 55–64 years) were similar to adults aged 65–74 years in their lengths of hospital stays, costs, and percentages of elective hospitalizations. Overall, baby boomers had 4.7 million hospitalizations in 2007 and accounted for 16% of the total hospital costs in the United States. Osteoporosis ranked second on the list, with 6.9 stays per 1,000 patients.

Insurance Premiums Exceed $13K

The average premium for employer-sponsored health insurance rose again this year, reaching $13,375 for family coverage and $4,824 for an individual, according to a survey of employers. Over the past decade, family premiums have risen 131%, outpacing both wages (up 38%) and inflation (up 28%) during the period. The annual survey, released by the Kaiser Family Foundation and the Health Research & Educational Trust, included responses from more than 3,100 firms. About 60% reported offering health benefits to their employees in 2009. But some said they had to cut back because of the poor economy. About 21% of businesses that offer insurance said they reduced benefits this year or increased employee cost sharing. The trend could continue into 2010. About 21% of the firms said they are “very likely” to raise their employees' premium contributions next year, and 16% said they are “very likely” to raise deductibles.

Supplement Maker Fined $70 M

In a case brought by the Federal Trade Commission, a marketing group that used infomercials to tout calcium and herbal supplements as effective treatments for autoimmune conditions cancer, Parkinson's disease, and heart disease has been ordered to pay about $70 million in consumer refunds. The U.S. District Court for the District of Massachusetts ruled in 2008 that the companies and individuals had falsely represented the supplements' safety and efficacy. Judge George O'toole considered financial penalties separately, and has now ordered the restitution in order to strip from the defendants all profits derived from the supplement sales.

MDs Lips Say 'No', Eyes Say 'Yes'

Despite concerns about physicians' willingness to accept new patients from public programs, most U.S. doctors say they're doing so, according to a Center for Studying Health System Change survey. About three-quarters of physicians reported accepting new Medicare patients and more than half took new Medicaid patients. The public programs provided nearly half of physicians' practice revenue in 2008, according to the survey. Other findings: Nearly one-third of physicians work in solo or two-physician practices. And the composition of the physician workforce by sex appears to be changing: Although nearly three-quarters of U.S. physicians were men in 2008, about 41% of those younger than 40 were women, a trend that the center says will continue.

Physicians have a little more than 2 years to complete their transition to new HIPAA X12 standards for submitting administrative transactions electronically, according to Medicare officials.

As of Jan. 1, 2012, physicians and all other entities covered under HIPAA (Health Insurance Portability and Accountability Act) will be required to use the HIPAA X12 version 5010 format when submitting claims, receiving remittances, and sending claim status or eligibility inquiries electronically. The new standard replaces the version 4010A1 currently in use. The change will affect dealings not only with Medicare, but also with all private payers.

The Medicare fee-for-service program will begin its own system testing next year and will begin accepting administrative transactions using the 5010 version as of Jan. 1, 2011. Throughout 2011, the Centers for Medicare and Medicaid Services will accept both the 5010 and 4010A1 versions. However, beginning on Jan. 1, 2012, only transactions submitted using the 5010 version will be accepted.

During a recent conference call to update providers, CMS officials urged physicians not to wait until the last minute to make the transition to the new format.

The switch is necessary, according to the CMS, because the 4010A1 version is outdated. For example, the industry currently relies heavily on companion guides to implement the standards, which limits their value.

The new version includes some new functions aimed at improving claims processing. But Medicare officials urged physicians to analyze the new version carefully prior to implementation. A comparison of the current and new formats can be viewed online at www.cms.hhs.gov/ElectronicBillingEDITrans/18_5010D0.asp

Physicians have a little more than 2 years to complete their transition to new HIPAA X12 standards for submitting administrative transactions electronically, according to Medicare officials.

As of Jan. 1, 2012, physicians and all other entities covered under HIPAA (Health Insurance Portability and Accountability Act) will be required to use the HIPAA X12 version 5010 format when submitting claims, receiving remittances, and sending claim status or eligibility inquiries electronically. The new standard replaces the version 4010A1 currently in use. The change will affect dealings not only with Medicare, but also with all private payers.

The Medicare fee-for-service program will begin its own system testing next year and will begin accepting administrative transactions using the 5010 version as of Jan. 1, 2011. Throughout 2011, the Centers for Medicare and Medicaid Services will accept both the 5010 and 4010A1 versions. However, beginning on Jan. 1, 2012, only transactions submitted using the 5010 version will be accepted.

During a recent conference call to update providers, CMS officials urged physicians not to wait until the last minute to make the transition to the new format.

The switch is necessary, according to the CMS, because the 4010A1 version is outdated. For example, the industry currently relies heavily on companion guides to implement the standards, which limits their value.

The new version includes some new functions aimed at improving claims processing. But Medicare officials urged physicians to analyze the new version carefully prior to implementation. A comparison of the current and new formats can be viewed online at www.cms.hhs.gov/ElectronicBillingEDITrans/18_5010D0.asp

Physicians have a little more than 2 years to complete their transition to new HIPAA X12 standards for submitting administrative transactions electronically, according to Medicare officials.

As of Jan. 1, 2012, physicians and all other entities covered under HIPAA (Health Insurance Portability and Accountability Act) will be required to use the HIPAA X12 version 5010 format when submitting claims, receiving remittances, and sending claim status or eligibility inquiries electronically. The new standard replaces the version 4010A1 currently in use. The change will affect dealings not only with Medicare, but also with all private payers.

The Medicare fee-for-service program will begin its own system testing next year and will begin accepting administrative transactions using the 5010 version as of Jan. 1, 2011. Throughout 2011, the Centers for Medicare and Medicaid Services will accept both the 5010 and 4010A1 versions. However, beginning on Jan. 1, 2012, only transactions submitted using the 5010 version will be accepted.

During a recent conference call to update providers, CMS officials urged physicians not to wait until the last minute to make the transition to the new format.

The switch is necessary, according to the CMS, because the 4010A1 version is outdated. For example, the industry currently relies heavily on companion guides to implement the standards, which limits their value.

The new version includes some new functions aimed at improving claims processing. But Medicare officials urged physicians to analyze the new version carefully prior to implementation. A comparison of the current and new formats can be viewed online at www.cms.hhs.gov/ElectronicBillingEDITrans/18_5010D0.asp

Medicare will cover both the seasonal influenza vaccine and a vaccine against the pandemic influenza A(H1N1) virus, once one becomes available this fall.

In a notice to physicians and other health care providers, officials at the Centers for Medicare and Medicaid Services said that the same billing rules will apply to the pandemic H1N1 vaccine and the seasonal vaccine. However, because the pandemic H1N1 vaccine will be provided at no cost by the government, Medicare will pay providers only for its administration.

The CMS has issued two new billing codes to address H1N1 vaccine this season. Providers can use G9141 for pandemic influenza A(H1N1) immunization administration, including physician counseling of the patient and family. Payment for G9141 will be the same as that for the administration of the seasonal influenza vaccine. The CMS also has created a billing code, G9142, for the pandemic influenza A(H1N1) vaccine itself. However, that code will not trigger payment. Neither will Medicare pay for an office visit when its sole purpose is administration of either seasonal influenza vaccine or pandemic H1N1 vaccine.

The CMS has notified its carriers to prepare for early claims for the seasonal influenza vaccine. “We understand that such preparations are critical for the upcoming flu season, especially in planning for the influenza [A(H1N1)] vaccine,” the CMS wrote online.

Private insurers are also planning to extend coverage to the pandemic H1N1 vaccine. Susan Pisano, a spokeswoman for America's Health Insurance Plans, the leading insurance industry trade group, said that if an insurer typically covers seasonal influenza vaccine, it will probably cover the pandemic H1N1 vaccination in the same way. As the CMS has announced for Medicare, private plans will not reimburse providers for the cost of the pandemic H1N1 vaccine.

Medicare will cover both the seasonal influenza vaccine and a vaccine against the pandemic influenza A(H1N1) virus, once one becomes available this fall.

In a notice to physicians and other health care providers, officials at the Centers for Medicare and Medicaid Services said that the same billing rules will apply to the pandemic H1N1 vaccine and the seasonal vaccine. However, because the pandemic H1N1 vaccine will be provided at no cost by the government, Medicare will pay providers only for its administration.

The CMS has issued two new billing codes to address H1N1 vaccine this season. Providers can use G9141 for pandemic influenza A(H1N1) immunization administration, including physician counseling of the patient and family. Payment for G9141 will be the same as that for the administration of the seasonal influenza vaccine. The CMS also has created a billing code, G9142, for the pandemic influenza A(H1N1) vaccine itself. However, that code will not trigger payment. Neither will Medicare pay for an office visit when its sole purpose is administration of either seasonal influenza vaccine or pandemic H1N1 vaccine.

The CMS has notified its carriers to prepare for early claims for the seasonal influenza vaccine. “We understand that such preparations are critical for the upcoming flu season, especially in planning for the influenza [A(H1N1)] vaccine,” the CMS wrote online.

Private insurers are also planning to extend coverage to the pandemic H1N1 vaccine. Susan Pisano, a spokeswoman for America's Health Insurance Plans, the leading insurance industry trade group, said that if an insurer typically covers seasonal influenza vaccine, it will probably cover the pandemic H1N1 vaccination in the same way. As the CMS has announced for Medicare, private plans will not reimburse providers for the cost of the pandemic H1N1 vaccine.

Medicare will cover both the seasonal influenza vaccine and a vaccine against the pandemic influenza A(H1N1) virus, once one becomes available this fall.

In a notice to physicians and other health care providers, officials at the Centers for Medicare and Medicaid Services said that the same billing rules will apply to the pandemic H1N1 vaccine and the seasonal vaccine. However, because the pandemic H1N1 vaccine will be provided at no cost by the government, Medicare will pay providers only for its administration.

The CMS has issued two new billing codes to address H1N1 vaccine this season. Providers can use G9141 for pandemic influenza A(H1N1) immunization administration, including physician counseling of the patient and family. Payment for G9141 will be the same as that for the administration of the seasonal influenza vaccine. The CMS also has created a billing code, G9142, for the pandemic influenza A(H1N1) vaccine itself. However, that code will not trigger payment. Neither will Medicare pay for an office visit when its sole purpose is administration of either seasonal influenza vaccine or pandemic H1N1 vaccine.

The CMS has notified its carriers to prepare for early claims for the seasonal influenza vaccine. “We understand that such preparations are critical for the upcoming flu season, especially in planning for the influenza [A(H1N1)] vaccine,” the CMS wrote online.

Private insurers are also planning to extend coverage to the pandemic H1N1 vaccine. Susan Pisano, a spokeswoman for America's Health Insurance Plans, the leading insurance industry trade group, said that if an insurer typically covers seasonal influenza vaccine, it will probably cover the pandemic H1N1 vaccination in the same way. As the CMS has announced for Medicare, private plans will not reimburse providers for the cost of the pandemic H1N1 vaccine.

As Congress debates the role that medical liability reform should play in a larger health reform bill, ob.gyns. are sounding the alarm on the impact of an unregulated liability environment.

A new survey from the American College of Obstetricians and Gynecologists found that 63% of ob.gyns. have changed the way they practice out of fear of being sued. Obstetricians say they have cut back on the number of high-risk patients they see, are no longer performing vaginal birth after a cesarean, and have increased the number of cesarean deliveries they perform. And gynecologists also have made changes because of the liability climate, with some decreasing the surgical procedures they perform.

The survey highlights the impact of medical liability on access to care, said Dr. Albert L. Strunk, deputy executive vice president of ACOG.

The survey shows that in 2009, about 91% of ob.gyns. had at least one liability claim filed against them during their professional careers, for an average of 2.69 claims per physician. Sixty-two percent of all reported claims were for obstetric care, and 38% were for gynecologic care.

This is the 10th time since 1983 that ACOG has assessed the effects of liability litigation and insurance issues on practice. The last survey was conducted in 2006.

Compared with 2006, the overall impact of medical liability remained relatively stable in 2009, Dr. Strunk said. But there were a few positive changes, he noted. For example, the percentage of ob.gyns. who reported having made changes to their practice because of affordability or availability of liability insurance dropped from about 70% in 2006 to 59% in 2009.

For Dr. Jay Trabin, a gynecologist in West Palm Beach, Fla., the cost of medical liability insurance was one of the reasons he gave up obstetrics in 2005. Four years later, he still can't afford liability insurance for his gynecology practice and is practicing “bare.”

At the time he stopped practicing obstetrics, Dr. Trabin said he was paying more than $60,000 a year for minimum coverage of about $250,000 per occurrence and $750,000 a year. That level of coverage probably wouldn't have been enough to protect his practice, he said, since malpractice awards in the state are high.

But the affordability of the insurance wasn't the only factor that led him to drop obstetrics. Dr. Trabin said it was a “perfect storm” of the long hours, decreasing reimbursement, and the view of many patients that any bad outcome was the result of negligence by the physician.

Those types of rising patient expectations and the fear of lawsuits are driving many physicians to practice defensive medicine, Dr. Trabin said in an interview.

Dr. Stuart Weinstein, chairman of Doctors for Medical Liability Reform, agreed that defensive medicine is pervasive and is one of the reasons that lawmakers need to reform the medical liability system.

Usually, defensive medicine comes in the form of assurance behavior, said Dr. Weinstein, who is the chair of orthopedic surgery at the University of Iowa in Iowa City. Physicians order additional tests and consultations to assure themselves they haven't missed anything. “You are protecting yourself, not doing what you think is in the best interests of the patient,” he said in an interview.

As Congress debates the role that medical liability reform should play in a larger health reform bill, ob.gyns. are sounding the alarm on the impact of an unregulated liability environment.

A new survey from the American College of Obstetricians and Gynecologists found that 63% of ob.gyns. have changed the way they practice out of fear of being sued. Obstetricians say they have cut back on the number of high-risk patients they see, are no longer performing vaginal birth after a cesarean, and have increased the number of cesarean deliveries they perform. And gynecologists also have made changes because of the liability climate, with some decreasing the surgical procedures they perform.

The survey highlights the impact of medical liability on access to care, said Dr. Albert L. Strunk, deputy executive vice president of ACOG.

The survey shows that in 2009, about 91% of ob.gyns. had at least one liability claim filed against them during their professional careers, for an average of 2.69 claims per physician. Sixty-two percent of all reported claims were for obstetric care, and 38% were for gynecologic care.

This is the 10th time since 1983 that ACOG has assessed the effects of liability litigation and insurance issues on practice. The last survey was conducted in 2006.

Compared with 2006, the overall impact of medical liability remained relatively stable in 2009, Dr. Strunk said. But there were a few positive changes, he noted. For example, the percentage of ob.gyns. who reported having made changes to their practice because of affordability or availability of liability insurance dropped from about 70% in 2006 to 59% in 2009.

For Dr. Jay Trabin, a gynecologist in West Palm Beach, Fla., the cost of medical liability insurance was one of the reasons he gave up obstetrics in 2005. Four years later, he still can't afford liability insurance for his gynecology practice and is practicing “bare.”

At the time he stopped practicing obstetrics, Dr. Trabin said he was paying more than $60,000 a year for minimum coverage of about $250,000 per occurrence and $750,000 a year. That level of coverage probably wouldn't have been enough to protect his practice, he said, since malpractice awards in the state are high.

But the affordability of the insurance wasn't the only factor that led him to drop obstetrics. Dr. Trabin said it was a “perfect storm” of the long hours, decreasing reimbursement, and the view of many patients that any bad outcome was the result of negligence by the physician.

Those types of rising patient expectations and the fear of lawsuits are driving many physicians to practice defensive medicine, Dr. Trabin said in an interview.

Dr. Stuart Weinstein, chairman of Doctors for Medical Liability Reform, agreed that defensive medicine is pervasive and is one of the reasons that lawmakers need to reform the medical liability system.

Usually, defensive medicine comes in the form of assurance behavior, said Dr. Weinstein, who is the chair of orthopedic surgery at the University of Iowa in Iowa City. Physicians order additional tests and consultations to assure themselves they haven't missed anything. “You are protecting yourself, not doing what you think is in the best interests of the patient,” he said in an interview.

As Congress debates the role that medical liability reform should play in a larger health reform bill, ob.gyns. are sounding the alarm on the impact of an unregulated liability environment.

A new survey from the American College of Obstetricians and Gynecologists found that 63% of ob.gyns. have changed the way they practice out of fear of being sued. Obstetricians say they have cut back on the number of high-risk patients they see, are no longer performing vaginal birth after a cesarean, and have increased the number of cesarean deliveries they perform. And gynecologists also have made changes because of the liability climate, with some decreasing the surgical procedures they perform.

The survey highlights the impact of medical liability on access to care, said Dr. Albert L. Strunk, deputy executive vice president of ACOG.

The survey shows that in 2009, about 91% of ob.gyns. had at least one liability claim filed against them during their professional careers, for an average of 2.69 claims per physician. Sixty-two percent of all reported claims were for obstetric care, and 38% were for gynecologic care.

This is the 10th time since 1983 that ACOG has assessed the effects of liability litigation and insurance issues on practice. The last survey was conducted in 2006.

Compared with 2006, the overall impact of medical liability remained relatively stable in 2009, Dr. Strunk said. But there were a few positive changes, he noted. For example, the percentage of ob.gyns. who reported having made changes to their practice because of affordability or availability of liability insurance dropped from about 70% in 2006 to 59% in 2009.

For Dr. Jay Trabin, a gynecologist in West Palm Beach, Fla., the cost of medical liability insurance was one of the reasons he gave up obstetrics in 2005. Four years later, he still can't afford liability insurance for his gynecology practice and is practicing “bare.”

At the time he stopped practicing obstetrics, Dr. Trabin said he was paying more than $60,000 a year for minimum coverage of about $250,000 per occurrence and $750,000 a year. That level of coverage probably wouldn't have been enough to protect his practice, he said, since malpractice awards in the state are high.

But the affordability of the insurance wasn't the only factor that led him to drop obstetrics. Dr. Trabin said it was a “perfect storm” of the long hours, decreasing reimbursement, and the view of many patients that any bad outcome was the result of negligence by the physician.

Those types of rising patient expectations and the fear of lawsuits are driving many physicians to practice defensive medicine, Dr. Trabin said in an interview.

Dr. Stuart Weinstein, chairman of Doctors for Medical Liability Reform, agreed that defensive medicine is pervasive and is one of the reasons that lawmakers need to reform the medical liability system.

Usually, defensive medicine comes in the form of assurance behavior, said Dr. Weinstein, who is the chair of orthopedic surgery at the University of Iowa in Iowa City. Physicians order additional tests and consultations to assure themselves they haven't missed anything. “You are protecting yourself, not doing what you think is in the best interests of the patient,” he said in an interview.

The percentage of Americans without health insurance stayed steady at about 15.4% in 2008, according to new data from the U.S. Census Bureau.

While the percentage of Americans with private coverage fell from 67.5% in 2007 to 66.7% in 2008, the percentage covered by government health insurance programs like Medicare and Medicaid rose from 27.8% in 2007 to 29% in 2008.

Overall, the number of uninsured Americans increased to 46.3 million in 2008, from 45.7 million the previous year. The new figures, which were released by the Census Bureau on Sept. 10, come from the Annual Social and Economic Supplement to the Current Population Survey. The survey asks questions about health coverage in the previous calendar year.

However, the data may underestimate the number of uninsured. David Johnson, chief of the Census Bureau's Housing and Household Economic Statistics division, said that the Current Population Survey counts individuals as having insurance if they were insured during any part of the year. This could undercount individuals who lost employer-based coverage later in the year due to layoffs.

The Census data also showed that 7.3 million U.S. children (about 9.9%) went without health insurance coverage in 2008. This is the lowest rate and number of uninsured children in the United States since 1987, according to the data. The change may be due to more children gaining health insurance through government programs like the Children's Health Insurance Program. The Census Bureau estimates about 33% of children were enrolled in some type of government health insurance program in 2008, up from 31% the previous year.

The percentage of Americans without health insurance stayed steady at about 15.4% in 2008, according to new data from the U.S. Census Bureau.

While the percentage of Americans with private coverage fell from 67.5% in 2007 to 66.7% in 2008, the percentage covered by government health insurance programs like Medicare and Medicaid rose from 27.8% in 2007 to 29% in 2008.

Overall, the number of uninsured Americans increased to 46.3 million in 2008, from 45.7 million the previous year. The new figures, which were released by the Census Bureau on Sept. 10, come from the Annual Social and Economic Supplement to the Current Population Survey. The survey asks questions about health coverage in the previous calendar year.

However, the data may underestimate the number of uninsured. David Johnson, chief of the Census Bureau's Housing and Household Economic Statistics division, said that the Current Population Survey counts individuals as having insurance if they were insured during any part of the year. This could undercount individuals who lost employer-based coverage later in the year due to layoffs.

The Census data also showed that 7.3 million U.S. children (about 9.9%) went without health insurance coverage in 2008. This is the lowest rate and number of uninsured children in the United States since 1987, according to the data. The change may be due to more children gaining health insurance through government programs like the Children's Health Insurance Program. The Census Bureau estimates about 33% of children were enrolled in some type of government health insurance program in 2008, up from 31% the previous year.

The percentage of Americans without health insurance stayed steady at about 15.4% in 2008, according to new data from the U.S. Census Bureau.

While the percentage of Americans with private coverage fell from 67.5% in 2007 to 66.7% in 2008, the percentage covered by government health insurance programs like Medicare and Medicaid rose from 27.8% in 2007 to 29% in 2008.

Overall, the number of uninsured Americans increased to 46.3 million in 2008, from 45.7 million the previous year. The new figures, which were released by the Census Bureau on Sept. 10, come from the Annual Social and Economic Supplement to the Current Population Survey. The survey asks questions about health coverage in the previous calendar year.

However, the data may underestimate the number of uninsured. David Johnson, chief of the Census Bureau's Housing and Household Economic Statistics division, said that the Current Population Survey counts individuals as having insurance if they were insured during any part of the year. This could undercount individuals who lost employer-based coverage later in the year due to layoffs.

The Census data also showed that 7.3 million U.S. children (about 9.9%) went without health insurance coverage in 2008. This is the lowest rate and number of uninsured children in the United States since 1987, according to the data. The change may be due to more children gaining health insurance through government programs like the Children's Health Insurance Program. The Census Bureau estimates about 33% of children were enrolled in some type of government health insurance program in 2008, up from 31% the previous year.

To help hospitals improve quality and reduce costs, the Institute for Healthcare Improvement has released a free online tool that allows hospitals to find best practices, assess performance, and design quality improvement plans.

The IHI Improvement Map includes best-practice information on 70 processes of care, 40 of which can help hospitals to control costs. “The improvement map is meant to be a resource that hospitals and their leaders, clinicians, and others can go to, to help them organize and make sense of their own improvement efforts in a very complex terrain as they try to improve quality and decrease costs at the same time,” Dr. Donald M. Berwick, president and CEO of IHI, said during a webinar.

For example, a physician using the tool could seek information on preventing catheter-associated urinary tract infections. In addition to detailed information about that process, the map includes the cost, time, and difficulty involved with implementing the changes. It also provides information about the level of evidence to support the process.

More than 100 U.S. hospitals helped test a prototype of the Improvement Map and are already using it as part of their quality improvement projects, according to IHI, an independent not-for-profit organization focused on improving health care processes and systems. The organization began rolling out the tool more broadly in September, and interest has been strong. In only a few weeks, more than 8,700 people tried it out, Dr. Berwick said.

The Improvement Map focuses on quality information related to hospital processes of care, but IHI officials said they expect to expand the map to other areas such as ambulatory care and home health care.

The Improvement Map is already getting high marks from physicians and hospital officials. “This is a landmark resource that is going to help accelerate the activities of hospitals,” said Stephen R. Mayfield, senior vice president for quality and performance improvement at the American Hospital Association.

The tool gives hospitals a place to start on quality improvement regardless of their size or financial resources or how many projects they already have underway, he said. It will also help hospital officials to choose projects that will give them the best return on investment.

Dr. Nancy Nielsen, past president of the American Medical Association, said the effort by the IHI is a great example of how to move forward on quality improvement, without waiting for the government to do so.

“These are things that we can take on as a health care community throughout the country and in fact throughout the world where we have influence,” she said.

To help hospitals improve quality and reduce costs, the Institute for Healthcare Improvement has released a free online tool that allows hospitals to find best practices, assess performance, and design quality improvement plans.

The IHI Improvement Map includes best-practice information on 70 processes of care, 40 of which can help hospitals to control costs. “The improvement map is meant to be a resource that hospitals and their leaders, clinicians, and others can go to, to help them organize and make sense of their own improvement efforts in a very complex terrain as they try to improve quality and decrease costs at the same time,” Dr. Donald M. Berwick, president and CEO of IHI, said during a webinar.

For example, a physician using the tool could seek information on preventing catheter-associated urinary tract infections. In addition to detailed information about that process, the map includes the cost, time, and difficulty involved with implementing the changes. It also provides information about the level of evidence to support the process.

More than 100 U.S. hospitals helped test a prototype of the Improvement Map and are already using it as part of their quality improvement projects, according to IHI, an independent not-for-profit organization focused on improving health care processes and systems. The organization began rolling out the tool more broadly in September, and interest has been strong. In only a few weeks, more than 8,700 people tried it out, Dr. Berwick said.

The Improvement Map focuses on quality information related to hospital processes of care, but IHI officials said they expect to expand the map to other areas such as ambulatory care and home health care.

The Improvement Map is already getting high marks from physicians and hospital officials. “This is a landmark resource that is going to help accelerate the activities of hospitals,” said Stephen R. Mayfield, senior vice president for quality and performance improvement at the American Hospital Association.

The tool gives hospitals a place to start on quality improvement regardless of their size or financial resources or how many projects they already have underway, he said. It will also help hospital officials to choose projects that will give them the best return on investment.

Dr. Nancy Nielsen, past president of the American Medical Association, said the effort by the IHI is a great example of how to move forward on quality improvement, without waiting for the government to do so.

“These are things that we can take on as a health care community throughout the country and in fact throughout the world where we have influence,” she said.

To help hospitals improve quality and reduce costs, the Institute for Healthcare Improvement has released a free online tool that allows hospitals to find best practices, assess performance, and design quality improvement plans.

The IHI Improvement Map includes best-practice information on 70 processes of care, 40 of which can help hospitals to control costs. “The improvement map is meant to be a resource that hospitals and their leaders, clinicians, and others can go to, to help them organize and make sense of their own improvement efforts in a very complex terrain as they try to improve quality and decrease costs at the same time,” Dr. Donald M. Berwick, president and CEO of IHI, said during a webinar.

For example, a physician using the tool could seek information on preventing catheter-associated urinary tract infections. In addition to detailed information about that process, the map includes the cost, time, and difficulty involved with implementing the changes. It also provides information about the level of evidence to support the process.

More than 100 U.S. hospitals helped test a prototype of the Improvement Map and are already using it as part of their quality improvement projects, according to IHI, an independent not-for-profit organization focused on improving health care processes and systems. The organization began rolling out the tool more broadly in September, and interest has been strong. In only a few weeks, more than 8,700 people tried it out, Dr. Berwick said.

The Improvement Map focuses on quality information related to hospital processes of care, but IHI officials said they expect to expand the map to other areas such as ambulatory care and home health care.

The Improvement Map is already getting high marks from physicians and hospital officials. “This is a landmark resource that is going to help accelerate the activities of hospitals,” said Stephen R. Mayfield, senior vice president for quality and performance improvement at the American Hospital Association.

The tool gives hospitals a place to start on quality improvement regardless of their size or financial resources or how many projects they already have underway, he said. It will also help hospital officials to choose projects that will give them the best return on investment.

Dr. Nancy Nielsen, past president of the American Medical Association, said the effort by the IHI is a great example of how to move forward on quality improvement, without waiting for the government to do so.

“These are things that we can take on as a health care community throughout the country and in fact throughout the world where we have influence,” she said.

The Food and Drug Administration is vowing to get tougher and act faster when it comes to protecting public health.

Planned changes aim to make FDA “as transparent as possible about our expectations [while] industry commits to working in as responsive a way as possible to address our concerns,” said Dr. Margaret A. Hamburg, the agency's new commissioner. In recent years, the FDA's enforcement activities have declined significantly, and those enforcement actions taken have been hamstrung by delays, mostly due to internal red tape, she said.

Speaking at a Food and Drug Law Institute conference, she outlined six steps to streamline the way the FDA handles enforcement across all regulated areas—drugs, devices, and food.

In cases where agency officials deem that public health is at risk, the FDA is prepared to take enforcement action before issuing a formal warning letter. Agency officials will also work with state, local, and international regulators to determine who can act fastest in an emergency.

The FDA also plans to change some of its internal processes, Dr. Hamburg said. The agency will establish a 15-day deadline for industry to respond once a significant problem is identified during an inspection. In addition, it will aim to get warning letters out the door more quickly by limiting review to significant legal issues.

Prompt follow-up on warning letters and other enforcement actions is also part of Dr. Hamburg's plan. The FDA will move more quickly in assessing corrective actions taken by industry after a warning letter is issued or a major product recall occurs. And in an effort to motivate industry to act quickly, the FDA is developing a formal warning letter “close-out” process. Once the FDA has confirmed that a firm has fully corrected its violations, the agency will issue a close-out notice and post the information online.

The Food and Drug Administration is vowing to get tougher and act faster when it comes to protecting public health.

Planned changes aim to make FDA “as transparent as possible about our expectations [while] industry commits to working in as responsive a way as possible to address our concerns,” said Dr. Margaret A. Hamburg, the agency's new commissioner. In recent years, the FDA's enforcement activities have declined significantly, and those enforcement actions taken have been hamstrung by delays, mostly due to internal red tape, she said.

Speaking at a Food and Drug Law Institute conference, she outlined six steps to streamline the way the FDA handles enforcement across all regulated areas—drugs, devices, and food.

In cases where agency officials deem that public health is at risk, the FDA is prepared to take enforcement action before issuing a formal warning letter. Agency officials will also work with state, local, and international regulators to determine who can act fastest in an emergency.

The FDA also plans to change some of its internal processes, Dr. Hamburg said. The agency will establish a 15-day deadline for industry to respond once a significant problem is identified during an inspection. In addition, it will aim to get warning letters out the door more quickly by limiting review to significant legal issues.

Prompt follow-up on warning letters and other enforcement actions is also part of Dr. Hamburg's plan. The FDA will move more quickly in assessing corrective actions taken by industry after a warning letter is issued or a major product recall occurs. And in an effort to motivate industry to act quickly, the FDA is developing a formal warning letter “close-out” process. Once the FDA has confirmed that a firm has fully corrected its violations, the agency will issue a close-out notice and post the information online.

The Food and Drug Administration is vowing to get tougher and act faster when it comes to protecting public health.

Planned changes aim to make FDA “as transparent as possible about our expectations [while] industry commits to working in as responsive a way as possible to address our concerns,” said Dr. Margaret A. Hamburg, the agency's new commissioner. In recent years, the FDA's enforcement activities have declined significantly, and those enforcement actions taken have been hamstrung by delays, mostly due to internal red tape, she said.

Speaking at a Food and Drug Law Institute conference, she outlined six steps to streamline the way the FDA handles enforcement across all regulated areas—drugs, devices, and food.

In cases where agency officials deem that public health is at risk, the FDA is prepared to take enforcement action before issuing a formal warning letter. Agency officials will also work with state, local, and international regulators to determine who can act fastest in an emergency.

The FDA also plans to change some of its internal processes, Dr. Hamburg said. The agency will establish a 15-day deadline for industry to respond once a significant problem is identified during an inspection. In addition, it will aim to get warning letters out the door more quickly by limiting review to significant legal issues.

Prompt follow-up on warning letters and other enforcement actions is also part of Dr. Hamburg's plan. The FDA will move more quickly in assessing corrective actions taken by industry after a warning letter is issued or a major product recall occurs. And in an effort to motivate industry to act quickly, the FDA is developing a formal warning letter “close-out” process. Once the FDA has confirmed that a firm has fully corrected its violations, the agency will issue a close-out notice and post the information online.

This fall, the American Psychiatric Association will begin field trials of the diagnostic criteria and dimensional assessments it plans to include in the next edition of the Diagnostic and Statistical Manual of Mental Disorders.

The field trials will test the reliability, feasibility, and clinical utility of the new diagnostic criteria being proposed, as well as a completely new element being introduced in the DSM-V—dimensional assessments. These assessments will allow clinicians to rate the symptomatology of their patients on a scale, rather than simply on a categorical or “yes or no” basis, said Dr. William E. Narrow, research director of the DSM-V Task Force.

One reason that the developers of the DSM-V chose to introduce dimensional assessments in this edition is to help clinicians document the complex symptom patterns of patients. Under the current DSM edition, a patient could receive three or four primary diagnoses, which is not necessarily clinically useful, Dr. Narrow said. With the addition of dimensional assessments, it could instead be possible to make one or two primary diagnoses and document the rest of the symptoms using the assessments.

The tool also could be useful to clinicians by providing quantitative evidence about whether their prescribed treatments are working. And they could help patients to better understand the treatment process by using the assessments as treatment targets. In that way, the dimensional assessment could be treated like a lab test, Dr. Narrow said, and could get patients more involved in their treatment.

“This really has the potential to be a big change in the way that clinicians operate and the way that we interact with our patients,” he said.

The developers of DSM-IV considered introducing dimensional assessments but concluded that the field wasn't ready for it, Dr. Narrow said. But since that time, evidence on the use of dimensional assessments, including the APA's own research on depression assessments, shows that they can be useful and reliable, he said.

But this fall's field testing will provide additional evidence about their use. Specifically, the DSM-V work groups are looking closely at the feasibility of introducing the assessments into most psychiatry practices. There's no question that the assessments will add time; the field trials will shed light on whether it is time well spent, Dr. Narrow said. The DSM-V developers will seek feedback from patients and clinicians about how well the questions are understood, how long the assessments take to fill out, and whether patients and clinicians like them and find them useful.

The field trials also will test how the assessments perform when they are used during follow-up visits. For example, the developers want to find out if the dimensional assessments will accurately track the patient's status and if they aid in making treatment decisions. “We don't want these to replace clinical judgment by any means, but do they help in clinical judgment?” Dr. Narrow said. “Do they confirm what the clinician suspects?”

The testing will take place at various sites around the United States and Canada including general psychiatric clinics, psychiatry office practices, specialty clinics, and primary care settings. Researchers want to include primary care among the trial sites because of the large number of patients with depression, anxiety, and sleep problems who seek care there, Dr. Narrow said.

Some of the field trials will begin in October; all the trials are set to wrap up by the end of 2010, according to Dr. Narrow. Once the field trials have been completed, the bulk of 2011 will be spent writing and reviewing the final DSM-V document, which is scheduled to be published in May 2012.

The trials include primary care settings because many patients with depression and anxiety seek care there.

Source DR. NARROW

This fall, the American Psychiatric Association will begin field trials of the diagnostic criteria and dimensional assessments it plans to include in the next edition of the Diagnostic and Statistical Manual of Mental Disorders.

The field trials will test the reliability, feasibility, and clinical utility of the new diagnostic criteria being proposed, as well as a completely new element being introduced in the DSM-V—dimensional assessments. These assessments will allow clinicians to rate the symptomatology of their patients on a scale, rather than simply on a categorical or “yes or no” basis, said Dr. William E. Narrow, research director of the DSM-V Task Force.

One reason that the developers of the DSM-V chose to introduce dimensional assessments in this edition is to help clinicians document the complex symptom patterns of patients. Under the current DSM edition, a patient could receive three or four primary diagnoses, which is not necessarily clinically useful, Dr. Narrow said. With the addition of dimensional assessments, it could instead be possible to make one or two primary diagnoses and document the rest of the symptoms using the assessments.

The tool also could be useful to clinicians by providing quantitative evidence about whether their prescribed treatments are working. And they could help patients to better understand the treatment process by using the assessments as treatment targets. In that way, the dimensional assessment could be treated like a lab test, Dr. Narrow said, and could get patients more involved in their treatment.

“This really has the potential to be a big change in the way that clinicians operate and the way that we interact with our patients,” he said.

The developers of DSM-IV considered introducing dimensional assessments but concluded that the field wasn't ready for it, Dr. Narrow said. But since that time, evidence on the use of dimensional assessments, including the APA's own research on depression assessments, shows that they can be useful and reliable, he said.

But this fall's field testing will provide additional evidence about their use. Specifically, the DSM-V work groups are looking closely at the feasibility of introducing the assessments into most psychiatry practices. There's no question that the assessments will add time; the field trials will shed light on whether it is time well spent, Dr. Narrow said. The DSM-V developers will seek feedback from patients and clinicians about how well the questions are understood, how long the assessments take to fill out, and whether patients and clinicians like them and find them useful.

The field trials also will test how the assessments perform when they are used during follow-up visits. For example, the developers want to find out if the dimensional assessments will accurately track the patient's status and if they aid in making treatment decisions. “We don't want these to replace clinical judgment by any means, but do they help in clinical judgment?” Dr. Narrow said. “Do they confirm what the clinician suspects?”

The testing will take place at various sites around the United States and Canada including general psychiatric clinics, psychiatry office practices, specialty clinics, and primary care settings. Researchers want to include primary care among the trial sites because of the large number of patients with depression, anxiety, and sleep problems who seek care there, Dr. Narrow said.

Some of the field trials will begin in October; all the trials are set to wrap up by the end of 2010, according to Dr. Narrow. Once the field trials have been completed, the bulk of 2011 will be spent writing and reviewing the final DSM-V document, which is scheduled to be published in May 2012.

The trials include primary care settings because many patients with depression and anxiety seek care there.

Source DR. NARROW

This fall, the American Psychiatric Association will begin field trials of the diagnostic criteria and dimensional assessments it plans to include in the next edition of the Diagnostic and Statistical Manual of Mental Disorders.

The field trials will test the reliability, feasibility, and clinical utility of the new diagnostic criteria being proposed, as well as a completely new element being introduced in the DSM-V—dimensional assessments. These assessments will allow clinicians to rate the symptomatology of their patients on a scale, rather than simply on a categorical or “yes or no” basis, said Dr. William E. Narrow, research director of the DSM-V Task Force.

One reason that the developers of the DSM-V chose to introduce dimensional assessments in this edition is to help clinicians document the complex symptom patterns of patients. Under the current DSM edition, a patient could receive three or four primary diagnoses, which is not necessarily clinically useful, Dr. Narrow said. With the addition of dimensional assessments, it could instead be possible to make one or two primary diagnoses and document the rest of the symptoms using the assessments.

The tool also could be useful to clinicians by providing quantitative evidence about whether their prescribed treatments are working. And they could help patients to better understand the treatment process by using the assessments as treatment targets. In that way, the dimensional assessment could be treated like a lab test, Dr. Narrow said, and could get patients more involved in their treatment.

“This really has the potential to be a big change in the way that clinicians operate and the way that we interact with our patients,” he said.

The developers of DSM-IV considered introducing dimensional assessments but concluded that the field wasn't ready for it, Dr. Narrow said. But since that time, evidence on the use of dimensional assessments, including the APA's own research on depression assessments, shows that they can be useful and reliable, he said.

But this fall's field testing will provide additional evidence about their use. Specifically, the DSM-V work groups are looking closely at the feasibility of introducing the assessments into most psychiatry practices. There's no question that the assessments will add time; the field trials will shed light on whether it is time well spent, Dr. Narrow said. The DSM-V developers will seek feedback from patients and clinicians about how well the questions are understood, how long the assessments take to fill out, and whether patients and clinicians like them and find them useful.

The field trials also will test how the assessments perform when they are used during follow-up visits. For example, the developers want to find out if the dimensional assessments will accurately track the patient's status and if they aid in making treatment decisions. “We don't want these to replace clinical judgment by any means, but do they help in clinical judgment?” Dr. Narrow said. “Do they confirm what the clinician suspects?”

The testing will take place at various sites around the United States and Canada including general psychiatric clinics, psychiatry office practices, specialty clinics, and primary care settings. Researchers want to include primary care among the trial sites because of the large number of patients with depression, anxiety, and sleep problems who seek care there, Dr. Narrow said.

Some of the field trials will begin in October; all the trials are set to wrap up by the end of 2010, according to Dr. Narrow. Once the field trials have been completed, the bulk of 2011 will be spent writing and reviewing the final DSM-V document, which is scheduled to be published in May 2012.

The trials include primary care settings because many patients with depression and anxiety seek care there.

Source DR. NARROW

Medicare will cover administration of both the seasonal influenza vaccine and the vaccine against 2009 pandemic influenza A(H1N1) virus.

In a notice to physicians and other health care providers, officials at the Centers for Medicare and Medicaid Services said that the same billing rules will apply to the pandemic H1N1 vaccine and the seasonal vaccine. However, because the pandemic H1N1 vaccine will be provided at no cost by the government, Medicare will pay providers only for administration.

The CMS has issued two new billing codes to address H1N1 vaccine this season. Providers can use G9141 for pandemic influenza A(H1N1) immunization administration, including physician counseling of the patient and family. Payment for G9141 will be the same as that for the administration of the seasonal influenza vaccine.

The CMS also has created a billing code, G9142, for the pandemic influenza A(H1N1) vaccine itself. However, that code will not trigger payment. Nor will Medicare pay for an office visit when its sole purpose is administration of either seasonal influenza vaccine or pandemic H1N1 vaccine.

Private insurers are also planning to extend coverage to the pandemic H1N1 vaccine.

Medicare will cover administration of both the seasonal influenza vaccine and the vaccine against 2009 pandemic influenza A(H1N1) virus.

In a notice to physicians and other health care providers, officials at the Centers for Medicare and Medicaid Services said that the same billing rules will apply to the pandemic H1N1 vaccine and the seasonal vaccine. However, because the pandemic H1N1 vaccine will be provided at no cost by the government, Medicare will pay providers only for administration.

The CMS has issued two new billing codes to address H1N1 vaccine this season. Providers can use G9141 for pandemic influenza A(H1N1) immunization administration, including physician counseling of the patient and family. Payment for G9141 will be the same as that for the administration of the seasonal influenza vaccine.

The CMS also has created a billing code, G9142, for the pandemic influenza A(H1N1) vaccine itself. However, that code will not trigger payment. Nor will Medicare pay for an office visit when its sole purpose is administration of either seasonal influenza vaccine or pandemic H1N1 vaccine.

Private insurers are also planning to extend coverage to the pandemic H1N1 vaccine.

Medicare will cover administration of both the seasonal influenza vaccine and the vaccine against 2009 pandemic influenza A(H1N1) virus.

In a notice to physicians and other health care providers, officials at the Centers for Medicare and Medicaid Services said that the same billing rules will apply to the pandemic H1N1 vaccine and the seasonal vaccine. However, because the pandemic H1N1 vaccine will be provided at no cost by the government, Medicare will pay providers only for administration.

The CMS has issued two new billing codes to address H1N1 vaccine this season. Providers can use G9141 for pandemic influenza A(H1N1) immunization administration, including physician counseling of the patient and family. Payment for G9141 will be the same as that for the administration of the seasonal influenza vaccine.

The CMS also has created a billing code, G9142, for the pandemic influenza A(H1N1) vaccine itself. However, that code will not trigger payment. Nor will Medicare pay for an office visit when its sole purpose is administration of either seasonal influenza vaccine or pandemic H1N1 vaccine.

Private insurers are also planning to extend coverage to the pandemic H1N1 vaccine.