Mary Ellen Schneider

Proposals Aim to Reduce Abortion

Democrats are taking on the abortion issue in the new Congress first by advocating prevention of unwanted pregnancies. Senate Majority Leader Harry Reid (D-Nev.) has reintroduced the Prevention First Act (S. 21), which would increase funding for the Title X national family planning program, expand Medicaid family planning services, and improve awareness of emergency contraception. The bill was also reintroduced in the House by Rep. Louise Slaughter (D-N.Y.) and Rep. Diana DeGette (D-Colo.) as H.R. 463. The legislation had garnered 15 cosponsors in the Senate and 110 in the House at press time. Some conservative lawmakers have objected that the legislation supports proabortion counseling. In another proposal seeking to establish “common ground” on the abortion debate, Sen. Bob Casey (D-Pa.), an abortion opponent, has reintroduced the Pregnant Women Support Act (S. 270) to increase funding for the Women, Infants and Children Program, fund home visits by nurses to poor pregnant women and first-time mothers, and eliminate pregnancy as a preexisting condition that health insurers can exclude from coverage.

Pap-Reading Exams Would Change

Officials at the Centers for Medicare and Medicaid Services are seeking to change proficiency testing of pathologists and cytotechnologists who interpret Pap tests. Under the proposed regulation, candidates would have to assess 20 slides, instead of the current 10, in their initial test and all retests. But retesting would be expanded to a biennial instead of annual schedule. Missing two high-grade lesions or cancers on any test would result in automatic failure, but the CMS would require testing agencies to offer an appeals process. The proposed rule has been published in the Federal Register, and the agency will be accepting public comments until March 17. The changes are largely the result of recommendations from the HHS's Clinical Laboratory Improvement Advisory Committee.

Economy Hurts Elder-Care Plans

About 60% of women say that the current economic downturn is limiting their ability to plan for long-term care costs, according to a survey commissioned by America's Health Insurance Plans. In a telephone survey of more than 1,000 women aged 30–59 conducted last November, nearly 80% said they would be somewhat or very likely to need long-term care services in the future, but only 19% said they had obtained long-term care insurance. Of women who don't have long-term care insurance, most said they would rely on government assistance, sell their assets to pay for their care, or use retirement savings.

CDC Warns on HBV, HCV

In the past decade, more than 60,000 people in the United States were advised to be tested for hepatitis B virus and hepatitis C virus because health personnel who cared for them in settings outside hospitals failed to follow basic infection control practices, according to the Centers for Disease Control and Prevention. The review of CDC investigations of health care-associated viral hepatitis outbreaks revealed 33 HBV or HCV outbreaks outside hospitals in 15 states during the past decade (12 in outpatient clinics, 6 in hemodialysis centers, and 15 in long-term care facilities). As a result, 450 people acquired HBV or HCV infections. “Thousands of patients are needlessly exposed to viral hepatitis and other preventable diseases in the very places where they should feel protected,” Dr. John Ward, director of the CDC's Division of Viral Hepatitis, said in a statement.

L.A. Court: Enforce HIV Law

The Los Angeles Superior Court has ordered the state to implement a 2002 law intended to extend Medi-Cal coverage to more HIV-positive Californians. The AIDS Healthcare Foundation sued to compel the Department of Health Care Services to include all HIV-positive, nondisabled individuals in Medi-Cal, California's Medicaid program. Prior to the 2002 law, only individuals with HIV who had been diagnosed with AIDS were considered eligible for Medi-Cal. The law was designed to encourage AIDS patients to move from Medi-Cal's fee-for-service program into managed care, and the state was to use savings from that change to cover HIV-positive people without AIDS. The court ruled that Medi-Cal failed to implement some measures specified by state lawmakers, such as outreach to individual AIDS patients, and made minimal efforts on others.

Proposals Aim to Reduce Abortion

Democrats are taking on the abortion issue in the new Congress first by advocating prevention of unwanted pregnancies. Senate Majority Leader Harry Reid (D-Nev.) has reintroduced the Prevention First Act (S. 21), which would increase funding for the Title X national family planning program, expand Medicaid family planning services, and improve awareness of emergency contraception. The bill was also reintroduced in the House by Rep. Louise Slaughter (D-N.Y.) and Rep. Diana DeGette (D-Colo.) as H.R. 463. The legislation had garnered 15 cosponsors in the Senate and 110 in the House at press time. Some conservative lawmakers have objected that the legislation supports proabortion counseling. In another proposal seeking to establish “common ground” on the abortion debate, Sen. Bob Casey (D-Pa.), an abortion opponent, has reintroduced the Pregnant Women Support Act (S. 270) to increase funding for the Women, Infants and Children Program, fund home visits by nurses to poor pregnant women and first-time mothers, and eliminate pregnancy as a preexisting condition that health insurers can exclude from coverage.

Pap-Reading Exams Would Change

Officials at the Centers for Medicare and Medicaid Services are seeking to change proficiency testing of pathologists and cytotechnologists who interpret Pap tests. Under the proposed regulation, candidates would have to assess 20 slides, instead of the current 10, in their initial test and all retests. But retesting would be expanded to a biennial instead of annual schedule. Missing two high-grade lesions or cancers on any test would result in automatic failure, but the CMS would require testing agencies to offer an appeals process. The proposed rule has been published in the Federal Register, and the agency will be accepting public comments until March 17. The changes are largely the result of recommendations from the HHS's Clinical Laboratory Improvement Advisory Committee.

Economy Hurts Elder-Care Plans

About 60% of women say that the current economic downturn is limiting their ability to plan for long-term care costs, according to a survey commissioned by America's Health Insurance Plans. In a telephone survey of more than 1,000 women aged 30–59 conducted last November, nearly 80% said they would be somewhat or very likely to need long-term care services in the future, but only 19% said they had obtained long-term care insurance. Of women who don't have long-term care insurance, most said they would rely on government assistance, sell their assets to pay for their care, or use retirement savings.

CDC Warns on HBV, HCV

In the past decade, more than 60,000 people in the United States were advised to be tested for hepatitis B virus and hepatitis C virus because health personnel who cared for them in settings outside hospitals failed to follow basic infection control practices, according to the Centers for Disease Control and Prevention. The review of CDC investigations of health care-associated viral hepatitis outbreaks revealed 33 HBV or HCV outbreaks outside hospitals in 15 states during the past decade (12 in outpatient clinics, 6 in hemodialysis centers, and 15 in long-term care facilities). As a result, 450 people acquired HBV or HCV infections. “Thousands of patients are needlessly exposed to viral hepatitis and other preventable diseases in the very places where they should feel protected,” Dr. John Ward, director of the CDC's Division of Viral Hepatitis, said in a statement.

L.A. Court: Enforce HIV Law

The Los Angeles Superior Court has ordered the state to implement a 2002 law intended to extend Medi-Cal coverage to more HIV-positive Californians. The AIDS Healthcare Foundation sued to compel the Department of Health Care Services to include all HIV-positive, nondisabled individuals in Medi-Cal, California's Medicaid program. Prior to the 2002 law, only individuals with HIV who had been diagnosed with AIDS were considered eligible for Medi-Cal. The law was designed to encourage AIDS patients to move from Medi-Cal's fee-for-service program into managed care, and the state was to use savings from that change to cover HIV-positive people without AIDS. The court ruled that Medi-Cal failed to implement some measures specified by state lawmakers, such as outreach to individual AIDS patients, and made minimal efforts on others.

Proposals Aim to Reduce Abortion

Democrats are taking on the abortion issue in the new Congress first by advocating prevention of unwanted pregnancies. Senate Majority Leader Harry Reid (D-Nev.) has reintroduced the Prevention First Act (S. 21), which would increase funding for the Title X national family planning program, expand Medicaid family planning services, and improve awareness of emergency contraception. The bill was also reintroduced in the House by Rep. Louise Slaughter (D-N.Y.) and Rep. Diana DeGette (D-Colo.) as H.R. 463. The legislation had garnered 15 cosponsors in the Senate and 110 in the House at press time. Some conservative lawmakers have objected that the legislation supports proabortion counseling. In another proposal seeking to establish “common ground” on the abortion debate, Sen. Bob Casey (D-Pa.), an abortion opponent, has reintroduced the Pregnant Women Support Act (S. 270) to increase funding for the Women, Infants and Children Program, fund home visits by nurses to poor pregnant women and first-time mothers, and eliminate pregnancy as a preexisting condition that health insurers can exclude from coverage.

Pap-Reading Exams Would Change

Officials at the Centers for Medicare and Medicaid Services are seeking to change proficiency testing of pathologists and cytotechnologists who interpret Pap tests. Under the proposed regulation, candidates would have to assess 20 slides, instead of the current 10, in their initial test and all retests. But retesting would be expanded to a biennial instead of annual schedule. Missing two high-grade lesions or cancers on any test would result in automatic failure, but the CMS would require testing agencies to offer an appeals process. The proposed rule has been published in the Federal Register, and the agency will be accepting public comments until March 17. The changes are largely the result of recommendations from the HHS's Clinical Laboratory Improvement Advisory Committee.

Economy Hurts Elder-Care Plans

About 60% of women say that the current economic downturn is limiting their ability to plan for long-term care costs, according to a survey commissioned by America's Health Insurance Plans. In a telephone survey of more than 1,000 women aged 30–59 conducted last November, nearly 80% said they would be somewhat or very likely to need long-term care services in the future, but only 19% said they had obtained long-term care insurance. Of women who don't have long-term care insurance, most said they would rely on government assistance, sell their assets to pay for their care, or use retirement savings.

CDC Warns on HBV, HCV

In the past decade, more than 60,000 people in the United States were advised to be tested for hepatitis B virus and hepatitis C virus because health personnel who cared for them in settings outside hospitals failed to follow basic infection control practices, according to the Centers for Disease Control and Prevention. The review of CDC investigations of health care-associated viral hepatitis outbreaks revealed 33 HBV or HCV outbreaks outside hospitals in 15 states during the past decade (12 in outpatient clinics, 6 in hemodialysis centers, and 15 in long-term care facilities). As a result, 450 people acquired HBV or HCV infections. “Thousands of patients are needlessly exposed to viral hepatitis and other preventable diseases in the very places where they should feel protected,” Dr. John Ward, director of the CDC's Division of Viral Hepatitis, said in a statement.

L.A. Court: Enforce HIV Law

The Los Angeles Superior Court has ordered the state to implement a 2002 law intended to extend Medi-Cal coverage to more HIV-positive Californians. The AIDS Healthcare Foundation sued to compel the Department of Health Care Services to include all HIV-positive, nondisabled individuals in Medi-Cal, California's Medicaid program. Prior to the 2002 law, only individuals with HIV who had been diagnosed with AIDS were considered eligible for Medi-Cal. The law was designed to encourage AIDS patients to move from Medi-Cal's fee-for-service program into managed care, and the state was to use savings from that change to cover HIV-positive people without AIDS. The court ruled that Medi-Cal failed to implement some measures specified by state lawmakers, such as outreach to individual AIDS patients, and made minimal efforts on others.

Researchers in North Carolina and New York are beginning to recruit the first volunteers as part of a huge federal study that will examine the relative effects of genes and environment on development.

The researchers plan to track 100,000 women through pregnancy and then follow their children through age 21 years as part of the National Children's Study. In addition to tracking their development, the researchers will collect biological and environmental samples from study participants. Researchers aim to use this information to help identify the environmental and genetic factors that contribute to conditions such as autism, cerebral palsy, learning disabilities, birth defects, diabetes, asthma, and obesity.

Women are being recruited and enrolled from areas of the country that are representative of the diversity of U.S. children in terms of race, ethnicity, socioeconomic status, and community size. The initial recruitment began in mid-January in the borough of Queens, N.Y., and in Duplin County, N.C. In April, five other centers will begin recruiting. Ultimately, the study is expected to recruit participants from 105 locations across the country.

The National Children's Study was authorized by Congress in the Children's Health Act of 2000 and has been developed by the National Institutes of Health, the Centers for Disease Control and Prevention, and the Environmental Protection Agency.

Researchers estimate that the first children to be part of the study will be born this summer. As a result, the study could yield data in the next few years on conditions such as prematurity and birth defects, according to the NIH.

“Findings from the study will ultimately benefit all Americans by providing researchers, health care providers, and public health officials with information from which to develop prevention strategies, health and safety guidelines, and possibly new treatments for disease,” Dr. Peter Scheidt, director of the National Children's Study, said during a press briefing last month to announce the recruitment phase of the study.

Researchers in North Carolina and New York are beginning to recruit the first volunteers as part of a huge federal study that will examine the relative effects of genes and environment on development.

The researchers plan to track 100,000 women through pregnancy and then follow their children through age 21 years as part of the National Children's Study. In addition to tracking their development, the researchers will collect biological and environmental samples from study participants. Researchers aim to use this information to help identify the environmental and genetic factors that contribute to conditions such as autism, cerebral palsy, learning disabilities, birth defects, diabetes, asthma, and obesity.

Women are being recruited and enrolled from areas of the country that are representative of the diversity of U.S. children in terms of race, ethnicity, socioeconomic status, and community size. The initial recruitment began in mid-January in the borough of Queens, N.Y., and in Duplin County, N.C. In April, five other centers will begin recruiting. Ultimately, the study is expected to recruit participants from 105 locations across the country.

The National Children's Study was authorized by Congress in the Children's Health Act of 2000 and has been developed by the National Institutes of Health, the Centers for Disease Control and Prevention, and the Environmental Protection Agency.

Researchers estimate that the first children to be part of the study will be born this summer. As a result, the study could yield data in the next few years on conditions such as prematurity and birth defects, according to the NIH.

“Findings from the study will ultimately benefit all Americans by providing researchers, health care providers, and public health officials with information from which to develop prevention strategies, health and safety guidelines, and possibly new treatments for disease,” Dr. Peter Scheidt, director of the National Children's Study, said during a press briefing last month to announce the recruitment phase of the study.

Researchers in North Carolina and New York are beginning to recruit the first volunteers as part of a huge federal study that will examine the relative effects of genes and environment on development.

The researchers plan to track 100,000 women through pregnancy and then follow their children through age 21 years as part of the National Children's Study. In addition to tracking their development, the researchers will collect biological and environmental samples from study participants. Researchers aim to use this information to help identify the environmental and genetic factors that contribute to conditions such as autism, cerebral palsy, learning disabilities, birth defects, diabetes, asthma, and obesity.

Women are being recruited and enrolled from areas of the country that are representative of the diversity of U.S. children in terms of race, ethnicity, socioeconomic status, and community size. The initial recruitment began in mid-January in the borough of Queens, N.Y., and in Duplin County, N.C. In April, five other centers will begin recruiting. Ultimately, the study is expected to recruit participants from 105 locations across the country.

The National Children's Study was authorized by Congress in the Children's Health Act of 2000 and has been developed by the National Institutes of Health, the Centers for Disease Control and Prevention, and the Environmental Protection Agency.

Researchers estimate that the first children to be part of the study will be born this summer. As a result, the study could yield data in the next few years on conditions such as prematurity and birth defects, according to the NIH.

“Findings from the study will ultimately benefit all Americans by providing researchers, health care providers, and public health officials with information from which to develop prevention strategies, health and safety guidelines, and possibly new treatments for disease,” Dr. Peter Scheidt, director of the National Children's Study, said during a press briefing last month to announce the recruitment phase of the study.

Bill for Paralysis Research, Rehab

Members of Congress have reintroduced legislation that would direct the National Institutes of Health to expand and better coordinate paralysis research. The Christopher and Dana Reeve Paralysis Act (H.R. 307) would also create a Clinical Trials Network to design and test rehabilitation protocols. Finally, the lawmakers want a national action plan to improve quality of life for people with paralysis by emphasizing independent living and self-sufficiency. “It is critical to help people with disabilities achieve and maintain their independence and to ensure that we are using the best research and technology to improve their quality of life,” Rep. Jim Langevin (D-R.I.), a cosponsor of the legislation, said in a statement. In the past Congress, the bill passed the House but not the Senate.

Veterans Sue Over Experiments

The Vietnam Veterans of America and six individual veterans are suing the Defense Department, the Central Intelligence Agency, and the U.S. Army for failing to care for them after they helped test toxic chemical and biologic substances starting in the 1950s. The lawsuit, which was filed last month in the U.S. District Court in the Northern District of California, alleges that until at least 1976 the government used troops to test nerve gas, psychoactive chemicals such as LSD, and toxic substances without proper informed consent. The plaintiffs are not seeking monetary damages but want medical treatment for such veterans in the future. The lawsuit also calls on the government to disclose all medical information about tests performed on the plaintiffs. The complaint is available in full online at

www.edgewoodtestvets.org

Lilly Settles Zyprexa Charges

As anticipated, Eli Lilly & Co. has agreed to settle various federal complaints about its off-label promotion of its antipsychotic Zyprexa (olanzapine). Lilly pleaded guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act for the illegal promotion of Zyprexa for dementia from 1999 to 2001. The company will pay $615 million in that plea. Lilly did not admit to civil allegations against it, but it will pay $800 million to settle those charges. Of that amount, $438 million will go to the federal government and $362 million will be set aside for ongoing state investigations. The manufacturer also entered into a corporate integrity agreement with the government that requires Lilly to submit to third-party review of all of its policies and procedures.

Most Favor Family Consent

University of Michigan health researchers say that a nationally representative survey of older adults shows that most of them believe that it's acceptable for a family surrogate to give consent for a cognitively impaired person to be a research subject. The surveyors questioned 1,515 people who were aged 51 years and older who had been randomly selected from the government-funded National Health and Retirement Survey. The group members responded to questions about a family member giving consent for a patient to join one of the following four research scenarios: a lumbar puncture study; a randomized, controlled trial of a new drug; a similar trial of a vaccine; or a gene-transfer study. In all, 82% of the subjects said that consent by a surrogate was allowable for a drug trial, 72% for a lumbar puncture, 70% for a vaccine trial, and 67% for gene transfer. The federal government defers to states on when surrogate consent may be authorized, but the states' rules are far from clear, the researchers reported in the survey. Their survey results have been published in the Jan. 13 issue of Neurology.

FDA Warns of Supplement Risk

The Food and Drug Administration is warning consumers to immediately stop taking the dietary supplement Venom Hyperdrive 3.0. The product contains significant, undeclared amounts of the appetite suppressant sibutramine, according to the FDA. Sibutramine is the active ingredient in an approved weight-loss drug, but it can increase blood pressure and pulse. The agency warned that the ingredient could be dangerous for individuals with a history of stroke or heart disease. The supplement came in 90-capsule, red plastic bottles labeled UPC# 094922534743. For more information about the recall, contact Applied Lifescience Research Industries Inc. at

legal@alrindustries.com

New EHR Certification Options

The Certification Commission for Healthcare Information Technology plans to endorse ambulatory electronic health record products that offer advanced capabilities in four new areas: clinical research, dermatology, advanced interoperability, and advanced quality. The commission currently offers voluntary certification in both the ambulatory and inpatient settings to vendors of electronic health records that support basic clinical tasks, are able to send and receive information, and provide security for medical information. The new options for product certification would be added in 2010. The certification commission is recognized by the federal government as the official reviewer of products in health information technology. “It's the right time to add more flexibility to our approach, so we can fine tune our programs to meet everyone's needs for health information technology certification,” the commission chair Dr. Mark Leavitt commented in a statement. He added that in the next few years, the commission may extend optional add-on certification to electronic records used in eye care, oncology, obstetrics and gynecology, advanced security, and advanced clinical decision support.

Bill for Paralysis Research, Rehab

Members of Congress have reintroduced legislation that would direct the National Institutes of Health to expand and better coordinate paralysis research. The Christopher and Dana Reeve Paralysis Act (H.R. 307) would also create a Clinical Trials Network to design and test rehabilitation protocols. Finally, the lawmakers want a national action plan to improve quality of life for people with paralysis by emphasizing independent living and self-sufficiency. “It is critical to help people with disabilities achieve and maintain their independence and to ensure that we are using the best research and technology to improve their quality of life,” Rep. Jim Langevin (D-R.I.), a cosponsor of the legislation, said in a statement. In the past Congress, the bill passed the House but not the Senate.

Veterans Sue Over Experiments

The Vietnam Veterans of America and six individual veterans are suing the Defense Department, the Central Intelligence Agency, and the U.S. Army for failing to care for them after they helped test toxic chemical and biologic substances starting in the 1950s. The lawsuit, which was filed last month in the U.S. District Court in the Northern District of California, alleges that until at least 1976 the government used troops to test nerve gas, psychoactive chemicals such as LSD, and toxic substances without proper informed consent. The plaintiffs are not seeking monetary damages but want medical treatment for such veterans in the future. The lawsuit also calls on the government to disclose all medical information about tests performed on the plaintiffs. The complaint is available in full online at

www.edgewoodtestvets.org

Lilly Settles Zyprexa Charges

As anticipated, Eli Lilly & Co. has agreed to settle various federal complaints about its off-label promotion of its antipsychotic Zyprexa (olanzapine). Lilly pleaded guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act for the illegal promotion of Zyprexa for dementia from 1999 to 2001. The company will pay $615 million in that plea. Lilly did not admit to civil allegations against it, but it will pay $800 million to settle those charges. Of that amount, $438 million will go to the federal government and $362 million will be set aside for ongoing state investigations. The manufacturer also entered into a corporate integrity agreement with the government that requires Lilly to submit to third-party review of all of its policies and procedures.

Most Favor Family Consent

University of Michigan health researchers say that a nationally representative survey of older adults shows that most of them believe that it's acceptable for a family surrogate to give consent for a cognitively impaired person to be a research subject. The surveyors questioned 1,515 people who were aged 51 years and older who had been randomly selected from the government-funded National Health and Retirement Survey. The group members responded to questions about a family member giving consent for a patient to join one of the following four research scenarios: a lumbar puncture study; a randomized, controlled trial of a new drug; a similar trial of a vaccine; or a gene-transfer study. In all, 82% of the subjects said that consent by a surrogate was allowable for a drug trial, 72% for a lumbar puncture, 70% for a vaccine trial, and 67% for gene transfer. The federal government defers to states on when surrogate consent may be authorized, but the states' rules are far from clear, the researchers reported in the survey. Their survey results have been published in the Jan. 13 issue of Neurology.

FDA Warns of Supplement Risk

The Food and Drug Administration is warning consumers to immediately stop taking the dietary supplement Venom Hyperdrive 3.0. The product contains significant, undeclared amounts of the appetite suppressant sibutramine, according to the FDA. Sibutramine is the active ingredient in an approved weight-loss drug, but it can increase blood pressure and pulse. The agency warned that the ingredient could be dangerous for individuals with a history of stroke or heart disease. The supplement came in 90-capsule, red plastic bottles labeled UPC# 094922534743. For more information about the recall, contact Applied Lifescience Research Industries Inc. at

legal@alrindustries.com

New EHR Certification Options

The Certification Commission for Healthcare Information Technology plans to endorse ambulatory electronic health record products that offer advanced capabilities in four new areas: clinical research, dermatology, advanced interoperability, and advanced quality. The commission currently offers voluntary certification in both the ambulatory and inpatient settings to vendors of electronic health records that support basic clinical tasks, are able to send and receive information, and provide security for medical information. The new options for product certification would be added in 2010. The certification commission is recognized by the federal government as the official reviewer of products in health information technology. “It's the right time to add more flexibility to our approach, so we can fine tune our programs to meet everyone's needs for health information technology certification,” the commission chair Dr. Mark Leavitt commented in a statement. He added that in the next few years, the commission may extend optional add-on certification to electronic records used in eye care, oncology, obstetrics and gynecology, advanced security, and advanced clinical decision support.

Bill for Paralysis Research, Rehab

Members of Congress have reintroduced legislation that would direct the National Institutes of Health to expand and better coordinate paralysis research. The Christopher and Dana Reeve Paralysis Act (H.R. 307) would also create a Clinical Trials Network to design and test rehabilitation protocols. Finally, the lawmakers want a national action plan to improve quality of life for people with paralysis by emphasizing independent living and self-sufficiency. “It is critical to help people with disabilities achieve and maintain their independence and to ensure that we are using the best research and technology to improve their quality of life,” Rep. Jim Langevin (D-R.I.), a cosponsor of the legislation, said in a statement. In the past Congress, the bill passed the House but not the Senate.

Veterans Sue Over Experiments

The Vietnam Veterans of America and six individual veterans are suing the Defense Department, the Central Intelligence Agency, and the U.S. Army for failing to care for them after they helped test toxic chemical and biologic substances starting in the 1950s. The lawsuit, which was filed last month in the U.S. District Court in the Northern District of California, alleges that until at least 1976 the government used troops to test nerve gas, psychoactive chemicals such as LSD, and toxic substances without proper informed consent. The plaintiffs are not seeking monetary damages but want medical treatment for such veterans in the future. The lawsuit also calls on the government to disclose all medical information about tests performed on the plaintiffs. The complaint is available in full online at

www.edgewoodtestvets.org

Lilly Settles Zyprexa Charges

As anticipated, Eli Lilly & Co. has agreed to settle various federal complaints about its off-label promotion of its antipsychotic Zyprexa (olanzapine). Lilly pleaded guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act for the illegal promotion of Zyprexa for dementia from 1999 to 2001. The company will pay $615 million in that plea. Lilly did not admit to civil allegations against it, but it will pay $800 million to settle those charges. Of that amount, $438 million will go to the federal government and $362 million will be set aside for ongoing state investigations. The manufacturer also entered into a corporate integrity agreement with the government that requires Lilly to submit to third-party review of all of its policies and procedures.

Most Favor Family Consent

University of Michigan health researchers say that a nationally representative survey of older adults shows that most of them believe that it's acceptable for a family surrogate to give consent for a cognitively impaired person to be a research subject. The surveyors questioned 1,515 people who were aged 51 years and older who had been randomly selected from the government-funded National Health and Retirement Survey. The group members responded to questions about a family member giving consent for a patient to join one of the following four research scenarios: a lumbar puncture study; a randomized, controlled trial of a new drug; a similar trial of a vaccine; or a gene-transfer study. In all, 82% of the subjects said that consent by a surrogate was allowable for a drug trial, 72% for a lumbar puncture, 70% for a vaccine trial, and 67% for gene transfer. The federal government defers to states on when surrogate consent may be authorized, but the states' rules are far from clear, the researchers reported in the survey. Their survey results have been published in the Jan. 13 issue of Neurology.

FDA Warns of Supplement Risk

The Food and Drug Administration is warning consumers to immediately stop taking the dietary supplement Venom Hyperdrive 3.0. The product contains significant, undeclared amounts of the appetite suppressant sibutramine, according to the FDA. Sibutramine is the active ingredient in an approved weight-loss drug, but it can increase blood pressure and pulse. The agency warned that the ingredient could be dangerous for individuals with a history of stroke or heart disease. The supplement came in 90-capsule, red plastic bottles labeled UPC# 094922534743. For more information about the recall, contact Applied Lifescience Research Industries Inc. at

legal@alrindustries.com

New EHR Certification Options

The Certification Commission for Healthcare Information Technology plans to endorse ambulatory electronic health record products that offer advanced capabilities in four new areas: clinical research, dermatology, advanced interoperability, and advanced quality. The commission currently offers voluntary certification in both the ambulatory and inpatient settings to vendors of electronic health records that support basic clinical tasks, are able to send and receive information, and provide security for medical information. The new options for product certification would be added in 2010. The certification commission is recognized by the federal government as the official reviewer of products in health information technology. “It's the right time to add more flexibility to our approach, so we can fine tune our programs to meet everyone's needs for health information technology certification,” the commission chair Dr. Mark Leavitt commented in a statement. He added that in the next few years, the commission may extend optional add-on certification to electronic records used in eye care, oncology, obstetrics and gynecology, advanced security, and advanced clinical decision support.

In less than 5 years, physicians and other health care providers will be required to begin using a new system of code sets to report health care diagnoses and procedures.

Under a final rule published in the Federal Register last month, the Health and Human Services department is replacing the International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) code sets now used with a significantly expanded ICD-10 code sets. Providers and health plans will have until Oct. 1, 2013, to implement the new code sets.

In addition, HHS also issued a final rule adopting new standards for certain electronic health care transactions. The rule requires health care providers to come into compliance with the updated X12 standard, Version 5010, which includes updated standards for claims, remittance advice, eligibility inquiries, referral authorization, and other administrative transactions. Use of the updated standard is necessary to use the ICD-10 code sets, according to HHS.

Providers and health plans must be in compliance with the updated transaction standard by Jan. 1, 2012.

At press time, the Obama administration was in the process of reviewing and approving all new and pending regulations written under the previous administration, including the ICD-10 rules. However, a spokesman for the Centers for Medicare and Medicaid Services said that until the review is complete, it is not possible to determine which regulations will be affected.

The move to the new code sets was necessary, HHS said, to replace the outdated ICD-9 code sets. The ICD-9-CM contains about 17,000 codes, compared with 155,000 in the ICD-10 code sets.

“These regulations will move the nation toward a more efficient, quality-focused health care system by helping accelerate the widespread adoption of health information technology,” Mike Leavitt, HHS Secretary, said in a statement. “The greatly expanded ICD-10 code sets will fully support quality reporting, pay-for-performance, biosurveillance, and other critical activities.”

The final rule gives health care providers and plans almost 2 extra years to implement the Version 5010 transaction standard and a full 2 years to switch to ICD-10, compared with the timeline originally proposed last year. HHS officials said they decided to allow extra time for implementation in response to concerns that a short implementation phase would result in high implementation costs and inadequate time for training and testing.

Physician groups praised HHS for providing additional time for implementation but said other issues persist.

Officials at the American College of Physicians said they believe the benefits of switching to the ICD-10 code sets in the ambulatory setting do not outweigh the collective costs, said Brett Baker, director of regulatory affairs.

The costs and administrative burdens related to adopting ICD-10 could slow adoption of health information technology and make it more difficult for physicians to engage in quality improvement efforts, said ACP.

ACP is urging HHS to explore alternatives to the implementation plan outlined in the final rule. For example, the department could delay implementation of ICD-10 in the outpatient setting until a certain percentage of physicians adopted interoperable electronic health record systems. Since EHRs would ease the adoption burden for physicians, it makes sense to wait until adoption of health information technology reaches a certain threshold point, Mr. Baker said.

The Medical Group Management Association echoed concerns that physician practices will struggle to implement the new code sets. The association is calling on the federal government to develop some type of implementation assistance program to help physicians, especially those in small practices and rural communities. If the value to the health system is as significant as HHS estimates, government officials should be prepared to invest that savings early on to ensure implementation runs smoothly, said Robert Tennant, who serves as senior policy adviser at MGMA.

HHS also should extend its outreach to the vendor community, Mr. Tennant said, since they will be the ones to provide updates to the practice management software. HHS also needs to work with private health plans to ensure there is no disruption in payments.

For their part, Mr. Tennant advised physician practices to get started by becoming familiar with the requirements and the compliance dates. Next, reach out to vendors of practice management software and find out their plans for updating the software, including the timeline and costs. With that information in hand, practices can formulate a budget for implementation that includes training and testing, he said.

In less than 5 years, physicians and other health care providers will be required to begin using a new system of code sets to report health care diagnoses and procedures.

Under a final rule published in the Federal Register last month, the Health and Human Services department is replacing the International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) code sets now used with a significantly expanded ICD-10 code sets. Providers and health plans will have until Oct. 1, 2013, to implement the new code sets.

In addition, HHS also issued a final rule adopting new standards for certain electronic health care transactions. The rule requires health care providers to come into compliance with the updated X12 standard, Version 5010, which includes updated standards for claims, remittance advice, eligibility inquiries, referral authorization, and other administrative transactions. Use of the updated standard is necessary to use the ICD-10 code sets, according to HHS.

Providers and health plans must be in compliance with the updated transaction standard by Jan. 1, 2012.

At press time, the Obama administration was in the process of reviewing and approving all new and pending regulations written under the previous administration, including the ICD-10 rules. However, a spokesman for the Centers for Medicare and Medicaid Services said that until the review is complete, it is not possible to determine which regulations will be affected.

The move to the new code sets was necessary, HHS said, to replace the outdated ICD-9 code sets. The ICD-9-CM contains about 17,000 codes, compared with 155,000 in the ICD-10 code sets.

“These regulations will move the nation toward a more efficient, quality-focused health care system by helping accelerate the widespread adoption of health information technology,” Mike Leavitt, HHS Secretary, said in a statement. “The greatly expanded ICD-10 code sets will fully support quality reporting, pay-for-performance, biosurveillance, and other critical activities.”

The final rule gives health care providers and plans almost 2 extra years to implement the Version 5010 transaction standard and a full 2 years to switch to ICD-10, compared with the timeline originally proposed last year. HHS officials said they decided to allow extra time for implementation in response to concerns that a short implementation phase would result in high implementation costs and inadequate time for training and testing.

Physician groups praised HHS for providing additional time for implementation but said other issues persist.

Officials at the American College of Physicians said they believe the benefits of switching to the ICD-10 code sets in the ambulatory setting do not outweigh the collective costs, said Brett Baker, director of regulatory affairs.

The costs and administrative burdens related to adopting ICD-10 could slow adoption of health information technology and make it more difficult for physicians to engage in quality improvement efforts, said ACP.

ACP is urging HHS to explore alternatives to the implementation plan outlined in the final rule. For example, the department could delay implementation of ICD-10 in the outpatient setting until a certain percentage of physicians adopted interoperable electronic health record systems. Since EHRs would ease the adoption burden for physicians, it makes sense to wait until adoption of health information technology reaches a certain threshold point, Mr. Baker said.

The Medical Group Management Association echoed concerns that physician practices will struggle to implement the new code sets. The association is calling on the federal government to develop some type of implementation assistance program to help physicians, especially those in small practices and rural communities. If the value to the health system is as significant as HHS estimates, government officials should be prepared to invest that savings early on to ensure implementation runs smoothly, said Robert Tennant, who serves as senior policy adviser at MGMA.

HHS also should extend its outreach to the vendor community, Mr. Tennant said, since they will be the ones to provide updates to the practice management software. HHS also needs to work with private health plans to ensure there is no disruption in payments.

For their part, Mr. Tennant advised physician practices to get started by becoming familiar with the requirements and the compliance dates. Next, reach out to vendors of practice management software and find out their plans for updating the software, including the timeline and costs. With that information in hand, practices can formulate a budget for implementation that includes training and testing, he said.

In less than 5 years, physicians and other health care providers will be required to begin using a new system of code sets to report health care diagnoses and procedures.

Under a final rule published in the Federal Register last month, the Health and Human Services department is replacing the International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) code sets now used with a significantly expanded ICD-10 code sets. Providers and health plans will have until Oct. 1, 2013, to implement the new code sets.

In addition, HHS also issued a final rule adopting new standards for certain electronic health care transactions. The rule requires health care providers to come into compliance with the updated X12 standard, Version 5010, which includes updated standards for claims, remittance advice, eligibility inquiries, referral authorization, and other administrative transactions. Use of the updated standard is necessary to use the ICD-10 code sets, according to HHS.

Providers and health plans must be in compliance with the updated transaction standard by Jan. 1, 2012.

At press time, the Obama administration was in the process of reviewing and approving all new and pending regulations written under the previous administration, including the ICD-10 rules. However, a spokesman for the Centers for Medicare and Medicaid Services said that until the review is complete, it is not possible to determine which regulations will be affected.

The move to the new code sets was necessary, HHS said, to replace the outdated ICD-9 code sets. The ICD-9-CM contains about 17,000 codes, compared with 155,000 in the ICD-10 code sets.

“These regulations will move the nation toward a more efficient, quality-focused health care system by helping accelerate the widespread adoption of health information technology,” Mike Leavitt, HHS Secretary, said in a statement. “The greatly expanded ICD-10 code sets will fully support quality reporting, pay-for-performance, biosurveillance, and other critical activities.”

The final rule gives health care providers and plans almost 2 extra years to implement the Version 5010 transaction standard and a full 2 years to switch to ICD-10, compared with the timeline originally proposed last year. HHS officials said they decided to allow extra time for implementation in response to concerns that a short implementation phase would result in high implementation costs and inadequate time for training and testing.

Physician groups praised HHS for providing additional time for implementation but said other issues persist.

Officials at the American College of Physicians said they believe the benefits of switching to the ICD-10 code sets in the ambulatory setting do not outweigh the collective costs, said Brett Baker, director of regulatory affairs.

The costs and administrative burdens related to adopting ICD-10 could slow adoption of health information technology and make it more difficult for physicians to engage in quality improvement efforts, said ACP.

ACP is urging HHS to explore alternatives to the implementation plan outlined in the final rule. For example, the department could delay implementation of ICD-10 in the outpatient setting until a certain percentage of physicians adopted interoperable electronic health record systems. Since EHRs would ease the adoption burden for physicians, it makes sense to wait until adoption of health information technology reaches a certain threshold point, Mr. Baker said.

The Medical Group Management Association echoed concerns that physician practices will struggle to implement the new code sets. The association is calling on the federal government to develop some type of implementation assistance program to help physicians, especially those in small practices and rural communities. If the value to the health system is as significant as HHS estimates, government officials should be prepared to invest that savings early on to ensure implementation runs smoothly, said Robert Tennant, who serves as senior policy adviser at MGMA.

HHS also should extend its outreach to the vendor community, Mr. Tennant said, since they will be the ones to provide updates to the practice management software. HHS also needs to work with private health plans to ensure there is no disruption in payments.

For their part, Mr. Tennant advised physician practices to get started by becoming familiar with the requirements and the compliance dates. Next, reach out to vendors of practice management software and find out their plans for updating the software, including the timeline and costs. With that information in hand, practices can formulate a budget for implementation that includes training and testing, he said.

Detailed descriptions of the quality measures and measures groups that can be used as part of the 2009 Medicare Physician Quality Reporting Initiative are now available online.

Officials at the Centers for Medicare and Medicaid Services also have posted an implementation guide for claims-based reporting in 2009 and instructions for reporting using measures groups.

Among the 153 measures eligible for reporting in 2009 are 52 new measures, including elder maltreatment screening and follow-up planning, glucocorticoid management in rheumatoid arthritis, and influenza immunization in pediatric end-stage renal disease. The measures and related guidance documents are available at www.cms.hhs.gov/PQRI/15_MeasuresCodes.asp

Late last year, CMS officials began listing the names of physicians and other health care professionals who reported on at least 1 of the 74 PQRI measures in 2007 at www.medicare.gov/physician

In additiona to the listing of physicians, CMS officials included general information about the PQRI program. They noted that physicians might have had good reasons not to report measures and that a failure to report through PQRI does not reflect a lack of commitment to high quality care.

For example, CMS officials wrote that reporting quality data may have been too costly for some physicians or that physicians may have been engaged in other quality improvement reporting activities.

Detailed descriptions of the quality measures and measures groups that can be used as part of the 2009 Medicare Physician Quality Reporting Initiative are now available online.

Officials at the Centers for Medicare and Medicaid Services also have posted an implementation guide for claims-based reporting in 2009 and instructions for reporting using measures groups.

Among the 153 measures eligible for reporting in 2009 are 52 new measures, including elder maltreatment screening and follow-up planning, glucocorticoid management in rheumatoid arthritis, and influenza immunization in pediatric end-stage renal disease. The measures and related guidance documents are available at www.cms.hhs.gov/PQRI/15_MeasuresCodes.asp

Late last year, CMS officials began listing the names of physicians and other health care professionals who reported on at least 1 of the 74 PQRI measures in 2007 at www.medicare.gov/physician

In additiona to the listing of physicians, CMS officials included general information about the PQRI program. They noted that physicians might have had good reasons not to report measures and that a failure to report through PQRI does not reflect a lack of commitment to high quality care.

For example, CMS officials wrote that reporting quality data may have been too costly for some physicians or that physicians may have been engaged in other quality improvement reporting activities.

Detailed descriptions of the quality measures and measures groups that can be used as part of the 2009 Medicare Physician Quality Reporting Initiative are now available online.

Officials at the Centers for Medicare and Medicaid Services also have posted an implementation guide for claims-based reporting in 2009 and instructions for reporting using measures groups.

Among the 153 measures eligible for reporting in 2009 are 52 new measures, including elder maltreatment screening and follow-up planning, glucocorticoid management in rheumatoid arthritis, and influenza immunization in pediatric end-stage renal disease. The measures and related guidance documents are available at www.cms.hhs.gov/PQRI/15_MeasuresCodes.asp

Late last year, CMS officials began listing the names of physicians and other health care professionals who reported on at least 1 of the 74 PQRI measures in 2007 at www.medicare.gov/physician

In additiona to the listing of physicians, CMS officials included general information about the PQRI program. They noted that physicians might have had good reasons not to report measures and that a failure to report through PQRI does not reflect a lack of commitment to high quality care.

For example, CMS officials wrote that reporting quality data may have been too costly for some physicians or that physicians may have been engaged in other quality improvement reporting activities.

The CBO reports are available online at www.cbo.gov

A health reform plan that calls for either subsidies of health insurance premiums or mandates alone would not result in universal coverage, according to an analysis from the Congressional Budget Office.

Lawmakers, however, could achieve near-universal coverage by combining those policies or implementing them with strategies that simplify the enrollment process, the CBO analysts wrote in one of two reports on health care released last month.

The CBO, created by Congress in the 1970s, provides legislators with objective, nonpartisan analyses to assist with economic and budgetary decisions regarding federal programs, according to the agency's Web site.

One option outlined by the CBO would be to enact an enforceable individual mandate accompanied by subsidies for low-income people. Another possible combination would be to have a voluntary health insurance system with significant government subsidies and a system that facilitates enrollment, similar to how seniors are enrolled in Medicare.

In “Key Issues in Analyzing Major Health Insurance Proposals,” the CBO analysts provide an overview of the major issues they will consider in analyzing health reform proposals. In a second report, “Budget Options, Volume I: Health Care,” they outline 115 specific health policy options and their costs or potential for savings. The options examined range from the establishment of association health plans to the limitation of awards from medical malpractice lawsuits.

The reports address some of the common elements from the major health reform proposals, but do not analyze any particular package. The CBO's projections are being closely watched as members of Congress prepare to consider significant changes to the U.S. health care system.

As part of this effort, the CBO also analyzed some commonly proposed approaches to reduce costs and improve the quality of health care. These include reducing rates of obesity and smoking, expanding the use of preventive medical care, adopting disease management programs, funding comparative effectiveness research, expanding the use of health information technology, and establishing a medical home for health plan enrollees.

While these ideas could improve quality and health, the evidence is unclear about their impact on overall federal spending, the CBO wrote.

For example, in the case of health information technology, as more physicians and hospitals adopt electronic medical records under current law, it becomes less cost effective to offer subsidy payments for adoption.

If a system of subsidies is established in the future, then the government would incur additional costs but might not significantly improve adoption rates over current levels, a phenomenon known as “buying out the base,” according to the CBO.

The impact of the medical home on health care spending is also unclear, according to the CBO analysis. The use of a medical home to coordinate care might help reduce costs if the primary care physician who was coordinating care had a financial incentive to limit the use of specialty care. However, the medical home could also result in a greater use of services and therefore increase costs, the CBO wrote.

The CBO reports are available online at www.cbo.gov

A health reform plan that calls for either subsidies of health insurance premiums or mandates alone would not result in universal coverage, according to an analysis from the Congressional Budget Office.

Lawmakers, however, could achieve near-universal coverage by combining those policies or implementing them with strategies that simplify the enrollment process, the CBO analysts wrote in one of two reports on health care released last month.

The CBO, created by Congress in the 1970s, provides legislators with objective, nonpartisan analyses to assist with economic and budgetary decisions regarding federal programs, according to the agency's Web site.

One option outlined by the CBO would be to enact an enforceable individual mandate accompanied by subsidies for low-income people. Another possible combination would be to have a voluntary health insurance system with significant government subsidies and a system that facilitates enrollment, similar to how seniors are enrolled in Medicare.

In “Key Issues in Analyzing Major Health Insurance Proposals,” the CBO analysts provide an overview of the major issues they will consider in analyzing health reform proposals. In a second report, “Budget Options, Volume I: Health Care,” they outline 115 specific health policy options and their costs or potential for savings. The options examined range from the establishment of association health plans to the limitation of awards from medical malpractice lawsuits.

The reports address some of the common elements from the major health reform proposals, but do not analyze any particular package. The CBO's projections are being closely watched as members of Congress prepare to consider significant changes to the U.S. health care system.

As part of this effort, the CBO also analyzed some commonly proposed approaches to reduce costs and improve the quality of health care. These include reducing rates of obesity and smoking, expanding the use of preventive medical care, adopting disease management programs, funding comparative effectiveness research, expanding the use of health information technology, and establishing a medical home for health plan enrollees.

While these ideas could improve quality and health, the evidence is unclear about their impact on overall federal spending, the CBO wrote.

For example, in the case of health information technology, as more physicians and hospitals adopt electronic medical records under current law, it becomes less cost effective to offer subsidy payments for adoption.

If a system of subsidies is established in the future, then the government would incur additional costs but might not significantly improve adoption rates over current levels, a phenomenon known as “buying out the base,” according to the CBO.

The impact of the medical home on health care spending is also unclear, according to the CBO analysis. The use of a medical home to coordinate care might help reduce costs if the primary care physician who was coordinating care had a financial incentive to limit the use of specialty care. However, the medical home could also result in a greater use of services and therefore increase costs, the CBO wrote.

The CBO reports are available online at www.cbo.gov

A health reform plan that calls for either subsidies of health insurance premiums or mandates alone would not result in universal coverage, according to an analysis from the Congressional Budget Office.

Lawmakers, however, could achieve near-universal coverage by combining those policies or implementing them with strategies that simplify the enrollment process, the CBO analysts wrote in one of two reports on health care released last month.

The CBO, created by Congress in the 1970s, provides legislators with objective, nonpartisan analyses to assist with economic and budgetary decisions regarding federal programs, according to the agency's Web site.

One option outlined by the CBO would be to enact an enforceable individual mandate accompanied by subsidies for low-income people. Another possible combination would be to have a voluntary health insurance system with significant government subsidies and a system that facilitates enrollment, similar to how seniors are enrolled in Medicare.

In “Key Issues in Analyzing Major Health Insurance Proposals,” the CBO analysts provide an overview of the major issues they will consider in analyzing health reform proposals. In a second report, “Budget Options, Volume I: Health Care,” they outline 115 specific health policy options and their costs or potential for savings. The options examined range from the establishment of association health plans to the limitation of awards from medical malpractice lawsuits.

The reports address some of the common elements from the major health reform proposals, but do not analyze any particular package. The CBO's projections are being closely watched as members of Congress prepare to consider significant changes to the U.S. health care system.

As part of this effort, the CBO also analyzed some commonly proposed approaches to reduce costs and improve the quality of health care. These include reducing rates of obesity and smoking, expanding the use of preventive medical care, adopting disease management programs, funding comparative effectiveness research, expanding the use of health information technology, and establishing a medical home for health plan enrollees.

While these ideas could improve quality and health, the evidence is unclear about their impact on overall federal spending, the CBO wrote.

For example, in the case of health information technology, as more physicians and hospitals adopt electronic medical records under current law, it becomes less cost effective to offer subsidy payments for adoption.

If a system of subsidies is established in the future, then the government would incur additional costs but might not significantly improve adoption rates over current levels, a phenomenon known as “buying out the base,” according to the CBO.

The impact of the medical home on health care spending is also unclear, according to the CBO analysis. The use of a medical home to coordinate care might help reduce costs if the primary care physician who was coordinating care had a financial incentive to limit the use of specialty care. However, the medical home could also result in a greater use of services and therefore increase costs, the CBO wrote.

About 38% of adults and nearly 12% of children in the United States used some type of complementary or alternative medicine therapy in 2007, according to survey data released by the Centers for Disease Control and Prevention and the National Institutes of Health.

Adults primarily reported using complementary and alternative medicine (CAM) therapies to help manage chronic pain such as back, neck, or joint pain, as well as arthritis. Among children, the most common reason for using CAM therapies was back or neck pain. However, children had a greater variety of conditions being treated with CAM than did adults, including head and chest colds, anxiety and stress, insomnia, attention-deficit/hyperactivity disorder, and musculoskeletal complaints.

“Although children and adults are using CAM at high rates, the types of therapies they use and the conditions for which they are using these therapies differ,” Richard Nahin, Ph.D., acting director of the division of extramural research at the National Center for Complementary and Alternative Medicine, part of NIH, said at a press briefing.

The survey data come from the 2007 National Health Interview Survey and include information on the use of CAM from more than 23,000 adults and 9,400 children. Officials at the CDC, which administers the survey, first collected data on CAM use in adults in 2002. This is the first time that information was collected about use by children.

In adults, the percentage of Americans using CAM appears to be holding steady, said Dr. Nahin, who coauthored the report on the survey data. In 2002, about 36% of U.S. adults reported using some type of CAM therapy, compared with about 38% in 2007.

Although the use of CAM in children seems much lower than in adults, that likely reflects the fact that adults have more health care needs, Dr. Nahin said. Children were five times more likely to use CAM if a parent or another relative also used CAM, according to the report.

For adults and children, natural products, including herbal medicines and dietary supplements, were the most commonly used CAM therapies. For adults, some of the most common natural products were fish oil, glucosamine, echinacea, flaxseed oil or pills, and ginseng.

Other popular CAM therapies used by adults were deep breathing exercises, chiropractic manipulation, massage, and yoga. For children, the most common natural product was echinacea, followed by fish oil, combination herb pills, and flaxseed oil or pills, as well as chiropractic manipulation, deep breathing exercises, yoga, and homeopathic treatment.

For both adults and children, natural products, including herbal medicines (shown here) and dietary supplements, were the most commonly used CAM therapies. ©Bob Stockfield/National Center for Complementary and Alternative Medicine

About 38% of adults and nearly 12% of children in the United States used some type of complementary or alternative medicine therapy in 2007, according to survey data released by the Centers for Disease Control and Prevention and the National Institutes of Health.

Adults primarily reported using complementary and alternative medicine (CAM) therapies to help manage chronic pain such as back, neck, or joint pain, as well as arthritis. Among children, the most common reason for using CAM therapies was back or neck pain. However, children had a greater variety of conditions being treated with CAM than did adults, including head and chest colds, anxiety and stress, insomnia, attention-deficit/hyperactivity disorder, and musculoskeletal complaints.

“Although children and adults are using CAM at high rates, the types of therapies they use and the conditions for which they are using these therapies differ,” Richard Nahin, Ph.D., acting director of the division of extramural research at the National Center for Complementary and Alternative Medicine, part of NIH, said at a press briefing.

The survey data come from the 2007 National Health Interview Survey and include information on the use of CAM from more than 23,000 adults and 9,400 children. Officials at the CDC, which administers the survey, first collected data on CAM use in adults in 2002. This is the first time that information was collected about use by children.

In adults, the percentage of Americans using CAM appears to be holding steady, said Dr. Nahin, who coauthored the report on the survey data. In 2002, about 36% of U.S. adults reported using some type of CAM therapy, compared with about 38% in 2007.

Although the use of CAM in children seems much lower than in adults, that likely reflects the fact that adults have more health care needs, Dr. Nahin said. Children were five times more likely to use CAM if a parent or another relative also used CAM, according to the report.

For adults and children, natural products, including herbal medicines and dietary supplements, were the most commonly used CAM therapies. For adults, some of the most common natural products were fish oil, glucosamine, echinacea, flaxseed oil or pills, and ginseng.

Other popular CAM therapies used by adults were deep breathing exercises, chiropractic manipulation, massage, and yoga. For children, the most common natural product was echinacea, followed by fish oil, combination herb pills, and flaxseed oil or pills, as well as chiropractic manipulation, deep breathing exercises, yoga, and homeopathic treatment.

For both adults and children, natural products, including herbal medicines (shown here) and dietary supplements, were the most commonly used CAM therapies. ©Bob Stockfield/National Center for Complementary and Alternative Medicine

About 38% of adults and nearly 12% of children in the United States used some type of complementary or alternative medicine therapy in 2007, according to survey data released by the Centers for Disease Control and Prevention and the National Institutes of Health.

Adults primarily reported using complementary and alternative medicine (CAM) therapies to help manage chronic pain such as back, neck, or joint pain, as well as arthritis. Among children, the most common reason for using CAM therapies was back or neck pain. However, children had a greater variety of conditions being treated with CAM than did adults, including head and chest colds, anxiety and stress, insomnia, attention-deficit/hyperactivity disorder, and musculoskeletal complaints.

“Although children and adults are using CAM at high rates, the types of therapies they use and the conditions for which they are using these therapies differ,” Richard Nahin, Ph.D., acting director of the division of extramural research at the National Center for Complementary and Alternative Medicine, part of NIH, said at a press briefing.

The survey data come from the 2007 National Health Interview Survey and include information on the use of CAM from more than 23,000 adults and 9,400 children. Officials at the CDC, which administers the survey, first collected data on CAM use in adults in 2002. This is the first time that information was collected about use by children.

In adults, the percentage of Americans using CAM appears to be holding steady, said Dr. Nahin, who coauthored the report on the survey data. In 2002, about 36% of U.S. adults reported using some type of CAM therapy, compared with about 38% in 2007.

Although the use of CAM in children seems much lower than in adults, that likely reflects the fact that adults have more health care needs, Dr. Nahin said. Children were five times more likely to use CAM if a parent or another relative also used CAM, according to the report.

For adults and children, natural products, including herbal medicines and dietary supplements, were the most commonly used CAM therapies. For adults, some of the most common natural products were fish oil, glucosamine, echinacea, flaxseed oil or pills, and ginseng.

Other popular CAM therapies used by adults were deep breathing exercises, chiropractic manipulation, massage, and yoga. For children, the most common natural product was echinacea, followed by fish oil, combination herb pills, and flaxseed oil or pills, as well as chiropractic manipulation, deep breathing exercises, yoga, and homeopathic treatment.

For both adults and children, natural products, including herbal medicines (shown here) and dietary supplements, were the most commonly used CAM therapies. ©Bob Stockfield/National Center for Complementary and Alternative Medicine

VA Accepts POWs' Osteoporosis

Officials at the Department of Veterans Affairs are proposing to extend benefits to former prisoners of war who suffer from disabling osteoporosis. In a proposed rule, the VA seeks to establish a presumption of service connection for osteoporosis that's at least 10% disabling in veterans held at least 30 days as POWs. Several studies have shown that POWs suffered serious bone loss following captivity because of dietary deficiencies during their imprisonment.

New Site for Arthritis Patients

The Arthritis Foundation has launched a new online resource to inspire people with arthritis to engage in physical activity. The “Let's Move Together” Web site (

www.letsmovetogether.org

OA Initiative Biospecimens Available

Researchers can now obtain serum, plasma, DNA, and other biospecimens collected as part of the Osteoarthritis Initiative. The Osteoarthritis Initiative is a research partnership between the National Institutes of Health and private industry that aims to improve the diagnosis and monitoring of osteoarthritis. The study, which began enrolling participants in 2004, includes men and women age 45 and older who are at risk for developing osteroarthritis and those who early disease. Biospecimens are available for the entire cohort (4,796 participants) for the baseline, 12-month, and 24-month follow-up visits. A committee appointed by NIH will review researcher requests for biospecimens based on significance, approach, innovation, investigator qualifications, plans for data sharing, and research environment. The committee will also take into account the potential for the proposed research to advance the understanding or treatment of osteoarthritis.

FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements funded even partially by a manufacturer. In its presentation to practitioners, an article shouldn't be highlighted, otherwise marked up, or attached to promotional materials.

PhRMA Revises Ad Guidelines

The Pharmaceutical Research and Manufacturers of America recently advised drug makers to state when actors portray medical professionals in direct-to-consumer drug advertisements and to acknowledge any compensation given to real medical professionals in ads. In addition, the new, nonbinding guidelines support the inclusion of “black box” warnings in the ads, and reinforce that companies shouldn't promote off-label uses. Rep. John Dingell (D-Mich.), who has led investigations into direct-to-consumer ads, commended PhRMA for the new guidelines but noted that the organization hasn't endorsed a 2-year prohibition on such ads for newly approved drugs, as recommended by the Institute of Medicine.

New EHR Certification Options

The Certification Commission for Healthcare Information Technology plans to endorse ambulatory electronic health record (EHR) products that offer advanced capabilities in four new areas: clinical research, dermatology, advanced interoperability, and advanced quality. The CCHIT currently offers voluntary certification in both the ambulatory and inpatient settings to vendors of EHRs that support basic clinical tasks, are able to send and receive information, and provide security for medical information. The new options for product certification would be added in 2010. The CCHIT is recognized by the federal government as the official reviewer of products in health information technology. CCHIT chair Dr. Mark Leavitt said in a statement that in the next few years, the commission may develop optional add-on certifications.

VA Accepts POWs' Osteoporosis

Officials at the Department of Veterans Affairs are proposing to extend benefits to former prisoners of war who suffer from disabling osteoporosis. In a proposed rule, the VA seeks to establish a presumption of service connection for osteoporosis that's at least 10% disabling in veterans held at least 30 days as POWs. Several studies have shown that POWs suffered serious bone loss following captivity because of dietary deficiencies during their imprisonment.

New Site for Arthritis Patients

The Arthritis Foundation has launched a new online resource to inspire people with arthritis to engage in physical activity. The “Let's Move Together” Web site (

www.letsmovetogether.org

OA Initiative Biospecimens Available

Researchers can now obtain serum, plasma, DNA, and other biospecimens collected as part of the Osteoarthritis Initiative. The Osteoarthritis Initiative is a research partnership between the National Institutes of Health and private industry that aims to improve the diagnosis and monitoring of osteoarthritis. The study, which began enrolling participants in 2004, includes men and women age 45 and older who are at risk for developing osteroarthritis and those who early disease. Biospecimens are available for the entire cohort (4,796 participants) for the baseline, 12-month, and 24-month follow-up visits. A committee appointed by NIH will review researcher requests for biospecimens based on significance, approach, innovation, investigator qualifications, plans for data sharing, and research environment. The committee will also take into account the potential for the proposed research to advance the understanding or treatment of osteoarthritis.

FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements funded even partially by a manufacturer. In its presentation to practitioners, an article shouldn't be highlighted, otherwise marked up, or attached to promotional materials.

PhRMA Revises Ad Guidelines

The Pharmaceutical Research and Manufacturers of America recently advised drug makers to state when actors portray medical professionals in direct-to-consumer drug advertisements and to acknowledge any compensation given to real medical professionals in ads. In addition, the new, nonbinding guidelines support the inclusion of “black box” warnings in the ads, and reinforce that companies shouldn't promote off-label uses. Rep. John Dingell (D-Mich.), who has led investigations into direct-to-consumer ads, commended PhRMA for the new guidelines but noted that the organization hasn't endorsed a 2-year prohibition on such ads for newly approved drugs, as recommended by the Institute of Medicine.

New EHR Certification Options

The Certification Commission for Healthcare Information Technology plans to endorse ambulatory electronic health record (EHR) products that offer advanced capabilities in four new areas: clinical research, dermatology, advanced interoperability, and advanced quality. The CCHIT currently offers voluntary certification in both the ambulatory and inpatient settings to vendors of EHRs that support basic clinical tasks, are able to send and receive information, and provide security for medical information. The new options for product certification would be added in 2010. The CCHIT is recognized by the federal government as the official reviewer of products in health information technology. CCHIT chair Dr. Mark Leavitt said in a statement that in the next few years, the commission may develop optional add-on certifications.

VA Accepts POWs' Osteoporosis

Officials at the Department of Veterans Affairs are proposing to extend benefits to former prisoners of war who suffer from disabling osteoporosis. In a proposed rule, the VA seeks to establish a presumption of service connection for osteoporosis that's at least 10% disabling in veterans held at least 30 days as POWs. Several studies have shown that POWs suffered serious bone loss following captivity because of dietary deficiencies during their imprisonment.

New Site for Arthritis Patients

The Arthritis Foundation has launched a new online resource to inspire people with arthritis to engage in physical activity. The “Let's Move Together” Web site (

www.letsmovetogether.org

OA Initiative Biospecimens Available

Researchers can now obtain serum, plasma, DNA, and other biospecimens collected as part of the Osteoarthritis Initiative. The Osteoarthritis Initiative is a research partnership between the National Institutes of Health and private industry that aims to improve the diagnosis and monitoring of osteoarthritis. The study, which began enrolling participants in 2004, includes men and women age 45 and older who are at risk for developing osteroarthritis and those who early disease. Biospecimens are available for the entire cohort (4,796 participants) for the baseline, 12-month, and 24-month follow-up visits. A committee appointed by NIH will review researcher requests for biospecimens based on significance, approach, innovation, investigator qualifications, plans for data sharing, and research environment. The committee will also take into account the potential for the proposed research to advance the understanding or treatment of osteoarthritis.

FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements funded even partially by a manufacturer. In its presentation to practitioners, an article shouldn't be highlighted, otherwise marked up, or attached to promotional materials.

PhRMA Revises Ad Guidelines

The Pharmaceutical Research and Manufacturers of America recently advised drug makers to state when actors portray medical professionals in direct-to-consumer drug advertisements and to acknowledge any compensation given to real medical professionals in ads. In addition, the new, nonbinding guidelines support the inclusion of “black box” warnings in the ads, and reinforce that companies shouldn't promote off-label uses. Rep. John Dingell (D-Mich.), who has led investigations into direct-to-consumer ads, commended PhRMA for the new guidelines but noted that the organization hasn't endorsed a 2-year prohibition on such ads for newly approved drugs, as recommended by the Institute of Medicine.

New EHR Certification Options

The Certification Commission for Healthcare Information Technology plans to endorse ambulatory electronic health record (EHR) products that offer advanced capabilities in four new areas: clinical research, dermatology, advanced interoperability, and advanced quality. The CCHIT currently offers voluntary certification in both the ambulatory and inpatient settings to vendors of EHRs that support basic clinical tasks, are able to send and receive information, and provide security for medical information. The new options for product certification would be added in 2010. The CCHIT is recognized by the federal government as the official reviewer of products in health information technology. CCHIT chair Dr. Mark Leavitt said in a statement that in the next few years, the commission may develop optional add-on certifications.

Detailed descriptions of the quality measures and measures groups that can be used as part of the 2009 Medicare Physician Quality Reporting Initiative are now available online at www.cms.hhs.gov/PQRI/15_MeasuresCodes.asp

Officials at the Centers for Medicare and Medicaid Services also have posted an implementation guide for claims-based reporting in 2009 and instructions for reporting using measures groups.

Among the 153 measures eligible for reporting in 2009 are 52 new measures including glucocorticoid management in rheumatoid arthritis and elder maltreatment screening and follow-up planning.

Late last year, CMS officials began listing the names of physicians and other health care professionals who reported on at least 1 of the 74 PQRI measures in 2007 at www.medicare.gov/physician

Along with the listing of physicians, CMS officials included general information about the PQRI program. They noted that physicians may have had good reasons not to report measures and that a failure to report through PQRI doesn't reflect a lack of commitment to high quality care. For example, reporting quality data may have been too costly for some physicians or that physicians may have been engaged in other quality improvement reporting activities.

Detailed descriptions of the quality measures and measures groups that can be used as part of the 2009 Medicare Physician Quality Reporting Initiative are now available online at www.cms.hhs.gov/PQRI/15_MeasuresCodes.asp

Officials at the Centers for Medicare and Medicaid Services also have posted an implementation guide for claims-based reporting in 2009 and instructions for reporting using measures groups.

Among the 153 measures eligible for reporting in 2009 are 52 new measures including glucocorticoid management in rheumatoid arthritis and elder maltreatment screening and follow-up planning.

Late last year, CMS officials began listing the names of physicians and other health care professionals who reported on at least 1 of the 74 PQRI measures in 2007 at www.medicare.gov/physician

Along with the listing of physicians, CMS officials included general information about the PQRI program. They noted that physicians may have had good reasons not to report measures and that a failure to report through PQRI doesn't reflect a lack of commitment to high quality care. For example, reporting quality data may have been too costly for some physicians or that physicians may have been engaged in other quality improvement reporting activities.

Detailed descriptions of the quality measures and measures groups that can be used as part of the 2009 Medicare Physician Quality Reporting Initiative are now available online at www.cms.hhs.gov/PQRI/15_MeasuresCodes.asp

Officials at the Centers for Medicare and Medicaid Services also have posted an implementation guide for claims-based reporting in 2009 and instructions for reporting using measures groups.

Among the 153 measures eligible for reporting in 2009 are 52 new measures including glucocorticoid management in rheumatoid arthritis and elder maltreatment screening and follow-up planning.

Late last year, CMS officials began listing the names of physicians and other health care professionals who reported on at least 1 of the 74 PQRI measures in 2007 at www.medicare.gov/physician

Along with the listing of physicians, CMS officials included general information about the PQRI program. They noted that physicians may have had good reasons not to report measures and that a failure to report through PQRI doesn't reflect a lack of commitment to high quality care. For example, reporting quality data may have been too costly for some physicians or that physicians may have been engaged in other quality improvement reporting activities.

In less than 5 years, physicians and other health care providers will be required to begin using a new system of code sets to report health care diagnoses and procedures.

Under a final rule published in the Federal Register last month, the Health and Human Services department is replacing the International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) code sets now used with a significantly expanded ICD-10 code sets. Providers and health plans will have until Oct. 1, 2013, to implement the new code sets.

HHS also issued a final rule adopting new standards for certain electronic health care transactions. The rule requires health care providers to come into compliance with the updated X12 standard, Version 5010, which includes updated standards for claims, remittance advice, eligibility inquiries, referral authorization, and other administrative transactions. Use of the updated standard is necessary to use the ICD-10 code sets, according to HHS. Providers and health plans must be in compliance with the updated transaction standard by Jan. 1, 2012.

At press time, the Obama administration was in the process of reviewing and approving all new and pending regulations written under the previous administration, including the ICD-10 rules. However, a spokesman for the Centers for Medicare and Medicaid Services said that until the review is complete, it is not possible to determine which regulations are affected.

According to HHS, the ICD-9 code sets are outdated.

The ICD-9-CM contains about 17,000 codes, compared with 155,000 codes in the ICD-10 code sets. “These regulations will move the nation toward a more efficient, quality-focused health care system by helping accelerate the widespread adoption of health information technology,” Mike Leavitt, HHS Secretary, said in a statement. The new codes will support quality reporting, pay for performance, and biosurveillance, he added.

The final rule gives health care providers and plans almost 2 extra years to implement the Version 5010 transaction standard and a full 2 years to switch to ICD-10, compared with the timeline originally proposed last year.

HHS officials said they decided to allow extra time for implementation in response to concerns that a short implementation phase would result in high implementation costs and inadequate time for training and testing.

Physician groups praised HHS for providing additional time for implementation but said other issues persist.

Officials at the American College of Physicians said that they believe that the benefits of switching to the ICD-10 code sets in the ambulatory setting do not outweigh the collective costs, said Brett Baker, director of regulatory affairs. The costs and administrative burdens related to adopting ICD-10 could slow adoption of health information technology and make it more difficult for physicians to engage in quality improvement efforts, according to the ACP.

The ACP is urging HHS to explore alternatives to the implementation plan outlined in the final rule.

For example, the department could delay implementation of ICD-10 in the outpatient setting until a certain percentage of physicians adopted interoperable electronic health record systems. Since EHRs would ease the adoption burden for physicians, it makes sense to wait until adoption of health information technology reaches a certain threshold point, Mr. Baker said.

The Medical Group Management Association expressed concern that physician practices will struggle to implement the new code sets. The association is calling on the federal government to develop some type of implementation assistance program to help physicians, especially those in small practices and rural communities. If the value to the health system is as significant as HHS estimates, government officials should be prepared to invest that savings early on to ensure implementation runs smoothly, said Robert Tennant, of MGMA.

Mr. Tennant advised physician practices to learn the requirements and the compliance dates. Next, medical practices should find out when vendors of practice management software plan to update the software and the cost.

With that information in hand, practices can formulate a budget for implementation that includes training and testing, he said.

In less than 5 years, physicians and other health care providers will be required to begin using a new system of code sets to report health care diagnoses and procedures.

Under a final rule published in the Federal Register last month, the Health and Human Services department is replacing the International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) code sets now used with a significantly expanded ICD-10 code sets. Providers and health plans will have until Oct. 1, 2013, to implement the new code sets.

HHS also issued a final rule adopting new standards for certain electronic health care transactions. The rule requires health care providers to come into compliance with the updated X12 standard, Version 5010, which includes updated standards for claims, remittance advice, eligibility inquiries, referral authorization, and other administrative transactions. Use of the updated standard is necessary to use the ICD-10 code sets, according to HHS. Providers and health plans must be in compliance with the updated transaction standard by Jan. 1, 2012.

At press time, the Obama administration was in the process of reviewing and approving all new and pending regulations written under the previous administration, including the ICD-10 rules. However, a spokesman for the Centers for Medicare and Medicaid Services said that until the review is complete, it is not possible to determine which regulations are affected.

According to HHS, the ICD-9 code sets are outdated.

The ICD-9-CM contains about 17,000 codes, compared with 155,000 codes in the ICD-10 code sets. “These regulations will move the nation toward a more efficient, quality-focused health care system by helping accelerate the widespread adoption of health information technology,” Mike Leavitt, HHS Secretary, said in a statement. The new codes will support quality reporting, pay for performance, and biosurveillance, he added.

The final rule gives health care providers and plans almost 2 extra years to implement the Version 5010 transaction standard and a full 2 years to switch to ICD-10, compared with the timeline originally proposed last year.

HHS officials said they decided to allow extra time for implementation in response to concerns that a short implementation phase would result in high implementation costs and inadequate time for training and testing.

Physician groups praised HHS for providing additional time for implementation but said other issues persist.

Officials at the American College of Physicians said that they believe that the benefits of switching to the ICD-10 code sets in the ambulatory setting do not outweigh the collective costs, said Brett Baker, director of regulatory affairs. The costs and administrative burdens related to adopting ICD-10 could slow adoption of health information technology and make it more difficult for physicians to engage in quality improvement efforts, according to the ACP.

The ACP is urging HHS to explore alternatives to the implementation plan outlined in the final rule.

For example, the department could delay implementation of ICD-10 in the outpatient setting until a certain percentage of physicians adopted interoperable electronic health record systems. Since EHRs would ease the adoption burden for physicians, it makes sense to wait until adoption of health information technology reaches a certain threshold point, Mr. Baker said.

The Medical Group Management Association expressed concern that physician practices will struggle to implement the new code sets. The association is calling on the federal government to develop some type of implementation assistance program to help physicians, especially those in small practices and rural communities. If the value to the health system is as significant as HHS estimates, government officials should be prepared to invest that savings early on to ensure implementation runs smoothly, said Robert Tennant, of MGMA.

Mr. Tennant advised physician practices to learn the requirements and the compliance dates. Next, medical practices should find out when vendors of practice management software plan to update the software and the cost.

With that information in hand, practices can formulate a budget for implementation that includes training and testing, he said.

In less than 5 years, physicians and other health care providers will be required to begin using a new system of code sets to report health care diagnoses and procedures.

Under a final rule published in the Federal Register last month, the Health and Human Services department is replacing the International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) code sets now used with a significantly expanded ICD-10 code sets. Providers and health plans will have until Oct. 1, 2013, to implement the new code sets.

HHS also issued a final rule adopting new standards for certain electronic health care transactions. The rule requires health care providers to come into compliance with the updated X12 standard, Version 5010, which includes updated standards for claims, remittance advice, eligibility inquiries, referral authorization, and other administrative transactions. Use of the updated standard is necessary to use the ICD-10 code sets, according to HHS. Providers and health plans must be in compliance with the updated transaction standard by Jan. 1, 2012.

At press time, the Obama administration was in the process of reviewing and approving all new and pending regulations written under the previous administration, including the ICD-10 rules. However, a spokesman for the Centers for Medicare and Medicaid Services said that until the review is complete, it is not possible to determine which regulations are affected.

According to HHS, the ICD-9 code sets are outdated.

The ICD-9-CM contains about 17,000 codes, compared with 155,000 codes in the ICD-10 code sets. “These regulations will move the nation toward a more efficient, quality-focused health care system by helping accelerate the widespread adoption of health information technology,” Mike Leavitt, HHS Secretary, said in a statement. The new codes will support quality reporting, pay for performance, and biosurveillance, he added.

The final rule gives health care providers and plans almost 2 extra years to implement the Version 5010 transaction standard and a full 2 years to switch to ICD-10, compared with the timeline originally proposed last year.

HHS officials said they decided to allow extra time for implementation in response to concerns that a short implementation phase would result in high implementation costs and inadequate time for training and testing.

Physician groups praised HHS for providing additional time for implementation but said other issues persist.

Officials at the American College of Physicians said that they believe that the benefits of switching to the ICD-10 code sets in the ambulatory setting do not outweigh the collective costs, said Brett Baker, director of regulatory affairs. The costs and administrative burdens related to adopting ICD-10 could slow adoption of health information technology and make it more difficult for physicians to engage in quality improvement efforts, according to the ACP.

The ACP is urging HHS to explore alternatives to the implementation plan outlined in the final rule.

For example, the department could delay implementation of ICD-10 in the outpatient setting until a certain percentage of physicians adopted interoperable electronic health record systems. Since EHRs would ease the adoption burden for physicians, it makes sense to wait until adoption of health information technology reaches a certain threshold point, Mr. Baker said.

The Medical Group Management Association expressed concern that physician practices will struggle to implement the new code sets. The association is calling on the federal government to develop some type of implementation assistance program to help physicians, especially those in small practices and rural communities. If the value to the health system is as significant as HHS estimates, government officials should be prepared to invest that savings early on to ensure implementation runs smoothly, said Robert Tennant, of MGMA.

Mr. Tennant advised physician practices to learn the requirements and the compliance dates. Next, medical practices should find out when vendors of practice management software plan to update the software and the cost.

With that information in hand, practices can formulate a budget for implementation that includes training and testing, he said.