Jane Anderson

Court Shields Billing Records

An appeals court has ruled against the release of Medicare billing records, which was sought by the group Consumers' Checkbook so that it could grade physicians on quality. The nonprofit had filed a Freedom of Information Act request for all 2004 Medicare claims from physicians in several locations, and the group won in a lower court in 2007. But the Department of Health and Human Services, joined by the American Medical Association, appealed, and the U.S. Circuit Court of Appeals for the District of Columbia ruled that HHS does not have to release the information. Disclosure of the requested data would constitute an invasion of physicians' privacy, the appeals court said. The AMA praised the decision. “The court clearly found that the release of personal physician payment data does not meet the standard of the Freedom of Information Act, which is to provide the public with information on how the government operates,” Dr. Jeremy Lazarus, AMA board member, said in a statement.

IOM Report: HIPAA Is Inadequate

The government's main health-privacy rule doesn't adequately protect people's health information, yet it hinders important health research, a report from the Institute of Medicine concluded. The privacy rule, stemming from the Health Insurance Portability and Accountability Act (HIPAA), is difficult to reconcile with other federal regulations governing research and personal information, the IOM report said. In addition, organizations that collect and use health data vary greatly in how they interpret and follow HIPAA, leading to potential privacy problems, the report said. Congress should create an entirely new approach to protecting personal health information in research, separate from the HIPAA rule, an IOM panel recommended. “We believe there is synergy between the goals of safeguarding privacy and enhancing health research,” said panel chairman Lawrence Gostin, a professor of health law at Georgetown University, Washington.

Many People Go Without Drugs

More children and working-age adults are failing to take needed prescription medications because of cost concerns, according to a national study by the Center for Studying Health System Change. In 2007, 1 in 7 Americans under age 65 years reported not filling a prescription in the previous year because they couldn't afford the medication, up from 1 in 10 in 2003. Rising prescription drug costs and less-generous drug coverage probably contributed to the change, the report said. Uninsured, working-age Americans saw the biggest jump in unmet prescription needs between 2003 and 2007, with the proportion going without medications rising from 26% to almost 35% in that time, the report said. However, a growing proportion of working-age Americans with employer-sponsored health insurance also reported going without prescription medications.

FDA on 'High-Risk' List

The Food and Drug Administration faces significant challenges that compromise its ability to protect Americans from unsafe and ineffective products, the Government Accountability Office said in adding the FDA to its biennial “high-risk” list. The GAO gives that label to government programs or agencies that need to address internal mismanagement. In its 2009 report, the GAO said the FDA needs to beef up its foreign-drug inspection program, better manage its reviews of companies' promotional materials, and ensure that drug makers properly present clinical data.

Poll: Affordability Is Tops

Making health insurance more affordable trumps improving quality and expanding coverage among the public's priorities for health care reform, according to a new poll. The survey from the Kaiser Family Foundation and the Harvard School of Public Health found that most people believe that action on health care is important to help the nation out of recession. But when respondents were asked to choose between coverage expansion, cost reduction, and delivery-system change, 4 in 10 named affordability as most important, followed by 3 in 10 who said that expanding coverage is the top priority. Roughly 2 in 10 picked improving the quality and cost-effectiveness of the health care delivery system. Two-thirds of those surveyed favored requiring all individuals to have health insurance, but when told that some people may then have to buy health insurance they consider too expensive or don't want, support for the mandate dropped to 19%.

Humana Supports ID Cards

Humana has become the first health insurer to publicly support the Medical Group Management Association's drive to get standardized, machine-readable insurance cards into people's wallets by next January. “Our goal is to continue working with MGMA and the industry to eliminate waste, create efficiencies, and reduce the hassle factor for providers,” Humana Senior Vice President Bruce Perkins said in a statement. Adopting readable cards is part of an overall drive by the company to simplify health insurance administration, he said. MGMA estimates that machine-readable insurance cards could save physician offices and hospitals as much as $1 billion a year by reducing paperwork and avoiding denial of many claims.

Court Shields Billing Records

An appeals court has ruled against the release of Medicare billing records, which was sought by the group Consumers' Checkbook so that it could grade physicians on quality. The nonprofit had filed a Freedom of Information Act request for all 2004 Medicare claims from physicians in several locations, and the group won in a lower court in 2007. But the Department of Health and Human Services, joined by the American Medical Association, appealed, and the U.S. Circuit Court of Appeals for the District of Columbia ruled that HHS does not have to release the information. Disclosure of the requested data would constitute an invasion of physicians' privacy, the appeals court said. The AMA praised the decision. “The court clearly found that the release of personal physician payment data does not meet the standard of the Freedom of Information Act, which is to provide the public with information on how the government operates,” Dr. Jeremy Lazarus, AMA board member, said in a statement.

IOM Report: HIPAA Is Inadequate

The government's main health-privacy rule doesn't adequately protect people's health information, yet it hinders important health research, a report from the Institute of Medicine concluded. The privacy rule, stemming from the Health Insurance Portability and Accountability Act (HIPAA), is difficult to reconcile with other federal regulations governing research and personal information, the IOM report said. In addition, organizations that collect and use health data vary greatly in how they interpret and follow HIPAA, leading to potential privacy problems, the report said. Congress should create an entirely new approach to protecting personal health information in research, separate from the HIPAA rule, an IOM panel recommended. “We believe there is synergy between the goals of safeguarding privacy and enhancing health research,” said panel chairman Lawrence Gostin, a professor of health law at Georgetown University, Washington.

Many People Go Without Drugs

More children and working-age adults are failing to take needed prescription medications because of cost concerns, according to a national study by the Center for Studying Health System Change. In 2007, 1 in 7 Americans under age 65 years reported not filling a prescription in the previous year because they couldn't afford the medication, up from 1 in 10 in 2003. Rising prescription drug costs and less-generous drug coverage probably contributed to the change, the report said. Uninsured, working-age Americans saw the biggest jump in unmet prescription needs between 2003 and 2007, with the proportion going without medications rising from 26% to almost 35% in that time, the report said. However, a growing proportion of working-age Americans with employer-sponsored health insurance also reported going without prescription medications.

FDA on 'High-Risk' List

The Food and Drug Administration faces significant challenges that compromise its ability to protect Americans from unsafe and ineffective products, the Government Accountability Office said in adding the FDA to its biennial “high-risk” list. The GAO gives that label to government programs or agencies that need to address internal mismanagement. In its 2009 report, the GAO said the FDA needs to beef up its foreign-drug inspection program, better manage its reviews of companies' promotional materials, and ensure that drug makers properly present clinical data.

Poll: Affordability Is Tops

Making health insurance more affordable trumps improving quality and expanding coverage among the public's priorities for health care reform, according to a new poll. The survey from the Kaiser Family Foundation and the Harvard School of Public Health found that most people believe that action on health care is important to help the nation out of recession. But when respondents were asked to choose between coverage expansion, cost reduction, and delivery-system change, 4 in 10 named affordability as most important, followed by 3 in 10 who said that expanding coverage is the top priority. Roughly 2 in 10 picked improving the quality and cost-effectiveness of the health care delivery system. Two-thirds of those surveyed favored requiring all individuals to have health insurance, but when told that some people may then have to buy health insurance they consider too expensive or don't want, support for the mandate dropped to 19%.

Humana Supports ID Cards

Humana has become the first health insurer to publicly support the Medical Group Management Association's drive to get standardized, machine-readable insurance cards into people's wallets by next January. “Our goal is to continue working with MGMA and the industry to eliminate waste, create efficiencies, and reduce the hassle factor for providers,” Humana Senior Vice President Bruce Perkins said in a statement. Adopting readable cards is part of an overall drive by the company to simplify health insurance administration, he said. MGMA estimates that machine-readable insurance cards could save physician offices and hospitals as much as $1 billion a year by reducing paperwork and avoiding denial of many claims.

Court Shields Billing Records

An appeals court has ruled against the release of Medicare billing records, which was sought by the group Consumers' Checkbook so that it could grade physicians on quality. The nonprofit had filed a Freedom of Information Act request for all 2004 Medicare claims from physicians in several locations, and the group won in a lower court in 2007. But the Department of Health and Human Services, joined by the American Medical Association, appealed, and the U.S. Circuit Court of Appeals for the District of Columbia ruled that HHS does not have to release the information. Disclosure of the requested data would constitute an invasion of physicians' privacy, the appeals court said. The AMA praised the decision. “The court clearly found that the release of personal physician payment data does not meet the standard of the Freedom of Information Act, which is to provide the public with information on how the government operates,” Dr. Jeremy Lazarus, AMA board member, said in a statement.

IOM Report: HIPAA Is Inadequate

The government's main health-privacy rule doesn't adequately protect people's health information, yet it hinders important health research, a report from the Institute of Medicine concluded. The privacy rule, stemming from the Health Insurance Portability and Accountability Act (HIPAA), is difficult to reconcile with other federal regulations governing research and personal information, the IOM report said. In addition, organizations that collect and use health data vary greatly in how they interpret and follow HIPAA, leading to potential privacy problems, the report said. Congress should create an entirely new approach to protecting personal health information in research, separate from the HIPAA rule, an IOM panel recommended. “We believe there is synergy between the goals of safeguarding privacy and enhancing health research,” said panel chairman Lawrence Gostin, a professor of health law at Georgetown University, Washington.

Many People Go Without Drugs

More children and working-age adults are failing to take needed prescription medications because of cost concerns, according to a national study by the Center for Studying Health System Change. In 2007, 1 in 7 Americans under age 65 years reported not filling a prescription in the previous year because they couldn't afford the medication, up from 1 in 10 in 2003. Rising prescription drug costs and less-generous drug coverage probably contributed to the change, the report said. Uninsured, working-age Americans saw the biggest jump in unmet prescription needs between 2003 and 2007, with the proportion going without medications rising from 26% to almost 35% in that time, the report said. However, a growing proportion of working-age Americans with employer-sponsored health insurance also reported going without prescription medications.

FDA on 'High-Risk' List

The Food and Drug Administration faces significant challenges that compromise its ability to protect Americans from unsafe and ineffective products, the Government Accountability Office said in adding the FDA to its biennial “high-risk” list. The GAO gives that label to government programs or agencies that need to address internal mismanagement. In its 2009 report, the GAO said the FDA needs to beef up its foreign-drug inspection program, better manage its reviews of companies' promotional materials, and ensure that drug makers properly present clinical data.

Poll: Affordability Is Tops

Making health insurance more affordable trumps improving quality and expanding coverage among the public's priorities for health care reform, according to a new poll. The survey from the Kaiser Family Foundation and the Harvard School of Public Health found that most people believe that action on health care is important to help the nation out of recession. But when respondents were asked to choose between coverage expansion, cost reduction, and delivery-system change, 4 in 10 named affordability as most important, followed by 3 in 10 who said that expanding coverage is the top priority. Roughly 2 in 10 picked improving the quality and cost-effectiveness of the health care delivery system. Two-thirds of those surveyed favored requiring all individuals to have health insurance, but when told that some people may then have to buy health insurance they consider too expensive or don't want, support for the mandate dropped to 19%.

Humana Supports ID Cards

Humana has become the first health insurer to publicly support the Medical Group Management Association's drive to get standardized, machine-readable insurance cards into people's wallets by next January. “Our goal is to continue working with MGMA and the industry to eliminate waste, create efficiencies, and reduce the hassle factor for providers,” Humana Senior Vice President Bruce Perkins said in a statement. Adopting readable cards is part of an overall drive by the company to simplify health insurance administration, he said. MGMA estimates that machine-readable insurance cards could save physician offices and hospitals as much as $1 billion a year by reducing paperwork and avoiding denial of many claims.

Court Shields Billing Records

An appeals court has ruled against the release of Medicare billing records, which was sought by the group Consumers' Checkbook so that it could grade physicians on quality. The nonprofit had filed a Freedom of Information Act request for all 2004 Medicare claims from physicians in several locations, and the group won in a lower court in 2007. But the Department of Health and Human Services, joined by the American Medical Association, appealed, and the U.S. Circuit Court of Appeals for the District of Columbia ruled that HHS does not have to release the information. Disclosure of the requested data would constitute an invasion of physicians' privacy, the appeals court said. The AMA praised the decision. “The court clearly found that the release of personal physician payment data does not meet the standard of the Freedom of Information Act, which is to provide the public with information on how the government operates,” Dr. Jeremy Lazarus, AMA board member, said in a statement.

IOM Report: HIPAA Is Inadequate

The government's main health-privacy rule doesn't adequately protect people's health information, yet it hinders important health research, a report from the Institute of Medicine concluded. The privacy rule, stemming from the Health Insurance Portability and Accountability Act (HIPAA), is difficult to reconcile with other federal regulations governing research and personal information, the IOM report said. In addition, organizations that collect and use health data vary greatly in how they interpret and follow HIPAA, leading to potential privacy problems, the report said. Congress should create an entirely new approach to protecting personal health information in research, separate from the HIPAA rule, an IOM panel recommended. “We believe there is synergy between the goals of safeguarding privacy and enhancing health research,” said panel chairman Lawrence Gostin, a professor of health law at Georgetown University, Washington.

Many People Go Without Drugs

More children and working-age adults are failing to take needed prescription medications because of cost concerns, according to a national study by the Center for Studying Health System Change. In 2007, 1 in 7 Americans under age 65 years reported not filling a prescription in the previous year because they couldn't afford the medication, up from 1 in 10 in 2003. Rising prescription drug costs and less-generous drug coverage probably contributed to the change, the report said. Uninsured, working-age Americans saw the biggest jump in unmet prescription needs between 2003 and 2007, with the proportion going without medications rising from 26% to almost 35% in that time, the report said. However, a growing proportion of working-age Americans with employer-sponsored health insurance also reported going without prescription medications.

FDA on High-Risk List

The Food and Drug Administration faces significant challenges that compromise its ability to protect Americans from unsafe and ineffective products, the Government Accountability Office said in adding the FDA to its biennial “high-risk” list. The GAO gives that label to government programs or agencies that need to address internal mismanagement. In its 2009 report, the GAO said the FDA needs to beef up its foreign-drug inspection program, better manage its reviews of companies' promotional materials, and ensure that drug makers properly present clinical data.

Poll: Affordability Is Tops

Making health insurance more affordable trumps improving quality and expanding coverage among the public's priorities for health care reform, according to a new poll. The survey from the Kaiser Family Foundation and the Harvard School of Public Health found that most people believe that action on health care is important to help the nation out of recession. But when respondents were asked to choose between coverage expansion, cost reduction, and delivery-system change, 4 in 10 named affordability as most important, followed by 3 in 10 who said that expanding coverage is the top priority. Roughly 2 in 10 picked improving the quality and cost-effectiveness of the health care delivery system. Two-thirds of those surveyed favored requiring all individuals to have health insurance, but when told that some people may then have to buy health insurance they consider too expensive or don't want, support for the mandate dropped to 19%.

Humana Supports ID Cards

Humana has become the first health insurer to publicly support the Medical Group Management Association's drive to get standardized, machine-readable insurance cards into people's wallets by next January. “Our goal is to continue working with MGMA and the industry to eliminate waste, create efficiencies, and reduce the hassle factor for providers,” Humana Senior Vice President Bruce Perkins said in a statement. Adopting readable cards is part of an overall drive by the company to simplify health insurance administration, he said. MGMA estimates that machine-readable insurance cards could save physician offices and hospitals as much as $1 billion a year by reducing paperwork and avoiding denial of many claims.

Court Shields Billing Records

An appeals court has ruled against the release of Medicare billing records, which was sought by the group Consumers' Checkbook so that it could grade physicians on quality. The nonprofit had filed a Freedom of Information Act request for all 2004 Medicare claims from physicians in several locations, and the group won in a lower court in 2007. But the Department of Health and Human Services, joined by the American Medical Association, appealed, and the U.S. Circuit Court of Appeals for the District of Columbia ruled that HHS does not have to release the information. Disclosure of the requested data would constitute an invasion of physicians' privacy, the appeals court said. The AMA praised the decision. “The court clearly found that the release of personal physician payment data does not meet the standard of the Freedom of Information Act, which is to provide the public with information on how the government operates,” Dr. Jeremy Lazarus, AMA board member, said in a statement.

IOM Report: HIPAA Is Inadequate

The government's main health-privacy rule doesn't adequately protect people's health information, yet it hinders important health research, a report from the Institute of Medicine concluded. The privacy rule, stemming from the Health Insurance Portability and Accountability Act (HIPAA), is difficult to reconcile with other federal regulations governing research and personal information, the IOM report said. In addition, organizations that collect and use health data vary greatly in how they interpret and follow HIPAA, leading to potential privacy problems, the report said. Congress should create an entirely new approach to protecting personal health information in research, separate from the HIPAA rule, an IOM panel recommended. “We believe there is synergy between the goals of safeguarding privacy and enhancing health research,” said panel chairman Lawrence Gostin, a professor of health law at Georgetown University, Washington.

Many People Go Without Drugs

More children and working-age adults are failing to take needed prescription medications because of cost concerns, according to a national study by the Center for Studying Health System Change. In 2007, 1 in 7 Americans under age 65 years reported not filling a prescription in the previous year because they couldn't afford the medication, up from 1 in 10 in 2003. Rising prescription drug costs and less-generous drug coverage probably contributed to the change, the report said. Uninsured, working-age Americans saw the biggest jump in unmet prescription needs between 2003 and 2007, with the proportion going without medications rising from 26% to almost 35% in that time, the report said. However, a growing proportion of working-age Americans with employer-sponsored health insurance also reported going without prescription medications.

FDA on High-Risk List

The Food and Drug Administration faces significant challenges that compromise its ability to protect Americans from unsafe and ineffective products, the Government Accountability Office said in adding the FDA to its biennial “high-risk” list. The GAO gives that label to government programs or agencies that need to address internal mismanagement. In its 2009 report, the GAO said the FDA needs to beef up its foreign-drug inspection program, better manage its reviews of companies' promotional materials, and ensure that drug makers properly present clinical data.

Poll: Affordability Is Tops

Making health insurance more affordable trumps improving quality and expanding coverage among the public's priorities for health care reform, according to a new poll. The survey from the Kaiser Family Foundation and the Harvard School of Public Health found that most people believe that action on health care is important to help the nation out of recession. But when respondents were asked to choose between coverage expansion, cost reduction, and delivery-system change, 4 in 10 named affordability as most important, followed by 3 in 10 who said that expanding coverage is the top priority. Roughly 2 in 10 picked improving the quality and cost-effectiveness of the health care delivery system. Two-thirds of those surveyed favored requiring all individuals to have health insurance, but when told that some people may then have to buy health insurance they consider too expensive or don't want, support for the mandate dropped to 19%.

Humana Supports ID Cards

Humana has become the first health insurer to publicly support the Medical Group Management Association's drive to get standardized, machine-readable insurance cards into people's wallets by next January. “Our goal is to continue working with MGMA and the industry to eliminate waste, create efficiencies, and reduce the hassle factor for providers,” Humana Senior Vice President Bruce Perkins said in a statement. Adopting readable cards is part of an overall drive by the company to simplify health insurance administration, he said. MGMA estimates that machine-readable insurance cards could save physician offices and hospitals as much as $1 billion a year by reducing paperwork and avoiding denial of many claims.

Court Shields Billing Records

An appeals court has ruled against the release of Medicare billing records, which was sought by the group Consumers' Checkbook so that it could grade physicians on quality. The nonprofit had filed a Freedom of Information Act request for all 2004 Medicare claims from physicians in several locations, and the group won in a lower court in 2007. But the Department of Health and Human Services, joined by the American Medical Association, appealed, and the U.S. Circuit Court of Appeals for the District of Columbia ruled that HHS does not have to release the information. Disclosure of the requested data would constitute an invasion of physicians' privacy, the appeals court said. The AMA praised the decision. “The court clearly found that the release of personal physician payment data does not meet the standard of the Freedom of Information Act, which is to provide the public with information on how the government operates,” Dr. Jeremy Lazarus, AMA board member, said in a statement.

IOM Report: HIPAA Is Inadequate

The government's main health-privacy rule doesn't adequately protect people's health information, yet it hinders important health research, a report from the Institute of Medicine concluded. The privacy rule, stemming from the Health Insurance Portability and Accountability Act (HIPAA), is difficult to reconcile with other federal regulations governing research and personal information, the IOM report said. In addition, organizations that collect and use health data vary greatly in how they interpret and follow HIPAA, leading to potential privacy problems, the report said. Congress should create an entirely new approach to protecting personal health information in research, separate from the HIPAA rule, an IOM panel recommended. “We believe there is synergy between the goals of safeguarding privacy and enhancing health research,” said panel chairman Lawrence Gostin, a professor of health law at Georgetown University, Washington.

Many People Go Without Drugs

More children and working-age adults are failing to take needed prescription medications because of cost concerns, according to a national study by the Center for Studying Health System Change. In 2007, 1 in 7 Americans under age 65 years reported not filling a prescription in the previous year because they couldn't afford the medication, up from 1 in 10 in 2003. Rising prescription drug costs and less-generous drug coverage probably contributed to the change, the report said. Uninsured, working-age Americans saw the biggest jump in unmet prescription needs between 2003 and 2007, with the proportion going without medications rising from 26% to almost 35% in that time, the report said. However, a growing proportion of working-age Americans with employer-sponsored health insurance also reported going without prescription medications.

FDA on High-Risk List

The Food and Drug Administration faces significant challenges that compromise its ability to protect Americans from unsafe and ineffective products, the Government Accountability Office said in adding the FDA to its biennial “high-risk” list. The GAO gives that label to government programs or agencies that need to address internal mismanagement. In its 2009 report, the GAO said the FDA needs to beef up its foreign-drug inspection program, better manage its reviews of companies' promotional materials, and ensure that drug makers properly present clinical data.

Poll: Affordability Is Tops

Making health insurance more affordable trumps improving quality and expanding coverage among the public's priorities for health care reform, according to a new poll. The survey from the Kaiser Family Foundation and the Harvard School of Public Health found that most people believe that action on health care is important to help the nation out of recession. But when respondents were asked to choose between coverage expansion, cost reduction, and delivery-system change, 4 in 10 named affordability as most important, followed by 3 in 10 who said that expanding coverage is the top priority. Roughly 2 in 10 picked improving the quality and cost-effectiveness of the health care delivery system. Two-thirds of those surveyed favored requiring all individuals to have health insurance, but when told that some people may then have to buy health insurance they consider too expensive or don't want, support for the mandate dropped to 19%.

Humana Supports ID Cards

Humana has become the first health insurer to publicly support the Medical Group Management Association's drive to get standardized, machine-readable insurance cards into people's wallets by next January. “Our goal is to continue working with MGMA and the industry to eliminate waste, create efficiencies, and reduce the hassle factor for providers,” Humana Senior Vice President Bruce Perkins said in a statement. Adopting readable cards is part of an overall drive by the company to simplify health insurance administration, he said. MGMA estimates that machine-readable insurance cards could save physician offices and hospitals as much as $1 billion a year by reducing paperwork and avoiding denial of many claims.

School Embraces Medical Home

A family practice residency program at the University of Kansas, Wichita, will establish a patient-centered medical home model of care, making it one of the first residency programs in the nation to offer training in a medical home environment, the university said. The transformation of the Smoky Hill Family Medicine Residency Program in Salina, Kan., will be supported in part by a $49,500 grant from the United Methodist Health Ministry Fund. The program is to focus on electronic health records and other health information technology, increased support for patients, better chronic disease management, scheduling innovations, and alternatives to routine office visits. “The adoption of the medical home model at the residency level is particularly important because the office practices [that] physicians learn in residency—good or bad—tend to translate into their 'real life' practice upon graduation,” Dr. Rick Kellerman, professor and chair of family and community medicine, said in a statement.

FDA Launches Safety Program

The Food and Drug Administration launched a pilot program aimed at ensuring the safety of drugs produced outside the United States. The agency said it plans to select 100 companies that volunteer to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to maintain control over drugs and active ingredients from the time of manufacture through entry into the United States. The FDA said it's testing the practicality of a comprehensive supply chain program that could identify foreign products that fail to comply with U.S. standards. The pilot program will run for 2 years, the FDA said.

CMS IDs Protected Drug Classes

The Centers for Medicare and Medicaid Services tried to guarantee that Medicare beneficiaries with certain conditions—including HIV infection, some cancers, and mental illness—may confidently enroll in Medicare Part D prescription plans. In June 2005, the CMS directed that Part D formularies include nearly all drugs in six classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals, and antineoplastics. A new CMS rule notified Part D plans that they must continue to provide coverage of these drugs through 2010, consistent with the policy already in place. For 2011 and beyond, the CMS may propose further steps to ensure availability of drugs in the six specified classes, the agency said.

Mixed Grades on Tobacco Control

In 23 states, smoking in workplaces and public spaces has been banned, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits—important because the Medicaid population smokes at a rate that's 50% higher than the national average, according to the association. The group's state-by-state report card on various tobacco-control measures is available at its Web site.

Jump in Singulair Psych Reports

Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the FDA in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.

Group Pushes Swipable Cards

The Medical Group Management Association has launched an effort to persuade providers and health insurers to adopt standardized, machine-readable insurance cards by next January. The initiative, dubbed Project SwipeIT, would save an estimated $1 billion annually that is currently spent on “wasteful, redundant administrative tasks,” said Dr. William F. Jessee, MGMA president. For example, because most people's health insurance cards have no machine-readable elements, providers usually photocopy the cards and then manually enter the information into their computers, a process that's prone to error. Many cards also feature photos, illustrations, and shading that make legible photocopying difficult. Machine-readable cards would automatically enter patient information correctly and cost-effectively, according to MGMA. The organization has developed a Web site to promote the initiative at

www.SwipeIT.org

School Embraces Medical Home

A family practice residency program at the University of Kansas, Wichita, will establish a patient-centered medical home model of care, making it one of the first residency programs in the nation to offer training in a medical home environment, the university said. The transformation of the Smoky Hill Family Medicine Residency Program in Salina, Kan., will be supported in part by a $49,500 grant from the United Methodist Health Ministry Fund. The program is to focus on electronic health records and other health information technology, increased support for patients, better chronic disease management, scheduling innovations, and alternatives to routine office visits. “The adoption of the medical home model at the residency level is particularly important because the office practices [that] physicians learn in residency—good or bad—tend to translate into their 'real life' practice upon graduation,” Dr. Rick Kellerman, professor and chair of family and community medicine, said in a statement.

FDA Launches Safety Program

The Food and Drug Administration launched a pilot program aimed at ensuring the safety of drugs produced outside the United States. The agency said it plans to select 100 companies that volunteer to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to maintain control over drugs and active ingredients from the time of manufacture through entry into the United States. The FDA said it's testing the practicality of a comprehensive supply chain program that could identify foreign products that fail to comply with U.S. standards. The pilot program will run for 2 years, the FDA said.

CMS IDs Protected Drug Classes

The Centers for Medicare and Medicaid Services tried to guarantee that Medicare beneficiaries with certain conditions—including HIV infection, some cancers, and mental illness—may confidently enroll in Medicare Part D prescription plans. In June 2005, the CMS directed that Part D formularies include nearly all drugs in six classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals, and antineoplastics. A new CMS rule notified Part D plans that they must continue to provide coverage of these drugs through 2010, consistent with the policy already in place. For 2011 and beyond, the CMS may propose further steps to ensure availability of drugs in the six specified classes, the agency said.

Mixed Grades on Tobacco Control

In 23 states, smoking in workplaces and public spaces has been banned, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits—important because the Medicaid population smokes at a rate that's 50% higher than the national average, according to the association. The group's state-by-state report card on various tobacco-control measures is available at its Web site.

Jump in Singulair Psych Reports

Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the FDA in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.

Group Pushes Swipable Cards

The Medical Group Management Association has launched an effort to persuade providers and health insurers to adopt standardized, machine-readable insurance cards by next January. The initiative, dubbed Project SwipeIT, would save an estimated $1 billion annually that is currently spent on “wasteful, redundant administrative tasks,” said Dr. William F. Jessee, MGMA president. For example, because most people's health insurance cards have no machine-readable elements, providers usually photocopy the cards and then manually enter the information into their computers, a process that's prone to error. Many cards also feature photos, illustrations, and shading that make legible photocopying difficult. Machine-readable cards would automatically enter patient information correctly and cost-effectively, according to MGMA. The organization has developed a Web site to promote the initiative at

www.SwipeIT.org

School Embraces Medical Home

A family practice residency program at the University of Kansas, Wichita, will establish a patient-centered medical home model of care, making it one of the first residency programs in the nation to offer training in a medical home environment, the university said. The transformation of the Smoky Hill Family Medicine Residency Program in Salina, Kan., will be supported in part by a $49,500 grant from the United Methodist Health Ministry Fund. The program is to focus on electronic health records and other health information technology, increased support for patients, better chronic disease management, scheduling innovations, and alternatives to routine office visits. “The adoption of the medical home model at the residency level is particularly important because the office practices [that] physicians learn in residency—good or bad—tend to translate into their 'real life' practice upon graduation,” Dr. Rick Kellerman, professor and chair of family and community medicine, said in a statement.

FDA Launches Safety Program

The Food and Drug Administration launched a pilot program aimed at ensuring the safety of drugs produced outside the United States. The agency said it plans to select 100 companies that volunteer to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to maintain control over drugs and active ingredients from the time of manufacture through entry into the United States. The FDA said it's testing the practicality of a comprehensive supply chain program that could identify foreign products that fail to comply with U.S. standards. The pilot program will run for 2 years, the FDA said.

CMS IDs Protected Drug Classes

The Centers for Medicare and Medicaid Services tried to guarantee that Medicare beneficiaries with certain conditions—including HIV infection, some cancers, and mental illness—may confidently enroll in Medicare Part D prescription plans. In June 2005, the CMS directed that Part D formularies include nearly all drugs in six classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals, and antineoplastics. A new CMS rule notified Part D plans that they must continue to provide coverage of these drugs through 2010, consistent with the policy already in place. For 2011 and beyond, the CMS may propose further steps to ensure availability of drugs in the six specified classes, the agency said.

Mixed Grades on Tobacco Control

In 23 states, smoking in workplaces and public spaces has been banned, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits—important because the Medicaid population smokes at a rate that's 50% higher than the national average, according to the association. The group's state-by-state report card on various tobacco-control measures is available at its Web site.

Jump in Singulair Psych Reports

Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the FDA in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.

Group Pushes Swipable Cards

The Medical Group Management Association has launched an effort to persuade providers and health insurers to adopt standardized, machine-readable insurance cards by next January. The initiative, dubbed Project SwipeIT, would save an estimated $1 billion annually that is currently spent on “wasteful, redundant administrative tasks,” said Dr. William F. Jessee, MGMA president. For example, because most people's health insurance cards have no machine-readable elements, providers usually photocopy the cards and then manually enter the information into their computers, a process that's prone to error. Many cards also feature photos, illustrations, and shading that make legible photocopying difficult. Machine-readable cards would automatically enter patient information correctly and cost-effectively, according to MGMA. The organization has developed a Web site to promote the initiative at

www.SwipeIT.org

FDA Launches Safety Program

The Food and Drug Administration launched a pilot program aimed at ensuring the safety of drugs produced outside the United States. The agency said it plans to select 100 companies that volunteer to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to maintain control over drugs and active ingredients from the time of manufacture through entry into the United States. The FDA said it's testing the practicality of a comprehensive supply chain program that could identify foreign products that fail to comply with U.S. standards. The pilot program will run for 2 years, the FDA said.

CMS IDs Protected Drug Classes

The Centers for Medicare and Medicaid Services tried to guarantee that Medicare beneficiaries with certain conditions—including HIV infection, some cancers, and mental illness—may confidently enroll in Medicare Part D prescription plans. In June 2005, the CMS directed that Part D formularies include nearly all drugs in six classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals, and antineoplastics. A new CMS rule notified Part D plans that they must continue to provide coverage of these drugs through 2010, consistent with the policy already in place. For 2011 and beyond, the CMS may propose further steps to ensure availability of drugs in the six specified classes, the agency said.

Mixed Grades on Tobacco Control

Smoking in workplaces and public spaces has been banned in 23 states, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits—important because the Medicaid population smokes at a rate that's 50% higher than the national average, according to the association. The group's state-by-state report card on tobacco-control measures is available at its Web site.

Jump in Singulair Psych Reports

Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the FDA in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.

School Embraces Medical Home

A family practice residency program at the University of Kansas, Wichita, will establish a patient-centered medical home model of care, making it one of the first residency programs in the nation to offer training in a medical home environment, the university said. The transformation of the Smoky Hill Family Medicine Residency Program in Salina, Kan., will be supported in part by a $49,500 grant from the United Methodist Health Ministry Fund. The program is to focus on electronic health records and other health information technology, increased support for patients, better chronic disease management, scheduling innovations, and alternatives to routine office visits. “The adoption of the medical home model at the residency level is particularly important because the office practices [that] physicians learn in residency—good or bad—tend to translate into their 'real life' practice upon graduation,” Dr. Rick Kellerman, professor and chair of family and community medicine, said in a statement.

Group Pushes Swipable Cards

The Medical Group Management Association has launched an effort to persuade providers and health insurers to adopt standardized, machine-readable insurance cards by next January. The initiative, dubbed Project SwipeIT, would save an estimated $1 billion annually that is currently spent on “wasteful, redundant administrative tasks,” said Dr. William F. Jessee, MGMA president. For example, because most people's health insurance cards have no machine-readable elements, providers usually photocopy the cards and then manually enter the information into their computers, a process that's prone to error. Many cards also feature photos, illustrations, and shading that make legible photocopying difficult. Machine-readable cards would automatically enter patient information correctly and cost-effectively, according to the MGMA. The organization has developed a Web site to promote the initiative at

www.SwipeIT.org

FDA Launches Safety Program

The Food and Drug Administration launched a pilot program aimed at ensuring the safety of drugs produced outside the United States. The agency said it plans to select 100 companies that volunteer to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to maintain control over drugs and active ingredients from the time of manufacture through entry into the United States. The FDA said it's testing the practicality of a comprehensive supply chain program that could identify foreign products that fail to comply with U.S. standards. The pilot program will run for 2 years, the FDA said.

CMS IDs Protected Drug Classes

The Centers for Medicare and Medicaid Services tried to guarantee that Medicare beneficiaries with certain conditions—including HIV infection, some cancers, and mental illness—may confidently enroll in Medicare Part D prescription plans. In June 2005, the CMS directed that Part D formularies include nearly all drugs in six classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals, and antineoplastics. A new CMS rule notified Part D plans that they must continue to provide coverage of these drugs through 2010, consistent with the policy already in place. For 2011 and beyond, the CMS may propose further steps to ensure availability of drugs in the six specified classes, the agency said.

Mixed Grades on Tobacco Control

Smoking in workplaces and public spaces has been banned in 23 states, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits—important because the Medicaid population smokes at a rate that's 50% higher than the national average, according to the association. The group's state-by-state report card on tobacco-control measures is available at its Web site.

Jump in Singulair Psych Reports

Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the FDA in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.

School Embraces Medical Home

A family practice residency program at the University of Kansas, Wichita, will establish a patient-centered medical home model of care, making it one of the first residency programs in the nation to offer training in a medical home environment, the university said. The transformation of the Smoky Hill Family Medicine Residency Program in Salina, Kan., will be supported in part by a $49,500 grant from the United Methodist Health Ministry Fund. The program is to focus on electronic health records and other health information technology, increased support for patients, better chronic disease management, scheduling innovations, and alternatives to routine office visits. “The adoption of the medical home model at the residency level is particularly important because the office practices [that] physicians learn in residency—good or bad—tend to translate into their 'real life' practice upon graduation,” Dr. Rick Kellerman, professor and chair of family and community medicine, said in a statement.

Group Pushes Swipable Cards

The Medical Group Management Association has launched an effort to persuade providers and health insurers to adopt standardized, machine-readable insurance cards by next January. The initiative, dubbed Project SwipeIT, would save an estimated $1 billion annually that is currently spent on “wasteful, redundant administrative tasks,” said Dr. William F. Jessee, MGMA president. For example, because most people's health insurance cards have no machine-readable elements, providers usually photocopy the cards and then manually enter the information into their computers, a process that's prone to error. Many cards also feature photos, illustrations, and shading that make legible photocopying difficult. Machine-readable cards would automatically enter patient information correctly and cost-effectively, according to the MGMA. The organization has developed a Web site to promote the initiative at

www.SwipeIT.org

FDA Launches Safety Program

The Food and Drug Administration launched a pilot program aimed at ensuring the safety of drugs produced outside the United States. The agency said it plans to select 100 companies that volunteer to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to maintain control over drugs and active ingredients from the time of manufacture through entry into the United States. The FDA said it's testing the practicality of a comprehensive supply chain program that could identify foreign products that fail to comply with U.S. standards. The pilot program will run for 2 years, the FDA said.

CMS IDs Protected Drug Classes

The Centers for Medicare and Medicaid Services tried to guarantee that Medicare beneficiaries with certain conditions—including HIV infection, some cancers, and mental illness—may confidently enroll in Medicare Part D prescription plans. In June 2005, the CMS directed that Part D formularies include nearly all drugs in six classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals, and antineoplastics. A new CMS rule notified Part D plans that they must continue to provide coverage of these drugs through 2010, consistent with the policy already in place. For 2011 and beyond, the CMS may propose further steps to ensure availability of drugs in the six specified classes, the agency said.

Mixed Grades on Tobacco Control

Smoking in workplaces and public spaces has been banned in 23 states, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits—important because the Medicaid population smokes at a rate that's 50% higher than the national average, according to the association. The group's state-by-state report card on tobacco-control measures is available at its Web site.

Jump in Singulair Psych Reports

Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the FDA in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.

School Embraces Medical Home

A family practice residency program at the University of Kansas, Wichita, will establish a patient-centered medical home model of care, making it one of the first residency programs in the nation to offer training in a medical home environment, the university said. The transformation of the Smoky Hill Family Medicine Residency Program in Salina, Kan., will be supported in part by a $49,500 grant from the United Methodist Health Ministry Fund. The program is to focus on electronic health records and other health information technology, increased support for patients, better chronic disease management, scheduling innovations, and alternatives to routine office visits. “The adoption of the medical home model at the residency level is particularly important because the office practices [that] physicians learn in residency—good or bad—tend to translate into their 'real life' practice upon graduation,” Dr. Rick Kellerman, professor and chair of family and community medicine, said in a statement.

Group Pushes Swipable Cards

The Medical Group Management Association has launched an effort to persuade providers and health insurers to adopt standardized, machine-readable insurance cards by next January. The initiative, dubbed Project SwipeIT, would save an estimated $1 billion annually that is currently spent on “wasteful, redundant administrative tasks,” said Dr. William F. Jessee, MGMA president. For example, because most people's health insurance cards have no machine-readable elements, providers usually photocopy the cards and then manually enter the information into their computers, a process that's prone to error. Many cards also feature photos, illustrations, and shading that make legible photocopying difficult. Machine-readable cards would automatically enter patient information correctly and cost-effectively, according to the MGMA. The organization has developed a Web site to promote the initiative at

www.SwipeIT.org

Agencies Issue Importer Guidance

Eight federal agencies, including the Consumer Product Safety Commission, have issued draft guidance on how importers can ensure that products such as toys are in compliance with U.S. laws and regulations. The document recommends that importers know the producers and distributors of the foreign products they purchase, along with hazards that could be associated with the products. The guidance recommends that U.S. companies establish procedures for identifying and minimizing risks associated with imported products. The document, “Good Importer Practices,” would not be binding. It is designed to anticipate potential product hazards and offer ways for firms to mitigate those hazards, the agencies said.

Activity Drops in Young Children

A significant reduction in physical activity appears to occur between the ages of 3 years and 5 years, according to research published in Medicine & Science in Sports & Exercise. The researchers used accelerometers to measure activity among 244 children in New Zealand. With the results in mind, pediatricians and parents can intervene during those childhood years to promote physical activity, lead author Rachael Taylor, Ph.D., said in a statement. “Considering that target age range of 4 and 5 [years], it is probably the right time to encourage more outside play where possible, or enroll a child in gymnastics, tennis, or another structured activity,” said Dr. Taylor, a professor at the University of Otago, Dunedin, New Zealand.

Bill Seeks Better Vision Care

Two U.S. senators have introduced bipartisan legislation aimed at avoiding undiagnosed and untreated vision problems in school-aged children. Sen. Kit Bond (R-Mo.), who is blind in one eye as a result of undiagnosed amblyopia during childhood, joined with Sen. Christopher Dodd (D-Conn.) to reintroduce the Vision Care for Kids Act. The bill would grant states money to provide professional eye exams and follow-up care for children who are identified by screening as needing care. It also would support existing state efforts to educate parents, teachers, and health care professionals about healthy vision for youngsters. “This measure would be a major milestone in partnership with the states to address the vision needs of our nation's uninsured children,” Dr. Mike Repka, a pediatric ophthalmologist in Maryland and an American Academy of Ophthalmology officer, said in a statement.

SCHIP Children Need Medicaid

Medicaid is critical for continuing coverage of many children who leave the State Children's Health Insurance Program, while private insurance does relatively little for such children, according to a study from Mathematica Policy Research Inc. Among children who left SCHIP during the study period, about 45% enrolled in Medicaid and 5% obtained private coverage. Thus, half were without care coverage upon leaving SCHIP; the children remain uninsured. In all but two of the states studied, California and Florida, children who departed SCHIP typically went without coverage for a year or more. “Coupled with the limited take-up of private coverage upon leaving SCHIP, these often lengthy uninsured spells suggest that many families lack access to affordable private insurance after leaving the program,” the report said.

Doctors Obtain Medicaid Papers

The Louisiana Chapter of the American Academy of Pediatrics has obtained most of the documents it wanted on the state's proposed Medicaid reform plan, the group's executive director, Sandra Adams, said in an interview. The AAP chapter filed a lawsuit in state court last December asking the judge to compel the state to produce documents that contain details of the plan but had been denied to the chapter, she said. Once the lawsuit was filed, the state provided most of the documents the AAP chapter wanted, and Ms. Adams said she expects to get the rest. “We want to be clear, this is a lawsuit over a records request, not a lawsuit over stopping health reform,” Ms. Adams said. Louisiana Gov. Bobby Jindal (R) has proposed allowing private insurance networks to administer the Medicaid program in some test areas. Currently, Louisiana's Medicaid reimbursement of physicians is among the lowest in the country, and physicians have expressed concern about potential rate cuts under the reform plan.

Thirdhand Smoke Hazard Noted

Smokers who believe that thirdhand smoke—tobacco contamination that remains after a cigarette is extinguished—harms their children are more likely than other parents to ban smoking in their homes, according to a study in Pediatrics. The researchers examined beliefs about the health effects of thirdhand smoke. They found that 65% of nonsmokers and 43% of smokers agreed that thirdhand smoke harms children. Strict rules prohibiting smoking in the home were far more prevalent among nonsmokers. But the belief that thirdhand smoke harms children was independently associated in both smokers and nonsmokers with rules prohibiting smoking in the home. In contrast, believing that secondhand smoke harms children appeared unrelated to rules against smoking in the home and car. “Emphasizing that thirdhand smoke harms the health of children may be an important element in encouraging home smoking bans,” they concluded.

Agencies Issue Importer Guidance

Eight federal agencies, including the Consumer Product Safety Commission, have issued draft guidance on how importers can ensure that products such as toys are in compliance with U.S. laws and regulations. The document recommends that importers know the producers and distributors of the foreign products they purchase, along with hazards that could be associated with the products. The guidance recommends that U.S. companies establish procedures for identifying and minimizing risks associated with imported products. The document, “Good Importer Practices,” would not be binding. It is designed to anticipate potential product hazards and offer ways for firms to mitigate those hazards, the agencies said.

Activity Drops in Young Children

A significant reduction in physical activity appears to occur between the ages of 3 years and 5 years, according to research published in Medicine & Science in Sports & Exercise. The researchers used accelerometers to measure activity among 244 children in New Zealand. With the results in mind, pediatricians and parents can intervene during those childhood years to promote physical activity, lead author Rachael Taylor, Ph.D., said in a statement. “Considering that target age range of 4 and 5 [years], it is probably the right time to encourage more outside play where possible, or enroll a child in gymnastics, tennis, or another structured activity,” said Dr. Taylor, a professor at the University of Otago, Dunedin, New Zealand.

Bill Seeks Better Vision Care

Two U.S. senators have introduced bipartisan legislation aimed at avoiding undiagnosed and untreated vision problems in school-aged children. Sen. Kit Bond (R-Mo.), who is blind in one eye as a result of undiagnosed amblyopia during childhood, joined with Sen. Christopher Dodd (D-Conn.) to reintroduce the Vision Care for Kids Act. The bill would grant states money to provide professional eye exams and follow-up care for children who are identified by screening as needing care. It also would support existing state efforts to educate parents, teachers, and health care professionals about healthy vision for youngsters. “This measure would be a major milestone in partnership with the states to address the vision needs of our nation's uninsured children,” Dr. Mike Repka, a pediatric ophthalmologist in Maryland and an American Academy of Ophthalmology officer, said in a statement.

SCHIP Children Need Medicaid

Medicaid is critical for continuing coverage of many children who leave the State Children's Health Insurance Program, while private insurance does relatively little for such children, according to a study from Mathematica Policy Research Inc. Among children who left SCHIP during the study period, about 45% enrolled in Medicaid and 5% obtained private coverage. Thus, half were without care coverage upon leaving SCHIP; the children remain uninsured. In all but two of the states studied, California and Florida, children who departed SCHIP typically went without coverage for a year or more. “Coupled with the limited take-up of private coverage upon leaving SCHIP, these often lengthy uninsured spells suggest that many families lack access to affordable private insurance after leaving the program,” the report said.

Doctors Obtain Medicaid Papers

The Louisiana Chapter of the American Academy of Pediatrics has obtained most of the documents it wanted on the state's proposed Medicaid reform plan, the group's executive director, Sandra Adams, said in an interview. The AAP chapter filed a lawsuit in state court last December asking the judge to compel the state to produce documents that contain details of the plan but had been denied to the chapter, she said. Once the lawsuit was filed, the state provided most of the documents the AAP chapter wanted, and Ms. Adams said she expects to get the rest. “We want to be clear, this is a lawsuit over a records request, not a lawsuit over stopping health reform,” Ms. Adams said. Louisiana Gov. Bobby Jindal (R) has proposed allowing private insurance networks to administer the Medicaid program in some test areas. Currently, Louisiana's Medicaid reimbursement of physicians is among the lowest in the country, and physicians have expressed concern about potential rate cuts under the reform plan.

Thirdhand Smoke Hazard Noted

Smokers who believe that thirdhand smoke—tobacco contamination that remains after a cigarette is extinguished—harms their children are more likely than other parents to ban smoking in their homes, according to a study in Pediatrics. The researchers examined beliefs about the health effects of thirdhand smoke. They found that 65% of nonsmokers and 43% of smokers agreed that thirdhand smoke harms children. Strict rules prohibiting smoking in the home were far more prevalent among nonsmokers. But the belief that thirdhand smoke harms children was independently associated in both smokers and nonsmokers with rules prohibiting smoking in the home. In contrast, believing that secondhand smoke harms children appeared unrelated to rules against smoking in the home and car. “Emphasizing that thirdhand smoke harms the health of children may be an important element in encouraging home smoking bans,” they concluded.

Agencies Issue Importer Guidance

Eight federal agencies, including the Consumer Product Safety Commission, have issued draft guidance on how importers can ensure that products such as toys are in compliance with U.S. laws and regulations. The document recommends that importers know the producers and distributors of the foreign products they purchase, along with hazards that could be associated with the products. The guidance recommends that U.S. companies establish procedures for identifying and minimizing risks associated with imported products. The document, “Good Importer Practices,” would not be binding. It is designed to anticipate potential product hazards and offer ways for firms to mitigate those hazards, the agencies said.

Activity Drops in Young Children

A significant reduction in physical activity appears to occur between the ages of 3 years and 5 years, according to research published in Medicine & Science in Sports & Exercise. The researchers used accelerometers to measure activity among 244 children in New Zealand. With the results in mind, pediatricians and parents can intervene during those childhood years to promote physical activity, lead author Rachael Taylor, Ph.D., said in a statement. “Considering that target age range of 4 and 5 [years], it is probably the right time to encourage more outside play where possible, or enroll a child in gymnastics, tennis, or another structured activity,” said Dr. Taylor, a professor at the University of Otago, Dunedin, New Zealand.

Bill Seeks Better Vision Care

Two U.S. senators have introduced bipartisan legislation aimed at avoiding undiagnosed and untreated vision problems in school-aged children. Sen. Kit Bond (R-Mo.), who is blind in one eye as a result of undiagnosed amblyopia during childhood, joined with Sen. Christopher Dodd (D-Conn.) to reintroduce the Vision Care for Kids Act. The bill would grant states money to provide professional eye exams and follow-up care for children who are identified by screening as needing care. It also would support existing state efforts to educate parents, teachers, and health care professionals about healthy vision for youngsters. “This measure would be a major milestone in partnership with the states to address the vision needs of our nation's uninsured children,” Dr. Mike Repka, a pediatric ophthalmologist in Maryland and an American Academy of Ophthalmology officer, said in a statement.

SCHIP Children Need Medicaid

Medicaid is critical for continuing coverage of many children who leave the State Children's Health Insurance Program, while private insurance does relatively little for such children, according to a study from Mathematica Policy Research Inc. Among children who left SCHIP during the study period, about 45% enrolled in Medicaid and 5% obtained private coverage. Thus, half were without care coverage upon leaving SCHIP; the children remain uninsured. In all but two of the states studied, California and Florida, children who departed SCHIP typically went without coverage for a year or more. “Coupled with the limited take-up of private coverage upon leaving SCHIP, these often lengthy uninsured spells suggest that many families lack access to affordable private insurance after leaving the program,” the report said.

Doctors Obtain Medicaid Papers

The Louisiana Chapter of the American Academy of Pediatrics has obtained most of the documents it wanted on the state's proposed Medicaid reform plan, the group's executive director, Sandra Adams, said in an interview. The AAP chapter filed a lawsuit in state court last December asking the judge to compel the state to produce documents that contain details of the plan but had been denied to the chapter, she said. Once the lawsuit was filed, the state provided most of the documents the AAP chapter wanted, and Ms. Adams said she expects to get the rest. “We want to be clear, this is a lawsuit over a records request, not a lawsuit over stopping health reform,” Ms. Adams said. Louisiana Gov. Bobby Jindal (R) has proposed allowing private insurance networks to administer the Medicaid program in some test areas. Currently, Louisiana's Medicaid reimbursement of physicians is among the lowest in the country, and physicians have expressed concern about potential rate cuts under the reform plan.

Thirdhand Smoke Hazard Noted

Smokers who believe that thirdhand smoke—tobacco contamination that remains after a cigarette is extinguished—harms their children are more likely than other parents to ban smoking in their homes, according to a study in Pediatrics. The researchers examined beliefs about the health effects of thirdhand smoke. They found that 65% of nonsmokers and 43% of smokers agreed that thirdhand smoke harms children. Strict rules prohibiting smoking in the home were far more prevalent among nonsmokers. But the belief that thirdhand smoke harms children was independently associated in both smokers and nonsmokers with rules prohibiting smoking in the home. In contrast, believing that secondhand smoke harms children appeared unrelated to rules against smoking in the home and car. “Emphasizing that thirdhand smoke harms the health of children may be an important element in encouraging home smoking bans,” they concluded.

FDA Posts Guidance on Handouts

The Food and Drug Administration 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. Guidance doesn't carry the same heft as regulation, but most manufacturers heed the FDA's advice. 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 that are 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. The FDA did not deem letters to the editor, publication abstracts, and results of phase I trials in healthy volunteers to be kosher.

Markets Offer Free Antibiotics

So far this cold and flu season, six supermarket chains have said they will offer free generic antibiotics to customers. Pleasanton, Calif.-based Safeway, the Mid-Atlantic chain Giant Food, the New England-based Stop & Shop, the Florida chain Publix Super Markets, Rochester, N.Y.-based Wegmans Food Markets, and the Midwestern chain Meijer Stores all said they would supply the most commonly prescribed generic oral antibiotics to customers with valid prescriptions at no charge. “As the provider of fresh, wholesome foods that help our customers stay healthy, we feel it is equally important to offer these free antibiotics to fight illness,” Andrea Astrachan, consumer adviser for Stop & Shop, said in a statement.

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.

Maryland Eyes Concierge Care

Maryland's insurance commissioner is considering whether to regulate models of medical practices known as “retainer,” “boutique,” or “concierge” practices. Ralph Tyler held an informational hearing in December in an effort to determine whether the arrangements “cross the line to trigger obligations as an authorized insurer.” In concierge practices, the patient pays an annual fee in exchange for certain medical services beyond what a health insurer covers. But the agreement generally covers only preventive services. The insurance commission “wants to be sure it understands these arrangements and will review the need for additional oversight or regulation,” Tyler said in a statement.

R.I. Medicaid Overhaul Okayed

Rhode Island Gov. Donald Carcieri and the Centers for Medicare and Medicaid Services have reached agreement on a Medicaid reform package for the state that would emphasize home- and community-based long-term care settings over nursing home care. Primary care case management would also get a boost. The deal, which must be approved by Rhode Island lawmakers, would set a $12 billion, 5-year spending cap on the state's program. As in other states, Medicaid costs are threatening to overwhelm other spending priorities in Rhode Island, whose 2009 budget counts on millions in savings from Medicaid changes. Under the new reform plan, assessment teams would determine medical risk levels for impoverished elderly people, and only those at most risk would be guaranteed placements in nursing homes or other high-cost facilities. Others would receive care from in-home services and in lower-cost assisted living facilities. The state would enroll all Medicaid beneficiaries without other third-party coverage into a managed care plan or a primary care case management practice.

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 measures specified by state lawmakers, such as outreach to individual AIDS patients, and made minimal efforts on others.

FDA Posts Guidance on Handouts

The Food and Drug Administration 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. Guidance doesn't carry the same heft as regulation, but most manufacturers heed the FDA's advice. 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 that are 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. The FDA did not deem letters to the editor, publication abstracts, and results of phase I trials in healthy volunteers to be kosher.

Markets Offer Free Antibiotics

So far this cold and flu season, six supermarket chains have said they will offer free generic antibiotics to customers. Pleasanton, Calif.-based Safeway, the Mid-Atlantic chain Giant Food, the New England-based Stop & Shop, the Florida chain Publix Super Markets, Rochester, N.Y.-based Wegmans Food Markets, and the Midwestern chain Meijer Stores all said they would supply the most commonly prescribed generic oral antibiotics to customers with valid prescriptions at no charge. “As the provider of fresh, wholesome foods that help our customers stay healthy, we feel it is equally important to offer these free antibiotics to fight illness,” Andrea Astrachan, consumer adviser for Stop & Shop, said in a statement.

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.

Maryland Eyes Concierge Care

Maryland's insurance commissioner is considering whether to regulate models of medical practices known as “retainer,” “boutique,” or “concierge” practices. Ralph Tyler held an informational hearing in December in an effort to determine whether the arrangements “cross the line to trigger obligations as an authorized insurer.” In concierge practices, the patient pays an annual fee in exchange for certain medical services beyond what a health insurer covers. But the agreement generally covers only preventive services. The insurance commission “wants to be sure it understands these arrangements and will review the need for additional oversight or regulation,” Tyler said in a statement.

R.I. Medicaid Overhaul Okayed

Rhode Island Gov. Donald Carcieri and the Centers for Medicare and Medicaid Services have reached agreement on a Medicaid reform package for the state that would emphasize home- and community-based long-term care settings over nursing home care. Primary care case management would also get a boost. The deal, which must be approved by Rhode Island lawmakers, would set a $12 billion, 5-year spending cap on the state's program. As in other states, Medicaid costs are threatening to overwhelm other spending priorities in Rhode Island, whose 2009 budget counts on millions in savings from Medicaid changes. Under the new reform plan, assessment teams would determine medical risk levels for impoverished elderly people, and only those at most risk would be guaranteed placements in nursing homes or other high-cost facilities. Others would receive care from in-home services and in lower-cost assisted living facilities. The state would enroll all Medicaid beneficiaries without other third-party coverage into a managed care plan or a primary care case management practice.

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 measures specified by state lawmakers, such as outreach to individual AIDS patients, and made minimal efforts on others.

FDA Posts Guidance on Handouts

The Food and Drug Administration 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. Guidance doesn't carry the same heft as regulation, but most manufacturers heed the FDA's advice. 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 that are 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. The FDA did not deem letters to the editor, publication abstracts, and results of phase I trials in healthy volunteers to be kosher.

Markets Offer Free Antibiotics

So far this cold and flu season, six supermarket chains have said they will offer free generic antibiotics to customers. Pleasanton, Calif.-based Safeway, the Mid-Atlantic chain Giant Food, the New England-based Stop & Shop, the Florida chain Publix Super Markets, Rochester, N.Y.-based Wegmans Food Markets, and the Midwestern chain Meijer Stores all said they would supply the most commonly prescribed generic oral antibiotics to customers with valid prescriptions at no charge. “As the provider of fresh, wholesome foods that help our customers stay healthy, we feel it is equally important to offer these free antibiotics to fight illness,” Andrea Astrachan, consumer adviser for Stop & Shop, said in a statement.

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.

Maryland Eyes Concierge Care

Maryland's insurance commissioner is considering whether to regulate models of medical practices known as “retainer,” “boutique,” or “concierge” practices. Ralph Tyler held an informational hearing in December in an effort to determine whether the arrangements “cross the line to trigger obligations as an authorized insurer.” In concierge practices, the patient pays an annual fee in exchange for certain medical services beyond what a health insurer covers. But the agreement generally covers only preventive services. The insurance commission “wants to be sure it understands these arrangements and will review the need for additional oversight or regulation,” Tyler said in a statement.

R.I. Medicaid Overhaul Okayed

Rhode Island Gov. Donald Carcieri and the Centers for Medicare and Medicaid Services have reached agreement on a Medicaid reform package for the state that would emphasize home- and community-based long-term care settings over nursing home care. Primary care case management would also get a boost. The deal, which must be approved by Rhode Island lawmakers, would set a $12 billion, 5-year spending cap on the state's program. As in other states, Medicaid costs are threatening to overwhelm other spending priorities in Rhode Island, whose 2009 budget counts on millions in savings from Medicaid changes. Under the new reform plan, assessment teams would determine medical risk levels for impoverished elderly people, and only those at most risk would be guaranteed placements in nursing homes or other high-cost facilities. Others would receive care from in-home services and in lower-cost assisted living facilities. The state would enroll all Medicaid beneficiaries without other third-party coverage into a managed care plan or a primary care case management practice.

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 measures specified by state lawmakers, such as outreach to individual AIDS patients, and made minimal efforts on others.

FDA Posts Guidance on Handouts

The Food and Drug Administration 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. Guidance doesn't carry the same heft as regulation, but most manufacturers heed the FDA's advice. On its Web site, the agency suggested 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 also should disclose conflicts. Acceptable articles can't be from special supplements that are 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. The FDA did not deem letters to the editor, publication abstracts, and results of phase I trials in healthy volunteers to be kosher.

Maryland Eyes Concierge Care

Maryland's insurance commissioner is considering whether to regulate models of medical practices known as “retainer,” “boutique,” or “concierge” practices. Ralph Tyler held an informational hearing in December in an effort to determine whether the arrangements “cross the line to trigger obligations as an authorized insurer.” In concierge practices, the patient pays an annual fee in exchange for certain medical services beyond what a health insurer covers. But the agreement generally covers only preventive services. The insurance commission “wants to be sure it understands these arrangements and will review the need for additional oversight or regulation,” Mr. Tyler said in a statement.

R.I. Medicaid Overhaul Okayed

Rhode Island Gov. Donald Carcieri and the Centers for Medicare and Medicaid Services have reached agreement on a Medicaid reform package for the state that would emphasize home- and community-based long-term care settings over nursing home care. Primary care case management also would get a boost. The deal, which must be approved by Rhode Island lawmakers, would set a $12 billion, 5-year spending cap on the state's program. As in other states, Medicaid costs threaten to overwhelm other spending priorities in Rhode Island, whose 2009 budget counts on millions in savings from Medicaid changes. Under the new reform plan, assessment teams would determine medical risk levels for impoverished elderly people, and only those at most risk would be guaranteed placements in nursing homes or other high-cost facilities. Others would receive care from in-home services and in lower-cost assisted living facilities. The state would enroll all Medicaid beneficiaries without other third-party coverage into a managed care plan or a primary care case management practice. Also, the state intends to expand performance-based payment incentives for Medicaid providers.

Court: Enforce Calif. 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. Medi-Cal must report to the court in April about what it has done to comply with the ruling.

Markets Offer Free Antibiotics

So far this cold and flu season, five supermarket chains have said they will offer free generic antibiotics to customers. Pleasanton, Calif.-based Safeway, the Mid-Atlantic chain Giant Food, the New England-based Stop & Shop, the Florida chain Publix Super Markets, Rochester, N.Y.-based Wegmans Food Markets, and the Midwestern chain Meijer Stores all said they would supply the most commonly prescribed generic oral antibiotics to customers with valid prescriptions at no charge.

FDA Posts Guidance on Handouts

The Food and Drug Administration 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. Guidance doesn't carry the same heft as regulation, but most manufacturers heed the FDA's advice. On its Web site, the agency suggested 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 also should disclose conflicts. Acceptable articles can't be from special supplements that are 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. The FDA did not deem letters to the editor, publication abstracts, and results of phase I trials in healthy volunteers to be kosher.

Maryland Eyes Concierge Care

Maryland's insurance commissioner is considering whether to regulate models of medical practices known as “retainer,” “boutique,” or “concierge” practices. Ralph Tyler held an informational hearing in December in an effort to determine whether the arrangements “cross the line to trigger obligations as an authorized insurer.” In concierge practices, the patient pays an annual fee in exchange for certain medical services beyond what a health insurer covers. But the agreement generally covers only preventive services. The insurance commission “wants to be sure it understands these arrangements and will review the need for additional oversight or regulation,” Mr. Tyler said in a statement.

R.I. Medicaid Overhaul Okayed

Rhode Island Gov. Donald Carcieri and the Centers for Medicare and Medicaid Services have reached agreement on a Medicaid reform package for the state that would emphasize home- and community-based long-term care settings over nursing home care. Primary care case management also would get a boost. The deal, which must be approved by Rhode Island lawmakers, would set a $12 billion, 5-year spending cap on the state's program. As in other states, Medicaid costs threaten to overwhelm other spending priorities in Rhode Island, whose 2009 budget counts on millions in savings from Medicaid changes. Under the new reform plan, assessment teams would determine medical risk levels for impoverished elderly people, and only those at most risk would be guaranteed placements in nursing homes or other high-cost facilities. Others would receive care from in-home services and in lower-cost assisted living facilities. The state would enroll all Medicaid beneficiaries without other third-party coverage into a managed care plan or a primary care case management practice. Also, the state intends to expand performance-based payment incentives for Medicaid providers.

Court: Enforce Calif. 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. Medi-Cal must report to the court in April about what it has done to comply with the ruling.

Markets Offer Free Antibiotics

So far this cold and flu season, five supermarket chains have said they will offer free generic antibiotics to customers. Pleasanton, Calif.-based Safeway, the Mid-Atlantic chain Giant Food, the New England-based Stop & Shop, the Florida chain Publix Super Markets, Rochester, N.Y.-based Wegmans Food Markets, and the Midwestern chain Meijer Stores all said they would supply the most commonly prescribed generic oral antibiotics to customers with valid prescriptions at no charge.

FDA Posts Guidance on Handouts

The Food and Drug Administration 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. Guidance doesn't carry the same heft as regulation, but most manufacturers heed the FDA's advice. On its Web site, the agency suggested 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 also should disclose conflicts. Acceptable articles can't be from special supplements that are 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. The FDA did not deem letters to the editor, publication abstracts, and results of phase I trials in healthy volunteers to be kosher.

Maryland Eyes Concierge Care

Maryland's insurance commissioner is considering whether to regulate models of medical practices known as “retainer,” “boutique,” or “concierge” practices. Ralph Tyler held an informational hearing in December in an effort to determine whether the arrangements “cross the line to trigger obligations as an authorized insurer.” In concierge practices, the patient pays an annual fee in exchange for certain medical services beyond what a health insurer covers. But the agreement generally covers only preventive services. The insurance commission “wants to be sure it understands these arrangements and will review the need for additional oversight or regulation,” Mr. Tyler said in a statement.

R.I. Medicaid Overhaul Okayed

Rhode Island Gov. Donald Carcieri and the Centers for Medicare and Medicaid Services have reached agreement on a Medicaid reform package for the state that would emphasize home- and community-based long-term care settings over nursing home care. Primary care case management also would get a boost. The deal, which must be approved by Rhode Island lawmakers, would set a $12 billion, 5-year spending cap on the state's program. As in other states, Medicaid costs threaten to overwhelm other spending priorities in Rhode Island, whose 2009 budget counts on millions in savings from Medicaid changes. Under the new reform plan, assessment teams would determine medical risk levels for impoverished elderly people, and only those at most risk would be guaranteed placements in nursing homes or other high-cost facilities. Others would receive care from in-home services and in lower-cost assisted living facilities. The state would enroll all Medicaid beneficiaries without other third-party coverage into a managed care plan or a primary care case management practice. Also, the state intends to expand performance-based payment incentives for Medicaid providers.

Court: Enforce Calif. 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. Medi-Cal must report to the court in April about what it has done to comply with the ruling.

Markets Offer Free Antibiotics

So far this cold and flu season, five supermarket chains have said they will offer free generic antibiotics to customers. Pleasanton, Calif.-based Safeway, the Mid-Atlantic chain Giant Food, the New England-based Stop & Shop, the Florida chain Publix Super Markets, Rochester, N.Y.-based Wegmans Food Markets, and the Midwestern chain Meijer Stores all said they would supply the most commonly prescribed generic oral antibiotics to customers with valid prescriptions at no charge.

CMS Launches Enrollment Site

A new, Internet-based system will allow physicians and nonphysician practitioners to apply for Medicare enrollment, check on their applications, make changes, and view their information on file. The Provider Enrollment, Chain and Ownership System is now available to physicians in 15 states and the District of Columbia, and the Centers for Medicare and Medicaid Services said it would expand availability to all states over the next 2 months. The online PECOS can process a provider's enrollment application up to 50% faster than can be done with paper, CMS said. Providers also are required to report certain changes in their enrollment information, such as practice location, and PECOS will allow them to make these changes much faster, CMS said.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. The agency has increased the annual number of novel therapies approved in recent years but is still failing to meet statutory deadlines for reviewing and approving products. FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. Many of the delays were attributable to resource constraints, the agency explained. There have been 800 new people hired by FDA to review drug and biologic applications, which should help reduce delays by the second half of 2009, according to analyst Ira Loss at the firm Washington Analysis. But delays may persist for new diabetes therapies and opioids, he said, noting that the potential for cardiac toxicity and abuse hangs over those products.

Coverage Gaps in Hospitalizations

Interruptions in Medicaid coverage are associated with a higher rate of hospitalizations for conditions that often can be treated in an ambulatory care setting, according to a study in the Annals of Internal Medicine. Researchers in California found that adults' increased risk for hospitalization for conditions including asthma, diabetes, and hypertension is highest in the first 3 months after an interruption in Medicaid coverage. The authors suggested that when states require enrollees to demonstrate eligibility frequently, the Medicaid programs see increases in hospitalizations for the common health conditions. “Although states may attempt to save money in the short term by dropping Medicaid coverage for those who cannot keep up with frequent reporting requirements, this study shows that disruptions in coverage come at the risk of increased hospitalization for conditions that can typically be treated in a less expensive primary care setting,” said lead author Dr. Andrew Bindman, professor of medicine at the University of California, San Francisco.

E-Rx Systems Boost Savings

Electronic prescribing systems that allow doctors to select lower cost or generic medications can save $845,000 per 100,000 patients per year and possibly more, according to a study funded by the Agency for Healthcare Research and Quality. The researchers examined the change in prescriptions written in community practices before and after two Massachusetts insurers launched e-prescribing systems. Although they found that the doctors prescribed electronically only 20% of the time—generally relying on traditional prescription pads—those who used e-prescribing with formulary support increased generic prescriptions by 3.3%. “Our results likely represent a conservative estimate of the potential savings,” said lead study author Dr. Michael Fischer of Brigham and Women's Hospital in Boston. “As doctors e-prescribe more frequently, the amount saved could increase dramatically.” Physicians who wrote electronic prescriptions were slightly younger and more likely to be female than those who did not.

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. “Although this revision is the first step toward protecting American consumers, there is much more that can be done,” he said.

Medical Home Issues Identified

Key issues that face medical home initiatives include how to qualify physician practices as medical homes, how to match patients to such practices, how to get physicians and other providers to coordinate their care of patients in medical homes, and how to pay practices that serve patients in this way, according to a study from the Center for Studying Health System Change, a think tank, and Mathematica Policy Research Inc., a research firm. These issues “have potential to make or break a successful program,” the report's authors said.

CMS Launches Enrollment Site

A new, Internet-based system will allow physicians and nonphysician practitioners to apply for Medicare enrollment, check on their applications, make changes, and view their information on file. The Provider Enrollment, Chain and Ownership System is now available to physicians in 15 states and the District of Columbia, and the Centers for Medicare and Medicaid Services said it would expand availability to all states over the next 2 months. The online PECOS can process a provider's enrollment application up to 50% faster than can be done with paper, CMS said. Providers also are required to report certain changes in their enrollment information, such as practice location, and PECOS will allow them to make these changes much faster, CMS said.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. The agency has increased the annual number of novel therapies approved in recent years but is still failing to meet statutory deadlines for reviewing and approving products. FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. Many of the delays were attributable to resource constraints, the agency explained. There have been 800 new people hired by FDA to review drug and biologic applications, which should help reduce delays by the second half of 2009, according to analyst Ira Loss at the firm Washington Analysis. But delays may persist for new diabetes therapies and opioids, he said, noting that the potential for cardiac toxicity and abuse hangs over those products.

Coverage Gaps in Hospitalizations

Interruptions in Medicaid coverage are associated with a higher rate of hospitalizations for conditions that often can be treated in an ambulatory care setting, according to a study in the Annals of Internal Medicine. Researchers in California found that adults' increased risk for hospitalization for conditions including asthma, diabetes, and hypertension is highest in the first 3 months after an interruption in Medicaid coverage. The authors suggested that when states require enrollees to demonstrate eligibility frequently, the Medicaid programs see increases in hospitalizations for the common health conditions. “Although states may attempt to save money in the short term by dropping Medicaid coverage for those who cannot keep up with frequent reporting requirements, this study shows that disruptions in coverage come at the risk of increased hospitalization for conditions that can typically be treated in a less expensive primary care setting,” said lead author Dr. Andrew Bindman, professor of medicine at the University of California, San Francisco.

E-Rx Systems Boost Savings

Electronic prescribing systems that allow doctors to select lower cost or generic medications can save $845,000 per 100,000 patients per year and possibly more, according to a study funded by the Agency for Healthcare Research and Quality. The researchers examined the change in prescriptions written in community practices before and after two Massachusetts insurers launched e-prescribing systems. Although they found that the doctors prescribed electronically only 20% of the time—generally relying on traditional prescription pads—those who used e-prescribing with formulary support increased generic prescriptions by 3.3%. “Our results likely represent a conservative estimate of the potential savings,” said lead study author Dr. Michael Fischer of Brigham and Women's Hospital in Boston. “As doctors e-prescribe more frequently, the amount saved could increase dramatically.” Physicians who wrote electronic prescriptions were slightly younger and more likely to be female than those who did not.

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. “Although this revision is the first step toward protecting American consumers, there is much more that can be done,” he said.

Medical Home Issues Identified

Key issues that face medical home initiatives include how to qualify physician practices as medical homes, how to match patients to such practices, how to get physicians and other providers to coordinate their care of patients in medical homes, and how to pay practices that serve patients in this way, according to a study from the Center for Studying Health System Change, a think tank, and Mathematica Policy Research Inc., a research firm. These issues “have potential to make or break a successful program,” the report's authors said.

CMS Launches Enrollment Site

A new, Internet-based system will allow physicians and nonphysician practitioners to apply for Medicare enrollment, check on their applications, make changes, and view their information on file. The Provider Enrollment, Chain and Ownership System is now available to physicians in 15 states and the District of Columbia, and the Centers for Medicare and Medicaid Services said it would expand availability to all states over the next 2 months. The online PECOS can process a provider's enrollment application up to 50% faster than can be done with paper, CMS said. Providers also are required to report certain changes in their enrollment information, such as practice location, and PECOS will allow them to make these changes much faster, CMS said.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. The agency has increased the annual number of novel therapies approved in recent years but is still failing to meet statutory deadlines for reviewing and approving products. FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. Many of the delays were attributable to resource constraints, the agency explained. There have been 800 new people hired by FDA to review drug and biologic applications, which should help reduce delays by the second half of 2009, according to analyst Ira Loss at the firm Washington Analysis. But delays may persist for new diabetes therapies and opioids, he said, noting that the potential for cardiac toxicity and abuse hangs over those products.

Coverage Gaps in Hospitalizations

Interruptions in Medicaid coverage are associated with a higher rate of hospitalizations for conditions that often can be treated in an ambulatory care setting, according to a study in the Annals of Internal Medicine. Researchers in California found that adults' increased risk for hospitalization for conditions including asthma, diabetes, and hypertension is highest in the first 3 months after an interruption in Medicaid coverage. The authors suggested that when states require enrollees to demonstrate eligibility frequently, the Medicaid programs see increases in hospitalizations for the common health conditions. “Although states may attempt to save money in the short term by dropping Medicaid coverage for those who cannot keep up with frequent reporting requirements, this study shows that disruptions in coverage come at the risk of increased hospitalization for conditions that can typically be treated in a less expensive primary care setting,” said lead author Dr. Andrew Bindman, professor of medicine at the University of California, San Francisco.

E-Rx Systems Boost Savings

Electronic prescribing systems that allow doctors to select lower cost or generic medications can save $845,000 per 100,000 patients per year and possibly more, according to a study funded by the Agency for Healthcare Research and Quality. The researchers examined the change in prescriptions written in community practices before and after two Massachusetts insurers launched e-prescribing systems. Although they found that the doctors prescribed electronically only 20% of the time—generally relying on traditional prescription pads—those who used e-prescribing with formulary support increased generic prescriptions by 3.3%. “Our results likely represent a conservative estimate of the potential savings,” said lead study author Dr. Michael Fischer of Brigham and Women's Hospital in Boston. “As doctors e-prescribe more frequently, the amount saved could increase dramatically.” Physicians who wrote electronic prescriptions were slightly younger and more likely to be female than those who did not.

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. “Although this revision is the first step toward protecting American consumers, there is much more that can be done,” he said.

Medical Home Issues Identified

Key issues that face medical home initiatives include how to qualify physician practices as medical homes, how to match patients to such practices, how to get physicians and other providers to coordinate their care of patients in medical homes, and how to pay practices that serve patients in this way, according to a study from the Center for Studying Health System Change, a think tank, and Mathematica Policy Research Inc., a research firm. These issues “have potential to make or break a successful program,” the report's authors said.

Policy & Practice

CMS Launches Enrollment Site

A new, Internet-based system will let physicians and nonphysician practitioners apply for Medicare enrollment, check on applications, make changes, and view information on file. The Provider Enrollment, Chain and Ownership System is now available in 15 states and the District of Columbia, and the Centers for Medicare and Medicaid Services said it would expand availability to all states in early 2009. PECOS, available at

https://pecos.cms.hhs.gov

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. Although the agency has increased the annual number of novel therapies approved in recent years, it is still not meeting statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. Many of the delays were attributable to resource constraints, the agency said. The FDA has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009, according to analyst Ira Loss at the firm Washington Analysis. However, delays may persist for new diabetes therapies and opioids, Mr. Loss said, noting that the potential for cardiac toxicity and abuse hangs over those products.

Hospitalizations Hit Coverage Gaps

Interruptions in Medicaid coverage are associated with a higher rate of hospitalizations for conditions that often can be treated in ambulatory care settings, according to a study in the Annals of Internal Medicine. Researchers in California found that adults' increased risk for hospitalization for conditions including asthma, diabetes, and hypertension is highest in the first 3 months after an interruption in Medicaid coverage. The authors suggested that when states require enrollees to demonstrate eligibility frequently, the Medicaid programs see increases in hospitalizations for the common health conditions. “Although states may attempt to save money in the short term by dropping Medicaid coverage for those who cannot keep up with frequent reporting requirements, this study shows that disruptions in coverage come at the risk of increased hospitalization for conditions that can typically be treated in a less expensive primary care setting,” said lead author Dr. Andrew Bindman, professor of medicine at the University of California, San Francisco.

E-Rx Systems Boost Savings

Electronic prescribing systems that let doctors select lower-cost or generic medications can save $845,000 per 100,000 patients per year and possibly more, according to a study funded by the Agency for Healthcare Research and Quality. The researchers examined the change in prescriptions written in community practices before and after two Massachusetts insurers launched e-prescribing systems. The doctors prescribed electronically only 20% of the time—generally relying on traditional prescription pads—but those who did use e-prescribing with formulary support increased generic prescriptions by 3.3%. “Our results likely represent a conservative estimate of the potential savings,” said lead study author Dr. Michael Fischer of Brigham and Women's Hospital in Boston. “As doctors e-prescribe more frequently, the amount saved could increase dramatically.” The physicians who wrote electronic prescriptions were slightly younger and more likely to be female than those who did not, the study indicated.

PhRMA Revises Ad Guidelines

The Pharmaceutical Research and Manufacturers of America has 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. The new, nonbinding guidelines also support the inclusion of “black box” warnings in the ads, and underscore 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. “Although this revision is the first step toward protecting American consumers, there is much more that can be done,” Rep. Dingell said.

Medical Home Issues Identified

Key issues that face medical home initiatives include how to qualify physician practices as medical homes, how to match patients to such practices, how to get physicians and other providers to coordinate their care of patients in medical homes, and how to pay practices that serve patients in this way, according to a study by the Center for Studying Health System Change, a think tank, and Mathematica Policy Research Inc., a research firm. These issues “have potential to make or break a successful program,” the report's authors said.

Policy & Practice

CMS Launches Enrollment Site

A new, Internet-based system will let physicians and nonphysician practitioners apply for Medicare enrollment, check on applications, make changes, and view information on file. The Provider Enrollment, Chain and Ownership System is now available in 15 states and the District of Columbia, and the Centers for Medicare and Medicaid Services said it would expand availability to all states in early 2009. PECOS, available at

https://pecos.cms.hhs.gov

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. Although the agency has increased the annual number of novel therapies approved in recent years, it is still not meeting statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. Many of the delays were attributable to resource constraints, the agency said. The FDA has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009, according to analyst Ira Loss at the firm Washington Analysis. However, delays may persist for new diabetes therapies and opioids, Mr. Loss said, noting that the potential for cardiac toxicity and abuse hangs over those products.

Hospitalizations Hit Coverage Gaps

Interruptions in Medicaid coverage are associated with a higher rate of hospitalizations for conditions that often can be treated in ambulatory care settings, according to a study in the Annals of Internal Medicine. Researchers in California found that adults' increased risk for hospitalization for conditions including asthma, diabetes, and hypertension is highest in the first 3 months after an interruption in Medicaid coverage. The authors suggested that when states require enrollees to demonstrate eligibility frequently, the Medicaid programs see increases in hospitalizations for the common health conditions. “Although states may attempt to save money in the short term by dropping Medicaid coverage for those who cannot keep up with frequent reporting requirements, this study shows that disruptions in coverage come at the risk of increased hospitalization for conditions that can typically be treated in a less expensive primary care setting,” said lead author Dr. Andrew Bindman, professor of medicine at the University of California, San Francisco.

E-Rx Systems Boost Savings

Electronic prescribing systems that let doctors select lower-cost or generic medications can save $845,000 per 100,000 patients per year and possibly more, according to a study funded by the Agency for Healthcare Research and Quality. The researchers examined the change in prescriptions written in community practices before and after two Massachusetts insurers launched e-prescribing systems. The doctors prescribed electronically only 20% of the time—generally relying on traditional prescription pads—but those who did use e-prescribing with formulary support increased generic prescriptions by 3.3%. “Our results likely represent a conservative estimate of the potential savings,” said lead study author Dr. Michael Fischer of Brigham and Women's Hospital in Boston. “As doctors e-prescribe more frequently, the amount saved could increase dramatically.” The physicians who wrote electronic prescriptions were slightly younger and more likely to be female than those who did not, the study indicated.

PhRMA Revises Ad Guidelines

The Pharmaceutical Research and Manufacturers of America has 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. The new, nonbinding guidelines also support the inclusion of “black box” warnings in the ads, and underscore 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. “Although this revision is the first step toward protecting American consumers, there is much more that can be done,” Rep. Dingell said.

Medical Home Issues Identified

Key issues that face medical home initiatives include how to qualify physician practices as medical homes, how to match patients to such practices, how to get physicians and other providers to coordinate their care of patients in medical homes, and how to pay practices that serve patients in this way, according to a study by the Center for Studying Health System Change, a think tank, and Mathematica Policy Research Inc., a research firm. These issues “have potential to make or break a successful program,” the report's authors said.

Policy & Practice

CMS Launches Enrollment Site

A new, Internet-based system will let physicians and nonphysician practitioners apply for Medicare enrollment, check on applications, make changes, and view information on file. The Provider Enrollment, Chain and Ownership System is now available in 15 states and the District of Columbia, and the Centers for Medicare and Medicaid Services said it would expand availability to all states in early 2009. PECOS, available at

https://pecos.cms.hhs.gov

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. Although the agency has increased the annual number of novel therapies approved in recent years, it is still not meeting statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. Many of the delays were attributable to resource constraints, the agency said. The FDA has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009, according to analyst Ira Loss at the firm Washington Analysis. However, delays may persist for new diabetes therapies and opioids, Mr. Loss said, noting that the potential for cardiac toxicity and abuse hangs over those products.

Hospitalizations Hit Coverage Gaps

Interruptions in Medicaid coverage are associated with a higher rate of hospitalizations for conditions that often can be treated in ambulatory care settings, according to a study in the Annals of Internal Medicine. Researchers in California found that adults' increased risk for hospitalization for conditions including asthma, diabetes, and hypertension is highest in the first 3 months after an interruption in Medicaid coverage. The authors suggested that when states require enrollees to demonstrate eligibility frequently, the Medicaid programs see increases in hospitalizations for the common health conditions. “Although states may attempt to save money in the short term by dropping Medicaid coverage for those who cannot keep up with frequent reporting requirements, this study shows that disruptions in coverage come at the risk of increased hospitalization for conditions that can typically be treated in a less expensive primary care setting,” said lead author Dr. Andrew Bindman, professor of medicine at the University of California, San Francisco.

E-Rx Systems Boost Savings

Electronic prescribing systems that let doctors select lower-cost or generic medications can save $845,000 per 100,000 patients per year and possibly more, according to a study funded by the Agency for Healthcare Research and Quality. The researchers examined the change in prescriptions written in community practices before and after two Massachusetts insurers launched e-prescribing systems. The doctors prescribed electronically only 20% of the time—generally relying on traditional prescription pads—but those who did use e-prescribing with formulary support increased generic prescriptions by 3.3%. “Our results likely represent a conservative estimate of the potential savings,” said lead study author Dr. Michael Fischer of Brigham and Women's Hospital in Boston. “As doctors e-prescribe more frequently, the amount saved could increase dramatically.” The physicians who wrote electronic prescriptions were slightly younger and more likely to be female than those who did not, the study indicated.

PhRMA Revises Ad Guidelines

The Pharmaceutical Research and Manufacturers of America has 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. The new, nonbinding guidelines also support the inclusion of “black box” warnings in the ads, and underscore 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. “Although this revision is the first step toward protecting American consumers, there is much more that can be done,” Rep. Dingell said.

Medical Home Issues Identified

Key issues that face medical home initiatives include how to qualify physician practices as medical homes, how to match patients to such practices, how to get physicians and other providers to coordinate their care of patients in medical homes, and how to pay practices that serve patients in this way, according to a study by the Center for Studying Health System Change, a think tank, and Mathematica Policy Research Inc., a research firm. These issues “have potential to make or break a successful program,” the report's authors said.

FTC Alleges Price Gouging

The Federal Trade Commission has alleged that a pharmaceutical company acted illegally in buying the only two medicines approved to treat a deadly congenital heart defect in premature babies and then raising the prices for the drugs by nearly 1,300%. Ovation Pharmaceuticals Inc. bought the drug NeoProfen (ibuprofen lysine) in early 2006, when it already held the rights to Indocin IV (indomethacin). Both drugs are used to treat patent ductus arteriosus in lieu of surgical repair. After acquiring NeoProfen, Ovation raised the price of Indocin from $36 to nearly $500 a vial, and set a similar price when it launched NeoProfen in July 2006, according to the FTC, which has filed a civil lawsuit to force Ovation to divest itself of one of the drugs and forfeit some of the profits. Ovation said in a statement that NeoProfen and Indocin are not interchangeable and that it would fight the allegations.

CDC Increasing Hib Surveillance

The Centers for Disease Control and Prevention said it will solicit Haemophilus influenzae type b (Hib) serotype information and vaccination histories for children younger than 5 years old from state health departments that report Hib infections during the next several months. The increased surveillance is important because of the extended vaccine shortage of Merck & Co.'s Hib conjugate vaccines, according to the agency. Merck said last year that the shortage of PedvaxHIB and Comvax will continue until mid-2009. Hib surveillance has been hampered in the United States by incomplete serotype reporting: Serotype data are missing for nearly 40% of H. influenzae cases in young children reported to the CDC.

Reform Urged in Adolescent Health

Current health services for adolescents are fragmented and poorly designed to meet the needs of the nation's adolescents, according to a report from the National Research Council and the Institute of Medicine. Although most U.S. adolescents are healthy, many engage in risky behavior, develop unhealthy habits, and have physical and mental conditions that can jeopardize their immediate and future health, the report said. The U.S. health care system should foster better coordination between primary and specialty care and should include opportunities for adolescents to receive primary care services in “safety-net settings” such as schools, hospitals, and community health centers, the report said. “The distinct problems faced by adolescents—such as risky behavior—deserve particular attention,” said Dr. Robert Lawrence, the Johns Hopkins School of Public Health professor who chaired the committee that wrote the report.

Secondhand Smoke Exposure High

Smoking may be declining (see story, p. 1), but 42% of all children in the United States still are exposed to secondhand smoke each week, according to a survey from the American Legacy Foundation, the American Academy of Pediatrics Julius B. Richmond Center of Excellence, and researchers from Mississippi State University, Starkville. The survey found that 25% of American households permit smoking at home and in cars, and more than one-quarter of smokers reported that their children had been exposed to secondhand smoke in their home. “Children especially deserve smoke-free environments, and all public places where children eat and play should be protected from secondhand smoke,” Dr. Jonathan Klein, director of the AAP center, said in a statement. “Adults have the power to make healthier decisions for their children.”

Children Use Alternative Medicine

Nearly 12% of children in the United States used some type of complementary or alternative medicine (CAM) therapy in 2007, and the most common reason for that use was back or neck pain, according to survey data from the CDC and the National Institutes of Health. Children also used CAM for head and chest colds, anxiety and stress, insomnia, attention-deficit/hyperactivity disorder, and musculoskeletal complaints, the survey found. The data came from the 2007 National Health Interview Survey and included information on the use of CAM from 9,400 children and more than 23,000 adults. Children were five times as likely to turn to an alternative medical therapy if a parent or another relative also used one. For both adults and children, natural products, including herbal medicines and dietary supplements, were the most commonly used CAM therapies, the survey found.

FTC Alleges Price Gouging

The Federal Trade Commission has alleged that a pharmaceutical company acted illegally in buying the only two medicines approved to treat a deadly congenital heart defect in premature babies and then raising the prices for the drugs by nearly 1,300%. Ovation Pharmaceuticals Inc. bought the drug NeoProfen (ibuprofen lysine) in early 2006, when it already held the rights to Indocin IV (indomethacin). Both drugs are used to treat patent ductus arteriosus in lieu of surgical repair. After acquiring NeoProfen, Ovation raised the price of Indocin from $36 to nearly $500 a vial, and set a similar price when it launched NeoProfen in July 2006, according to the FTC, which has filed a civil lawsuit to force Ovation to divest itself of one of the drugs and forfeit some of the profits. Ovation said in a statement that NeoProfen and Indocin are not interchangeable and that it would fight the allegations.

CDC Increasing Hib Surveillance

The Centers for Disease Control and Prevention said it will solicit Haemophilus influenzae type b (Hib) serotype information and vaccination histories for children younger than 5 years old from state health departments that report Hib infections during the next several months. The increased surveillance is important because of the extended vaccine shortage of Merck & Co.'s Hib conjugate vaccines, according to the agency. Merck said last year that the shortage of PedvaxHIB and Comvax will continue until mid-2009. Hib surveillance has been hampered in the United States by incomplete serotype reporting: Serotype data are missing for nearly 40% of H. influenzae cases in young children reported to the CDC.

Reform Urged in Adolescent Health

Current health services for adolescents are fragmented and poorly designed to meet the needs of the nation's adolescents, according to a report from the National Research Council and the Institute of Medicine. Although most U.S. adolescents are healthy, many engage in risky behavior, develop unhealthy habits, and have physical and mental conditions that can jeopardize their immediate and future health, the report said. The U.S. health care system should foster better coordination between primary and specialty care and should include opportunities for adolescents to receive primary care services in “safety-net settings” such as schools, hospitals, and community health centers, the report said. “The distinct problems faced by adolescents—such as risky behavior—deserve particular attention,” said Dr. Robert Lawrence, the Johns Hopkins School of Public Health professor who chaired the committee that wrote the report.

Secondhand Smoke Exposure High

Smoking may be declining (see story, p. 1), but 42% of all children in the United States still are exposed to secondhand smoke each week, according to a survey from the American Legacy Foundation, the American Academy of Pediatrics Julius B. Richmond Center of Excellence, and researchers from Mississippi State University, Starkville. The survey found that 25% of American households permit smoking at home and in cars, and more than one-quarter of smokers reported that their children had been exposed to secondhand smoke in their home. “Children especially deserve smoke-free environments, and all public places where children eat and play should be protected from secondhand smoke,” Dr. Jonathan Klein, director of the AAP center, said in a statement. “Adults have the power to make healthier decisions for their children.”

Children Use Alternative Medicine

Nearly 12% of children in the United States used some type of complementary or alternative medicine (CAM) therapy in 2007, and the most common reason for that use was back or neck pain, according to survey data from the CDC and the National Institutes of Health. Children also used CAM for head and chest colds, anxiety and stress, insomnia, attention-deficit/hyperactivity disorder, and musculoskeletal complaints, the survey found. The data came from the 2007 National Health Interview Survey and included information on the use of CAM from 9,400 children and more than 23,000 adults. Children were five times as likely to turn to an alternative medical therapy if a parent or another relative also used one. For both adults and children, natural products, including herbal medicines and dietary supplements, were the most commonly used CAM therapies, the survey found.

FTC Alleges Price Gouging

The Federal Trade Commission has alleged that a pharmaceutical company acted illegally in buying the only two medicines approved to treat a deadly congenital heart defect in premature babies and then raising the prices for the drugs by nearly 1,300%. Ovation Pharmaceuticals Inc. bought the drug NeoProfen (ibuprofen lysine) in early 2006, when it already held the rights to Indocin IV (indomethacin). Both drugs are used to treat patent ductus arteriosus in lieu of surgical repair. After acquiring NeoProfen, Ovation raised the price of Indocin from $36 to nearly $500 a vial, and set a similar price when it launched NeoProfen in July 2006, according to the FTC, which has filed a civil lawsuit to force Ovation to divest itself of one of the drugs and forfeit some of the profits. Ovation said in a statement that NeoProfen and Indocin are not interchangeable and that it would fight the allegations.

CDC Increasing Hib Surveillance

The Centers for Disease Control and Prevention said it will solicit Haemophilus influenzae type b (Hib) serotype information and vaccination histories for children younger than 5 years old from state health departments that report Hib infections during the next several months. The increased surveillance is important because of the extended vaccine shortage of Merck & Co.'s Hib conjugate vaccines, according to the agency. Merck said last year that the shortage of PedvaxHIB and Comvax will continue until mid-2009. Hib surveillance has been hampered in the United States by incomplete serotype reporting: Serotype data are missing for nearly 40% of H. influenzae cases in young children reported to the CDC.

Reform Urged in Adolescent Health

Current health services for adolescents are fragmented and poorly designed to meet the needs of the nation's adolescents, according to a report from the National Research Council and the Institute of Medicine. Although most U.S. adolescents are healthy, many engage in risky behavior, develop unhealthy habits, and have physical and mental conditions that can jeopardize their immediate and future health, the report said. The U.S. health care system should foster better coordination between primary and specialty care and should include opportunities for adolescents to receive primary care services in “safety-net settings” such as schools, hospitals, and community health centers, the report said. “The distinct problems faced by adolescents—such as risky behavior—deserve particular attention,” said Dr. Robert Lawrence, the Johns Hopkins School of Public Health professor who chaired the committee that wrote the report.

Secondhand Smoke Exposure High

Smoking may be declining (see story, p. 1), but 42% of all children in the United States still are exposed to secondhand smoke each week, according to a survey from the American Legacy Foundation, the American Academy of Pediatrics Julius B. Richmond Center of Excellence, and researchers from Mississippi State University, Starkville. The survey found that 25% of American households permit smoking at home and in cars, and more than one-quarter of smokers reported that their children had been exposed to secondhand smoke in their home. “Children especially deserve smoke-free environments, and all public places where children eat and play should be protected from secondhand smoke,” Dr. Jonathan Klein, director of the AAP center, said in a statement. “Adults have the power to make healthier decisions for their children.”

Children Use Alternative Medicine

Nearly 12% of children in the United States used some type of complementary or alternative medicine (CAM) therapy in 2007, and the most common reason for that use was back or neck pain, according to survey data from the CDC and the National Institutes of Health. Children also used CAM for head and chest colds, anxiety and stress, insomnia, attention-deficit/hyperactivity disorder, and musculoskeletal complaints, the survey found. The data came from the 2007 National Health Interview Survey and included information on the use of CAM from 9,400 children and more than 23,000 adults. Children were five times as likely to turn to an alternative medical therapy if a parent or another relative also used one. For both adults and children, natural products, including herbal medicines and dietary supplements, were the most commonly used CAM therapies, the survey found.