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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
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
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
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.